US20120150201A1 - Vascular suturing device with needle capture - Google Patents

Abstract

A surgical device of suturing vascular vessels is described, as well as methods for suturing tissue employing the surgical device. The device includes at least one needle advanceable through tissue and into a needle capture element within a distal end of the surgical device to draw lengths of suture material which can then be used to close various puncture wounds, particularly in vascular tissue.

Description

BACKGROUND OF THE INVENTION
• The present invention generally relates to surgical instruments and methods of suturing tissue.
• A number of diagnostic and treatment procedures are conducted intravascularly. Typically, a catheter is introduced into the vascular system at a convenient access location and is then guided to the target treatment site. The Seldinger Technique is one of the well-known early examples of this type of procedure which can include catheterization and angioplasty techniques. Procedures such as this require a vascular access. Typically an introducer sheath with or without a guide wire is inserted through a puncture wound in a vessel such as the femoral artery at a location near the groin. A catheter and other instrumentation can then be inserted through the sheath and guided to the targeted treatment site. After the diagnostic and/or treatment procedure has been completed, the puncture wound must be closed. Closing the wound can be difficult because of the substantial bleeding that can occur through an open wound in the vascular vessel. One technique for hemostasis includes applying pressure near or upstream of the puncture site. This approach suffers from many deleterious effects, not the least of which are that it can be time consuming and extremely uncomfortable—even painful—for the patient because the pressure is applied directly on or adjacent to the traumatized site. Frequently anticoagulants are employed for the original diagnostic/treatment procedures. This delays clot formation during the procedure, and this effect lasts through the initial recovery period, lengthening the time during which pressure must be applied to the wound for up to twelve hours or more. During this initial recovery period, it is imperative that the patient remain still, further adding to the patient's discomfort.
• Alternatively, the puncture wound can be closed with sutures. This can be extremely difficult because the vascular vessel with the puncture lies underneath the patient's outer skin. Some vascular vessels, notably the femoral artery, appear to be relatively large; however, in practice, even the largest arteries cannot be readily sutured. Therefore, devices have been developed to facilitate subcutaneous suturing of arteries and veins. These devices can extend through the outer tissue to the puncture wound in the vascular vessel. Needles are then deployed from the device to suture the tissue adjacent the puncture wound.
• Certain devices are inserted through the wound and initially deploy a needle to pierce the tissue in from outside the vascular vessel and continue on into a receptacle in the portion of the device located within the lumen of the vessel. The suturing device can be removed from the vessel (and the patient) by withdrawing the needles and suture material at the same time. However, under certain conditions the needles may not be fully captured within the depository or the needles can become dislodged upon removal of the device from the patient. This can be particularly prone to occur when the needles remain attached to the suture material. For example, as the device (with the suture attached to needles) is withdrawn, friction from drawing the suture material through tissue tends to pull the needles out of the depository. In any event, the dislodged needles catch on tissue. This can result in snagging and possibly tearing of the vascular tissue or the upper tissue layers depending upon when the needles become dislodged.
• In view of the above background, there remain needs for improved and/or alternative methods and devices for closing vascular opening or punctures. The present invention is addressed to these needs.
SUMMARY OF THE INVENTION
• The present invention relates to a suturing device and the use thereof. Various aspects of the invention are novel, nonobvious, and provide various advantages. While the actual nature of the invention covered herein can only be determined with reference to the claims appended hereto, certain forms and features, which are characteristic of the preferred embodiments disclosed herein, are described briefly as follows.
• In one form, the present invention provides a suturing device for suturing. The suturing device provides particular advantages, for suturing a wall portion of a vascular vessel. The device comprises: a proximal member including an elongate body with a channel sized to receive a needle therein; a distal member comprising a receptacle therein, where the distal member is configured to be inserted into a vascular vessel, and wherein the receptacle is sized to receive at least one needle therein; an intermediate member disposed between the proximal member and distal member, where the intermediate member defines a tissue receiving area and provides a first passageway from the channel to the tissue receiving area and second passageway from the receptacle in the distal member to the tissue receiving area. In preferred embodiments a needle capture element positioned in the receptacle of the distal member. The needle capture element is configured to secure a needle inserted into the receptacle.
• In another form, the present invention provides a method of suturing vascular tissue adjacent an opening in a vascular vessel. The method uses a suturing device which can be inserted through the opening in the vascular vessel. The device comprises: a proximal member with a needle channel formed therein; a distal member configured to be inserted into the lumen of the vascular vessel, where the distal member has a receptacle that includes a needle capture element and which is sized to receive at least one needle; and an intermediate member disposed between the proximal member and the distal member. The intermediate member defines a tissue receiving area and is configured to provide a linear needle pathway between the channel and the receptacle. A needle is advanced through or along the needle channel to pierce the vascular tissue drawing a portion of the length of suture material through the vascular tissue. The needle is further advanced so that a portion of the needle engages with the needle capture element in the receptacle. Preferable the needle capture element prevents and in adverting dislodging of the needle from the receptacle during the surgical procedure. However, the same needle capture element also allows the surgeon to remove the needle when and if desired.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a cross-sectional view of one embodiment of a suturing device with a needle capture element in accordance with the present invention.
• FIG. 2 is an enlarged view in cross section of the distal member of the suturing device ofFIG. 1.
• FIG. 3 is an enlarged view in cross section of the distal member of the suturing device ofFIG. 1 with a needle disposed within a receptacle in the distal member.
• FIG. 4 is an enlarged view in cross section of an intermediate member with needle engaging projections of an alternative suturing device in accordance with the present invention.
• FIG. 5 is an enlarged view in cross section of the distal member illustrated inFIG. 4 with a needle disposed in the receptacle.
• FIG. 6 is a perspective view of an alternative embodiment of a suturing device with a needle cartridge for use in accordance with the present invention.
• FIGS. 7-12 illustrate methods of use of the suturing device according to the present invention.
• FIG. 13 is a perspective view of one embodiment of a suture securing device for use in the present invention.
• FIG. 14 is a perspective view of an alterative embodiment of a suture securing device for use in the present invention.
DETAILED DESCRIPTION OF THE INVENTION
• FIG. 1 shows a suturing device110 for suturing vascular vessels in accordance with the present invention. Device110 includes a proximal member112, a distal member114, and an intermediate member116 located therebetween. Device110 includes one or more needles118a,118b,118c. . . disposable withinneedle channel124 of proximal member112.
• Each of needles118a,118b,118c. . . can include a length of suture material120a,120b,120c. . . secured to the proximal end of the needles . Needle pusher126 can be used to advance the needles118a,118b,118c,. . . throughchannel124 out throughfirst opening150 into atissue receiving area145 defined by intermediate member116. Preferably, proximal member112 and/or distal member114 define a longitudinal axis and (either/both) is/are essentially linear about this axis. In one embodiment, the intermediate member116 can be configured to deviate from the lineality defined by either the proximal member (or the distal member).First opening150 andsecond opening152 in intermediate member can be axially aligned to permit needles118a,118b,118c. . . to travel in an essentially linear needle path that extends through tissue received withintissue receiving area145. In one form, suture material can be attached to the needle118a.The needle is then advanced in a distal direction through tissue. A second needle118b(and subsequent needles) can be similarly configured and manipulated to place sutures about tissue adjacent a puncture wound in a vascular vessel. The suture material(s) threaded through the vascular tissue can be drawn taut closing the puncture wound. A surgical knot or other suture securing device can complete the wound closure.
• As used herein, the term “proximal” refers to a direction toward the surgeon and away from the patient or a location closer to the surgeon, while the term “distal” refers to a direction towards the patient and away from the surgeon or a location closer to the patient.
• Proximal member112 is provided as an elongated portion and can exhibit a substantially cylindrical or oval radial cross section. Member112 includes a first end of sufficient dimensions to be readily grasped by the surgeon to manipulate the device during the procedures. Proximal member112 can also include agripping portion135 to facilitate handling during the surgical procedure.Needle channel124 runs longitudinally along at least a portion of proximal member112. In one embodiment,channel124 extends along the entire length of proximal member from a first end positioned proximal to the surgeon to a second end adjacent to intermediate member116. In this embodiment, one or more needle(s)118a,118b,118c,. . . and a needle pusher126 and grip136 can be inserted into and retrieved fromchannel124 at the first end. In other embodiments,channel124 extends only partly through the proximal member112.Needle channel124 can be centrally located along proximal member112. In preferred embodiments, proximal member112 includes asingle needle channel124 through which one, two, three, or more needles can be advanced. Alleviating multiple needle channels within the suturing device provides a more compact member, which can be particularly advantageous for subcutaneous procedures.Channel124 is sized and dimensioned to allow one or more needles118a,118b,118c. . . to be advanceable therethrough and into vascular tissue around the puncture wound. Furthermore,channel124 can be either partly or completely encased within the body of proximal member112. However, in a preferred embodiment,channel124 is not encased within the body of proximal member112. Rather,channel124 is provided as a slot formed into the surface of proximal member112. Preferably the slot is configured to retain one or more needles within the slot. For example, the slot can be formed to have an opening at the exterior surface of proximal member that is narrower than the diameter of the needles (and optionally the pusher126) while the internal portion or diameter of the slot can be dimensioned to permit facile movement of the needle therethrough. An exit opening is located at the distal end ofchannel124.
• Proximal member112 includes ablood return line125 that terminates in a fitting127, for example, a luer lock that can be mated to a syringe. Alternatively,line125 can terminate in a valve or shunt to control and stop blood flow therethrough. It is preferable thatblood line125 allow visible observation of blood originating from inside the vascular vessel. This can facilitate proper placement of the device for suturing.
• Referring additionally toFIGS. 2 and 3, distal member114 is sized and/or configured to be received within a lumen of a patient's vascular vessel similar to distal member114. In additional embodiments, distal member14 can be coated or impregnated with a lubricant, bioactive agent, such as an anticoagulant material, and the like. In certain embodiments, it is preferable that at least distal member14 be formed of a flexible or elastomeric material that is biocompatible—particularly with blood. For example, distal member14 can be composed of a biocompatible polymeric material commonly used for catheters, such as silicone rubber, polyethylene, polyolefin, polyurethane, polytetrafluoroethylene, polyvinyl chloride and the like.
• Distal member114 includes a receptacle122 sized and configured to receive and retain at least one needle118a,and preferably two or more needles118b,118c. . . Preferably, receptacle122 is sized to retain one or more needles such that the proximal end of each of the needles does not extend beyondopening152.
• A needle catching element123 located in receptacle122 is provided to engage with at least a portion of needles118a,118b,118c. . . Element123 can be configured as a plug of pierceable material. The material can be any biocompatible material pierceable with a surgical needle. Representative examples include materials such as silicone rubber, polyethylene, or polyurethane. In certain embodiments, the plug of material is composed of the same material as that used to form the distal member. The plug of material can be friction fit, adhesively bound, or mechanically retained inside receptacle122. In other embodiments, the plug of material can include a molded flap extending from an interior wall portion of receptacle122. In still other embodiments, the needle catching element123 can be integral with, or alternatively define, a bottom wall portion of receptacle122. Needle capture element123 can completely close off or block receptacle122. In other forms, element123 need not completely block receptacle122.
• Referring back toFIG. 1, distal member14 can also include alumen139 extending at least partially therethrough. Preferably,lumen139 is separate from receptacle122.Lumen139 can be provided to receive or follow a guide wire left in place after a particular diagnostic or treatment procedure. This can allow the facile insertion of distal member114 into the patient's vascular vessel. In a preferred embodiment,lumen139 exits through a side of distal member114 at opening140 to permit a guide wire (not shown) to extend out without interfering with the needles, needle path, or suture material. The guide wire can be removed after placement of the suture device or left in as desired or considered medically prudent by the surgeon.
• Intermediate member116 is located between proximal member112 and distal member114. Intermediate member116 defines a tissue-receivingarea145. In the illustrated embodiment, intermediate member is configured to include an arcuate portion or a crooked section. The arcuate portion or crook can defines a concaveinterior surface147 and a convexexterior surface148. Intermediate member116 includes afirst opening150 providing access from thechannel124 to thetissue receiving area145 and asecond opening152 from the receptacle122 providing to thetissue receiving area145. Preferably, first andsecond openings150 and152 are linearly or axially aligned. Intermediate member116 can be composed of a biocompatible material that is substantially resistant to deformation and therefore can maintain the linearity betweenchannel124 and receptacle/chamber122 and the respective first andsecond openings150 and152. Examples of suitable materials include TEFLON, NYLON, polyamids, and the like.
• Intermediate member116 also includes means and structure for reliable positioning of the device during surgery to facilitate closing the vascular puncture wound with sutures. Part of the positioning structure includes anopening154 providing fluid communication toblood return line125 in proximal member112. In a preferred embodiment, opening154 is located on a portion of theconvex surface148 of the intermediate member116 opposite thetissue receiving region145. In use, with the distal member of the device suitably positioned within the lumen of a vascular vessel, opening154 is also located in the interior of the lumen. This permits blood from the vessel to enterblood return line125, which can then be visibly observed by the surgeon. If blood is not observed inblood return line125, then the distal member may not have been inserted to a sufficient depth into the lumen of the vascular vessel.
• Additionally, a ridge or stop156 extends from the concave surface into the tissue receiving region. Stop156 is configured to bear against vascular tissue adjacent the puncture wound. In a preferred embodiment,first opening150 extends through a portion of stop56 permitting needle118 to pierce tissue adjacent thereto. Stop156 is sized to bear against the vascular tissue and avert further insertion of the device110 into the vascular vessel. When provided together, stop156 andopening150 withblood return line125 cooperate to ensure accurate placement of the suturing device in the patient's vascular vessel. Ridge or stop156 can also extend radially about the entire circumference of intermediate member116.
• FIG. 2 shows needle118aenteringopening152 in distal member114 and traversing receptical122 in response to distal movement of needle pusher126.
• FIG. 3 illustrates the capture of needle118awithin receptacle122. Element123 is positioned in receptacle122 to engage with at least thedistal tip132 of needle118a. Preferably element123 is positioned at a location or depth within receptacle122 such that the proximal end134 of a captured needle does not extend out of opening152 of receptacle122 to snag on any tissue or other structure as the suturing device is manipulated and eventually removed from the vascular vessel.
• FIGS. 4 and 5 illustrate partial views of an alternative embodiment of a suturing device210 with a needle capture element223. The illustrated distal and intermediate members214 and216 are configured similarly to distal and intermediate members114 and116. However, distal member214 includes a receptacle222. Receptacle222 is configured to receive one or more needles therein. Needle capture element223 comprises at least one projection229 and preferably at a second projection231 each extending radially inwardly from an interior wall portion233. It will be understood that receptacle222 can include a plurality of projections similarly configured as illustrated and/or described for projections229 and231. The projections229 and231 are configured to engage and capture or retain one or more needles218 within the interior of receptacle222. The projections229 and231 can frictionally engage the tips or sides of inserted needles to prevent their accidental dislodgement during surgical manipulation. In the illustrated embodiment, projections229 and231 are configured as a plurality of paired leaves projecting from the interior wall portion233 of receptacle222. It will be understand that in other embodiments, the leaves need not be paired; or, if paired, the leaves can be axially and/or radially offset from each other. In still other embodiments, projections229 and231 can be configured as protuberances, bumps, ridges, or threads extending from an internal wall portion of receptacle222 to engage and retain one or needles218 therein. Further, one or more of needles118a,118b,and118ccan include a recessed surface configured for engagement with at least one of the projections229 and231. For example, a needle can be configured with a barbed point or alternative with a tip similar to a tip as described in copending US Patent Application, filed on Aug. 8, 2005, (Attorney Docket No. 7323USO1, which is incorporated by reference herein.)
• Referring specifically toFIG. 5, a needle218 with a length of suture material220 is illustrated as captured within lumen222. As can be observed in the illustration, a plurality of projections229 and231 frictionally engage with the sides of the inserted needle218. Preferably, the projections229 and231 are angled in the distal direction from their point of connection to wall233 of receptical222. This causes the frictional engagement resisting needle movement in a proximal direction to be greater than the frictional engagement resisting a needle movement in a distal direction. This engagement effectively prevents the inserted needle218 from being dislodged by manipulation of suturing device210 within the patient or upon withdrawing the suturing device from the vascular vessel.
• FIG. 6 is a perspective view of another embodiment of asuturing device80 with a needle cartridge in accordance with the present invention.Device80 includes a proximal member81, a distal member82, and an intermediate member83 therebetween. Proximal member81 includes a needle cartridge84 slidably mounted in body85. Needle cartridge84 can include a plurality of needle slots, for example, two, three, four, or more slots86a.86b,86c. . . , each for a separate needle. Each needle in needle cartridge84 is individually advanceable through a central needle channel along a length of proximal member81. Needle cartridge84 is slidably disposed within body85 to axially align the selected needle slot86a.86b,86c. . . with asingle needle channel87. If desired, needle cartridge84 can be biased to automatically align the successive needle slots with the needle channel after the preceding needle has been advanced along the channel. Alternatively, suturingdevice80, body85, and/or cartridge84 can include one or more of ratchetings, positive stops, or locks to individually align the desired needle slot with the channel. In other embodiments, needle cartridge84 can be provided as a revolving barrel that can hold two, three, or more needles in respective needle slots radially disposed about the barrel. The barrel can be rotatably mounted on or about proximal member81. Distal member82 and intermediate member83 can be configured substantially as described above for members114 and116, respectively.
• FIGS. 7 through 13, illustrate the use of suturing device110 for closure of a puncture wound96 in avascular vessel93. A puncture wound in a vascular vessel can be sutured closed using the suturing device110. Suturing device110 can be inserted distally into the vascular vessel. This can be accomplished with or without the use of a guide wire. In a procedure where a guide wire has been previously used, suturing device can be threaded onto a guide wire92 which extends frominternal vessel lumen94 throughvessel93 and a portion of theoverlying tissue95 to be exposed to the surgeon. In that regard, opening140 oflumen139 can be threaded onto guide wire92 which then extends out throughopening140. Thus, the flexible portion of distal member114 can be gingerly threaded into thelumen94 ofvessel93. The distal member114 of device110 can be positioned withinlumen94 such that intermediate member116 engages with a portion of thetissue surrounding puncture96. Distal member114 is advanced in a distal direction until blood is observed inblood return line125. Additionally, when provided, stop156 abuts or bears against the external surface of the vascular vessel. This can be detected by the increased resistance to further advancement of the device in the distal direction. Bothblood return line125 and stop156 can be used to ascertain that the device has been correctly positioned within thelumen94 of thevascular vessel93 to allow suturing ofpuncture96. It should be noted that observance of blood inneedle channel124 is an indication that device110 has been inserted too far into thelumen94 such thatfirst opening150 is exposed to the interior or blood side ofvessel93. If desired, guide wire92 can then be withdrawn fromlumen139 and out ofvascular vessel93—if it is no longer needed for subsequent procedures.
• After the distal member is positioned as desired, the vascular tissue adjacent the puncture wound is received within thetissue receiving area145. As noted above, intermediate member116 provides an essentially linear needle pathway betweenneedle channel124, receptacle122, and the vascular tissue in thetissue receiving area145.
• Consequently, when needle118ais advanced throughchannel124, it pierces thevascular tissue93 at afirst suture site97 adjacent the puncture wound96.
• FIG. 8 illustrates suturing device110 at a first suture position. Intermediate member116 provides an essentially linear needle pathway betweenchannel124 and receptacle122. A first needle118aadvancing throughchannel124 using needle pusher126 pierces vascular tissue intissue receiving area145 at thefirst suture site97. Needle118atrails a length of suture material120apulling it through the vascular atsuture site97adjacent wound96. From there,needle tip132 is advanced into to receptacle122 to engage needle capture element123. Thereafter, needle118aand optionally a portion of the suture material120 are inserted into receptacle122 where at least a portion of the needle118aengages with needle capture element123. Needle capture element123 reliably retains needle118awithin receptacle122 during the rest of the suturing procedure or until the surgeon decides to withdraw the needle.
• As shown inFIG. 9 suturing device110 is rotated into a second suture position. Suture device110 can be rotated approximately 180° so that in the second suture position, suture device110 is positioned to operate on a second side ofwound96 diametrically oppositefirst suture site97.
• FIG. 10 illustrates suturing device110 in the second suture position. A second needle118bcan be advanced through or along receptacle122 using the needle pusher126, either the same needle pusher or a second, different needle pusher. Needle118bexits first opening150 to pierce vascular tissue received in thetissue receiving area145 at a second suture site100. Continuing the advancement of needle118bthrough the needle path draws the attached suture material120bthrough second suture site100adjacent wound96. Thereafter at least a portion of needle118bis captured and retained by needle capture element123 within receptacle122. If desired, suturing device110 can again be repositioned to draw suture material through a third and any desired subsequent suturing sites. It will be understood that suture material120aand120bcan be opposite ends of the same piece of suture material. Alternatively, suture material120aand120bcan be two separate lengths of suture material.
• FIG. 11 illustrates device110 being removed in a distal direction fromvascular vessel93. As suture device110 is withdrawn in the distal direction, needles118aand118bremain embedded within the needle catching element123 in receptacle122. Consequently, the attached lengths of suture material120aand120bare pulled in a distal direction through the vascular tissue at the first andsecond suture sites97 and100, respectively and then out through thewound96. One implementation of the suturing device can be a common length of suture material120 attached to the proximal ends of needles118aand118b.As illustrated inFIG. 12, the resulting suture path extends from the proximal side ofvessel94 across the wound opening and through the first andsecond suture sites97 and100 into thelumen94. The suture material120 then extends out through wound opening96 back to the distal side ofvessel93.
• FIG. 12 depicts wound closure. The free ends of the suture material120 can be gathered and a suture knot tied. As with the other procedures described above, a knot pusher115, knot boxes as described in WO 01/19258, and knot replacement technologies (seeFIGS. 13 and 14) can be used to close the wound and secure the suture material. The lengths of suture material can be gathered. The length of suture material can be separated from the needles. Pulling the lengths of suture material taut closes the wound in the vessel. A surgical knot can be tied securing the wound closure. A knot pusher, for example, the knot pushers described in U.S. Pat. No. 5,304,184 issued to Hathaway et al., U.S. Pat. No. 5,746,755 issued to Wood et al., and U.S. Pat. No. 6,132,439 issued to Kontos, can be used to advance the loosely tied knot to the exterior surface of the vascular vessel. In selected embodiments, the surgeon can then tie a suitable surgical knot using the respective lengths of suture material to close the puncture wound96.
• In other embodiments, the suture material can be secured using a variety of knot replacement technologies such as that disclosed in U.S. patent application Ser. No. 10/164,606 (US Patent Publication No. 2003/0229377) and in Ser. No. 10/305,923 (US Patent Publication No. 2004/0102809) and depicted inFIGS. 13 and 14. Each of the above-noted references are incorporated by reference in their entirety.
• FIG. 13 is a perspective view asuturing securing device102 for use in the present invention. Suture securingdevice102 is described and illustrated in US Patent Publication No. 2004/0102809 which is incorporated herein by reference. Inuse device102 can secure ends of one, two, three or more lengths of suture material. Two lengths of suture material120aand120bare illustrated withdevice102. The lengths of suture material are threaded into theflexible elements105aand105bwhich are then locked or fixed together securing the suture material therein.
• FIG. 14 is another embodiment ofsuture securing devices106aand106bfor use in the present invention.Devices106aand106bare described in US Patent Publication No. 2003/0229377 which is incorporated herein by reference in its entirety.Devices106aand106bcooperate by separately clipping onto a selected length ofsuture material104aor104bwhich have previously pulled taut to close wound or complete the surgical procedure. The devices prevent the suture material from regressing back through the sutured tissue.
• The present invention provides a variety of means, devices and methods for closing wounds in tissue and is particularly but not exclusively suitable for vascular tissue. It will be understood that the present invention contemplates modifications as would occur to those skilled in the art without departing from the spirit of the present invention. In addition, the various structures, elements, and procedural steps or stages have been described with reference to specified embodiments and devices. Each of the individual or a combination of the structures, elements, and procedural steps or stages are contemplated to be combinable with each of the other embodiments and devices described herein and as such are contemplated to be within the scope of the present invention.
• All publications, patents, and patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference and set forth in its entirety herein. Further, any theory of operation, proof, or finding stated herein is meant to further enhance understanding of the present invention and is not intended to make the scope of the present invention dependent upon such theory, proof, or finding.

Claims (21)

1. A suturing device for suturing a wall portion of a vascular vessel, said device comprising:

a proximal member including an elongate body with a channel sized to receive a needle therein;

a distal member comprising a receptacle therein, said distal member configured to be inserted into a vascular vessel, and wherein the receptacle is sized to receive at least one needle therein;

an intermediate member disposed between the proximal member and distal member, said intermediate member defining a tissue receiving area and including a first passageway from the channel to the tissue receiving area and second passageway from the receptacle in the distal member to the tissue receiving area; and

a needle capture element positioned in the receptacle of the distal member configured to retain a needle inserted into the receptacle.

2. The device ofclaim 1 wherein the receptacle of the distal member is sized to receive two or more needles.

3. The device ofclaim 2 wherein the needle capture element is configured to secure each of the two or more needles inserted into the receptacle.

4. The device ofclaim 1 wherein the needle capture element comprises a plug of resilient material.

5. The device ofclaim 4 wherein resilient material is selected from the group consisting of: polyurethane, polyethylene, poly(tetrafluoroethylene), poly(vinyl chloride), polyolefin, and silicon rubber.

6. The device ofclaim 4 wherein the plug of resilient material defines an internal wall portion of the receptacle.

7. The device ofclaim 1 wherein the needle capture element comprises at least one projection extending from an internal wall of the receptacle.

8. The device ofclaim 10 wherein the projection is configured to bias a needle inserted into the receptacle against an internal wall surface of the receptacle.

9. The device ofclaim 1 wherein the needle capture element comprises one or more leaves.

10. The device ofclaim 1 wherein the needle capture element comprises a pair of leaves extending radially inward from an internal wall portion of the receptacle and in a distal direction.

11. The device ofclaim 1 wherein the needle capture element comprises at least one tab extending radially inwardly from a surface of the receptacle of the distal member to engage with a recessed engagement surface of the needle.

12. The device ofclaim 1 wherein the proximal member comprises a needle cartridge slidably mounted thereon.

13. The device ofclaim 13 wherein said needle cartridge comprises a two or more needle slots capable of being sequentially aligned with a single needle channel.

14. The device ofclaim 1 comprising a first needle and slidably disposed in the needle cartridge.

15. The device ofclaim 14 comprising a second needle attached to a second end of the length and slidably disposed in the needle cartridge.

16. The device ofclaim 15 comprising a needle pusher slidably disposed in the needle channel to sequentially advance the first and second needles along the needle channel.

17. The device ofclaim 15 wherein the first needle is attached to a first end of a length of suture material, and the second needle is attached to a second end of the length of suture material.

18. The device ofclaim 1 wherein the intermediate member is curved or angled to offset the first and second passageways from wall portion of the vascular vessel disposed in the tissue receiving area.

19. The device ofclaim 18 wherein the intermediate member is configured to provide a linear pathway for a needle from the first passageway through the tissue receiving area to the second passageway.

20-33. (canceled)

34. A suturing device for suturing a wall portion of a vascular vessel, said device comprising:

a proximal member having a needle channel and a first needle and a second needle therein, said first needle and said second needle carrying a length of suture material;

a distal member configured to be inserted into the lumen of the vascular vessel, the distal member having a receptacle comprising a needle capture element and being sized to receive said first needle and said second needle therein, the needle capture member including an interior wall portion and a first plurality of projections and a second plurality of projections, the first and second pluralities of projections extending at an angle away from the interior wall portion toward a distal end of the distal member, the first plurality of projections being longitudinally offset from the second plurality of projections;

an intermediate member disposed between the proximal member and distal member, said intermediate member defining a tissue receiving area and configured to provide a linear needle pathway between the needle channel and the receptacle; and

a needle capture element positioned in the receptacle of the distal member configured to retain a needle inserted into the receptacle.

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