US20060064124A1 - Vascular wound closure device - Google Patents

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

CROSS-REFERENCE TO RELATED APPLICATIONS
• 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.
BACKGROUND OF THE INVENTION
• 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.
SUMMARY OF THE INVENTION
• 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.
BRIEF DESCRIPTION OF THE DRAWINGS
• 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 line8-8 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 the2 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 the2 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. 42ais a front view of a tissue opening locator with a guidewire lumen located on its outside.
• FIG. 42bis 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.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• 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 toFIG. 1, there is shown a side view of a portion of a human body, showing asite5 where afemoral artery10 is typically accessed and punctured during angioplasty or angiography. During these procedures, ahollow needle15 is first inserted through the skin and into thefemoral artery10. Aguidewire20 is then inserted through the proximal end of thehollow needle15 and into theartery10, as illustrated inFIG. 4, and theneedle15 is withdrawn from the patient. Theguidewire20 is advanced through the patient's vasculature, often using x-ray imaging as an aid in directing theguidewire20 to the desired location.
• Once theguidewire20 is in the desired location, a catheter is used. The proximal end of theguidewire21 is inserted into the distal end of the catheter, and the catheter is threaded over theguidewire20 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 theguidewire20 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 guidewire20 are withdrawn from the blood vessel and the patient. The puncture wound25 in thefemoral artery10 caused by the insertion of thehollow needle15, guidewire20 and catheter must be closed and the bleeding through thepuncture site25 in theartery10 stopped.
• Construction of the Retractor
• In order to facilitate the closure of thewound25 in thefemoral artery10, aretractor30 is employed. Theretractor30, illustrated inFIGS. 2 and 3, comprises abody portion35 and acap40. Thebody35 of theretractor30 has a narrow, tapereddistal end37, and a broader circular proximal end41. Thedevice30 has twohandles43,45 located on itsbody35, one on each half35a,35b. Thehandles43,45 are positioned approximately one-third of the way from the proximal end of the retractor41, and extend laterally from the body of theretractor35. These handles43,45 assist the user in handling thedevice30. Theretractor30 also comprises acircular cap40 at its proximal end41, having ahole47 therethrough. Thishole47 extends into achannel50 which runs the entire length of thedevice30.
• As illustrated inFIG. 3, thecap40 andbody35 of theretractor30 comprise three separable pieces: thecap portion40 and the two halves of thebody portion35a,35b. Theremovable cap40 is internally threaded55. Theproximal end39 of the two halves of thebody35a,35bare externally threaded60, and are adapted to removably receive thecap40. Each half of the body of theretractor35a,35bhas asemi-circular groove65 on its flatinternal surface67. When thecap40 is securely screwed onto the two halves of thebody35a,35bas illustrated inFIG. 2, the three pieces are joined together, and thesemicircular grooves65 form achannel50 running through the interior of thedevice30, which starts at the hole in thecap47 at the proximal end41 and continues through thebody35, ending at asmall hole49 in the distal end of theretractor37 where the two halves of thebody35a,35bcome together. When thecap40 is unscrewed from thebody35, the two halves of thebody35a,35bmay be moved apart from one another, as illustrated inFIG. 3.
• Alternate Embodiment of the Retractor
• Another preferred embodiment of the invention is illustrated inFIGS. 9-10. In this embodiment, theretractor100 includes a retraction mechanism whereby the twohalves102a,102bof theretractor body102 can be moved apart from one another a desired distance, while maintaining their alignment. The retractor again comprises abody portion102, and anannular cap104. The twohalves102a,102bof the body are initially held together by the internally threaded105cap104. Thiscap104 is screwed on and off the externally threadedhalves102a,102bof the retractor body. The outer surface of thecap106 can be textured to ease hand tightening and loosening of thecap106. As illustrated inFIG. 10, each half102a,102bof the retractor body again has asemicircular groove126 running longitudinally down the center of its flatinternal surface128. When thecap104 is securely screwed onto the twohalves102a,102bof the retractor body, such that theinternal surfaces128 abut one another, thesemicircular grooves126 form achannel108. Thecap104 is open on both ends and through its center to permit access to thechannel108.
• Theretractor100, as illustrated inFIGS. 9-10, further comprises acollar110 located on theretractor body102 just distal to the externally threadedproximal end103; apin assembly116, comprising twoparallel pins116a,116battached at one end to aperpendicular handle116c; and two setscrews120a,120b. As illustrated inFIG. 10, thepins116a,116btraverseguide passages118a,118bbored through thecollar region110bof onehalf102bof the retractor body and are insertable withinholes124a,124bin thecollar region110aof theother half102aof the retractor body, such that onehalf102bof the retractor body can slide apart from theother half102aon thepins116a,116b. Thecollar110bincludes internally threadedholes122a,122badapted to receive externally threadedset screws120a,120b. The set screw holes122a,122benter thecollar region110aat right angles to thepin guide passages118a,118b, such that when theset screws120a,120bare advanced, they tighten upon thepins116a,116band thus, fix the distance between the twohalves102a,102bof the retractor body.
• Second Alternate Embodiment of the Retractor
• Yet another embodiment of the retractor of the present invention is illustrated inFIGS. 21 and 22. Theretractor200 comprises abody portion202 having adistal end204, and a broader,collar portion206 at itsproximal end205. Like the embodiment described above, thisretractor200 is formed in twohalves202a,202band preferably has a tapereddistal end204. Each half of the body of theretractor202a,202b, has a semicircular groove208 on its flatinternal surface209. When the twohalves202a,202bare joined together, the semi-circular grooves208 form achannel210 running through the interior of thedevice200, extending from theproximal end205 to thedistal end204.
• Thecollar206 of thedevice200 includes apin assembly212 comprising twoparallel pins212a,212battached at one end to ahandle212c, and two setscrews214a,214b. As illustrated inFIG. 22, thepins212a,212btraverseguide passages216a,216bbored through thecollar region206 of one half of theretractor body202b, and are insertable withinholes218a,218bin thecollar region206 of the other half of the retractor body202a, such that one half of theretractor body202bcan slide apart from the other half202aon thepins212a,212b. Thecollar206 also includes internally threadedholes220a,220badapted to receive externally threadedset screws214a,214b. The set screw holes220a,220benter thecollar region206 at right angles to thepin guide passages216a,216bsuch that when theset screws214a,214bare advanced, they tighten upon thepins212a,212band thus, fix the distance between the two halves of theretractor body202a,202b.
• Third Alternate Embodiment of the Retractor
• Still another embodiment of the retractor of the present invention is illustrated inFIGS. 28 and 29. Theretractor300 comprises adistal body portion302, and aproximal handle portion304. Thedistal body portion302 of theretractor300 is formed in two portions orhalves302a,302b. At thedistal end306 of thebody portion302, a retractingportion308 extends away from, and at an angle to thebody portion302. Preferably, the retractingportion308 extends substantially perpendicular to thebody portion302. The retractingportion308 is also formed in two separable portions orhalves308a,308b. Each of theseportions308a,308bcan be semi-circular in shape, or have asemicircular groove312 in its flat, internal surface (FIG. 29). The external surfaces are preferably rounded, and tapered toward thedistal end310. When the twoportions308a,308bare brought together such that the two portions abut one another, as seen inFIG. 28, a channel314 is formed through the interior of the retractingportion308 of theretractor300.
• Handles316a,316bare located at theproximal end304 of theretractor300. Thehandles316a,316bare preferably elongate and of a dimension sufficient to permit manipulation by hand. Thehandles316a,316bare securely connected to thebody portion302 of theretractor300. Thehandles316a,316bare used to control the movement of the retractingportion308 of theretractor300.
• FIGS. 28 and 29 also illustrate aloop320 extending from one of thehandles316ain the direction of theother handle316b. Theother handle316bhas ascrew322 inserted therethrough. Theloop320 surrounds thescrew322, such that when thescrew322 is tightened, theloop320 is held securely between thescrew322 and the underlying surface. This mechanism acts to control the distance between thehandles316a,316bthereby controlling the distance between the two halves of the retractingportion308a,308b. Thehandles316a,316b, and the corresponding retractingportions308a,308bmay be locked into any position by sliding theloop320 along thescrew322, then tightening thescrew322 to securely fix theloop320 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 theretractor300.
• Fourth Alternate Embodiment of the Retractor
• Yet another embodiment of the retractor of the present invention is illustrated inFIGS. 48-50. Theretractor600 comprises adistal body portion602 and aproximal handle portion604. Thedistal body portion602 of theretractor600 is formed in two portions orhalves602a,602b. At thedistal end606 of thebody portion602, a retractingportion608 extends away from, and at an angle to, thebody portion602. Preferably, the retractingportion608 extends substantially perpendicular to thebody portion602. The retractingportion608 is also formed in two separable portions orhalves608a,608b. Each of theseportions608a,608bpreferably has asemi-circular groove612 in its internal surface. The external surfaces are preferably rounded, and tapered toward thedistal end610. When the twoportions608a,608bare brought together such that the two portions abut one another, as seen inFIG. 49, achannel614 is formed through the interior of the retractingportion608 of theretractor600.
• Handles616a,616bare located at theproximal end604 of theretractor600. Thehandles616a,616bare preferably elongate and of a dimension sufficient to permit manipulation by hand. Each handle616a,616bis preferably formed as a unitary piece with acorresponding body portion602a,602b, respectively. Thehandles616a,616bare used to control the movement of the retractingportion608 of theretractor600. Ahinge618 operating between the handle/body pairs616a/602a,616b/602bis adapted so that when thehandles616a,616bare moved away from each other, the body halves602a,602bare moved toward each other.
• FIGS. 48-50 also show astop bar620 extending from one of thehandles616band through a cavity formed in theother handle616a. Thestop bar620 is preferably curved along an arc having thehinge618 as a center of curvature.Teeth622 are formed along a surface of thearcuate stop bar620. A ratchetingrelease member624 comprising anarm626 and ahead portion628 extends through and from thehandle half616athrough which thestop member620 passes. Therelease member624 is pivotably connected to thehandle half616aby apivot pin630 extending through thehead628. Thehead628 comprises astop634, which is adapted to engage theteeth622 of thestop bar620, and alobe636 which extends through thehandle616a. Abar spring638 connected to thehandle half616acontacts thelobe636 and exerts a force F thereon. The force F exerted by thebar spring638 on thelobe636 biases the head stop634 into engagement with thestop bar teeth622. Thearm626 of therelease member624 is preferably arcuate and is adapted to be easily manipulated by a hand also grasping thehandles616a,616b. Pulling thearm626 toward thehandle616aovercomes the biasing force F and moves the head stop634 out of engagement with thestop bar teeth622.
• Aspring640 is attached to and operates between thehandles616a,616b. Preferably, thespring640 is adapted to exert force F′ on thehandles616a,616b, biasing the handles apart from each other. Thus, thespring640 biases the retractingportion halves602a,602btowards each other. Engagement of therelease member stop634 in thestop bar teeth622 is adapted to prevent movement of the handles apart from each other. However, therelease member stop634 is also adapted so that when thehandles616a,616bare squeezed toward each other, opening the retraction portion halves602a,602b, the head stop634 “ratchets” over theteeth622. Thus, movement of the handle halves616a,616btoward each other is accommodated by thestop634, but movement of the handle halves616a,616baway from each other is prevented by thestop634 when it is engaged with thestop bar teeth622. Thus, a clinician using theretractor600 can open the retractor halves602a,602bto a precise point by simply squeezing the handle halves616a,616btogether. Thestop634 and stopbar620 prevent the retractor halves602a,602bfrom closing again once the desired open position is reached. When the clinician desires to close theretractor600, the clinician need only manipulate therelease member arm626, thus disengaging thestop634 from thestop bar teeth622. Thehinge640 then urges the handle halves616a,616baway from each other and the retractor halves602,602btoward 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 inFIGS. 11-13, theretractor100 is preferably used in conjunction with adilator150. As is known to those of ordinary skill in the art, thehollow dilator150 preferably includes a standardmale connector149, such as a Luer connector, at its proximal end and is narrowly tapered at itsdistal end151. The inside diameter of thedilator channel160 is large enough to accommodate aguidewire144, so that thedilator150 can be fed along theguidewire144 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 notched152 near itsdistal end151 around its entire circumference. Thisnotch152 provides a seat and guide point for the tapered distal tips of the twohalves102a,102bof the retractor body, such that when theretractor100 is closed upon thedilator150, the sharp distal tip of theretractor body112 is buried in thenotch152 of the dilator. This forms a smooth transition between thedilator150 and retractor100 (FIG. 12). As will be explained more fully below, when theguidewire144 is inserted through thedilator150 and thedilator150 is then inserted through theretractor100, (FIGS. 12-13), thedilator150 lies securely within the interior circular channel108 (FIG. 9) running the length of theretractor body102.
• Thedilator150 also preferably includes at least oneindicator hole154. Thedilator150 illustrated inFIGS. 11-13 includes twoindicator holes154 directly opposed to one another, located a few millimeters distal to thenotch152; the distance X between theholes154 and thenotch152 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 thedilator150, may be used in conjunction with thedilator150 and indicator holes154. Use of the indicator holes154 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 inFIG. 13. Theguidewire144 which emerges from the original puncture wound is fed through thedilator150, and then thedilator150 is inserted through theretractor100. Theretractor100 is advanced along thedilator150 until the distal tips of theretractor112 stop within thenotch152 in thedilator150. Preferably, themale fitting149 on the proximal end of thedilator150 is connected to one port of a commercially available3-way Y-connector156. Asyringe158 or other means of applying negative pressure is connected to one of the other ports on the Y-connector156 and the proximal end of theguidewire144 exits the Y-connector156 via the remaining port. The Y-connector156 therefore acts as a seal at the proximal ends ofdilator150 andguidewire144.
• Alternate Embodiments of the Dilator
• In another embodiment of the invention, a modifieddilator150 is used. As illustrated inFIG. 17, a double-sleeved balloon170 is removably attached to thedilator150 near itsdistal end151, proximal to asingle indicator hole154. Preferably, theballoon170 is placed a distance from theindicator hole154 which is approximately the width of the arterial wall, e.g., about 1.5 mm. The inflatable, double-sleeved balloon170 is angled at itsdistal end172 to allow the balloon to better fit thefemoral artery10. Theballoon170 includes inflation means which allow the balloon to be inflated and deflated from the proximal end of thedilator150. Use of the double-sleeved balloon170 will be described in detail below.
• In yet another embodiment, illustrated inFIGS. 23-25, thedilator220 has both a double-sleeved balloon222 and a secondinflatable balloon224 mounted on itsdistal end226. The double-sleeved balloon222 is removably attached to thedilator220 near itsdistal end226, proximal to thesingle indicator hole228. The secondinflatable balloon224 is mounted on thedilator220 just distal to theindicator hole228. When inflated, thissecond balloon224 helps anchor thedilator220 in place in thefemoral artery10, preventing thedilator220 from being pulled out of theartery10 during the procedure. Thus, the distal,second balloon224 is positioned together with theindicator hole228, within theartery10, while the double-sleeved balloon222, proximal to theindicator hole228, remains outside of theartery10 as illustrated inFIG. 25. Theballoons222,224 assist in the proper positioning of thedilator220, and help anchor thedilator220 once it is properly positioned, as will be explained in detail below.
• Theinner sleeve230 of the double-sleeved balloon222 is preferably shaped to facilitate the insertion of theretractor200 between the twosleeves229,230, as will be described in more detail below. As illustrated inFIG. 24, theinner sleeve230 can be in the shape of an “I”, thus providing additional space between the inner surface of theouter sleeve229, and the outer surface of theinner sleeve230. This allows the two halves of theretractor body202a,202bto be inserted between the twosleeves229,230 more easily. The two sleeves of theballoon229,230 can be shaped in any form that would help facilitate insertion of theretractor200.
• Thedilator220 having both a double-sleeved balloon222 and a second,distal balloon224, is further illustrated inFIG. 26. As can be seen from the drawing, thedilator220 has 4different lumens232,234,236,238 extending from the proximal end of thedilator225 to the distal end of thedilator226. Aguidewire240 is inserted through one of thelumens236. Anotherlumen232 is used to inflate the double-sleeved balloon222, while athird lumen238 is used to inflate thesecond balloon224 at the distal end of thedilator226. Thefourth lumen234 is used to aspirate blood through theindicator hole228 at the distal end of thedilator226. Syringes are preferably used to provide the aspiration and inflation pressure through theselumens232,234,236,238. The proximal end of thedilator225 is preferably adapted to allow for fluid communication between the syringes and thevarious lumens232,234,236,238 in the dilator. Of course, other means of aspirating blood and inflating the balloons may also be used, and connectors specifically adapted for these devices can be attached at the proximal end of thedilator225 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 inFIGS. 30 and 31, thecatheter340 has aninner lumen342 which extends from the proximal end of thecatheter344 all the way to the distal end of thecatheter346. Thisinner lumen342 is adapted to receive aninner catheter360 orguidewire350, as will be explained in more detail below.
• The outer lumen of the dual-lumen catheter340 surrounds theinner lumen342, and also extends from the proximal end of thecatheter344 to thedistal end346. Near the distal end of thecatheter346, at least oneindicator hole352 is positioned in the outer wall of thecatheter340. Theindicator hole352 provides fluid communication between the area outside of thecatheter340 and the outer lumen. The outer surface of thecatheter354 surrounding theindicator hole352 is preferably raised, acting as a stop. Preferably, the distance between theindicator hole352 and the proximal end of the raised surface of theretractor354, is approximately the same as the thickness of the wall of the femoral artery. As will be explained below, theretractor300 is first mounted on the distal end of the catheter, and positioned such that the distal tip of the retractingportion310 stops at a guide point just proximal to the raisedsurface354, about 0.5 mm proximal to theindicator hole352. This assures that the distal tip of the retractingportion310 will be properly positioned inside the patient's body at the site of the wound in the artery.
• At the proximal end of thecatheter344, theproximal end358 of the outer lumen is preferably joined to aconnector364, such as a Luer-type connector, which is adapted to receive asyringe360 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 asurgical clip applicator70. Asurgical clip applicator70 for use with theretractor30 of the present invention is illustrated inFIG. 5. As shown in this figure, the distal end of theclip applicator75 is fitted with two triangular protrusions orwings77a,77bthat extend laterally from the sides of the distal end of theclip applicator75. Thesewings77a,77bare configured to fit within thegrooves65 located on the interior surface of the twohalves35a,35bof the body of theretractor30, as is best seen inFIG. 8. With thewings77a,77bof theclip applicator70 in thegrooves65 in the two halves of the body of theretractor35a,35b, theclip applicator70 is guided into proper position within the patient's body, as will be discussed in more detail below. In addition, thesurgical clip applicator70 preferably has aguide80 attached to itsdistal end75. Theguide80 preferably extends laterally from the side of theclip applicator70, and is open at its proximal and distal ends such that aguidewire20 may be threaded therethrough. Thisguide80 is used in combination with theguidewire20 to accurately guide theclip applicator70 to the site of thevascular puncture25, as will be described below.
• Thesurgical clip applicator70 preferably also has astop85 located proximal of thedistal end75, at the point where the proximal ends of the wings of theapplicator77a,77bend. As will be explained, thestop85 also aids in the proper positioning of theclip applicator70 at the site of thevascular puncture25, and prevents theclip applicator70 from being inserted too far into the patient's body.
• Alternate Surgical Clip Applicator Assembly
• Referring now toFIGS. 14-16, there is illustrated an alternate embodiment of a surgicalclip applicator assembly130. Theclip applicator assembly130 incorporates a standard commercially availablesurgical clip applicator132. In accordance with the present invention, the applicator is modified to include aguide assembly134 reversibly fastened near its distal end. The guide assembly comprises awinged guide plate138 which is reversibly secured to abody140. In the embodiment illustrated inFIGS. 14-16, allen screws142 are used to attach theguide plate138 but other well known means of attachment can also be used. The distal end of thesurgical clip applicator132 slides within the channel148 (FIG. 15) formed when thewinged guide plate138 is fastened to theguide body140.
• Attached to theguide body140 is aguidetube136 which is adapted to accept theguidewire144. A preferred embodiment of said guidetube136 includes a mechanism to close theguidetube136 once theguidewire144 has entered. Such a mechanism may involve a second partially open tube which fits within saidguidetube136. This second tube can be rotated within theguidetube136 to open theguidetube136 when the openings in both tubes are aligned or close theguidetube136 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 guidetube136. This mechanism can be spring-loaded like the closures commonly used on pieces of jewelry.
• The surgical clipapplicator guide assembly134, together with theretractor100 and theguidewire144, is designed to accurately guide theclip applicator132 to the site of the femoral artery puncture as detailed below. As explained above, the lateral edges of thewinged guide plate138 are configured to fit within the groove126 (FIG. 10) located on the interior surface of each half of theretractor body102a,102b. Thesurgical clip applicator132 is guided between the retracted halves of theretractor body102a,102bfollowing theguidewire144 which passes through theguidetube136 at the distal most end of thesurgical clip applicator132.
• Second Alternate Surgical Clip Applicator Assembly
• An alternate embodiment of the surgicalclip applicator assembly250 is illustrated inFIG. 27. Again, theclip applicator assembly250 incorporates a standard commercially availablesurgical clip applicator252. Theapplicator252 is modified to include aguide assembly254 reversibly fastened near itsdistal end256. Theguide assembly254 is adapted to receive anindicator tube260. Theindicator tube260 is a hollow tube having anindicator hole264 near itsdistal end262. Theindicator tube260 is adapted to receive aguidewire240 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 hole264. When properly positioned on theclip applicator252, the distal end of theindicator tube262 and theindicator hole264 extend past the distal end of theclip applicator256. Preferably, the distance between theindicator hole264 and the distal tip of theclip applicator256 is approximately equal to the width of the arterial wall, e.g., about 1.5 mm.
• Methods of Use
• Referring first toFIGS. 4-8, a first method of use of theretractor30 in conjunction with asurgical clip applicator70 to close awound25 in thefemoral artery10 will now be described. As noted above, during angioplasty or angiography, thefemoral artery10 is first punctured with ahollow needle15 and aguidewire20 is inserted therethrough (FIG. 4). A proximal portion of theguidewire21 remains outside the patient's body. After the distal end of theguidewire23 is in position within thefemoral artery10, thehollow needle15 is removed. A catheter (not shown) is then threaded over theguidewire20, and inserted into the patient's body.
• In a preferred embodiment, a specially designedguidewire20 having aninflatable balloon24 located near itsdistal end23 is used for the diagnostic or therapeutic procedure. Theguidewire20 is threaded through thehollow needle15 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 theballoon24 located on theguidewire20.
• Following completion of the therapeutic or diagnostic procedure, the catheter used during the procedure is removed. Theguidewire20 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 theballoon24 on theguidewire20 described below). When the physician desires to close thewound25 in thefemoral artery10, he or she first withdraws theguidewire20 and/or catheter through the patient's vasculature using the portion of theguidewire20 and/or catheter that remains outside the patient'sbody21, until thedistal end23 of theguidewire20 and/or catheter is within thefemoral artery10 close to the femoralartery puncture site25. Theballoon24 on thedistal end23 of theguidewire20 or catheter is then inflated, and theguidewire20 or catheter is withdrawn further until the physician feels some resistance. This will indicate that theballoon24 is inside thefemoral artery10 and at the site of the puncture wound25. The physician then threads the proximal end of theguidewire21 into thehole49 located at thedistal end37 of the fully assembled retractor30 (FIGS. 2, 3 and6). Theguidewire20 is threaded through thechannel50 formed in the body of theretractor35, until the proximal end of theguidewire21 emerges through thehole47 in thecap40 at the proximal end of the retractor41 (FIG. 6). Theretractor30 is then slowly advanced along theguidewire20 and into the patient's body, until resistance is felt. This resistance indicates that the distal tip of theretractor37 is contacting theinflated balloon24 in thefemoral artery10. The distal tip of theretractor37 therefore will be properly located at the site of the puncture in thefemoral artery25, as is shown inFIG. 6.
• In a preferred embodiment, theguidewire20 used in conjunction with the femoralartery closure retractor30 has a marking27 on it which also helps to indicate when theretractor30 has been properly positioned (FIG. 6). This marking27 preferably consists of a tiny bead or colored line on theguidewire20. The marking on theguidewire27 is placed proximal of the proximal end of theballoon26. The length of theretractor30 is measured, and the marking27 is made at least that same length in a proximal direction on theguidewire20, measured from the proximal end of theballoon26. Thus, when theretractor30 is advanced over theguidewire20 and resistance is felt, the physician checks to see if the marking on theguidewire27 has emerged through the proximal end of the retractor41, as is illustrated inFIG. 6. If the marking27 is not yet visible, the physician must advance theretractor30 further to ensure that it contacts the femoralartery puncture site25.
• Once theretractor30 is properly positioned within the patient's body, thesurgical clip applicator70 or other method of closing the puncture wound25 is used. Thecap40 on theretractor30 is first removed from the body by unscrewing (FIG. 3). The proximal end of theguidewire21 emerging from the proximal end of the retractor41 is threaded through theguide80 located on the outer surface of theapplicator70, as illustrated inFIG. 7. The wings on thesurgical clip applicator77a,77bare inserted into thehole90 formed at the proximal end of the body of theretractor39, by lining up thewings77a,77bon theapplicator30 with thegrooves65 located on theinner surface67 of the retractor body halves35a,35b(FIGS. 7 and 8). The wings on theclip applicator77a,77bare sized to fit within thegrooves65 of theretractor30, as is best illustrated inFIG. 8. Theclip applicator70 is then advanced, which causes the two halves of the body of theretractor35a,35bto separate, as shown inFIG. 7. As the twohalves35a,35bseparate, the patient's tissue is displaced laterally, allowing better access to thepuncture site25 in thefemoral artery10 below the overlying tissues. Theclip applicator70 is advanced through theretractor30 until the stop on theapplicator85 contacts the proximal end of theretractor39. At this time, the balloon on theguidewire24 or catheter is deflated, and the catheter and/orguidewire20 is removed from the patient. The surgical clips located at the distal tip of theclip applicator75 are applied to the puncture wound25, preferably using the method well known to those of ordinary skill in the art. Once the femoral artery puncture wound25 is closed, theclip applicator70 andretractor30 are removed from the patient.
• First Alternate Method
• Referring now toFIGS. 9-16, a method of using the alternate embodiment of theretractor100 in conjunction with thedilator150 and surgicalclip applicator assembly130 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 assembly101 (FIG. 13) is used, a standard dilator of a smaller diameter than that150 incorporated into the retractor-dilator assembly101 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 assembly101 through the surrounding tissue.
• If the tissue has been dilated as above, the smaller bore standard dilator is first removed. The proximal end of theguidewire144 is first inserted into the distal channel160 (FIG. 11) of thedilator150. Thedilator150 has been previously inserted through the internal channel of theretractor100, and theretractor100 advanced over thedilator150 until thedistal tip112 comes to rest in thenotch152 on the distal tip of thedilator150. The Y-connector156 is then attached to the proximal end of thedilator150 and asyringe158 attached to one of the ports of theconnector156. The retractor-dilator assembly101 is then advanced over theguidewire144 into the patient's body.
• While the retractor-dilator assembly101 is advanced into the patient's body, suction is continuously applied via thesyringe158 or other means of negative pressure (FIG. 13) to thedilator150. At the moment the indicator holes154 enter the lumen of the femoral artery, blood is aspirated into thesyringe158, indicating that thedilator150 has been inserted through the puncture site into the femoral artery. Thus, the distal tip of theretractor112, still buried within thenotch152 in thedilator150, is located just proximal or outside the artery wall at the site of the puncture wound and the indicator holes154 in thedilator150 are located just distal or inside the artery lumen. The artery wall is thus disposed in thearea153 between thenotch152 and theholes154.
• Alternatively, thedilator150 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 thedilator150. 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 thedilator150, is inserted over theguidewire144 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 theretractor100 is stopped, such that the distal tip of theretractor112 is located just proximal theartery wall10 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 thedilator150 andretractor100 are in proper position, thecap104 is removed from theretractor100 and the twohalves102a,102bof the retractor body are separated slightly (FIG. 10) by loosening theset screws120a,120band sliding the twohalves102a,102bof the retractor laterally away from one another. This causes thedistal tips112 of twohalves102a,102bto emerge from thenotch152 in the dilator150 (FIG. 11) and straddle the puncture site. The set screws120a,120b, are then tightened to hold the twohalves102a,102bof theretractor100 in this separated position. While pressing theretractor100 down against the outer wall of the femoral artery, thedilator150 is withdrawn, leaving only theretractor100 and theguidewire144 in position at the site of the puncture wound in the artery.
• To close the wound, theretractor100 must be retracted far enough to allow the surgicalclip applicator assembly130 to access the puncture site. Upon loosening theset screws120a,120b, the twohalves102a,102bof the retractor are further separated by applying pressure on the retractor pin handle116c(FIGS. 9-10). When sufficiently retracted, theset screws120a,120bon theretractor assembly100 are tightened to maintain the proper distance between the retractor halves. If necessary, a separate retractor, having a thickness suited for sliding within thegrooves126 in each half102a,102bof the retractor body, and a width equal to that of the winged guide plate138 (FIG. 14) of the surgical clip applicator guide assemble134, can be used to open the retractor body to the proper distance.
• Second Alternate Method
• In an alternate embodiment illustrated inFIG. 17, the modifieddilator150 having a double-sleevedinflatable balloon170 removably attached to the distal end of thedilator151, just proximal to theindicator hole154, is used. Theballoon dilator apparatus175 is inserted over theguidewire144 into the patient's body. As described above, as the balloon-dilator apparatus175 is advanced, negative pressure is applied to the system via the syringe or other source. The advance of the balloon-dilator apparatus175 is stopped as soon as blood is aspirated. The double-sleeved balloon170 is then inflated to form atunnel176 between the femoral artery puncture wound and the surface of the patient's body, as illustrated inFIG. 18.
• The double-sleeved balloon170 advantageously prevents the femoralartery closure retractor100 from entering thefemoral artery10 and damaging it. Should the deflatedballoon170 be advanced into thefemoral artery10, the process of inflating theballoon170 will pull theballoon170 out of theartery10, thereby safely creating atunnel176 used to access theartery10.
• Theballoon170 is preferably angled at itsdistal end172 to allow theballoon170 to “fit” thefemoral artery10, as shown inFIGS. 17-19.
• Once theballoon170 is inflated (FIG. 18) theretractor100 is advanced between the two sleeves of theballoon170, until the distal tip of theretractor112 reaches the distal end of the doublesleeved balloon170. Once theretractor100 is positioned between the two sleeves of theballoon170, the two halves of theretractor102a,102bare moved laterally away from one another, as described above. The inner sleeve178 and thedilator150 are removed from the patient, leaving the separatedretractor100 and theouter sleeve180 of theballoon170 in the patient. Thedilator150 and the inner sleeve178 are removed from the patient along theguidewire144.
• Theretractor100 and the outer sleeve of theballoon180 form anaccess tunnel182 between the femoral artery puncture wound and the surface of the patient's body, as illustrated inFIG. 20. Thistunnel182 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 theguidewire144 is inserted into theguidetube136 on the surgicalclip applicator assembly130 and the wings on the guide plate are fitted within thegrooves126 of the opened retractor body102 (FIGS. 14-16). Theclip applicator assembly130 can now be advanced toward the puncture wound, sliding within thegrooves126 in theretractor body102, guided by theguidewire144 passing through theguidetube136 at the distal tip of the surgicalclip applicator assembly130. When the distal tip of thesurgical clip applicator130 has reached the outer wall of thefemoral artery10, at the site of the puncture wound, the surgeon withdraws theguidewire144 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, theflexible guidewire144 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 toFIGS. 21-27, a method of using the alternate embodiment of theretractor200 in conjunction with thedilator220 and surgicalclip applicator assembly250 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 theguidewire240 threaded into thefemoral artery10.
• The proximal end of theguidewire240 is first inserted into the distal lumen236 (FIG. 26) of thedilator220. Thedilator220 is advanced over theguidewire240 into the patient's body. As described above, as the balloon-dilator apparatus250 is advanced, negative pressure is applied to the system via the syringe or other source connected at the proximal end of thedilator225. The advance of thedilator220 is stopped as soon as blood is aspirated through theindicator hole228, thus indicating that the distal end of thedilator226 is positioned within thefemoral artery10. Thedistal balloon224 and the double-sleeved balloon222 are then inflated to anchor thedilator220 in place and to form a tunnel between the femoral artery puncture wound and the surface of the patient's body.
• Once theballoons222,224 are inflated, theretractor200 is advanced between the twosleeves229,230 of the doublesleeved balloon222. As illustrated inFIG. 24, theinner sleeve230 of the doublesleeved balloon222 can be in an “I” shape, which provides more space between the two sleeves to insert the twohalves202a,202bof thereactor200. Theretractor200 is advanced between the twosleeves229,230, as described above, until the distal tip of theretractor204 is positioned just proximal to the puncture wound in thefemoral artery10.
• Once theretractor200 is positioned between the two sleeves of theballoon229,230, the two halves of theretractor202a,202bare moved laterally away from one another. This is done by loosening theset screws214a,214b, and sliding one half of theretractor body202baway from the other half202aon thepins212a212b. Theinner sleeve230 of the double-sleeved balloon222 and thedilator220 are removed from the patient along theguidewire240, leaving the separatedretractor200 and theouter sleeve229 of theballoon222 in the patient. Theretractor200 and the outer sleeve of theballoon229 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 theretractor200 and outer sleeve of theballoon229 providing access to thefemoral artery10, the proximal end of theguidewire240 is inserted into thedistal end262 of theindicator tube260 which is mounted on thesurgical clip applicator252. As described above, thedistal end262 of theindicator tube260 having anindicator hole264 in it is positioned so that theindicator hole264 extends past thedistal end256 of theclip applicator252. Theindicator tube260 and theclip applicator252 are advanced over theguidewire240 while aspiration pressure is applied to the proximal end of theindicator tube260. As soon as blood is aspirated through theindicator hole264, the advancement of theindicator tube260 andclip applicator256 is stopped. At this point, the distal end of thesurgical clip applicator256 is positioned at the site of the puncture wound in thefemoral artery10. Surgical clips are then applied to seal the wound.
• Preferably, the distal end of theindicator tube262 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 end262 of theindicator tube260, the puncture wound is stretched into a linear slit, making it more amenable to closure by surgical clips.
• Fourth Alternate Method
• Referring now toFIGS. 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 aguidewire350 is inserted therethrough. A proximal portion of theguidewire351 remains outside the patient's body. After the distal end of theguidewire353 is in position within the femoral artery, the hollow needle is removed. Diagnostic and/or therapeutic procedures are then carried out, using theguidewire350 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. Theguidewire350 remains in place in the patient's vasculature. When the physician desires to close the wound in the artery, he or she first mounts theretractor300 on the distal end of the dual-lumen catheter340. This is done by loosening thescrew322 on one of thehandles316b, and moving thehandles316a,316baway from one another to separate the two halves of the retractingportion308, and the two parts of the retractingportion308a,308bare positioned around the dual-lumen catheter340. Thedual lumen catheter340 fits within the semi-circular channel orgrooves312 formed in the inner surface of the retractingportion308 of theretractor300. The two halves of the retractingportion308a,308bare brought together using thehandles316a,316bto surround thecatheter340. The retractingportion308 is positioned on thecatheter340 just proximal to the raised portion of thecatheter354, so the distal tip of the retractingportion310 is located just proximal to theindicator hole352. Preferably, the distal tip of the retractingportion308 will be approximately 0.5 mm behind the indicator hole352 (seeFIG. 31). Once in position, thescrew322 is tightened on theloop320 to lock the two parts of the retractingportion308a,308bin position on thecatheter340.
• Once theretractor300 is properly positioned on the dual-lumen catheter340, the physician inserts theproximal end351 of theguidewire350 into the distal end of theinner lumen342 in the dual-lumen catheter340. The dual-lumen catheter340 andretractor300 are advanced over theguidewire350 and into the patient. As thecatheter340 andretractor300 are advanced, negative pressure is applied to the outer lumen of the catheter, for example, through use of asyringe360 attached to the proximal end of theouter lumen358. Once theindicator hole352 is advanced to a position inside the artery, blood will be drawn through theindicator hole352 and will become visible in the outer lumen of thecatheter340 and thesyringe360. At this point, advancement of thecatheter340 andretractor300 are stopped, as thecatheter340 andretractor300 are properly positioned in the patient.
• Once properly positioned at the site of the puncture wound, the two halves of the retractingportion308a,308bare separated slightly, using thehandles316a,316bat theproximal end304 of theretractor300. To separate the retractingportions308a,308b, thescrew322 is loosened, and thehandles316a,316bmanipulated into the desired position. Thescrew322 is then tightened down upon theloop320, prohibiting further movement of thehandles316a,316b, and the corresponding retractingportions308a,308b.
• 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 catheter340 is removed from the patient by withdrawing it over theguidewire350. Theguidewire350 is left in place, and the wound closure device, such as a clip applicator, is inserted over theguidewire350 to the site of the wound. Clips, such as those made of titanium or a biodegradable material, are preferably applied to the wound, as theguidewire350 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 theretractor300 is removed from the patient.
• Alternatively, a separateinner catheter360 is used in the system of the present invention. In this embodiment, once theretractor300 and dual-lumen catheter340 are in place, and the retractingportion308 is in an open position, the dual-lumen catheter340 is left in place, and theguidewire350 is withdrawn from the patient through theinner lumen342. Aninner catheter360 having aninflatable balloon362 at its distal end is inserted through theinner lumen342 and into the patient. Once thedistal balloon362 is advanced past thedistal tip346 of the dual-lumen catheter340, theballoon362 is inflated. The dual-lumen catheter340 is removed from the patient, leaving theinner catheter360 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 catheter346 to just outside the patient's body when thecatheter340 is properly positioned. The physician then inserts theinner catheter360 just slightly more than that distance, to ensure that thedistal balloon362 is within the artery. The physician then pulls theinner catheter360 in a proximal direction until resistance is felt. This will place theballoon362 at the site of the puncture wound. Theballoon362 is properly positioned just inside the artery of the patient. Theballoon362 helps to stop the flow of blood out of the puncture wound. Theinner catheter360 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 balloon362. As the wound is closed, theballoon362 is slowly deflated, and theinner catheter360 is removed from the patient. Finally, once the physician is confident that the wound is closed, theretractor300 is removed from the patient.
• This method of closing a wound in the femoral artery of a patient can also be performed using theretractor600 described inFIGS. 48-50 in place of theretractor300 discussed above. To mount theretractor600 on the distal end of thedual lumen catheter340, the clinician squeezes therelease member arm626 so that the head stop664 is clear of thestop member teeth622. The handles are also squeezed together in order to separate the twohalves608a,608bof the retracting portion so that the retracting portion halves may be positioned around thedual lumen catheter340. As above, the catheter fits within the semi-circular channel orgrooves612 of the retractingportion halves608a,608b. When the retractingportion608 is positioned on thecatheter340 just proximal to a raised portion of the catheter so that thedistal tip610 of the retractingportion608 is located just proximal to theindicator hole352, the clinician releases the squeezing hold on thehandles616a,616b. Thus, thespring640 urges the retractinghalves608a,608bto close around the catheter. The force F′ exerted by thespring640 on thehandles616a,616boperates to retain thecatheter340 securely between the retractor halves602a,602b.
• Thedual lumen catheter340 andretractor600 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 retractingportions608a,608bare next separated in order to displace the surrounding tissue. To separate retracting portions, the clinician squeezes thehandles616a,616b. During the squeezing operation, thehead stop634 ratchets over thestop member teeth622. Thus, when the desired open position is reached, the clinician need only release thehandles616a,616band thestop634 will engage theteeth622 in order to hold the retractinghalves608a,608bin the chosen open position. With the surrounding tissues displaced, forming an access path to the vascular puncture wound, the vascular wound can be closed by using a suitable apparatus or method.
• To remove theretractor600 from the patient, the retractingportions608a,608bare first brought together into the closed position by the clinician squeezing therelease arm626 toward thehandle616a. Thestop634 is thus disengaged from thestop arm teeth622 and thespring640 urges thehandles616a,616bapart. Thus, the retractingportions608a,608bare drawn together into the closed position. Theretractor600 is then easily removed from the patient.
• Alternate Apparatus for Vessel Closure
• Referring now toFIG. 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.Apparatus400 includesvascular closure instrument402 and a vacuum source404 (shown schematically inFIG. 32) which is connectable to the vascular closure instrument. Vacuumsource404 may be any vacuum generator suitable for the surgical procedure to be described.
• With references toFIGS. 32-34,vascular closure instrument402 includeshandle406, and anelongated portion408 extending distally from thehandle406 and defininglongitudinal axis408a. Handle406 is generally cylindrical in configuration, however, other designs are contemplated as well.Vascular closure instrument402 includes alongitudinal lumen410 extending the length of theinstrument402 throughhandle406 andelongated portion408 and terminating in distalaxial opening412. Longitudinal orvacuum lumen410 conveys the vacuum provided byvacuum source404.FIG. 34 illustrates suitable tubing “t” connectingvacuum source404 andclosure instrument402.
• Vascular closure instrument402 further includes a pair ofsurgical clips414 supported at the distal end ofelongated portion408.Surgical clips414 may be any conventional surgical clip fabricated from a suitable biocompatible material including absorbable and non-absorbable materials.Clips414 are characterized by having backspan414aandclip legs414b(FIG. 35).Clip legs414bare adapted to move or pivot inwardly to a closed or formed condition thereof in response to inward force applied to theclip legs414b.
• Surgical clips414 are releasably mounted toelongated portion408. In one arrangement,elongated portion408 includes first and second pairs oflongitudinal grooves416 formed in the distal end of theelongated portion408.Longitudinal grooves416 extend in a longitudinal direction and terminate in transverse grooves418 (FIG. 33) adjacent the proximal end of thelongitudinal grooves416.Transverse grooves418 receivesurgical clips414, more specifically, backspans414aof thesurgical clips414 to mount thesurgical clips414 in a releasable manner.Transverse grooves418 are preferably dimensioned such that a frictional relationship is established to further facilitate mounting of theclips414 to theinstrument402. Eachsurgical clip414 is loaded by positioning backspan414awithinlongitudinal groove416, advancing theclips414 in a proximal direction adjacenttransverse grooves418 and manipulating thebackspans414ato be received within thetransverse groves418. Other means for mountingsurgical clips414 toelongated portion408 may be readily appreciated by one skilled in the art.
• With continued reference toFIGS. 32-35,vascular closure instrument402 further includes clip forming mechanism, generally identified asreference numeral420, mounted toelongated portion408 of the instrument. In the preferred embodiment,clip forming mechanism420 includes a pair of manuallyoperable levers422 mounted to the outer surface ofelongated portion408 in diametrically opposed relation. Manuallyoperable levers422 are mounted at their proximal end portions via mountingpins424 whereby the distal end portions of the manuallyoperable levers422 may move in a radially direction, i.e., toward each other, to formsurgical clips414.
• As best depicted inFIGS. 32-33,elongated portion408 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 instrument402 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 portion408. In addition, the oval cross-section corresponds to the internal dimension of the aforedescribed retractors, includingretractor100 andretractor300, when in an open condition, thereby facilitating use of thewound closure instrument402 with these instruments, e.g., positioning of theclosure instrument402 within the open retractor and advancing theinstrument402 therewithin. For a typical puncture wound having a diameter or length of about 1 mm, theelongated portion408 preferably has a major axis “a” of about 3-5 mm and most preferably about 4 mm.
• Elongated portion408 of vascular closure instrument may further include awrap425, e.g., shrink wrapping, or the like shown cut-away inFIG. 32.Wrap425 preferably extends to the distal end ofelongated portion408 ofvascular closure instrument402 to at least partially encloselongitudinal grooves416 andtransverse grooves418 to preserve the integrity of the vacuum withinvacuum lumen408.
• 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 toFIGS. 34-35,vascular closure instrument402 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. Vacuumsource402 is actuated which thereby creates a vacuum withinvacuum lumen410. 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 opening412 ofelongated portion408 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 legs414bofsurgical clips414, manuallyoperable levers422 are moved radially inwardly in the direction of directional arrows “f” by a force exerted by the user to pivotclip legs414band formsurgical clips414. In the formed condition, cliplegs414bengage the vessel edge portions “e” to generally approximate the edges “e” to close the opening. Thereafter,surgical clips414 are released from their mounting toelongated portion408 by manipulating thevascular closure instrument402 to align clip backspan414awithlongitudinal grooves416 thereby permitting the instrument to be withdrawn leaving thesurgical clips414 in place.
• FIGS. 38-39 illustrate an alternate embodiment of the vascular closure instrument. In accordance with this embodiment, a side opening port430 (shown in phantom) is provided in theelongated portion408 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 opening412 and manipulated to theside opening port430 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 portion408 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 opening412 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 theopening412. Also, a separate guidewire lumen or tube may be incorporated inelongated portion408 to receive the guidewire “g.” If in the form of a tube, such tube may be attached to the inner wall ofelongated portion408 and extend to side openingport430.
• Locating a Tissue Opening
• Referring toFIGS. 40-41, an apparatus and method for locating a vessel opening is described. InFIG. 40, thelocator apparatus500, which is in communication with a vacuum or source of suction (not shown), has not completely isolated thevessel opening25. Thus, thelocator apparatus500 draws both blood and other bodily fluid with its suction. InFIG. 41, thelocator apparatus500 has completely isolated thevessel opening25 and now only draws blood through its lumen. The blood is transferred to the proximal end of theapparatus500 or to some other location external of the body to provide a visual indication that theapparatus500 has located theopening25. In this position, thelocator apparatus500 can hold onto thevessel10 with its suction and maintain theapparatus500 over the opening.
• Referring toFIGS. 42aand42b, analternate locator apparatus500 is shown with anexternal guidewire lumen507. Aninternal guidewire lumen508 is shown inFIG. 42b.
• Referring toFIG. 43, apreferred locator apparatus500 is shown with externalmedical delivery devices508aand508b, which can deliver medical treatment to the area surrounding thevessel opening25. Also, internalmedical delivery devices509aand509bcan deliver medical treatment to thevessel opening25 or to thevessel10 itself. The medical treatment can be therapeutic, e.g. radiation or drug delivery.
• Referring toFIG. 47, a preferred apparatus for locating a vessel opening is illustrated.Suction apparatus500 includes a vacuum source505 (shown schematically). Thesuction apparatus500 may also be connected to a closure device504 (shown schematically) viaattachment ports506. Vacuumsource505 may be any vacuum generator suitable for the surgical procedure to be described. Theapparatus500 may also include closure devices504 (shown schematically), which may also be inside theapparatus500.
• Referring toFIGS. 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 apparatus500 has the guidewire “g” strung through it by theguidewire guide503. As the distalaxial opening502 nears thevessel opening25, the vacuum forces of thesuction apparatus500 draws both blood and clear bodily fluid from the area surrounding thevessel opening25. When the distalaxial opening502 completely covers thevessel opening25, thesuction apparatus500 has isolated thevessel opening25. At this point, the vacuum forces of thesuction apparatus500 only draws blood. Also, once thevessel opening25 has been isolated, the vacuum forces of thesuction device500 cause the edges of thevessel opening25 toevert26.
• Once thevessel opening25 has been isolated, aclosure device504 attached to thesuction device500 can be used to close thevessel opening25.
• 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 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 inclaim 11, wherein the guide point comprises a notch formed in the catheter.

13. A device as inclaim 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 inclaim 13, wherein the distance is at least about 0.5 mm.

15. A device as inclaim 11, wherein the retractor additionally comprises a handle portion operatively connected to the movable members.

16. A device as inclaim 15, wherein the handle portion comprises two handles and a locking mechanism, and the handles are operatively connected at a hinge.

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