CA2015889A1 - Bone fracture reduction and fixation devices with identity tags - Google Patents
Bone fracture reduction and fixation devices with identity tagsInfo
- Publication number
- CA2015889A1 CA2015889A1 CA002015889A CA2015889A CA2015889A1 CA 2015889 A1 CA2015889 A1 CA 2015889A1 CA 002015889 A CA002015889 A CA 002015889A CA 2015889 A CA2015889 A CA 2015889A CA 2015889 A1 CA2015889 A1 CA 2015889A1
- Authority
- CA
- Canada
- Prior art keywords
- bone
- plate
- affixation
- sections
- identification tag
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8085—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with pliable or malleable elements or having a mesh-like structure, e.g. small strips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/90—Identification means for patients or instruments, e.g. tags
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S606/00—Surgery
- Y10S606/907—Composed of particular material or coated
Abstract
ABSTRACT
The present invention relates to a bone fracture reduction device for the internal fixation and immobilization of bone fragments The device is comprised of a thin malleable bone affixation plate, formed of a biocompatible metallic material with at least two spaced openings extending therethrough each for receiving a bone screw, with a thin bone plate identification tag formed as an integral extension of the bone affixation plate The identification tag bears at least the name of the plate manufacturer, the manufacturer's product number, and the manufacturer's production lot number for the bone affixation plate to provide full traceability of the device, and the identification tag provides the surgeon using the bone plate with means for handling and manipulating the plate during its affixation to bone fragments at a fracture site and after plate affixation the tag is severable from the plate for archiving.
The present invention relates to a bone fracture reduction device for the internal fixation and immobilization of bone fragments The device is comprised of a thin malleable bone affixation plate, formed of a biocompatible metallic material with at least two spaced openings extending therethrough each for receiving a bone screw, with a thin bone plate identification tag formed as an integral extension of the bone affixation plate The identification tag bears at least the name of the plate manufacturer, the manufacturer's product number, and the manufacturer's production lot number for the bone affixation plate to provide full traceability of the device, and the identification tag provides the surgeon using the bone plate with means for handling and manipulating the plate during its affixation to bone fragments at a fracture site and after plate affixation the tag is severable from the plate for archiving.
Description
BONE FRACTURE REDUCTION AND FIXATION ~EVICES WITH IDENTITY TAGS
BACKGROUND OF THE IN~ENTION
A bone fracture is a traumatic disruption of the continuity of a bone. If there is relative mo-tion of the bone fragments at the fracture site~ irritation of the surrounding tissues and heavy pain ensue and the time of fracture healing is r~jO;.~ q usually extended. Proper ~e~e~r-do~ of bone fragments is thus dependent upon immobilization of the fracture site.
Classically, bone fragment reduction (bone fragments properly aligned and abutted along the fracture line or lines) and immobilization for limb bones has been accomplished by external limb casts. Such casts must be worn for long periods of time, are heavy and unbalancing to the body skeletal structure and muscular system, inhibit bone vascularity (promotes fast and effective bone healing), and may result in bone resorption because of the total absence of tensile and compressive functional loading throughout the fractured bone structure.
Fractures in bones other than the arms and legs are more difficult to immobilize and the use of exterior casts may not be possible, particularly in the facial areas.
Over the past twenty years the use of stabilization and compression plate techniques for internal fixation of fractures ~aY~Sbeen developed and widely applied. With internal fixation, by means of bone screws and plates (particularly plates made of biocompatible metals and metal alloys ~such as titanium, stainless steel and cobalt-chromium), immediate and 2~
absolute immobilization is achieved through interfragmentary stabilization and compression. Other materials and devices such as wires, intramedullary nails or externally fixed pins are used mainly to reduce bone fracture mobility and improve the position of the fracture segments. The aim of internal bGne fracture fixation is to allow early, pain-free movement and use of the injured limb, mandible, etc., thus avoiding the consequel7ces of long lasting immobilization, i.e., bone fracture disease, bone resorption, etc.
With internal bone fixation it is important that the application of the stabilization or compression plate or fracture reduction device result in relative immobility of the bone fragments and tight closure of the fracture interface or fracture interfaces. Wlthout such immobility and tight closure, changing tension and compression loads tend to produce relative motion between the fracture fragments with resultant undesirable fragment shortening due to bone resorption.
Through the proper use of a bio-compatible metallic fracture reduction device (a surgically applied implant), static forces applied as interfragmentary compression by t.he device prevent relative motion between the fracture interfacing surfaces.
Thus, compressive pre-loading of the bone fragments (through the stabili~ation or compression device) prevents relative motion at the fracture site in spite of functional use of the limb, mandible, e-tc., without external immobilization or splinting.
With mechanical stimuli (forces and motion) permitted via the 2~
internal bone fixation techniques, rapid and healthy healing of the fracture is promoted and bone vascularity is maintained and restored. Vascularity OT bone is interrupted by the fracture trauma and by surgical intervention (application of the bone fixation device or devices) but revascularization is restored and enhanced by the rigid immobilization of the bone fragments or fracture interfaces through internal fixat;on techniques.
During the early application of stabilization and compression device techniques~ the devices were meant to be merely fixed to the bone fragments of the fracture for alignment purposes. Later, the value of interfragmentary compression, through devices and plates applied under tension, was recognized. A number of internal fixation devices have been developed with built-in compression devices - devices for tensioning the device or plate to create interfragmentary compression. Some of such systems have required that the plate-tensioning device remain implanted with the plate. Other systems have been designed with removable plate-tensioning apparatus.
Further developments in compression plate designs and attachment screws (also formed of bio-compatible metals and metal alloys - particularly titanium) have related to screw head and screw hole geometry, i.e., conical geometry of the screw shoulder and o~al screw holes in the compression plate for promoting bone fragment compression during screw application.
Attempts ~o obtain optimal stability of fixation have most 2~ 3~
recently resulted in the use congruent fitment between screw head and screw hole including both conical counter-sunk screw holes and hemicylindrical screw holes.
Numerous problems remain in the application of the various compression plate systems that are commercially available for internal bone fixation. Some systems require great care in the installation of bone screws so that their orientation is always perpendicular to the plate. When contouring a plate to fit a curved bone surface, circularly fitting screw holes may become distorted and cause high friction against screw rotation or may completely inhibit a screw from entering the screw hole. Buckling or kinking of bone fragments at the fracture line may occur as a result of improper tensioning at the end of the compression plate during plate application.
In the last 10-15 years titanium mesh sheets and strips have gained wide-spread use in reconstructive, orthognathic and trauma surgery with excellent clinical results and implant survival rates. The rnalleability of such sheets and strips allows quick and easy bending for adaption to bone contours.
In more recent years small bone plates in numerous configurations have come into high use in maxillofacial reconstructive surgery with such plates being deformable and contourable for fitment to virtually every fracture or osteotomy no matter how complex or how irregular the surgical site.
Thus~ contourable bone plates of "Y", "T', "L" and 'I shape J~ J~3 configurations, and of more complex geometrical shapes, are available in a variety of thichnesses and with a selection of degrees of malleability.
Many of the implantable titanium mesh sheets and strips, and titanium plates, as described above, are relatively small (25-40 mm. in their major dimension) and difficult to maneuver into, and hold at, -the appropriate fracture site location during affixation to bone fragments, particularly in maxillofacial areas which have experienced severe trauma. It is also of concern to the entire medical community dealing with implantable devices and products that material biocompatibility, durability and structural integrity, and sterility be assured in compliance with increasing interest in and control by the Food and Drug Administration in the United States.
It is a principal object of the present invention to provide unique implantable bone fracture reduction devices of relatively small but effective structure which can be easily manipulated and applied in surgical procedures involving the internal fixation of fractures.
It is a further object of the invention -to provide perforated metallic sheets and strip and metallic bone plates, for use as implantable devices in the internal reduction and ~ixation of bone fractures, which may be easily and rapidly installed over complex or irregular surgical sites, and which have associated therewith a removable tag portion for handling of the devices during their installation and for thereafter providing identifying historical information respecting the type and structural integrity of such devices.
It is a still further object of the invention to provide relatively small implantable bone fracture internal fixation devices which may be easily held and manipulated by removable identifying implant tag portions which provide historical information respecting the type and manufact-lring and structural integrity of sucll devices.
It is yet another object of the invention to provide small implantable metallic bone fracture internal fixation devices which may be easily held and manipulated by integral, removable identifying implant tag portions which are metallurgically identical to the implankable devices and which comprise a "witness sample" of the devices for archiving and subsequent retrieving to yield historical information respecting the product type, material specifications, manufacturing procedures and quality controls applicable to such devices.
Other objec-ts and advantages of the invention will be apparent from the following summary and detailed description of the bone fracture reduction and fixation devices of the invention taken together with the accompanying drawing figures.
SUMMARY OF THE INVENTION
The present invention relates to improved bone fracture reduction devices for use in the internal fixation of bone fractures and the immobilization of the fracture fragments.
The bone fracture reduction devices,of the invention, formed of 2~
biocompatible metal and metal alloys such as titanium, stainless steel and cobalt-chromium, have a size, structure and configuration dependen-t upon the size, arrangement and location of the bone fragments requiring internal fixation and immobilization. The bone fracture reduction devices of the invention are relatively small (many having a major dimension of about 25 mm. to about 40 mm.) and are particularly applicable to fractures of the human skull or cranium.
The metallic fracture reduction devices of the invention are thin perforated mesh sheets and strips and thin plates (containing two or more screw holes) of 'Y", "T", 'L' and "I' shape configuration or of more complex geometrical shapes including deformable leg portions. The bone fracture reduction devices are held in place by biocompatible (like metal or alloy) bone screws set into abutting bone fragments with the mesh or plate leg portions extending across the fracture lines between such fragments. Before affixation the reduction devices (of varying degrees of malleability) may be contoured to comply with the bone irregularities and topography presented at the fracture site. After partial or full affixation the leg portions of the devices may be bent or kinked to reduce the effective lengths thereof to create tension forces through the leg portions thereby applying compression force or loading to the fracture interfaces of the bone fragments with the result that the fracture or fractures are reduced and immobilized.
In accordance with the present invention, each X~ 3 imp'lantable metallic -f'racture reduction devices (mesh sheet or strip, or geometrically configured bone plate) bears as an integral part thereof a depending or projecting product identification tag which may be utilized, during at least the initial stages of device affixation, to hold and manipulate the device. After the aFfixation of the fracture reduction device to the bone fragments, the meta'ilurgically identical identification tag portion thereof may be easily removed from the device (cut at the point of its joinder to the device) and retained for further re-ference as to the manufacturer's identity, product number and production lot number. Such identification information provides -the reconstructive surgeon utili~ing the implantable device with full traceability of the product and product type to the manufacturer and the material specifications, manufacturing procedures and quallty controls applicable to the device.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
FIG. l is a top p'lan view of a malleable, perforated, meta'llic, mesh-type bone fracture reduction plate or sheet in accordance ~ith the Present invention showing one form of an integral, severable implant product identification tag which provides ease of plate handling and manipulation during affixation thereof to bone fragments at a fracture site;
FIG. 2 is a top plan view of a perforated metallic bone fracture reduction strip showing another form of an associated product identification tag in accordance with the invention;
FIG. 3 is a top plan view of a malleable metallic "`f"
shaped bone plate with appropriate bone screw holes for mounting the plate to bone fragments, such plate including deformab'le leg portions and a severable implant product identification tag;
S FIG. 4 is a top plan view of a deformable meta'llic bone plate strip with appropriate bone mounting holes and a severable implant holding and manipulating product identifica-tion tag;
FIG. 5 is a top plan view of another deformable metallic bone plate strip with an associated and severable product identification tag;
FIG. 6 is a top plan Yiew of another Y shaped metallic bone plate with deformable leg or arm portions with outboard screw hole portions and with an associated and severable product holding and identification tag;
FIG. 6a is a top plan view of the 'Y" shaped bone plate of FIG. 5 in affixed placement position with respect to a complex bone fracture, with one of the legs of the plate kinked to close the fracture line straddled by such leg, and with the associated product holding and identification tag separated from the plate;
FIG. 7 is an enlarged top plan view of one form of a product identification tag associated with the bone reduction devices of tlle invention showing a manufacturer's name, product catalog number and manufacturing lot number; and FIG. 8 is an enlarged top plan view of another stylized form of a product identification tag associated with the bone reduction devices of the invention.
It should be noted that no side or edge view has been shown of any of the bone reduction devices illustrated in FIGS.
1 through 6a, or of either of the product identification tag forms shown in FIGS. 7 and 8, since such devices and tags are all of flat metallic structure having a thickness in the range of about 0.6 mm. to about 1.2 mm.
DETAILED DESCRIPTION OF THE INVENTION
Referring to FIG. 1 of the drawing sheet, there is illustrated in a top plan view a bone fracture reduction device 10 of the invention in the form of a malleable, perforated, metallic, mesh-type sheet wllich provides the user with a matrix of holes or perforated openings 12 through which bone screws may be applied to bone fragments at a fracture site. Affixed to, and a part of, the mesh-type reduction device is a severable implant product identification tag 14 which provides the surgeon utilizing the device with a handle for holding and manipulating such device during its placement and affixation to bone fragments at the fracture site via a multiplicity of biocompatible bone screws (not shown).
The ID tag 14 bears manufacturer name identification, product catalog number designation and manufacturing lot number designation 14a and is attached to the bone fracture reduction device (mesh sheet) 10 via an integral tag leg or stem portion 14b. At the point of joinder of the tag leg portion 14b to the bone fracture reduction device 10 there is provided a reduced neck area 14c which makes the ID tag 14 easily severable from the device 10 either by cutting of the metal at the neck area or by twisting flexure of the ID tag 14 to break it away from the device 10. After implantation of the bone fracture reduction device 10, with its affixation to bone fragments at a fracture site, the severed ID tag 14 (with its leg or stem portion 14b) may be placed in the patients surgery file for subsequent identifying and or billing use with respect to the implant product. For retainment purposes the ID tag 14 is therefore provided with a perforation or hole 14d whereby the tag may be clipped, stapled or otherwise affixed to the patient file.
In FIG. 2 there is shown, in a top plan view, another bone fracture reduction device 20 of the invention in the form of a malleable, perforated, metallic, mesh-type strip which provides the user-surgeon with a straight course of holes or perforations 22 through which bone screws may be applied to affix the implantable device for fracture reduction at the fracture site. Affixed to, and a part of, the strip 20 is a severable implant product identification tag 24, of alternative design, whioh is available to the surgeon -ror holding -and manipulating such strip during its placement ana affixation to bone fragments at the fracture site via bone screws. As in the case of the ID tag 14 shown in FIG. 1, the ID tag 24 bears the manufacturer's name, product catalog number and manufacturing lot number designations 24a and is attached to the bone fracture reduction device (mesh strip) 20 via an integral tag leg portion 2~ 3 24b. The ID tag or 'witness sample 24 of the implantable strip 20, as illustrated in FIG. 2, is of shield configuration and the tag (with its leg portion 24b) is severable from the implantable device 20 ~t the reduced necl; area 24c proximate the S point whereat the tag leg portion 24b attaches to the device 20.
As wit.h the ID tag 14 of FIG. 1, the ID tag 2~ of FIG. 2 is provided with a perforation or Inole 24d whereby the tag may be c l i pped, stap 1 ed or othe rw i se af f i xed to the pat i ent f i 1 e .
In FIG. 3 of the drawing sheet there is i 1 lustrated in 10 a top plan view a bone fracture reduction device 30 of the invention in the form of a mal leable (defor~iable), metal 1 ic plate of "Y' shape. The plate 30 includes leg portions 30a, 30b and 30c each provided with mounting holes 32a, 3~b and 32c, respect i ve 1 y, f or rece i v i ng b i ocompat i b 1 e bone sc rews ( not 15 shown) during the mounting of the plate 30 to bone fragments at a fractul e site. Affixed to, and a part of, the '`~' shaped bone plate 30 is a severable implant product identification tag 34 of the tyDe shown in FIG. 1 and described hereinbefore.
In FIGS. 4, 5 and 6 thel-e are i11ustrated addi-tional 20 mal1eable (cleformable), metallic bone p1ates 40, 50 and 60, respectively, of various designs with each such plates provided, in accordance with the invention, with associated sevérable implant product identification tags 44, 54, and 64, respectively. Each of these boné plates is provided with an 25 appropriate number of screw holes for mounting of such plates to bone f ragnients at a f racture s i te .
In FIG. 6a the "Y' shaped bone fracture reduction plate 60 of FIG. 6 is shown mounted to bone fragments at a fracture site involving a complex system of fracture lines F1, F2, and F3 illustrated by dashed line representations. The bone plate 60 includes three lil<e outboard bone affixation portions 62, each interconnected by a relatively narrow leg section 62a to an intermediate or hub bone affixation portion 62b. The outboard bone af~fixation portions 62 of the plate 60 each contain two counter-sunk screw holes (see FIG. 6 for screw holes 62c) and the hub portion 62b (as shown in FIG. 6) contains a single counter-sunk screw hole 62d. The bone plate 60 is mounted to the fracture site bone fragments via bone screws 62e (see FIG.
6a). To close an open fracture line (after appropriate affixation of the 'Y" shaped plate 60 to adjacent bone fragments) the plate legs 62a may be kinked, to a relatively more or less extent. As shown in FIG. 6a the fracture line F1 has been closed by kinking of the plate leg 62a which spans such fracture line. The other fracture lines F2 and F3 (as shown) remain open with the spanning plate leg 62a in each case still in its original non-deformed sllape at full length. As shown in FIG. 6a, the ID tag 64, originally an integra1 part of the plate 60, has been severed from the plate.
Kinking of the interconnecting plate legs of bone plates of the type shown in FIGS. 5 and 6 (after such plates have been secured to the bone fragments presenting open fracture lines) may be accomplished by the use of "Aderer" type pliers commonly ~ 3 used by ortllodontists for Icinl<ing wires connectiny orthodontic bands to increase the tension t`orces applied by such wires to such bands. This type of plier has two prongs on one side and one prong on the opposing side of the plier jaws. Kinking deformation of the leg sections of bone plates may also be accomplished by needle nose type pliers of well-known design.
Tlle preferred material of cons-truction of the metallic mesh-type sheets and strips forming bone fracture reduction devices in accordance with the invention and of bone plates of the type described hereinbefore is commercially pure titanium ~ith a yield strength in the range .of 30 000 ta 40 000 psi.
Bone screws utilized to accomplish internal fracture fixation in accordance with the invention should also preFerably be fabricated from commercially pure titanium. Also the armamentarium (tools) utilized should have workins parts and surfaces of the same biocompatible metal or metal alloy so as to avoid foreign metal contamination of the bone fixation devices.
In FIGS. 7 and 8 of the drawing shee~ there is shown enlarged views OT the produc-t identification tags illustrated in FIGS. l-6. Tl~us in FIG. 7 the ID tay 70 is an enlarged sllowing of tlle tag portion of the internal bone fixation devices of FIGS. l 3 and 5 and in FIG. ~ the ID tag 80 is an enlarged showillg of the -t~g portion of the internal bone fixation devices of FIGS. 2 4 and 6. As previously mentioned tl~e fixation devices illustrated in FIGS. 3-6 and 6a are of relatively small size having a major dimension ot about 25 mm. to about 40 mm.
l4 2 '' k ~ ~ 9 Also, the bone fixation devices of all figures are (in their "as supplied" form) of flat structure having a thickness in the range o~ about 0.6 mm. to about 1.2 mm.
It is to be understood that further alternative configurations of implantable bone fracture reduction devices, in accordance with the invention, have been fabricated. Also, it should be apparent that numerous other shapes of the identification tag portion of the implantable devices of the invention can be formed as integral parts thereof. After -the affixation of a fracture reduction device to bone fragments at a fracture site, the identification tag portion thereof may be easily removed from the device and retained for further reference as to the manufacturer's identity, product number and production lot number. Such identification information provides the reconstructive surgeon and associated medical team administrative authorities with full traceability of the product to the manufacturer and the material specifications, manufacturing procedures and quality controls applicable to the implantable device.
While the invention has been described in connection with particular structural embodiments of bone fracture reduction devices, many modifications of the inventiol- will be apparent to tllose skilled in the art. ~ccordingly, such modifications are to be included within the spirit and scope of ~5 tlle invention as def`ined by the following claims.
BACKGROUND OF THE IN~ENTION
A bone fracture is a traumatic disruption of the continuity of a bone. If there is relative mo-tion of the bone fragments at the fracture site~ irritation of the surrounding tissues and heavy pain ensue and the time of fracture healing is r~jO;.~ q usually extended. Proper ~e~e~r-do~ of bone fragments is thus dependent upon immobilization of the fracture site.
Classically, bone fragment reduction (bone fragments properly aligned and abutted along the fracture line or lines) and immobilization for limb bones has been accomplished by external limb casts. Such casts must be worn for long periods of time, are heavy and unbalancing to the body skeletal structure and muscular system, inhibit bone vascularity (promotes fast and effective bone healing), and may result in bone resorption because of the total absence of tensile and compressive functional loading throughout the fractured bone structure.
Fractures in bones other than the arms and legs are more difficult to immobilize and the use of exterior casts may not be possible, particularly in the facial areas.
Over the past twenty years the use of stabilization and compression plate techniques for internal fixation of fractures ~aY~Sbeen developed and widely applied. With internal fixation, by means of bone screws and plates (particularly plates made of biocompatible metals and metal alloys ~such as titanium, stainless steel and cobalt-chromium), immediate and 2~
absolute immobilization is achieved through interfragmentary stabilization and compression. Other materials and devices such as wires, intramedullary nails or externally fixed pins are used mainly to reduce bone fracture mobility and improve the position of the fracture segments. The aim of internal bGne fracture fixation is to allow early, pain-free movement and use of the injured limb, mandible, etc., thus avoiding the consequel7ces of long lasting immobilization, i.e., bone fracture disease, bone resorption, etc.
With internal bone fixation it is important that the application of the stabilization or compression plate or fracture reduction device result in relative immobility of the bone fragments and tight closure of the fracture interface or fracture interfaces. Wlthout such immobility and tight closure, changing tension and compression loads tend to produce relative motion between the fracture fragments with resultant undesirable fragment shortening due to bone resorption.
Through the proper use of a bio-compatible metallic fracture reduction device (a surgically applied implant), static forces applied as interfragmentary compression by t.he device prevent relative motion between the fracture interfacing surfaces.
Thus, compressive pre-loading of the bone fragments (through the stabili~ation or compression device) prevents relative motion at the fracture site in spite of functional use of the limb, mandible, e-tc., without external immobilization or splinting.
With mechanical stimuli (forces and motion) permitted via the 2~
internal bone fixation techniques, rapid and healthy healing of the fracture is promoted and bone vascularity is maintained and restored. Vascularity OT bone is interrupted by the fracture trauma and by surgical intervention (application of the bone fixation device or devices) but revascularization is restored and enhanced by the rigid immobilization of the bone fragments or fracture interfaces through internal fixat;on techniques.
During the early application of stabilization and compression device techniques~ the devices were meant to be merely fixed to the bone fragments of the fracture for alignment purposes. Later, the value of interfragmentary compression, through devices and plates applied under tension, was recognized. A number of internal fixation devices have been developed with built-in compression devices - devices for tensioning the device or plate to create interfragmentary compression. Some of such systems have required that the plate-tensioning device remain implanted with the plate. Other systems have been designed with removable plate-tensioning apparatus.
Further developments in compression plate designs and attachment screws (also formed of bio-compatible metals and metal alloys - particularly titanium) have related to screw head and screw hole geometry, i.e., conical geometry of the screw shoulder and o~al screw holes in the compression plate for promoting bone fragment compression during screw application.
Attempts ~o obtain optimal stability of fixation have most 2~ 3~
recently resulted in the use congruent fitment between screw head and screw hole including both conical counter-sunk screw holes and hemicylindrical screw holes.
Numerous problems remain in the application of the various compression plate systems that are commercially available for internal bone fixation. Some systems require great care in the installation of bone screws so that their orientation is always perpendicular to the plate. When contouring a plate to fit a curved bone surface, circularly fitting screw holes may become distorted and cause high friction against screw rotation or may completely inhibit a screw from entering the screw hole. Buckling or kinking of bone fragments at the fracture line may occur as a result of improper tensioning at the end of the compression plate during plate application.
In the last 10-15 years titanium mesh sheets and strips have gained wide-spread use in reconstructive, orthognathic and trauma surgery with excellent clinical results and implant survival rates. The rnalleability of such sheets and strips allows quick and easy bending for adaption to bone contours.
In more recent years small bone plates in numerous configurations have come into high use in maxillofacial reconstructive surgery with such plates being deformable and contourable for fitment to virtually every fracture or osteotomy no matter how complex or how irregular the surgical site.
Thus~ contourable bone plates of "Y", "T', "L" and 'I shape J~ J~3 configurations, and of more complex geometrical shapes, are available in a variety of thichnesses and with a selection of degrees of malleability.
Many of the implantable titanium mesh sheets and strips, and titanium plates, as described above, are relatively small (25-40 mm. in their major dimension) and difficult to maneuver into, and hold at, -the appropriate fracture site location during affixation to bone fragments, particularly in maxillofacial areas which have experienced severe trauma. It is also of concern to the entire medical community dealing with implantable devices and products that material biocompatibility, durability and structural integrity, and sterility be assured in compliance with increasing interest in and control by the Food and Drug Administration in the United States.
It is a principal object of the present invention to provide unique implantable bone fracture reduction devices of relatively small but effective structure which can be easily manipulated and applied in surgical procedures involving the internal fixation of fractures.
It is a further object of the invention -to provide perforated metallic sheets and strip and metallic bone plates, for use as implantable devices in the internal reduction and ~ixation of bone fractures, which may be easily and rapidly installed over complex or irregular surgical sites, and which have associated therewith a removable tag portion for handling of the devices during their installation and for thereafter providing identifying historical information respecting the type and structural integrity of such devices.
It is a still further object of the invention to provide relatively small implantable bone fracture internal fixation devices which may be easily held and manipulated by removable identifying implant tag portions which provide historical information respecting the type and manufact-lring and structural integrity of sucll devices.
It is yet another object of the invention to provide small implantable metallic bone fracture internal fixation devices which may be easily held and manipulated by integral, removable identifying implant tag portions which are metallurgically identical to the implankable devices and which comprise a "witness sample" of the devices for archiving and subsequent retrieving to yield historical information respecting the product type, material specifications, manufacturing procedures and quality controls applicable to such devices.
Other objec-ts and advantages of the invention will be apparent from the following summary and detailed description of the bone fracture reduction and fixation devices of the invention taken together with the accompanying drawing figures.
SUMMARY OF THE INVENTION
The present invention relates to improved bone fracture reduction devices for use in the internal fixation of bone fractures and the immobilization of the fracture fragments.
The bone fracture reduction devices,of the invention, formed of 2~
biocompatible metal and metal alloys such as titanium, stainless steel and cobalt-chromium, have a size, structure and configuration dependen-t upon the size, arrangement and location of the bone fragments requiring internal fixation and immobilization. The bone fracture reduction devices of the invention are relatively small (many having a major dimension of about 25 mm. to about 40 mm.) and are particularly applicable to fractures of the human skull or cranium.
The metallic fracture reduction devices of the invention are thin perforated mesh sheets and strips and thin plates (containing two or more screw holes) of 'Y", "T", 'L' and "I' shape configuration or of more complex geometrical shapes including deformable leg portions. The bone fracture reduction devices are held in place by biocompatible (like metal or alloy) bone screws set into abutting bone fragments with the mesh or plate leg portions extending across the fracture lines between such fragments. Before affixation the reduction devices (of varying degrees of malleability) may be contoured to comply with the bone irregularities and topography presented at the fracture site. After partial or full affixation the leg portions of the devices may be bent or kinked to reduce the effective lengths thereof to create tension forces through the leg portions thereby applying compression force or loading to the fracture interfaces of the bone fragments with the result that the fracture or fractures are reduced and immobilized.
In accordance with the present invention, each X~ 3 imp'lantable metallic -f'racture reduction devices (mesh sheet or strip, or geometrically configured bone plate) bears as an integral part thereof a depending or projecting product identification tag which may be utilized, during at least the initial stages of device affixation, to hold and manipulate the device. After the aFfixation of the fracture reduction device to the bone fragments, the meta'ilurgically identical identification tag portion thereof may be easily removed from the device (cut at the point of its joinder to the device) and retained for further re-ference as to the manufacturer's identity, product number and production lot number. Such identification information provides -the reconstructive surgeon utili~ing the implantable device with full traceability of the product and product type to the manufacturer and the material specifications, manufacturing procedures and quallty controls applicable to the device.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
FIG. l is a top p'lan view of a malleable, perforated, meta'llic, mesh-type bone fracture reduction plate or sheet in accordance ~ith the Present invention showing one form of an integral, severable implant product identification tag which provides ease of plate handling and manipulation during affixation thereof to bone fragments at a fracture site;
FIG. 2 is a top plan view of a perforated metallic bone fracture reduction strip showing another form of an associated product identification tag in accordance with the invention;
FIG. 3 is a top plan view of a malleable metallic "`f"
shaped bone plate with appropriate bone screw holes for mounting the plate to bone fragments, such plate including deformab'le leg portions and a severable implant product identification tag;
S FIG. 4 is a top plan view of a deformable meta'llic bone plate strip with appropriate bone mounting holes and a severable implant holding and manipulating product identifica-tion tag;
FIG. 5 is a top plan view of another deformable metallic bone plate strip with an associated and severable product identification tag;
FIG. 6 is a top plan Yiew of another Y shaped metallic bone plate with deformable leg or arm portions with outboard screw hole portions and with an associated and severable product holding and identification tag;
FIG. 6a is a top plan view of the 'Y" shaped bone plate of FIG. 5 in affixed placement position with respect to a complex bone fracture, with one of the legs of the plate kinked to close the fracture line straddled by such leg, and with the associated product holding and identification tag separated from the plate;
FIG. 7 is an enlarged top plan view of one form of a product identification tag associated with the bone reduction devices of tlle invention showing a manufacturer's name, product catalog number and manufacturing lot number; and FIG. 8 is an enlarged top plan view of another stylized form of a product identification tag associated with the bone reduction devices of the invention.
It should be noted that no side or edge view has been shown of any of the bone reduction devices illustrated in FIGS.
1 through 6a, or of either of the product identification tag forms shown in FIGS. 7 and 8, since such devices and tags are all of flat metallic structure having a thickness in the range of about 0.6 mm. to about 1.2 mm.
DETAILED DESCRIPTION OF THE INVENTION
Referring to FIG. 1 of the drawing sheet, there is illustrated in a top plan view a bone fracture reduction device 10 of the invention in the form of a malleable, perforated, metallic, mesh-type sheet wllich provides the user with a matrix of holes or perforated openings 12 through which bone screws may be applied to bone fragments at a fracture site. Affixed to, and a part of, the mesh-type reduction device is a severable implant product identification tag 14 which provides the surgeon utilizing the device with a handle for holding and manipulating such device during its placement and affixation to bone fragments at the fracture site via a multiplicity of biocompatible bone screws (not shown).
The ID tag 14 bears manufacturer name identification, product catalog number designation and manufacturing lot number designation 14a and is attached to the bone fracture reduction device (mesh sheet) 10 via an integral tag leg or stem portion 14b. At the point of joinder of the tag leg portion 14b to the bone fracture reduction device 10 there is provided a reduced neck area 14c which makes the ID tag 14 easily severable from the device 10 either by cutting of the metal at the neck area or by twisting flexure of the ID tag 14 to break it away from the device 10. After implantation of the bone fracture reduction device 10, with its affixation to bone fragments at a fracture site, the severed ID tag 14 (with its leg or stem portion 14b) may be placed in the patients surgery file for subsequent identifying and or billing use with respect to the implant product. For retainment purposes the ID tag 14 is therefore provided with a perforation or hole 14d whereby the tag may be clipped, stapled or otherwise affixed to the patient file.
In FIG. 2 there is shown, in a top plan view, another bone fracture reduction device 20 of the invention in the form of a malleable, perforated, metallic, mesh-type strip which provides the user-surgeon with a straight course of holes or perforations 22 through which bone screws may be applied to affix the implantable device for fracture reduction at the fracture site. Affixed to, and a part of, the strip 20 is a severable implant product identification tag 24, of alternative design, whioh is available to the surgeon -ror holding -and manipulating such strip during its placement ana affixation to bone fragments at the fracture site via bone screws. As in the case of the ID tag 14 shown in FIG. 1, the ID tag 24 bears the manufacturer's name, product catalog number and manufacturing lot number designations 24a and is attached to the bone fracture reduction device (mesh strip) 20 via an integral tag leg portion 2~ 3 24b. The ID tag or 'witness sample 24 of the implantable strip 20, as illustrated in FIG. 2, is of shield configuration and the tag (with its leg portion 24b) is severable from the implantable device 20 ~t the reduced necl; area 24c proximate the S point whereat the tag leg portion 24b attaches to the device 20.
As wit.h the ID tag 14 of FIG. 1, the ID tag 2~ of FIG. 2 is provided with a perforation or Inole 24d whereby the tag may be c l i pped, stap 1 ed or othe rw i se af f i xed to the pat i ent f i 1 e .
In FIG. 3 of the drawing sheet there is i 1 lustrated in 10 a top plan view a bone fracture reduction device 30 of the invention in the form of a mal leable (defor~iable), metal 1 ic plate of "Y' shape. The plate 30 includes leg portions 30a, 30b and 30c each provided with mounting holes 32a, 3~b and 32c, respect i ve 1 y, f or rece i v i ng b i ocompat i b 1 e bone sc rews ( not 15 shown) during the mounting of the plate 30 to bone fragments at a fractul e site. Affixed to, and a part of, the '`~' shaped bone plate 30 is a severable implant product identification tag 34 of the tyDe shown in FIG. 1 and described hereinbefore.
In FIGS. 4, 5 and 6 thel-e are i11ustrated addi-tional 20 mal1eable (cleformable), metallic bone p1ates 40, 50 and 60, respectively, of various designs with each such plates provided, in accordance with the invention, with associated sevérable implant product identification tags 44, 54, and 64, respectively. Each of these boné plates is provided with an 25 appropriate number of screw holes for mounting of such plates to bone f ragnients at a f racture s i te .
In FIG. 6a the "Y' shaped bone fracture reduction plate 60 of FIG. 6 is shown mounted to bone fragments at a fracture site involving a complex system of fracture lines F1, F2, and F3 illustrated by dashed line representations. The bone plate 60 includes three lil<e outboard bone affixation portions 62, each interconnected by a relatively narrow leg section 62a to an intermediate or hub bone affixation portion 62b. The outboard bone af~fixation portions 62 of the plate 60 each contain two counter-sunk screw holes (see FIG. 6 for screw holes 62c) and the hub portion 62b (as shown in FIG. 6) contains a single counter-sunk screw hole 62d. The bone plate 60 is mounted to the fracture site bone fragments via bone screws 62e (see FIG.
6a). To close an open fracture line (after appropriate affixation of the 'Y" shaped plate 60 to adjacent bone fragments) the plate legs 62a may be kinked, to a relatively more or less extent. As shown in FIG. 6a the fracture line F1 has been closed by kinking of the plate leg 62a which spans such fracture line. The other fracture lines F2 and F3 (as shown) remain open with the spanning plate leg 62a in each case still in its original non-deformed sllape at full length. As shown in FIG. 6a, the ID tag 64, originally an integra1 part of the plate 60, has been severed from the plate.
Kinking of the interconnecting plate legs of bone plates of the type shown in FIGS. 5 and 6 (after such plates have been secured to the bone fragments presenting open fracture lines) may be accomplished by the use of "Aderer" type pliers commonly ~ 3 used by ortllodontists for Icinl<ing wires connectiny orthodontic bands to increase the tension t`orces applied by such wires to such bands. This type of plier has two prongs on one side and one prong on the opposing side of the plier jaws. Kinking deformation of the leg sections of bone plates may also be accomplished by needle nose type pliers of well-known design.
Tlle preferred material of cons-truction of the metallic mesh-type sheets and strips forming bone fracture reduction devices in accordance with the invention and of bone plates of the type described hereinbefore is commercially pure titanium ~ith a yield strength in the range .of 30 000 ta 40 000 psi.
Bone screws utilized to accomplish internal fracture fixation in accordance with the invention should also preFerably be fabricated from commercially pure titanium. Also the armamentarium (tools) utilized should have workins parts and surfaces of the same biocompatible metal or metal alloy so as to avoid foreign metal contamination of the bone fixation devices.
In FIGS. 7 and 8 of the drawing shee~ there is shown enlarged views OT the produc-t identification tags illustrated in FIGS. l-6. Tl~us in FIG. 7 the ID tay 70 is an enlarged sllowing of tlle tag portion of the internal bone fixation devices of FIGS. l 3 and 5 and in FIG. ~ the ID tag 80 is an enlarged showillg of the -t~g portion of the internal bone fixation devices of FIGS. 2 4 and 6. As previously mentioned tl~e fixation devices illustrated in FIGS. 3-6 and 6a are of relatively small size having a major dimension ot about 25 mm. to about 40 mm.
l4 2 '' k ~ ~ 9 Also, the bone fixation devices of all figures are (in their "as supplied" form) of flat structure having a thickness in the range o~ about 0.6 mm. to about 1.2 mm.
It is to be understood that further alternative configurations of implantable bone fracture reduction devices, in accordance with the invention, have been fabricated. Also, it should be apparent that numerous other shapes of the identification tag portion of the implantable devices of the invention can be formed as integral parts thereof. After -the affixation of a fracture reduction device to bone fragments at a fracture site, the identification tag portion thereof may be easily removed from the device and retained for further reference as to the manufacturer's identity, product number and production lot number. Such identification information provides the reconstructive surgeon and associated medical team administrative authorities with full traceability of the product to the manufacturer and the material specifications, manufacturing procedures and quality controls applicable to the implantable device.
While the invention has been described in connection with particular structural embodiments of bone fracture reduction devices, many modifications of the inventiol- will be apparent to tllose skilled in the art. ~ccordingly, such modifications are to be included within the spirit and scope of ~5 tlle invention as def`ined by the following claims.
Claims (7)
1. An implantable bone fracture reduction device for the internal fixation and immobilization of bone fragments at a bone fracture site comprising:
a) a thin malleable bone affixation plate formed of a biocompatible metallic material, said plate having at least two spaced openings extending therethrough each for receiving a bone screw to be driven into bone fragments at a fracture site to affix said plate to said bone fragments; and b) a thin bone plate identification tag formed as an integral extension of said bone plate, said identification tag bearing at least the name of the plate manufacturer, the manufacturer's product number, and the manufacturer's production lot number for said plate to provide full traceability of the device with respect to material specifications, manufacturing procedures and quality controls, and said identification tag providing means for handling and manipulating said bone plate during its affixation to bone Fragments at a fracture site and being severable from said bone plate for archiving.
a) a thin malleable bone affixation plate formed of a biocompatible metallic material, said plate having at least two spaced openings extending therethrough each for receiving a bone screw to be driven into bone fragments at a fracture site to affix said plate to said bone fragments; and b) a thin bone plate identification tag formed as an integral extension of said bone plate, said identification tag bearing at least the name of the plate manufacturer, the manufacturer's product number, and the manufacturer's production lot number for said plate to provide full traceability of the device with respect to material specifications, manufacturing procedures and quality controls, and said identification tag providing means for handling and manipulating said bone plate during its affixation to bone Fragments at a fracture site and being severable from said bone plate for archiving.
2. An implantable bone fracture reduction device for the internal fixation and immobilization of bone fragments at a bone fracture site as claimed in claim 1 wherein said thin malleable bone affixation plate comprises a generally rectangular perforated mesh-type structure fabricated of a biocompatible metal or metallic alloy selected from the group consisting of titanium, titanium alloys, cobalt-chromium alloys and stainless steels, said severable bone plate identification tag extending from one end of said mesh-type structure.
3. An implantable bone fracture reduction device for the internal fixation and immobilization of bone fragments at a bone fracture site as claimed in claim 1 wherein said thin malleable bone affixation plate includes two plate sections interconnected by a relatively narrow deformable leg section with at least two screw holes extending through each plate section, the screw holes of each plate section being in general alignment with the long axis of said leg section, said severable bone plate identification tag extending from one of said plate sections.
4. An implantable bone fracture reduction device for the internal fixation and immobilization of bone fragments at a bone fracture site as claimed in claim 1 wherein said thin malleable bone affixation plate includes two terminal plate sections with at least two screw holes extending therethrough, an intermediate plate section having at least one screw hole extending therethrough, and two relatively narrow deformable leg sections with each of said leg sections interconnecting one of said terminal plate sections to said intermediate plate section, said severable bone plate identification tag extending from one of said terminal plate sections.
5. An implantable bone fracture reduction device for the internal fixation and immobilization of bone fragments at a bone fracture site as claimed in claim 1 wherein said thin malleable bone affixation plate includes three or more terminal plate sections with at least two screw holes extending therethrough, a central hub-type plate section having a single screw hole extending therethrough, and a relatively narrow deformable leg section interconnecting each of said terminal sections with said central plate section, said severable bone plate identification tag extending from one of said terminal plate sections.
6. An implantable bone fracture reduction device for the internal fixation and immobilization of bone fragments at a bone fracture site as claimed in claim 1 wherein said thin malleable bone affixation plate includes three or more like bone plate sections each with at least one screw hole extending therethrough, each of said plate sections interconnected by relatively narrow deformable leg sections of equal or unequal length to two adjacent like plate sections whereby said bone plate takes on the form of a closed multiple sided geometrical plane figure, said severable bone plate identification tag extending from one of said plate sections.
7. An implantable bone fracture reduction device for the internal fixation and immobilization of bone fragments at a bone fracture site as claimed in claims 3, 4, 5, or 6 wherein said thin malleable bone affixation plate is fabricated of a biocompatible metal or metallic alloy selected from the group consisting of titanium, titanium alloys, cobalt-chromium alloys and stainless steels.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/422,741 US4923471A (en) | 1989-10-17 | 1989-10-17 | Bone fracture reduction and fixation devices with identity tags |
| US07/422,741 | 1989-10-17 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2015889A1 true CA2015889A1 (en) | 1991-04-17 |
Family
ID=23676162
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002015889A Abandoned CA2015889A1 (en) | 1989-10-17 | 1990-05-02 | Bone fracture reduction and fixation devices with identity tags |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US4923471A (en) |
| EP (1) | EP0423420B1 (en) |
| CA (1) | CA2015889A1 (en) |
| DE (1) | DE69029245T2 (en) |
| ES (1) | ES2097118T3 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3488779A (en) * | 1967-09-27 | 1970-01-13 | Robert W Christensen | Orthopedic prosthetic appliances for attachment to bone |
| GB2125295B (en) * | 1982-08-17 | 1985-11-13 | Bristol Myers Co | Bone fixation plate |
| DE8528003U1 (en) * | 1985-10-02 | 1986-01-09 | Oswald Leibinger GmbH, 7202 Mühlheim | Bone plate |
| US4769040A (en) * | 1986-11-18 | 1988-09-06 | Queen's University At Kingston | Tibial prosthesis |
| DE3839859A1 (en) * | 1988-02-03 | 1989-08-17 | Bristol Myers Co | Bone plate |
-
1989
- 1989-10-17 US US07/422,741 patent/US4923471A/en not_active Expired - Lifetime
-
1990
- 1990-05-02 ES ES90108320T patent/ES2097118T3/en not_active Expired - Lifetime
- 1990-05-02 DE DE69029245T patent/DE69029245T2/en not_active Expired - Fee Related
- 1990-05-02 CA CA002015889A patent/CA2015889A1/en not_active Abandoned
- 1990-05-02 EP EP90108320A patent/EP0423420B1/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| EP0423420B1 (en) | 1996-11-27 |
| DE69029245D1 (en) | 1997-01-09 |
| EP0423420A3 (en) | 1991-10-23 |
| ES2097118T3 (en) | 1997-04-01 |
| US4923471A (en) | 1990-05-08 |
| DE69029245T2 (en) | 1997-05-22 |
| EP0423420A2 (en) | 1991-04-24 |
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Legal Events
| Date | Code | Title | Description |
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| EEER | Examination request | ||
| FZDE | Discontinued |