US20040068272A1 - System for wound closure - Google Patents

Abstract

A system is provided for closure of a wound in a patient, such as a puncture hole in a blood vessel, with a suture having a first apparatus for applying a suture capable of closing the wound and a second apparatus for securing a sleeve member over the suture to secure the wound closed. The first apparatus includes a housing, a shaft having first and second ends in which the first end is coupled to the housing, a tissue engaging section coupled to the second end of the shaft, and first and second needles which extend from the housing through the shaft into the tissue engaging section. The tissue engaging section is directed through the wound, and has first and second gaps in which each gap has opposing surfaces into which different sides of the wound can be received. The first needle is extendable into a holder through the first gap to capture one of the two ends of a suture material or thread, and is retractable with the captured suture. The second needle is extendable into another holder through the second gap to capture the opposite end of the suture material, and is retractable with the captured suture. A selecting mechanism enables the selection of the first or second needles. The user operates an actuator member to drive and retract each of the selected needles to retrieve each end of the suture material through the tissue about the wound. After removal of the first apparatus, the suture material is left across the wound, and the second apparatus secures a sleeve member over the two ends of the suture material in proximity of the wound to maintain the wound closed and then cuts the suture material exiting the sleeve member.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a divisional application of, and claims the benefit of, U.S. patent application Ser. No. 09/713,558, filed on Nov. 15, 2000, which is herein incorporated by reference in its entirety, which claims the benefit of Provisional Patent Application No. 60/166,338, filed on Nov. 19, 1999, which is herein incorporated by reference in its entirety.[0001]
FIELD OF THE INVENTION
• The present invention relates to a system (method and apparatus) for wound closure, and in particular to a system for vascular wound closure utilizing a tissue suturing apparatus and a suture securing apparatus. The invention is suitable for applying at least one suture to close a wound, such as a puncture hole in a blood vessel, after an intravascular catheterization procedure. The invention is also suitable for applying a suture to a wound in other bodily tissue, such as the bowel. The term wound generally refers to herein to a hole, puncture, or any opening in tissue requiring closure.[0002]
BACKGROUND OF THE INVENTION
• When performing catheterization procedures, such an angiography or angioplasty, a catheter is generally introduced percutaneously (i.e., through the skin) into the vascular system by first penetrating the skin and underlying tissue, and then the blood vessel with a sharpened hollow needle. Location of a blood vessel, such as an artery, is typically achieved by feeling for the pulse, since such structures usually cannot be seen through the skin. Next, a guide wire is commonly inserted through the lumen of the hollow needle and is caused to enter the selected blood vessel. Subsequently, the needle is typically slid off the guide wire and a combination of a dilator and sheath are fed over the guide wire and pushed through the skin to enter the vessel. The guide wire and dilator can then be removed and the desired catheter to carry out the procedure is fed through the lumen of the sheath and advanced through the vascular system until the working end of the catheter is appropriately positioned. Following the conclusion of the catheterization procedure, the working catheter will be withdrawn and, subsequently, the sheath can also be removed from the wound, or left in place to facilitate closure.[0003]
• At this point in the procedure, the vessel leakage must be controlled in order to stem the flow of blood through the puncture. Because it is common practice to administer a blood thinning agent to the patient prior to many of the catheterization procedures, stemming the blood flow can be troublesome. A common method of sealing the wound is to maintain external pressure over the vessel until the puncture naturally seals. This method of puncture closure typically takes at least thirty minutes, with the length of time usually being substantially greater if the patient is hypertensive or anti-coagulated. In some anti-coagulated patients, the sheath is left in place for hours to allow the anti-coagulant to wear off. When human hand pressure is utilized, it can be uncomfortable for the patient and can use costly professional time on the part of the hospital staff. Other pressure techniques, such as pressure bandages, sandbags or clamps, have been employed, but these devices also require the patient to remain motionless for an extended period of time and the patient must be closely monitored to ensure their effectiveness.[0004]
• Other devices have been disclosed which plug or otherwise provide an obstruction in the area of the puncture. See, for example, U.S. Pat. Nos. 4,852,568 and 4,890,612, wherein a collagen plug is disposed in the blood vessel opening. When the plug is exposed to body fluids, it swells to create a block for the wound in the vessel wall. A potential problem of plugs introduced into the vessel is that particles may break off and float downstream to the point where they may lodge in a smaller vessel, causing an infarct to occur. Collagen material also acts as a nidus for platelet aggregation and, therefore, can cause intraluminal deposition of hemostatic agent, thereby creating the possibility of a thrombosis at the puncture sight. Other plug-like devices are disclosed, for example, in U.S. Pat. Nos. 5,342,393, 5,370,660 and 5,411,520.[0005]
• Surgical clips and clip appliers are known have also been used in vascular surgery, particularly to join severed vessels. For example, U.S. Pat. No. 4,929,240 describes clips generally arcuate in shape, which have two legs that are biased towards each other by clip applier jaws to capture vessel tissue therebetween. While vascular clips have been successfully used in surgery, the surgical procedures in which the clips are typically used allow the surgeon to view the area to be clipped. In catheter puncture repair procedures, however, the wound is generally not visible, making proper clip application, if attempted, difficult.[0006]
• The use of suturing instruments to close a puncture at the end of a tissue tract is disclosed in U.S. Pat. No. 5,368,601, wherein one of the instruments has a pair of needles, with the tips or points of the needles oriented in a proximal direction, releasably disposed at a distal end thereof. Once in the puncture wound, the instrument is activated to expose the needles. Thereafter, proximal movement of the instrument causes the needles to pass through the wound edge (from the inside to the outside) on either side of the puncture and the needles are withdrawn. A strand of suture material secured between the blunt ends of the needles is also drawn through the needle puncture holes, thereby leaving a span of suture across the hole on the inside of the vessel. The suture can then be tied to close the puncture. A disadvantage to this approach is the potential for needles to deflect in undesirable directions, and the potential difficultly of retrieving the needle tips. Also, the instruments used in this approach are relatively complex, may be unreliable in small sizes, and are costly to manufacture. A similar instrument is also described in U.S. Pat. No. 5,417,699.[0007]
• Another suturing instrument is described in U.S. Pat. No. 5,431,666 having a pair of longitudinally movable needles to pick up corresponding ends of suture at a distal end of the instrument. A needle capture mechanism provides two needle receiving portions, called ferrules, having a strand of suture material disposed therebetween, which are initially separated from the needles by a single gap in the instrument. In use, tissue to be sutured is disposed in the gap between the needles and the two needle receiving portions called ferrules. A first needle punctures the tissue, engages one end of the suture, and draws it back through the tissue. The instrument can then be relocated to another portion of tissue and the second needle is actuated to pick up and draw the second end of the suture through the tissue. The suture material can then be tied or otherwise cinched in place to secure the tissue closed. In using this instrument, the surgeon is typically able to view the surgical site.[0008]
• Typically, the user, such as a surgeon or interventional cardiologist, cannot directly view the percutaneous vascular wound that would otherwise facilitate suture placement on opposite sides of the puncture wound. U.S. Pat. No. 5,766,183 describes a suture instrument for vascular wound closure in which the user does not need to view the wound. The suture instrument has a pair of longitudinally movable needles to pick up corresponding suture ends at a distal end of the instrument. As in U.S. Pat. No. 5,431,666, the strand of suture material can have ferrules at each end. To suture the vascular wound, the instrument is placed through a sheath immediately above vascular wound, or through a tissue tract larger than the vascular wound. One side of the tissue near the wound is punctured by a first needle which engages a ferrule and drawn back through the tissue with the ferrule. The instrument is then rotated to puncture the vascular tissue near another side of the wound with a second needle, which engages the other ferrule and drawn back through the tissue with the other ferrule. After the suture is in place, the instrument is withdrawn leaving the suture behind. Another instrument crimps a sleeve member over the free ends of the suture near the wound and cuts the suture such that the wound secured closed.[0009]
• One drawback of the suture instrument of the U.S. Pat. No. 5,766,183 is that since the user does not directly view the site of the vascular wound to be closed, it can be difficult for the user after the first needle punctures the tissue to rotate the instrument such that the second needle is properly aligned at a location which will provide a suture capable of maintaining the wound closed. Preferably, the second needle when applied to the tissue is approximately 180 degrees opposite the location where the first needle punctured the tissue, in respect to the puncture wound along a direction longitudinal with the blood vessel. If the suture is not properly placed across the wound, the suture may not completely close the wound. Another potential problem with this approach is the need for the tissue tract to be larger than the vascular wound.[0010]
• It is therefore desirable to provide surgical techniques and instrumentation for closing wounds in blood vessels which reliably allows a user without viewing the wound to direct a suture at two locations about the wound which does not need instrument rotation to suture and to facilitate maximizing the distance between the suture and the edges of the wound.[0011]
• Moreover, improved medical equipment is needed to allow suturing instruments to pass through the sheath already in place in the body of a patient to suture a vascular wound.[0012]
SUMMARY OF THE INVENTION
• Accordingly, it is the principal object of the present invention to provide an improved system for closure of a wound in a blood vessel that overcomes the drawbacks of the prior art.[0013]
• Briefly described, the system embodying the invention includes a first apparatus for applying a suture capable of closing the wound and a second apparatus for securing a sleeve member over the suture to secure the wound closed. The first apparatus includes a housing, a shaft having first and second ends in which the first end is coupled to the housing, a tissue engaging section coupled to the second end of the shaft, and first and second needles which extend from the housing through the interior of the shaft into the tissue engaging section, although the needles could be shorter and their movement through the shaft could be assisted by an additional driving mechanism. The shaft and tissue engaging section may be directed to the wound through a sheath (or cannula) previously inserted in the body of the patient. The tissue engaging section has first and second gaps disposed opposite each other. Each gap has opposing surfaces into which different sides of the wound can be received. The first needle is extendable into the first gap through an opening of the tissue engaging section into a needle capturing portion coupled to one of the ends of a suture material, and is retractable with the captured end of the suture material. The second needle is extendable into the second gap through another opening of the tissue engaging section into another needle capturing portion coupled to the other end of the suture material, and is retractable with the captured end of the suture material. A suture tube in the housing extends through the housing and the shaft to the tissue engaging section, and is loaded with loop of suture material having two ends that extend to the needle capturing portions in the tissue engaging section. A selecting mechanism enables automatic or manual selection of each one of the first and second needles. A user operates an actuator member in the housing to drive and retract the selected needle to locate each end of the suture through the tissue about the wound. After removal of the first apparatus, the suture material is left across the wound and the ends of the suture material extend from the sheath. The second apparatus secures a sleeve member over the two ends of the suture material to maintain the wound closed and then cuts the suture material exiting the secured sleeve member.[0014]
• The first apparatus may further include a tubule flexible guide section coupled to the tissue engaging section to guide the tissue engaging section through the sheath and wound into the blood vessel over a guide wire previously situated therein, and enable the guide wire to be removed. The shaft of the first apparatus may be circular, or oval in cross-section having a major axis of the oval in a first dimension as its extends from the housing, and then oval in cross-section in a second dimension for at least a substantial portion of the shaft near the tissue engaging section to accommodate the two needles being substantially parallel in a first plane near the housing and then substantially parallel in a second plane orthogonal to the first plane near the tissue engaging section. The oval shape of the shaft enables the needles to have a larger distance apart from each other than would otherwise be provided if the shaft were circular in cross-section. The sheath (or cannula) through which the suture instrument is located to access the wound is generally circular in cross-section and made of a flexible material, such that it can deform to accommodate the oval shaft of the suture instrument.[0015]
• The suture securing instrument of the system includes a tube extending from a housing to a distal end, and a rod extending through the tube in which the rod has first and second ends. The first end of the rod is coupled to a lever pivotally mounted in the housing to move the rod, while the second end of the rod extends into the chamber of the distal end. The distal end has a chamber into which the tube is received, a receptacle at its tip for receiving a round or oval tubular securing sleeve member, and an opening in chamber through which the two ends of suture material can extended after passing through the sleeve member. The second end of the rod is shaped to have an upper surface that is downwardly sloped to provide a step and then terminates at a hammer shaped section at the tip of the distal end. The hammer-shaped section may be adjacent a sleeve member loaded in the receptacle through a slot at the bottom of the receptacle. When a sleeve member is loaded in the receptacle, the user may pull the lever to retract the rod which enables the hammer-shaped section of the rod to be raised by a ramp located at the bottom of the chamber of the distal end, such that the pressure applied upon the sleeve member by the hammer-shaped section crimps at least part of the sleeve member. A knife is pivotally mounted in the chamber of the distal end, and, responsive to the hammer-shaped section of the rod abutting the knife as the rod is further retracted, rotates the knife upwards to cut the suture material extending from the crimped sleeve member. The suture securing instrument may then be withdrawn through the cannula leaving the crimped sleeve member to maintain the wound closure by the suture.[0016]
• The invention further includes a method for using the first and second apparatuses to close a vascular wound, and a surgical kit including both the first and second apparatuses as parts of the kit.[0017]
• One advantage of first apparatus is that it allows a suture to be placed through a sheath and thus, there is no need to expand the diameter of the a puncture wound in order to place a suture across the wound, such as often needed in prior art suturing techniques. A further advantage of the first apparatus is the ability to locate the edges of the wound to be sutured from inside a blood vessel.[0018]
BRIEF DESCRIPTION OF THE DRAWINGS
• The foregoing objects, features and advantages of the invention will become more apparent from a reading of the following description in connection with the accompanying drawings, in which:[0019]
• FIG. 1 is a perspective view of the tissue suturing apparatus in accordance with the present invention;[0020]
• FIG. 2 is a partial side view of the tissue suturing apparatus of FIG. 1 in which the right cover of the housing of the apparatus is removed;[0021]
• FIG. 2A shows an extension member for the suture tube of the tissue suturing apparatus of FIG. 2;[0022]
• FIG. 3 is an exploded view of the tissue suturing apparatus of FIG. 1 in which the right cover of the housing is removed;[0023]
• FIG. 3A is a partial view of the guide section of the tissue suturing apparatus of FIG. 3;[0024]
• FIG. 4 is an exploded perspective view of the tissue suturing apparatus of FIG. 1 in which the right cover of the housing is removed;[0025]
• FIG. 4A is another perspective view of the retainer member of FIG. 4;[0026]
• FIGS. 4B and 4C are front and side views of the cam member of FIG. 4;[0027]
• FIG. 5 is a right perspective view of the needle selection mechanism in the tissue suturing apparatus of FIG. 1 showing the needle selector lever in a left position;[0028]
• FIG. 6 is a left perspective view of the needle selection mechanism in the tissue suturing apparatus of FIG. 1 showing the needle selector lever in a right position;[0029]
• FIG. 7A is a partial cross-sectional view of the needle selection mechanism and the actuator member of the apparatus of FIG. 1 showing the ends of the two needles in which one needle is positioned downwards to be driven by the actuator member and the other needle is positioned upwards in the needle retainer member;[0030]
• FIG. 7B is another partial cross-sectional view of the needle selection mechanism of the apparatus of FIG. 1 in which one of needles of FIG. 7A is being driven forward;[0031]
• FIG. 7C is another partial cross-sectional view showing an embodiment of the needle selection mechanism of the apparatus of FIG. 1 in which the needles are automatically selected;[0032]
• FIG. 7D is a partial side view of the embodiment of the needle selection mechanism of FIG. 7C;[0033]
• FIG. 7E is another partial cross-sectional view of the embodiment of the needle selection mechanism of FIG. 7C showing the position of the selector lever of the apparatus of FIG. 1 after the selector lever has been automatically moved responsive to forward rotation of the actuator member of the apparatus;[0034]
• FIG. 7F is a partial side view of the embodiment of the needle selection mechanism of FIG. 7E;[0035]
• FIG. 7G is a perspective view showing the transverse of the two needles in the shaft of the apparatus of FIG. 1;[0036]
• FIG. 8 is a perspective view of the tissue engaging section of the apparatus of FIG. 1;[0037]
• FIG. 9A is a cross-sectional view of the tissue engaging section along[0038]lines9A-9A of FIG. 8 in which ferrules have been loaded into ferrule holders;
• FIG. 9B is a cross-sectional view of the tissue engaging section along[0039]lines9B-9B of FIG. 9A when loaded with ferrules;
• FIGS.[0040]9C-9F are cross-sectional views of the tissue engaging section alonglines9A-9A of FIG. 8 showing one of the needles capturing a ferrule;
• FIGS.[0041]10A-10D are cross-sectional views of the tissue engaging section alonglines9A-9A of FIG. 8 showing another one of the needles capturing a ferrule;
• FIG. 10E is a cross-sectional view of one embodiment of the tip of each of the needles in the apparatus of FIG. 1;[0042]
• FIG. 11 is a perspective view of the suture securing apparatus in accordance with the present invention;[0043]
• FIG. 11A is a perspective view of the distal end of the suture securing apparatus of FIG. 11 showing the top and right side of the distal end;[0044]
• FIG. 12 is a partial side view of the suture securing apparatus of FIG. 11 in which the right cover of the housing of the apparatus is removed;[0045]
• FIG. 13 is an exploded view of the suture securing apparatus of FIG. 11 in which the right cover of the housing is removed;[0046]
• FIG. 13A is an expanded view of the distal end of the suture securing apparatus of FIG. 13;[0047]
• FIG. 14 is an exploded perspective view of the suture securing apparatus of FIG. 11 in which the right cover of the housing is removed;[0048]
• FIG. 15 is an exploded perspective view of the distal end of the suture securing apparatus of FIG. 13;[0049]
• FIG. 15A is a cross-sectional view of the sleeve member along[0050]lines15A-15A of FIG. 15;
• FIG. 16A is a cross-sectional view of the distal end along[0051]lines16A-16A of FIG. 11A with a sleeve member;
• FIG. 16B is a cross-sectional view of the distal end along[0052]lines16A-16A of FIG. 11A showing the loading of a sleeve member;
• FIG. 16C is a cross-sectional view of the distal end along[0053]lines16A-16A of FIG. 11A showing loading of the two ends of suture material with the aid of an attachment through the sleeve member of FIG. 16A;
• FIG. 16D is a cross-sectional view of the distal end along[0054]lines16A-16A of FIG. 11A showing the crimping of the sleeve member of FIG. 16A;
• FIG. 16E is a cross-sectional view of the distal end along[0055]lines16A-16A of FIG. 11A showing the cutting of the suture material after the sleeve member of FIG. 16A is crimped;
• FIG. 16F is a cross-sectional view of the distal end along[0056]lines16A-16A of FIG. 11A showing the release of crimped sleeve member of FIG. 16A from the suture securing apparatus of FIG. 11;
• FIG. 16G is a top view of the attachment to aid loading of two ends of suture material into the suture securing apparatus of FIG. 16C;[0057]
• FIGS.[0058]17A-17M show an example of the procedure for using the tissue suturing apparatus of FIG. 1 and the suture securing apparatus of FIG. 11 to close a wound in a blood vessel; and
• FIG. 18 shows an example of the apparatuses of FIGS. 1 and 11 included as parts of a kit.[0059]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Referring to the drawings, wherein like reference numerals identify similar or identical elements throughout the several views, an apparatus for applying a suture to body tissue is illustrated in FIGS.[0060]1-10D and is designated generally byreference numeral10. Another apparatus is also disclosed, designated byreference numeral100 and illustrated in FIGS.11-16F, for applying a connecting sleeve around the suture after it has been applied to the body tissue byapparatus10 in order to secure the suture. Note that the terms “first” and “second” as used herein are for the reader's convenience and should not be interpreted as necessarily denoting the order in which the components are actuated. The system for wound closure of the present invention encompasses the combination ofapparatuses10 and100.
• Referring to FIGS.[0061]1-4,apparatus10 is shown having ahousing12, atissue engaging section16, ashaft14 extending from anopening13 in the housing to thetissue engaging section16, and aflexible guide tube18 coupled to thetissue engaging section16. Thehousing12 has a body shaped like a pistol having ahandle portion12a, and may be made of a two-piece construction of molded plastic. Theapparatus10 includes a pair ofneedles20 and21, which extend fromhousing12 through theshaft14 into thetissue engaging section16. Eachneedle20 and21 has a non-tissue engaging end in the housing having aspherical member20aand21a, such as a ball or bearing, respectively, attached thereto. Both needles20 and21 andspherical members20aand21amay be a made of metal, such as surgical stainless steel. Thespherical member20aand21amay have a bore into which the non-tissue engaging ends of theneedles20 and21, respectively, extend and joined thereto, such as by welding.
• The[0062]apparatus10 includes anactuator member22 having twopins22aextending into holes in the sides ofhousing12 upon which the actuator member is pivotally mounted in the housing.Actuator member22 has a portion which extends through anopening12binhousing12 to provide atrigger23. Acoil spring24 is provided which hooks at one end in anotch22bofactuator member22 and is wound at the other end around apin26 located in holes in the sides ofhousing12, such that theactuator member22 is spring biased to retaintrigger23 normally in a forward position, as shown for example in FIG. 2. The body ofhousing12 has afront portion15 providing a stop that limits the pivotal movement of theactuator member22 to define the forward position of thetrigger23. Anotch22cis provided in theactuator member22 which is shaped to received one of the non-engaging ends ofneedles20 or21, i.e.,spherical members20aor21a, to be driven forward by theactuator member22 by a user pulling thetrigger23 portion ofactuator member22 towardshandle portion12a. Twogrooves22dare provided by threefingers22einto which theneedle20 or21 near thespherical members20aor21a, respectively, may lie.
• A[0063]retainer member28 is fixed inhousing12 by twoflanges28aabove actuator member22. As best shown in FIG. 4A, theretainer member28 has achamber28bhaving alower opening28cand twogrooves28dformed byfingers28ewhich allow thespherical members20aor21aofneedles20 or21, respectively, to be received inchamber28bto restrict movement of the needle when held therein. Thelower surface28fofretainer member28 is curved and faces correspondingly curvedupper surface22fofactuator member22, such that theactuator member22 is slidable alonglower surface28fresponsive to a user pulling and releasingtrigger23.
• To select which of the[0064]needles20 and21 is to be driven byactuator member21,apparatus10 has a needle selection mechanism having a selector lever (or arm)34 which is rotationally coupled with acam member30. Thecam member30 andselector lever34 is supported by anadapter32 inhousing12.Adapter32 is mounted inhousing12 by twoflanges32a. Theselector lever34 is pivotally mounted by apin32cextending upwards fromadapter32 at ahole34athrough the lever.Selector lever34 extends through anopening12cinhousing12 and has a downwardly protrudingmember34bwhich is received in anotch30cofcam member30 to rotatecam member30 in apocket32bin theadapter32 as the selector lever is moved left or right. Thecam member30 has a taperedsurface30cto facilitate its rotation inpocket32band twotapered apertures30aand30bthrough which needles20 and21 respectively extend, as best shown in FIGS. 4B and 4C. To selectneedle20 to be driven, theselector34 is moved left which rotates thecam member30 to positionneedle20 down andneedle21 up, such thatend20ais located in notch20cand end21ais located in retainer member28 (FIG. 5). To selectneedle21 to be driven, theselector34 is moved right which rotates thecam member30 to positionneedle20 up andneedle21 down, such thatend21ais located in notch20cand end20ais located in retainer member28 (FIGS. 6 and 7A). FIG. 7B shows the forward movement ofactuator member22 to driveneedle21 asneedle20 is retained in theneedle retainer member28.
• The[0065]needle selector34 may further have another downwardly protrudingmember34cwhich rides in a slot28gon the upper surface ofretainer member28. The slot28gis contoured to have angled lower regions on either side of a raised region into whichmember34ccan be located to releasably lock the position oflever34 left or right.
• The[0066]adapter32 has a bore extending therethrough in which aneedle spreader36 is located. Needle spreader has two channels into which needles20 and21 are respectively located to increase the distance between theneedles20 and21 as they extend towardcam member30, such that the needles are properly aligned to apertures30aand30bin the cam member.
• The[0067]shaft14 is mounted tohousing12 by ashaft mount38 which is D-shaped at one end to register into a corresponding shaped opening in theadapter32, an extendingmember40 into which theshaft14 is received, and a threadednut42 having an opening which extends over theshaft14, extendingmember40 andshaft mount38, and screws onto the end of theadapter32 to secure theshaft14 tohousing12.Shaft14 may be made of extruded plastic, or other substantially rigid material. Extendingmember40 has a taperedannular portion40aand agap40bonto which a sheath159 (such as shown in FIG. 17A) can be inserted to releasably attach the sheath toapparatus10 when theshaft14,tissue engaging section16, and guidesection18 is passed through the sheath. For example, such a sheath may be part of a percutaneous catheter introducer set sold by C.R. Bard Ireland Limited of Galway, Ireland.Sheath159 has ahead159ahaving an opening capable of receiving the extendingmember40, such when the extending member is inserted into the sheath, a gasket within the opening ofhead159aregisters intogap40band held in place by taperedannual portion40a. Theapparatus10 may be released fromsheath159 by pulling the sheath away fromhousing12. The taperedannular portion40amay be made of a rigid material capable of sufficient elasticity to pass through the gasket in thesheath159, and is shaped and sized in accordance with the opening ofhead159a. In addition to releasably attachinghousing12 to a sheath, the housing may also be releasably attached to a catheter.
• [0068]Apparatus10 has asuture tube44 which extends through anopening12din thehandle portion12aofhousing12, through notches17 (FIG. 4) along the interior of the left side ofhousing12, agroove36ain needle spreader36 (FIG. 4), and throughshaft14 totissue engaging section16. When a strand of suture material is loaded throughtube44, as shown in FIG. 2, thesuture material62 extends in a loop through thetube44 in which the two ends of the suture material are located in thetissue engaging section16. For example, the suture material may represent monofilament suture material or braided suture material. Thesuture tube44 may have anoptional extension member43 coupled to the end44aof the suture tube, as shown in FIG. 2A. Theextension member43 has asplitter43awhich forks to splittube44 into twotubes43band43c. Each of thetubes43band43cmay then be coupled to a separate compartment provided by hollowtransparent member43dand43e, respectively. When a strand of suture material is loaded throughtube44 andextension member43, the suture material has amidpoint63 between its two ends insplitter43a, theloop62 is divided into twoloops62aand62bdrawn through each oftransparent members43dand43ethroughtubes43band43c, respectively. Thus,loop62ais closer to one of the ends of the suture material, andloop62bis closer to the other end of the suture material. Thetransparent members43dand43eare optional, but can be used to protect each loop of suture material therein. The end of eachtransparent member43dand43emay be open or closed. Theextension member43 provides the user ofapparatus10 with a status indicator for the deployment of the suture. In other words, the user can visualize the suture material associated withloop62aor62b, respectively, when each end of the suture material is drawn up throughsuture tube44 as eachneedle20 and21, respectively, places one end of the suture material through tissue.
• Another embodiment of the selection mechanism is shown in FIGS.[0069]7C-7E in which the selection mechanism automatically positionsselector lever34 to selectneedle21 asneedle20 is driven forward by actuatormember22, rather than the manual positioning ofselector lever34 described earlier. In this embodiment, the selection mechanism includes aramp35 coupled toactuator22 which is sloped alongsurface35a. The selection mechanism further includes a downwardly extendingmember35bfromselector lever34 having a slopedsurface35c, such that when theactuator member22 withramp35 rotates forward (in the direction ofarrow19aof bi-directional arrow19),surface35cof extendingmember35babuts and slides alongsurface35aoframp35 to push theselector lever34 from the left to the right (in the direction indicated byarrow19b). FIGS.7C-7D show the position ofselector lever34 before the selector lever is automatically moved, and FIGS.7E-7F show the position of theselector lever34 after the selector lever is automatically moved. Theselector lever34 need not extend throughopening12cofhousing12. In this manner, theselector lever34 is initially positioned to the left whenapparatus10 is assembled, such that thatneedle20 is pre-selected for the user to be driven, and then while the user drives theneedle20 forward, the selector lever is automatically moved to the right to selectneedle21. In response,cam member30 rotates as described earlier. When theselector lever34 is automatically moved to its right position, the non-tissue engaging end ofneedle21 will still be retained in theretainer member28 and the non-tissue engaging end ofneedle20 lies innotch22cof the actuator member, until the actuator member fully retractsneedle20. Upon full retraction ofneedle20 byactuator member22, theneedles20 and21 will automatically switch their positions with respect toretainer member28 and notch22cto enable subsequent driving ofactuator22 whenneedle21 is moved forward.
• Referring to FIG. 7G, to orient the[0070]needles20 and21 for thetissue engagement section16, the twoneedles20 and21 are substantially parallel in an x-z plane (parallel to the x axis45) as they exithousing12 intoshaft14 and then cross within the shaft to be substantially parallel in a y-z plane (parallel to the y axis46) orthogonal to the x-z plane at thetissue engaging section16. To maximize the separation of theneedles20 and21, theshaft14 is oval in cross-section having a major axis of the oval for at least a substantial portion of the shaft as it extends to shaft end14b(FIG. 4) near thetissue engaging section16 in the y-z plane (parallel to the y-axis46). Near thehousing12 at shaft end14a, theshaft14 may be circular in cross-section (or oval in cross-section having a major axis along the plane parallel to the x-z plane), and then shaped to provide the desired oval cross-sectional shape as it extends nearshaft end14b. Theshaft14 may have an interior structure in which needles and suture tube extend in channels along the shaft from the housing to the tissue engagement section.
• Referring to FIGS. 8 and 9A, the[0071]tissue engaging section16 of thetissue suturing apparatus10 is shown in more detail. Thetissue engaging section16 has achannel48 forneedle20 to afirst opening50, achannel52 forneedle21 to asecond opening54, and achannel55 forsuture tube44 to athird opening57.End16aof thetissue engaging section16 is received intoshaft14, such thatedge56 abuts the end ofshaft14. Thetissue engaging section16 has two holders orreceptacles58 and60 which are each capable of holding aneedle capturing portion58aand60a, respectively, received throughopenings64 and66, respectively.Needle capturing portions58aand60aare referred to herein as ferrules, such as described, for example, in U.S. Pat. Nos. 5,431,666 and 5,766,183, but may be any means by which a suture may be captured at the tip of a needle. Theferrules58aand60aeach have an opening to an interior cavity shaped to enable the ferrule to frictionally engage the end of theneedles20 and21, respectively, when received in the interior cavity. Each ferrule may be made of metal or plastic and may be oval in cross-section such that they can frictionally engage the tip of a needle. Theferrules58aand60aare each connected to one end of the two ends of a length of suture material orthread62 extending through the suture tube44 (FIG. 2). Eachferrule holder58 and60 has achannel58band60b, respectively, through which thesuture material62 from each ferrule58aand60a, respectively, extends.
• The[0072]tissue engaging section16 has afirst gap68 and asecond gap70 in which thefirst gap68 is along the lower side ofsection16 and thesecond gap70 is along the opposite upper side ofsection16 and forward with respect to the first gap along the length of thesection16 in a direction distal fromhousing12. Thefirst gap68 has two opposingsurfaces71 and72 into which one side of a wound can be received, whereopening50 is located alongsurface71 andopening64 toferrule holder58 is located alongsurface72 facingopening50. Similarly, thesecond gap70 has two opposingsurfaces74 and76 into which the other side of the wound can be received, whereopening54 is located alongsurface74 and theopening66 toferrule holder60 is located alongsurface76 and facesopening54. Eachgap68 and70 is shaped to have a depth to facilitate the placement of the edge of a wound therein.Surface72, which is the distal face of thefirst gap68, andsurface74, which is the proximal face of thesecond gap70 both serve as stop surfaces for thetissue engaging section16. Such stop surfaces72,74 assist in the placement of thetissue engaging section16 relative to the wound as will be described further below. An opening61 (FIG. 9B) extends throughsurfaces72 and74 ofgaps68 and70, respectively, through which thesuture material62 fromferrule60apasses through to opening57 into thesuture tube44. The length ofneedle21 is longer thanneedle20, as shown in FIG. 9A, such that the distance from the tip of each needle to their associatedferrules60aand58a, respectively, are approximately equal, and thus, theamount actuator member22 must be pivoted to drive and retract each needle is approximately equal. Ends16aand16bof the tissue engaging section are angled with respect to each other as shown in FIG. 9A to facilitate placement ofend16bwithguide section18 through a sheath (or cannula) and the puncture wound to maximize blood vessel engagement. The twoferrules58aand60aandsuture material62 maybe located inapparatus10 during manufacture. For example, the ferrules may be loaded into their associated ferrule holders, and then a wire with a hook draws the suture through opening57 in thetissue engagement section16 through opening44aof the suture tube in housing12 (FIG. 2) ortubes43cand43bof optional extension member43 (FIG. 2A).
• The[0073]tissue engagement section16 may be made of metal, such as stainless steel, or other rigid biocompatible material. For example, the tissue engagement section may be made of two pieces of shaped metal having bores providing the desired openings, channels, and receptacles, joined together down the middle alongsection9A-9A by welding or heat shrinking of heat shrinkable tubing connecting the two pieces. The components in thehousing12, such as theactuator member22,selector lever34, andneedle retainer28, may be made of molded plastic.
• FIGS. 9C and 9D show the[0074]needle20 being extended in the direction of arrow78 intogap68 to captureferrule58aupontip20bof the needle, and FIGS. 9E and 9F showneedle20 retracting with the capturedferrule58ain the direction toarrow80 intochannel48. FIGS. 10A and 10B show theneedle21 being extended in the direction ofarrow82 intogap70 to captureferrule60aupontip21bof the needle, and FIGS. 10C and 10D showneedle21 retracting with the capturedferrule60ain the direction toarrow84 intochannel52. Each of theneedles20 and21 can be manually or automatically successively selected to extend and retract the selected needle withactuator member22 to puncture through each side of a wound, as will be described later in connection with FIGS.17A-17H.
• One embodiment of the[0075]tips20band21bof theneedles20 and21, respectively, is shown in FIG. 10E. For purposes of illustration,tip196 in the figure is exemplary of each oftips20band21bofneedles20 and21, andferrule198 is exemplary offerrules58aand60a.Tip196 has aregion200 before itspoint202 having a surface which tapers back towards theshaft204 of the needle, such that when thetip196 captures a ferrule, the ferrule'sinterior surface205 engages at theinterface206 ofpoint202 withregion200. The diameter of thetip196 along interface206 (indicated by arrow208) is slightly larger than the interior width offerrule198 along its oval cross-section (indicated by arrow210). For example, the ferrule's interior width may be about 0.14 to 0.18 inches and the diameter of the tip alonginterface207 may be about 0.002-0.004 inches larger than the ferrule's interior width. In this manner, the ferrule may be held better onto the tip when captured by the needle. In another embodiment oftips20band21b, the surface ofregion200 may be parallel with the surface ofshaft204, as illustrated inneedle tips20band21bof FIGS.9A,9C-9F, and10A-10D.
• A[0076]guide section18 is attached to end16b(FIG. 9A) of thetissue engaging section16. As shown best in FIG. 3, theguide section18 has aflexible tube18ahaving a conical shapedend18bwith an opening through which a guide wire may be received, and a fixedramp member18clocated under anopening18din the guide section, such that a guide wire may be extended throughend18band directed byramp member18cthroughopening18d. Thetube18amay be made of a biocompatible plastic, like heat shrink tubing, and the ramp may be made of plastic or metal which is attached or joined withintube18a.
• Referring to FIGS.[0077]11-14, thesuture securing instrument100 of the system is shown having ahousing102 similar tohousing12 ofapparatus10, ahollow tube104 coupled to thehousing102 through anopening103, and adistal end106 coupled totube104. Arod108 extends fromhousing102 throughtube104 to thedistal end106. Oneend108aofrod108 is coupled to alever110 inhousing102.Lever110 is pivotally mounted inhousing102 upon apin112 which extends through twoholes115 between upwardly extendingflanges113 of the lever. The ends ofpin112 fit intoholes114aof a pair of supportingmembers114 located in the sides ofhousing102. Thelever110 provides atrigger116 extending through anopening102binhousing102. In the alternative,support members114 may be moved, such thatpin112 extends into openings within the sides ofhousing102 to enablelever110 to pivot. Thelever110 andtube104 may be made of plastic.
• The[0078]rod108 has a spherical member orball109 attached at itsend108avia a hole in the ball. Theball109 is mounted in auniversal joint118 provided by barrel-shapedmember120,adjuster shaft122, and cover124. Barrel-shapedmember120 extends through twoholes123 betweenflanges113 oflever110. The barrel-shapedmember120 is joined to oneend122aof anadjuster shaft122 via ahole120aextending through the barrel-shaped member. The other end of theadjuster shaft122 has asocket122binto whichball109 is disposed. Thecover124 is a cylindrical member having an interior shaped to receive theball109 andsocket122bat an opening in one end, and a hole in the other end through which therod108 extends fromball109. Cover124 holdsball109 ofrod108 insocket122b, but allows the ball to be movable therein. Thus,ball109 andsocket122benables therod108 to rotate with respect tohousing102, while the barrel-shapedmember120 is rotatable inlever110 to move the rod linearly within the slot123adefined byflanges113 as thehousing102 is tilted upwards or downwards. Alternatively, thelever110 may be solid betweenflanges113 and a slot provided for therein to enable therod108 to move linearly while barrel-shapedmember120 is rotated.
• The[0079]rod108 extends from theuniversal joint118 totube104 through anadapter126, which may be similar toadapter32 ofapparatus10.Tube104 is mounted in anassembly125 using components similar to components36-42 inapparatus10. Therod108 may be composed of a rigid wire, such as piano wire, which is sufficiently flexible to bend inadapter126 to theuniversal joint118. In the alternative, theuniversal joint118 may be removed, such that ball119 ofrod108 is captured in a socket withinbarrel member120.
• The[0080]distal end106 has aninterior chamber128 into which end108bofrod108 is received and in linearly movable therein by auser moving trigger116 towardshandle portion102ain the direction ofarrow127. In this manner, theend108bofrod108 can be retracted through theinterior chamber128 ofdistal end106.
• Referring to FIGS. 13A, 15 and[0081]16A, thedistal end106 and theend108aofrod108 are shown in more detail.End108bofrod108 is shaped to have a contouredupper surface130, such as by cutting the wire by Electron Discharge Machining, or other similar wire shaping method. Theupper surface130 ofend108b, in the direction toward thetip106aof thedistal end106, is first downwardly sloped towardstip106ato provide a step orledge130a. Theupper surface130 is then further downwardly sloped afterstep130ato provide aflat region130bwhich is substantially parallel with thelower surface132 of theend108bofrod108, and thenupper surface130 is upwardly sloped to terminateend108bin a hammer shapedsection134. Thelower surface132 ofend108bofrod108 is slightly downwardly sloped to form awedge134aalong the hammer-shapedsection134.Tip106aofdistal end106 and the lower interior surface128dofchamber128 is shaped to receive the hammer-shapedsection134, such as shown in FIG. 16A, in which aramp136 faces thewedge134aof the hammer-shapedsection134.
• A compartment or receptacle[0082]137 is located attip106ahaving anopening138 through which a securingsleeve member140 may be loaded until astop141 provided by a ledge in the compartment.Sleeve member140 held in place by hammer-shapedsection134, which extends upwards through aslot135 along the length ofcompartment136. The securingsleeve member140 may be a Ti-Knot titanium tube manufactured by LaserSurge, Inc. of Rochester, N.Y. Anotherslot142 extends from theopening138 throughtip106ato enable the hammer-shapedsection134 to pass there through when asleeve member140 is loaded intocompartment136, such as shown in FIG. 16B. In FIG. 16B, the sleeve member is loaded in the direction of arrow143 by pushing forwards trigger116 until hammer-shapedsection134 extends throughslot142. Anopening128bis provided in the top128aof thechamber128, such that two ends of suture material can be received through the securingsleeve member140, when a sleeve member is loaded incompartment136, and passed throughopening128b. Thesleeve member140 inapparatus100 may be loaded during manufacture or by the user. Thesleeve member140 is preferably oval in cross-section as shown in FIG. 15A, such that it is pre-deformed to facilitate the crimping of the sleeve member described below. The two ends ofsuture material156 are shown, for example, passing through the interior140aof the sleeve member.
• A[0083]knife144 is pivotally mounted on apin146 inchamber128. Thepin146 extends through twoholes148 on the sides ofchamber128.Knife144 has aback portion144a, afront portion144b, and aU-shaped opening144ctherebetween through whichpin146 extends.Front portion144bhas anupper cutting surface144dand alower surface144e. Theback portion144aof the knife may lie onstep130ato prevent thefront portion144bfrom rotating upwards until the cutting of suture material extending throughsleeve member140 is needed. Theend144bof theknife144 has a rampedsurface144fto facilitate the passing of the suture material out throughopening128b. The top128amay also have a rampedsurface128cto further facilitate the passing of the suture material out throughopening128b.
• Referring to FIGS. 16C and 16G, an[0084]optional attachment150 may be located overdistal end106 having afunnel152 with anaperture154 in communication withsleeve member140 throughopening138 to assist a user in loading the ends of thesuture material156 through thesleeve member140 andopening128b. Theattachment150 has anopening150awhich is shaped to receiveend106, and aslot150bextending through thetop surface150calong the length of the attachment into which the ends of the suture material may be threaded prior to being directed throughsleeve member140. Theattachment150 is removed after the suture ends of the suture material are extended throughopening128band grasped by the user.
• Once loaded with a[0085]sleeve member140 incompartment136 and two ends of suture material from the wound are passed through the sleeve member to exit opening128b, a user, such as a surgeon, operatesapparatus100 by directing the apparatus through a sheath (cannula or tissue tract) through a tissue opening to the wound intissue163 through which the suture has been applied, such as byapparatus10. The user applies tension to the suture material and pullstrigger116 to retractrod108. The retraction ofrod108 applies tension to the rod and force to raise the hammer-shapedsection134 uponramp136 and apply crimping pressure to substantially compress and deform at least part of thesleeve member140, as shown in FIG. 16D. Retraction ofrod108 pulls steppedsurface130aaway from theknife144 to release it for rotation. Continued retraction of therod108 enables part of theupper surface130 along hammer-shapedsection134 to abut thelower surface144eof theknife144, which rotates the knife upwards, such thatupper cutting surface144dof the knife cuts the suture material exiting thesleeve member140, as shown in FIG. 16E. Thecrimped sleeve member140 then is released fromcompartment136 ofdistal end106.Apparatus100 may be removed from the sheath (or cannula or tissue tract). The required tension pressure on the rod applied by the user, via thelever110, to crimp the sleeve member is substantially less than the compression force which needs to be applied by a user using the instrument described in U.S. Pat. No. 5,766,183 to crimp a sleeve member. Accordingly,apparatus100 is easier to operate than the sleeve crimping instrument disclosed in this patent. The operation ofapparatus100 will be further described in connection with FIGS.17K-17M.
• Referring to FIGS.[0086]17A-17M, the method of closing a wound with the system of the present invention is shown. (Preferably, theapparatuses10 and100 are each directed through a sheath or cannula, however, they may be also be directed through a tract of tissue to a wound without a sheath or cannula.) FIG. 17A illustrates guide wire (or spring)158 extending through asheath159 inserted percutaneously throughskin157 andtissue160, and through puncture wound162 invessel163.Vessel163 may be a femoral artery, whereinpuncture162 was created to access for a catheter into the circulatory system of a patient to perform, for example, an angioplasty or angiography procedure. As shown and described herein, the distal end ofguide wire158 is directed towards the torso of the patient. Typically, a catheter (not shown) is also inserted through thesheath159 in thewound162. The catheter is removed prior to use oftissue suturing apparatus10. In use,guide wire158 is reinserted through the sheath left in the puncture wound at the end of the catherization procedure. If the selection mechanism is manual, the user verifies thatneedle20 is selected, and if not,positions selector lever34 of the selection mechanism to selectneedle20. Thetissue suturing apparatus10 is threaded over theguide wire158 by passing theguide wire158 through opening18dof the guide section18 (FIG. 17B). Theguide wire159 is then removed by pulling the wire throughopening18b(FIGS. 17B and 17C). Theguide section18 ofapparatus10 reduces potential trauma to the inside of the vessel, enhance wound edge engagement and permits reinsertion of the guide wire if desired by the user. Next, thetissue engaging section16 is passed through thesheath159 in thewound162 into theblood vessel163 until the extending member40 (FIG. 1) locks and connectsapparatus10 to thehead159aof the sheath (FIG. 17D), as described earlier. Thetissue engaging section16 is angled at itsend16bwith respect to end16ato facilitate engagement of the blood vessel wound. The user then gradually retractsapparatus10 with its attachedsheath159 to withdraw thetissue engaging section16 by pulling theapparatus10 downwards and out through thewound162 and lowers the apparatus untiledge162aof the wound is received in gap68 (FIG. 17E). The user next pullsactuator member22 to drive theneedle20 to puncture through the vessel in proximity ofwound162 and return withcapture ferrule58a, such that a first end of thesuture material164 is placed in the vessel tissue (FIG. 17F). If the needle section mechanism is manual, the user next selectsneedle21 withselector lever34. The user then lifts up and pushesforward apparatus10 untiledge162bof the wound is received in gap70 (FIG. 17G). The user then pullsactuator member22 to driveneedle21 to puncture through thevessel163 in proximity ofwound162 and return withcapture ferrule60a, such that a second end of thesuture material164 is placed in the vessel tissue (FIG. 17H). The wound is thus sutured from inside the blood vessel and no rotation of theapparatus10 is needed to place the suture across the wound. If theoptional extension member43 is used, it illustrates the status of suture deployment through the tissue engagement sites on opposite sides of the wound. If this display indicates that only one suture end has been placed (i.e., only one ofloop62aor62b(FIG. 2A) moved instead of both loops) then theapparatus10 can be partially removed, the suture material cut and removed, the guide wire reintroduced through theguide section18, and the closure procedure described above started again with anotherapparatus10 loaded with suture material.
• Next, the[0087]apparatus10 is removed from the sheath159 (FIG. 17I), and as theapparatus10 is withdrawn, the two ends of the suture material are retained in the tissue engaging section by the ferrules captured on theneedles20 and21, such that the suture material is drawn through the vascular tissue until a loop ofsuture material164 extends across the wound162 (FIG. 17J). Theapparatus10 may need to be rotated about 90 degrees to allow thetissue engaging section16 to be removed fromwound162 and theblood vessel163. Thesuture material164 is then cut to releasetissue engaging section16 from the stand of suture now spanning both sides of the wound, such that the two cut ends of the suture material extend fromsheath159. The two ends of the suture material are next threaded, preferably throughattachment150, into the distal end ofapparatus100 having been loaded with asleeve member140, such as shown FIG. 16C. Thetube104 ofapparatus100 is then inserted intosheath159 such thatdistal end106 lies in proximity of the wound (FIG. 17K). While applying tension to thesuture material164 extending from thesheath159, the user pullslever110 to crimp thesleeve member140 and then cut the suture, as described earlier in connection with FIGS.16D-16E.Apparatus100 is then withdrawn fromsheath159. A small loop ofsuture166 is now secured by acrimped sleeve140aleft behind to close wound162 (FIG. 17L), as described earlier in connection with FIG. 16D. Thesheath159 is then removed from the patient (FIG. 17M), and a topical bandage may be applied.
• [0088]Apparatuses10 and100 may be sizes to accommodate the cross-section of thesheath159. For example, if the sheath is six French (2 mm in diameter), the size ofshaft14 andtissue engaging section16 ofapparatus10, and the size oftube114 anddistal end106 ofapparatus100 may be sized to accommodate this diameter. Theapparatus10 can provide, for example, bite sizes between each tissue engagement site of the suture invascular tissue163 and the edge of the wound of about 3 mm. Moreover, as only theneedles20 and21 are movable in thetissue engaging section16 ofapparatus10,apparatus10 can be easily miniaturized to the desired application. In addition, the user can receive tactile feedback throughapparatus10 when opposing sides, representing the superior and inferior sides of the wound, are respectively received ingaps68 and70.
• Preferably,[0089]apparatuses10 and100 are used in combination such as described above. However, each apparatus may also be used separately to suture a wound or seal a suture closed, respectively.
• Referring to FIG. 18,[0090]apparatus10 and100 may be provided as part of a surgical kit167 useful for closing a puncture wound in a blood vessel. The kit167 preferably includesapparatus10,apparatus100,sheath159 and adialator assembly172. Thesheath159 hastubing159bto valves(s)159cthrough which fluid may be inserted. The kit packaging has a base168 molded to inset the parts of the kit, and acover170 over the base to seal such parts therein. The base168 can be at least partially fabricated from thermoformed plastic602 fabricated from polyethylene fibers, such as TYVEK available from Dupont, to facilitate sterilization.
• From the foregoing description, it will be apparent that there has been provided an improved system, method, and apparatuses for wound closure. Variations and modifications in the herein described system, method, and apparatuses in accordance with the invention will undoubtedly suggest themselves to those skilled in the art. For example, the use of two additional needles to[0091]needles20 and21 may be provided for inapparatus10 to place an additional suture across the suture described above, such as may be desirable for closing larger diameter wounds. Such additional needles may be provided by adding two additional apertures throughcam member130 selected byselector lever134, and two additional channels and gaps intissue engaging section16 substantial orthogonal togaps68 and70 into which edges of the wound may be received. If needed, pledgets or bolsters may be preloaded onto such sutures to provide added tissue support. Accordingly, the foregoing description should be taken as illustrative and not in a limiting sense.

Claims (7)

What is claimed is:

1. A needle for use in a tissue suturing apparatus, the needle comprising

a shaft having a diameter;

a tip including a point tapering to a distal end of the needle; and,

a groove between the shaft and the tip.

2. The needle ofclaim 1 wherein a diameter at a proximal end of the point defines a maximum diameter of the tip, a region of the tip tapering proximally towards the shaft, wherein the region has a proximal end diameter less than the diameter of the shaft.

3. The needle ofclaim 2 further comprising a section between the shaft and the tip, the section tapering distally from the diameter of the shaft to the proximal end diameter of the region of the tip, the section and the region defining the groove.

4. The needle ofclaim 1 wherein the shaft has a substantially circular cross-section.

5. The needle ofclaim 1 wherein the shaft of the needle is a length adapted for receipt in a shaft of a tissue suturing apparatus.

6. The needle ofclaim 1 wherein the shaft of the needle has a distal end adjacent the tip and a proximal end having a spherical member for receipt within a handle member of a tissue suturing apparatus.

7. The needle ofclaim 1 wherein the point is conically shaped.

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