US20060064124A1 - Vascular wound closure device - Google Patents
Vascular wound closure device Download PDFInfo
- Publication number
- US20060064124A1 US20060064124A1 US11/280,029 US28002905A US2006064124A1 US 20060064124 A1 US20060064124 A1 US 20060064124A1 US 28002905 A US28002905 A US 28002905A US 2006064124 A1 US2006064124 A1 US 2006064124A1
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- Prior art keywords
- retractor
- dilator
- catheter
- guidewire
- members
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- Abandoned
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Classifications
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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
- A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/0206—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with antagonistic arms as supports for retractor elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/122—Clamps or clips, e.g. for the umbilical cord
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3439—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
- A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2067/00—Use of polyesters or derivatives thereof, as moulding material
- B29K2067/003—PET, i.e. poylethylene terephthalate
Abstract
An apparatus is provided for facilitating the locating and closing of an opening in a blood vessel. The apparatus includes a catheter and retractor that are advanced over a guidewire until they are positioned at or adjacent the vascular wound. The retractor comprises a plurality of members that close upon and engage the catheter. A coupling member selectively maintains the retractor members in the closed position.
Description
- This application is a continuation of U.S. application Ser. No. 09/929,700, filed Aug. 13, 2001, which is a divisional of U.S. application Ser. No. 09/325,982, filed Jun. 4, 1999, now U.S. Pat. No. 6,287,322, which is a continuation-in-part of U.S. application Ser. No. 09/092,282, now U.S. Pat. No. 6,524,326, filed Jun. 5, 1998, which is a continuation-in-part of U.S. application Ser. No. 08/984,757, now U.S. Pat. No. 6,425,901, filed Dec. 4, 1997, which is a continuation-in-part of U.S. application Ser. No. 08/943,369, filed Oct. 3, 1997, now abandoned, which is a continuation-in-part of U.S. application Ser. No. 08/764,611, U.S. Pat. No. 6,004,341 filed Dec. 5, 1996, which claims the benefit of U.S. Provisional Application Ser. No. 60/009,643, filed Dec. 7, 1995. The entirety of each of the priority applications is hereby incorporated herein by reference.
- 1. Field of the Invention
- The present invention relates to a system which assists in the locating of openings in tissue, including punctures, and facilitates the treatment, diagnosis or revision, of those areas. More specifically, in the case of closure of the opening, the invention relates to devices which aid in locating and isolating the opening.
- 2. Description of the Related Art
- In many medical procedures, there is a necessity to locate an opening in tissue so that some form of treatment, diagnosis or revision, can be applied to that opening. For example, in order to use transluminal balloon angioplasty an opening must be created in order to insert a balloon; this opening must be later located to be closed. Transluminal balloon angioplasty is used in the treatment of peripheral vascular disease to increase or restore blood flow through a significantly narrowed artery in a limb; it is also used in the treatment of blockage of the coronary arteries. In fact, coronary angioplasty has emerged as a major viable alternative to bypass surgery for revascularization of stenotic and occluded coronary arteries. Unlike bypass surgery, angioplasty does not require general anesthesia, opening of the chest wall, use of a heart-lung machine, or transfusion of blood. Angioplasty is not only less invasive and less traumatic to the patient, it is also less expensive because of the shorter hospital stay and shorter recovery time.
- Transluminal balloon angioplasty is performed by first inserting a hollow needle through the skin and into the patient's femoral artery. A guidewire is advanced through the hollow needle and into the artery, then along the patient's vasculature toward the site of the blocked blood vessel or heart valve to be treated. X-ray imaging is used to help move the guidewire through the vascular system and into position just past the stenosis to be treated. A balloon catheter is then threaded over the guidewire and advanced until the deflated balloon is within the stenosis. The balloon is then repeatedly inflated to widen the narrowed blood vessel. After the procedure is complete, the catheter and guidewire are withdrawn from the blood vessels and the patient.
- Angiography, which is used to detect diseases that alter the appearance of blood vessels, is performed in a similar manner. A hollow needle is first inserted through the skin and into the femoral artery, and a guidewire is then inserted through the needle and into the affected blood vessel. A catheter is then threaded over the guidewire and into the blood vessel to be examined, using x-ray imaging to guide the catheter to the desired position. Contrast medium is then injected, and a rapid sequence of x-ray pictures are taken so that blood flow along the affected vessel can be studied. Once complete, the catheter and guidewire are removed from the patient's body.
- After the catheter and guidewire used during angioplasty or angiography are removed, the puncture wound in the femoral artery must be closed and the bleeding through the puncture site in the artery stopped. Currently, ice packs and/or pressure are applied to the artery for a period lasting up to several hours in an attempt to stop the bleeding. There exists, however, a significant chance that upon movement by the patient, the wound will reopen and begin bleeding again. Although efforts have been made to close the puncture wound using staples, clips, and sutures, they have been unsuccessful, largely due to the inability to clearly locate and visualize the puncture wound in the femoral artery.
- Other wounds in the vasculature of a patient can also be difficult to locate and access. Thus, a device and method to facilitate the location of such wounds in the vasculature of a patient, such as femoral artery puncture wounds following transluminal balloon angioplasty and angiography, would be extremely beneficial. A device having the ability to aid in locating and isolating the puncture wound and facilitating the closure of the wound by everting the edges of the wound opening and then using staples, clips, sutures, plugs or adhesives would eliminate the prolonged bleeding currently associated with such wounds.
- The preferred form of the invention facilitates the location of the tissue opening, e.g., an opening in a vessel. The purpose of such location is to allow for the performing of other medical procedures on the opening or surrounding tissue. These procedures include but are not limited to therapeutic (e.g., radiation, drug delivery, etc.), closure of the opening, or modification of the opening (e.g., enlarging the opening) procedures.
- In accordance with one embodiment, the present invention provides a vascular wound locator device, comprising an elongate body having proximal and distal ends. At least a portion of the body is tapered toward the distal end. The body comprises two separately-formed elongate body members. Each body member has an inner surface having an elongate groove formed therein. When the internal surfaces of the body members abut one another, the grooves cooperate to form a channel extending along the length of the body. An elongate hollow dilator is included and has an elongate lumen comprising a proximal opening and a distal opening at the proximal and distal ends, respectively, of the dilator. The lumen is sized and adapted to accommodate a guidewire therethrough. The dilator is sized and adapted so that part of the dilator fits within the body channel, and the distal end of the dilator extends from the body channel. An annular cap of the embodiment is configured to fit over the proximal end of the body when the body members are engaged with one another. The annular cap has a hole adapted to generally align with the body channel. A coupling structure is adapted to engage the annular cap with the proximal end of the body so that the body members are held together at least partially by the annular cap.
- In accordance with another embodiment, a vascular wound closure device is provided. The device comprises a retractor comprising two elongate members adapted to move relative to each other between open and closed positions. Each retractor member has a distal end and a proximal end. The members are adapted to define a longitudinal channel therebetween when in the closed position An elongate catheter has a lumen adapted to slidably accommodate a guidewire. The catheter is configured to at least partially fit into the longitudinal channel so that a distal portion of the catheter extends from a distal end of the retractor. Means are provided for aligning the elongate retractor members and selectively maintaining the retractor members in the closed position so that the retractor members engage the catheter and hold the catheter in place. The aligning means comprises an aperture generally aligned with the longitudinal channel.
- In yet another embodiment, the present invention provides an apparatus for facilitating closure of an opening in a blood vessel, which includes a closure instrument having an elongated member defining a longitudinal axis with proximal and distal ends. The elongated member has a vacuum lumen extending at least a portion of the length thereof for conveying a vacuum and terminating in a vacuum port adjacent the distal end of the elongated member. The distal end of the elongated member is dimensioned to be positioned proximal a vessel opening in a blood vessel whereby vessel edge portions defining the vessel opening are at least drawn toward the vacuum port in response to a vacuum conveyed through the vacuum lumen. At least one surgical clip, preferably, two, is mounted adjacent the distal end of the elongated member and is adapted to be formed to an at least partially formed condition thereof. The one clip is positioned with respect to the vacuum port to engage the vessel edge portions drawn toward the vacuum port upon movement of the one clip to the formed condition thereof to generally approximate the vessel edge portions to at least partially close the vessel opening.
- The apparatus may further include a clip forming member mounted to the elongated member and engageable with the one clip. The clip forming member is movable relative to the elongated member to move the one clip to the formed condition thereof. Preferably, first and second clip forming members are mounted to the elongated member in diametrically opposed relation.
- In another preferred embodiment, an apparatus for facilitating closure of an opening in a blood vessel, includes an elongated member having a vacuum lumen extending at least a portion of the length thereof for conveying a vacuum and terminating in an axial vacuum port, a source of vacuum connectable to the elongated member in communication with the vacuum lumen whereby vacuum forces conveyed through the vacuum lumen and vacuum port cause vessel edge portions defining the vessel opening to be at least partially drawn into the vacuum port such that the vessel edge portions assume a general everted condition, and a pair of surgical clips releasably mounted to the distal end of the elongated member adjacent the vacuum port and positioned to engage the vessel edge portions drawn into the vacuum port upon movement of the surgical clips to respective formed conditions thereof to thereby approximate the vessel edge portions to at least partially close the vessel opening. The apparatus may further include a manually actuable clip forming mechanism mounted to the elongated member. The clip forming mechanisms are movable to move the surgical clips to respective formed conditions thereof.
- A method for locating a vessel opening in a blood vessel is also disclosed. The method includes the steps of applying a vacuum to the blood vessel adjacent the vessel opening such that the apparatus applying the vacuum first locates the area surrounding the vessel opening by drawing a mixture of blood and bodily fluid, then isolates the exact location of the vessel opening by being moved to the location where only blood is drawn. Once the location and isolation of a vessel opening is achieved, other medical procedures can be performed on the opening or its surrounding tissue. These medical procedures can be therapeutic (drug or radiation delivery) or closing or modifying (e.g. enlargement of vessel opening) in type. Also, once the vessel opening has been isolated, the further vacuum application everts vessel edge portions defining the vessel opening. Once eversion of the vessel edge portions occur, closing techniques can be used to close the opening.
- Due to the use of a vacuum, contaminants and blood clots are cleaned off the puncture site allowing better healing of the wound. Also, re-entry is made easier and less scarring is produced.
-
FIG. 1 is a side view of a portion of a human body, showing the site where the femoral artery is typically accessed and punctured during angioplasty or angiography. -
FIG. 2 is a perspective view of one embodiment of the wound closure device of the present invention. -
FIG. 3 is an exploded perspective view of the wound closure device of the present invention. -
FIG. 4 is a cross-sectional view of a portion of a human body, showing the femoral artery accessed via a hollow needle, and a guidewire having an inflatable balloon attached, inserted through the hollow needle and into the femoral artery. -
FIG. 5 is a side view of the distal end of a surgical clip applicator to be used in conjunction with the wound closure device of the present invention. -
FIG. 6 is a partial cross-sectional view of a portion of a human body, showing the femoral artery having a guidewire positioned therein, and a perspective view of the retractor of the present invention positioned over the guidewire, with its distal tip at the site of the puncture in the femoral artery. -
FIG. 7 is a side view of the retractor with its cap removed and the wings of the surgical clip applicator inserted into the grooves within the retractor. -
FIG. 8 is a cross-sectional view of the clip applicator and retractor taken along line 8-8 inFIG. 7 . -
FIG. 9 is a perspective view of an alternate embodiment of a femoral artery closure device in accordance with the present invention. -
FIG. 10 is an exploded perspective view of the alternate embodiment of the femoral artery closure device illustrated inFIG. 9 . -
FIG. 11 is a side view of the 2 halves of the retractor ofFIGS. 9 and 10 separated slightly and having a dilator inserted therethrough. -
FIG. 12 is a cross-sectional view of the distal end of the retractor having a dilator and a guidewire inserted therethrough. -
FIG. 13 is a side view of the components of the femoral artery localization and closure assembly. -
FIG. 14 is a side view of the 2 halves of the retractor separated slightly and having a surgical clip applicator with an applicator guide and a guidewire inserted therethrough. -
FIG. 15 is a top view of the surgical clip applicator guide of the present invention. -
FIG. 16 is a side view of the clip applicator guide, having a guidewire inserted therethrough. -
FIG. 17 is an enlarged perspective view of a dilator having a removable double-sleeved balloon at its distal end. -
FIG. 18 is an enlarged perspective view of the dilator ofFIG. 17 with the sleeves of the balloon inflated. -
FIG. 19 is an enlarged perspective view of the dilator ofFIG. 18 having the retractor inserted between the sleeves of the balloon. -
FIG. 20 is an enlarged perspective view of the dilator and retractor ofFIG. 19 with the dilator removed, illustrating the tunnel formed by the retractor and the outer sleeve of the balloon. -
FIG. 21 is a perspective view of another alternate embodiment of a retractor in accordance with the present invention. -
FIG. 22 is an exploded perspective view of the alternate embodiment of the retractor illustrated inFIG. 21 . -
FIG. 23 is a perspective view of an alternate embodiment of a dilator having a double-sleeved balloon and a distal balloon mounted thereon in accordance with the present invention. -
FIG. 24 is a top view of another embodiment of the double-sleeved balloon, illustrating the I-shaped inner sleeve. -
FIG. 25 is a perspective view of the alternate embodiment of the dilator ofFIG. 23 , showing the balloons inflated. -
FIG. 26 is a cross-sectional view of the dilator of the present invention, illustrating the various lumens in the dilator. -
FIG. 27 is a side view of the distal end of a surgical clip applicator with an indicator tube mounted thereon. -
FIG. 28 is a perspective view of an alternate embodiment of a retractor of the present invention, shown in a closed position. -
FIG. 29 is a perspective view of an alternate embodiment of a retractor of the present invention, shown in an open position. -
FIG. 30 is a side view of a dual-lumen indicator tube of the present invention, having a guidewire inserted through its central lumen. -
FIG. 31 is a side view of the dual-lumen indicator tube of the present invention, with the retractor mounted thereon. -
FIG. 32 is a perspective view of an apparatus for facilitating closure of an opening in a vascular organ illustrating the vascular closure instrument and a vacuum source connected to the closure instrument. -
FIG. 33 is an enlarged isolated view of the distal end of the closure instrument illustrating the pair of clips releasably mounted to the instrument. -
FIG. 34 is a cross-sectional view of the closure instrument in a non-actuated condition illustrating positioning of the distal end of the closure instrument proximal the vascular opening. -
FIG. 35 is an enlarged isolated view of the distal end of the closure instrument in the non-actuated condition proximal the vascular opening. -
FIG. 36 is a cross-sectional view of the closure instrument illustrating the closure instrument in an actuated condition. -
FIG. 37 is an enlarged isolated view of the distal end of the closure instrument in the actuated condition illustrating the surgical clips formed to close the vascular opening. -
FIG. 38 is a perspective view of an alternate embodiment of the vascular closure instrument ofFIG. 32 . -
FIG. 39 is an enlarged isolated view of the distal end of the closure instrument ofFIG. 38 . -
FIG. 40 is a cross-sectional view of a vessel opening and its surrounding, showing a tissue opening locator drawing both blood and other bodily fluid. -
FIG. 41 is a cross-sectional view of a vessel opening and its surrounding, showing a tissue opening locator solely drawing blood since the located has isolated the tissue opening. -
FIG. 42 a is a front view of a tissue opening locator with a guidewire lumen located on its outside. -
FIG. 42 b is a front view of a tissue opening locator with a guidewire lumen located inside. -
FIG. 43 is a cross-sectional view of a vessel opening and its surrounding, showing a tissue opening locator with medical procedure deliver devices located both inside and outside the tissue opening locator. -
FIG. 44 is a cross-sectional view of a vessel opening and its surrounding area, showing a guidewire that enters the vessel opening. -
FIG. 45 is a cross-sectional view of a vessel opening and its surrounding area, showing a tissue opening locator locate the vessel opening. -
FIG. 46 is a cross-sectional view of a vessel opening and its surrounding area, showing a tissue opening locator isolate a vessel opening and evert the vessel opening edges. -
FIG. 47 is cross-sectional view of a vessel opening and its surrounding, showing a tissue opening locator an attached general closure device. -
FIG. 48 is a top view of an alternate embodiment of a retractor having features of the present invention, shown in an open position. -
FIG. 49 is a top view of the retractor ofFIG. 48 , shown in a closed position. -
FIG. 50 is a bottom perspective view of the retractor ofFIG. 48 . - Although the description which follows details the location, eversion, and closure of a puncture wound in a femoral artery, the present invention is not intended to be limited to use only with the femoral artery. Rather, the description which follows is exemplary and preferred only, and those of skill in the art can readily modify the apparatus and method described below to use with other types of tissue openings.
- Referring first to
FIG. 1 , there is shown a side view of a portion of a human body, showing asite 5 where afemoral artery 10 is typically accessed and punctured during angioplasty or angiography. During these procedures, ahollow needle 15 is first inserted through the skin and into thefemoral artery 10. Aguidewire 20 is then inserted through the proximal end of thehollow needle 15 and into theartery 10, as illustrated inFIG. 4 , and theneedle 15 is withdrawn from the patient. Theguidewire 20 is advanced through the patient's vasculature, often using x-ray imaging as an aid in directing theguidewire 20 to the desired location. - Once the
guidewire 20 is in the desired location, a catheter is used. The proximal end of theguidewire 21 is inserted into the distal end of the catheter, and the catheter is threaded over theguidewire 20 and advanced to the desired location. In the case of angioplasty, the catheter has an inflatable balloon attached at its distal end. Once in position within the stenosis, the balloon is repeatedly inflated and deflated to widen the narrowed blood vessel. In the case of angiography, a catheter is threaded over theguidewire 20 as just described and into the blood vessel to be examined. Contrast medium is then injected, and a rapid sequence of x-ray pictures are taken so that blood flow along the affected vessel can be studied. - After either of these procedures is completed, the catheter and guidewire 20 are withdrawn from the blood vessel and the patient. The puncture wound 25 in the
femoral artery 10 caused by the insertion of thehollow needle 15, guidewire 20 and catheter must be closed and the bleeding through thepuncture site 25 in theartery 10 stopped. - Construction of the Retractor
- In order to facilitate the closure of the
wound 25 in thefemoral artery 10, aretractor 30 is employed. Theretractor 30, illustrated inFIGS. 2 and 3 , comprises abody portion 35 and acap 40. Thebody 35 of theretractor 30 has a narrow, tapereddistal end 37, and a broader circular proximal end 41. Thedevice 30 has twohandles body 35, one on each half 35 a, 35 b. Thehandles retractor 35. These handles 43, 45 assist the user in handling thedevice 30. Theretractor 30 also comprises acircular cap 40 at its proximal end 41, having ahole 47 therethrough. Thishole 47 extends into achannel 50 which runs the entire length of thedevice 30. - As illustrated in
FIG. 3 , thecap 40 andbody 35 of theretractor 30 comprise three separable pieces: thecap portion 40 and the two halves of thebody portion removable cap 40 is internally threaded 55. Theproximal end 39 of the two halves of thebody cap 40. Each half of the body of theretractor semi-circular groove 65 on its flatinternal surface 67. When thecap 40 is securely screwed onto the two halves of thebody FIG. 2 , the three pieces are joined together, and thesemicircular grooves 65 form achannel 50 running through the interior of thedevice 30, which starts at the hole in thecap 47 at the proximal end 41 and continues through thebody 35, ending at asmall hole 49 in the distal end of theretractor 37 where the two halves of thebody cap 40 is unscrewed from thebody 35, the two halves of thebody FIG. 3 . - Alternate Embodiment of the Retractor
- Another preferred embodiment of the invention is illustrated in
FIGS. 9-10 . In this embodiment, theretractor 100 includes a retraction mechanism whereby the twohalves retractor body 102 can be moved apart from one another a desired distance, while maintaining their alignment. The retractor again comprises abody portion 102, and anannular cap 104. The twohalves cap 104. Thiscap 104 is screwed on and off the externally threadedhalves cap 106 can be textured to ease hand tightening and loosening of thecap 106. As illustrated inFIG. 10 , each half 102 a, 102 b of the retractor body again has asemicircular groove 126 running longitudinally down the center of its flatinternal surface 128. When thecap 104 is securely screwed onto the twohalves internal surfaces 128 abut one another, thesemicircular grooves 126 form achannel 108. Thecap 104 is open on both ends and through its center to permit access to thechannel 108. - The
retractor 100, as illustrated inFIGS. 9-10 , further comprises acollar 110 located on theretractor body 102 just distal to the externally threadedproximal end 103; apin assembly 116, comprising twoparallel pins perpendicular handle 116 c; and two setscrews FIG. 10 , thepins guide passages collar region 110 b of onehalf 102 b of the retractor body and are insertable withinholes collar region 110 a of theother half 102 a of the retractor body, such that onehalf 102 b of the retractor body can slide apart from theother half 102 a on thepins collar 110 b includes internally threadedholes set screws collar region 110 a at right angles to thepin guide passages set screws pins halves - Second Alternate Embodiment of the Retractor
- Yet another embodiment of the retractor of the present invention is illustrated in
FIGS. 21 and 22 . Theretractor 200 comprises abody portion 202 having adistal end 204, and a broader,collar portion 206 at itsproximal end 205. Like the embodiment described above, thisretractor 200 is formed in twohalves 202 a, 202 b and preferably has a tapereddistal end 204. Each half of the body of theretractor 202 a, 202 b, has a semicircular groove 208 on its flatinternal surface 209. When the twohalves 202 a, 202 b are joined together, the semi-circular grooves 208 form achannel 210 running through the interior of thedevice 200, extending from theproximal end 205 to thedistal end 204. - The
collar 206 of thedevice 200 includes apin assembly 212 comprising twoparallel pins handle 212 c, and two setscrews FIG. 22 , thepins guide passages 216 a, 216 b bored through thecollar region 206 of one half of theretractor body 202 b, and are insertable withinholes collar region 206 of the other half of the retractor body 202 a, such that one half of theretractor body 202 b can slide apart from the other half 202 a on thepins collar 206 also includes internally threadedholes 220 a, 220 b adapted to receive externally threadedset screws collar region 206 at right angles to thepin guide passages 216 a, 216 b such that when theset screws pins retractor body 202 a, 202 b. - Third Alternate Embodiment of the Retractor
- Still another embodiment of the retractor of the present invention is illustrated in
FIGS. 28 and 29 . Theretractor 300 comprises adistal body portion 302, and aproximal handle portion 304. Thedistal body portion 302 of theretractor 300 is formed in two portions orhalves distal end 306 of thebody portion 302, a retractingportion 308 extends away from, and at an angle to thebody portion 302. Preferably, the retractingportion 308 extends substantially perpendicular to thebody portion 302. The retractingportion 308 is also formed in two separable portions orhalves portions semicircular groove 312 in its flat, internal surface (FIG. 29 ). The external surfaces are preferably rounded, and tapered toward thedistal end 310. When the twoportions FIG. 28 , a channel 314 is formed through the interior of the retractingportion 308 of theretractor 300. -
Handles proximal end 304 of theretractor 300. Thehandles handles body portion 302 of theretractor 300. Thehandles portion 308 of theretractor 300. -
FIGS. 28 and 29 also illustrate aloop 320 extending from one of thehandles 316 a in the direction of theother handle 316 b. Theother handle 316 b has ascrew 322 inserted therethrough. Theloop 320 surrounds thescrew 322, such that when thescrew 322 is tightened, theloop 320 is held securely between thescrew 322 and the underlying surface. This mechanism acts to control the distance between thehandles portion handles portions loop 320 along thescrew 322, then tightening thescrew 322 to securely fix theloop 320 in the desired position. Of course, other locking mechanisms well known to those of skill in the art may also be used to control the positioning of theretractor 300. - Fourth Alternate Embodiment of the Retractor
- Yet another embodiment of the retractor of the present invention is illustrated in
FIGS. 48-50 . Theretractor 600 comprises adistal body portion 602 and aproximal handle portion 604. Thedistal body portion 602 of theretractor 600 is formed in two portions orhalves distal end 606 of thebody portion 602, a retractingportion 608 extends away from, and at an angle to, thebody portion 602. Preferably, the retractingportion 608 extends substantially perpendicular to thebody portion 602. The retractingportion 608 is also formed in two separable portions orhalves portions semi-circular groove 612 in its internal surface. The external surfaces are preferably rounded, and tapered toward thedistal end 610. When the twoportions FIG. 49 , achannel 614 is formed through the interior of the retractingportion 608 of theretractor 600. -
Handles proximal end 604 of theretractor 600. Thehandles corresponding body portion handles portion 608 of theretractor 600. Ahinge 618 operating between the handle/body pairs 616 a/602 a, 616 b/602 b is adapted so that when thehandles -
FIGS. 48-50 also show astop bar 620 extending from one of thehandles 616 b and through a cavity formed in theother handle 616 a. Thestop bar 620 is preferably curved along an arc having thehinge 618 as a center of curvature.Teeth 622 are formed along a surface of thearcuate stop bar 620. A ratchetingrelease member 624 comprising anarm 626 and ahead portion 628 extends through and from thehandle half 616 a through which thestop member 620 passes. Therelease member 624 is pivotably connected to thehandle half 616 a by apivot pin 630 extending through thehead 628. Thehead 628 comprises astop 634, which is adapted to engage theteeth 622 of thestop bar 620, and alobe 636 which extends through thehandle 616 a. Abar spring 638 connected to thehandle half 616 a contacts thelobe 636 and exerts a force F thereon. The force F exerted by thebar spring 638 on thelobe 636 biases the head stop 634 into engagement with thestop bar teeth 622. Thearm 626 of therelease member 624 is preferably arcuate and is adapted to be easily manipulated by a hand also grasping thehandles arm 626 toward thehandle 616 a overcomes the biasing force F and moves the head stop 634 out of engagement with thestop bar teeth 622. - A
spring 640 is attached to and operates between thehandles spring 640 is adapted to exert force F′ on thehandles spring 640 biases the retractingportion halves release member stop 634 in thestop bar teeth 622 is adapted to prevent movement of the handles apart from each other. However, therelease member stop 634 is also adapted so that when thehandles teeth 622. Thus, movement of the handle halves 616 a, 616 b toward each other is accommodated by thestop 634, but movement of the handle halves 616 a, 616 b away from each other is prevented by thestop 634 when it is engaged with thestop bar teeth 622. Thus, a clinician using theretractor 600 can open the retractor halves 602 a, 602 b to a precise point by simply squeezing the handle halves 616 a, 616 b together. Thestop 634 and stopbar 620 prevent the retractor halves 602 a, 602 b from closing again once the desired open position is reached. When the clinician desires to close theretractor 600, the clinician need only manipulate therelease member arm 626, thus disengaging thestop 634 from thestop bar teeth 622. Thehinge 640 then urges the handle halves 616 a, 616 b away from each other and the retractor halves 602, 602 b toward each other into the closed position. - The retractors of the present invention are preferably formed of one of many strong, biocompatible engineering polymers. Plastics such as polypropylene, polyethylene, or polyterephthalate, are preferred. Elastomers such as silastics or silicones can also be used. Most preferably, metals such stainless or surgical steel, or titanium, are used to form the retractor.
- Construction of the Dilator
- As illustrated in
FIGS. 11-13 , theretractor 100 is preferably used in conjunction with adilator 150. As is known to those of ordinary skill in the art, thehollow dilator 150 preferably includes a standardmale connector 149, such as a Luer connector, at its proximal end and is narrowly tapered at itsdistal end 151. The inside diameter of thedilator channel 160 is large enough to accommodate aguidewire 144, so that thedilator 150 can be fed along theguidewire 144 and into the lumen of the femoral artery. Dilators are commonly used in procedures such as angioplasty and angiography to enlarge the puncture site and provide improved access to the femoral artery. - In one embodiment of the present invention, the dilator is preferably notched 152 near its
distal end 151 around its entire circumference. Thisnotch 152 provides a seat and guide point for the tapered distal tips of the twohalves retractor 100 is closed upon thedilator 150, the sharp distal tip of theretractor body 112 is buried in thenotch 152 of the dilator. This forms a smooth transition between thedilator 150 and retractor 100 (FIG. 12 ). As will be explained more fully below, when theguidewire 144 is inserted through thedilator 150 and thedilator 150 is then inserted through theretractor 100, (FIGS. 12-13 ), thedilator 150 lies securely within the interior circular channel 108 (FIG. 9 ) running the length of theretractor body 102. - The
dilator 150 also preferably includes at least oneindicator hole 154. Thedilator 150 illustrated inFIGS. 11-13 includes twoindicator holes 154 directly opposed to one another, located a few millimeters distal to thenotch 152; the distance X between theholes 154 and thenotch 152 is preferably only slightly larger than the thickness of the wall of the femoral artery. - Alternatively, a transducer-tipped pressure monitoring catheter, mounted to the outside of the
dilator 150, may be used in conjunction with thedilator 150 and indicator holes 154. Use of the indicator holes 154 and pressure sensor will be described in detail below. - Dilator/Retractor Assembly
- Another embodiment of the present invention comprises an entire femoral artery localization and closure assembly illustrated in
FIG. 13 . Theguidewire 144 which emerges from the original puncture wound is fed through thedilator 150, and then thedilator 150 is inserted through theretractor 100. Theretractor 100 is advanced along thedilator 150 until the distal tips of theretractor 112 stop within thenotch 152 in thedilator 150. Preferably, themale fitting 149 on the proximal end of thedilator 150 is connected to one port of a commercially available 3-way Y-connector 156. Asyringe 158 or other means of applying negative pressure is connected to one of the other ports on the Y-connector 156 and the proximal end of theguidewire 144 exits the Y-connector 156 via the remaining port. The Y-connector 156 therefore acts as a seal at the proximal ends ofdilator 150 andguidewire 144. - Alternate Embodiments of the Dilator
- In another embodiment of the invention, a modified
dilator 150 is used. As illustrated inFIG. 17 , a double-sleeved balloon 170 is removably attached to thedilator 150 near itsdistal end 151, proximal to asingle indicator hole 154. Preferably, theballoon 170 is placed a distance from theindicator hole 154 which is approximately the width of the arterial wall, e.g., about 1.5 mm. The inflatable, double-sleeved balloon 170 is angled at itsdistal end 172 to allow the balloon to better fit thefemoral artery 10. Theballoon 170 includes inflation means which allow the balloon to be inflated and deflated from the proximal end of thedilator 150. Use of the double-sleeved balloon 170 will be described in detail below. - In yet another embodiment, illustrated in
FIGS. 23-25 , thedilator 220 has both a double-sleeved balloon 222 and a secondinflatable balloon 224 mounted on itsdistal end 226. The double-sleeved balloon 222 is removably attached to thedilator 220 near itsdistal end 226, proximal to thesingle indicator hole 228. The secondinflatable balloon 224 is mounted on thedilator 220 just distal to theindicator hole 228. When inflated, thissecond balloon 224 helps anchor thedilator 220 in place in thefemoral artery 10, preventing thedilator 220 from being pulled out of theartery 10 during the procedure. Thus, the distal,second balloon 224 is positioned together with theindicator hole 228, within theartery 10, while the double-sleeved balloon 222, proximal to theindicator hole 228, remains outside of theartery 10 as illustrated inFIG. 25 . Theballoons dilator 220, and help anchor thedilator 220 once it is properly positioned, as will be explained in detail below. - The
inner sleeve 230 of the double-sleeved balloon 222 is preferably shaped to facilitate the insertion of theretractor 200 between the twosleeves FIG. 24 , theinner sleeve 230 can be in the shape of an “I”, thus providing additional space between the inner surface of theouter sleeve 229, and the outer surface of theinner sleeve 230. This allows the two halves of theretractor body 202 a, 202 b to be inserted between the twosleeves balloon retractor 200. - The
dilator 220 having both a double-sleeved balloon 222 and a second,distal balloon 224, is further illustrated inFIG. 26 . As can be seen from the drawing, thedilator 220 has 4different lumens dilator 225 to the distal end of thedilator 226. Aguidewire 240 is inserted through one of thelumens 236. Anotherlumen 232 is used to inflate the double-sleeved balloon 222, while athird lumen 238 is used to inflate thesecond balloon 224 at the distal end of thedilator 226. Thefourth lumen 234 is used to aspirate blood through theindicator hole 228 at the distal end of thedilator 226. Syringes are preferably used to provide the aspiration and inflation pressure through theselumens dilator 225 is preferably adapted to allow for fluid communication between the syringes and thevarious lumens dilator 225 to accommodate the means chosen. - Dual Lumen Catheter
- In yet another embodiment of the invention, a dual-lumen catheter is used to locate the exact site of the puncture wound. As illustrated in
FIGS. 30 and 31 , thecatheter 340 has aninner lumen 342 which extends from the proximal end of thecatheter 344 all the way to the distal end of thecatheter 346. Thisinner lumen 342 is adapted to receive aninner catheter 360 orguidewire 350, as will be explained in more detail below. - The outer lumen of the dual-
lumen catheter 340 surrounds theinner lumen 342, and also extends from the proximal end of thecatheter 344 to thedistal end 346. Near the distal end of thecatheter 346, at least oneindicator hole 352 is positioned in the outer wall of thecatheter 340. Theindicator hole 352 provides fluid communication between the area outside of thecatheter 340 and the outer lumen. The outer surface of thecatheter 354 surrounding theindicator hole 352 is preferably raised, acting as a stop. Preferably, the distance between theindicator hole 352 and the proximal end of the raised surface of theretractor 354, is approximately the same as the thickness of the wall of the femoral artery. As will be explained below, theretractor 300 is first mounted on the distal end of the catheter, and positioned such that the distal tip of the retractingportion 310 stops at a guide point just proximal to the raisedsurface 354, about 0.5 mm proximal to theindicator hole 352. This assures that the distal tip of the retractingportion 310 will be properly positioned inside the patient's body at the site of the wound in the artery. - At the proximal end of the
catheter 344, theproximal end 358 of the outer lumen is preferably joined to aconnector 364, such as a Luer-type connector, which is adapted to receive asyringe 360 or other source of negative pressure, as will be explained in more detail below. - The Surgical Clip Applicator
- The retractor of the present invention is used to facilitate closure of wounds to the vasculature of a patient using surgical clips, staples, or sutures. One aspect of the present invention therefore includes the use of a
surgical clip applicator 70. Asurgical clip applicator 70 for use with theretractor 30 of the present invention is illustrated inFIG. 5 . As shown in this figure, the distal end of theclip applicator 75 is fitted with two triangular protrusions orwings clip applicator 75. Thesewings grooves 65 located on the interior surface of the twohalves retractor 30, as is best seen inFIG. 8 . With thewings clip applicator 70 in thegrooves 65 in the two halves of the body of theretractor clip applicator 70 is guided into proper position within the patient's body, as will be discussed in more detail below. In addition, thesurgical clip applicator 70 preferably has aguide 80 attached to itsdistal end 75. Theguide 80 preferably extends laterally from the side of theclip applicator 70, and is open at its proximal and distal ends such that aguidewire 20 may be threaded therethrough. Thisguide 80 is used in combination with theguidewire 20 to accurately guide theclip applicator 70 to the site of thevascular puncture 25, as will be described below. - The
surgical clip applicator 70 preferably also has astop 85 located proximal of thedistal end 75, at the point where the proximal ends of the wings of theapplicator stop 85 also aids in the proper positioning of theclip applicator 70 at the site of thevascular puncture 25, and prevents theclip applicator 70 from being inserted too far into the patient's body. - Alternate Surgical Clip Applicator Assembly
- Referring now to
FIGS. 14-16 , there is illustrated an alternate embodiment of a surgicalclip applicator assembly 130. Theclip applicator assembly 130 incorporates a standard commercially availablesurgical clip applicator 132. In accordance with the present invention, the applicator is modified to include aguide assembly 134 reversibly fastened near its distal end. The guide assembly comprises awinged guide plate 138 which is reversibly secured to abody 140. In the embodiment illustrated inFIGS. 14-16 , allen screws 142 are used to attach theguide plate 138 but other well known means of attachment can also be used. The distal end of thesurgical clip applicator 132 slides within the channel 148 (FIG. 15 ) formed when thewinged guide plate 138 is fastened to theguide body 140. - Attached to the
guide body 140 is aguidetube 136 which is adapted to accept theguidewire 144. A preferred embodiment of said guidetube 136 includes a mechanism to close theguidetube 136 once theguidewire 144 has entered. Such a mechanism may involve a second partially open tube which fits within saidguidetube 136. This second tube can be rotated within theguidetube 136 to open theguidetube 136 when the openings in both tubes are aligned or close theguidetube 136 when the openings of the tubes are offset. To facilitate the opening and closing, the inner tube preferably includes a handle that passes through a slot in theouter guidetube 136. This mechanism can be spring-loaded like the closures commonly used on pieces of jewelry. - The surgical clip
applicator guide assembly 134, together with theretractor 100 and theguidewire 144, is designed to accurately guide theclip applicator 132 to the site of the femoral artery puncture as detailed below. As explained above, the lateral edges of thewinged guide plate 138 are configured to fit within the groove 126 (FIG. 10 ) located on the interior surface of each half of theretractor body surgical clip applicator 132 is guided between the retracted halves of theretractor body guidewire 144 which passes through theguidetube 136 at the distal most end of thesurgical clip applicator 132. - Second Alternate Surgical Clip Applicator Assembly
- An alternate embodiment of the surgical
clip applicator assembly 250 is illustrated inFIG. 27 . Again, theclip applicator assembly 250 incorporates a standard commercially availablesurgical clip applicator 252. Theapplicator 252 is modified to include aguide assembly 254 reversibly fastened near itsdistal end 256. Theguide assembly 254 is adapted to receive anindicator tube 260. Theindicator tube 260 is a hollow tube having anindicator hole 264 near itsdistal end 262. Theindicator tube 260 is adapted to receive aguidewire 240 therethrough, and to be connected to a source of negative pressure at its proximal end. This source of negative pressure, such as a syringe, is used to provide aspiration through theindicator hole 264. When properly positioned on theclip applicator 252, the distal end of theindicator tube 262 and theindicator hole 264 extend past the distal end of theclip applicator 256. Preferably, the distance between theindicator hole 264 and the distal tip of theclip applicator 256 is approximately equal to the width of the arterial wall, e.g., about 1.5 mm. - Methods of Use
- Referring first to
FIGS. 4-8 , a first method of use of theretractor 30 in conjunction with asurgical clip applicator 70 to close awound 25 in thefemoral artery 10 will now be described. As noted above, during angioplasty or angiography, thefemoral artery 10 is first punctured with ahollow needle 15 and aguidewire 20 is inserted therethrough (FIG. 4 ). A proximal portion of theguidewire 21 remains outside the patient's body. After the distal end of theguidewire 23 is in position within thefemoral artery 10, thehollow needle 15 is removed. A catheter (not shown) is then threaded over theguidewire 20, and inserted into the patient's body. - In a preferred embodiment, a specially designed
guidewire 20 having aninflatable balloon 24 located near itsdistal end 23 is used for the diagnostic or therapeutic procedure. Theguidewire 20 is threaded through thehollow needle 15 and into the patient's vasculature. Alternatively, such as for balloon angioplasty procedures, a standard guidewire well known to those of skill in the art can be used in conjunction with a balloon catheter. The balloon on the distal end of the catheter can be used in place of theballoon 24 located on theguidewire 20. - Following completion of the therapeutic or diagnostic procedure, the catheter used during the procedure is removed. The
guidewire 20 remains in place in the patient's vasculature. (Note that when a balloon catheter is used in place of a guidewire having a balloon on its distal end, the catheter is left inside the patient, and use of its balloon is identical to the use of theballoon 24 on theguidewire 20 described below). When the physician desires to close thewound 25 in thefemoral artery 10, he or she first withdraws theguidewire 20 and/or catheter through the patient's vasculature using the portion of theguidewire 20 and/or catheter that remains outside the patient'sbody 21, until thedistal end 23 of theguidewire 20 and/or catheter is within thefemoral artery 10 close to the femoralartery puncture site 25. Theballoon 24 on thedistal end 23 of theguidewire 20 or catheter is then inflated, and theguidewire 20 or catheter is withdrawn further until the physician feels some resistance. This will indicate that theballoon 24 is inside thefemoral artery 10 and at the site of the puncture wound 25. The physician then threads the proximal end of theguidewire 21 into thehole 49 located at thedistal end 37 of the fully assembled retractor 30 (FIGS. 2, 3 and 6). Theguidewire 20 is threaded through thechannel 50 formed in the body of theretractor 35, until the proximal end of theguidewire 21 emerges through thehole 47 in thecap 40 at the proximal end of the retractor 41 (FIG. 6 ). Theretractor 30 is then slowly advanced along theguidewire 20 and into the patient's body, until resistance is felt. This resistance indicates that the distal tip of theretractor 37 is contacting theinflated balloon 24 in thefemoral artery 10. The distal tip of theretractor 37 therefore will be properly located at the site of the puncture in thefemoral artery 25, as is shown inFIG. 6 . - In a preferred embodiment, the
guidewire 20 used in conjunction with the femoralartery closure retractor 30 has a marking 27 on it which also helps to indicate when theretractor 30 has been properly positioned (FIG. 6 ). This marking 27 preferably consists of a tiny bead or colored line on theguidewire 20. The marking on theguidewire 27 is placed proximal of the proximal end of theballoon 26. The length of theretractor 30 is measured, and the marking 27 is made at least that same length in a proximal direction on theguidewire 20, measured from the proximal end of theballoon 26. Thus, when theretractor 30 is advanced over theguidewire 20 and resistance is felt, the physician checks to see if the marking on theguidewire 27 has emerged through the proximal end of the retractor 41, as is illustrated inFIG. 6 . If the marking 27 is not yet visible, the physician must advance theretractor 30 further to ensure that it contacts the femoralartery puncture site 25. - Once the
retractor 30 is properly positioned within the patient's body, thesurgical clip applicator 70 or other method of closing the puncture wound 25 is used. Thecap 40 on theretractor 30 is first removed from the body by unscrewing (FIG. 3 ). The proximal end of theguidewire 21 emerging from the proximal end of the retractor 41 is threaded through theguide 80 located on the outer surface of theapplicator 70, as illustrated inFIG. 7 . The wings on thesurgical clip applicator hole 90 formed at the proximal end of the body of theretractor 39, by lining up thewings applicator 30 with thegrooves 65 located on theinner surface 67 of the retractor body halves 35 a, 35 b (FIGS. 7 and 8 ). The wings on theclip applicator grooves 65 of theretractor 30, as is best illustrated inFIG. 8 . Theclip applicator 70 is then advanced, which causes the two halves of the body of theretractor FIG. 7 . As the twohalves puncture site 25 in thefemoral artery 10 below the overlying tissues. Theclip applicator 70 is advanced through theretractor 30 until the stop on theapplicator 85 contacts the proximal end of theretractor 39. At this time, the balloon on theguidewire 24 or catheter is deflated, and the catheter and/orguidewire 20 is removed from the patient. The surgical clips located at the distal tip of theclip applicator 75 are applied to the puncture wound 25, preferably using the method well known to those of ordinary skill in the art. Once the femoral artery puncture wound 25 is closed, theclip applicator 70 andretractor 30 are removed from the patient. - First Alternate Method
- Referring now to
FIGS. 9-16 , a method of using the alternate embodiment of theretractor 100 in conjunction with thedilator 150 and surgicalclip applicator assembly 130 to localize and close the femoral artery puncture wound is now described. As described above, following completion of the angioplasty or angiography, the catheter used during the procedure is removed from the patient's body, leaving only the guidewire threaded into the femoral artery. If desired, before the retractor-dilator assembly 101 (FIG. 13 ) is used, a standard dilator of a smaller diameter than that 150 incorporated into the retractor-dilator assembly 101 can be fed onto the proximal end of the guidewire and advanced down the guidewire and into the artery. This preliminary step dilates the overlying tissue if necessary, making it easier to subsequently pass the larger retractor-dilator assembly 101 through the surrounding tissue. - If the tissue has been dilated as above, the smaller bore standard dilator is first removed. The proximal end of the
guidewire 144 is first inserted into the distal channel 160 (FIG. 11 ) of thedilator 150. Thedilator 150 has been previously inserted through the internal channel of theretractor 100, and theretractor 100 advanced over thedilator 150 until thedistal tip 112 comes to rest in thenotch 152 on the distal tip of thedilator 150. The Y-connector 156 is then attached to the proximal end of thedilator 150 and asyringe 158 attached to one of the ports of theconnector 156. The retractor-dilator assembly 101 is then advanced over theguidewire 144 into the patient's body. - While the retractor-
dilator assembly 101 is advanced into the patient's body, suction is continuously applied via thesyringe 158 or other means of negative pressure (FIG. 13 ) to thedilator 150. At the moment the indicator holes 154 enter the lumen of the femoral artery, blood is aspirated into thesyringe 158, indicating that thedilator 150 has been inserted through the puncture site into the femoral artery. Thus, the distal tip of theretractor 112, still buried within thenotch 152 in thedilator 150, is located just proximal or outside the artery wall at the site of the puncture wound and the indicator holes 154 in thedilator 150 are located just distal or inside the artery lumen. The artery wall is thus disposed in thearea 153 between thenotch 152 and theholes 154. - Alternatively, the
dilator 150 includes a pressure sensor (not shown) such as a fiber optic pressure sensor, near its distal tip. The sensor is preferably mounted to the outside wall of thedilator 150. In a preferred embodiment, a transducer-tipped pressure monitoring catheter, such as the Camino Catheter available from Camino Laboratories, San Diego, Calif., is used. The pressure sensor, mounted on the outside of thedilator 150, is inserted over theguidewire 144 and into the femoral artery. The pressure sensor, in conjunction with a pressure monitoring system, will indicate an increase in pressure when it is inserted into the femoral artery. At that point, the advancement of theretractor 100 is stopped, such that the distal tip of theretractor 112 is located just proximal theartery wall 10 at the site of the puncture wound. This allows the physician to properly locate the site of the femoral artery puncture wound in the patient. - Once the
dilator 150 andretractor 100 are in proper position, thecap 104 is removed from theretractor 100 and the twohalves FIG. 10 ) by loosening theset screws halves distal tips 112 of twohalves notch 152 in the dilator 150 (FIG. 11 ) and straddle the puncture site. The set screws 120 a, 120 b, are then tightened to hold the twohalves retractor 100 in this separated position. While pressing theretractor 100 down against the outer wall of the femoral artery, thedilator 150 is withdrawn, leaving only theretractor 100 and theguidewire 144 in position at the site of the puncture wound in the artery. - To close the wound, the
retractor 100 must be retracted far enough to allow the surgicalclip applicator assembly 130 to access the puncture site. Upon loosening theset screws halves FIGS. 9-10 ). When sufficiently retracted, theset screws retractor assembly 100 are tightened to maintain the proper distance between the retractor halves. If necessary, a separate retractor, having a thickness suited for sliding within thegrooves 126 in each half 102 a, 102 b of the retractor body, and a width equal to that of the winged guide plate 138 (FIG. 14 ) of the surgical clip applicator guide assemble 134, can be used to open the retractor body to the proper distance. - Second Alternate Method
- In an alternate embodiment illustrated in
FIG. 17 , the modifieddilator 150 having a double-sleevedinflatable balloon 170 removably attached to the distal end of thedilator 151, just proximal to theindicator hole 154, is used. Theballoon dilator apparatus 175 is inserted over theguidewire 144 into the patient's body. As described above, as the balloon-dilator apparatus 175 is advanced, negative pressure is applied to the system via the syringe or other source. The advance of the balloon-dilator apparatus 175 is stopped as soon as blood is aspirated. The double-sleeved balloon 170 is then inflated to form atunnel 176 between the femoral artery puncture wound and the surface of the patient's body, as illustrated inFIG. 18 . - The double-
sleeved balloon 170 advantageously prevents the femoralartery closure retractor 100 from entering thefemoral artery 10 and damaging it. Should the deflatedballoon 170 be advanced into thefemoral artery 10, the process of inflating theballoon 170 will pull theballoon 170 out of theartery 10, thereby safely creating atunnel 176 used to access theartery 10. - The
balloon 170 is preferably angled at itsdistal end 172 to allow theballoon 170 to “fit” thefemoral artery 10, as shown inFIGS. 17-19 . - Once the
balloon 170 is inflated (FIG. 18 ) theretractor 100 is advanced between the two sleeves of theballoon 170, until the distal tip of theretractor 112 reaches the distal end of the doublesleeved balloon 170. Once theretractor 100 is positioned between the two sleeves of theballoon 170, the two halves of theretractor dilator 150 are removed from the patient, leaving the separatedretractor 100 and theouter sleeve 180 of theballoon 170 in the patient. Thedilator 150 and the inner sleeve 178 are removed from the patient along theguidewire 144. - The
retractor 100 and the outer sleeve of theballoon 180 form anaccess tunnel 182 between the femoral artery puncture wound and the surface of the patient's body, as illustrated inFIG. 20 . Thistunnel 182 allows for the introduction of the wound closure device to seal the femoral artery puncture wound. - At this point, with the retractor providing access to the femoral artery, the proximal end of the
guidewire 144 is inserted into theguidetube 136 on the surgicalclip applicator assembly 130 and the wings on the guide plate are fitted within thegrooves 126 of the opened retractor body 102 (FIGS. 14-16 ). Theclip applicator assembly 130 can now be advanced toward the puncture wound, sliding within thegrooves 126 in theretractor body 102, guided by theguidewire 144 passing through theguidetube 136 at the distal tip of the surgicalclip applicator assembly 130. When the distal tip of thesurgical clip applicator 130 has reached the outer wall of thefemoral artery 10, at the site of the puncture wound, the surgeon withdraws theguidewire 144 from the patient's body and immediately deploys a surgical clip. A second clip can then be deployed a millimeter or two away from the first clip in order to ensure that the wound is closed. - In a preferred embodiment, just prior to closure of the puncture site, the
flexible guidewire 144 used during the primary procedure is replaced with a commercially available guidewire that can become rigid at its distal end, forming a hook. The hooked distal end can be pulled back, “hooking” the puncture wound in the artery. As the guidewire is pulled back further, the puncture wound is stretched into a linear slit, making it more amenable to closure by surgical clips. - Third Alternate Method
- Referring now to
FIGS. 21-27 , a method of using the alternate embodiment of theretractor 200 in conjunction with thedilator 220 and surgicalclip applicator assembly 250 to localize and close the femoral artery puncture wound is now described. As described above, following completion of the angioplasty or angiography, the catheter used during the procedure is removed from the patient's body, leaving only theguidewire 240 threaded into thefemoral artery 10. - The proximal end of the
guidewire 240 is first inserted into the distal lumen 236 (FIG. 26 ) of thedilator 220. Thedilator 220 is advanced over theguidewire 240 into the patient's body. As described above, as the balloon-dilator apparatus 250 is advanced, negative pressure is applied to the system via the syringe or other source connected at the proximal end of thedilator 225. The advance of thedilator 220 is stopped as soon as blood is aspirated through theindicator hole 228, thus indicating that the distal end of thedilator 226 is positioned within thefemoral artery 10. Thedistal balloon 224 and the double-sleeved balloon 222 are then inflated to anchor thedilator 220 in place and to form a tunnel between the femoral artery puncture wound and the surface of the patient's body. - Once the
balloons retractor 200 is advanced between the twosleeves sleeved balloon 222. As illustrated inFIG. 24 , theinner sleeve 230 of the doublesleeved balloon 222 can be in an “I” shape, which provides more space between the two sleeves to insert the twohalves 202 a, 202 b of thereactor 200. Theretractor 200 is advanced between the twosleeves retractor 204 is positioned just proximal to the puncture wound in thefemoral artery 10. - Once the
retractor 200 is positioned between the two sleeves of theballoon retractor 202 a, 202 b are moved laterally away from one another. This is done by loosening theset screws retractor body 202 b away from the other half 202 a on thepins 212 a 212 b. Theinner sleeve 230 of the double-sleeved balloon 222 and thedilator 220 are removed from the patient along theguidewire 240, leaving the separatedretractor 200 and theouter sleeve 229 of theballoon 222 in the patient. Theretractor 200 and the outer sleeve of theballoon 229 form an access tunnel between the femoral artery puncture wound and the surface of the patient's body. This tunnel allows for the introduction of the wound closure device to seal the femoral artery puncture wound. - At this point, with the
retractor 200 and outer sleeve of theballoon 229 providing access to thefemoral artery 10, the proximal end of theguidewire 240 is inserted into thedistal end 262 of theindicator tube 260 which is mounted on thesurgical clip applicator 252. As described above, thedistal end 262 of theindicator tube 260 having anindicator hole 264 in it is positioned so that theindicator hole 264 extends past thedistal end 256 of theclip applicator 252. Theindicator tube 260 and theclip applicator 252 are advanced over theguidewire 240 while aspiration pressure is applied to the proximal end of theindicator tube 260. As soon as blood is aspirated through theindicator hole 264, the advancement of theindicator tube 260 andclip applicator 256 is stopped. At this point, the distal end of thesurgical clip applicator 256 is positioned at the site of the puncture wound in thefemoral artery 10. Surgical clips are then applied to seal the wound. - Preferably, the distal end of the
indicator tube 262 is curved or hooked. The hooked distal end is used to hook the puncture wound in the artery, bringing the edges of the wound together to facilitate application of the clip. Using the hookeddistal end 262 of theindicator tube 260, the puncture wound is stretched into a linear slit, making it more amenable to closure by surgical clips. - Fourth Alternate Method
- Referring now to
FIGS. 28-31 , still another method of closing a wound in the femoral artery of a patient will be described. Here again, the femoral artery is first punctured with a hollow needle and aguidewire 350 is inserted therethrough. A proximal portion of theguidewire 351 remains outside the patient's body. After the distal end of theguidewire 353 is in position within the femoral artery, the hollow needle is removed. Diagnostic and/or therapeutic procedures are then carried out, using theguidewire 350 to guide the insertion of the other medical instruments into the vasculature of the patient. - Following completion of the therapeutic or diagnostic procedure, the devices used during the procedure are removed. The
guidewire 350 remains in place in the patient's vasculature. When the physician desires to close the wound in the artery, he or she first mounts theretractor 300 on the distal end of the dual-lumen catheter 340. This is done by loosening thescrew 322 on one of thehandles 316 b, and moving thehandles portion 308, and the two parts of the retractingportion lumen catheter 340. Thedual lumen catheter 340 fits within the semi-circular channel orgrooves 312 formed in the inner surface of the retractingportion 308 of theretractor 300. The two halves of the retractingportion handles catheter 340. The retractingportion 308 is positioned on thecatheter 340 just proximal to the raised portion of thecatheter 354, so the distal tip of the retractingportion 310 is located just proximal to theindicator hole 352. Preferably, the distal tip of the retractingportion 308 will be approximately 0.5 mm behind the indicator hole 352 (seeFIG. 31 ). Once in position, thescrew 322 is tightened on theloop 320 to lock the two parts of the retractingportion catheter 340. - Once the
retractor 300 is properly positioned on the dual-lumen catheter 340, the physician inserts theproximal end 351 of theguidewire 350 into the distal end of theinner lumen 342 in the dual-lumen catheter 340. The dual-lumen catheter 340 andretractor 300 are advanced over theguidewire 350 and into the patient. As thecatheter 340 andretractor 300 are advanced, negative pressure is applied to the outer lumen of the catheter, for example, through use of asyringe 360 attached to the proximal end of theouter lumen 358. Once theindicator hole 352 is advanced to a position inside the artery, blood will be drawn through theindicator hole 352 and will become visible in the outer lumen of thecatheter 340 and thesyringe 360. At this point, advancement of thecatheter 340 andretractor 300 are stopped, as thecatheter 340 andretractor 300 are properly positioned in the patient. - Once properly positioned at the site of the puncture wound, the two halves of the retracting
portion handles proximal end 304 of theretractor 300. To separate the retractingportions screw 322 is loosened, and thehandles screw 322 is then tightened down upon theloop 320, prohibiting further movement of thehandles portions - At this point, the surrounding tissues have been displaced, forming an access path to the puncture wound, and the puncture wound may be visible. The dual-
lumen catheter 340 is removed from the patient by withdrawing it over theguidewire 350. Theguidewire 350 is left in place, and the wound closure device, such as a clip applicator, is inserted over theguidewire 350 to the site of the wound. Clips, such as those made of titanium or a biodegradable material, are preferably applied to the wound, as theguidewire 350 is removed. If necessary, the artery is compressed to stop the flow of blood out of the puncture wound during the closing of the wound. The closing device is removed when the physician is confident that the wound is closed, and theretractor 300 is removed from the patient. - Alternatively, a separate
inner catheter 360 is used in the system of the present invention. In this embodiment, once theretractor 300 and dual-lumen catheter 340 are in place, and the retractingportion 308 is in an open position, the dual-lumen catheter 340 is left in place, and theguidewire 350 is withdrawn from the patient through theinner lumen 342. Aninner catheter 360 having aninflatable balloon 362 at its distal end is inserted through theinner lumen 342 and into the patient. Once thedistal balloon 362 is advanced past thedistal tip 346 of the dual-lumen catheter 340, theballoon 362 is inflated. The dual-lumen catheter 340 is removed from the patient, leaving theinner catheter 360 in place. - To properly position the balloon inside the patient's artery, the physician can measure the distance from the distal tip of the dual-
lumen catheter 346 to just outside the patient's body when thecatheter 340 is properly positioned. The physician then inserts theinner catheter 360 just slightly more than that distance, to ensure that thedistal balloon 362 is within the artery. The physician then pulls theinner catheter 360 in a proximal direction until resistance is felt. This will place theballoon 362 at the site of the puncture wound. Theballoon 362 is properly positioned just inside the artery of the patient. Theballoon 362 helps to stop the flow of blood out of the puncture wound. Theinner catheter 360 is used as a guide for the clip applicator or other closing device used to close the wound. The closing device is advanced until it contacts theinflated balloon 362. As the wound is closed, theballoon 362 is slowly deflated, and theinner catheter 360 is removed from the patient. Finally, once the physician is confident that the wound is closed, theretractor 300 is removed from the patient. - This method of closing a wound in the femoral artery of a patient can also be performed using the
retractor 600 described inFIGS. 48-50 in place of theretractor 300 discussed above. To mount theretractor 600 on the distal end of thedual lumen catheter 340, the clinician squeezes therelease member arm 626 so that the head stop 664 is clear of thestop member teeth 622. The handles are also squeezed together in order to separate the twohalves dual lumen catheter 340. As above, the catheter fits within the semi-circular channel orgrooves 612 of the retractingportion halves portion 608 is positioned on thecatheter 340 just proximal to a raised portion of the catheter so that thedistal tip 610 of the retractingportion 608 is located just proximal to theindicator hole 352, the clinician releases the squeezing hold on thehandles spring 640 urges the retractinghalves spring 640 on thehandles catheter 340 securely between the retractor halves 602 a, 602 b. - The
dual lumen catheter 340 andretractor 600 are next advanced over the guidewire, preferably in the same manner described above, until the assembly is properly positioned at the vascular puncture wound. The retractingportions handles head stop 634 ratchets over thestop member teeth 622. Thus, when the desired open position is reached, the clinician need only release thehandles stop 634 will engage theteeth 622 in order to hold the retractinghalves - To remove the
retractor 600 from the patient, the retractingportions release arm 626 toward thehandle 616 a. Thestop 634 is thus disengaged from thestop arm teeth 622 and thespring 640 urges thehandles portions retractor 600 is then easily removed from the patient. - Alternate Apparatus for Vessel Closure
- Referring now to
FIG. 32 , there is illustrated another apparatus contemplated for closure of an opening in a vascular organ, e.g., blood vessel subsequent to an angiography, angioplasty procedure, etc.Apparatus 400 includesvascular closure instrument 402 and a vacuum source 404 (shown schematically inFIG. 32 ) which is connectable to the vascular closure instrument. Vacuumsource 404 may be any vacuum generator suitable for the surgical procedure to be described. - With references to
FIGS. 32-34 ,vascular closure instrument 402 includeshandle 406, and anelongated portion 408 extending distally from thehandle 406 and defininglongitudinal axis 408 a. Handle 406 is generally cylindrical in configuration, however, other designs are contemplated as well.Vascular closure instrument 402 includes alongitudinal lumen 410 extending the length of theinstrument 402 throughhandle 406 andelongated portion 408 and terminating in distalaxial opening 412. Longitudinal orvacuum lumen 410 conveys the vacuum provided byvacuum source 404.FIG. 34 illustrates suitable tubing “t” connectingvacuum source 404 andclosure instrument 402. -
Vascular closure instrument 402 further includes a pair ofsurgical clips 414 supported at the distal end ofelongated portion 408.Surgical clips 414 may be any conventional surgical clip fabricated from a suitable biocompatible material including absorbable and non-absorbable materials.Clips 414 are characterized by having backspan 414 a andclip legs 414 b (FIG. 35 ).Clip legs 414 b are adapted to move or pivot inwardly to a closed or formed condition thereof in response to inward force applied to theclip legs 414 b. -
Surgical clips 414 are releasably mounted toelongated portion 408. In one arrangement,elongated portion 408 includes first and second pairs oflongitudinal grooves 416 formed in the distal end of theelongated portion 408.Longitudinal grooves 416 extend in a longitudinal direction and terminate in transverse grooves 418 (FIG. 33 ) adjacent the proximal end of thelongitudinal grooves 416.Transverse grooves 418 receivesurgical clips 414, more specifically, backspans 414 a of thesurgical clips 414 to mount thesurgical clips 414 in a releasable manner.Transverse grooves 418 are preferably dimensioned such that a frictional relationship is established to further facilitate mounting of theclips 414 to theinstrument 402. Eachsurgical clip 414 is loaded by positioning backspan 414 a withinlongitudinal groove 416, advancing theclips 414 in a proximal direction adjacenttransverse grooves 418 and manipulating thebackspans 414 a to be received within thetransverse groves 418. Other means for mountingsurgical clips 414 toelongated portion 408 may be readily appreciated by one skilled in the art. - With continued reference to
FIGS. 32-35 ,vascular closure instrument 402 further includes clip forming mechanism, generally identified asreference numeral 420, mounted toelongated portion 408 of the instrument. In the preferred embodiment,clip forming mechanism 420 includes a pair of manuallyoperable levers 422 mounted to the outer surface ofelongated portion 408 in diametrically opposed relation. Manuallyoperable levers 422 are mounted at their proximal end portions via mountingpins 424 whereby the distal end portions of the manuallyoperable levers 422 may move in a radially direction, i.e., toward each other, to formsurgical clips 414. - As best depicted in
FIGS. 32-33 ,elongated portion 408 defines a non-circular or oval cross-section having a major cross-sectional dimension “a” (FIG. 33 ). Such configuration advantageously facilitates closure of an elongated incision formed in the blood vessel. In particular, an incision made in the blood vessel in connection with an angioplasty or angiography procedure is preferably elongated in the direction of the axis of the blood vessel. Accordingly, by applyingvascular closure instrument 402 to the opening with the major axis “a” extending in the general direction of the opening, the surgeon is assured that the vessel opening is confined within the perimeter of theelongated portion 408. In addition, the oval cross-section corresponds to the internal dimension of the aforedescribed retractors, includingretractor 100 andretractor 300, when in an open condition, thereby facilitating use of thewound closure instrument 402 with these instruments, e.g., positioning of theclosure instrument 402 within the open retractor and advancing theinstrument 402 therewithin. For a typical puncture wound having a diameter or length of about 1 mm, theelongated portion 408 preferably has a major axis “a” of about 3-5 mm and most preferably about 4 mm. -
Elongated portion 408 of vascular closure instrument may further include awrap 425, e.g., shrink wrapping, or the like shown cut-away inFIG. 32 .Wrap 425 preferably extends to the distal end ofelongated portion 408 ofvascular closure instrument 402 to at least partially encloselongitudinal grooves 416 andtransverse grooves 418 to preserve the integrity of the vacuum withinvacuum lumen 408. - The operation of vascular closure instrument in conjunction with closing an opening in a blood vessel wall will now be discussed. Access to the puncture site is preferably achieved with the guidewire, dilator, retractor instruments discussed above. With reference to
FIGS. 34-35 ,vascular closure instrument 402 is positioned adjacent the opening “o” in vessel “v” with the major axis of the oval extending in the general direction of the axis “a” of the blood vessel “v.” By virtue of the oval cross-section, the entire opening or incision “o” is confined within the perimeter of the elongated portion. Vacuumsource 402 is actuated which thereby creates a vacuum withinvacuum lumen 410. Due to the effect of the vacuum forces, shown inFIG. 34 by the directional arrows “s,” the vessel edge portions “e” defining the vessel opening “o” are at least partially drawn into distalaxial opening 412 ofelongated portion 408 to assume an everted condition as shown. With reference now toFIGS. 36-37 , with the vessel edge portions “e” everted and in position to be engaged byclip legs 414 b ofsurgical clips 414, manuallyoperable levers 422 are moved radially inwardly in the direction of directional arrows “f” by a force exerted by the user to pivotclip legs 414 b and formsurgical clips 414. In the formed condition, cliplegs 414 b engage the vessel edge portions “e” to generally approximate the edges “e” to close the opening. Thereafter,surgical clips 414 are released from their mounting toelongated portion 408 by manipulating thevascular closure instrument 402 to align clip backspan 414 a withlongitudinal grooves 416 thereby permitting the instrument to be withdrawn leaving thesurgical clips 414 in place. -
FIGS. 38-39 illustrate an alternate embodiment of the vascular closure instrument. In accordance with this embodiment, a side opening port 430 (shown in phantom) is provided in theelongated portion 408 to permit passage of the proximal end of a guidewire “g.” When used with the guidewire “g” in place within the vessel opening, the guidewire “g” is introduced withindistal opening 412 and manipulated to theside opening port 430 and passed therethrough. Thereafter, the vascular closure instrument is advanced along the guidewire to the opening site. As best depicted inFIG. 39 , the guidewire “g” is preferably positioned adjacent the periphery of theelongated portion 408 so as to not interfere with the clip forming process. More preferably, the guidewire “g” is placed about ¼-½ of the length of the major axis “a” from the periphery of theaxial opening 412 so as not to interfere with the everted vessel edges. Most preferably, the guidewire “g” is positioned about ⅓ of the length of the major axis “a” into theopening 412. Also, a separate guidewire lumen or tube may be incorporated inelongated portion 408 to receive the guidewire “g.” If in the form of a tube, such tube may be attached to the inner wall ofelongated portion 408 and extend to side openingport 430. - Locating a Tissue Opening
- Referring to
FIGS. 40-41 , an apparatus and method for locating a vessel opening is described. InFIG. 40 , thelocator apparatus 500, which is in communication with a vacuum or source of suction (not shown), has not completely isolated thevessel opening 25. Thus, thelocator apparatus 500 draws both blood and other bodily fluid with its suction. InFIG. 41 , thelocator apparatus 500 has completely isolated thevessel opening 25 and now only draws blood through its lumen. The blood is transferred to the proximal end of theapparatus 500 or to some other location external of the body to provide a visual indication that theapparatus 500 has located theopening 25. In this position, thelocator apparatus 500 can hold onto thevessel 10 with its suction and maintain theapparatus 500 over the opening. - Referring to
FIGS. 42 a and 42 b, analternate locator apparatus 500 is shown with anexternal guidewire lumen 507. Aninternal guidewire lumen 508 is shown inFIG. 42 b. - Referring to
FIG. 43 , apreferred locator apparatus 500 is shown with externalmedical delivery devices 508 a and 508 b, which can deliver medical treatment to the area surrounding thevessel opening 25. Also, internalmedical delivery devices 509 a and 509 b can deliver medical treatment to thevessel opening 25 or to thevessel 10 itself. The medical treatment can be therapeutic, e.g. radiation or drug delivery. - Referring to
FIG. 47 , a preferred apparatus for locating a vessel opening is illustrated.Suction apparatus 500 includes a vacuum source 505 (shown schematically). Thesuction apparatus 500 may also be connected to a closure device 504 (shown schematically) viaattachment ports 506. Vacuumsource 505 may be any vacuum generator suitable for the surgical procedure to be described. Theapparatus 500 may also include closure devices 504 (shown schematically), which may also be inside theapparatus 500. - Referring to
FIGS. 44-47 , a method of locating a vessel opening is illustrated. In particular, a guidewire “g” is strung though the vessel opening as described previously. Thesuction apparatus 500 has the guidewire “g” strung through it by theguidewire guide 503. As the distalaxial opening 502 nears thevessel opening 25, the vacuum forces of thesuction apparatus 500 draws both blood and clear bodily fluid from the area surrounding thevessel opening 25. When the distalaxial opening 502 completely covers thevessel opening 25, thesuction apparatus 500 has isolated thevessel opening 25. At this point, the vacuum forces of thesuction apparatus 500 only draws blood. Also, once thevessel opening 25 has been isolated, the vacuum forces of thesuction device 500 cause the edges of thevessel opening 25 toevert 26. - Once the
vessel opening 25 has been isolated, aclosure device 504 attached to thesuction device 500 can be used to close thevessel opening 25. - The present invention can also be used with surgical staples or sutures. After the retractor is inserted into the patient's body and positioned at the puncture site as described above, the two halves of the retractor are separated, laterally displacing the tissues surrounding the puncture site. The retractor acts much like a dilator, gradually increasing the displacement of the overlying tissues, until the puncture wound is visible to the physician. The wound can then be closed using any acceptable means for wound closure, including surgical staples and sutures.
- Although certain embodiments and examples have been used to illustrate and describe the present invention, it is intended that the scope of the invention not be limited to the specific embodiments set forth herein. The scope of the invention is to be defined by the claims which follow.
Claims (16)
1. A vascular wound closure device, comprising:
an elongate body having proximal and distal ends, at least a portion of the body being tapered toward the distal end, the body comprising two separately-formed elongate body members, each body member having an inner surface having an elongate groove formed therein, such that when the internal surfaces of the body members abut one another, the grooves cooperate to form a channel extending along the length of the body;
an elongate hollow dilator having an elongate lumen comprising a proximal opening and a distal opening at the proximal and distal ends, respectively, of the dilator, the lumen sized and adapted to accommodate a guidewire therethrough, the dilator sized and adapted so that part of the dilator fits within the body channel, and the distal end of the dilator extends from the body channel;
an annular cap configured to fit over the proximal end of the body when the body members are engaged with one another, the annular cap having a hole adapted to generally align with the body channel; and
a coupling structure adapted to engage the annular cap with the proximal end of the body so that the body members are held together at least partially by the annular cap.
2. A vascular wound closure device as in claim 1 , wherein the annular cap in internally threaded, and proximal ends of the body members are externally threaded so that the cap is threadable onto the engaged body members.
3. A vascular wound closure device as in claim 1 , wherein the dilator comprises a hole formed through a side of the dilator and into the lumen, and the dilator is positioned relative to the body so that the side hole is disposed distal of the distal end of the body.
4. A vascular wound closure device as in claim 3 , wherein the body is disposed on the dilator so that the distal end of the body is disposed proximal of the side hole a distance at least equal to a thickness of a blood vessel wall.
5. A vascular wound closure device as in claim 4 , wherein the body is disposed on the dilator so that the distal end of the body is about 0.5-1.5 mm proximal the side hole.
6. A vascular wound closure device as in claim 4 , wherein a pin extends from one of the body members, a guide passage is formed in the other body member, and the pin is configured to fit in the guide passage so as to align the body members.
7. A vascular wound closure device as in claim 1 , wherein a pin extends from one of the body members, a guide passage is formed in the other body member, and the pin is configured to fit in the guide passage so as to align the body members.
8. A vascular wound closure device as in claim 7 , wherein the coupling structure is configured so that the annular cap readily couples to the body members when the body members are aligned with the pin fit into the guide passage.
9. A vascular wound closure device as in claim 8 , wherein the proximal ends of the body members are threaded and an interior surface of the annular cap is threaded so as to engage the body member threads.
10. A vascular closure device, comprising:
a retractor comprising two elongate members adapted to move relative to each other between open and closed positions, each member having a distal end and a proximal end, and the members are adapted to define a longitudinal channel therebetween when in the closed position;
an elongate catheter having a lumen adapted to slidably accommodate a guidewire, the catheter configured to at least partially fit into the longitudinal channel so that a distal portion of the catheter extends from a distal end of the retractor; and
means for aligning the elongate retractor members and selectively maintaining the retractor members in the closed position so that the retractor members engage the catheter and hold the catheter in place, the aligning means comprising an aperture generally aligned with the longitudinal channel.
11. A vascular closure device as in claim 10 additionally comprising:
a source of negative pressure connected to the catheter lumen;
an opening formed through an outer wall of the catheter and communicating with the lumen; and
a guide point defined on an outer surface of the catheter proximal of the opening, a longitudinal distance between the opening and the guide point being at least the same as the thickness of a vascular vessel wall;
wherein the distal ends of the retractor members are positioned at or adjacent the guide point.
12. A device as in claim 11 , wherein the guide point comprises a notch formed in the catheter.
13. A device as in claim 11 , wherein a longitudinal distance between the guide point and the opening is slightly greater than a wall thickness of a human femoral artery.
14. A device as in claim 13 , wherein the distance is at least about 0.5 mm.
15. A device as in claim 11 , wherein the retractor additionally comprises a handle portion operatively connected to the movable members.
16. A device as in claim 15 , wherein the handle portion comprises two handles and a locking mechanism, and the handles are operatively connected at a hinge.
Priority Applications (1)
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US09/092,282 US6524326B1 (en) | 1995-12-07 | 1998-06-05 | Tissue opening locator and everter and method |
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US09/929,700 US6964675B2 (en) | 1995-12-07 | 2001-08-13 | Tissue opening locator and everter and method |
US11/280,029 US20060064124A1 (en) | 1995-12-07 | 2005-11-15 | Vascular wound closure device |
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