US20080039873A1 - Method and device for securing body tissue - Google Patents
Method and device for securing body tissue Download PDFInfo
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- US20080039873A1 US20080039873A1 US11/874,323 US87432307A US2008039873A1 US 20080039873 A1 US20080039873 A1 US 20080039873A1 US 87432307 A US87432307 A US 87432307A US 2008039873 A1 US2008039873 A1 US 2008039873A1
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- suture
- retainer
- suture retainer
- energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0485—Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/1206—Generators therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
- A61B2017/0454—Means for attaching and blocking the suture in the suture anchor the anchor being crimped or clamped on the suture
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
- A61B2017/0488—Instruments for applying suture clamps, clips or locks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
- A61B2017/0619—Sutures thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it
Abstract
A suture and a suture retainer are positioned relative to body tissue. Ultrasonic vibratory energy is utilized to heat the suture retainer and effect a bonding of portions of the suture retainer to each other and/or to the suture. Portions of the body tissue may be pressed into linear apposition with each other and held in place by cooperation between the suture and the suture retainer. The suture retainer may include one or more portions between which the suture extends. The suture retainer may include sections which have surface areas which are bonded together. If desired, the suture may be wrapped around one of the sections of the suture retainer. The suture retainer may be formed with a recess in which the suture is received. If desired, the suture retainer may be omitted and the sections of the suture bonded to each other.
Description
- This application is a continuation of U.S. patent application Ser. No. 10/797,685, filed Mar. 9, 2004, the contents of which are herein incorporated by reference.
- The present invention relates to methods and devices for securing body tissue by using ultrasonic vibratory energy and other forms of energy.
- Difficulty has been encountered in securing sutures against movement relative to body tissue. A knot may be tied in a suture to prevent loosening of the suture. However, the knot weakens a portion of the suture and reduces the overall force transmitting capability of the suture. It has been suggested that a suture could be secured using a suture retainer in the manner disclosed in U.S. Pat. Nos. 5,735,875 and 6,010,525.
- When a suture retainer is used to maintain a suture in a desired position relative to body tissue, the material of the suture retainer may be pressed against the suture. During pressing of the material of the retainer against the suture, the suture may be heated to promote a flowing of the material of the suture retainer and bonding to the material of the suture retainer to the surface of the suture by heating material of the suture retainer into its transition temperature range.
- When the material of the suture retainer is heated into its transition temperature range, the material changes from a solid condition in which it has a fixed form to a soft or viscous condition. When the material of a suture retainer has been heated into the transition temperature range, the material can be molded around an outer side surface of a suture and bonded to the suture without significant deformation of the suture. The transition temperature ranges for various polymers which are suitable for forming suture retainers are disclosed in the aforementioned U.S. Pat. No. 5,735,875.
- The present invention provides a new and improved method for use in securing body tissue. If desired, a suture retainer may be used to grip the suture. When a suture retainer is used, ultrasonic vibratory energy is transmitted to the material of the suture retainer to effect a heating of at least some of the material of the suture retainer. Portions of the suture retainer are then bonded to each other and/or to the suture.
- It may be desired to retain layers of body tissue in linear apposition with each other. When this is to be done, a suture is used to hold the layers of body tissue in linear apposition after they have been approximated to each other. The suture may be secured relative to the body tissue by a suture retainer or crimp. Alternatively, sections of the suture may be secured together. To secure the suture relative to the body tissue, ultrasonic vibratory energy is applied to either the suture or the suture retainer. The ultrasonic energy may be applied while the suture is being tensioned with a predetermined force and while a predetermined force is being transmitted to the body tissue.
- The suture retainer or crimp may have any one of many different constructions. One specific suture retainer constructed in accordance with one of the features of the present invention includes one or more passages through which one or more sections of the suture are inserted. In another embodiment of the invention, the suture retainer has sections which are formed separately from each other. The sections of the suture retainer are connected with the suture and/or each other by transmitting ultrasonic vibratory energy to at least one of the sections of the suture.
- If desired, the suture may be wrapped around a portion of the suture retainer. The suture retainer may be provided with one or more recesses into which one or more sections of the suture are moved. The transmission of ultrasonic vibratory energy to the suture retainer is utilized to effect a bonding of portions of the suture retainer with each other and/or with the suture.
- The suture retainer may be omitted and sections of the suture bonded to each other. When this is to be done, ultrasonic vibratory energy is transmitted to the sections of the suture. Force is applied against opposite sides of the sections of the suture to increase the extent of the sections of the suture in a direction transverse to the sections of the suture. As the transverse extent of the suture is increased, areas on outer side surfaces of the sections of the suture are increased.
- The foregoing and other features of the invention will become more apparent upon a consideration of the following description taken in connection with the accompanying drawings wherein:
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FIG. 1 is a schematic illustration depicting the manner in which layers of body tissue are moved into linear apposition with each other and secured with a suture and suture retainer; -
FIG. 2 is a schematic fragmentary sectional view illustrating the manner in which the suture and suture retainer ofFIG. 1 are positioned relative to each other; -
FIG. 3 is a fragmentary schematic illustration depicting the manner in which ultrasonic vibratory energy is applied to the suture retainer ofFIG. 2 ; -
FIG. 4 is a schematic fragmentary sectional view of another embodiment of the invention and illustrating the approximation of layers of tissue by tensioning a suture with a predetermined force and pressing a suture retainer against the body tissue with a predetermined force; -
FIG. 5 is a schematic fragmentary sectional view of another embodiment of the invention and illustrating the manner in a vibration applicator member engages a suture retainer which is being pressed against body tissue with a predetermined force while an associated suture is tensioned with a predetermined force; -
FIG. 6 is a schematic fragmentary pictorial illustration of another embodiment of the invention and depicting the construction of sections of a suture retainer and the relationship of the sections of the suture retainer to apparatus for applying ultrasonic vibratory energy to the suture retainer; -
FIG. 7 is a schematic pictorial illustration of an embodiment of the invention in which a suture retainer has a pair of passages for receiving sections of a suture; -
FIG. 8 is a schematic illustration depicting the manner in which ultrasonic vibratory energy is applied to the suture retainer ofFIG. 7 ; -
FIG. 9 is an exploded fragmentary schematic illustration of another embodiment of the invention and depicting the manner in which a suture is wrapped around a section of a suture retainer and the relationship of apparatus for applying ultrasonic vibratory energy to sections of the suture retainer; -
FIG. 10 is a schematic pictorial illustration of another embodiment of the invention and depicting the manner in which sections of a suture extend through passages in a section of a suture retainer; -
FIG. 11 is a schematic fragmentary sectional view depicting the relationship of the section of the suture retainer illustrated inFIG. 10 to other sections of the suture retainer and to an apparatus for applying ultrasonic vibratory energy to the suture retainer; -
FIG. 12 is a schematic illustration of another embodiment of the invention and depicting the relationship between sections of a suture and sections of a suture retainer; -
FIG. 13 is a top plan view, taken generally along the line 13-13 ofFIG. 12 , illustrating the relationship of the sections of the suture retainer and suture to an apparatus for applying ultrasonic vibratory energy to the suture retainer; -
FIG. 14 is a schematic illustration of another embodiment of the invention and depicting the manner in which sections of a suture are wrapped around a section of a suture retainer; -
FIG. 15 is a schematic sectional view, taken generally along the line 15-15 ofFIG. 14 , illustrating the relationship between sections of the suture retainer and an apparatus for applying ultrasonic vibratory energy to the suture retainer; -
FIG. 16 is a schematic plan view of another embodiment of the invention, illustrating the relationship of sections of a suture to recesses formed in a suture retainer which is disposed between portions of an apparatus for applying ultrasonic vibratory energy to the suture retainer; -
FIG. 17 is an enlarged fragmentary schematic illustration depicting the manner in which a section of the suture is moved into one of the recesses in the suture retainer ofFIG. 16 ; -
FIG. 18 is a schematic pictorial illustration depicting the manner in which another embodiment of the suture retainer is positioned relative to the suture; -
FIG. 19 is a plan view, taken generally along the line 19-19 ofFIG. 18 , illustrating the relationship between the suture retainer and the suture; -
FIG. 20 is a plan view, generally similar toFIG. 19 , illustrating the relationship of an apparatus for applying ultrasonic vibratory energy to the suture retainer and the suture retainer and suture ofFIG. 19 ; -
FIG. 21 is a schematic pictorial illustration of an embodiment of the suture retainer having a recess which receives a portion of a suture; -
FIG. 22 is a plan view of another embodiment of the invention and illustrating the manner in which a suture is positioned in a recess in the suture retainer and the relationship of apparatus for applying ultrasonic vibratory energy to the suture retainer; -
FIG. 23 is a schematic illustration of another embodiment of the invention and depicting the manner in which a suture and a suture retainer are utilized to hold layers of body tissue in apposition with each other; -
FIG. 24 is a schematic illustration of one apparatus for applying ultrasonic vibratory energy to a suture retainer; -
FIG. 25 is a schematic illustration of a second apparatus for applying ultrasonic vibratory energy to a suture retainer; -
FIG. 25A is a schematic illustration of an ultrasonic vibratory transmission device forFIGS. 24 and 25 ; -
FIG. 26 is a schematic illustration, similar toFIG. 1 , depicting the manner in which layers of body tissue are moved into linear apposition with each other and secured with a suture; -
FIG. 27 is a schematic fragmentary sectional view illustrating the manner in which sections of the suture ofFIG. 26 are positioned relative to each other and to apparatus which applies ultrasonic vibratory energy to the sections of the suture; -
FIG. 28 is a schematic illustration depicting the manner in which sections of the suture ofFIG. 27 are extended; -
FIG. 29 is a schematic illustration of another embodiment of the suture retainer ofFIGS. 1-4 ; -
FIGS. 30A-30B are schematic illustrations of another embodiment of the invention and depicting the relationship between sections of a suture and sections of a suture retainer; -
FIG. 31 is a schematic illustration of another embodiment of the invention and depicting the relationship between sections of a suture and sections of a suture retainer; -
FIG. 32 is a schematic illustration of another embodiment of the invention and depicting the relationship between sections of a suture and sections of a suture retainer; -
FIGS. 33A-33B are schematic illustrations of another embodiment of the invention and depicting the relationship between sections of a suture and sections of a suture retainer; -
FIGS. 34A-34B are schematic illustrations of another embodiment of the invention and depicting the relationship between sections of a suture and the suture retainer; -
FIGS. 35A-35B are schematic illustrations of another embodiment of the invention and depicting the relationship between sections of a suture and the suture retainer; -
FIGS. 36A-36C are schematic illustrations of exemplary shaped horn configurations for use with the suture retainer ofFIG. 35 ; -
FIGS. 37A-37B are schematic illustrations of another embodiment of the invention and depicting the relationship between sections of a suture and the suture retainer; -
FIG. 38A-38B are schematic illustrations of another embodiment of the invention and depicting the relationship between sections of a suture and the suture retainer; -
FIGS. 39A-39B are schematic illustrations of a tissue retainer of the present invention; -
FIG. 40 is a fragmentary schematic illustration depicting the manner in which a suture and an suture retainer are positioned relative to body tissue; -
FIG. 41 is an enlarged schematic illustration of the retainer ofFIG. 40 ; -
FIG. 42 is an exploded schematic pictorial illustration depicting the construction of a base section and cover section of the retainer ofFIGS. 40 and 41 ; -
FIG. 43 is an exploded schematic pictorial illustration, further illustrating the construction of the base and cover sections of the retainer; -
FIG. 44 is an exploded schematic pictorial illustration, further illustrating the construction of the base and cover sections of the retainer; -
FIG. 45 is an exploded schematic pictorial illustration further illustrating the construction of the base and cover sections of the retainer; -
FIG. 46 is a schematic sectional view depicting the relationship between the base and cover sections of the retainer ofFIGS. 40-45 with portions of the suture disposed in passages in the retainer; and -
FIG. 47 is a schematic fragmentary sectional view, generally similar toFIG. 46 , depicting the manner in which end portions of projections on the cover section of the retainer are bonded to bottom portions of recesses in the base section of the retainer; -
FIG. 48 is a schematized sectional view of an embodiment of the apparatus ofFIG. 25 for applying ultrasonic vibratory energy to a suture retainer; -
FIG. 49 is a schematic pictorial illustration of one embodiment of the applicator assembly ofFIG. 48 ; -
FIG. 50 is an enlarged fragmentary schematic pictorial illustration of a portion of the applicator assembly ofFIG. 49 , illustrating a trigger and spring housing; -
FIG. 51 is an enlarged fragmentary schematic illustration of an end portion of the applicator assembly ofFIG. 49 ; -
FIG. 52 is a schematic illustration of a sleeve member for the apparatus ofFIG. 48 ; -
FIG. 53 is a schematic illustration of the sleeve member on the apparatus ofFIG. 48 ; -
FIG. 54 is a sectional view of the distal portion of the apparatus ofFIG. 53 showing the sleeve member in a closed position; -
FIG. 55 is a sectional view of the distal portion of the apparatus ofFIG. 53 showing the sleeve member in an open position; -
FIG. 56 is a perspective view of an energy application device of the present invention; -
FIG. 57 is a perspective view of a handle assembly of the energy application device ofFIG. 56 ; -
FIG. 58 is a perspective view of an end portion of the handle assembly ofFIG. 57 ; -
FIG. 59 is a perspective view of a controller assembly of the energy application device ofFIG. 56 ; -
FIG. 60 is a sectional view of the end portion of the controller assembly ofFIG. 59 ; -
FIG. 61 is a sectional perspective view of the latch assembly of the energy application device ofFIG. 56 ; -
FIG. 62 is a sectional perspective view of the handle and controller assemblies of the energy application device ofFIG. 56 ; -
FIG. 63 is a sectional perspective view of the controller bias member of the energy application device ofFIG. 56 ; -
FIG. 64 is a sectional perspective view of the suture tensioners of the energy application device ofFIG. 56 ; -
FIG. 65 is a perspective view of a suture retainer for use with the energy application device ofFIG. 56 ; -
FIG. 66 is a perspective view of a upper section of the suture retainer ofFIG. 65 ; -
FIG. 67 is a perspective view of a lower section of the suture retainer ofFIG. 65 ; -
FIG. 68 is a front view of the lower section of the suture retainer ofFIG. 65 ; and -
FIG. 69 depicts the suture retainer ofFIG. 65 positioned within an end portion of the energy application device ofFIG. 56 . - Embodiment of
FIGS. 1-3 - A tissue securing system 30 (
FIG. 1 ) includes asuture 32 and a suture retainer or crimp 34. Thesuture 32 includes left andright sections connector section 42. Thesuture retainer 34 grips the left andright sections suture 32. - The
tissue securing system 30 is used in a sterile, operating room environment to secure upper andlower layers layers suture 32. Although the twolayers FIG. 1 as being spaced apart from each other, they are held in a side-by-side relationship with each other and pressed together by tightening thetissue securing system 30. Pressing the twolayers tissue securing system 30 promotes healing of the tissue. - Although the
tissue securing system 30 has been illustrated inFIG. 1 as being used to hold layers of soft tissue in linear apposition with each other, it is contemplated that the tissue securing system may be used in many different locations in a patient's body to secure tissue. For example, thetissue securing system 30 could be utilized to secure soft tissue, such as a ligament or tendon, against movement relative to a bone. Alternatively, thetissue securing system 30 could be utilized to interconnect portions of a flexible conduit, such as a blood vessel or intestine. It should be understood that thetissue securing system 30 may be used with either hard body tissue, or soft body tissue, or both hard and soft body tissue. - If desired, a force distribution member, such as a button, could be utilized between the
connector section 42 of thesuture 32 and thelower layer 48 of body tissue. The force distribution member would distribute force over a relative large area of thelower layer 48 of body tissue. Similarly, a force distribution member, such as a button, could be utilized between theupper layer 46 of soft tissue and the left andright sections suture 32 and thesuture retainer 34. - It is also contemplated that the
suture 32 could extend through a suture anchor and/or be connected with body tissue in a manner similar to that disclosed in U.S. Pat. Nos. 5,584,862; 5,549,631; and/or 5,527,343. Of course, thesuture 32 could be connected with body tissue in a different manner if desired. For example, theconnector section 42 could be eliminated. If this is done, theleft section 38 of thesuture 32 could be connected with one suture anchor and theright section 40 of the suture could be connected with a second suture anchor. - Although the
sections suture 32 could extend straight through thesuture retainer 34, in the illustrated embodiment of the invention, thesections suture 32 are wrapped around portions of thesuture retainer 34. Thus, theleft section 38 of thesuture 32 is wrapped around a portion 52 (FIG. 2 ) of thesuture retainer 34. Similarly, theright section 40 of the suture is wrapped around aportion 54 of thesuture retainer 34. - In the illustrated embodiment of the invention, the
left section 38 of thesuture 32 is wrapped for more than a complete turn around theportion 52 of the suture retainer and theright section 40 of the suture is wrapped for more than a complete turn around theportion 54 of the suture retainer. However, if desired, wrapping of thesections suture 32 around thesuture retainer 34 could be omitted or each of the sections of the suture could be wrapped for less than one complete turn around a portion of the suture retainer. - When the
sections suture 32 are wrapped around theportions suture retainer 34, a plurality of bends are formed in each of the sections of the suture. Thus, bends 58, 60, 62 and 64 are formed in thesection 38 of thesuture 32 as it is wrapped around theportion 52 of thesuture retainer 34. Similarly, bends 66, 68, 70 and 72 are formed in thesection 40 of thesuture 32 as it is wrapped around theportion 54 of thesuture retainer 34. Of course, a greater number of bends would be formed in each of thesections suture 32 if they were wrapped a greater number of times around thesuture retainer 34. - Although the
suture retainer 34 could have many different constructions and configurations, in the illustrated embodiment of the invention, thesuture retainer 34 is integrally formed as one piece and has a spherical configuration. A cylindricalcentral passage 76 extends axially through thesuture retainer 34 between upper and lower (as viewed inFIG. 2 ) polar regions of the spherical suture retainer. The twosections suture 32 extend through thepassage 76. Thesuture retainer 34 is formed separately from thesuture 32 and is initially disconnected from the suture. - In the illustrated embodiment of the invention, two lengths of the
left suture section 38 and two lengths of theright suture section 40 extend through thepassage 76 as a result of the wrapping of the sections of the suture around theportions suture retainer 34. However, the twosections suture 32 could extend straight through thepassage 76 without being wrapped around theportions suture retainer 34. If this was done, only a single length of theleft section 38 of thesuture 32 would be disposed in thepassage 76 adjacent to a single length of theright section 40 of thesuture 32. Of course, if thesections suture 32 were wrapped around theportions sections suture 32 would extend through thepassage 76. - In the illustrated embodiment of the
suture retainer 34, a pair of grooves or recesses 80 and 82 extend radially inward from a sphericalouter side surface 84 of thesuture retainer 34. The grooves or recesses 80 and 82 are relatively deep so that theportions sections suture retainer 34 adjacent to the upper and lower polar regions of the suture retainer. - In the embodiment of the invention illustrated in
FIG. 2 , the grooves or recesses 80 and 82 extend inward from theouter side surface 84 of thesuture retainer 34. The depth of the grooves or recesses 80 and 82 varies along the vertical (as viewed inFIG. 2 ) length of the grooves. However, it is contemplated that thegrooves grooves outer side surface 84 of thesuture retainer 34. - Rather than opening radially outward to the
outer side surface 84 of thesuture retainer 34, thegrooves suture 32 disposed in the grooves. It is contemplated that the grooves could have any one of the groove configurations disclosed in U.S. Pat. No. 6,010,525. The disclosure from the aforementioned U.S. Pat. No. 6,010,525 is incorporated herein in its entirety by this reference thereto. Alternatively, thegrooves suture retainer 34 parallel to and spaced apart from thecentral passage 76. - It is contemplated that the
suture retainer 34 may be formed of many different materials. However, it is contemplated that it will be preferred to form thesuture retainer 34 of a biodegradable polymer. One biodegradable polymer which may be utilized is polycaperlactone. Alternatively, thesuture retainer 34 could be formed of polyethylene oxide terephthalate or polybutylene terephthalate. Thesuture retainer 34 could be formed as a polyhydroxyalkanoate if desired. It is also contemplated that other biodegradable or other bioerodible copolymers could be utilized if desired. - Although it is preferred to form the
suture retainer 34 of a biodegradable material, the suture retainer could be formed of a material which is not biodegradable. For example, thesuture retainer 34 could be formed of an acetyl resin, such as “Delrin”™. Alternatively, thesuture retainer 34 could be formed of a para-dimethylamino-benzenediazo sodium sulfonate, such as “Dexon”™. If desired, thesuture retainer 34 could be formed of nylon. Additionally, thesuture retainer 34 may be made of a heat shrink material. - The
suture 32 may be formed of the same material as thesuture retainer 34 or of a different material. Thesuture 32 may be formed of natural or synthetic materials. Thesuture 32 may be a monofilament or may be formed of a plurality of interconnected filaments. Thesuture 32 may be biodegradable or non-biodegradable. It is contemplated that thesuture retainer 34 could be utilized in association with force transmitting elements other than a suture. It is believed that it may be preferred to form thesuture 32 of the same material as thesuture retainer 34. - In accordance with a feature of the present invention, ultrasonic vibratory energy is utilized to cause the
suture retainer 34 to grip thesuture 32. The ultrasonic vibratory energy is at a frequency above that which can normally be detected by the human ear, that is, above 16 to 20 kilohertz. Although there are a wide range of frequencies which may be utilized, it is believed that it will be desirable to use ultrasonic energy having a frequency of between 20 kilohertz and 70 kilohertz. However, higher frequency vibratory energy could be utilized if desired. - The ultrasonic vibratory energy may be continuously applied, pulsed or modulated in various fashions. Any one of many known transducers may be utilized to change electrical energy into mechanical vibrations having an ultrasonic frequency. The transducers may be piezoelectric, ferroelectric, or magnetostrictive. One commercial source of apparatus which may be utilized to provide ultrasonic vibratory energy is Dukane Corporation, Ultrasonics Division, 2900 Dukane Drive, St. Charles, Ill. Of course, there are other sources of apparatus which can be utilized to provide ultrasonic vibratory energy.
- The ultrasonic vibratory energy creates frictional heat at the areas where the
suture retainer 34 andsuture 32 are disposed in engagement with each other. The frictional heat provided by the ultrasonic vibratory energy is effective to heat the material of thesuture retainer 34 into its transition temperature range while the material of thesuture 32 remains at a temperature close to or below its transition temperature range. For example, thesuture 32 may be formed of a material having a transition temperature range which is above 190 degrees Celsius. Thesuture retainer 34 may have a transition temperature range which, for the most part, is at a temperature below 190 degrees Celsius. - However, it should be understood that at least a portion or even the entire transition temperature range for the
suture 32 could be co-extensive with the transition range for thesuture retainer 34. In fact, the transition temperature range of thesuture 32 could extend below the transition temperature range of thesuture retainer 34. However, it is believed that it may be preferred to have the transition temperature range for thesuture 32 above at least a portion of the transition temperature range of thesuture retainer 34. - Once the material of the
suture retainer 34 has been heated into its transition temperature range by the ultrasonic vibratory energy, the plastic material of thesuture retainer 34 loses its rigidity and becomes soft and viscous. The softened material of the suture retainer is moldable and flows, when subjected to pressure, around thesuture 32 without significant deformation of the suture. However, the temperature range into which thesuture 32 is heated and the pressure applied against the suture may result in some deformation of the suture. - Although it is contemplated that the
suture 32 andsuture retainer 34 could be made of many different materials, the suture and suture retainer may be formed of a plastic material which is a biopolymer. For example, thesuture 32 and/orsuture retainer 34 may be formed of polyglycolide which is commercial available under the trademark “Dexon”. Polyglycolide is a crystalline material that melts at about 225° Celsius. However, the suture could be formed of a glycolide-based copolymer which is commercially available under the trademark “Vicryl”. - The
suture retainer 34 is also made of a plastic material which may be a biopolymer. For example, thesuture retainer 34 may be made of polydellactide. The transition temperature of polydellactide will vary depending upon the specific characteristics of the material. However, asuture retainer 34 formed of polydellactide may have a transition temperature range of about 75° Celsius to about 120° Celsius. Other materials which may be utilized for forming thesuture 32 and/orsuture retainer 34 are disclosed in U.S. Pat. No. 5,735,875. The disclosure in the aforementioned U.S. Pat. No. 5,735,875 is hereby incorporated herein in its entirety by this reference thereto. - In order to promote a bonding of the material of the
suture retainer 34 to thesuture 32, both the suture and suture retainer may be formed of the same amorphous thermoplastic material. For example, both thesuture 32 andsuture retainer 34 may be formed of a polyhydroxy-alkanoate. Alternatively, both thesuture 32 andsuture retainer 34 may be formed of nylon. It is contemplated that thesuture 32 andsuture retainer 34 could be formed of different amorphous polymers which are similar, that is, have the same or similar chemical properties. - When the ultrasonic vibratory energy is to be applied to the
suture retainer 34, a supportive member or anvil 90 (FIG. 3 ) is positioned in engagement with one side of thesuture retainer 34. A horn oracoustic tool 92 is positioned in engagement with the opposite side of thesuture retainer 34. Force, indicated schematically byarrows FIG. 3 , is applied against thesuture retainer 34 by theanvil 90 andhorn 92. - The horn is vibrated, horizontally as viewed in
FIG. 3 , at a rate in excess of 20 kilohertz. Although thehorn 92 may be vibrated at any desired frequency within range of 20 kilohertz to 70 kilohertz, it is believed that it may be desirable to vibrate thehorn 92 at a rate which is close to or greater than 70 kilohertz. Thehorn 92 is vibrated for a dwell time which is sufficient to transmit enough ultrasonic vibratory energy to thesuture retainer 34 to heat at least a portion of the material of thesuture retainer 34 into its transition temperature range. - To effect a heating of the material of the
suture retainer 34, mechanical vibrations are transmitted from thehorn 92 through the material of theretainer 34 to a location adjacent to an interface between thesuture 32 and thesuture retainer 34. The frictional heat created by the ultrasonic vibratory energy transmitted to the suture retainer from thehorn 92 is sufficient to heat the material of thesuture retainer 34 at locations adjacent to thesuture 32, into the transition temperature range of the material of the suture retainer. As this occurs, thepassage 76 andgrooves FIG. 3 and the ultrasonic vibratory energy transmitted from thehorn 92. - The vibration of the
horn 92 is then interrupted and the material of thesuture retainer 34 begins to cool. The clamping force, indicated by thearrows suture retainer 34 by theanvil 90 andhorn 92 during the time which ultrasonic vibratory energy is transmitted from thehorn 92 to the material of thesuture retainer 34. After interruption of the transmission of ultrasonic vibratory energy, the clamping force, indicated schematically by thearrows anvil 90 andhorn 92, is maintained for a predetermined amount of time sufficient to allow the material of the suture retainer to cool and bond to both itself and thesuture 32. - If desired, the force, indicated schematically by the
arrows FIG. 3 , applied by theanvil 90 andhorn 92 to thesuture retainer 34 may be increased as the transmission of ultrasonic vibratory energy to thesuture retainer 34 from thehorn 92 is interrupted. The force, indicated schematically by thearrows FIG. 3 , is sufficient to cause thepassage 76 and recesses 80 and 82 to collapse as thesuture retainer 34 is heated by ultrasonic vibratory energy and subsequently allowed to cool. - The length of time for which ultrasonic vibratory energy is transmitted to the
suture retainer 34 may vary as a function of the amplitude and frequency of the ultrasonic vibratory energy transmitted to the suture retainer. It is contemplated that the frequency of the ultrasonic vibratory energy will be in a range of between 20 kilohertz and 70 kilohertz. It is contemplated that the amplitude of the ultrasonic vibrations may vary within a range of 0.0008 inches to 0.0050 inches depending upon the design of thesuture retainer 34 and the material forming the suture retainer. - It is also contemplated that the force, indicated schematically by the
arrows suture retainer 34 may vary depending upon the construction of thesuture retainer 34 and the material forming the suture retainer. For example, a force of approximately 1-20 pounds may be applied against thesuture retainer 34 by both theanvil 90 andhorn 92. The amount of force applied is a function of a number of factors, including, the material of the retainer and suture, the size of the retainer and suture, the frequency of the ultrasonic vibratory energy and the duration of application of the ultrasonic vibratory energy. - It is believed that the ultrasonic vibratory energy may be transmitted from the
horn 92 to thesuture retainer 34 for a period of time which varies between 0.25 seconds and 1.0 second. After the transmission of ultrasonic vibratory energy has been interrupted, the force, indicated by thearrows suture retainer 34 by theanvil 90 andhorn 92 for approximately 1.0 seconds. - The extent to which the
suture retainer 34 is compressed by theforce anvil 90 andhorn 92 has been illustrated schematically inFIG. 3 . It is contemplated that the distance through which theanvil 90 andhorn 92 move toward each other to compress thesuture retainer 34 may be from 0.010 inches to 0.050 inches. Of course, the distance through which thesuture retainer 34 is compressed by theanvil 90 andhorn 92 may be different for suture retainers having different constructions and/or formed of different materials. - It should be understood that the foregoing specific operating characteristics, for example, amplitude and frequency of the ultrasonic vibratory energy transmitted from the
horn 92 to thesuture retainer 34, force applied against the suture retainer by theanvil 90 andhorn 92, time for which force and/or ultrasonic vibratory energy is applied, and the distance through which the suture retainer is compressed, have been set forth herein for purposes of clarity of description. It is contemplated that the foregoing specific numerical values will be different for different embodiments of the invention and may vary extensively from the exemplary values set forth. - When the two
layers tissue securing system 30, thesuture 32 is positioned relative to the layers of body tissue. The left andright sections suture 32 extend through the twolayers sections suture 32 have been illustrated schematically inFIG. 1 as extending through passages in thelayers suture 32 sewn through the body tissue without forming passages in the body tissue. - In the embodiment of the invention illustrated in
FIG. 1 , thesections suture 32 are interconnected by theconnector section 42 which extends along one side of thelayer 48 of body tissue. If desired, thesections suture 32 could be connected with a single anchor embedded in either hard or soft body tissue. Alternatively, a separate anchor could be provided for each of thesections suture 32. These anchors could be embedded in the body tissue or disposed adjacent to one side of the body tissue. - When the
suture 32 has been positioned relative to the twolayers suture retainer 34 is then connected with thesuture 32. When thesuture retainer 34 is to be connected with thesuture 32, the left (as viewed inFIG. 2 )section 38 of the suture is inserted through thecentral passage 76 in thesuture retainer 34. Theleft section 38 of thesuture 32 is then wrapped around theportion 52 of thesuture retainer 34 and again inserted through thecentral passage 76. - Similarly, the
right section 40 of thesuture 32 is inserted through thecentral passage 76 and wrapped around theportion 54 of thesuture retainer 34. Theright section 40 of the suture is then inserted through thecentral passage 76 for a second time. This results in thesuture 32 being connected with thesuture retainer 34 in the manner illustrated schematically inFIG. 2 . - The
suture retainer 34 is then moved downward (as viewed inFIGS. 1 and 2 ) along thesuture 32 toward theupper layer 46 of body tissue. Thesuture 32 is tensioned with a predetermined force during downward movement of thesuture retainer 34 toward the body tissue. As thesuture retainer 34 moves downward (as viewed inFIGS. 1 and 2 ) along thesuture 32 toward theupper layer 46 of body tissue, the turns formed in the sections of the suture around theportions suture retainer 34 move downward toward the body tissue. Thus, the bends 58-64 in thesection 38 of thesuture 32 and the bends 66-72 in thesection 40 of thesuture 32 move along the suture toward theupper layer 46 of body tissue with thesuture retainer 34. - As the
suture retainer 34 is moved along thesuture 32 toward theupper layer 46 of body tissue, a predetermined tension, indicated byarrows 102 and 104 inFIG. 3 , is maintained in thesections suture 32. The magnitude of the tension forces 102 and 104 in thesections suture 32 is selected as a function of the characteristics of thelayers - As the
suture retainer 34 moves downward (as viewed inFIGS. 1-3 ), the leading portion of the suture retainer moves into engagement with theupper layer 46 of body tissue (FIG. 3 ). Thesuture retainer 34 is then pressed against theupper layer 46 of body tissue. If desired, a force distribution member, such as a button, could be provided between thesuture retainer 34 and thebody tissue 46. - The
suture retainer 34 is pressed downward against thebody tissue 46 with a predetermined force, indicated schematically by an arrow 106 inFIG. 3 , while a predetermined tension, indicated schematically by thearrows 102 and 104, is maintained in thesuture 32. The force transmitted from thesuture 32 andsuture retainer 34 to thelayers layers - The force, indicated by the
arrows 102 and 104, with which thesections suture 32 are tensioned, may vary depending upon the material from which the suture is constructed and the size of the suture. By consulting a chart, a surgeon can select a suture size and strength suitable for a particular use. Thus, a relatively large suture having substantial strength may be selected when body tissue is to be connected with a bone or when portions of a bone are to be interconnected by the suture. On the other hand, a relatively small suture size having a relatively small strength may be selected when delicate body tissue, such as stomach or intestinal tissue, is to be interconnected with the suture. The tension forces 102 and 104 in thesections strength 32 of the suture and the characteristics of the body tissue through which the suture extends - The
suture 34 is pressed against the body tissue with a force which is also a function of the size and strength of thesuture 32 and the characteristics of thebody tissue suture 32 is tensioned and with which thesuture 34 is pressed against body tissue is disclosed in U.S. Pat. No. 6,159,234 filed Jul. 7, 1999 by Peter M. Bonutti et al. and entitled “Method and Apparatus for Securing a Suture”. The disclosure in the aforementioned '234 patent is hereby incorporated herein by this reference thereto. - After the
suture retainer 34 has been pressed against the body tissue with a predetermined force and thesuture 32 tensioned with a predetermined force to compress thelayers suture retainer 34, the anvil 90 (FIG. 3 ) is positioned in engagement with one side of the suture retainer and thehorn 92 is positioned in engagement with the opposite side of the suture retainer. Theanvil 90 andhorn 92 are urged toward each other with a predetermined force, indicated schematically by thearrows FIG. 3 . - The specific magnitude of the
force suture retainer 34 and the construction of the suture retainer. In addition, the magnitude of theforce suture retainer 34. When thesuture retainer 34 has been heat softened by ultrasonic vibratory energy, the material of the suture retainer is pliable and is plastically deformed by the force applied against the suture retainer by theanvil 90 andhorn 92. - In addition to the
anvil 90 andhorn 92, the apparatus for transmitting ultrasonic vibratory energy to thesuture retainer 34 includes a generator (not shown) which changes standard electrical power into electrical energy at the desired ultrasonic frequency. A transducer (not shown) changes the electrical energy into low amplitude mechanical motion or vibration. These vibrations are transmitted to a booster which is used to increase or decrease the amplitude of the vibrations. The vibrations are then transmitted to thehorn 92. - The ultrasonic vibratory energy transmitted to the
suture retainer 34 from thehorn 92 is converted into heat energy. When this occurs, the temperature of the material forming thesuture retainer 34 increases. The heat tends to concentrate at a boundary between thesuture 32 and thesuture retainer 34. Thus, the heat tends to concentrate in the areas where thesuture 32 engages thegrooves FIG. 2 ). - As the temperature of the
suture retainer 34 increases, the material of the suture retainer is heated into the transition temperature range and softens. However, the material of thesuture retainer 34 does not melt and become liquid. As the material of thesuture retainer 34 softens, theforces 96 and 98 (FIG. 3 ) applied against the suture retainer cause the material of the suture retainer to flow or ooze around and engage thesuture 32. - As the ultrasonic vibratory energy is effective to heat soften the material of the
suture retainer 34, thegrooves grooves central passage 76 also closes. As thegrooves central passage 76 close, the softened material of thesuture retainer 34 moves into engagement with the suture (FIG. 3 ). - The viscous material of the
suture retainer 34 engages thesuture 32 and bonds to the suture without significant deformation of the suture. The materials of thesuture 32 andsuture retainer 34 should be chemically compatible so that a molecular bond can be established between the suture retainer and the suture. Like materials, that is materials having chemical properties which are the same or very similar will usually bond together. However, dissimilar materials may bond if their melt temperatures are reasonably close and they are of like molecular structure. Generally speaking, amorphous polymers are readily bonded to each other. - The
suture retainer 34 is formed separately from thesuture 32. As the material of thesuture retainer 34 bonds to thesuture 32, thesuture retainer 34 becomes fixedly connected to the suture. - If desired, heat may be transmitted directly to the
suture retainer 34 during the transmission of ultrasonic vibratory energy to the suture retainer. The heat may be transmitted from a heating element disposed in theanvil 90 and/or thehorn 92. Alternatively, a separate member could be utilized to transmit heat to thesuture retainer 34. - In the embodiment of the invention illustrated in
FIGS. 1-3 , theanvil 90 andhorn 92 have a configuration which corresponds to the arcuate configuration of the spherical outer side surface 84 (FIG. 2 ) of thesuture retainer 34. Theanvil 90 andhorn 92 are configured so as to engage the material of thesuture retainer 34 and to be spaced from thesuture 32. This is to prevent excessive heating of the material of thesuture 32 by the direct application of ultrasonic vibratory energy to the suture. - Embodiment of
FIG. 4 - In the embodiment of the invention illustrated in
FIGS. 1-3 ,sections suture 32 are wrapped aroundportions suture retainer 34. In the embodiment of the invention illustrated inFIG. 4 , a single section of the suture extends straight through a passage in the suture retainer. Since the embodiment of the invention illustrated inFIG. 4 is generally similar to the embodiment of the invention illustrated inFIGS. 1-3 , similar terminology will be utilized to designate similar components. It should be understood that one or more of the features of any of the various embodiments of the invention disclosed herein may be used with the embodiment of the invention illustrated inFIG. 4 . - In the embodiment of the invention illustrated in
FIG. 4 , asuture 112 is inserted through upper and lower (as viewed inFIG. 4 ) layers 114 and 116 of human body tissue in a sterile operating room environment. A first orinner end portion 118 of thesuture 112 is connected with asuture anchor 120. Thesuture anchor 120 could have any desired construction, including the construction disclosed in U.S. Pat. Nos. 5,584,862; 5,549,631; and/or 5,527,343. However, the illustrated embodiment of thesuture anchor 120 is a circular disc or button having a pair of central openings around which theend portion 118 of thesuture 112 is tied. - The
suture 112 extends straight through thelower layer 116 andupper layer 114 of body tissue. The two layers of body tissue are disposed in linear apposition with each other and are compressed between thesuture anchor 120 and asuture retainer 124. The upper andlower layers suture retainer 124 andsuture anchor 120. By having thelayers - Although the
layers suture 112,suture anchor 120, andsuture retainer 124 could be used with hard body tissue in the manner disclosed in U.S. Pat. No. 5,921,986. Alternatively, thesuture 112,suture anchor 120, andsuture retainer 124 could be used to connect soft body tissue with hard body tissue. - The
suture retainer 124 has a spherical configuration and is formed separately from thesuture 112. Acylindrical passage 126 extends axially through thesuture retainer 124. Although thesuture 112 extends straight through thepassage 126 in thesuture retainer 124, bends and/or loops could be formed in thesuture 112 around thesuture retainer 124. - The
suture retainer 124 is formed of one piece of spherical polymeric material having a relatively low coefficient of friction. Thesuture retainer 124 may be formed of many different materials. However, it is believed that it may be preferred to form thesuture retainer 124 of a biodegradable polymer such as polycaperlactone or polyhydroxyalkanoate. It is contemplated that other biodegradable or bioerodible polymers could be utilized if desired. It is believed that it may be preferred to form thesuture retainer 124 of an amorphous thermoplastic material. - The
suture 112 may be a monofilament or may be formed of a plurality of interconnected filaments. Thesuture 112 may be biodegradable or non-biodegradable. It is believed that it will be preferred to form thesuture 112 of the same material as thesuture retainer 124. However, thesuture 112 could be formed of a material which is different than the material of the suture retainer. Thesuture 112 may be formed of an amorphous thermoplastic having chemical properties which are the same or similar to the chemical properties of thesuture retainer 124. For example, both thesuture retainer 124 and thesuture 112 may be formed of the same biodegradable polymer, such as polycaperlactone or polyhydroxyalkanoate. - The
suture 112 is tensioned with a force which is a function of the size and strength of the suture. In addition, thesuture retainer 124 is pressed against theupper layer 114 of body tissue with a force which is a function of the size and strength of thesuture 112. Although thesuture retainer 124 is disposed in direct engagement with and is pressed against an outer side surface of theupper layer 114 of body tissue, a force distribution member or button could be positioned between the suture retainer and theupper layer 114 of body tissue. - The
suture 112 is tensioned by aforce application assembly 130 which is connected with a second orouter end portion 132 of thesuture 112. Theforce application assembly 130 includes a transducer orload cell 134 which provides an output signal indicative of a force, indicated schematically at 136 inFIG. 4 , which is applied to the second orouter end portion 132 of thesuture 112. Theforce 136 has a magnitude which is a function of the size and strength of thesuture 112 and the characteristics of the body tissue with which the suture is associated, that is, theupper layer 114 andlower layer 116 of body tissue. - The
suture retainer 124 is pressed against the body tissue with a force which is also a function of the strength and size of thesuture 112. Aforce application member 140 is used to apply force against thesuture retainer 124. Theforce application member 140 has acylindrical opening 142 which extends through the force application member. - The
suture 112 extends through theopening 142 in theforce application member 140. A slot may be formed in theforce application member 140 to enable the suture to be moved into theopening 142. Alternatively, thesuture 112 could be inserted through theopening 142 before the end portion of the suture is connected with theforce application assembly 130. - Forces, indicated schematically at 146 and 148 in
FIG. 4 , are applied againstopposite end portions force application member 140 to press thesuture retainer 124 against theupper layer 114 of body tissue or against a force transmitting member disposed between thesuture retainer 124 and theupper layer 114 of body tissue. The combined force indicated schematically by thearrows FIG. 4 , is a function of the size and strength of thesuture 112 and the characteristics of thelayers forces force 136. Alternatively, the summation of theforces force 136 or be less than theforce 136. - The
suture retainer 124 slides downward (as viewed inFIG. 4 ) along thesuture 112 under the influence of theforce application member 140. At this time, thesuture 112 is tensioned by theforce application assembly 130 so that the portion of the suture extending between thesuture anchor 120 and theforce application assembly 130 is straight, as illustrated inFIG. 4 . However, at this time, the force which is applied to theouter end portion 132 by the force transmitting assembly may be substantially less than the force which is indicated schematically by thearrow 136 inFIG. 4 . - After the
suture retainer 124 has been moved along thesuture 112 to the position illustrated inFIG. 4 , the force applied against the suture retainer by theforce application member 140 is increased. At the same time, the force applied to theouter end portion 132 of thesuture 112 by theforce application assembly 130 is increased. The force applied against the suture retainer by theforce application member 140 is increased until the force, indicated schematically by thearrows FIG. 4 , is equal to a predetermined force which is a function of the strength of thesuture 112 and the characteristics of thelayers outer end portion 132 of thesuture 112 by theforce application assembly 130 is increased to the force indicated schematically by thearrow 136 inFIG. 4 . As was previously mentioned, the force indicated by thearrow 136 is a predetermined function of the strength of thesuture 112 and the characteristics of thelayers - While the
suture 112 is being pulled straight under the influence of tension in the suture due to theforce 136 and while thesuture retainer 124 is being pressed against theupper layer 114 of body tissue or against a suitable force distribution member, thesuture retainer 124 is heated to grip thesuture 112. In accordance with one of the features of the invention, thesuture retainer 124 is heated by the application of ultrasonic vibratory energy to the suture retainer. The ultrasonic vibratory energy is converted into heat by the molecules of thesuture retainer 124. Thus, the mechanical ultrasonic vibrations applied against thesuture retainer 124 cause molecular vibration of the material of the suture retainer and a heating of the suture retainer. - When a portion of the material forming the
suture retainer 124 has been heated into its transition temperature range, the application of ultrasonic vibratory energy to thesuture retainer 124 is interrupted. Heating the material forming thesuture retainer 124 causes the material to lose its rigidity and soften. The material of thesuture retainer 124 is not melted and does not become liquid by being heated into its transition temperature range. The softened material of thesuture retainer 124 bonds to thesuture 112 without significant deformation of the suture. - To apply ultrasonic vibratory energy to the
suture retainer 124, a support member oranvil 160 engages one side, that is the left side as viewed inFIG. 4 , of thesuture retainer 124. At the same time, a horn or acoustic tool is pressed against the opposite or right side (as viewed inFIG. 4 ) of thesuture retainer 124. - The
anvil 160 and horn 162 are pressed against opposite sides of thesuture retainer 124 with predetermined forces, indicated schematically byarrows FIG. 4 . After thesuture retainer 124 has been firmly clamped between theanvil 160 andhorn 162, the horn is vibrated with an ultrasonic frequency, that is with a frequency which is greater than 20 kilohertz. It is contemplated that thehorn 162 may be vibrated at a selected frequency within a range of ultrasonic frequencies which extends between 20 kilohertz and 70 kilohertz. Although the particular ultrasonic frequency with which thehorn 162 is vibrated will vary depending upon the composition and construction of thesuture retainer 124, it is believed that it may be preferred to vibrate thehorn 162 with a frequency which is close to or greater than 70 kilohertz. - The mechanical vibrations applied to the
suture retainer 124 by thehorn 162 are effective to heat a portion of the material of thesuture retainer 124 into the transition temperature range. The heat tends to concentrate on the portion of thesuture retainer 124 adjacent to thepassage 126 and thesuture 112. When the material of thesuture retainer 124 adjacent to thesuture 112 has been heated into its transition temperature range, the application of ultrasonic vibratory energy to thesuture retainer 124 is interrupted. Theforces passage 126 and to press the softened material of thesuture retainer 124 against thesuture 112. - Although the application of ultrasonic vibratory energy to the
suture retainer 124 is interrupted, theanvil 160 and horn 162 continue to apply theforces forces suture retainer 124 by thehorn 162 is interrupted. Theforces suture retainer 124 into thepassage 126 to collapse the passage. The heat softened material of thesuture retainer 124 is plastically deformed and pressed against thesuture 112 by theforces anvil 160 andhorn 162. - The
forces suture retainer 124 flow about thesuture 112, securing thesuture 112, without significant deformation of the suture. Once this has been achieved, application of theforces anvil 160 and horn 162 are withdrawn. Theforce application member 140 may then be disengaged from the suture retainer and theforce application assembly 130 disconnected from theouter end portion 132 of thesuture 112. - When the
layers suture 112,suture anchor 120 andsuture retainer 124, theupper layer 114 is moved into apposition with thelower layer 116 of body tissue. Thesuture 112 is then connected with thesuture anchor 120 and is inserted through thelayers outer end portion 132 of thesuture 112 is then inserted through thepassage 126. - The
suture retainer 124 is then moved along thesuture 112 into engagement with theupper layer 114 of body tissue. Theforce application member 140 is utilized to transmit theforces suture retainer 124 to press the suture retainer against theupper layer 114 of body tissue. This results in the twolayers suture retainer 124 andsuture anchor 112. Theforces suture retainer 124 through theforce application member 140. Thesuture 112 is tensioned with aforce 136 by theforce application assembly 130. - The
anvil 160 and horn 162 then compress thesuture retainer 124 under the influence of theforces suture retainer 124, the transmission of ultrasonic energy to the suture retainer is interrupted and a securing of thesuture 112 by the suture retainer occurs. After thesuture retainer 124 has firmly gripped thesuture 112, the application of theforces - In the foregoing explanation of the manner in which the
layers suture 112,suture anchor 120 andsuture retainer 124, the suture retainer has been heated by only the application of ultrasonic vibratory energy to the suture retainer. However, it is contemplated that heat energy could be transmitted directly to the suture retainer along with the ultrasonic vibratory energy. If this was to be done, a heating element could be provided in theanvil 160 and/orhorn 162. If desired, a separate heating element could engage the suture retainer to transmit the heat to the suture retainer separately from theanvil 160 andhorn 162. - It is believed that it probably will be preferred to have the
anvil 160 and horn 162 engage thesuture retainer 124 at locations spaced from thesuture 112 to prevent excessive heating of the material of the suture. If desired, protective collars could be provided around thesuture 112 at opposite ends of thepassage 126. - Embodiment of
FIG. 5 - In the embodiment of the invention illustrated in
FIG. 4 , a single section of thesuture 112 extends through asingle passage 126 in thesuture retainer 124. In addition, in the embodiment of the invention illustrated inFIG. 4 , ultrasonic vibratory energy is applied to thesuture retainer 124 by thehorn 162 which also applies acompressive force 166 against the suture retainer. In the embodiment of the invention illustrated inFIG. 5 , a plurality of sections of the suture extend through a plurality of passages in the suture retainer. In addition, ultrasonic vibratory energy is applied to the suture retainer by a member which is separate from the members which apply force against opposite sides of the suture retainer. Since the suture retainer of the embodiments of the invention illustrated inFIGS. 1-4 are similar to the embodiment of the suture retainer illustrated inFIG. 5 , similar terminology will be utilized to designate similar components. It should be understood that one or more of the features of any of the embodiments of the invention disclosed herein may be used with the embodiment of the invention illustrated inFIG. 5 . - A
tissue securing system 174 is used in a sterile, operating room environment and includes asuture 176 and asuture retainer 178. Thesuture 176 has left andright sections human body tissue 186. Thebody tissue 186 may include a plurality of layers which are approximated in linear apposition with each other in the manner previously described in conjunction with the embodiment of the invention illustrated inFIG. 1 . - Although the
suture 176 has been illustrated inFIG. 5 in association withsoft body tissue 186, it is contemplated that thesuture 176 could be associated with hard or hard and soft body tissue. In the embodiment of the invention illustrated inFIG. 5 , thesuture sections FIG. 1 . However, it should also be understood that thesuture 176 could be associated with a suture anchor, similar to thesuture anchor 120 ofFIG. 4 , if desired. Rather than being disposed in engagement with an outer side surface of a layer of body tissue, the suture anchor could be embedded in the body tissue. - The
suture retainer 178 has a spherical configuration and is formed separately from thesuture 176. A pair ofparallel passages suture retainer 178 at locations offset to opposite sides of a central or polar axis of the suture retainer. Aforce transmitting member 194 is provided between thesuture retainer 178 and thebody tissue 186. - The
sections suture 176 press against opposite sides of theforce transmitting member 194. If desired, theforce transmitting member 194 could be provided with grooves or passages to receive thesections suture 176. Theforce transmitting member 194 could be integrally formed as one piece with thesuture retainer 178. Both theforce transmitting member 194 andsuture retainer 178 are formed separately from thesuture 176. - In accordance with a feature of this embodiment of the invention, ultrasonic vibratory energy is applied to the
suture retainer 178 by a horn oracoustic tool 200. Thehorn 200 extends into acylindrical passage 202 formed in thesuture retainer 178. Thepassage 202 extends parallel to and is disposed midway between thepassages sections suture 176. - In the embodiment of the invention illustrated in
FIG. 5 , thehorn 200 has a generally cylindrical configuration which corresponds to the cylindrical configuration of thepassage 202. However, thehorn 200 andpassage 202 could have different configurations if desired. For example, thehorn 200 andpassage 202 could have frustroconical configurations. - A pair of force application members or
anvils suture retainer 178 with predetermined forces, indicated schematically byarrows FIG. 5 . Theanvils suture retainer 178. Of course, theanvils - When the
tissue securing system 174 is to be utilized to secure thebody tissue 186, thesuture 176 is positioned relative to the body tissue in the manner illustrated schematically inFIG. 1 . However, if desired, a separate anchor, similar to theanchor 120 ofFIG. 4 , could be connected with an end portion of each of thesections suture 176. If this was done, thesections suture 176 could be separate from each other and interconnected by thebody tissue 176 andsuture retainer 178. Thus, two separate segments of suture, that is thesections - After the
suture 176 has been positioned relative to the body tissue, the upper (as viewed inFIG. 5 ) end portions of thesections suture 176 are inserted through thepassages force distribution member 194 is positioned between thesuture retainer 178 and thebody tissue 176. Thesections suture retainer 178 is moved along thesections suture 176 into engagement with theforce distribution member 194. - When the
suture retainer 178 has been moved along thesections suture 176 into engagement with theforce distribution member 194, a predetermined force is applied againstsuture retainer 178, in the manner similar to that indicated schematically inFIG. 4 , to press theforce transmitting member 194 against thebody tissue 186 with a predetermined force. At the same time, thesections suture 176 are tensioned with a predetermined force. If thesections suture 176, in the manner illustrated schematically inFIG. 1 , a connector section of the suture is pulled against the body tissue to compress the body tissue between thesuture retainer 178 and the connector section of the suture. Alternatively, if separate suture anchors are connected with thesections suture 176, the two spaced apart suture anchors are pulled against the body tissue to compress thebody tissue 186 between the suture anchors and thesuture retainer 178. - While the
suture 176 is being tensioned with a predetermined force and while thesuture retainer 178 is being pressed against theforce distribution member 194 with a predetermined force, thesuture retainer 178 is deformed to grip thesections suture 176. This deformation of thesuture retainer 178 results in a firm gripping of thesections suture 176 to maintain a desired tension force in the suture and to maintain a desired compression force against thebody tissue 186. - To deform the
suture retainer 178 to grip thesuture 176, theanvils arrows FIG. 5 . Thehorn 200 is then vibrated with an ultrasonic frequency to transmit ultrasonic vibratory energy to thesuture retainer 178. It is contemplated that thehorn 200 may be vibrated at a frequency of between 20 and 70 kilohertz. It is believed that it may be preferred to vibrate thehorn 200 at a frequency which is close to or greater than 70 kilohertz. - Vibration of the
horn 200 at ultrasonic frequencies transmits mechanical vibrational energy form thehorn 200 to thesuture retainer 178. This ultrasonic vibrational energy is converted into heat energy and results in a heating of thesuture retainer 178. The heat in the suture retainer tends to be concentrated in the material of the suture retainer at locations adjacent to thepassages suture retainer 178 adjacent to thepassages suture retainer 178 does not melt and become liquid. The transmission of ultrasonic vibratory energy from thehorn 200 to thesuture retainer 178 is then interrupted. - The
anvils suture retainer 178 with the forces indicated schematically by thearrows FIG. 5 . If desired, the force applied against thesuture retainer 178 may be increased upon interruption of the transmission of ultrasonic vibratory energy to the suture retainer. Theforce anvils suture retainer 178 is effective to plastically deform the heat softened material of the suture retainer. The force applied by theanvils passages suture retainer 178 against thesections suture 176. - The
suture retainer 178 andsuture 176 may be formed of many different materials. However, it is believed that it will be preferred to form thesuture retainer 178 and thesuture 176 of a biodegradable polymer. The biodegradable polymer may advantageously be an amorphous thermoplastic. A bonding of the material of thesuture retainer 178 with the material of thesuture 176 is promoted by forming the suture retainer and suture of the same material. However, thesuture retainer 178 andsuture 176 could be formed of different materials having similar chemical properties and which are compatible with each other. - In the embodiment of the invention illustrated in
FIG. 5 , the material of thesuture retainer 178 is heated by the application of ultrasonic vibratory energy to the suture retainer by thehorn 200. However, it is contemplated that heat energy could be directly transmitted to thesuture retainer 178 during the transmission of ultrasonic vibratory energy to the suture retainer if desired. To effect the transmission of heat energy to thesuture retainer 178, heating elements could be provided in theanvils - Referring to
FIG. 29 , another embodiment of the suture retainer illustrated inFIGS. 1-5 includes substantiallyflat edges 730, having a non-circular cross section when viewed from the top or the bottom surface. The removal of material, which creates the non-circular shape can help make the suture retainer better remain against smaller surfaces. In this regard, the top and/or bottom surface can include a convex or concave surface. - Embodiment of
FIG. 6 - In the embodiment of the invention illustrated in
FIGS. 1-5 , the suture retainer has a generally spherical configuration and is formed as one piece. In the embodiment of the invention illustrated inFIG. 6 , the suture retainer is formed as two pieces. Since the suture retainer ofFIG. 6 is similar to the suture retainers ofFIGS. 1-5 , similar terminology will be utilized to identify similar components. It should be understood that one or more features of other embodiments of the invention disclosed herein could be used with the embodiment of the invention illustrated inFIG. 6 . - A tissue securing system 218 (
FIG. 6 ) is used in a sterile, operating room environment and includes asuture retainer 220 andsuture 228. Thesuture retainer 220 includes two sections, that is, a left (as viewed inFIG. 6 )section 222 and aright section 224. The left andright sections suture retainer 220 are formed separately from each other. However, it is contemplated that the twosections left section 222 and theright section 224 of thesuture retainer 220. - A
suture 228 includessections sections suture retainer 220. Thesuture 228 is positioned relative tohuman body tissue 234 with thesections outer side surface 236 of the body tissue. Thesuture 228 may be connected with thebody tissue 234 in the same manner as illustrated schematically inFIG. 1 if desired. - Although the
suture 228 has been illustrated schematically inFIG. 6 in association withsoft body tissue 234, it is contemplated that the suture could be associated with hard body tissue or with both hard and soft body tissue. It is also contemplated that thesuture 228 could extend through a suture anchor which is disposed in engagement with a surface of the body tissue or embedded in the body tissue. - The
left section 222 of thesuture retainer 220 has a generally rectangular configuration. Theleft section 222 of thesuture retainer 220 includes a pair ofparallel grooves grooves FIG. 6 , from a flatmajor side surface 244 of theleft section 222 of thesuture retainer 220. Thegrooves - Each of the
grooves grooves suture sections grooves suture sections groove - The
right section 224 of thesuture retainer 222 has a configuration which is the same as the configuration of theleft section 222. Thus, theright section 224 of thesuture retainer 220 includes a pair ofgrooves grooves FIG. 6 , from a flat major side surface 252 of theright section 224 of thesuture retainer 220. - The
grooves grooves grooves suture sections - In one specific embodiment of the invention, the identical left and
right sections major side surfaces 244 and 252 had a length, as measured transversely to thegrooves major side surfaces 244 and 252 had a width, as measured parallel to thegroves right sections major side surfaces 244 and 252, of approximately 0.055 inches. Thegrooves grooves - It should be understood that the foregoing dimensions for one specific preferred embodiment of the
suture retainer 222 have been set forth herein for purposes of clarity of description. It is contemplated that thesections suture retainer 220 will be constructed with dimensions which are substantially different from the specific dimensions which have been set forth herein. - The two
sections suture retainer 220 may be formed of many different materials. However, it is believed that it will be preferred to form thesections suture retainer 220 of a biodegradable polymer. The twosections suture retainer 220 may be formed of an amorphous thermoplastic material. Thesuture 228 and thesuture retainer 220 may be formed of any of the materials previously mentioned herein or other materials. Thesuture 228 and thesuture retainer 220 may be formed from the same material or from different materials having the same or similar chemical properties which are compatible with each other. - When the
suture 228 andsuture retainer 220 are to be used to secure thehuman body tissue 234, thesuture 228 is positioned relative to the body tissue. Thesuture 228 may be positioned relative to the body tissue in the manner illustrated schematically inFIG. 1 . Alternatively, thesuture 228 may be connected with one or more suture anchors. A predetermined tension force is then applied to thesections - The two
sections suture retainer 220 are positioned in engagement with thesections suture 228. Thesuture retainer 220 is pressed against thebody tissue 234 with a predetermined force. This results in the body tissue being pressed between thesuture retainer 220 and the portion of the suture connected with thebody tissue 234. A force distribution member could be provided between thesuture retainer 220 andbody tissue 234 if desired. - The
left section 222 of thesuture retainer 220 is positioned in abutting engagement with thesections suture 228 and with thebody tissue 234 in the manner illustrated schematically inFIG. 6 . Theright section 224 of thesuture retainer 220 is moved into engagement with thesections suture 228 and is also pressed against thebody tissue 234. At this time, the major side surface 252 on theright section 224 of thesuture retainer 220 is spaced from and extends parallel to themajor side surface 244 on theright section 222 of thesuture retainer 220. The twosections suture retainer 220 are spaced apart by a distance which is a function of the extent by which the diameters of thesuture sections grooves grooves sections suture retainer 220. - In the specific example for which dimensions have been set forth herein, the
major side surface 244 of theleft section 222 of thesuture retainer 220 is spaced 0.010 inches from the major side surface 252 of theright section 224 of thesuture retainer 220. It should be understood that a different spacing could be provided between themajor side surfaces 244 and 252 of thesuture sections grooves suture section 222 are in engagement with thesuture sections grooves right suture section 224 are in engagement with thesuture sections - In order to bond the
sections suture retainer 220 to each other and to thesections suture 228, ultrasonic vibratory energy is transmitted to thesuture retainer 220. At this time, thesuture retainer 228 is pressed against thebody tissue 234 with a predetermined force and thesections suture 228 are tensioned with a predetermined force. - To effect the transmission of ultrasonic vibratory energy to the
sections suture retainer 220, ananvil 258 is moved into engagement with theleft section 222 of thesuture retainer 220. A horn oracoustic tool 260 is moved into engagement with theright section 224 of thesuture retainer 220. Theanvil 258 and horn 260 are pressed against thesections suture retainer 220 with a predetermined force to firmly press the sections of the suture retainer against thesections suture 228. - While the
anvil 258 and horn 260 are being pressed against thesuture retainer sections horn 260 to thesuture retainer 220. The ultrasonic vibrations transmitted from thehorn 260 to thesuture retainer 220 have a frequency in excess of 20 kilohertz. The ultrasonic vibrations transmitted to sutureretainer 220 by thehorn 260 may have a frequency of between 20 kilohertz and 70 kilohertz. It is believed that it may be preferred to transmit ultrasonic vibrations having a frequency close to or greater than 70 kilohertz to thesuture retainer 220 from thehorn 260. - The ultrasonic vibrations transmitted to the
suture retainer 220 create frictional heat and cause portions of the material of thesuture retainer 220 to be heated into the transition temperature range for the material. As the material of thesuture retainer 220 is heated into its transition temperature range, the material loses some of its rigidity and softens. The material of thesuture retainer 220 does not melt and become liquid. The heat in thesuture retainer 220 will tend to be concentrated adjacent to thegrooves major side surfaces 244 and 252. - As the material of the
suture retainer 220 is heated and softened by the ultrasonic vibratory energy, thesections suture retainer 220 are pressed together by force applied against the sections of the suture retainer by theanvil 258 andhorn 260. As this occurs, the material of thesections suture retainer 220 is plastically deformed and pressed against thesections suture 228 at thegrooves major side surfaces 248 and 252 on thesections suture retainer 220 will move into engagement with each other. - When this has occurred, the transmission of ultrasonic energy to the
suture retainer 228 is interrupted. However, the force applied against thesections sections suture retainer 220 by theanvil 258 and horn 260 as the application of ultrasonic vibratory energy to thesuture retainer 220 is interrupted. - While the clamping force applied by the
anvil 258 andhorn 260 is maintained, the left andright sections suture retainer 220 bond to each other. In addition, the left andright sections suture retainer 220 bond to thesections suture 228. This results in thesuture 228 being firmly gripped by the sections of thesuture retainer 220. Thesections suture retainer 220 bond to thesuture 228 without significant deformation of the suture. - The left and
right sections suture retainer 220 bond to each other at a joint formed between thesurfaces 244 and 252 of the sections of the suture retainer. This results in a bonding of thesections suture retainer 220 at locations offset to both sides of thesuture 228 and at locations offset to both sides of thesuture 230. The material of thesections suture retainer 220 defining thegrooves sections suture 228. - Although it is preferred to heat the
sections suture retainer 220 with ultrasonic vibratory energy in the manner previously explained, it is contemplated that heat energy could be directly transmitted to the suture retainer if desired during the transmission of ultrasonic vibratory energy to the suture retainer. The heat energy could be transmitted to thesuture retainer 220 from heating coils in theanvil 258 and/orhorn 260. If desired, a separate heat application member could be provided. - The
sections suture retainer 220 prevent direct engagement of theanvil 258 and horn 260 with thesuture 228. This prevents excessive heating of thesuture 228. - Embodiment of
FIGS. 7 and 8 - In the embodiment of the invention illustrated in
FIG. 6 , thesuture retainer 220 is formed in twosections FIGS. 7 and 8 , the suture retainer is formed as one piece having passages for receiving the sections of the suture. Since the embodiment of the invention illustrated inFIGS. 7 and 8 is generally similar to the embodiment of the invention illustrated inFIGS. 1-6 , similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the other embodiments of the invention illustrated herein could be utilized in association with the embodiment of the invention illustrated inFIGS. 7 and 8 . - A
tissue securing system 268 is used in a sterile, operating room environment and includes asuture retainer 270 and asuture 280. Thesuture retainer 270 is integrally formed as one piece and has a cylindrical configuration. A pair ofcylindrical passages 272 and 274 (FIG. 7 ) extend diametrically through thesuture retainer 270. Of course, thesuture retainer 270 andpassages suture retainer 270 could have an oval or a polygonal configuration. - Left and
right sections suture 280 extend through thepassages suture sections FIG. 1 . However, thesuture sections sections suture 280 could be connected with a separate suture anchor, in much the same manner as in which the one section of thesuture 112 ofFIG. 4 is connected with thesuture anchor 120. - It is contemplated that the
suture retainer 270 andsuture 280 could be used in association with hard body tissue, soft body tissue, or hard and soft body tissue. Thesuture retainer 270 andsuture 280 may be used with body tissue in any one of the ways previously described herein. Of course, the suture retainer and suture may be used with body tissue in other known ways if desired. - The
suture retainer 270 may be formed of many different materials. However, It is believed that it will be preferred to form thesuture retainer 270 of a biodegradable polymer. It is believed that it may be preferred to form both thesuture retainer 270 and thesuture 280 of the same amorphous thermoplastic material. However, if desired, thesuture 280 andsuture retainer 270 could be formed of different materials which have the same or similar chemical properties and are compatible with each other. Thesuture 280 and/or thesuture retainer 270 may be formed of either biodegradable or non-biodegradable materials. - In one specific embodiment of the invention, the
cylindrical suture retainer 270 had a diameter of 0.119 inches. Thisparticular suture retainer 270 had an axial extent of 0.236 inches. Thepassages passages - It should be understood that the foregoing specific dimensions for embodiments of the
suture retainer 270 have been set forth herein for purposes of clarity of description. It is contemplated that thesuture retainer 270 can and will be formed with dimensions which are different than these specific dimensions. It is also contemplated that thesuture retainer 270 will be constructed with a configuration which is different than the specific configuration illustrated herein. For example, thesuture retainer 270 could have a prismatic configuration with thepassages - The
suture 280 is positioned relative to body tissue in much the same manner as illustrated inFIG. 1 . Thesections suture 280 are then inserted through thepassages 272 and 274 (FIG. 7 ). While thesuture 280 is tensioned, thesuture retainer 270 is moved along the suture toward the body tissue. A predetermined force is transmitted from thesuture retainer 270 to the body tissue while thesections suture 280 are tensioned with a predetermined force in the manner previously described in conjunction with the embodiment of the invention illustrated inFIG. 4 . - While the body tissue is compressed between the
suture 280 and thesuture retainer 270, ultrasonic vibratory energy is transmitted to thesuture retainer 270. To transmit ultrasonic vibratory energy to thesuture retainer 270, an anvil 286 (FIG. 8 ) and a horn oracoustic tool 288 are pressed against opposite sides of thesuture retainer 270 with a predetermined force. Thesuture 280 is tensioned and thesuture retainer 270 is pressed against body tissue with predetermined forces while theanvil 286 and horn 288 are pressed against the suture retainer. - The
horn 288 is then vibrated at an ultrasonic frequency, that is, at a frequency greater than 20 kilohertz. Thehorn 280 may be vibrated at a frequency of between 20 and 70 kilohertz. It is believed that it may be preferred to vibrate thehorn 288 at a frequency close to or greater than 70 kilohertz. As this occurs, vibratory mechanical energy at ultrasonic frequencies is transmitted from thehorn 288 to thesuture retainer 270. - The ultrasonic vibratory energy transmitted from the
horn 288 to thesuture retainer 270 is effective to heat the suture retainer. The heat tends to be concentrated in the portion of thesuture retainer 270 adjacent to thesections suture 280. - When the portion of the
suture retainer 270 adjacent to thesections suture 280 have been heated to a temperature in the transition temperature range for the material of thesuture retainer 270, the application of ultrasonic vibratory energy to thesuture retainer 270 by thehorn 288 is interrupted. When material of thesuture retainer 270 is heated into the transition temperature range, the material of the suture retainer becomes soft and pliable. Although the material of thesuture retainer 270 does not melt and become liquid, the material of thesuture retainer 270 is softened and loses its rigidity when it is heated into the transition temperature range. - The force applied against the
suture retainer 270 is then maintained or increased. The force applied against thesuture retainer 270 by theanvil 286 andhorn 288 is effective to plastically deform the material of the suture retainer. As the heat softened material of thesuture retainer 270 is plastically deformed by theanvil 286 andhorn 288, the material of the suture retainer is firmly pressed against thesections suture 280. - As the heated and softened material of the
suture retainer 270 cools, the material of the suture retainer bonds to thesuture 280. This results in thesuture retainer 270 securely gripping thesections suture 280. Thesuture 280 is not significantly deformed as thesuture retainer 270 is heated and bonded to the suture. Therefore, the strength of thesuture 280 is not significantly reduced. - In the foregoing description, the
suture retainer 270 was heated by the application of ultrasonic vibratory energy to the suture retainer. It is contemplated that heat energy could be transmitted to thesuture retainer 270 along with the ultrasonic vibratory energy. This could be accomplished in many different ways. For example, a heating element could be provided in theanvil 286 and/orhorn 288. Alternatively, a separate heating element could be moved into contact with thesuture retainer 270. - Embodiment of
FIG. 9 - In the embodiment of the invention illustrated in
FIGS. 7 and 8 , thesuture 280 extends throughpassages suture retainer 270. In the embodiment of the invention illustrated inFIG. 9 , the suture is wrapped around a section of the suture retainer and is engaged by other sections of the suture retainer. Since the suture retainer of the embodiments of the invention illustrated inFIGS. 1-8 is similar to the suture retainer of the embodiment of the invention illustrated inFIG. 9 , similar terminology will be utilized to identify similar components. It should be understood that one or more features of other embodiments of the invention disclosed herein may be used with the embodiment of the invention illustrated inFIG. 9 . - A
tissue securing system 291 is used in a sterile, operating room environment and includes asuture retainer 292 and asuture 302. Thesuture retainer 292 includes a cylindricalcentral section 294 which is disposed between left andright side sections central section 294 is formed separately from theside sections side sections side sections side sections central section 294 andside sections - A
suture 302 is wrapped around thecentral section 294. Thesuture 302 is received in agroove 304 in thecentral section 294. Thegroove 304 has a circular configuration and has a central axis which is coincident with a central axis of the cylindricalcentral section 294. - The
groove 304 has an extent which is greater than 360° and extends completely around thecentral section 294 of thesuture retainer 292. Thegroove 304 is formed as a portion of a helix. Opposite end portions of thegroove 304 are disposed in an overlapping relationship on thecentral portion 294 of thesuture retainer 292. Thesuture 302 is disposed in thegroove 304 throughout the extent of its engagement with thecentral section 294. - Although the
groove 304 has been shown as having somewhat more than a single turn inFIG. 8 , the groove could have a plurality of turns around thecentral section 294 of thesuture retainer 292 if desired. If this was done, thesuture 302 would be wrapped a plurality of times around thecentral section 294. Thus, rather than having a single wrap of thesuture 302 around thecentral section 294 of thesuture retainer 292 in the manner illustrated inFIG. 9 , thesuture 302 could be wrapped a plurality of times around the central section of thesuture retainer 294. - The
suture 302 andsuture retainer 292 may be formed of the same material or different materials. Similarly, thecentral section 294 andside sections suture 302 and thesuture retainer 294 from biodegradable materials. However, thesuture 302 and/or thesuture retainer 292 could be formed of materials which are not biodegradable. It may also be preferred to form thesuture retainer 292 andsuture 302 of an amorphous polymeric material. Thesuture retainer 292 andsuture 302 may be formed of any of the materials previously mentioned herein or other materials. - When the
suture retainer 292 is to be utilized to secure human body tissue, thesuture 302 is positioned relative to the body tissue in the manner illustrated inFIG. 4 . Of course, thesuture 302 could be positioned relative to body tissue in a different manner if desired. Thesuture 302 andsuture retainer 292 may be used with hard, soft, or hard and soft body tissue. - The
suture 302 is wrapped around thecentral section 294 of the suture retainer, in the manner illustrated schematically inFIG. 9 . Once thesuture 302 has been wrapped around thecentral section 294 of thesuture retainer 292, the central section of the suture retainer is moved along thesuture 302 toward the body tissue. - As the
central section 294 of thesuture retainer 292 moves toward the body tissue, a wrap or turn of thesuture 302 around the central section of the suture retainer moves along the suture toward the body tissue. Thecentral section 294 of thesuture retainer 292 may be moved along a straight path toward the body tissue without rotating while tension is maintained in thesuture 302 and the suture slides along thegroove 304 in the central section of the suture retainer. Alternatively, thecentral section 294 of the suture retainer could be rolled along thesuture 302 toward the body tissue. - The
central section 294 of thesuture retainer 292 is moved along thesuture 302 until the central section of the suture retainer engages the body tissue in the manner illustrated inFIG. 4 or engages a force distribution member in the manner illustrated inFIG. 5 . A predetermined tension force is then applied to thesuture 302 and thecentral section 294 of the suture retainer is urged toward the body tissue with a predetermined force. The body tissue engaged by thesuture 302 is compressed between thecentral section 294 of thesuture retainer 292 and a suture anchor, similar to thesuture anchor 120 ofFIG. 4 . - While the
suture 302 is tensioned with a predetermined force and a predetermined force is transmitted from thecentral section 294 of thesuture retainer 292 to the body tissue, theside sections central section 294 of the suture retainer. Theside sections concave surfaces suture 302 which extends around thecentral portion 294 of thesuture retainer 292. Thesurfaces outer side surface 314 on theside sections suture 302 projects out of thegroove 304, the side surfaces 310 and 312 on theside sections side surface 314 on thecentral section 294 of thesuture retainer 292. - In accordance with a feature of the present invention, ultrasonic vibratory energy is applied to the
suture retainer 292. To apply the ultrasonic vibratory energy to thesuture retainer 292, a support member oranvil 320 is pressed against theside section 296 of thesuture retainer 292. A horn oracoustic tool 322 is pressed against theside section 298 of thesuture retainer 292. Theanvil 320 and horn 322 are pressed against theopposite side sections suture retainer 292 with a predetermined force. - While the
suture retainer 292 is clamped between theanvil 320 andhorn 322, mechanical vibrations at an ultrasonic frequency are transmitted from thehorn 322 to thesuture retainer 292. The ultrasonic vibratory energy is transmitted from thehorn 322 to thesuture retainer 292 at frequency above 20 kilohertz. Thehorn 322 may transmit the ultrasonic vibratory energy to thesuture retainer 292 at a frequency between 20 kilohertz and 70 kilohertz. It is contemplated that it may be desired to have the ultrasonic vibratory energy transmitted to the suture retainer at a frequency close to or greater than 70 kilohertz. However, it should be understood that the ultrasonic vibratory energy could be transmitted to thesuture retainer 292 at any desired frequency above the frequency normally detected by the human ear, that is above approximately 20 kilohertz. - The ultrasonic vibratory energy transmitted to the
suture retainer 292 is converted into heat. The heat tends to concentrate at the joints between theside sections central section 294 of thesuture retainer 292. This results in the material forming theside sections central section 294 of thesuture retainer 292 being heated into the transition temperature range of the material forming the suture retainer. The application of the ultrasonic vibratory energy to thesuture retainer 292 by thehorn 322 is then interrupted. - As the material of the
suture retainer 292 is heated into its transition temperature range, the material loses its rigidity and softens. Theanvil 320 and horn 322 apply force against thesuture retainer 292 to plastically deform the material of the suture retainer. The softened side surfaces 310 and 312 on theside sections suture 302. As this occurs, the softened side surfaces 310 and 312 of theside sections side surface 314 on thecentral section 294 of thesuture retainer 292. - Although the application of ultrasonic vibratory energy to the
suture retainer 292 is interrupted, theanvil 320 and horn 322 continue to be pressed against theside sections suture retainer 292 with a predetermined force. If desired, the force with which theanvil 320 and horn 322 are pressed against thesuture retainer 292 can be increased as the transmission of ultrasonic vibratory energy to the suture retainer is interrupted. - As the material of the
suture retainer 292 cools, theside sections central section 294 of thesuture retainer 292. In addition, thesuture 302 is bonded to thecentral section 294 and to theside sections suture retainer 292. - The
groove 304 in thecentral section 294 of thesuture retainer 292 is deep enough to prevent significant deformation and loss of strength of thesuture 302. As the heat softened material of theside sections suture 302, the material of the side sections is plastically deformed. - It is contemplated that a of the
suture 302 with thecentral section 294 andside sections suture retainer 292 may be promoted by forming the suture and the sections of the suture retainer of the same material. The material may be an amorphous thermoplastic which is biodegradable. - If desired, the
groove 304 could be omitted from thecentral section 294 of thesuture retainer 292. Alternatively, thegroove 304 could be deepened so that the groove has a depth which is equal to or slightly greater than the diameter of thesuture 302. If desired, thegroove 304 could be formed with an undercut configuration so that the portion of thesuture 302 in thegroove 304 is not exposed to theside sections suture retainer 292. If this was done, thesuture 302 would be bonded to only thecentral section 294 of thesuture retainer 292 and would not be bonded to theside sections - If the configuration of
groove 304 is changed to an undercut configuration, thesuture 302 would be completely enclosed by the groove. A groove having this configuration is disclosed in U.S. Pat. No. 6,010,525 which has been and hereby is incorporated herein in its entirety. If thegroove 304 has such an undercut configuration, theside sections anvil 320 and horn 322 would then be pressed against opposite sides of the cylindricalouter side surface 314 of thecentral section 294 in the same manner as is disclosed inFIG. 8 in association with thesuture retainer 270. As is disclosed in the aforementioned U.S. Pat. No. 6,010,525, the groove and suture could extend for a plurality of turns around thecentral portion 294 of thesuture retainer 292. - In the foregoing description, it has been assumed that only ultrasonic vibrational energy may be transmitted to the
suture retainer 292 to effect a securing of thesuture 302 by thesuture retainer 292. However, thermal energy in the form of heat could be directly applied to thesuture retainer 292 if desired. This could be accomplished in many different ways. For example, a heating element could be provided in theanvil 320 and/or thehorn 322. - Embodiment of
FIGS. 10 and 11 - In the embodiment of the invention illustrated in
FIG. 9 , thesuture 302 is wrapped around acentral section 294 of thesuture retainer 292. In the embodiment of the invention illustrated inFIGS. 10 and 11 , sections of the suture extend through passages in a central section of the suture retainer. Since the embodiment of the invention illustrated inFIGS. 10 and 11 is generally similar to the embodiments of the invention illustrated inFIGS. 1-9 , similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the other embodiments of the invention disclosed herein could be used with the embodiment of the invention illustrated inFIGS. 10 and 11 if desired. - A
tissue securing system 328 is used in a sterile, operating room environment and includes asuture 330 andsuture retainer 340. The suture 330 (FIGS. 10 and 11 ) has a pair ofsections sections suture 330 may connected with body tissue in the manner illustrated schematically inFIG. 1 . Thesections suture 330 extend through acentral section 338 of the suture retainer 340 (FIG. 11 ). In addition to thecentral section 338, thesuture retainer 340 includes a pair ofside sections - The
central section 338 andside sections side sections FIG. 11 ) could have a different configuration if desired. Thecentral section 338 is thinner (as viewed inFIG. 11 ) than theside sections sections suture 330 extend throughcylindrical passages central section 338. - The relatively thin
central section 338 and the relativelythick side sections suture retainer 340 are formed of a biodegradable material. Thesuture 330 is also formed of a biodegradable material. Thesuture 330 andsuture retainer 340 may be formed of the same biodegradable material. It may be preferred to form thesuture 330 andsuture retainer 340 of an amorphous polymer. If desired, thesuture 330 andsuture retainer 340 could be formed of different materials which are compatible and have the same or similar chemical properties. Thesuture 330 andsuture retainer 340 may be formed of any of the materials previously mentioned herein or of other known materials. - When the
suture 330 andsuture retainer 340 are to be used to secure human body tissue, thesections suture 330 are positioned relative to body tissue in a manner similar to that disclosed inFIG. 1 . Thesections suture 330 are then inserted through thepassages central section 338 of thesuture retainer 340. While thesuture 330 is tensioned, thecentral section 338 of thesuture retainer 340 is moved along the suture toward the body tissue. - The
central section 338 of thesuture retainer 340 is pressed against either the body tissue in the manner illustrated schematically inFIG. 4 or against a force distribution member in the manner illustrated schematically inFIG. 5 . While a predetermined force is transmitted from thecentral section 338 of thesuture retainer 340 to the body tissue and while thesections suture 330 are tensioned with a predetermined force, thethick side sections suture retainer 340 are positioned in engagement with opposite sides of the thincentral section 338, in the manner illustrated inFIG. 11 . - An apparatus for transmitting ultrasonic vibratory energy to the
suture retainer 340 is then moved into engagement with theside sections suture retainer 340 includes an anvil orsupport portion 354 and a horn oracoustic tool 356. Theanvil 354 and horn 356 are pressed against opposite sides of the suture retainer with a predetermined force. While thesuture retainer 340 is clamped between theanvil 354 andhorn 356, ultrasonic vibratory energy is transmitted from thehorn 356 to thesuture retainer 340. - The ultrasonic vibratory energy transmitted from the
horn 356 to thesuture retainer 340 is effective to heat the material of the suture retainer. The heat tends to be concentrated at the joints between thethick side sections central section 338 of thesuture retainer 340. In addition, the heat tends to be concentrated at the joint between thesections central section 338 of the suture retainer. This results in a substantial portion of the material of the thincentral section 338 of thesuture retainer 340 being heated into its transition temperature range. - As the material of the
suture retainer 340 is heated into its transition temperature range, the material of the suture retainer loses its rigidity and becomes soft. However, the material of the suture retainer is not heated enough to melt the material of the suture retainer. Since thecentral section 338 is relatively thin, the material of the central section becomes very pliable while theside sections - Once a substantial portion of the material of the
central section 338 of thesuture retainer 340 has been softened by being heated into its transition temperature range, the transmission of ultrasonic vibratory energy from thehorn 356 to thesuture retainer 340 is interrupted. However, theanvil 354 and horn 356 continue to apply force against opposite sides of thesuture retainer 340. The magnitude of the force applied against opposite sides of thesuture retainer 340 by theanvil 354 and horn 356 may be increased as the transmission of ultrasonic vibratory energy from thehorn 356 to thesuture retainer 340 is interrupted. The force applied against opposite sides of thesuture retainer 340 by theanvil 354 andhorn 356 is effective to plastically deform the heat softened material of thesuture retainer 340. - As the
suture retainer 340 cools, theside sections central section 338 of the suture retainer. In addition, thecentral section 338 of thesuture retainer 340 is bonded to thesections suture 330. This results in thesuture 330 being securely gripped by thesuture retainer 340. However, there is no significant deformation of thesuture 330 so that the strength of thesuture 330 is not significantly reduced. - In the foregoing description, the material of the
central section 338 of thesuture retainer 340 was heated by the transmission of ultrasonic vibratory energy to thesuture retainer 340. However, it is contemplated that thermal energy could be applied to thesuture retainer 340 along with the ultrasonic vibratory energy. This could be accomplished by providing a heating element in theanvil 354 and/orhorn 356. Alternatively, a separate member could be utilized to apply heat directly to thesuture retainer 340. - The
anvil 354 and horn 356 engage only thesuture retainer 340. Theanvil 354 and horn 356 are maintained in a spaced apart relationship with thesuture 330. This prevents excessive heating and/or deformation of the suture. - Embodiment of
FIGS. 12 and 13 - In the embodiment of the invention illustrated in
FIGS. 10 and 11 , the sections of the suture extend through passages in a central section of the suture retainer. In the embodiment of the invention illustrated inFIGS. 12 and 13 , the sections of the suture are disposed in grooves formed in the central section of the suture retainer. Since the embodiment of the invention illustrated inFIGS. 12 and 13 is generally similar to the embodiments of the invention illustrated inFIGS. 1-11 , similar terminology will be utilized to designate similar components. It should be understood that one or more of the features of other embodiments of the invention disclosed herein could be used with the embodiment of the invention illustrated inFIGS. 12 and 13 . - A tissue securing system 359 (
FIGS. 12 and 13 ) is used in a sterile, operating room environment and includes asuture 360 and asuture retainer 368. Thesuture 360 has left andright sections sections suture 360 are connected with human body tissue in a manner similar to the manner illustrated schematically inFIG. 1 . However, thesections suture 360 could be connected with body tissue in a different manner if desired. For example, thesections sections suture 360. - A
suture retainer 368 includes acentral section 370. A pair ofside sections central section 370. Thecentral section 370 andside sections 374 all have a generally rectangular configuration. However, thecentral section 370 is thinner than theside sections 372 and 374 (FIG. 13 ). - A pair of
grooves central section 370. Thegrooves grooves central section 370 and open in opposite directions. - In addition, a
groove 384 is formed in theside section 372. Thegroove 384 extends parallel to and is aligned with thegroove 380 in thecentral section 370. Similarly, agroove 386 is formed in theside section 374. Thegroove 386 extends parallel to and is aligned with thegroove 378 in thecentral section 370. Thesection 362 of thesuture 360 is received in thegrooves 378 and 386 (FIG. 13 ). Similarly, thesection 364 of thesuture 360 is received in thegrooves - The
grooves grooves sections suture 360 being offset from each other (FIG. 13 ). However, if desired, thegrooves grooves sections - The
central section 370 andside sections suture retainer 368 are formed of a biodegradable material. Thesuture 360 is also formed of a biodegradable material. Thesuture 360 andsuture retainer 368 may be formed of the same biodegradable material. It may be preferred to form thesuture 360 andsuture retainer 368 of an amorphous polymer. If desired, thesuture 360 andsuture retainer 368 could be formed of different materials which are compatible and have the same or similar chemical properties. It is contemplated that thesuture 360 andsuture retainer 368 could be formed of any of the materials previously mentioned herein or of other materials. - The
suture 360 is positioned relative to body tissue in the same manner as is illustrated schematically inFIG. 1 . While thesections central section 370 of thesuture retainer 368 is positioned relative to thesections suture 360. In addition, theside sections sections central section 370. Thecentral section 370 andside sections suture retainer 368 are urged toward the body tissue in the manner illustrated schematically inFIG. 4 . This results in the transmission of a predetermined force from thesuture retainer 360 to the body tissue while thesections suture 360 are tensioned with a predetermined force. - In accordance with one of the features of the present invention, ultrasonic vibratory energy is then transmitted to the
suture retainer 368. To transmit ultrasonic vibratory energy to thesuture retainer 368, an anvil or support member 390 (FIG. 13 ) is pressed against theside section 372 of thesuture retainer 368. In addition, a horn oracoustic tool 392 is pressed against theside section 374 of thesuture retainer 368. While thesuture retainer 368 is clamped between theanvil 390 andhorn 392, ultrasonic vibratory energy is transmitted from the horn to the suture retainer. - The ultrasonic vibratory energy transmitted from the
horn 392 to thesuture retainer 368 may have a frequency in a range between 20 kilohertz and 70 kilohertz. It is believed that it will be preferred to transmit ultrasonic vibratory energy having a frequency of approximately 70 kilohertz or more from thehorn 392 to thesuture retainer 368. - The ultrasonic vibratory energy is effective to heat the
suture retainer 368. The heat is concentrated at the joints between the thincentral section 370 andthick side sections suture retainer 368. Since thecentral section 370 is thinner than theside sections central section 370 is heated into its transition temperature range while a smaller percentage of the material of theside sections - Heating the material of the
suture retainer 368 into the transition temperature range is effective to cause the material of the suture retainer to soften and lose its rigidity. Although the material of thesuture retainer 368 softens, the material does not melt and become liquid. The softened material of the suture retainer is pliable and plastically deforms under the influence of the clamping force applied by theanvil 390 andhorn 392. - As the material of the
suture retainer 368 plastically deforms, a flatmajor side surface 396 on thecentral section 370 of thesuture retainer 368 and aflat side surface 398 on theside section 372 of the suture retainer move into engagement. At the same time, aflat side surface 402 on thecentral section 370 of thesuture retainer 368 and aflat side surface 404 on theside section 374 of the suture retainer move into engagement. As this occurs, the softened material of thecentral section 370 of thesuture retainer 368 is deformed by force applied to the central section through thesections suture 360. - After material of the
suture retainer 368 has been heated into its transition temperature range, the application of ultrasonic vibratory energy to the suture retainer is interrupted. However, the force pressing theanvil 390 and thehorn 392 against the suture retainer is maintained. If desired, the magnitude of the force applied against thesuture retainer 368 by theanvil 390 and horn 392 may be increased simultaneously with the interruption of the application of ultrasonic vibratory energy to the suture retainer. - As the material of the
suture retainer 368 cools, the flatmajor side surface 396 on thecentral section 370 bonds to the flatmajor side surface 398 on theside section 372. In addition, the flatmajor side surface 402 on thecentral section 370 bonds to the flatmajor side surface 404 on theside section 374. The surfaces defining thegrooves central section 370 of thesuture retainer 368 bond to thesections suture 360. The surfaces defining thegrooves side sections suture retainer 368 also bond to thesections suture 360. - In the foregoing description, the
suture retainer 368 was heated by the application of ultrasonic vibratory energy to the suture retainer. It is contemplated that thesuture retainer 368 could also be heated by the direct application of thermal energy to the suture retainer. If this is to be done, a heating element could be provided in theanvil 390 and/orhorn 392. If desired, a separate heating element could be moved into engagement with the suture retainer to transmit heat to the suture retainer. - The
anvil 390 and horn 392 engage only thesuture retainer 368. Theanvil 390 and horn 392 are maintained in a spaced apart relationship with thesuture 360. This prevents excessive heating and/or deformation of thesuture 360. - Embodiment of
FIGS. 14 and 15 - In the embodiment of the invention illustrated in
FIGS. 12 and 13 ,straight sections suture 360 are connected with thesuture retainer 368. In the embodiment of the invention illustrated inFIGS. 14 and 15 , sections of the suture are wrapped around a portion of the suture retainer. Since the embodiment of the invention illustrated inFIGS. 14 and 15 is generally similar to the embodiments of the invention illustrated inFIGS. 1-13 , similar terminology will be utilized to describe similar components. It should be understood that one or more of the features of other embodiments of the invention could be utilized in association with the embodiment of the invention illustrated inFIGS. 14 and 15 if desired. - A tissue securing system 408 (
FIG. 15 ) is used in a sterile, operating room environment and includes asuture 410 and asuture retainer 418. Thesuture 410 includes left andright sections right sections suture 410 are connected with human body tissue in the manner illustrated schematically inFIG. 1 . Alternatively, the left andright sections suture 410 could be connected with a single suture anchor. If desired, a suture anchor could be provided in association with each of thesections suture 410. - The suture retainer 418 (
FIG. 15 ) includes acentral section 420 and a pair ofside sections 422 and 424. Thecentral section 420 andside sections 422 and 424 of thesuture retainer 418 are formed of a biodegradable material. Thesuture 410 is also formed of a biodegradable material. Thesuture 410 andsuture retainer 418 may be formed of the same biodegradable material. It may be preferred to form thesuture 410 andsuture retainer 418 of an amorphous polymer. If desired, thesuture 410 andsuture retainer 418 could be formed of different materials having the same or substantially similar chemical properties. Thesuture 410 andsuture retainer 418 could be formed of any of the materials previously mentioned herein or other materials. - When the
suture retainer 418 is to be utilized to secure body tissue, thesuture sections central section 420 of the suture retainer in the manner illustrated schematically inFIG. 14 . While thesections suture 410 are tensioned, thecentral section 420 of the suture retainer is moved along thesuture 410 toward the body tissue. Of course, the turns or wraps formed around thecentral section 420 of thesuture retainer 418 are moved toward the body tissue along with the central section. - The
central section 420 of the suture retainer is moved into engagement with the body tissue or with a force distribution member in the manner similar to that illustrated in eitherFIG. 4 orFIG. 5 . While a predetermined force is transmitted from thecentral section 420 of the suture retainer to the body tissue, thesections suture 410 are tensioned with a predetermined force. This results in the body tissue being compressed under the influence of force being transmitted to the body tissue from thecentral section 420 of thesuture retainer 418 and from thesuture 410. - While the suture is being tensioned with a predetermined force and while the predetermined force is being transmitted from the
central section 420 of thesuture retainer 418, theside sections 422 and 424 are moved into juxtaposition with thecentral section 420 of thesuture retainer 418. Theside sections 422 and 424 are thicker than thecentral section 420. Force is also transmitted from theside sections 422 and 424 to the body tissue. - To effect the application of ultrasonic vibratory energy to the
suture retainer 418, and anvil orsupport portion 428 is pressed against the relatively thick side section 422 of thesuture retainer 418. At the same time, a horn oracoustic tool 430 is pressed against the relativelythick side section 424 of thesuture retainer 418. This results in thesuture retainer 418 being clamped between theanvil 428 and horn 430 with a predetermined force. The clamping force presses thesuture 410 against the relatively thincentral section 420 of the suture retainer. - While maintaining the predetermined clamping force on the
suture retainer 418, ultrasonic vibratory energy is transmitted from thehorn 430 to the suture retainer. The ultrasonic vibratory energy is transmitted at a frequency of between 20 kilohertz and 70 kilohertz. It is believed that it may be preferred to transmit the ultrasonic vibratory energy at a frequency close to or greater than 70 kilohertz. - The ultrasonic vibratory energy is effective to heat the
suture retainer 418. The heat tends to be concentrated at the joints between the thincentral section 420 andthick side sections 422 and 424 of thesuture retainer 418. Since thecentral section 420 of thesuture retainer 418 is thinner than theside sections 422 and 424 of the suture retainer, a larger percentage of the material of thecentral section 420 of thesuture retainer 418 is heated into its transition temperature range by the ultrasonic vibratory energy before a corresponding percentage of theside sections 422 and 424 is heated into the transition temperature range. - When the material of the
suture retainer 418 has been heated into its transition temperature range, the material becomes soft and pliable. The clamping force applied against theside sections 422 and 424 causes the turns in thesections suture 410 to indent and plastically deform the heat softened material of thecentral section 420 andside sections 422 and 424. As this occurs, theside sections 422 and 424 move into abutting engagement with thecentral section 410 under the influence of the clamping force applied by theanvil 428 andhorn 430. - Once the material of the
central section 420 andside sections 422 and 424 adjacent to the turns in thesections suture 410 have been heated into the transition temperature range, the application of ultrasonic vibratory energy to thesuture retainer 418 is interrupted. However, the clamping force applied against the suture retainer by theanvil 428 andhorn 430 is maintained constant or increased as the application of ultrasonic vibratory energy to the suture retainer is interrupted. As the material of thesuture retainer 418 cools, while the suture retainer is clamped between theanvil 428 andhorn 430, theside sections 422 and 424 of thesuture retainer 418 bond to thecentral section 420 of the suture retainer. In addition, theside sections 422 and 424 and thecentral section 420 of thesuture retainer 418 bond to thesuture 410. - Embodiment of
FIGS. 16 and 17 - In the embodiments of the invention illustrated in
FIGS. 9 through 15 , the suture retainer is formed by a plurality of sections which are bonded together. In the embodiment of the invention illustrated inFIGS. 16 and 17 , the suture retainer is formed as one piece. Since the suture retainer in the embodiment ofFIGS. 16 and 17 is generally similar to the suture retainers ofFIGS. 1-16 , similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of any of the other embodiments of the invention disclosed herein could be utilized with the embodiment of the invention illustrated inFIGS. 16 and 17 . - A
tissue securing system 438 is used in a sterile, operating room environment and includes asuture 440 and asuture retainer 448. Thesuture 440 includes left andright sections right sections suture 440 are connected with human body tissue in a manner similar to the manner illustrated schematically inFIG. 1 . However, thesuture 440 could be connected with body tissue in a different manner if desired. For example, thesections sections - A one-
piece suture retainer 448 is formed separately from thesuture 440. Thesuture retainer 448 has a generally H-shaped configuration. Thesuture retainer 448 includes arectangular base section 450 and a pair ofarm sections arm sections base section 450 by aconnector section 456. Although only the one side, which may be considered as the top side of thesuture retainer 448 is illustrated inFIG. 16 , the suture retainer has a generally rectangular configuration. The extent of thesuture retainer 448 along thesections suture 440 may be equal to the distance between longitudinal central axes of the sections of the suture. - The
suture retainer 448 has a pair ofrecesses sections suture 440 are received. Anentrance 466 to the recess 460 (FIG. 17 ) is partially blocked by a nose ordetent portion 468 of thearm section 452. When thesuture section 442 is to be moved into therecess 460, the cylindrical outer side surface of thesuture section 442 is pressed against acam surface 472 on thenose portion 468 of thearm section 452. Force applied against thecam surface 472 resiliently deflects thearm section 452 away from thebase section 450 from the position shown in solid lines inFIG. 17 to the position shown in dashed lines. As this occurs, thesection 442 of thesuture 440 moves into therecess 460. As thesection 442 of thesuture 440 moves into therecess 460, thearm section 452 springs back to the initial position shown in solid lines inFIG. 17 to block the entrance 446 to therecess 460. This results in thesuture section 442 being retained in therecess 460. - The
arm section 454 has the same construction as thearm section 452. Thus, thearm section 454 has a nose or detent portion 476 (FIG. 16 ) which is engaged by thesuture section 444 to deflect thearm section 454 as the suture section moves into therecess 462. Once thesuture section 444 has moved into therecess 462, thenose portion 476 on thearm section 454 blocks the entrance to the recess to retain thesuture section 444 in the recess. - The
suture 440 andsuture retainer 448 are both formed of a biodegradable polymer. It is believed that it may be preferred to form thesuture retainer 448 and suture 440 from an amorphous thermoplastic. Thesuture 440 andsuture retainer 448 may be formed of the same material or different materials having similar chemical properties which are compatible. Thesuture 440 andsuture retainer 448 may be formed of any of the materials previously mentioned herein or of other materials. - When the
suture 440 andsuture retainer 448 are to be utilized to secure human body tissue, thesuture 440 is positioned relative to the body tissue, in a manner similar to that illustrated schematically inFIG. 1 . Thesections suture 440 are then moved into therecesses suture retainer 448. Thenose portions arm sections suture sections recesses - While the
suture sections suture retainer 448 is moved along thesuture 440 toward the body tissue. Thenose portions arm sections suture sections recesses suture retainer 448 is moved along thesuture 440 toward the body tissue. Thesuture retainer 448 is moved into engagement with either the body tissue, in the manner similar to that illustrated inFIG. 4 , or into engagement with a force distribution member, in the manner similar to that illustrated inFIG. 5 . - While a predetermined tension force is applied to the
sections suture 440 and while thesuture retainer 448 is urged toward the body tissue with a predetermined force, thesuture retainer 448 is bonded to thesuture 440. This results in a predetermined tension being maintained in the portion of thesuture 440 connected with the body tissue and in the transmission of a predetermined force from thesuture retainer 448 to the body tissue. - To bond the
suture 440 to thesuture retainer 448, an anvil orsupport portion 480 is pressed against thebase section 450 of thesuture retainer 448. A horn oracoustic tool 482 is pressed against thearm sections suture retainer 448. Thearm sections suture retainer 448 haveprotuberances horn 482. - The
suture retainer 448 is clamped between theanvil 480 andhorn 482. The force applied against thearm sections horn 482 resiliently deflects the arm sections toward thebase section 450 of thesuture retainer 448. This results in thenose portions arm sections base section 450.Protuberances arm sections horn 482 to deflect the arm sections through a sufficient distance to enable the arm sections to engage thebase section 450. - Once the
suture retainer 448 has been securely clamped between theanvil 480 andhorn 482, ultrasonic vibratory energy is transmitted from thehorn 482 to thesuture retainer 448. The ultrasonic vibratory energy transmitted from thehorn 482 to thesuture retainer 448 is at a frequency of between 20 kilohertz and 70 kilohertz. It is believed that it may be preferred to apply ultrasonic vibratory energy at a frequency of approximately 70 kilohertz or more to thesuture retainer 448. - The ultrasonic vibratory energy transmitted from the
horn 482 to thesuture retainer 448 is effective to heat the material of the suture retainer. The heat tends to be concentrated at the joints between thearm sections base section 450. In addition, the heat tends to be concentrated at the joints between thesuture sections suture retainer 448. - The material of the
suture retainer 448 is heated into a transition temperature range for the material. As the material of thesuture retainer 448 is heated into the transition temperature range, the material of the suture retainer softens and becomes pliable. However, the material of thesuture retainer 448 does not melt and become a liquid. - The heat softened material of the
suture retainer 448 is plastically deformed by the force applied against the suture retainer by theanvil 480 andhorn 482. As the material of thesuture retainer 448 is plastically deformed, therecesses suture retainer 448 is firmly pressed against thesuture 440. - Once the material of the
suture retainer 448 adjacent to thesections nose portions suture retainer 448 into its transition temperature range causes the material to lose its rigidity and soften. The heat softened material of thesuture retainer 448 can be deformed by the clamping force applied by theanvil 480 andhorn 482. - Although the application of ultrasonic vibratory energy to the
suture retainer 448 is interrupted, the suture retainer continues to be clamped between theanvil 480 andhorn 482. If desired, the clamping force applied against thesuture retainer 448 by theanvil 480 and horn 482 could be increased as the application of ultrasonic vibratory energy to the suture retainer is interrupted. - As the material of the suture retainer cools, the
arm sections base section 450 of the suture retainer. In addition, thearm sections connector section 456 andbase section 450 of thesuture retainer 448 are bonded to thesections suture 440. This results in thesuture 440 and thesuture retainer 448 being securely interconnected. - In the foregoing description, the
suture retainer 448 has been heated under the influence of ultrasonic vibratory energy transmitted from thehorn 482 to the suture retainer. It is contemplated that thesuture retainer 448 could also be heated by the direct application of thermal energy to the suture retainer. For example, a heating element could be provided in theanvil 480 and/or thehorn 482 to function as a heat source. Alternatively, a heating element could be moved into contact with thesuture retainer 448. - The
anvil 480 and horn 482 do not engage thesuture 440. Theanvil 480 and horn 482 engage only thesuture retainer 448. This prevents excessive heating and deformation of thesuture 440. There is no significant deformation of thesuture 440 so that it maintains its strength. - Embodiment of
FIGS. 18-20 - In the embodiment of the invention illustrated in
FIGS. 16 and 17 , thesections suture 440 are positioned in a pair ofrecesses suture retainer 448. In the embodiment of the invention illustrated inFIGS. 18-20 , a single section of a suture is positioned in a single recess in a suture retainer. Since the suture retainer of the embodiment of the invention illustrated inFIGS. 18-20 is generally similar to the suture retainers of the embodiments of the invention illustrated inFIGS. 1-17 , similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the other embodiments of the invention disclosed herein could be utilized in association with the embodiment of the invention illustrated inFIGS. 18-20 . - A tissue securing system 489 (
FIG. 18 ) is used in a sterile, operating room environment and includes asuture 490 and asuture retainer 496. The suture 490 (FIG. 18 ) has asection 492 which is connected with human body tissue in a manner generally similar to the manner illustrated schematically inFIG. 4 . Thesuture section 492 may be connected with a suture anchor disposed in engagement with one side of a layer of body tissue. Alternatively, thesuture section 492 may be connected with a suture anchor which is embedded in body tissue. Thesuture 490 could be connected with a suture anchor having a construction generally similar to the construction of the suture anchors disclosed in U.S. Pat. Nos. 5,584,862; 5,549,631; and/or 5,527,343. - A one-
piece suture retainer 496 includesmain sections main sections suture retainer 496 are interconnected by ahinge section 502. Thesuture retainer 496 is formed separately from thesuture 490. - The
main sections hinge section 502 of thesuture retainer 496 are integrally formed as one piece. Thesuture 490 andsuture retainer 496 are both formed of a biodegradable polymer. It is believed that it may be preferred to form thesuture 490 andsuture retainer 496 from the same amorphous thermoplastic material. However, thesuture 490 andsuture retainer 496 may be formed of different amorphous thermoplastic materials having similar chemical properties. Thesuture 490 andsuture retainer 496 may be formed from any of the materials previously mentioned herein or other materials. - The
main sections suture retainer 496 are initially skewed at an angle of approximately 30° to each other. Themain sections hinge section 502 to define a generally V-shaped recess 506 (FIG. 19 ) in which thesection 492 of the suture is received. If desired, therecess 506 could have a configuration which is different than the illustrated V-shaped configuration. - While a predetermined tension is maintained in the
suture 490, thesuture retainer 496 is moved along the suture into engagement with the body tissue, in a manner generally similar to the manner illustrated inFIG. 4 or into engagement with a force distribution member, in the manner generally similar to the manner illustrated inFIG. 5 . While a predetermined force is being transmitted from thesuture retainer 496 to the body tissue and while thesuture 490 is being tensioned with a predetermined force, thesuture 490 is bonded to thesuture retainer 496 and themain sections suture retainer 496 are bonded together. - To effect securing of the
suture 490 by thesuture retainer 496, an anvil 512 (FIG. 20 ) is moved into engagement with themain section 498 of thesuture retainer 496. At the same time, a horn oracoustic tool 514 is moved into engagement with themain section 500 of thesuture retainer 496. The anvil 512 and horn 514 apply force against thesuture retainer 496 to clamp the suture retainer against thesuture 490. - As the anvil 512 and horn 514 are clamped against the
suture retainer 496, themain sections FIG. 19 to the bent configuration illustrated inFIG. 20 . The anvil 512 and horn 514 have a configuration which corresponds to the desired configuration of thesuture retainer 496 when the suture retainer is clamped against thesuture 490 by the anvil and horn. - The
suture retainer 496 is heated to effect a bonding between themain sections suture 490 between themain sections hinge section 502 of the suture retainer. To effect this, ultrasonic vibratory energy is transmitted from thehorn 514 to thesuture retainer 496. The ultrasonic vibratory energy transmitted from thehorn 514 to thesuture retainer 496 has a frequency of between 20 kilohertz and 70 kilohertz. It is believed that it may be preferred to transmit ultrasonic vibratory energy having a frequency of 70 kilohertz or more from thehorn 514 to thesuture retainer 496. - The ultrasonic vibratory energy transmitted from the
horn 514 to thesuture retainer 496 heats the material of the suture retainer. The heat tends to be concentrated at the joints between themain section suture 490 and themain sections hinge section 502 of the suture retainer. The material of thesuture retainer 496 is heated into a transition temperature range for the material. - When the material adjacent to the
main sections suture retainer 496 and adjacent to the joint between thesuture 490 and thesuture retainer 496 has been heated into a transition temperature range, the application of ultrasonic vibratory energy to thesuture retainer 496 is interrupted. Although the application of ultrasonic vibratory energy from thehorn 514 to thesuture retainer 496 is interrupted, the suture retainer continues to be clamped between the anvil 512 and thehorn 514. If desired, the force applied against thesuture retainer 496 by the anvil 512 and horn 514 could be increased simultaneously with interruption of ultrasonic vibratory energy to thesuture retainer 496. - As the material of the
suture retainer 496 is heated into its transition temperature range, the material softens and loses its rigidity. Although the material of thesuture retainer 496 softens as the material is heated into its transition temperature range, the material does not melt and become liquid. As the material of thesuture retainer 496 softens, the force applied against thesuture retainer 496 by the anvil 512 and horn 514 plastically deforms the suture retainer from the configuration illustrated inFIG. 19 to the configuration illustrated inFIG. 20 . - As the material of the
suture retainer 496 cools, a bond is formed between themain sections main sections hinge section 502 of thesuture retainer 496 are bonded to thesuture 490. This results in thesuture retainer 496 having a firm grip on thesuture 490. The firm grip of thesuture retainer 496 on thesuture 490 enables a predetermined tension force to be transmitted through thesuture 490 to the body tissue and enables a predetermined force to be transmitted from thesuture retainer 496 to the body tissue. - The anvil 512 and horn 514 do not engage the
suture 490. The anvil 512 and horn 514 engage only thesuture retainer 496. This prevents excessive heating and deformation of thesuture 490. Thesuture retainer 496 is bonded to thesuture 490 without significant deformation of the suture. - In the embodiment of the invention illustrated in
FIGS. 18-20 , asingle section 492 of thesuture 490 is engaged by thesuture retainer 496. However, a plurality of sections of suture could be gripped by thesuture retainer 496. Thus, a pair of suture sections, corresponding to thesuture sections FIG. 5 , could be positioned in the recess 506 (FIG. 19 ) in thesuture retainer 496 and gripped by the suture retainer. If desired, a force distribution member corresponding to theforce distribution member 194 ofFIG. 5 could be provided between thesuture retainer 496 and the body tissue. - Embodiment of
FIG. 21 - In the embodiment of the invention illustrated in
FIGS. 18-20 , thesuture retainer 496 includes a pair ofmain sections flexible hinge section 502 and which define arecess 506 in which thesuture 490 is received. In the embodiment of the invention illustrated inFIG. 21 , one section of a suture retainer cooperates with another section of the suture retainer to define a recess in which a suture is received. Since the embodiment of the invention illustrated inFIG. 21 is generally similar to the embodiment of the invention illustrated inFIGS. 1-20 , similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the other embodiments of the invention illustrated herein could be used with the embodiment of the invention illustrated inFIG. 21 . - A
tissue securing system 518 is used in a sterile, operating room environment and includes asuture 520 and asuture retainer 528. The suture 520 (FIG. 21 ) includes asection 522 which is connected with body tissue. Thesection 522 of thesuture 520 may be connected with body tissue in the manner illustrated schematically inFIG. 4 . However, it should be understood that thesuture 520 could be connected with body tissue in a different manner if desired. - The
suture retainer 528 is formed separately from thesuture 520 and encloses a portion of the suture. Thesuture retainer 528 has a rectangular configuration and includes abase section 530 and anarm section 532. The base andarm sections suture retainer 528 are integrally formed as one piece. Thearm section 532 cooperates with thebase section 530 to define a generallyU-shaped recess 534 in which thesuture 520 is received. - The
suture retainer 528 may have a configuration which is different than the configuration illustrated inFIG. 21 . For example, thesuture retainer 528 could have an ovoidal configuration rather than the illustrated rectangular configuration. Although thebase section 530 has been illustrated as being substantially wider than thearm section 532, the base and arm sections could be of approximately the same width if desired. The base andarm sections base section 450 andarm section 452 ofFIG. 16 if desired. If desired, therecess 534 could have a different configuration. For example, therecess 534 could have a configuration similar to the configuration of therecess 460 ofFIG. 16 . - The
suture retainer 528 may be formed of any one of many different materials, including any of the materials previously mentioned herein. It may be preferred to form thesuture retainer 528 of a biodegradable material. Thesuture 520 may be formed of the same biodegradable material as thesuture retainer 528. It is believed that it may be preferred to form both thesuture 520 andsuture retainer 528 of an amorphous polymer, such as polyhydroxyalkanoate. Of course, thesuture 520 and suture retainer may be formed of other materials if desired. - When the
suture 520 andsuture retainer 528 are to be utilized to secure body tissue, thesuture 520 is positioned relative to body tissue by engagement with a suture anchor or other device. Thesuture 520 is then positioned in therecess 534 in thesuture retainer 528. Thesuture 520 may be positioned in therecess 534 by moving the suture through an entrance to the recess. Alternatively, thesuture retainer 528 could be moved relative to the suture. - Once the
suture 520 has been positioned in therecess 534, a predetermined tension force is applied to thesuture 520. Thesuture retainer 528 is moved along the suture toward the body tissue. The suture retainer is pressed against the body tissue in the manner illustrated schematically inFIG. 4 or pressed against a force distribution member in the manner illustrated schematically inFIG. 5 . A predetermined force is transmitted from thesuture retainer 528 to the body tissue while the predetermined tension is maintained in thesuture 520. - To interconnect the
suture 520 andsuture retainer 528, the suture retainer is clamped between a horn and anvil of an ultrasonic energy application apparatus. Ultrasonic energy is then transmitted from the horn to thesuture retainer 528 in the manner previously described in conjunction with the embodiments of the invention illustrated inFIGS. 1-20 . - The clamping force applied against the
suture retainer 528 by the horn and anvil deflects thearm section 532 of the suture retainer toward thebase section 530 of the suture retainer. The arm section moves into engagement with thebase section 530 of thesuture retainer 528 and firmly grips thesuture 520 under the influence of the clamping force applied by the anvil and horn. - Ultrasonic energy at a frequency of between 20 kilohertz and 70 kilohertz is then applied to the
suture retainer 528 by the horn. The ultrasonic vibratory energy heats the material of thesuture retainer 528 into its transition temperature range. As the material of thesuture retainer 528 is heated into the transition temperature range, the material of the suture retainer softens and loses its rigidity. As this occurs, the softened material of thesuture retainer 528 is plastically deformed by the clamping force applied against the suture retainer by the anvil and horn. - The transmission of ultrasonic vibratory energy to the
suture retainer 520 is then interrupted. However, the clamping force against the suture retainer is maintained and may even be increased. - As the material of the
suture retainer 528 cools, thesuture retainer 528 is securely connected to thesuture 520. Thus, thearm section 532 is bonded to thebase section 530 of the suture retainer. Both thebase section 530 and thearm section 532 are bonded to thesuture 520. This results in thesuture retainer 528 having a firm grip on thesuture 520 to maintain the tension in the suture and the transmission of force from the suture retainer to body tissue. - Embodiment of
FIG. 22 - In the embodiment of the invention illustrated in
FIG. 21 , thearm section 532 is generally straight and cooperates with thebase section 530 to form arecess 534. In the embodiment of the invention illustrated inFIG. 22 , the suture retainer has an arcuate arm section which cooperates with a base section to form a recess which receives a suture. Since the embodiment of the invention illustrated inFIG. 22 is generally similar to the embodiments of the invention illustrated inFIGS. 1-21 , similar terminology will be utilized to designate similar components. It should be understood that one or more of the features of the other embodiments of the invention disclosed herein could be utilized in conjunction with the embodiment of the invention illustrated inFIG. 22 . - A
suture 540 is connected with body tissue in the manner illustrated schematically inFIG. 4 . Asuture retainer 542 at least partially encloses thesuture 540. Thesuture retainer 542 is integrally formed as one piece which is separate from thesuture 540. - The
suture retainer 542 includes a base section 544 and anarm section 546. The base section 544 andarm section 546 of the suture retainer are integrally formed as one piece. Thesuture retainer 542 has the same generally rectangular configuration as thesuture retainer 528 ofFIG. 21 . However, thesuture retainer 542 could have a different configuration if desired. - The
suture retainer 542 may be formed of a biodegradable polymeric material. It is believed that it may be preferred to form both thesuture 540 and thesuture retainer 542 from the same biodegradable polymeric material. Thesuture 540 and suture anchor may be formed from an amorphous thermoset polymer. If desired, thesuture retainer 542 andsuture 540 could be formed of different polymeric materials which are compatible with each other. Thesuture 540 andsuture retainer 542 could be formed from many different materials, including any of the materials mentioned herein. - The
arm section 546 of thesuture retainer 542 cooperates with the base section 544 of the suture retainer to define arecess 550 which receives a portion of thesuture 540. Thearm section 546 has anose portion 554 which partially blocks anentrance 556 to therecess 550. Thenose portion 554 on thearm section 546 is effective to retain thesuture 540 in therecess 550. - When the
suture 540 andsuture retainer 542 are to be utilized to secure body tissue, thesuture 540 is positioned relative to the body tissue in a manner similar to that illustrated inFIG. 4 . Of course, thesuture 540 could be connected with the body tissue in a different manner if desired. For example, thesuture 540 could be connected with a suture anchor which is embedded in the body tissue. - Once the
suture 540 has been positioned relative to the body tissue, the suture is tensioned and positioned in therecess 550 in thesuture retainer 542. To position thesuture 540 in therecess 550, the suture can be moved relative to the recess or the recess can be moved relative to the suture. - As the
suture 540 moves into therecess 556, the a cylindrical outer side surface of the suture applies force against acam surface 558 on thenose portion 554 of thearm section 546. The force applied against thecam surface 558 deflects thearm section 546 outward away from the base section 544 of thesuture retainer 542 to open theentrance 556 to therecess 550. This enables thesuture 540 to move into therecess 550. - After the
suture 540 has moved into therecess 550, thearm section 546 springs back to its initial position, illustrated inFIG. 22 . When this occurs, thenose portion 554 on thearm section 546 partially blocks theentrance 556 to therecess 550 to retain thesuture 540 in the recess. - Once the
suture 540 has been positioned in therecess 550, thesuture 540 is tensioned with a predetermined force and thesuture retainer 542 is moved along the suture toward the body tissue. Thesuture retainer 542 is moved into engagement with the body tissue in the manner illustrated inFIG. 4 or is moved into engagement with a force distribution member in the manner illustrated inFIG. 5 . A predetermined force is transmitted from thesuture retainer 542 to the body tissue while the predetermined tension is maintained in thesuture 540. This results in layers of body tissue being pressed against each other. - The
suture retainer 542 andsuture 540 are then interconnected to maintain the predetermined tension in the portion of thesuture 540 connected with the body tissue and to maintain the transmission of the predetermined force from the suture retainer to the body tissue. To interconnect thesuture retainer 542 andsuture 540, the suture retainer is clamped between ananvil 562 and ahorn 564 of an ultrasonic energy application apparatus. The clamping force applied against thesuture retainer 542 by theanvil 562 and horn 564 resiliently deflects thearm section 546 so that thenose portion 554 of the arm section moves into engagement with the base section 544 of the suture retainer. In addition, thearm section 546 is firmly pressed against thesuture 540. - While the clamping force is applied to the
suture retainer 542 by theanvil 562 andhorn 564, ultrasonic vibratory energy is transmitted from the horn to the suture retainer. The ultrasonic vibratory energy has a frequency of between 20 kilohertz and 70 kilohertz. It is believed that it may be preferred to utilize ultrasonic vibratory energy having a frequency of approximately 70 kilohertz or more. - The ultrasonic vibratory energy heats the material of the suture retainer into its transition range. The heat tends to be concentrated at the joint between the
arm section 546 and the base section 544 of thesuture retainer 542. In addition, the heat is concentrated at the joint between thesuture 540 and thesuture retainer 542. - Once the material of
suture retainer 542 has been softened by being heated into its transition temperature range, the application of ultrasonic vibratory energy to the suture retainer is interrupted. Even though the application of ultrasonic vibratory energy to the suture retainer is interrupted, the clamping force applied against thesuture retainer 542 by theanvil 562 andhorn 564 is maintained or even increased. - As the material of the
suture retainer 542 cools, a secure bond is formed between thearm section 546 and the base section 544 of the suture retainer. In addition, a secure bond is formed between thesuture 540 and the base section 544 andarm section 546 of thesuture retainer 542. - Embodiment of
FIG. 23 - In the embodiments of the invention illustrated in
FIGS. 1-22 , various types of suture retainers for use in securing a suture relative to body tissue have been illustrated. The embodiment of the invention illustrated inFIG. 23 is not limited to any particular suture retainer construction. However, similar terminology will be utilized in describing the components of the embodiment of the invention illustrated inFIG. 23 as were previously utilized in connection with the embodiments of the invention illustrated inFIGS. 1-22 . - In the embodiment of the invention illustrated in
FIG. 23 , a relatively thick layer of tissue, designated by the numeral 570, is to be connected with a relatively thin layer of tissue, designated by the numeral 572. Atissue securing system 574 is utilized to interconnect the thick and thin layers of tissue. Thetissue securing system 574 is located a precise distance from anend 578 of thethick layer 570 of tissue and anend 580 of thethin layer 572 of tissue. - In the illustrated embodiment of the invention, the
tissue securing system 574 is located the same distance from theend 578 of the thick layer of tissue as in which the tissue fixation system is located from theend 580 of the thin layer of tissue. This results in the two layers of tissue growing together with a minimum of scarring. In addition, thetissue securing system 574 holds thethick layer 570 and thethin layer 572 of tissue against shifting relative to each other. - If a staple of loop-type suture was used to interconnect the
thick layer 570 andthin layer 572 of tissue, a shifting could occur between the two layers of tissue. This shifting could occur inside of the loop formed by the suture or the staple. The shifting can result in extensive scarring and could result in a non-uniform repair of the tissue. The obtaining of a uniform repair of tissue is particularly important when interconnecting a conduit, such as a blood vessel, which has been severed. By using thetissue securing system 574, shifting movement can not occur between thethick layer 570 andthin layer 572 of tissue. This prevents one of the layers from being deflected into the path of flow of material, such as blood, through the conduit in a manner which restricts the conduit and subsequently results in a blockage. - The specific
tissue securing system 574 illustrated inFIG. 23 includes asuture anchor 584 which is disposed in engagement with an outer side surface of thethin layer 572 of tissue. Asuture 586 extends through both thethin layer 572 of tissue and thethick layer 570 of tissue. Thesuture 586 is disposed the same distance from theend 578 of thethick layer 570 of tissue as it is located from theend 580 of thethin layer 572 of tissue. Asuture retainer 590 is connected with a portion of thesuture 586 opposite from theanchor 584. Thesuture retainer 590 may have any one of the constructions described herein or a different construction. - In accordance with a feature of the present invention, the
suture retainer 590 is connected with thesuture 586 by the application of ultrasonic vibratory energy to thesuture retainer 590. The application of ultrasonic vibratory energy to thesuture retainer 590 results in a rapid heating of the material of the suture anchor. The very short time which is required to heat the material of thesuture retainer 590 by the application of ultrasonic vibratory energy enables the suture retainer to be heated into its transition temperature range and softened without detrimentally affecting thelayers - Although it is contemplated that the amount of heat which is required to heat material of the
suture retainer 590 into the transition temperature range by the application of ultrasonic vibratory energy will vary depending upon the construction of thesuture retainer 590, an ultrasonic vibratory energy application time of between 0.25 seconds and 1.0 seconds is required to connect any one of the suture retainers ofFIGS. 1-22 with a suture. After thesuture retainer 590 has been heated and the application of ultrasonic vibratory energy interrupted, the suture retainer is allowed to cool for approximately one second. Since thesuture retainer 590 is heated into its transition temperature range for an extremely short period of time, the suture retainer can be heated to relatively high temperatures which would be detrimental to thelayers - In the embodiments of the invention illustrated in
FIGS. 1, 4 and 23, the tissue securing systems are being utilized to interconnect layers of soft tissue disposed in juxtaposition with each other. However, it contemplated that the tissue securing system could be utilized to interconnect body tissues having different characteristics. For example, the tissue securing system could be utilized to connect soft tissue, such as a tendon, or ligament, with bone. If the tissue securing system was utilized to connect soft tissue with bone, the suture anchor would engage the bone in a manner similar to that disclosed in U.S. Pat. No. 5,403,348 and/or 5,534,012. The suture would then extend from the anchor positioned in the bone into engagement with the soft body tissue. The suture could be wrapped around the soft body tissue or, alternatively, could extend through the soft body tissue. A suture retainer having any of the constructions illustrated inFIGS. 1-22 could be connected with one or two sections of the suture to hold the soft body tissue in place relative to the bone. - Although it is preferred to connect the suture retainers illustrated in
FIGS. 1-22 with a suture, the suture retainers could be connected with other force transmitting members or directly with body tissue if desired. For example, any one of the suture retainers ofFIGS. 1-22 could be connected with a K-wire or a rigid force transmitting member such as a rod or externally threaded stud. Alternatively, the suture retainer could be connected directly to body tissue, such as a ligament or tendon. - In the embodiments of the invention illustrated in
FIGS. 1-22 , the suture retainers have been connected with sutures formed of polymeric material. However, the sutures could be formed of metal if desired. Thus, the suture retainers illustrated inFIGS. 1-22 could be connected with any desired type of member which transmits force, including body tissue. - It is contemplated that the suture retainers illustrated in
FIGS. 1-22 will be utilized in an operating room environment. The suture retainers may be positioned within and fully enclosed by a patient's body. Alternatively, the suture retainers may be partially disposed outside of the patient's body. - Embodiment of
FIG. 24 - It is contemplated that the suture retainers of
FIGS. 1-23 may be heated by the application of ultrasonic vibratory energy. The ultrasonic vibratory energy may be applied in many different ways. One known apparatus for applying the ultrasonic vibratory energy to any one of the suture retainers ofFIGS. 1-23 is illustrated schematically inFIG. 24 . - An ultrasonic vibratory
energy application apparatus 600 includes a pair ofcompression members pivot connection 606. An anvil orsupport member 610 is mounted on one end portion of themember 602. A horn or ultrasonicenergy application member 612 is mounted on one end portion of themember 604 -
Sections anvil 610 andhorn 612. Thesections sections suture retainer 220 ofFIG. 6 . When handleend portions members anvils 610 and horn 612 press thesections sections - Referring to
FIG. 25A , agenerator 630 is connected with a standard electrical power supply (120-240 volts). Thegenerator 630 converts the standard electrical power supply from 50/60 hertz to an ultrasonic frequency, that is a frequency greater than 20 kilohertz. The high frequency electrical energy is conducted through acable 632 to themember 604. - Suitable electrically insulated conductors in the
member 604 conduct the high frequency electrical energy through a transducer (not shown) connected with the horn. The transducer changes the electrical energy into longitudinal ultrasonic signal resulting in a low amplitude mechanical vibrations. These vibrations may be transmitted to a booster to increase or decrease the amplitude of the vibrations. The vibrations are then transmitted to thehorn 612. - The
horn 612 has a longitudinal axis 634 along which the longitudinal ultrasonic signal is propagated. The ultrasonic energy is directed through thehorn 612 to end portion 636 of thehorn 612. As a result the vibrational energy at the end portion 636 of thehorn 612 is greater then the vibrational energy at a side portion 638, wherein the side portion 638 is substantially orthogonal to the end portion 636 of thehorn 612. - In an embodiment, the
horn 612 is affixed tomember 604, such that the end portion 636 of thehorn 612 presses thesections sections handle end portions members horn 612 to thesuture retainer sections horn 612 and the suture retainer. The end deflector transfers the energy from thehorn 612 to the suture retainer. - In an embodiment, the
horn 612 is affixed tomember 604, such that the side portion 638 of thehorn 612 presses thesections sections handle end portions members horn 612 to thesuture retainer sections horn 612 and the suture retainer. The end deflector transfers the energy from thehorn 612 to the suture retainer. - Alternatively, the
generator 630 converts the energy of the standard electrical power supply to an ultrasonic frequency. Suitable electrically insulated conductors in themember 604 conduct the high frequency electrical energy through a transducer (not shown) connected with thehorn 612. The transducer changes the electrical energy into torsional ultrasonic signal resulting in low amplitude mechanical vibrations. - The
horn 612 is a cylindrical member affixed tomember 604, such that the side portion 638 of thehorn 612 presses thesections sections handle end portions members horn 612, wherein the vibrational energy from the torsional ultrasonic signal is transmitted about the side portion 638 of thehorn 612 to thesuture retainer sections horn 612 and the suture retainer. The end deflector transfers the energy from thehorn 612 to the suture retainer. - It is also contemplated that the above described
horn 612 can have different configurations, including, but not limited to, a hollow cylinder, wherein the torsional ultrasonic signal propagates about the circumference of the hollow cylinder, and a flattened side portion configured for receiving at least one of thesuture retainer sections - In an embodiment, the ultrasonic vibratory
energy application apparatus 600 includes a bias member, biasing theanvils 610 andhorn 612 in a closed position. The suture retainer is loaded in the apparatus by moving thehandle end portions members anvil 610 andhorn 612. Thesuture retainer sections anvil 610 andhorn 612. The suture retainer can be loaded in the apparatus either intra-corporally or extra-corporally. - When a suture and suture retainer are to be used to secure the human body tissue, the suture is positioned relative to the body tissue. The
suture sections second sections suture sections FIG. 1 if desired. A predetermined tension force is then applied to thesuture sections - The suture is positioned in the suture retainer by moving the
handle end portions members energy application apparatus 600 to separate theanvil 610 andhorn 612. Thesuture sections suture retainer sections anvils 610 and horn 612 together, pressingsuture retainer sections suture sections suture retainer sections suture retainer sections suture sections - Embodiment of
FIG. 25 - In the embodiment of the invention illustrated in
FIG. 24 , the horn and anvil are disposed on a pair ofcompression members FIG. 25 , the horn and anvil of an ultrasonic energy application apparatus are movable relative to each other along a linear path. - The ultrasonic
energy application apparatus 640 ofFIG. 25 includes a handle 642. A first compression member including ahorn 644 is connected with the handle 642. A second compression member including ananvil 646 is integrally formed as one piece with amember 648 which is movable along a linear path relative to the handle 642. Anactuator member 650 is connected with themember 648 and is movable toward the left (as viewed inFIG. 25 ) to move theanvil 646 toward thehorn 644. -
Sections sections FIG. 6 . - Referring also to
FIG. 25A , agenerator 666 is connected with the handle 642 by acable 668. Thecable 668 connects thegenerator 666 with a transducer which changes high frequency electrical energy conducted from thegenerator 666 to a longitudinal ultrasonic signal resulting in low amplitude mechanical vibrations. These vibrations are transmitted to a booster. The vibrations are then transmitted to the horn. The horn applies the vibrations to thesections 658 of the suture retainer. - The
horn 644 has a longitudinal axis 670 along which the ultrasonic signal is propagated. The ultrasonic signal is directed through thehorn 644 to end portion 672 of thehorn 644. As a result the vibrational energy at the end portion 672 of thehorn 644 is greater then the vibrational energy at a side portion 674, wherein the side portion 674 is substantially orthogonal to the end portion 672 of thehorn 644. - In an embodiment, the
horn 644 is affixed to the handle 642, such that the end portion 670 of thehorn 612 presses thesections sections actuator member 650 andmember 648 are moved toward the left (as viewed inFIG. 25 ). The vibrational energy is transmitted through the end portion 670 of thehorn 644 to thesuture retainer sections horn 644 and the suture retainer. The end deflector transfers the energy from thehorn 644 to the suture retainer. - In an embodiment, the
horn 644 is affixed to the handle 642, such that the side portion 672 of thehorn 644 presses thesections sections actuator member 650 andmember 648 are moved toward the right (as viewed inFIG. 25 ). The vibrational energy is transmitted through the side portion 672 of thehorn 644 to thesuture retainer sections horn 644 and the suture retainer. The end deflector transfers the energy from thehorn 644 to the suture retainer. - Alternatively, the
generator 666 converts the energy of the standard electrical power supply to an ultrasonic frequency. Suitable electrically insulated conductors in the conduct the high frequency electrical energy through a transducer (not shown) connected with thehorn 644. The transducer changes the electrical energy into torsional ultrasonic signal resulting in low amplitude mechanical vibrations. - The
horn 644 is a cylindrical member affixed to the handle 642, such that the side portion 672 of thehorn 644 presses thesections sections actuator member 650 andmember 648 are moved toward the right (as viewed inFIG. 25 ). The torsional ultrasonic signal propagates about the circumference of thehorn 644, wherein the vibrational energy from the torsional ultrasonic signal is transmitted through the side portion 672 of thehorn 644 to thesuture retainer sections horn 644 and the suture retainer. The end deflector transfers the energy from thehorn 644 to the suture retainer. - It is also contemplated that the above described
horn 644 can have different configurations, including, but not limited to, a hollow cylinder, wherein the torsional ultrasonic signal propagates about the circumference of the hollow cylinder, and a flattened side portion configured for receiving at least one of thesuture retainer sections - In an embodiment, the
actuator member 650 can include a bias member, biasing theanvils 646 andhorn 644 in a closed position. The suture retainer is loaded in the apparatus by moving theactuator member 650 to separate theanvil 646 andhorn 644. The suture retainer is then positioned between theanvil 646 andhorn 644. The suture retainer can be loaded in the apparatus either intra-corporally or extra-corporally. - When a suture and suture retainer are to be used to secure the human body tissue, the suture is positioned relative to the body tissue. The suture is formed separately from the suture retainer. The suture is positioned relative to human body tissue with the suture extending away from an outer side surface of the body tissue. The suture may be connected with the body tissue in the same manner as illustrated schematically in
FIG. 1 if desired. A predetermined tension force is then applied to the suture. - The suture is positioned in the suture retainer by moving the
actuator member 650 to separate theanvil 646 andhorn 644. The suture is then positioned in relation to the suture retainer. The bias member moves theanvils 646 and horn 644 together, pressing suture retainer against suture, securing the suture retainer about the suture. The bias member compresses the suture retainer with a compressive force between about 1 lb. to 20 lbs. The suture can be positioned in the suture retainer either intra-corporally or extra-corporally. - It should be understood that the ultrasonic energy application apparatus of
FIGS. 24 and 25 could have any desired construction. It is contemplated that ultrasonic energy application apparatus which is commercially available from Dukane Corporation may be utilized. Of course, ultrasonic energy application apparatus which is commercially available from other sources may be used if desired. It should be understood that the suture retainers ofFIGS. 1-23 may be utilized in association with any desired ultrasonic energy application apparatus. - Embodiment of
FIGS. 26-28 - In the embodiments of the invention illustrated in
FIGS. 1-22 , a suture retainer has been utilized to interconnect sections of a suture. In the embodiment of the invention illustrated inFIGS. 26 through 28 , the sections of the suture are directly connected to each other. Since the embodiment of the invention illustrated inFIGS. 26-28 is generally similar to the embodiments of the invention illustrated inFIGS. 1-22 , similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of other embodiments of the invention illustrated herein could be used with the embodiment of the invention illustrated inFIGS. 26-28 . - A tissue securing system 680 (
FIG. 26 ) includes asuture 682. Thesuture 682 includes left andright sections sections FIGS. 27 and 28 . - The
tissue securing system 680 secures upper andlower layers layers suture 682. Although the twolayers FIG. 26 as being spaced apart from each other, they are held in a side-by-side relationship with each other and pressed together by tightening thetissue securing system 680. Pressing the twolayers tissue securing system 680 promotes healing of the tissue. - Although the
tissue securing system 680 has been illustrated inFIG. 26 as being used to hold layers of soft tissue in linear apposition with each other, it is contemplated that the tissue securing system may be used in many different locations in a patient's body to secure tissue. For example, thetissue securing system 680 could be utilized to secure soft tissue such as a ligament or tendon against movement relative to a bone. Alternatively, thetissue securing system 680 could be utilized to interconnect portions of a flexible conduit, such as a blood vessel or intestine. It should be understood that thetissue securing system 680 may be used with either hard body tissue or soft body tissue or both hard and soft body tissue. - A
force distribution member 694 is disposed between the twosections suture 682. When thesuture 682 is tensioned, theforce distribution member 694 distributes the force over a relatively large area of theupper layer 690 of body tissue. Although only theforce distribution member 694 is illustrated inFIG. 26 in association with theupper layer 690 of body tissue, a similar force distribution member could be provided in association with thelower layer 692 of body tissue if desired. - In accordance with a feature of this embodiment of the invention, the
sections suture 682 are interconnected without using a suture retainer similar to the suture retainers illustrated inFIGS. 1-22 herein. In the embodiment of the invention illustrated inFIGS. 26-28 , the twosections suture 682 are heated, flattened, and bonded together. Heating thesuture sections cylindrical sections suture 682 increases the area at which the suture sections can be interconnected and thereby increases the strength of the connection between the suture sections. - The
suture 682 may be formed of many different materials, including the materials previously mentioned herein. Thesuture 682 may be formed of either a biodegradable or a non-biodegradable material. It is believed that it will be preferred to form thesuture 682 of a biodegradable material. It may be preferred to form thesuture 682 of a biodegradable amorphous polymer. For example, thesuture 682 could be formed of polyhydroxyalkanoate. Of course, thesuture 682 could be formed of other materials if desired. Additionally, thesuture 682 may be a monofilament or multifilament, being formed of a plurality of interconnected filaments. - When the
suture 682 is to be connected with thelayers FIG. 26 . Thesections suture 682 are tensioned with a predetermined force. While thesections force distribution member 694 is pressed against theupper layer 690 of body tissue. This results in the upper andlower layers - Once the
layers sections suture 682 and pressing theforce distribution member 694 against the body tissue, the sections of the suture are interconnected. To interconnect thesections suture 682, the two sections are pulled tight across the force distribution member and disposed in an overlapping relationship. Ananvil 700 is positioned on one side of the twosections suture 682. Ahorn 702 is positioned on the opposite side of thesections suture 682. Theanvil 700 and horn 702 are pressed against the opposite sides of thesuture 682 with a predetermined force. - The
suture sections anvil 700 andhorn 702. Theanvil 700 engages one suture section and thehorn 702 engages the other suture section. Thus, theanvil 700 may engage thesuture section 684 and thehorn 702 my engage thesuture section 686. - While the
sections suture 682 are clamped between theanvil 700 andhorn 702, ultrasonic vibratory energy is transmitted from thehorn 702 to thesections suture 682 at a frequency of 70 kilohertz or more. - The ultrasonic vibratory energy transmitted from the
horn 702 to thesuture 682 is effective to heat the material of the suture into its transition temperature range. As the material of thesuture 682 is heated into its transition temperature range, the material loses its rigidity and softens. However, the material of thesuture 682 does not melt and become a liquid as it is heated into the transition temperature range. - The heated and softened material of the
sections suture 682 are flattened from the cylindrical configuration ofFIG. 27 to form thin layers which are disposed in a side-by-side relationship and have a generally plate-like configuration which is illustrated schematically inFIG. 28 . Thus, thesection 684 of the suture is flattened to form alayer 706 having an uppermajor side surface 708 which extends parallel to a lowermajor side surface 710 of thelayer 706. Similarly, thesection 686 of thesuture 682 is flattened to form alayer 714 having a flat uppermajor side surface 716 which extends parallel to a lowermajor side surface 718 of thelayer 714. - As the
section 684 of thesuture 682 is flattened, it is extended sideways in opposite directions along a path which extends perpendicular to a central axis 722 (FIG. 28 ) of thesuture section 684. Similarly, as thesection 686 of thesuture 682 is flattened, it is extended sideways in opposite directions along a path which extends perpendicular to acentral axis 724 of thesuture section 686. Although the flattenedsuture sections suture sections FIG. 27 ) away from thebody tissue 690. - The side surfaces 708, 710, 716 and 718 all have a relatively large area. The area of each unit of length as measured along a longitudinal
central axes FIG. 27 . - Thus, a one-inch length of a cylindrical portion of the
suture 682 has a circumferential area of pi (3.1416) times the diameter of thecylindrical section 684 of thesuture 682. A one inch length, as measured along a longitudinalcentral axis 722 of thesuture section 684, of theupper side surface 708 of thelayer 706 has an area which is greater than pi (3.1416) times the diameter of the cylindrical portion of thesuture 682. Similarly, a unit of length of the uppermajor side surface 716 of thelayer 714 is greater than the area of a unit of length of the cylindrical portion of thesuture 682. - When the
sections suture 682 have been heated and flattened from the cylindrical configuration ofFIG. 27 to the plastically deformed and flattened configuration ofFIG. 28 by theanvil 700 andhorn 702, the application of ultrasonic vibratory energy to thelayers horn 702 is interrupted. As the material of thelayers layers major side surface 710 of theupper layer 706 and the uppermajor side surface 716 of thelower layer 714. The relatively large area of the bond between the twolayers suture sections - In the foregoing description, the
sections horn 702, and flattened to have surface areas which are greater than the surface area of a corresponding length of a cylindrical portion of thesuture 682. However, it is contemplated that thesections suture 682 could be flattened to a lesser extent. If this was done, the area of one of the major side surfaces, for example the lowermajor side surface 710 of thelayer 706, might not be as great as the area of a corresponding length of a cylindrical portion of thesuture 682. Thus, thesections suture 682 may be flattened and extended sideways to a greater or lesser extent. Even a relatively small extent of flattening of thesections suture 682 will result in an increase in the area at which the two sections of the suture are bonded together. This is because the circumferential extent of a bond formed between a pair of cylindrical surfaces disposed in tangential engagement is relatively small. The extent of the bond between thesurfaces FIG. 28 . - Embodiment of
FIGS. 30A-30B - Referring to
FIGS. 30A-30B , thesuture retainer 740 includes afirst section 742 and asecond section 744 formed separately from each other. However, it is contemplated that the twosections first section 742 and thesecond section 744 of thesuture retainer 740. - The
first section 742 of thesuture retainer 740 includes atop surface 746 and abottom surface 748. Thebottom surface 748 includes a pair ofparallel channels bottom surface 748. Theparallel channels center extension 754 extending along the length of thebottom surface 748. - The
second section 744 of thesuture retainer 740 includes atop surface 756 and abottom surface 758, wherein thetop surface 756 includes acenter channel 760 configured for receiving thecenter extension 754 of thefirst section 742. The width of thesecond section 744 is less then the width of thefirst section 742, such that thesecond section 744 is positionable within thefirst section 742. - The end portion of the
center extension 754 has a pointed configuration. Thus, the end portion of thecenter extension 754 terminates in a tip. Therefore, there is line contact between the of thecenter extension 754 and the end of thecenter channel 760. - By forming the end portion of the
center extension 754 with a pointed configuration, the end portion of thecenter extension 754 is effective to function as energy director for ultrasonic vibratory energy. The pointed end of thecenter extension 754 is effective to direct ultrasonic vibratory energy transmitted from thefirst section 742 of thesuture retainer 740 to the end portion of thecenter extension 754 andcenter channel 760. The pointed configuration of the end portion of thecenter extension 754 concentrates the energy and facilitates melting of the material of the projections. To a lesser extent, the material of thesecond section 744 of theretainer 740 is melted adjacent to the bottom surfaces of thecenter channel 760. This results in a secure bonding and interconnection between the first andsecond sections retainer 740. - When a
suture 762 andsuture retainer 740 are to be used to secure human body tissue, thesuture 762 is positioned relative to the body tissue. The suture includes ends 764 and 766 which are formed separately from the first andsecond sections suture retainer 740. Thesuture 762 is positioned relative to human body tissue with theends suture 762 may be connected with the body tissue in the same manner as illustrated schematically inFIG. 1 if desired. A predetermined tension force is then applied to theends suture 762. - The two
sections suture retainer 740 are positioned in engagement with the suture ends 764 and 766, wherein the suture ends 764 and 766 are positioned one each in theparallel channels first section 742 of thesuture retainer 740. Thesecond section 744 of thesuture retainer 740 engages thefirst section 742 of thesuture retainer 740 such that thecenter extension 754 is positioned within thecenter channel 760 and the suture ends 764 and 766 are interposed between thebottom surface 748 of thefirst section 742 and thetop surface 756 of thesecond section 744 of thesuture retainer 740. Thesuture retainer 740 is pressed against the body, resulting in the body tissue being pressed between thesuture retainer 740 and the portion of thesuture 762 connected with the body tissue. A force distribution member could be provided between thesuture retainer 740 and body tissue if desired. - In order to bond the
suture retainer sections suture retainer 740. To effect the transmission of ultrasonic vibratory energy to thesuture retainer sections anvil 768 is moved into engagement with thesecond section 744 of thesuture retainer 740. A horn oracoustic tool 770 is moved into engagement with thefirst section 742 of thesuture retainer 740. Alternatively, theanvil 768 can engage thefirst section 742 and thehorn 770 can engage thesecond section 744. Theanvil 768 and horn 770 are pressed against thesuture retainer sections sections - While the
anvil 768 and horn 770 are being pressed against thesuture retainer sections horn 770 to thesuture retainer 740. The ultrasonic vibrations transmitted to thesuture retainer 740 create frictional heat and cause portions of the material of thesuture retainer 740 to be heated into the transition temperature range for the material. As the material of thesuture retainer 740 is heated into its transition temperature range, the material loses some of its rigidity and softens. The material of thesuture retainer 740 does not melt and become liquid. The heat in thesuture retainer 740 will tend to be concentrated adjacent to thechannels center extension 754. - As the material of the
suture retainer 740 is heated and softened by the ultrasonic vibratory energy, thesuture retainer sections anvil 768 andhorn 770. As this occurs, the material of thesuture retainer sections channels suture retainer 740. At the same time, at least portions of thebottom surface 748 of thefirst section 742 and thetop surface 756 of thesecond section 744 of thesuture retainer 740 will move into engagement with each other. - When this has occurred, the transmission of ultrasonic energy to the
suture retainer 740 is interrupted. However, the force applied against thesuture retainer sections suture retainer sections anvil 768 and horn 770 as the application of ultrasonic vibratory energy to thesuture retainer 740 is interrupted. For example, the force applied to thesuture retainer 740 can be substantially between 1 to 20 lbs. - While the clamping force applied by the
anvil 768 andhorn 770 is maintained, the first andsecond sections suture retainer 740 bond to each other. In addition, the first andsecond sections suture retainer 740 are compressed about the suture ends 764 and 766. This results in thesuture 762 being firmly gripped by thesuture retainer sections suture retainer sections suture 762 without significant deformation of thesuture 762. - Embodiment of
FIG. 31 - Referring to
FIG. 31 , thesuture retainer 780 includes afirst section 782 and asecond section 784 formed separately from each other. However, it is contemplated that the twosections first section 782 and thesecond section 784. - The
first section 782 of thesuture retainer 780 includes atop surface 786 and abottom surface 788. Thebottom surface 788 includes a pair ofparallel extensions bottom surface 788. - The
second section 784 of thesuture retainer 780 includes atop surface 794 and abottom surface 796, wherein thetop surface 794 includes a pair ofparallel channels parallel channels parallel extensions first section 782. - The end portions of the
parallel extensions parallel extensions parallel channels - By forming the end portions of the
parallel extensions parallel extensions first section 782 of thesuture retainer 780 to the ends of theparallel extensions parallel channels parallel extensions parallel extensions second section 784 of theretainer 780 is melted adjacent to theparallel channels second sections retainer 780. - When a
suture 802 andsuture retainer 780 are to be used to secure the human body tissue, thesuture 802 is positioned relative to the body tissue. Thesuture 802 includesends second sections suture 802 is positioned relative to human body tissue with theends suture 802 may be connected with the body tissue in the same manner as illustrated schematically inFIG. 1 if desired. A predetermined tension force is then applied to the suture ends 804 and 806. - The
suture retainer sections parallel extensions first section 782. The suture retainerfirst section 782 engages the suture retainersecond section 784, such that theparallel extensions parallel channels bottom surface 788 of thefirst section 782 and thetop surface 794 of thesecond section 784 of thesuture retainer 780. Thesuture retainer 780 is pressed against the body, resulting in the body tissue being pressed between thesuture retainer 780 and the portion of thesuture 802 connected with the body tissue. A force distribution member could be provided between thesuture retainer 780 and body tissue if desired. - The
suture retainer sections suture retainer 780 as previously described in relation toFIGS. 30A-30B . However, in the present embodiment the heat in thesuture retainer 780 will tend to be concentrated adjacent to theparallel extensions parallel channels - Embodiment of
FIG. 32 - Referring to
FIG. 32 , thesuture retainer 810 includes afirst section 812 and asecond section 814 formed separately from each other. However, it is contemplated that the twosections first section 812 and thesecond section 814 of thesuture retainer 810. - The
first section 812 of thesuture retainer 810 includes atop surface 816 and abottom surface 818. Thebottom surface 818 includes acenter post 820 extending therefrom. Thesecond section 814 of thesuture retainer 810 includes atop surface 822 and abottom surface 824, wherein thetop surface 822 includes acenter flange 826 defining apassage 828 configured for receiving thecenter post 820. - The end portion of the
center post 820 has a pointed configuration. Thus, the end portion of thecenter post 820 includes a substantially conical shape forming a point. Therefore, there is a point of contact between the end portion of thecenter post 820 and the flat bottom surface of thepassage 828 of thesecond section 814. - By forming the end portion of the
center post 820 with a pointed configuration, the end portion of thecenter post 820 is effective to function as energy director for ultrasonic vibratory energy. The pointed end portion of thecenter post 820 is effective to direct ultrasonic vibratory energy transmitted from thefirst section 812 to the ends of thecenter post 820 to the bottom surfaces of thepassage 828 of thesecond section 814. The pointed configuration of the end portion of thecenter post 820 concentrates the energy and facilitates melting of the material of thecenter post 820. To a lesser extent, the material of the second section of theretainer 810 is melted adjacent to the bottom surfaces of thepassage 828. This results in a secure bonding and interconnection between the first andsecond sections retainer 810. - When a
suture 830 andsuture retainer 810 are to be used to secure the human body tissue, thesuture 830 is positioned relative to the body tissue. Thesuture 830 includesends second sections suture 830 is positioned relative to human body tissue with theends suture 830 may be connected with the body tissue in the same manner as illustrated schematically inFIG. 1 if desired. A predetermined tension force is then applied to the suture ends 832 and 834. - In use, the suture ends 832 and 834 are wrapped around the
center post 820 of the suture retainerfirst section 812. Thecenter post 820 and wrapped suture ends 832 and 834 are inserted into thepassage 828 on thetop surface 822 of the suture retainersecond section 814. Thesuture retainer 810 is pressed against the body, resulting in the body tissue being pressed between thesuture retainer 810 and the portion of thesuture 830 connected with the body tissue. A force distribution member could be provided between thesuture retainer 830 and body tissue if desired. - The
suture retainer sections suture retainer 810 as previously described in relation toFIGS. 30A-30B . However, in the present embodiment the heat in thesuture retainer 810 will tend to be concentrated adjacent to thecenter post 820 andpassage 828. - Embodiment of
FIGS. 33A-33B - Referring to
FIGS. 33A-33B , thesuture retainer 840 includes afirst section 842 and asecond section 844 formed separately from each other. Thefirst section 842 of thesuture retainer 840 includes afirst end 846, asecond end 848, and a first andsecond surface second section 844 of thesuture retainer 840 includes afirst end 854, asecond end 856, and a first andsecond surface first end 846 and the second sectionfirst end 854 are coupled such that the first sectionsecond surface 850 and the second sectionfirst surface 858 are facing each other. The first sectionsecond end 848 can include anengagement member 861 configured for engaging the second sectiontop surface 858. - The end portion of the
engagement member 861 has a pointed configuration. Thus, theengagement member 861 includes a flat side surface area which intersects a flat side surface area at a linear point or peak. Therefore, there is line contact between the end portion of theengagement member 861 and the second sectiontop surface 858. - By forming the end portion of the
engagement member 861 with a pointed configuration, the end portion of theengagement member 861 is effective to function as energy director for ultrasonic vibratory energy. The pointed end portion of theengagement member 861 is effective to direct ultrasonic vibratory energy transmitted from thefirst section 842 to the second sectiontop surface 858. The pointed configuration of the end portion of theengagement member 861 concentrates the energy and facilitates melting of the material of theengagement member 861. To a lesser extent, the material of the second section of theretainer 840 is melted adjacent to theengagement member 861. This results in a secure bonding and interconnection between the first andsecond sections retainer 840. - When a
suture 862 andsuture retainer 840 are to be used to secure the human body tissue, thesuture 862 is positioned relative to the body tissue. Thesuture 862 includesends second sections suture 862 is positioned relative to human body tissue with theends suture 862 forms a loop. Thesuture 862 may be connected with the body tissue in the same manner as illustrated schematically inFIG. 1 if desired. A predetermined tension force is then applied to the suture ends 864 and 866. - The
suture retainer sections second surface 850 and the second sectionfirst surface 858, wherein theengagement member 861 hold thesuture 862 within thesuture retainer 840. - The
suture retainer sections suture retainer 840 as previously described in relation toFIGS. 30A-30B . The anvil and horn engage the first sectionfirst surface 846 and the second sectionsecond surface 852. The anvil and horn are pressed against the first sectionfirst surface 846 and the second sectionsecond surface 852 with a predetermined force to firmly press the first sectionsecond surface 848 and the second sectionfirst surface 850 against theends suture 862. - In an alternative embodiment, as shown in
FIGS. 37A-37B , the suture retainerfirst section 842 andsecond section 844 are hingedly connected. The hingedsection 868 collapses when the first sectionsecond surface 850 and the second sectionfirst surface 858 are compressed together, such that the first sectionsecond surface 850 and the second sectionfirst surface 858 remain substantially parallel. Additionally, the first sectionsecond surface 850 and the second sectionfirst surface 858 can include opposingserrated surfaces 870. The opposingserrated surfaces 870 are configured to grip the suture ends 864 and 866 when compressed. The opposing serrated surfaces also increase the surface area of the first sectionsecond surface 850 and the second sectionfirst surface 858, providing an increase bonding area for welding. - Embodiment of
FIGS. 34A-34B - Referring to
FIGS. 34A-34B , thesuture retainer 880 has a generally rectangular configuration and includes atop surface 882 and abottom surface 884, with thetop surface 882 including a pair ofparallel grooves suture retainer 880. Theparallel grooves major side surfaces grooves grooves - The end portions of the
major side surfaces grooves major side surfaces grooves horn 902. - The
suture retainer 880 is positioned in an engagement with the suture, wherein the suture ends 896 and 898 are disposed within thegrooves suture retainer 880 is pressed against the body tissue with a predetermined force. This results in the body tissue being pressed between thesuture retainer 880 and the portion of the suture 890 connected with the body tissue. A force distribution member could be provided between thesuture retainer 880 and body tissue if desired. - When the suture and
suture retainer 880 are to be used to secure the human body tissue, the suture is positioned relative to the body tissue. The suture may be positioned relative to the body tissue in the manner illustrated schematically inFIG. 1 . A predetermined tension force is then applied to the suture endssections - To effect the transmission of ultrasonic vibratory energy to the
suture retainer 880, ananvil 900 is moved into engagement with the sutureretainer bottom surface 884. A horn oracoustic tool 902 is moved into engagement with the suture retainertop surface 882. Theanvil 900 and horn 902 are pressed against the suture retainertop surface 882 andbottom surface 884 with a predetermined force. - While the
anvil 900 and horn 902 are being pressed against thesuture retainer 880 with a predetermined force, ultrasonic vibrations are transmitted from thehorn 902 to thesuture retainer 880. The ultrasonic vibrations transmitted to thesuture retainer 880 create frictional heat and cause portions of the material of thesuture retainer 880 to be heated into the transition temperature range for the material. As the material of thesuture retainer 880 is heated into its transition temperature range, the material loses some of its rigidity and softens. The material of thesuture retainer 880 does not melt and become liquid. The heat in thesuture retainer 880 will tend to be concentrated adjacent to thegrooves major side surfaces - As the material of the
suture retainer 880 is heated and softened by the ultrasonic vibratory energy, themajor side surfaces anvil 900 andhorn 902. For example, the force applied to thesuture retainer 880 can be substantially between 1 to 20 lbs. As this occurs, the material of themajor side surfaces grooves suture retainer 880. - When this has occurred, the transmission of ultrasonic energy to the
suture retainer 880 is interrupted. However, the force applied against thesuture retainer 880top surface 882 andbottom surface 884 is maintained. It is believed that it may be desired to increase the force applied against thetop surface 882 andbottom surface 884 by theanvil 900 and horn 902 as the application of ultrasonic vibratory energy to thesuture retainer 880 is interrupted. While the clamping force applied by theanvil 900 andhorn 902 is maintained or increased, thedeformed suture retainer 880 secures the suture ends 896 and 898 without significant deformation of the suture. - To facilitate the flow of the plastically deformed sections of the
suture retainer 880 over the suture ends 896 and 898 and thesuture retainer grooves horn 902 can include shaped sections. Thehorn 902 includes a first and secondcurved section major side surfaces suture retainer 880. The first and secondcurved sections major side surfaces grooves - Embodiment of
FIG. 35 - Referring to
FIG. 35 , thesuture retainer 910 has a generally rectangular configuration and includes atop surface 912 and abottom surface 914, wherein the top surface includes a pair ofparallel grooves center extension 920 such that one each of the suture ends 922 and 924 are disposed in agroove - The
suture retainer 910 is positioned in an engagement with the suture, wherein the suture ends 922 and 924 are disposed with thegrooves suture retainer 910 is pressed against the body tissue with a predetermined force. This results in the body tissue being pressed between thesuture retainer 910 and the portion of the suture connected with the body tissue. A force distribution member could be provided between thesuture retainer 910 and body tissue if desired. - The
suture retainer 910 secures to the suture ends 922 and 924 using ultrasonic vibratory energy transmitted to thesuture retainer 910 as previously described in relation toFIGS. 34A-34B . However, in the present embodiment the heat in thesuture retainer 910 will tend to be concentrated adjacent to thecenter extension 920. As this occurs, the material of thecenter extension 920 of thesuture retainer 910 is plastically deformed and pressed over the suture ends 922 and 924 and thesuture retainer grooves - To facilitate the flow of the plastically deformed sections of the
suture retainer 910 over the suture ends 922 and 924 and thesuture retainer grooves horn 926 can include shaped sections. Thehorn 926 includes a first and secondcurved section point tip 932 for engaging the sutureretainer center extension 920. Thepointed tip 932 of thehorn 926 directs the ultrasonic energy into thecenter extension 920. As thecenter extension 920 is heated, the first and secondcurved sections deformed center extension 920 over the suture ends 922 and 924 and thesuture retainer grooves - It is contemplated that the horn can include any shaped section which focus the energy and directs the plastically deformed section of the suture retainer over the suture ends, securing the suture retainer and the suture end. Referring to
FIGS. 36A-36C , exemplary horn shapes are provided which include, but are not limited to, a convex surface, a concave surface, a triangular surface, inverted triangular surface, etc. - The suture retainer of the present invention can include a textured surface. The textured surface increases the surface area, thereby providing an increased bonding area. For example, as shown in
FIGS. 37A and 37B , the first sectionsecond surface 850 and the second sectionfirst surface 858 of thesuture retainer 840 includes a texture surface, namely a serrated surface. The textured surface increases surface areas of the first sectionsecond surface 850 and the second sectionfirst surface 858, providing an increased bonding area. The textured surface can include any geometric pattern which provides an increase in surface bonding area. Additionally, texture surface provides an increase in the surface friction between the suture retainer and the suture. - Embodiment of
FIG. 38 - Referring to
FIG. 38 , thesuture retainer 940 is a heat shrink material, wherein thesuture retainer 940 is wrapped around the suture 942. While the suture 942 is being pulled straight under the influence of tension in the suture due to the force and while thesuture retainer 940 is being pressed against the upper layer of body tissue or against a suitable force distribution member, thesuture retainer 940 is heated, causing the suture retainer to shrink around and grip thesuture 940. In accordance with one of the features of the invention, thesuture retainer 940 is heated by the application of ultrasonic vibratory energy to the suture retainer. The ultrasonic vibratory energy is converted into heat by the molecules of thesuture retainer 940. Thus, the mechanical ultrasonic vibrations applied against thesuture retainer 940 cause molecular vibration of the material of the suture retainer and a heating of the suture retainer. - The
suture retainer 940 can be substantially cylindrical in shape, wherein the suture ends 944 and 946 are inserted through thesuture retainer 940. Additionally, the suture retainer can be of other geometric shapes configured for receiving the suture. - Embodiment of
FIG. 39 - In the previous embodiments, a suture retainer and suture has been utilized to interconnect sections of a suture to secure tissue segments. In the embodiment of the invention illustrated in
FIG. 39 , the tissue securing system includes aretainer device 960 to secure body tissue, either soft body tissue to soft body tissue or soft body tissue to hard body tissue. - The
retainer device 960 includes first andsecond sections first section 962 includes anengagement member 968 and thesecond section 964 includes slottedmember 970 configured for receiving theengagement member 968. - The end portion of the
engagement member 968 has a pointed configuration. Thus, theengagement member 968 includes a flat side surface area which intersects a flat side surface area at a linear point or peak. Therefore, there is line contact between the end portion of theengagement member 968 and the second section slottedmember 970. - By forming the end portion of the
engagement member 968 with a pointed configuration, the end portion of theengagement member 968 is effective to function as energy director for ultrasonic vibratory energy. The pointed end portion of theengagement member 968 is effective to direct ultrasonic vibratory energy transmitted from thefirst section 962 to the second section slottedmember 970. The pointed configuration of the end portion of theengagement member 968 concentrates the energy and facilitates melting of the material of theengagement member 968. To a lesser extent, the material of thesecond section 964 of theretainer 960 is melted adjacent to the slottedmember 970. This results in a secure bonding and interconnection between the first andsecond sections 982 and 964 of theretainer 960. - The
retainer device 960 secures upper and lower layers of soft, human body tissue in linear apposition with each other. Thus, the two layers of human body tissue are approximated and held against movement relative to each other byretainer device 960. Pressing the two layers together with theretainer device 940 promotes healing of the tissue. - Although the
retainer device 960 has been described as being used to hold layers of soft tissue in linear apposition with each other, it is contemplated that the tissue securing system may be used in many different locations in a patient's body to secure tissue. For example, theretainer device 960 could be utilized to secure soft tissue such as a ligament or tendon against movement relative to a bone. Alternatively, theretainer device 960 could be utilized to interconnect portions of a flexible conduit, such as a blood vessel or intestine. It should be understood that theretainer device 960 may be used with either hard body tissue or soft body tissue or both hard and soft body tissue. - In use, the
retainer device 960 is used to secure the layers of soft tissue, by passing the first andsecond sections mid-section 966 of theretainer device 960 should proximate to the upper service of the upper tissue layer. - In accordance with a feature of this embodiment of the invention, the first and
second sections engagement member 968 is positioned within the slottedmember 970. The first andsecond sections second sections engagement member 968 and the slottedmember 970, allowing them to be plastically deformed and bonded together. The first andsecond sections - Embodiment of
FIGS. 40-47 - Referring to
FIGS. 40-47 thesuture retainer 1030 is utilized to fixedly interconnectopposite portions suture 1036. Theportions suture 1036 extend in opposite directions through theretainer 1030. Anintermediate portion 1038 of the suture extends between theportions body tissue 1040 to theretainer 1030. It should be understood that thesuture 1036 andretainer 1030 could be connected with each other and/or thebody tissue 1040 in a manner which is different than the specific manner illustrated inFIG. 40 . For example, theportions suture 1036 may extend in the same direction from theretainer 1030. - It is contemplated that the
suture 1036 andretainer 1030 may be utilized to securebody tissue 1040 in many different ways. For example, thesuture 1036 andretainer 1030 may be utilized to secure one piece of body tissue to another piece of body tissue. Thesuture 1036 andretainer 1030 may be utilized to secure soft body tissue to hard body tissue (bone). Thesuture 1036 andretainer 1030 may be utilized to connect hard body tissue to hard body tissue in the manner disclosed in U.S. Pat. No. 6,238,395. Thesuture 1036 andretainer 1030 may be disposed entirely within a patient's body or may engage a surface area on the patient's body. - It is contemplated that the
suture 1036 can be constructed of a single filament or of a plurality of filaments. Thesuture 1036 may be formed of biodegradable or nonbiodegradable material. Similarly, theretainer 1030 may be formed of biodegradable or nonbiodegradable material. - The
retainer 1030 includes a lower or base section 1046 (FIGS. 41 and 42 ) and an upper orcover section 1048. Theportions suture 1036 extend throughpassages 1052 and 1054 (FIGS. 41 and 46 ) formed between the upper andlower sections retainer 1030. Thepassages FIG. 46 ). Therefore, theportions suture 1036 can be readily pulled through thepassages retainer 1030 is in the initial or undeformed condition illustrated inFIG. 46 . It should be understood that thepassages FIG. 46 . - Once the
suture 1036 has been tensioned with a desired force, theretainer 1030 is plastically deformed in the manner illustrated schematically inFIG. 47 . This results in theportions suture 1036 being securely gripped between the lower andupper sections retainer 1030. Theportions suture 1036 are gripped with a clamping action which holds them against movement relative to each other and to theretainer 1030. This results in the desired tension being maintained in thesuture 1036. - The
lower section 1046 of theretainer 1030 includes a right (as viewed inFIG. 42 )recess 1058 and aleft recess 1060. The right and leftrecesses lower section 1046 of theretainer 1030. Although therecesses lower section 1046. - The
upper section 1048 has acircular body 1064 from which right (as viewed inFIG. 42 ) and leftprojections projections recesses 1058 and 1060 (FIGS. 43-46 ). Theprojections circular body 1064 of theupper section 1048 of theretainer 1030. Theprojections upper section 1048. It is contemplated that theprojections FIGS. 43-46 . - A
center projection 1072 is disposed on thelower section 1046 of theretainer 1030 at a location midway between the right and leftrecesses 1058 and 1060 (FIGS. 42, 43 and 46). The left andright projections upper section 1048 of theretainer 1030 are telescopically received in the right and leftrecesses lower section 1046 of the retainer 1030 (FIGS. 41, 42 , and 46). This results in theupper section 1038 of the retainer being positioned in a coaxial relationship with thelower section 1036 of the retainer. Thecenter projection 1072 is disposed midway between the right and leftprojections recesses recesses projections retainer 1048 with the longitudinal axes of the right and leftprojections center section 1072. - When the right and left
projections recesses 1058 and 1060 (FIG. 46 ), thecenter projection 1072 cooperates with the right and left projections to partially form thepassages FIG. 46 ) of thepassage 1052 is formed by agripper surface area 1078. The bottom of thepassage 1054 is formed by agripper surface area 1080. - The
gripper surface areas lower section 1046 face and are parallel togripper surface areas 1082 and 1084 (FIG. 46 ) on theupper section 1048. Thegripper surface areas projections parallel passages gripper surface areas suture 1036. - The right and left
projections inner side surfaces 1088 and 1090 (FIGS. 43 and 46 ). Theinner side surfaces projections gripper surface areas circular body 1064 of theupper section 1048 of theretainer 1030. In addition, the right and leftprojections 1068 and 1070 haveouter side surfaces inner side surfaces - The
center projection 1072 has parallel right and leftside surfaces gripper surface areas FIG. 43 ). When the right and leftprojections circular body 1064 of theupper section 1048 of theretainer 1030 are disposed in the right and leftrecesses FIG. 46 ), the right and leftside surfaces center projection 1072 extend parallel to theinner side surfaces projections - The
passages retainer 1030 are formed by flat surfaces on the lower andupper sections parallel passages suture 1036 as the suture is inserted into the passage. Thus, the leading end of theportion 1032 of the suture is directed by the side surfaces 1078, 1088, 1082, and 1098 (FIG. 46 ) formed on thelower section 1046,right projection 1066,body 1064 andcenter projection 1072 respectively. Similarly, the leading end of theportion 1034 of thesuture 1036 is directed by the side surfaces 1080, 1090, 1084 and 1096 formed on thelower section 1046, leftprojection 1068,body 1064 andcenter projection 1072. By forming thepassages portions suture 1036 into the passages is facilitated. This is because once aportion suture 1036 has been inserted into one of thepassages - The
center projection 1072 is effective to position theportions suture 1036 so that they are disposed on opposite sides of and equal distances from a central axis of theretainer 1030. This results in off setting movements being applied to theretainer 1030 by forces transmitted to the retainer from theportions suture 1036. Therefore, there is little or no tendency for theretainer 1030 to rotate or flip relative to thebody tissue 1040. - The right and left
projections upper section 1048 of theretainer 1030 are disposed in therecesses lower section 1046 of the retainer 1078 (FIG. 46 ) during insertion of theportions suture 1036 into thepassages retainer 1030. To hold theprojections recesses outer side surface 1102 of the right recess 1058 (FIG. 56 ) and aninner side surface 1104 of the right recess is slightly less than the distance between theouter side surface 1092 andinner side surface 1088 on theright projection 1066. The resulting interference between theright projection 1066 and theright recess 1058 is effective to hold the right projection in the right recess. - Similarly, the
left recess 1060 has parallel outer andinner side surfaces inner side surfaces left recess 1060 are spaced apart by distance which is slightly less than the distance between theouter side surface 1094 andinner side surface 1090 on theleft projection 1068. When theleft projection 1068 is pressed into theleft recess 1060, the resulting interference between the side surfaces 1090 and 1094 on theprojection 1068 and the side surfaces 1110 and 1112 on therecess 1060 hold the left projection in the left recess. The side surfaces 1102, 1104, 1110 and 1112 on therecesses center projection 1072 and perpendicular to thegripper surface areas lower section 1046. - The interference fit between the
projections upper section 1048 of the retainer with therecesses lower section 1046 of the retainer holds the two sections of the retainer against movement relative to each other during insertion of theportions suture 1036 into thepassages upper section 1048 andlower section 1046 of theretainer 1030 may be held against movement relative to each other by means other than an interference fit. For example, latch surfaces on theprojections recesses lower section 1046 of the retainer and theprojections upper section 1048 of the retainer to hold the upper section against movement relative to the lower section. - The
lower section 1046 andupper section 1048 of theretainer 1030 are formed as two separate pieces. However, it is contemplated that the lower andupper sections retainer 1030 could be formed as one piece. If this is done, relatively weak connectors may be provided between theprojections base section 1046 to hold the base andupper sections portions suture 1036 into thepassages portions suture 1036 to be gripped between theretainer sections base section 1046 andupper section 1048. By deflecting the strap, theprojections recesses - When the right and left
projections right recess 1058 and leftrecess 1060, the leading or lower (as viewed inFIG. 46 ) end portions of the projections engageflat bottom surfaces recesses 1058 and 1060 (FIG. 56 ). Theflat bottom surfaces gripper surface areas lower section 1046 and perpendicular to the side surfaces 1102, 1104, 1110 and 1112 of therecesses end portions projections bottom surfaces recesses upper sections passages passages portions suture 1036 to enable the suture to be readily inserted into the passages. - The
center projection 1072 has a flatupper side surface 1130 which extends parallel to the gripper surfaces 1078, 1080, 1082 and 1084. Theupper side surface 1130 on thecenter projection 1072 is spaced from theupper section 1048 when theend portions projections bottom surfaces recesses center projection 1072 may be disposed in engagement with theupper section 1048 when theend portions projections bottom surfaces recesses - When the
end portions projections bottom surfaces recesses portions passages retainer 1060 to be slid along thesuture 1036 to a desired position relative to thebody tissue 1040. Theretainer 1030 may be slid along thesuture 1036 under the influence of force manually applied against the retainer or under the influence of force applied against the retainer by a surgical instrument, such as forceps. As this occurs, the intermediate portion 1038 (FIG. 40 ) of the suture is tightened around the body tissue with a desired force. - Once the
retainer 1030 has been positioned in a desired location relative to thebody tissue 1040 and thesuture 1036 tensioned with a predetermined force, the retainer is plastically deformed from the initial condition illustrated inFIG. 46 to the condition illustrated inFIG. 47 . Plastic deformation of theretainer 1030 results in the size of thepassages upper side 1130 on thecenter projection 1072 moves into engagement with theupper section 1048 of theretainer 1030. Engagement of thecenter projection 1072 with theupper section 1048 of theretainer 1030 tends to limit the extent to which the lower andupper section retainer 1030. - If the
retainer 1030 is constructed so that thecenter projection 1072 engages theupper section 1048 of the retainer when theend portions projections bottom surface areas recesses FIG. 46 to the condition ofFIG. 47 . With this construction of theretainer 1030, thecenter projection 1072 would be deformed to the same extent as theprojections center projection 1072 may be formed with an upper end portion which has the same configuration as thelower end portions projections 1066 and 10168. - To plastically deform and interconnect the lower and
upper sections retainer 1030, a member 1140 (FIG. 47 ) is moved into agroove 1142 in thelower section 1046. Themember 1140 acts as an anvil to hold thelower section 1048 during welding. Themember 1040 is shown as a bar, it is also contemplated that themember 1040 can be a flat plate for engaging the flat outside surface of thelower section 1046, wherein the plate can include a lip around its peripheral edge to prevent thelower section 1046 from moving during welding. - In addition, a
second member 1144 engages a flat outer side surface 1146 on theupper section 1048 of theretainer 1030. The lower andupper sections retainer 1030 are firmly pressed together by force transmitted between themembers upper sections retainer 1030 are gripped between themembers member 1144 to theretainer 1030. - The energy applied to the
retainer 1030 is effective to heat theend portions projections retainer 1030 by themembers 1140 and 1144 (FIG. 47 ) causes the heat softened material of theprojections recesses lower section 1046 is heated and also flows in therecesses - As this occurs, the heated material of the
projections portions suture 1036. The heated material tends to bond to theportions suture 1036. It should be understood that the extent of deformation and flow of the heat softened material of theprojections FIG. 47 . - If the
retainer 1030 is constructed so that thecenter projection 1072 is deformed to the same extent as theprojections passages upper section 1048 of theretainer 1030 has the construction shown inFIG. 43 , the upper end portion of the center projection would engage the flat lower side surface of thebody 1064. However, theupper section 1048 of theretainer 1030 may be formed with a recess to receive the upper end portion of thecenter projection 1072. This recess may have the same configuration as therecesses lower section 1046 of theretainer 1030. - If desired, the
retainer 1030 may be constructed with thecenter projection 1072 extending from theupper section 1048 of the retainer. If this is done, thecenter projection 1072 from theupper section 1048 of the retainer may have the same configuration as the illustrated configuration of the center projection inFIGS. 43 and 44 . A recess may be provided in thelower section 1046 to receive a portion of a center projection from theupper section 1048 of theretainer 1030. - As the heated material of the
projections recess passages portions suture 1036 being firmly clamped between thegripper surface areas lower section 1046 and thegripper surface areas upper section 1048 of theretainer 1030. The force applied to theportions suture 1036 by thegripper surface areas upper sections retainer 1030 is effective to deform the suture from the circular cross sectional configuration illustrated inFIG. 46 to a generally oval cross sectional configuration illustrated schematically inFIG. 47 . Although the illustratedsuture 1036 is a monofilament, it is contemplated that the suture could be formed by a plurality of filaments which are braided or twisted together. - The energy which is applied to the
retainer 1030 by themember 1144 may be thermal energy, vibratory energy, or light energy. The energy may be transmitted by radio frequency waves, ultrasonic waves, heat waves, or light waves. The energy may be vibratory ultrasonic, light, heat, or radio frequency energy. Rather than positioning themember 1140 in thegroove 1142 in thelower section 1046 of theretainer 1030, thegroove 1142 may be omitted and a flat member, similar to themember 1144, may be pressed against thelower section 1046 of theretainer 1030. Energy may be transmitted to the retainer through either themember 1140 or themember 1144 or both of themembers - In the embodiment of the invention illustrated in
FIG. 47 , theportions suture 1036 are clamped between thelower section 1046 andupper section 1048 of theretainer 1030. The clamping force applied against theportions suture 1036 by theretainer 1030, holds the retainer and the portions of the suture against relative movement. This results in thesuture 1036 andretainer 1030 being securely interconnected. - There is some bonding of material of the retainer to the
portions suture 1036 to further interconnect suture and the retainer. However, the amount of force and energy transmitted from themember 1140 or both of themembers retainer 1030 is sufficient to effect a plastic deformation of the material of the retainer without excessive plastic deformation of the material of thesuture 1036. By avoiding excessive deformation of the material of thesuture 1036, weakening of the suture is avoided. Thus, once the plastic deformation of theretainer 1030 has been effected by the transmission of force and energy to the retainer, the lower andupper sections suture 1036 without significantly weakening of the suture. - The
end portions projections projection 1066 includes a flatside surface area 1150 which intersects a flatside surface area 1152 at a linear point or peak. Therefore, there is line contact between theend portion 1124 of theright projection 1066 and theflat bottom surface 1118 of theright recess 1058. Similarly, theend portion 1126 of the left projection 1168 has aflat side surface 1156 which intersects aflat side surface 1158 at a linear point or peak on theend portion 1126 of theleft projection 1068. This results in line contact between the pointed end portion of theleft projection 1068 and theflat bottom surface 1120 of theleft recess 1060. However, theend portions projections - By forming the
end portions projections pointed end portions 1124 and 1026 of the right and leftprojections member 1144 to the ends of the projections and to thebottom surfaces recesses end portions projections lower section 1046 of theretainer 1030 is melted adjacent to thebottom surfaces upper sections retainer 1030. - Referring to
FIG. 29 , the suture retainer illustrated inFIGS. 40-47 includes substantiallyflat edges 730, having a non-circular cross section when viewed from the top or the bottom surface. Additionally, the top or bottom surface can include a convex or concave surface. - Although generally shown as using ultrasonic energy, it is understood that in other embodiments the types of energy or combination of energies can be utilized to heat the suture retainer, suture, and retainer device. These types of energy or combination of energies can include, but not be limited to, radio frequency (RF) energy, laser energy, infrared energy, microwave energy, ultrasound energy, and contact heating energy.
- It is contemplated that the viable cells may be incorporated or positioned on the suture retainer of the present invention. The viable cells may be any desired type of viable cells. It is contemplated that the viable cells may correspond to cells which were in a damaged organ or other portion of a patient's body. More than one type of viable cell may be positioned on the suture retainer.
- When the suture retainer is to be positioned in an organ, it is contemplated that the viable cells on the suture retainer will have characteristics associated with the characteristics of normal cells in the organ in which the support structure is to be positioned. Many organs contain cells which have different characteristics and perform different functions within the organ. It is contemplated that the viable cells on the suture retainer may have different characteristics corresponding to the different characteristics of cells of an organ. When the suture retainer is to be positioned outside of an organ, the cells positioned on the support structure may have any desired characteristic or combination of characteristics.
- It is also contemplated that the viable cells can be pluripotent cells that are directed to differentiate into the desired cell type or types. One example of such cells is stem cells. The differentiation can be controlled by applying or exposing the cells to certain environmental conditions such as mechanical forces (static or dynamic), chemical stimuli (e.g. pH), and/or electromagnetic stimuli.
- More than one type of cell may be positioned on the suture retainer. The type of cell positioned at a particular location on the suture retainer will be determined by the orientation of the support structure in a patient's body and by the specific type of tissue desired at a particular location in a patient's body. For example, stromal cells may be positioned at a location where foundation tissue is desired and another type of cell may be positioned at locations where it is desired to have tissue perform a special function.
- In order to promote the attachment of the viable cells to the suture retainer, the suture retainer can be pretreated with an agent that promotes cell adhesion. One such agent is an organic substance based on a biofilm. A biofilm is a slimy, glue-like substance that forms when bacteria attach to surfaces exposed to water. Typically, colonies of biofilm bacteria are unwanted as they carry out a variety of detrimental reactions. However, a sterile biofilm may be used to promote initial attachment of cells to the suture retainer.
- The sterile biofilm could be engineered to isolate the glue-like substance while eliminating the adverse properties of the bacteria. The resulting sterile glue-like substance would be used to help the cells stick to the suture retainer. The engineered biofilm could be added to the suture retainer in the laboratory that produces the suture retainer or just prior to the addition of the cells by the user. Alternatively, the biofilm and suture retainer could be combined intra-corporally.
- This biofilm also could be used as an independent polysaccharide based adhesive with mild to moderate adhesion forces. The biofilm could serve as a surgical adhesion or grouting for cells, for tissue fixation (soft tissue to soft tissue, soft tissue to bone, etc.) and as a sealant.
- Additionally, it is contemplated that pharmaceutical agents such as tissue inductive growth factors, additives, and/or other therapeutic agents may be provided on or incorporated into the suture retainer of the present invention. Such additives may include materials such as plasticizers, citrate esters, hexametholsebacate, antibiotics (e.g., tetracyclines, penicillins, mefronidazole, clindamycin, etc.), to prevent infection, etc., or to accomplish other desired conditions or results, including for example, tissue inductive growth factors to promote a growth of tissue. Addition additives or therapeutic agents include osteoinductive, biocidal, or anti-infection substances. Suitable osteoinductive substances include, for example, growth factors. The growth factors may be selected from the group of IGF (insulin-like growth factors), TGF (transforming growth factors), FGB (fibroblast growth factors), EGF (epidermal growth factors), BMP (bone morphogenic proteins), and PDGF (platelet-derived growth factors).
- The inductive growth factors, additives, and/or other therapeutic agents may be provided on or incorporated into the suture retainer prior to connection to the suture. Alternatively, the inductive growth factors, additives, and/or other therapeutic agents may be provided on or incorporated after connection to the suture.
- Embodiment of
FIG. 48-55 - Referring to
FIGS. 48-51 , the ultrasonicenergy application apparatus 640 ofFIG. 25 includes a rigidenergy transmission member 1170 and a rigid tubularforce transmitting member 1172 extends around and is coaxial with the cylindricalenergy transmission member 1170. A biasingassembly 1174 continuously urges theforce transmitting member 1172 toward the left (as viewed inFIG. 48 ) with a constant predetermined force. The illustrated embodiment of the biasingassembly 1174 includes ahelical spring 1176 which is disposed between anannular flange 1178 on areaction member 1180 and anannular piston 1182. Theannular piston 1182 is fixedly connected to ahousing 1184. Thehousing 1184 is connected to the tubularforce transmitting member 1172. Thereaction member 1180 is fixedly connected to a manually engagable handle 11186. - A
trigger 1188 is pivotally connected with thehandle 1186. Thetrigger 1188 is manually pivotal in a clockwise direction (as viewed inFIGS. 48 and 50 ). Clockwise pivotal movement of thetrigger 1188 transmits force through ayoke 1190. The force transmitted through theyoke 1190 moves thehousing 1184 toward the right (as viewed inFIGS. 48 and 50 ). This rightward movement of thehousing 1184 moves aflange 1192 on the right (as viewed inFIGS. 48 and 51 ) or distal end of the tubularforce transmitting member 1172 away from acircular end surface 1194 on theenergy transmission member 1170. Theflange 1192 is shown as bar, it is also contemplated that themember 1040 can be a flat plate for engaging the flat outside surface of the suture retainer, wherein the plate can include a lip around its peripheral edge to prevent the movement of the suture retainer during welding. - The rightward (as viewed in
FIGS. 48 and 51 ) movement of theforce transmitting member 1172 relative to theenergy transmission member 1170 increases space between theflange 1192 andend surface 1194 on theenergy transmission member 1172. Increasing the space between theflange 1192 and theend surface 1194 enables the retainer to be positioned between theflange 1192 and theend surface 1194. - Once the retainer has been positioned in the space between the
flange 1192 and theend surface 1194 on the energy transmission member 1170 (FIGS. 48 and 51 ), thetrigger 1188 is released. When thetrigger 1188 is released, thebiasing spring 1176 is effected to urge thehousing 1184 toward the left (as viewed inFIGS. 48 and 50 ). The leftward force applied by thespring 1176 against thehousing 1184 is transmitted through theforce transmitting member 1172 andflange 1192 to the retainer. This results in the retainer being clamped between theflange 1192 on theforce transmitting member 1172 andend surface 1194 on theenergy transmission member 1170. Thespring 1176 is effective to apply a constant predetermined biasing force to thepiston ring 1182. This constant biasing force is transmitted through thehousing 1184 andforce transmitting member 1172 to the retainer. - While the retainer is gripped with a predetermined constant force by the
applicator assembly 640, the retainer is moved to a desired position relative to the body tissue. To position the retainer relative to the body tissue, the surgeon holds thehandle 1186 of theapplicator assembly 640 in one hand and tensions the suture with the other hand. The surgeon then manually applies force against thehandle 1186 to slide the retainer along the tensioned suture toward the body tissue. The relatively longforce transmitting member 1172 andenergy transmitting member 1170 enable theapplicator assembly 640 to move the retainer through a small incision to a remote location in a patient's body as the retainer slides along the suture. - During performance of a surgical procedure, the suture may be moved through a cannula to a location disposed within a patient's body. The suture is then positioned relative to the tissue at the remote location in the patient's body. However, it should be understood that the cannula may be omitted and the suture moved through an open incision.
- Once the suture has been moved to the desired location relative to the tissue in the patient's body, the suture may be positioned in the retainer while the retainer is disposed outside of the patient's body. Once the suture has been positioned in the retainer, the retainer is gripped by the
applicator assembly 640. Theflange 1192 on theforce transmitting member 1172 andend surface 1194 on theenergy transmission member 1170 of theapplicator assembly 640 are effective to apply a predetermined constant force against opposite sides of the retainer to securely grip the retainer with theapplicator assembly 640. - While the retainer is gripped by the
applicator assembly 640, the suture is manually tensioned and the retainer is slid along the suture toward the body tissue. As the retainer is slid along the suture toward the body tissue, theapplicator assembly 640 moves the retainer into the patient's body. As the retainer is moved into the patient's body, it is gripped with a constant predetermined force by theapplicator assembly 640. - Alternatively, the retainer may be gripped by the
applicator assembly 640 outside of the patient's body prior to positioning of the suture with the retainer. The suture may then be positioned in the retainer while the retainer is gripped by theapplicator assembly 640. If desired, positioning of the suture in the retainer may be performed with the retainer inside the patient's body. - If the
applicator assembly 640 is utilized to move the retainer through a cannula into the patient's body before the suture is positioned the retainer, suitable instruments may be utilized to grip the suture in the patient's body and to move the suture through the retainer. The instruments which engage the suture and move it through the retainer while the retainer is gripped by theapplicator assembly 640, may extend through the cannula along with the applicator assembly. Alternatively, the instruments which move the suture through the retainer may be moved into the patient's body through a cannula spaced from the cannula through which theapplicator assembly 640 moves the retainer into the patient's body. In order to minimize incisions in the patient's body, it may be preferred to utilize a single cannula to accommodate movement of the applicator assembly 1640, retainer, suture positioning instruments, and the suture into the patient's body. - Once the retainer has been positioned in a desired relationship with body tissue and the suture, the suture is pulled with a predetermined force. This results in a predetermined tension being established in the suture. While the predetermined tension is maintained in the suture, the retainer is connected to suture, holding the suture against movement relative to the retainer. To effect plastic deformation of the retainer and connection of the retainer with the suture, energy is transmitted from an energy source 1196 (
FIG. 48 ) through theenergy transmission member 1170 to the retainer. At this time, the retainer is clamped between theflange 1192 on theforce transmitting member 1172 and theend surface 1194 on the energy transmission member 11170. - In the illustrated embodiment of the
applicator assembly 640, theenergy source 1196 is a source of ultrasonic vibratory energy at a frequency above that which can normally be detected by the human ear, that is about 16 to 20 kilohertz. Although there are a wide range of frequencies which may be utilized, it is believed that it may be desirable to use ultrasonic energy having a frequency of between 20 kilohertz and 70 kilohertz. It is believed that it may be desired to use ultrasonic vibratory energy of a frequency between 39.5 and 41 kilohertz. When an actuated switch 1198 (FIG. 48 ) is closed, ultrasonic vibratory energy is transmitted through theenergy transmission member 1170 to the retainer. The ultrasonic vibratory energy creates frictional heat which is effective to heat material of the retainer into its transition temperature range while the material of the suture remains at a temperature below its transition temperature range. The actuatedswitch 1198 can be external to theapplicator assembly 640, for example, a foot peddle, or incorporated into theapplicator assembly 640, for example a bottom of trigger. - However, it should be understood that even the entire transition temperature range for the suture could be co-extensive with the transition temperature range for the retainer. In fact, the transition temperature range of the suture could extend below the transition temperature range of the retainer. However, it is believed that it may be preferred to have the transition temperature range for the suture above at least a portion of the transition temperature range of the retainer.
- Although one specific preferred embodiment of the
applicator assembly 640 has been illustrated inFIGS. 49-51 , it is contemplated that the applicator assembly could have a different construction and/or mode of operation. For example, theapplicator assembly 640 may have any one of the constructions and mode of operations disclosed in U.S. Pat. No. 6,585,750, the contents of which are incorporated herein by reference. - The leading end portion of the force transmitting member 1172 (
FIG. 51 ) extends part way around theend surface 1194 on theenergy transmission member 1170. This results in the formation of ashield 1200 which extends part way around the retainer when the retainer is clamped between theflange 1192 and theend surface 1194 on theenergy transmission member 1170. Theshield 1200 has aninner side surface 1202 which forms a portion of a cylinder. Theside surface 1202 engages the periphery of the retainer to position the retainer relative to theenergy transmission member 1170 in a direction transverse to a longitudinal central axis of the energy transmission member. - The
shield 1200 is effective to at least partially block engagement of body tissue with the retainer as the retainer is positioned in a patient's body and as energy is transmitted to the retainer from theenergy transmission member 1170. It is contemplated that theshield 1200 could be constructed in such a manner as to extend completely around the retainer. This would allow use of theapplicator assembly 640 in a moist environment or in an aqueous environment in which the retainer is completely or almost completely submerged in liquid. - The
force transmitting member 1172 has aflange 1192 which engages the retainer. However, it is contemplated that theflange 1192 could be eliminated and a circular end plate provided at the distal end of theforce transmitting member 1172. The use of a plate would provide for a wider area of engagement of theforce transmitting member 1172 with the retainer. - Referring to
FIGS. 52-55 , the ultrasonicenergy application apparatus 640 has been provided with an elongated,tubular sleeve member 1204 defining a passage therethrough, wherein thesleeve member 1204 is slidable over theforce transmitting member 1172. Thesleeve member 1204 includes a proximal end and a distal end, wherein the proximal end includes achannel 1206 for engaging apin 1208 positioned on theforce transmitting member 1172. Thechannel 1206 andpin 1208 cooperate to limit the range of motion of thesleeve member 1204 over theforce transmitting member 1172. In a first position, the distal end of thesleeve member 1204 is positioned to provide access to the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172, for insertion and removal of the suture retainer. In a second position, the distal end of thesleeve member 1204 covers the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172 for the application of ultrasonic energy. Thesleeve member 1204 acts to protect the suture and adjacent tissue from the ultrasonic energy by shielding them from the ultrasonic energy while in the second position. - The proximal end of the
sleeve member 1204 further includes acollar member 1210 having at least onenotch 1212 configured to receive the suture. Thecollar member 1210 maintains the tension on the suture. For example, in a method of use thesleeve member 1204 is manually slid into the first position, providing access to the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172. Thesuture 1214 is then positioned in relation to thesuture retainer 1216 and thesuture 1214 and theretainer 1216 are positioned in the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172, where thesuture 1214 andretainer 1216 are disposed between theend surface 1194 and theflange 1192. The suture leads 1218 a position in thecollar member notches 1212, tensioning thesuture 1214. Thetrigger 1188 is released, such that thebiasing spring 1178 is effected to urge thehousing 1184 to the left (as viewed inFIGS. 48 and 50 ). The force applied by thehousing 1184 is transmitted through theforce transmitting member 1172 andflange 1192 to theretainer 1216. Thesleeve member 1204 is moved to the second position, wherein the distal end of thesleeve member 1204 covers the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172. In the second position, thesleeve member 1204 forces thesuture 1214 away from theend surface 1194 of theenergy transmission member 1170. The non-engaged portion of thesuture 1214 is positioned along the outer surface of thesleeve member 1204 and engages thenotch 1212 in thecollar member 1210. The ultrasonic energy is provided to theend surface 1194 of theenergy transmission member 1170, securing theretainer 1216 to thesuture 1214. - To remove the coupled
suture 1214 andsuture retainer 1216, thesleeve member 1204 is moved to the first position, providing access to the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172. Thetrigger 1118 is positioned to move thehousing 1184 to the right (as viewed inFIGS. 48 and 50 ). The rightward movement of thehousing 1184 separates theforce transmitting member 1172 andflange 1192 to theretainer 1216. Thesuture 1214 andretainer 1216 are removed from the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172. - It is further contemplated that the
sleeve member 1204 includes a bias member, wherein the bias member biases the sleeve member into the second position. Thesleeve member 1204 is manually slid into the first position, providing access to the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172. Thesuture 1214 is then positioned in relation to theretainer 1216 and thesuture 1214 and theretainer 1216 are positioned in the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172, where thesuture 1214 andretainer 1216 are disposed between theend surface 1194 and theflange 1192. Thesleeve member 1204 can be held in the first position, for example, by thepin 1208 engaging a locking notch in thechannel 1206. - Alternatively, the
sleeve member 1204 includes a bias member, wherein the bias member biases thesleeve member 1204 into the first position, providing access to the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172. Thesuture 1214 is then positioned in relation to theretainer 1216 and thesuture 1214 and theretainer 1216 are positioned in the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172, where thesuture 1214 andretainer 1216 are disposed between theend surface 1194 and theflange 1192. Thesleeve member 1204 is manually slid into the second position, wherein the distal end of thesleeve member 1204 covers the gap between theend surface 1194 on theenergy transmission member 1170 and theflange 1192 connected with theforce transmitting member 1172. Thesleeve member 1204 can be held in the second position, for example, by thepin 1208 engaging a locking notch in thechannel 1206. - In an embodiment, the ultrasonic
energy application apparatus 640 includes a safety switch. The safety switch is operably connected to thesleeve member 1204 and theforce transmitting member 1172, such that the safety switch can prevent theenergy source 1196 from transmitting ultrasonic vibratory energy to theenergy transmission member 1170 when thesleeve member 1204 is in the first position. For example, when thesleeve member 1204 is in the first position, the safety switch is actuated into an “OFF” position, preventing theenergy source 1196 from supplying ultrasonic vibratory energy to theenergy transmission member 1170. This places the ultrasonicenergy application apparatus 640 in a “SAFE MODE.” When thesleeve member 1204 is moved into the second position, the safety switch is actuated into an “ON” position, allowing theenergy source 1196 to transmit ultrasonic vibratory energy to theenergy transmission member 1170. The actuation of the safety switch to the “ON” position does not initiate the transmission of energy to theenergy transmission member 1170, but instead places the ultrasonicenergy application apparatus 640 in an “ACTIVE MODE,” wherein theenergy source 1196 is capable of transmitting energy to theenergy transmission member 1170. - Embodiment of
FIGS. 56-69 - Referring to
FIG. 56 , theenergy application apparatus 640 ofFIG. 25 includes ahandle assembly 1300 and acontroller assembly 1302 removable attachable thereto. Thecontroller assembly 1302 is slidably positionable on thehandle assembly 1300, providing a substantially constant force to a suture retainer disposed therein. - Referring to
FIGS. 57 and 58 , thehandle assembly 1300 includes ahandle 1304 having anose portion 1306 with agroove 1308 there around. Anend effector 1310 is connected to thehandle 1304, through thenose portion 1306, being operably connected to an energy source. Theend effector 1310 transmits the energy from the energy source to atip 1312 portion of theend effector 1310. The endeffector tip portion 1312 includes atip protrusion 1314 for engaging a portion of the suture retainer. - A
plunger key 1316 is positioned about theend effector 1310, adjacent to thehandle nose portion 1306. Theend effector 1310 includes flattenside portions 1318 configured for receiving theplunger key 1316, thereby preventing the plunger key 1316 from rotating about theend effector 1310. Theplunger key 1316 includes arectangular protrusion 1320 for engaging and properly aligning thecontroller assembly 1302. - Referring to
FIG. 59 , thecontroller assembly 1302 includes atubular section 1322 operably connected to acontroller 1324. Thetubular section 1322 is dimensioned to slide over theend effector 1310, such that the endeffector tip portion 1312 is substantially positioned in anend portion 1326 of thetubular section 1322. Theend portion 1326 of thetubular section 1322 is configured to receive a suture retainer, which can thereby prevent movement of the suture retainer within thetubular section 1322. For example, theend portion 1326 of thetubular section 1322 can include adove tail configuration 1327 for receiving a corresponding shaped suture retainer (SeeFIG. 60 ). Thetubular section 1322 is effective to at least partially protect the suture and adjacent tissue from the energy transmitted through theend effector 1312 as the suture retainer is positioned in a patient's body. - The
controller 1324 includes atension lever 1328 pivotally connected thereto. Thetension lever 1328 is operatively connected to thetubular section 1322, such that a substantially constant force is applied to a suture retainer position in thetubular section 1322 between the tubularsection end portion 1326 and the endeffector tip portion 1312. The operative connection between thetubular section 1322 and thetension lever 1328 includes abias member 1330 for applying the substantially constant force to the suture retainer. The tensionlever bias member 1330 compresses the suture retainer between the tubularsection end portion 1326 and the endeffector tip portion 1312 with a compressive force of about 1 lb. to 20 lbs. This range of compressive force has been found to be particularly effective with ultrasonic and or R F energy. However, higher or lower forces can be applied if desired. - The
controller assembly 1302 further includes alatch assembly 1332 for connecting thecontroller assembly 1302 to thehandle assembly 1300. Thelatch assembly 1330 include alatch post 1334 rotatably mounted in thecontroller 1324. Thelatch post 1334 is substantially cylindrical in shape, having a radius dimensioned for engaging thegroove 1308 in thehandle nose portion 1306. Thelatch post 1334 includes a flattenedsection 1336, such that when the flattenedsection 1336 is adjacent to the handlenose portion groove 1308 thelatch post 1334 does not engage the handlenose portion groove 1308, allowing for removal of thecontroller assembly 1302 for thehandle assembly 1300. (See alsoFIG. 61 ). Alatch lever 1338 is connected to thelatch post 1334 for selectively rotating thelatch post 1334 for engaging and disengaging the handlenose portion groove 1308. Abias member 1340 is positioned about thelatch post 1334, biasing thelatch post 1334 in an engaging position. - Referring to
FIGS. 61 and 62 , thecontroller assembly 1302 is connected to thehandle assembly 1300 by sliding theend effector 1310 through thecontroller 1324 into thetubular section 1322. Thecontroller assembly 1302 is slid over thehandle assembly 1300 until therectangular protrusion 1320 of the plunger key 1316 slibably engages a slottedsection 1342 of thecontroller 1324, aligning thecontroller assembly 1300 on thehandle assembly 1302. Thelatch lever 1328 is actuated, positioning thelatch post 1334 in a non-engaging position. Thecontroller assembly 1302 is slid over thehandle assembly 1300 until thelatch post 1334 is positioned adjacent to the handlenose portion groove 1308. Thelatch lever 1338 is released such that thelatch post 1334 engages the handlenose portion groove 1308, securing thecontroller assembly 1302 to thehandle assembly 1300. - To load a suture retainer in the
energy application apparatus 640 of the present invention, thetension lever 1328 is actuated, opening a gap between the tubularsection end portion 1326 and the endeffector tip portion 1312. A suture retainer is positioned between the gap between the tubularsection end portion 1326 and the endeffector tip portion 1312. Thetension lever 1328 is released, closing the gap, with theend effector 1310 pressing against the suture retainer. Thetip protrusion 1314 on the endeffector tip portion 1312 will engage an upper section of the suture retainer, capturing the upper section of the suture retainer. This enables the upper section of the suture retainer to be separated from a lower section of the suture retainer when thetension lever 1328 is actuated. - When the suture retainer is in the separated position, the
energy application apparatus 640 securely holds the upper and lower sections of the suture retainer, preventing the upper and lower sections from being dislodged from theenergy application apparatus 640 into the body. The separation of the upper and lower sections of the suture retainer advantageously allows the suture to be loaded intra-corporally from the front into the suture retainer, without the suture having to be threaded through the suture retainer. For example, theenergy application apparatus 640 is positioned in the body, wherein the retainer sections are disposed about the suture. Thetension lever 1328 is released, closing the upper and lower suture retainer sections about the suture. The suture can be loaded extra-corporally into the suture retainer in a similar fashion. - Referring to
FIG. 63 , tensionlever bias member 1330 can be a spring 1346 inside thecontroller 1324, interposed betweentubular section 1322 and aring key 1348. The ring key 1348 assists in aligning thetubular section 1322 with thecontroller 1324. Thetension lever 1328 is used to compress the spring 1346, opening the gap between the tubularsection end portion 1326 and the endeffector tip portion 1312. - Referring to
FIGS. 63 and 64 , asuture tensioner 1350 is provided on thetubular section 1322. Thesuture tensioner 1350 places a substantially constant tension on a suture lead. Thesuture tensioner 1350 includes aprojection 1352 having apulley portion 1354 and acleat portion 1356. The suture is threaded about thepulley portion 1354 and pulled downward, being cinched in thecleat portion 1356. Thesuture tensioner 1350 includes abias member 1358 allowing thesuture tensioner 1350 to be displaced about 0.5 inches on thetubular section 1322 and providing a 2-10 lb. tension to the suture. Thebias member 1358 can be aspring 1360 within thesuture tensioner 1350, interposed between thesuture tensioner 1350 and aring key 1362. It is envisioned that one ormore suture tensioners 1350 can be provided on thetubular section 1322. The use of thesuture tensioner 1350 to hold the suture, frees up the surgeon from holding the suture, maintaining the predetermined force on the suture during the connection of the suture retainer to the suture. - Referring to
FIG. 65 , asuture retainer 1364 is utilized to fixedly interconnect opposite portions a suture.Suture retainer 1364, like other suture retainers disclosed herein, and those known in the art, can be used withenergy application apparatus 640. The suture retaining can also be used with other energy applicators. Thesuture retainer 1364 includes an upper orcover section 1368 and a lower orbase section 1370. The suture extends throughpassages lower sections suture retainer 1364. Thepassages passages suture retainer 1364 is in the initial or undeformed condition illustrated. It should be understood that thepassages - Referring to
FIGS. 65 and 66 , theupper section 1368 of thesuture retainer 1364 has a rectangular body from which first andsecond projections second projections upper section 1368 of thesuture retainer 1364. Although the first andsecond projections projections upper section 1368. - Referring to
FIGS. 65 and 67 , thelower section 1370 has a rectangular body including first andsecond recesses second recesses second projections upper section 1368. The first andsecond recesses lower section 1370 of thesuture retainer 1364. The first andsecond recesses lower section 1370. It is contemplated that the first andsecond recesses - A
center projection 1384 is disposed on thelower section 1370 of thesuture retainer 1364 at a location midway between the first andsecond recesses second projections upper section 1368 of thesuture retainer 1364 are telescopically received in the first andsecond recesses lower section 1370 of thesuture retainer 1364. This results in thelower section 1370 being positioned in a coaxial relationship with theupper section 1368 of thesuture 1364. Thecenter projection 1384 is disposed midway between the first andsecond projections second recesses second recesses second projections upper section 1368 with the longitudinal axes of the first andsecond projections center section 1384. - When the first and
second projections second recesses center projection 1384 cooperates with the first andsecond projections passages passages passages - The
center projection 1384 is effective to position the suture so that end portions of the suture are disposed on opposite sides of and equal distances from a central axis of thesuture retainer 1364. This results in off setting movements being applied to thesuture retainer 1364 by forces transmitted to thesuture retainer 1364 from the suture. Therefore, there is little or no tendency for thesuture retainer 1364 to rotate or flip relative to the body tissue. - The first and
second projections upper section 1368 of thesuture retainer 1364 are disposed in the first andsecond recesses lower section 1370 of thesuture retainer 1364 during insertion of the suture into thepassages suture retainer 1364. To hold theprojections recesses projections recesses first recess 1380 is slightly less than the distance between and outer side surface and inner side surface on thefirst projection 1376. The resulting interference between thefirst projection 1376 and thefirst recess 1380 is effective to hold thefirst projection 1376 in thefirst recess 1380. - Similarly, the
second recess 1382 has parallel outer and inner side surfaces which are spaced apart by distance which is slightly less than the distance between outer and inner side surfaces on thesecond projection 1378. When thesecond projection 1378 is pressed into thesecond recess 1382, the resulting interference between the side surfaces on theprojection 1378 and the side surfaces on therecess 1382 holds thesecond projection 1378 in thesecond recess 1382. - The interference fit between the
projections upper section 1368 with therecesses lower section 1370 of thesuture retainer 1364 holds the twosections suture retainer 1364 against movement relative to each other during insertion of the suture into thepassages lower section - Referring again to
FIG. 65 , theupper section 1368 of thesuture retainer 1364 includes acenter recess 1386, interposed between the first andsecond projections center recess 1386 is configured to receive the endeffector tip portion 1312, such that the endeffector tip portion 1312 captures theupper section 1368 of thesuture retainer 1364. The endeffector tip portion 1312 capturing of theupper section 1368 facilitates the separation ofupper section 1368 from thelower section 1370 when thetension lever 1328 is actuated, forming the gap between the upper andlower section suture retainer 1364 and allowing the suture to be loaded from the front, which can be done intra- or extracorporally. Additionally, endeffector tip portion 1312 acts to prevent rotational movement of thelower section 1370 andupper section 1368 of thesuture retainer 1364. - Referring to
FIG. 68 , thelower section 1370 of thesuture retainer 1364 is configured to be securely inserted in thetubular section 1322 of thecontroller assembly 1302. Theend portion 1326 of thetubular section 1322 is configured to receive thelower section 1370 of the suture retainer, preventing movement of thelower section 1370 with respect to theupper section 1368 of thesuture retainer 1364 and within thetubular section 1322. For example, theside portions 1388 of thelower section 1370 can have a dove tailed configuration, dimensioned for insertion into an oppositely dove tailed configured end portion of thetubular section 1326. - The upper and
lower section suture retainer 1364 are formed as two separate pieces. However, it is contemplated that the upper andlower sections suture retainer 1364 could be formed as one piece. If this is done, relatively weak connectors may be provided between theprojections lower section 1370 to hold the upper andlower sections passages suture retainer sections lower sections projections recesses - Once the suture has been tensioned with a desired force, the
suture retainer 1364 is plastically deformed, resulting in the suture being securely gripped between the upper andlower sections suture retainer 1364. The suture is gripped with a clamping action which holds the suture against movement relative to thesuture retainer 1364. This results in the desired tension being maintained in the suture. - To plastically deform and interconnect the upper and
lower sections suture retainer 1364, thesuture retainer 1364 is loaded into theenergy application apparatus 640. Thesuture retainer 1364 is loaded into thetubular section 1322 such that the endeffector tip portion 1312 captures theupper section 1368 and the tubularsection end portion 1326 captures thelower section 1370. (See alsoFIG. 69 ). After the suture is loaded into thesuture retainer 1364, as described above, thetension lever 1328 is released, compressing thesuture retainer 1364 between tubularsection end portion 1326 and endeffector tip portion 1312, such that the first andsecond projections upper section 1368 are inserted into the first andsecond recesses lower section 1370 of thesuture retainer 1364. Thecontroller bias member 1330 provides a substantially constant compressive force to thesuture retainer 1364. - Energy is applied to the
suture retainer 1364 through theend effector 1310 to effectively heat the end portions of the first andsecond projections upper section 1368 into a transition temperature range for the polymeric material of theprojections suture retainer 1364 by thecontroller bias members 1330 causes the heat softened material of theprojections recesses upper section 1368 is heated and also flows in therecesses - As this occurs, the heated material of the
projections suture retainer 1364 is constructed so that thecenter projection 1384 is deformed to the same extent as theprojections center projection 1384 would flow into thepassages - As the heated material of the
projections recesses passages lower sections suture retainer 1364. The force applied to the suture by the upper andlower sections suture retainer 1364 is effective to deform the suture from the circular cross sectional configuration into a generally oval cross sectional configuration. - There is some bonding of material of the
suture retainer 1364 to the suture to further interconnect suture and thesuture retainer 1364. However, the amount of force and energy transmitted fromend effector 1312 to thesuture retainer 1364 is sufficient to effect a plastic deformation of the material of thesuture retainer 1364 without excessive plastic deformation of the material of the suture. By avoiding excessive deformation of the material of the suture, weakening of the suture is avoided. Thus, once the plastic deformation of thesuture retainer 1364 has been effected by the transmission of force and energy to thesuture retainer 1364, the upper andlower sections suture retainer 1364 are fixedly interconnected with the suture without significantly weakening of the suture. - The energy which is applied to the
suture retainer 1364 by theenergy application apparatus 640 may be thermal energy, vibratory energy, or light energy. The energy may be transmitted by radio frequency waves, ultrasonic waves, heat waves, or light waves. The energy may be vibratory ultrasonic, light, heat, or radio frequency energy. - In method of use, the
controller assembly 1302 is secured to thehandle assembly 1300 as described above. Thesuture retainer 1364 is loaded into thetubular section 1322, between the tubularsection end portion 1326 and the endeffector tip portion 1312. Thesuture retainer 1364 is loaded into thetubular section 1322 by actuating thetension lever 1328, transmitting a force to thebias member 1330. The force transmitted through thebias member 1300 moves thetubular section 1322, forming a gap between the tubularsection end portion 1326 and the endeffector tip portion 1312. Thesuture retainer 1364 is positioned in the gap, with thelower section 1370 of thesuture retainer 1364 engaging the end portion of thetubular section 1326. - Once the
suture retainer 1364 has been positioned in the gap between the tubularsection end portion 1326 and the endeffector tip portion 1312, thetension lever 1328 is released. When thetension lever 1328 is released, thebias member 1330 is effected to urge the tubularsection end portion 1326 towards the endeffector tip portion 1312, closing the gap. This results in thesuture retainer 1364 being clamped between the tubularsection end portion 1326 and the endeffector tip portion 1312. Thetip protrusion 1314 on the endeffector tip portion 1312 is pressed into therecess 1386 in aupper section 1368 of thesuture retainer 1364, capturing theupper section 1368 of thesuture retainer 1364. Thebias member 1330 is effective to apply a constant predetermined biasing force to thesuture retainer 1364. - During performance of a surgical procedure, the suture may be moved through a cannula to a location disposed within a patient's body. The suture is then positioned relative to the tissue at the remote location in the patient's body. However, it should be understood that the cannula may be omitted and the suture moved through an open incision.
- If the
applicator assembly 640 is utilized to move thesuture retainer 1364 through a cannula into the patient's body before the suture is positioned thesuture retainer 1364, suitable instruments may be utilized to grip the suture in the patient's body and to move the suture through thesuture retainer 1364. The instruments which engage the suture and move it through thesuture retainer 1364 while thesuture retainer 1364 is gripped by theapplicator assembly 640 may extend through the cannula along with theapplicator assembly 640. Alternatively, the instruments which move the suture through thesuture retainer 1364 may be moved into the patient's body through a cannula spaced from the cannula through which theapplicator assembly 640 moves thesuture retainer 1364 into the patient's body. In order to minimize incisions in the patient's body, it may be preferred to utilize a single cannula to accommodate movement of theapplicator assembly 640,suture retainer 1364, suture positioning instruments, and the suture into the patient's body. - While the
suture retainer 1364 is gripped with a predetermined constant force by theapplicator assembly 640, thesuture retainer 1364 is moved to a desired position relative to the body tissue. To position thesuture retainer 1364 relative to the body tissue, the surgeon holds thehandle 1304 of theapplicator assembly 640 in one hand and tensions the suture with the other hand. The surgeon then manually applies force against thehandle 1304 to slide thesuture retainer 1364 along the tensioned suture toward the body tissue. The relativelylong tubular section 1322 andend effector 1310 enable theapplicator assembly 640 to move thesuture retainer 1364 through a small incision to a remote location in a patient's body as thesuture retainer 1364 slides along the suture. - Once the
suture retainer 1364 has been positioned in a desired relationship with body tissue and the suture, the suture is pulled with a predetermined force. This results in a predetermined tension being established in the suture. While the predetermined tension is maintained in the suture, thesuture retainer 1364 is connected to suture, holding the suture against movement relative to thesuture retainer 1364. To effect plastic deformation of thesuture retainer 1364 and connection of thesuture retainer 1364 with the suture, energy is transmitted from an energy source through theend effector 1310 to thesuture retainer 1364. At this time, thesuture retainer 1364 is clamped between the tubularsection end portion 1326 and the endeffector tip portion 1312. - As noted above, the surgeon pulls on the suture with a predetermined force, holding the suture in tension and maintaining the predetermined force on the suture during the connection of the
suture retainer 1364 to the suture. Alternatively, the suture may be tensioned using thesuture tensioners 1350 on thecontroller assembly 1302. Once thesuture retainer 1364 has been positioned in a desired relationship with body tissue and the suture, the suture is pulled with a predetermined force. This results in a predetermined tension being established in the suture. The suture in wrapped about thepulley portion 1354 of thesuture tension projection 1352, and cinched to thecleat 1356. Thesuture tensioner 1350 maintains the tension on the suture. While the predetermined tension is maintained in the suture, thesuture retainer 1364 is connected to suture, holding the suture against movement relative to thesuture retainer 1364. To effect plastic deformation of thesuture retainer 1364 and connection of thesuture retainer 1364 with the suture, energy is transmitted from an energy source through theend effector 1310 to thesuture retainer 1364. The use of thesuture tensioner 1350 to hold the suture, frees up the surgeon from holding the suture, maintaining the predetermined force on the suture during the connection of thesuture retainer 1364 to the suture. - In the illustrated embodiment of the
applicator assembly 640, the energy source is a source of ultrasonic vibratory energy at a frequency above that which can normally be detected by the human ear, that is about 16 to 20 kilohertz. Although there are a wide range of frequencies which may be utilized, it is believed that it may be desirable to use ultrasonic energy having a frequency of between 20 kilohertz and 70 kilohertz. It is believed that it may be desired to use ultrasonic vibratory energy of a frequency between 39.5 and 41 kilohertz. When an actuated switch is closed, ultrasonic vibratory energy is transmitted through theend effector 1310 to thesuture retainer 1364. The ultrasonic vibratory energy creates frictional heat which is effective to heat material of thesuture retainer 1364 into its transition temperature range while the material of the suture remains at a temperature below its transition temperature range. The actuated switch can be external to theapplicator assembly 640, for example, a foot peddle, or incorporated into theapplicator assembly 640, for example a trigger on the handle. - Referring again to
FIG. 25 , agenerator 666 is connected with a standard electrical power supply (120-240 volts). Thegenerator 666 converts the standard electrical power supply from 50/60 hertz to an ultrasonic frequency, that is a frequency greater than 20 kilohertz. The high frequency electrical energy is conducted through a cable 638 to themember 640. - The
generator 666 includes a transducer which transforms electrical energy from the power supply into mechanical vibration. This is accomplished by using electrostrictive elements called piezoelectric crystals. The piezoelectric crystals give off electricity when a compressing or expanding pressure is exerted on them. The opposite is also true: when an electric current is applied, the crystals expand or contract and exert a force. The piezoelectric crystals expand and contract as an alternating electrical (AC) current is applied to them. This mechanical energy is then passed to the booster. It is contemplated that the power supply can be an external power supply connected to thegenerator 666, such as a wall socket. - Alternatively, the
applicator assembly 640 can include an internal power supply, cordless, wherein the power supply is disposed in the handle 642 of theapplicator assembly 640. Similarly, thegenerator 666 is disposed in the handle 642, wherein the generator includes, for example, piezoelectric crystals operably connected to the internal power supply. The internal power supply can be a battery or a rechargeable battery with an external recharging unit, which provides a direct electrical (DC) current. A converter is interposed between the battery and the piezoelectric crystals, converting the DC to AC current for supply to the piezoelectric crystals. - Although described as using ultrasonic energy, it is understood that in other embodiments, different types of energy or combination of energies can be utilized to plastically deform the
suture retainer 1364. These types of energy or combination of energies can include, but not be limited to, ultrasonic energy, radio frequency (RF) energy, laser energy, infrared energy, microwave energy, ultrasound energy, and contact heating energy. For example theapplicator assembly 640 of the present invention can include a bimodal energy source, wherein ultrasonic and/or RF energy can be provided to plastically deform thesuture retainer 1364. This is particularly useful since one energy type tends to heat from the inside of an object and spreads outwardly, while the other type tends to heat from the outside of an object and spreads inwardly. - It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention, which is limited only by the following claims.
Claims (36)
1. A surgical device for attaching a retainer to a suture for securing tissue in a patient's body, comprising:
an elongated shaft having an longitudinal axis;
a first elongated member including a first compression element, the first elongated member having a longitudinal axis;
a second member including a second compression element moveably connected with the first elongated member, the second member being movable along the longitudinal axis of the first elongated member from a first position to a second position, wherein the first compression element and the second compression element are configured to receive the retainer there between;
a suture tensioner connected with the elongated shaft and configured to receive the suture, maintaining a substantially constant tension on the suture during attachment of the retainer thereto; and
an energy source operably connected to the first compression element for transmitting an energy to the retainer for attachment to the suture, the energy selected from the group consisting of radio frequency energy, laser energy, microwave energy, ultrasound energy, contact heating energy, and combinations thereof,
wherein the first compression element is configured to transmit at least two different types of energy from the energy source to the retainer.
2. The surgical device of claim 1 wherein the second member includes a tubular section including a proximal end and a distal end, the distal end having a gapped portion with the second compression element integrated into the gapped portion.
3. The surgical device of claim 2 wherein the first elongated member is positioned through the tubular section, such that the first compression element is in opposing relation to the second compression element.
4. The surgical device of claim 3 wherein the second compression element is configured to receive a first portion of the retainer.
5. The surgical device of claim 4 wherein the first compressive element is configured to receive a second portion of the retainer, such that the second portion of the retainer is separated from the first portion of the retainer when the second member is moved from the first position to the second position.
6. The surgical device of claim 2 wherein the second member further includes an actuation member operably connected to the proximal end of the tubular section, wherein the actuation member operates to move the tubular section from the first position to the second position.
7. A surgical device for attaching a retainer to a suture for securing tissue in a patient's body, comprising:
a handle assembly;
a controller assembly operatively connected to the handle assembly and configured to receive a suture retainer therein, wherein a portion of the controller assembly is movable from a first position to a second position relative to the handle assembly;
a suture tensioner positioned on the controller assembly and configured to receive the suture, maintaining a substantially constant tension on the suture through the retainer during attachment of the retainer thereto; and
an energy source operably connected to the handle assembly for transmitting an energy to the retainer for attachment to the suture, the energy selected from the group consisting of radio frequency energy, laser energy, microwave energy, ultrasound energy, contact heating energy, and combinations thereof,
wherein the energy source is configured to transmit at least two different types of energy to the retainer.
8. The surgical device of claim 7 wherein the handle assembly includes a handle portion and an end effector operably connected thereto, the end effector having a tip portion for transmitting the energy to the retainer.
9. The surgical device of claim 8 wherein the controller assembly includes a controller and a tubular section having an end portion configured for receiving the retainer therein, wherein the retainer is positionable between the tip portion of the end effector and the end portion of the tubular section.
10. The surgical device of claim 9 wherein the handle assembly is slidably positionable through the controller assembly positioning the end effector through the tubular section, wherein the tubular section is in movable relation with the end effector from the first position to the second position.
11. The surgical device of claim 10 wherein the tip portion of the end effector includes a protrusion configured for capturing a first portion of the retainer.
12. The surgical device of claim 11 wherein the end portion of the tubular section is configured to capture a second section of the retainer, such that the second section of the retainer is separated from the first section of the retainer when the tubular section is moved from the first position to the second position.
13. The surgical device of claim 9 wherein the suture tensioner is positioned on the tubular section.
14. The surgical device of claim 13 wherein the suture tensioner includes a suture bias member.
15. The surgical device of claim 14 wherein the suture bias member imparts a tension of between about 2 lbs. to 10 lbs. on the suture.
16. The surgical device of claim 7 wherein the energy source is an external energy source.
17. The surgical device of claim 7 wherein the energy source is an internal energy source disposed within a handle portion of the first member.
18. The surgical device of claim 17 wherein the internal energy source is a rechargeable battery.
19. A method for affixing a suture retainer to a suture, the method comprising:
providing an elongated surgical instrument including a distal portion having a first compression element and a second compression element, the second compression element being moveable along the longitudinal axis of the surgical instrument;
attaching a first portion of the suture retainer to the first compression element;
attaching a second portion of the suture retainer to the second compression element;
positioning a section of the suture between the first and second portions of the retainer while the portions of the retainer are attached to the compression elements, the suture section being generally perpendicular to the longitudinal axis of the instrument; and
transmitting energy to at least one portion of the suture retainer while the suture is positioned between the portions of the retainer to thereby secure the retainer to the suture.
20. The method of claim 19 wherein positioning the section of suture includes moving the second compression element relative to the first compression element along the longitudinal axis of the instrument.
21. The method of claim 19 further comprising, tensioning the suture before energy is transmitted to the at least one portion of the suture retainer.
22. The method of claim 19 wherein transmitting energy includes transmitting energy selected from the group consisting of radio frequency energy, laser energy, microwave energy, ultrasound energy, and contact heating energy.
23. The method of claim 22 wherein transmitting energy includes transmitting at least two different types of energy.
24. The method of claim 19 wherein attaching the first portion of the suture retainer includes attaching the first portion to a dovetail configuration of the first compression element.
25. A method for affixing a suture retainer to a suture, the method comprising:
providing an elongated surgical instrument including a distal portion having a first compression element and a second compression element, the second compression element moveable parallel to the longitudinal axis of the surgical instrument;
attaching a first portion of the suture retainer to the first compression element;
attaching a second portion of the suture retainer to the second compression element;
moving the second compression element relative to the first compression element parallel to the longitudinal axis of the instrument to form a gap between the first and second portions of the suture retainer;
positioning a suture in the gap;
moving the second compression element relative to the first compression element parallel to the longitudinal axis of the instrument to pinch the suture between the first and second portions of the suture retainer; and
transmitting energy to at least one portion of the suture retainer to thereby plastically deform the retainer to the suture.
26. The method of claim 25 further comprising, tensioning the suture before energy is transmitted to the suture retainer.
27. The method of claim 25 wherein transmitting energy includes transmitting energy selected from the group consisting of radio frequency energy, laser energy, microwave energy, ultrasound energy, and contact heating energy.
28. The method of claim 27 wherein transmitting energy includes transmitting at least two different types of energy.
29. The method of claim 25 wherein attaching the first portion of the suture retainer includes attaching the first portion to a dovetail configuration of the first compression element.
30. A method for affixing a suture retainer to a suture, the method comprising:
providing an elongated surgical instrument including a distal portion having an energy-producing end effector and a compression element, the compression element moveable along the longitudinal axis of the surgical instrument;
attaching a first portion of the suture retainer to the end effector;
attaching a second portion of the suture retainer to the compression element;
inserting the distal portion of the surgical instrument into a patient while the suture retainer is attached to the surgical instrument;
moving the compression element relative to the end effector along the longitudinal axis of the instrument to form a gap between the first and second portions of the suture retainer;
positioning a suture in the gap while the distal portion of the instrument is inserted in the patient;
moving the compression element relative to the end effector along the longitudinal axis of the instrument to pinch the suture between the first and second portions of the suture retainer;
tensioning the suture while the suture is positioned between the first and second portions of the suture retainer;
transmitting energy from the end effector to the first portion the suture retainer to thereby secure the retainer to the tensioned suture; and
detaching the first portion of the suture retainer from the end effector and the second portion of the suture retainer from the compression element.
31. The method of claim 30 wherein inserting the distal portion of the surgical instrument includes moving the distal portion of the instrument through a cannula.
32. The method of claim 30 wherein positioning the suture includes moving the suture through a cannula.
33. The method of claim 30 wherein transmitting energy includes transmitting energy selected from the group consisting of radio frequency energy, laser energy, microwave energy, ultrasound energy, and contact heating energy.
34. The method of claim 33 wherein transmitting energy includes transmitting at least two different types of energy.
35. The method of claim 30 wherein attaching the second portion of the suture retainer includes sliding the second portion onto a dovetail configuration of the compression element.
36. The method of claim 35 wherein detaching the second portion of the suture retainer includes sliding the second portion out of the dovetail configuration of the compression element.
Priority Applications (3)
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US14/940,366 US9888916B2 (en) | 2004-03-09 | 2015-11-13 | Method and device for securing body tissue |
US15/855,952 US20180132844A1 (en) | 2004-03-09 | 2017-12-27 | Method and device for securing body tissue |
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US15/855,952 Abandoned US20180132844A1 (en) | 2004-03-09 | 2017-12-27 | Method and device for securing body tissue |
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