Abstract:
A vessel wound closure device that separately deploys a suture and a snare within a vessel to produce a stitch across a puncture site of a vessel. Once deployed within the vessel, the suture is captured within the snare, withdrawn, and then secured to provide a stitch across the puncture site of the vessel. The vessel wound closure device minimizes the amount of material introduced or left within the vessel or between edges of the puncture site, maximizes healing of the puncture site, and renders the vessel amenable to subsequent interventional or therapeutic procedures at or near the same site.

Description:
BACKGROUND OF THE MENTION  
       [0001]     1. Field of the Invention  
         [0002]     The invention generally relates to a vessel wound closure device. More particularly, the invention relates to a vessel wound closure device for sealing puncture wounds in a blood vessel such as those that result from certain interventional procedures.  
         [0003]     2. Related Art  
         [0004]     A large number of therapeutic and diagnostic procedures involve the percutaneous introduction of instrumentation into a blood vessel, for example, percutaneous transluminal coronary angioplasty (PTCA). Such procedures most often involve accessing an intended site through the femoral artery. Ideally, closing and healing of the resultant vascular puncture wound successfully completes the procedure.  
         [0005]     Traditionally, the application of external pressure to the skin at the entry site of the instrumentation into the patient has been employed to stem bleeding from the wound. A nurse or physician, for example, applies pressure to the wound site until clotting and tissue rebuilding has occurred sufficiently to seal the perforation. In some situations, the external pressure is maintained for an hour or more, during which time the patient is uncomfortably immobilized. Thus patient comfort and physician efficiency are impaired where such external pressure techniques are employed. Moreover, the patient may require immobilization even after the wound is sealed to minimize the risk of wound re-opening.  
         [0006]     Additionally, the risk of hematoma exists while bleeding from the vessel occurs. Such hematoma risk continues until sufficient clotting of the wound site occurs. Moreover, external pressure devices, such as femoral compression systems, are often unsuitable for some patients. For example, patients with substantial amounts of subcutaneous adipose tissue, as the skin surface in such patients may be a considerable distance away from the vasculature puncture site. Inaccurate skin compression, and thus less effective wound healing, tends to occur as a result.  
         [0007]     U.S. Pat. No. 5,383,896 to Gershony, et al. discloses a device that applies pressure to a puncture site internally for a limited period of time, after which the device is removed. The device in Gershony includes a shaft with an expandable balloon and a guidewire tip at its distal end. The distal end of the device is introduced into a blood vessel through an introducer sheath that is typically used in percutaneous interventional procedures. The balloon is then inflated and withdrawn until the balloon hemostatically engages the inner surface of the blood vessel, after which the introducer sheath is removed. A fixation collar on the shaft applies tension to the balloon for a medically sufficient time and thereafter the balloon is deflated and the entire device is removed from the body.  
         [0008]     U.S. Pat. No. 5,645,566 to Brenneman, et al. discloses a device that applies pressure to the outside wall of a punctured blood vessel from a distance using a balloon, a sheet and a foam pad. The pressure applying device is located using a balloon in the vessel (similar to that of Gershony) and a radiopaque marker.  
         [0009]     PCT Application WO 98/11830, published Mar. 26, 1998, S. Barak, Inventor, discloses various embodiments of an apparatus for hemostasis. Among them is a device that positions an “anchor” against an inner surface of an artery wall and a balloon outside the wall. The balloon is inflated to pinch the artery wall, after which the anchor is withdrawn. The balloon is maintained against the puncture until hemostasis is achieved.  
         [0010]     Other arterial closure devices include bioabsorbable materials intended to remain in the body until they are absorbed as in U.S. Pat. Nos. 5,282, 827 and 5,662,681.  
         [0011]     U.S. Pat. No. 5,391,183 to Janzen, et al. describes a device that inserts hemostatic material through a tissue channel and against the outside wall of the vessel around the puncture site.  
         [0012]     U.S. Pat. No. 5,690,674 to Diaz discloses a biodegradable plug that has two substantially parallel disks joined at their centers by a waist. The plug is positioned so that the distal disk is on the interior wall of the blood vessel, the proximal disk is on the exterior wall, and the waist is in the wound of the vessel wall.  
         [0013]     Another known closure devices include U.S. Pat. No. 5,741,223 to Janzen, et al. This &#39;223 patent discloses the placement of a plug to seal a puncture site.  
         [0014]     U.S. Pat. No. 5,354,271 to Voda which discloses suture threads with barbed ends, wherein the suture threads are deployed into a vessel and then the barbed ends penetrate through the vessel wall and expand to prevent retraction thereof back into the vessel. The suture threads are then tied or otherwise secured across the puncture site.  
         [0015]     U.S. Pat. No. 5,324,306 discloses a mass of hemostatic material pushed against the outside wall of a vessel at a puncture site. Manual pressure is applied to ensure blood flow has stopped.  
         [0016]     U.S. Pat. No. 5,868,778 discloses a balloon used in combination with a procoagulant injected at the puncture site in order to seal a puncture site of a vessel.  
         [0017]     U.S. Pat. No. 5,792,152 discloses a flexible needle with suture attached thereto that is deployed across a puncture site of a vessel. The flexible needle and suture are introduced into the vessel via an entry lumen, proceed through a U-shaped return lumen, and exit the vessel through an exit lumen. Thereafter the suture is drawn further outward from the vessel and tied or otherwise secured across the puncture site.  
         [0018]     U.S. Pat. No. 5,441,517 discloses an anchor inserted into a vessel and urged against an inner wall of the vessel as a collagen plug is deployed externally of the puncture site to expand and fill the tissue tract leading to the puncture site. A filament attaches the plug to the anchor. After emplacement, a tamping member may be used to urge the plug against the external puncture site to help seal the same.  
         [0019]     U.S. Patent Publication No. 2004/0006352 discloses an arterial closure device comprising an assembly in which clasp arms, to which a suture is initially secured, are deployed within a vessel. Penetrating members including suture catches are then separately deployed to snag or capture the sutures associated with a respective clasp arm. The sutures are then pulled taught by pulling the penetrating member with suture catches out from the vessel, and then tied or otherwise secured to close the puncture site. Thereafter the assembly is withdrawn from the body.  
         [0020]     None of the known art disclose or suggest a vessel wound closure device that separately deploys a suture and snare within a vessel, whereby the suture is captured within the snare, withdrawn, and then tied to produce a suture stitch across the puncture site of the vessel, thereby minimizing the amount of material introduced or left within the lumen of the vessel, maximizing wound healing, and rendering the vessel more amenable to subsequent interventional or therapeutic procedures at or near the same site.  
       SUMMARY OF THE INVENTION  
       [0021]     Various embodiments of the invention described herein comprise a vessel wound closure device that separately deploys a suture and a snare within a vessel to produce a suture across a puncture site of a vessel. Once deployed within the vessel, the suture is captured within the snare, withdrawn, and then secured to provide a stitch across the puncture site of the vessel. The various embodiments of the vessel wound closure device described herein thus minimize the amount of material introduced or left within the vessel or between edges of the puncture site, maximize healing of the puncture site, and render the vessel amenable to subsequent interventional or therapeutic procedures at or near the same site.  
         [0022]     In some embodiments, the vessel wound closure device comprises a sheath, a pair of movable vessel penetrating members associated with the sheath, whereby the vessel penetrating members are moved to penetrate the vessel wall adjacent a puncture site, each penetrating member creating a small hole in the vessel wall adjacent the puncture site. A suture is deployed into the vessel through one of the penetrating members, and a single filament snare loop is deployed into the vessel through the other of the penetrating members. The single filament snare loop includes a pair of strands that extend beyond a proximal end of the sheath, whereby movement of one or both of the strands determines the size of the snare loop within the vessel. The suture is captured by the snare loop within the vessel, and then withdrawn by retracting the respective penetrating members. Thereafter, the suture is tightened by further withdrawing the suture and snare via withdrawal of the respective penetrating members. Once tightened as desired, the suture is tied, or otherwise secured, externally of the puncture site so as to create a stitch across the puncture site. Excess suture material is then cut and the wound closure device and its components removed from the patient. In some instances, the sheath of the vessel wound closure device is inserted through an introducer already in place from a preceding procedure. In other instances, the sheath of the vessel closure device is inserted over a guidewire remaining from a preceding procedure, the introducer from the preceding procedure having been removed. Where the introducer from the preceding procedure has been removed and the sheath of the vessel wound closure device is inserted over a guidewire in the vessel, then the location of the vessel penetrating members of the vessel wound closure device is determined by blood flashback through one or both of the respective vessel penetrating members of the device.  
         [0023]     A collar, knot or other locking means may also be used to help tighten the suture prior to tying or otherwise securing the suture to form the stitch across the puncture wound of the vessel. Collagen or other thrombogenic material can be incorporated into the locking means to aid hemostasis at the puncture site. The collar, knot or other locking means is preferably bioabsorbable to accommodate resorption thereof in vivo. The collagen or other thrombogenic material may include therapeutic agents such as procoagulants, antimicrobial agents, anesthetics, or the like.  
         [0024]     In other embodiments, the vessel wound closure device comprises a body, a first movable vessel penetrating member associated with the body and a second vessel penetrating member associated with the body, a suture slidably housed within one of the vessel penetrating members and a snare slidably housed within the other of the vessel penetrating members, whereby the first and second vessel penetrating members are movable relative to one another and the body so as to penetrate the vessel wall adjacent a puncture site, each vessel penetrating member creating a small hole in the vessel wall adjacent the puncture site. The body has a proximal end and a distal end and further comprises a first exit port at a distal end thereof through which a first vessel penetrating member is deployed, a second exit port at the distal end thereof through which a second vessel penetrating member is deployed, a movable stabilizer foot at the distal end thereof which foot is deployable upon entry of the distal end of the body sufficiently into the vessel, and a flashback port through which flashback blood escapes to indicate when the distal end of the body is located sufficiently within the vessel to deploy the stabilizer foot and the first and second vessel penetrating members. Separately designated slides control the movement and deployment of the stabilizer foot, the first and second vessel penetrating members, the suture, and the snare. The suture is deployed into the vessel through one of the vessel penetrating members, and the snare loop is deployed into the vessel through the other of the vessel penetrating members. In practice, the suture is captured by the snare loop within the vessel, and then withdrawn by retracting the respective vessel penetrating members. Thereafter, the suture is tightened by further withdrawing the suture and the snare via withdrawal of the respective vessel penetrating members. Once tightened as desired, the suture is tied, or otherwise secured, externally of the puncture site so as to create a stitch across the puncture site. Excess suture material is then cut and the vessel wound closure device and its various components are removed from the patient.  
         [0025]     In some embodiments, the vessel wound closure device with the stablizer foot is inserted through an introducer already in place from a preceding procedure. In other cases, the introducer from the preceding procedure has been removed and the vessel wound closure device with the stabilizer foot is inserted into the vessel over a guidewire already in place.  
         [0026]     The above and other features of the invention, including various novel details of construction and combinations of parts, will now be more particularly described with reference to the accompanying drawings and claims. It will be understood that the various exemplary embodiments of the invention described herein are shown by way of illustration only and not as a limitation thereof. The principles and- features of this invention may be employed in various alternative embodiments without departing from the scope of the invention. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0027]     These and other features, aspects, and advantages of the apparatus and methods of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings where:  
         [0028]      FIG. 1  illustrates a schematic depiction of an embodiment of a vessel wound closure device according to the invention.  
         [0029]      FIG. 2  illustrates a partial schematic depiction of the vessel wound closure device of  FIG. 1  advanced to a vessel according to the invention.  
         [0030]      FIG. 3  illustrates advancement of the vessel penetrating members of  FIG. 1  according to the invention.  
         [0031]      FIG. 4  illustrates advancement of the snare of  FIG. 1  according to the invention.  
         [0032]      FIG. 5  illustrates advancement and capture of the suture of  FIG. 1  according to the invention.  
         [0033]      FIG. 6  illustrates retraction of the retraction of the captured suture within the snare of  FIG. 1  according to the invention.  
         [0034]      FIG. 7  illustrates securement of the suture stitch of  FIG. 1  according to the invention.  
         [0035]      FIGS. 7   a - 7   c  illustrate various other suture arrangements to create the suture stitch according to the invention.  
         [0036]      FIGS. 8   a  and  8   b  illustrates various options of deploying the snare relative to the suture according to the embodiment of  FIG. 1 .  
         [0037]      FIG. 9  illustrates a schematic depiction of another embodiment of a vessel wound closure device according to the invention.  
         [0038]      FIG. 10  illustrates in greater detail the inset A of  FIG. 9 .  
         [0039]      FIG. 11  illustrates a single filament snare loop having a mesh. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0040]      FIG. 1  illustrates one embodiment of a vessel wound closure device  1  according to the invention. The vessel wound closure device  1  comprises a sheath  10  having a distal end and a proximal end, wherein distal is understood as furthest from an operator and proximal is understood as closest to an operator. The vessel wound closure device  1  further comprises a first vessel penetrating member  20  and a second vessel penetrating member  30 , each of which is movable relative to the sheath  10 . A first guide  11  is preferably provided along an interior surface of the sheath to movably house the first vessel penetrating member  20 , and a second guide  12  is preferably provided along an interior surface of the sheath  10  to movably house the second vessel penetrating member  30 .  
         [0041]     The first guide  11  is preferably opposite the second guide  12 , although other arrangements of the first guide  11  relative to the second guide  12  are readily accommodated, in the artisan&#39;s discretion. Although  FIG. 1  illustrates the first and second vessel penetrating members  20 ,  30  in guides  11 ,  12  along an interior surface of the sheath  10 , such penetrating members could alternatively be movably housed through guides  11 ,  12  located on an exterior surface of the sheath  10  as well, in the discretion of the artisan.  
         [0042]     The vessel wound closure device  1  of  FIG. 1 , further comprises a suture  22  extending through the first vessel penetrating member  20 , and a single filament snare  32  extending through the second vessel penetrating member  30 . As shown in  FIG. 1 , a distal end of the first vessel penetrating member  20  comprises a pointed needle  21 , and a distal end of the second vessel penetrating member  30  comprises a pointed needle  31 . The respective needles  21 ,  31  are movable from a first position to a second position beyond a distal end of the sheath  10  to penetrate through the vessel wall to create holes adjacent a puncture wound when the associated first and second vessel penetrating members  20 ,  30  are deployed. The suture  22  and the single filament snare  32  are thus positioned in the vessel through the holes created by the respective needles. In practice, the sheath  10  of the vessel wound closure device  1  is placed through an introducer already in place from a preceding procedure, or over a guidewire  40 , where the preceding introducer has been removed.  
         [0043]     Although the first vessel penetrating member  20  and the second vessel penetrating member  30  are shown as generally circular in cross-section, the artisan should readily appreciate that other cross-sectional configurations are contemplated by the various embodiments described herein. For example, an oval cross-section of either or both of the first and second vessel penetrating members may help assure a more reliable orientation of the snare  32  or suture  22  relative to one another when deployed within the vessel.  
         [0044]     Further, either or both of the suture  22  and snare  32  could be pre-bent to help orient the suture and snare relative to one another when deployed within the vessel. The materials comprising the suture and snare may be, for example, a polypropylene, a shape memory alloy, or a stainless/coated steel, in the various embodiments described herein. Ideally, where a shape memory alloy is used to comprise a pre-bent suture or snare. The suture  22  may further comprise knots  22 A, or other projections, to assist the capturing of the suture  22  by the single filament snare  32 . Moreover, the size of the loop of the single filament snare  32  within the vessel is readily increased or decreased by the medical practitioner by movement of a snare strand  32 A extending beyond a proximal end of the wound closure device  1  while maintaining another snare strand  32 B in place, the other snare strand  32 B also extending beyond the proximal end of the wound closure device.  
         [0045]      FIGS. 2-7  illustrate various stages of deployment of the suture  22  and the single filament snare  32  and the creation of a stitch across the puncture wound site of a vessel using the embodiment of the vessel wound closure device  1  of  FIG. 1 , wherein emplacement and use of the vessel wound closure device  1  is generally the same whether it is through an introducer from a preceding procedure, or over a guidewire where the preceding introducer has been removed, unless otherwise specified herein.  
         [0046]     In particular,  FIG. 2  illustrates a partial schematic view of a distal portion of the vessel wound closure device  1  of  FIG. 1  emplaced and used in a vessel V having blood flow proceeding in the direction of arrow a. The blood flow direction of that shown in  FIGS. 2-7  is understood to be in the direction of arrow a of  FIG. 2 , even where arrow a is not otherwise explicitly shown. As shown in  FIG. 2 , the sheath  10  is inserted through the incision tract over the guidewire  40 , for example, and to the vessel wall w. The sheath  10  is preferably oriented such that the second vessel penetrating member is located in the downstream direction of the blood flow so that, when deployed, the single filament snare  32  is downstream of the suture  22 , thus rendering capture of the suture  22  by the snare  32  more reliable.  
         [0047]     In  FIG. 3 , the needles  21 ,  31  of the respective first vessel penetrating member  20  and the second vessel penetrating member  30  are deployed through the vessel wall w, so as to create holes adjacent the puncture wound site of the vessel V. Thereafter, in  FIG. 4 , the single filament snare  32  is advanced beyond the needle  31  of the second vessel penetrating member  30  and into the vessel V.- As mentioned above, the snare  32  is deployed downstream of the first vessel penetrating member  20  and the suture  22  to be deployed therefrom. The size of the loop of the snare  32  within the vessel V may be increased or decreased by movement of one or both of the strands  32 A,  32 B extending beyond the proximal end of the sheath  10  of the vessel wound closure device.  
         [0048]     As shown in  FIG. 5 , the suture  22  is advanced beyond the needle  21  of the first vessel penetrating member  20  and into the vessel V. Ideally the naturally occurring blood flow in the direction of arrow a ( FIG. 2 ) carries the suture  22  downstream and into the waiting snare  32 . The suture  22  may includes knots  22 A or other projections to help capture the suture  22  within the snare  32 . Ideally, the operator can feel a resistance in at least one of the vessel penetrating members  20 ,  30  that indicates the suture  22  has been successfully captured within the snare  32 . Thereafter, as shown in  FIG. 6 , the snare  32  and the suture  22  captured therein are withdrawn from the vessel V by retraction of the second vessel penetrating member  30 .  
         [0049]     The resistance identifying the capture of the suture  22  within the snare  32  is often best felt as the second penetrating member  30  is being retracted. When such retraction of the second vessel penetrating member  30  does not result in resistance to indicate that the suture  22  has been successfully captured within the snare  32 , then the snare  32  is re-deployed, as before, within the vessel V until successful capture of the suture  22  in the snare  32  is achieved. After retraction of the second vessel penetrating member  30  with the captured suture  22  and snare  32  is achieved, the first vessel penetrating member  20  is also retracted, leaving only the loose ends of the suture  22  and snare  32  along the extravascular surface of the vessel wall w of the vessel V adjacent the puncture site. The guidewire  40  may then be withdrawn in conventional manner.  
         [0050]     The suture  22  and snare  32  are then cut and tied, or otherwise secured, as shown, for example, in  FIG. 7 , in order to form a stitch  50  across the puncture wound of the vessel V. A one-way collar  55 , knot, or other extravascular locking means, such as snap fittings, male-female ratcheting connections, and sutures and wires with a knot pushing device, or the like, could be slid down extravascularly over the suture  22  and snare  32  and tamped down in order minimize vessel puckering as the suture  22  and snare  32  are drawn to tighten and form the stitch  50  across the puncture site.  
         [0051]     Alternatively, as shown in  FIG. 7   a , the suture  22  could include barbs  23 , one of which that would embed within the outer surface of the vessel after the suture  22  has been withdrawn from the vessel by the snare  32  and then tightened to form the stitch  50  across the puncture site. The barbs  23  would permit one way transgression of the suture  22  through the vessel wall w in order to enter the vessel V, as described above, and would permit further one way transgression of the suture  22  through the vessel wall w in order to exit the vessel V when captured within the snare  32 . Tightening of the suture  22  after sufficient withdrawal of the suture  22  from the vessel V by the snare  32 , as before, would cause one barb  23  to expand extravascularly against the vessel wall w, whereafter the suture  22  is tied or otherwise secured to form the stitch  50  as before.  
         [0052]     A still further alternative, as shown in  FIG. 7   b , provides a mesh or other fibrous structure  24  at the distal end of the suture  22 , through which mesh or other fibrous structure  24  the suture  22  is passed and then tightened across the wound until one of the barbs  23  expands against the mesh or other fibrous structure  24 . In this way, tying or other knotting of the suture to create the stitch  50  across the vessel is minimized, or ideally eliminated, while still providing an effective stitch across the vessel wound. In any case, once tightened and secured as desired across the vessel wound, the suture  22  is cut to leave the stitch  50  in place across the vessel wound. A cutting member, such as a guillotine-like cutting member  60  ( FIG. 1 ) having a blade  61 , a backing plate  62  and a drawstring  63  connected to one of the blade  61  or backing plate  62  for severing excess suture  22  after the stitch  50  is in place. Ideally, such cutting member is integrated with the vessel wound closure device  1 , but may be separately deployed through the vessel wound closure device  1 , in order to cut the excess suture.  
         [0053]     A still further alternative, as shown in  FIG. 7   c , provides a suture  22  having one set of barbs  23  facing in one direction at a distal portion of the suture  22 , and another set of barbs  25  facing in an opposite direction along a portion of the suture  22  spaced apart from the barbs  23 . The spacing of the barbs  25  from the barbs  23  is preferably a sufficient distance such that the barbs  23  along the distal portion of the suture  22  penetrate through the vessel wall w to gain entry into the vessel and penetrate through the vessel wall w after capture by the snare  32  to exit the vessel, whereas the barbs  25  never pass through the vessel wall w or enter the vessel V. In this case, after the suture  22  is captured and withdrawn from the vessel V by the snare  32 , the distal portion of the suture  22  is drawn until a barb  25  expands against the outer surface of the vessel wall w. The distal portion of the suture  22  is then further drawn to tighten the suture  22  across the wound sufficiently to form the stitch  50  thereacross as one of the barbs  23  also expands against the outer surface of the vessel wall w. Tying is likewise minimized, or ideally eliminated, using this technique as the expanded barbs  23 ,  25  anchor the stitch  50  in place across the vessel wound. Again, excess suture is cut as before.  
         [0054]     Collagen or other thrombogenic material can be incorporated into the locking means to aid hemostasis at the puncture site where such a locking means is used. The collar  55 , knot, or locking means is preferably bioabsorbable to accommodate resorption thereof in vivo. The collagen or other thrombogenic material may include therapeutic agents such as procoagulants, antimicrobial agents, anesthetics, or the like.  
         [0055]      FIGS. 8   a  and  8   b  illustrate various options for positioning the snare  32  relative to the suture  22  and vessel V, wherein that option illustrated in  FIG. 8   b  is preferred. In  FIG. 8   a , for example, the snare  32  is advanced from the second vessel penetrating member  30  so as to be generally perpendicularly situated between the vessel walls w of the vessel V.  FIG. 8   b , on the other hand, illustrates the snare  32  advanced from the second vessel penetrating member  30  so as to have a portion of the snare  32  lying generally beneath the upstream needle  21  of the first vessel penetrating member  20 , from which the suture  22  is advanced.  
         [0056]     Preferably the needles  21 ,  31  of the respective first and second vessel penetrating members  20 ,  30  are as small as possible in order to limit damage to the vessel wall. Such needles generally 18 gauge to 22 gauge needles, and preferably 21 gauge needles. The outer diameter of 21 gauge needles is approximately 0.032 inches. Of course, the artisan will readily appreciate that needles of other sizes are readily usable with the vessel wound closure device described herein. Similarly, the materials that comprise the sutures or snare are preferably biocompatible materials exhibiting high tensile and knot strength, although other materials may also be used with the vessel wound closure device described herein.  
         [0057]      FIGS. 9-10  illustrate another embodiment of a vessel wound closure device  101  according to the invention. The vessel wound closure device  101  of  FIGS. 9-10  may be inserted within an introducer already in place from a preceding procedure, or may be inserted over a guidewire after removal of an introducer from a preceding procedure. Emplacement and use of the vessel wound closure device  101  is generally the same unless otherwise specified herein, regardless of whether the device  101  is inserted within a preexisting introducer or over a guidewire wherein the preexisting introducer has been removed.  
         [0058]      FIG. 9  illustrates the vessel wound closure device  101  comprising a sheath  110  having a distal end and a proximal end, wherein the distal end is understood as furthest from the operator and the proximal end is understood as closest to the operator. The distal end of the vessel wound closure device  101 , encircled in inset A of  FIG. 9 , is shown in greater detail in  FIG. 10 .  
         [0059]     The portion of the wound closure device  101  proximal of the sheath  110  comprises a pair of generally parallel rails  102 ,  103  upon which ride slides  123 ,  124 ,  133  and  134  that regulate movement of various components discussed in further detail below. A grip  104 , having an exterior surface and an interior channel, provides a rest for an operator&#39;s hand or digits along the exterior surface thereof, and provides a transition piece in which the various components passing therethrough the interior of said grip  104  are appropriately connected to extend proximal to distal and are regulated by the slides  123 ,  124 ,  133  and  134   
         [0060]     Referring to  FIGS. 9 and 10 , the sheath  110  further comprises a first vessel penetrating member  120  having a needle  121  and a suture  122  extending therethrough, similar to the earlier described embodiments herein. The sheath  110  further comprises a second vessel penetrating member  130  having a needle  131  and a snare  132  extending therethrough, also similar to the earlier described embodiments herein. The distal end of the vessel wound closure device  101  further comprises a stabilizer foot  150  that is flush with the exterior surface of the sheath  110  when retracted, but that projects laterally out from the exterior surface of the  110  when deployed. Although shown as a generally solid component in  FIGS. 9 and 10 , the stabilizer foot  150  may also be configured as a non-solid component, such as a spiral or other web, mesh or wire configuration, or combinations thereof, as the artisan should readily appreciate, provided such stabilizer foot  150  is retractable and deployable as described herein and comprised of biocompatible materials known or later developed in the art that are suitable for use within the vasculature of a patient. A foot actuating lever  151  provided in the grip  104  regulates movement of the stabilizer foot  150  in conventional manner via a cable or other linkage system.  
         [0061]     A first vessel penetrating member slide  123  is connected to a proximal portion of the first vessel penetrating member  120  and regulates movement thereof. A suture slide  124  is connected to a proximal end of the suture  122  and regulates movement thereof. A distal end of the introducer  110  also includes a first exit port  125 , through which the first vessel penetrating member  120  and suture  122  are manipulated. A suture storage unit  126  may be provided at a proximal end of the vessel wound closure device  101 , if desired, in order to spool suture material therefrom as needed in practice.  
         [0062]     A second vessel penetrating member slide  133  is connected to a proximal portion of the second vessel penetrating member  130  and regulates movement thereof. A snare slide  134  is connected to a proximal end of the snare  132  and regulates movement thereof. A distal end of the sheath  110  also includes a second exit port  135 , through which the second vessel penetrating member  130  and snare  132  are manipulated.  
         [0063]     For those instances when the vessel wound closure device  101  is inserted over a guidewire, and not within a preexisting introducer from a preceding procedure, then positioning of the device  101  appropriately within the vessel may be achieved by the identification of blood flashback. Accordingly, a flashback port  160  is provided on the grip  104 , for example. Of course, the flashback port  160  could instead be located elsewhere along the introducer in the artisan&#39;s discretion.  
         [0064]     In practice, the vessel wound closure device  101  is inserted into a vessel through a preexisting introducer from a preceding procedure, or over a guidewire extending into a vessel after removal of the preexisting introducer. In the former case, positioning of the vessel wound closure device  101  within the vessel is determined in conventional manner relying on the dimensions, position or markings of the preexisting introducer, whereas in the latter case, flashback of blood from the vessel through the flashback port  160  determines when the vessel wound closure device  101  is appropriately positioned within the vessel.  
         [0065]     Once the distal end of the sheath  110  of the vessel wound closure device  101  is appropriately positioned within the vessel, then remaining procedures are generally as follows regardless of whether the device  101  is inserted through a preexisting introducer or over a guidewire, unless otherwise indicated herein. First, the stabilizer foot activation lever  160  is activated to deploy the stabilizer foot  150  within the vessel. Then, the entire vessel wound closure device  101  is retracted until the stabilizer foot  150  abuts the interior wall of the vessel.  
         [0066]     The second vessel penetrating member slide  133  is then pushed distally to deploy the second vessel penetrating member  130 . The snare slide  134  moves in unison with the second vessel penetrating member slide  133  at this point. Once the second vessel penetrating member  130  is deployed, the second vessel penetrating member slide  133  is locked and the snare slide  134  is slid independently further distally until the snare  132  is deployed beyond the needle  131  and within the vessel.  
         [0067]     Next, the first vessel penetrating member slide  123  is pushed distally to deploy the first vessel penetrating member  120 . The suture slide  124  moves in unison with the first vessel penetrating member slide  123  at this point. Once the first vessel penetrating member  120  is deployed within the vessel, then the first vessel penetrating member  123  is locked and the suture slide  124  is slid independently further distally until the suture  122  is deployed beyond the needle  121  and within the vessel.  
         [0068]     As in earlier embodiments, the snare  132  is deployed downstream of the suture  122  to enhance the capture of the suture by the snare. The suture  122  may further comprise knots or other projections, as in earlier described embodiments, also to enhance capture thereof by the snare. Capture of the suture  122  by the snare  132  is identified by resistance felt by an operator as the snare slide  134  is slid proximally to retract the snare  132 , ideally with the suture  122  captured thereby. Should resistance not be experienced by the operator, then the snare slide  133  is moved distally again to redeploy the snare  132  as before. This process repeats itself until the suture  122  is successfully captured by the snare  132 .  
         [0069]     Once the suture  122  is captured by the snare  132 , then the snare  132  is retracted by proximally sliding of the snare slide  134 , and the second vessel penetrating member  130  is retracted by proximally sliding of the slide  133 . The first vessel penetrating member  120  is also retracted by proximally sliding of the slide  123 . The stabilizer foot  150  is de-activated and returned to its non-deployed state flush with the exterior surface of the sheath  110  by the stabilizer foot lever  151 . The entire vessel wound closure device  101  is then removed from the vessel through the incision tract, and loose ends of the of suture are knotted as in earlier described embodiments to form a stitch across the puncture site.  
         [0070]      FIG. 11  illustrates the looped end of a snare  32  or  132 . The looped end of the snare  32  or  132  is shown in  FIG. 11  as further comprising a mesh basket  35 . Where used, the mesh basket  35  enables the capture of more suture  22  or  122  therein, whereafter the captured suture is withdrawn to create the stitch across the puncture wound as described in the various embodiments herein.  
         [0071]     Of course, although the various embodiments described herein are directed to creating a single stitch across a vessel wound by deployment of a suture and snare from a first vessel penetrating and a second vessel penetrating member, various other embodiments could comprise creating more than a single stitch across the vessel wound. Such embodiments may comprise additional vessel penetrating members, sutures and snares, for example, that are otherwise deployable as described herein.  
         [0072]     The various exemplary embodiments of the invention as described hereinabove do not limit different embodiments of the systems and methods of the invention. The material described herein is not limited to the materials, designs or shapes referenced herein for illustrative purposes only, and may comprise various other materials, designs or shapes suitable for the systems and methods described herein, as should be appreciated by the artisan.  
         [0073]     While there has been shown and described what is considered to be preferred embodiments of the invention, it will, of course, be understood that various modifications and changes in form or detail could readily be made without departing from the spirit or scope of the invention. It is therefore intended that the invention be not limited to the exact forms described and illustrated herein, but should be construed to cover all modifications that may fall within the scope of the appended claims.