Abstract:
A device for closing an opening in a tissue includes a closure body, a fastening element, and a capture strip coupleable to the closure body such that the capture strip is moveable from a first position to a second position relative to the closure body, the capture strip including a receptacle configured to receive the fastening element when the capture strip is in the first position such that movement of the capture strip from the first position to the second position causes the fastening element to urge the closure body toward the tissue.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/428,841, filed on Dec. 30, 2010, which is hereby incorporated in its entirety by reference thereto. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to closure systems and methods for use in surgical procedures. 
       BACKGROUND 
       [0003]    Minimally invasive procedures are continually increasing in number and variation in part because such techniques offer an immediate advantage over more traditional, yet highly invasive surgeries. Endoscopic surgery, for example, uses one or more scopes inserted through small incisions for diagnosing and treating disease. In particular, endovascular surgery gives access to many regions of the body, such as the heart, through major blood vessels. Typically, the technique involves introducing a surgical instrument percutaneously into a blood vessel, such as, for example, the femoral artery. The currently emerging percutaneous endovascular procedures include aortic valve replacement, mitral valve repair, abdominal and thoracic aneurysm repair and tricuspid valve replacement. Other procedures requiring access to the femoral artery include coronary, carotid and cerebral angiographic procedures. 
         [0004]    A key feature of these minimally invasive surgical procedures is the forming of a temporary pathway, usually an incision, to the surgical site. For example, in the emerging percutaneous endovascular procedures, an access site (e.g. incision) ranging from approximately 10 to 30 French units is formed as a temporary pathway to access the surgical site. Various instruments, such as procedural sheaths, guidewires and catheters, are then inserted through the access site, as well as specialized medical instruments, such as, balloon catheters and stents. 
         [0005]    Currently, incision or access sites are routinely closed via cut-down surgical repair. This method is very invasive and fraught with complications. Accordingly, the rapid development of percutaneous endovascular surgery, of which interventional radiology and cardiology are a major component, has led to the need for instrumentation to minimize the risk of complications associated with closing the access site after a procedure. 
       SUMMARY 
       [0006]    In accordance with example embodiments of the present invention, a device for closing an opening in a tissue includes: a closure body; a fastening element; and a capture strip coupleable to the closure body such that the capture strip is moveable from a first position to a second position relative to the closure body, the capture strip including a receptacle configured to receive the fastening element when the capture strip is in the first position such that movement of the capture strip from the first position to the second position causes the fastening element to urge the closure body toward the tissue. 
         [0007]    The receptacle may include a through hole and/or a blind hole. 
         [0008]    The receptacle may include a release mechanism configured to release the fastening element from the capture strip. 
         [0009]    The release mechanism may include at least one of (a) a cut detail configured deform to release the fastening element, (b) a structurally weakened element configured to break to release the fastening element, and (c) one ore more arms configured to interact with or disengage an outer sleeve to release the fastening element. 
         [0010]    The release mechanism may be configured to release the fastening element when the capture strip is in the second position. 
         [0011]    The closure body may include one or more surfaces configured to form an interference fit with the fastening element in order to maintain a position of the fastening element after the fastening element is released from the capture. 
         [0012]    The capture strip may include two receptacles spaced apart from each other along the length of the capture strip. 
         [0013]    The capture strip may include at least one opening configured to maintain the capture strip in place relative to the closure body. 
         [0014]    The capture strip may be configured to allow protrusions of a delivery system to pass through the capture strip and hold the capture strip in place during delivery and deployment of the device. 
         [0015]    The capture strip may be the only capture strip included in the device, such that the device includes exactly one unitary capture strip. 
         [0016]    The capture strip may be integrally formed as a single monolithic piece. 
         [0017]    The device may include a plurality of fastening elements, the capture strip having a plurality of receptacles configured to respectively receive the plurality of fastening elements. 
         [0018]    The device may include a plurality of capture strips. 
         [0019]    The capture strip may be formed, in whole or in part, of a super-elastic metal. 
         [0020]    The capture strip may be formed, in whole or in part, of stainless steel. 
         [0021]    The capture strip may be formed, in whole or in part, of a polymeric material. 
         [0022]    The capture strip may be formed, in whole or in part, of a plastic material. 
         [0023]    The capture strip may include a recess configured to receive an actuator configured to move the capture strip from the first position to the second position. The recess may be disposed approximately at the longitudinal center of the capture strip or at any other suitable location. 
         [0024]    The recess may be configured to receive at least one of (a) a wire of the actuator, (b) a suture of the actuator, and (c) a rod of the actuator. 
         [0025]    The recess may be arch-shaped or of any other suitable geometry. 
         [0026]    The device may also include a looped element configured to engage and actuate the capture strip between the first position and the second position. The suture may be a braided suture or a monofilament suture. The metal wire may be a braided metal wire or a monofilament metal wire. 
         [0027]    The looped element may be formed, in whole or in part, of, for example, (a) a suture or a suture material, (b) polypropylene, or (c) a metal wire. 
         [0028]    The looped element may be formed, in whole or in part, of, for example, a metal wire, the metal wire being, for example, (a) a stainless steel wire or (b) a nitinol wire. 
         [0029]    The looped element may be configured to withdraw the capture strip from the closure body by pulling the capture strip from the second position to a third position in which the capture strip is detached from the closure body and disposed, for example, in a delivery shaft. 
         [0030]    The fastening element may be a suture assembly and the capture strip may be formed as a single piece and configured to capture the suture assembly after delivery of the suture assembly via a needle assembly. 
         [0031]    The closure body may include a central core including orifices configured to facilitate securement of the closure body to a delivery system. 
         [0032]    The orifices may be keyed holes configured to interface with, for example, shafts and tangs of the delivery system. 
         [0033]    The closure body may include a central core including openings configured to accommodate the capture strip. 
         [0034]    The openings may allow the capture strip to engage one or more fastening elements when the capture strip is in the first position. 
         [0035]    The closure body may include an occluder formed of polydioxanone and/or any other suitable material. 
         [0036]    The closure body may include an occluder formed of (a) polylacticglycolic acid, (b) a blend of polylacticglycolic acid and polyethylene glycol, (c) polycaprolactone, (d) a blend of polycaprolactone and polyethylene glycol, or (e) a bioabsorbable metal, e.g., magnesium. 
         [0037]    The device may further include a tubular needle having a distal penetrating tip and being configured to deliver the fastening element into engagement with the receptacle of the capture strip. 
         [0038]    The tubular needle may be configured to engage with a suture which extends axially from the distal tip. 
         [0039]    The tubular needle may include a lumen configured to hold a pusher rod. 
         [0040]    The fastening element may include a suture configured to engage with the needle via a shuttle. 
         [0041]    The tubular needle may include a lumen configured to hold a pusher rod such that forward movement of the pusher rod relative to the needle tube translates the movement to the shuttle and suture and ejects the suture from the needle tube. 
         [0042]    The fastening element may be a suture assembly including: a suture; a bolster attached to a proximal end of the suture; and a shuttle attached to a distal end of the suture. 
         [0043]    The shuttle may be conical. 
         [0044]    The shuttle may be cylindrical. 
         [0045]    The shuttle may be co-axial to the suture. 
         [0046]    Some or all of the suture assembly may be bioabsorbable. 
         [0047]    The closure body may include a central core sized to be smaller in diameter than a diameter of the opening in the tissue. For example, the central core may be sized to be smaller than the diameter of the opening in the tissue when defined by the outer diameter of an introducer tube of the surgical system. 
         [0048]    The central core may include a pair of support receptacles configured to receive respective support prongs of a delivery device in order to support the central core from the delivery device. 
         [0049]    Each of the support receptacles may be configured as a hole, recess, or any other suitable structure. 
         [0050]    At least one of the support receptacles may be configured as a blind hole. 
         [0051]    At least one of the support receptacles may be configured as a through hole. 
         [0052]    The core may have an elongated shape. 
         [0053]    The longitudinal axis of the core may be coplanar to the longitudinal axis of the capture strip when the capture strip is in the first position and when the capture strip is in the second position. 
         [0054]    The core may have an upper surface shaped to correspond to the interior surface geometry of a tubular vessel, e.g., a blood vessel such as an artery or a vein. 
         [0055]    The core may be configured such that mating of the upper surface to the interior surface geometry of the tubular vessel results in the longitudinal axis of the core being coplanar with the longitudinal axis of the tubular vessel. 
         [0056]    The core may include a longitudinally extending orifice configured to receive the capture strip. 
         [0057]    The core may include a pair of lateral orifices extending transversely to the longitudinal axis of the core and disposed at opposite end regions of the core, the lateral orifices being configured to receive respective fastening elements therethrough. 
         [0058]    The core may be configured such that movement of the capture strip from the first position to the second position causes the engaged fastening element to be drawn into the longitudinally extending orifice. 
         [0059]    The closure body may further include a flexible wing supported by the core. 
         [0060]    The flexible wing may be formed, in whole or in part, of a bioabsorbable material. 
         [0061]    In accordance with example embodiments of the present invention, a device for closing an opening in a vessel includes: a wing element configured to form a seal with tissue surrounding the opening; and a central core configured to support the wing element against an interior surface of the vessel when the wing element forms the seal, wherein the central core includes a plurality of retaining recesses configured to releasably receive a corresponding plurality of retaining projections of a delivery device to allow the core to be detached from the delivery device after an implantation of the device to seal the opening. 
         [0062]    In accordance with example embodiments of the present invention, a surgical occluder for sealing an opening in a blood vessel includes: a disk-shaped wing formed of polydioxanone and having a flexibility sufficient to allow conformance of the wing to an interior surface of the blood vessel adjacent the opening, the wing having an aperture for mounting the wing to a support core. 
         [0063]    In accordance with example embodiments of the present invention, a method for sealing an opening in a tissue includes: inserting a fastening element through the tissue such that a distal portion of the fastening element is received by a receptacle of a distal sealing element and a proximal portion of the fastening element remains secured on the proximal side of the tissue; and moving the receptacle between a first position and a second position in order to draw the distal portion of the fastening element toward the proximal portion of the fastening element, thereby urging the sealing assembly proximally toward the tissue. 
         [0064]    Example embodiments of the present invention provide a minimally invasive surgical closure system. In some embodiments, a provided closure system includes a method and apparatus for deployment of the closure system. Details of the closure system, and uses thereof, are described herein, infra. 
         [0065]    Further features and aspects of example embodiments of the present invention are described in more detail below with reference to the appended Figures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0066]    Certain features of a provided closure system are described in detailed herein below with reference to the figures, wherein: 
           [0067]      FIG. 1  is a cross-sectional perspective view of an artery having an arterial closure device positioned on a closed arteriotomy, in accordance with embodiments of the present invention; 
           [0068]      FIG. 2  is a cross-sectional perspective view of the artery and arterial closure device depicted in  FIG. 1 ; 
           [0069]      FIG. 3  illustrates a tapered suture assembly having a distal needle tip and a proximal bolster, in accordance with embodiments of the present invention; 
           [0070]      FIG. 4  shows an alternative view of the suture assembly depicted in  FIG. 3 ; 
           [0071]      FIG. 5  illustrates views of a bolster component, profiled to match the curvature of an arterial surface, in accordance with embodiments of the present invention; 
           [0072]      FIG. 6  is a cross-sectional side view of the artery and arterial closure device shown in  FIGS. 1 and 2 ; 
           [0073]      FIG. 7  is an end view of the artery and arterial closure device shown in  FIGS. 1 ,  2 , and  6 ; 
           [0074]      FIG. 8  is a cross-sectional side view illustrating an arterial closure device positioned on a closed arteriotomy, in accordance with embodiments of the present invention; 
           [0075]      FIG. 9  is an isometric view of an intra-arterial foot and wing, in accordance with embodiments of the present invention; 
           [0076]      FIG. 10  is an end view of the intra-arterial foot and wing shown in  FIG. 9 ; 
           [0077]      FIG. 11  is an isometric view of a central core component of the intra-arterial foot shown in  FIGS. 9 and 10 ; 
           [0078]      FIG. 12  is an isometric view of a flexible wing component of the intra-arterial foot shown in  FIGS. 9 and 10 ; 
           [0079]      FIG. 13  is an isometric end view of the intra-arterial foot of  FIGS. 9 and 10  positioned within a delivery sheath; 
           [0080]      FIG. 14  is an isometric side view of the intra-arterial foot of  FIGS. 9 and 10  positioned within a sectioned delivery sheath; 
           [0081]      FIG. 15  is an isometric side view of the intra-arterial foot of  FIGS. 9-14  illustrating the flexible wing component folded within a delivery sheath; 
           [0082]      FIG. 16  is an isometric side view of the intra-arterial foot of  FIGS. 9-14  illustrating the flexible wing component deployed when the intra-arterial foot is advanced through the delivery sheath into the artery; 
           [0083]      FIG. 17  is an isometric view of the flexible wing component illustrating a central opening, in accordance with various embodiments of the present invention; 
           [0084]      FIG. 18  is an isometric view of a profiled flexible wing component having a plurality of openings for facilitating alignment of the central core component of  FIG. 11 , in accordance with other embodiments of the present invention; 
           [0085]      FIG. 19  illustrates a plan view of one embodiment of the flexible wing component of  FIG. 12 , having patterned holes and a non-porous mid-section; 
           [0086]      FIG. 20  illustrates a plan view of another embodiment of the flexible wing component of  FIG. 12 , having patterned slots and a non-porous mid-section; 
           [0087]      FIG. 21  illustrates a plan view of another embodiment of the flexible wing component of  FIG. 12 , having parallel slots and a non-porous mid-section; 
           [0088]      FIG. 22  illustrates a plan view of yet another embodiment of the flexible wing component of  FIG. 12 , having parallel slots and non-porous mid-section; 
           [0089]      FIG. 23  illustrates a plan view of yet another embodiment of the flexible wing component of  FIG. 12 , having profiled patterned holes and non-porous mid-section; 
           [0090]      FIG. 24  illustrates a plan view of yet another embodiment of the flexible wing component of  FIG. 12 , having profiled slots and non-porous mid-section; 
           [0091]      FIG. 25  illustrates a plan view of yet another embodiment of the flexible wing component of  FIG. 12 , having patterned holes and non-porous border around the edges; 
           [0092]      FIG. 26  illustrates a plan view of another embodiment of the flexible wing component of  FIG. 12 , having patterned holes and solid non-porous mid-section; 
           [0093]      FIG. 27  is a plan view of an embodiment of the central core component of  FIG. 11 ; 
           [0094]      FIG. 28  is an end view of the central core component of  FIGS. 11 and 27 ; 
           [0095]      FIG. 29  is an elevated cross-sectional view of the intra-arterial foot, illustrating the dimensions of the intra-arterial foot relative to an arteriotomy, in accordance with embodiments of the present invention; 
           [0096]      FIG. 30  is an isometric view of another embodiment of an intra-arterial foot illustrating the central core portion with a uniform thickness; 
           [0097]      FIG. 31  is an end view of the intra-arterial foot of  FIG. 30 ; 
           [0098]      FIG. 32  is a side view of another embodiment of an intra-arterial foot illustrating the central core portion having a circular profile with uniform thickness; 
           [0099]      FIG. 33  is an end view of the intra-arterial foot of  FIG. 32 ; 
           [0100]      FIG. 34  is an end view of yet another embodiment of an intra-arterial foot illustrating the central core portion having a circular profile with varying thickness; 
           [0101]      FIG. 35  is a bottom view of the intra-arterial foot of  FIG. 34 ; 
           [0102]      FIG. 36  is an end view of yet another embodiment of an intra-arterial foot illustrating the central core portion having a circular profile with varying thickness and hollowed sections; 
           [0103]      FIG. 37  is a bottom view of the intra-arterial foot of  FIG. 36 ; 
           [0104]      FIG. 38  is an end view of yet another embodiment of an intra-arterial foot illustrating the central core portion having a circular profile and varying thickness; 
           [0105]      FIG. 39  is a bottom view of the intra-arterial foot of  FIG. 38 ; 
           [0106]      FIG. 40  illustrates an isometric view of another embodiment of the intra-arterial foot, in accordance with embodiments of the present invention; 
           [0107]      FIG. 41  is an end view of the intra-arterial foot of  FIG. 40 ; 
           [0108]      FIG. 42  illustrates an isometric view of another embodiment of the intra-arterial foot, in accordance with embodiments of the present invention; 
           [0109]      FIG. 43  is an end view of the intra-arterial foot of  FIG. 42 ; 
           [0110]      FIG. 44  is illustrates an isometric view of yet another embodiment of the intra-arterial foot, in accordance with embodiments of the present invention; 
           [0111]      FIG. 45  is an end view of the intra-arterial foot of  FIG. 44 ; 
           [0112]      FIG. 46  is illustrates an isometric view of yet another embodiment of the intra-arterial foot, in accordance with embodiments of the present invention; 
           [0113]      FIG. 47  is an end view of the intra-arterial foot of  FIG. 46 ; 
           [0114]      FIG. 48  illustrates an isometric view of another embodiment of the intra-arterial foot, in accordance with embodiments of the present invention; 
           [0115]      FIG. 49  is an end view of the intra-arterial foot of  FIG. 48 ; 
           [0116]      FIG. 50  illustrates top, front, side and isometric views of a needle, in accordance with embodiments of the present invention; 
           [0117]      FIG. 51  illustrates side, front, top and isometric views of a needle, in accordance with embodiments of the present invention; 
           [0118]      FIG. 52  illustrates side, front, top and isometric views of a needle, in accordance with embodiments of the present invention; 
           [0119]      FIG. 53  illustrates top, front, side and isometric views of a needle having a cylindrical profile, in accordance with embodiments of the present invention; 
           [0120]      FIG. 54  illustrates top, front, side and isometric views of a needle having an elliptical profile, in accordance with embodiments of the present invention; 
           [0121]      FIG. 55  illustrates side, front, top and isometric views of a needle, in accordance with embodiments of the present invention; 
           [0122]      FIG. 56  illustrates side, front, top and isometric views of a needle, in accordance with embodiments of the present invention; 
           [0123]      FIG. 57  illustrates an isometric view of a wound spreader and an intra-arterial foot attached to the distal end of a delivery device, in accordance with embodiments of the present invention; 
           [0124]      FIG. 58  is a side view of the delivery device of  FIG. 57  positioned within a delivery sheath and having the distal end advanced into the lumen of an artery, in accordance with embodiments of the present invention; 
           [0125]      FIG. 59  is a side view of the delivery device of  FIGS. 57 and 58  illustrating the wound spreader in a retracted position, engaging the wound edges of an arteriotomy; 
           [0126]      FIG. 60  illustrates a perspective view of a wound spreader according to embodiments of the present invention; 
           [0127]      FIG. 61  illustrates a perspective view of the wound spreader of  FIG. 60  from below the spreader; 
           [0128]      FIG. 62  illustrates a bottom view of the wound spreader of  FIG. 60 ; 
           [0129]      FIG. 63  illustrates two isometric views of the distal end of a delivery device having first and second clips attached to the flexible wing of the intra-arterial foot of  FIGS. 9 and 10 ; 
           [0130]      FIG. 64  is an end view of a delivery sheath having spreader tangs for spreading the wound edges an arteriotomy; 
           [0131]      FIG. 65  illustrates an isometric view of the delivery device of  FIG. 64 ; 
           [0132]      FIG. 66  is an isometric side view of a closure device attached to a delivery device, in accordance with embodiments of the present invention, with the closure device shown in cross section; 
           [0133]      FIG. 67  is another isometric side view of the closure device and delivery device of  FIG. 66 ; 
           [0134]      FIG. 68  is an isometric side view of the delivery device of  FIGS. 66 and 67 , illustrating the needle drivers in an advanced position; 
           [0135]      FIG. 69  is an isometric side view of the delivery device of  FIGS. 66-68  illustrating the ejection and release of the needle tip/suture assembly, in accordance with embodiments of the present invention; 
           [0136]      FIG. 70  is an isometric bottom view of the intra-arterial foot of  FIGS. 8 and 9  with needles anchored to an underside portion of the intra-arterial foot; 
           [0137]      FIG. 71  is a cross-sectional view of the intra-arterial foot of  FIGS. 66-70  illustrating a capture ribbon in a retracted position; 
           [0138]      FIG. 72  is a partial cross-sectional view of a closure device positioned on an arteriotomy, in accordance with embodiments of the present invention; 
           [0139]      FIG. 73  is an isometric view of a needle driver, with a needle/suture subassembly attached thereto, advancing through an opening of a capture ribbon component, in accordance with embodiments of the present invention; 
           [0140]      FIG. 74  is an isometric view of the needle driver of  FIG. 73  advanced through the opening of the capture ribbon component; 
           [0141]      FIG. 75  is an isometric view of the needle/suture subassembly of  FIG. 73  deployed within the opening of the capture ribbon component; 
           [0142]      FIG. 76  is an isometric view of the needle of  FIG. 51 , having a suture attached thereto for forming a needle/suture subassembly, positioned on a distal end of a needle driver, in accordance with embodiments of the present invention; 
           [0143]      FIG. 77  is an isometric view of an ejector pin ejecting the needle/suture subassembly of  FIG. 76 ; 
           [0144]      FIG. 78  is an isometric view of the needle/suture subassembly of  FIG. 76 , in accordance with embodiments of the present invention; 
           [0145]      FIG. 79  is an isometric view of an ejector pin in position next to the needle/suture subassembly of  FIGS. 73 and 74 , in accordance with embodiments of the present invention; 
           [0146]      FIG. 80  is a cross-sectional view of the assembly illustrated by  FIG. 79 ; 
           [0147]      FIG. 81  is a cross-sectional view of the needle/suture subassembly of  FIGS. 79 and 80  ejected from the needle driver; 
           [0148]      FIG. 82  is an isometric view of the needle/suture subassembly of  FIG. 81 ; 
           [0149]      FIGS. 83 and 84  are enlarged views of  FIGS. 82 and 79 , respectively; 
           [0150]      FIGS. 85 and 86  are enlarged views of  FIGS. 81 and 80 , respectively; 
           [0151]      FIG. 87  illustrates a needle assembly in accordance with embodiments of the present invention. 
           [0152]      FIG. 88  illustrates the needle assembly of  FIG. 87  during actuation; 
           [0153]      FIG. 89  illustrates the needle assembly of  FIG. 87  after ejection of a suture; 
           [0154]      FIG. 90  illustrates a cross-sectional side view of the needle assembly of  FIG. 87 ; 
           [0155]      FIG. 91  illustrates a cross-sectional side view of the needle assembly of  FIG. 87  ejecting a suture; 
           [0156]      FIG. 92  illustrates an embodiment of a suture assembly in accordance with embodiments of the present invention; 
           [0157]      FIG. 93  illustrates a side view of the suture assembly of  FIG. 92 ; 
           [0158]      FIG. 94  illustrates the suture assembly of  FIG. 92  with an alternative shuttle in accordance with embodiments of the present invention; 
           [0159]      FIG. 95  illustrates the suture assembly of  FIG. 92  with yet another alternative shuttle in accordance with embodiments of the present invention; 
           [0160]      FIG. 96  depicts a perspective view of the central core of an intra-arterial foot in accordance with embodiments of the present invention; 
           [0161]      FIG. 97  shows a cross-sectional view of the central core depicted in  FIG. 96 ; 
           [0162]      FIG. 98  shows another cross-sectional view of the central core depicted in  FIG. 96 ; 
           [0163]      FIG. 99  illustrates a top view of the central core depicted in  FIG. 96 ; 
           [0164]      FIG. 100  illustrates a bottom perspective view of the central core depicted in  FIG. 96 ; 
           [0165]      FIG. 101  provides a view of  FIG. 100  from the opposite end of the central core; 
           [0166]      FIG. 102  shows a bottom the central core of  FIG. 96 ; 
           [0167]      FIG. 103  shows a side view of the central core of  FIG. 96 ; 
           [0168]      FIGS. 104 and 105  illustrate end views the central core of  FIG. 96 ; 
           [0169]      FIG. 106  illustrates a central core prior to insertion of a ribbon wire engageable with a ribbon in accordance with embodiments of the present invention; 
           [0170]      FIG. 107  illustrates the central core of  FIG. 106  after insertion of the ribbon wire; 
           [0171]      FIG. 108  illustrates the central core of  FIG. 106  after the ribbon wire engages the ribbon inserted into the central core; 
           [0172]      FIG. 109  illustrates the central core of  FIG. 106  prior to insertion of an anchor assembly; 
           [0173]      FIG. 110  shows a cross-sectional view of  FIG. 109 ; 
           [0174]      FIG. 111  illustrates a cross-sectional view of the central core shown in  FIG. 106  with the ribbon inserted into the core and with the ribbon wire and anchor engaging the ribbon wire; 
           [0175]      FIG. 112  illustrates a cross-sectional view of the central core shown in  FIG. 106  during removal of a ribbon from the central core via the ribbon wire; 
           [0176]      FIG. 113  illustrates a cross-sectional view of the central core shown in  FIG. 106  after the ribbon has been removed from the core via the ribbon wire; 
           [0177]      FIGS. 114-117  are perspective views of various embodiments of the capture and release ribbon component, in accordance with various embodiments of the present disclosure; 
           [0178]      FIG. 118  is a perspective view of a capture and release ribbon component, in accordance with embodiments of the present invention; and 
           [0179]      FIG. 119  is a cross-sectional view of the capture and release ribbon component of  FIGS. 114-117  positioned within a sleeve, in accordance with embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
     1. General Description of Certain Embodiments of the Invention 
       [0180]    As described herein, the present invention provides a surgical closure system (also referred to herein as a “device”). As such, a provided device is useful for closing a perforation (i.e., a hole, puncture, tear, rip, or cut, etc.) in any hollow vessel associated with a mammalian surgical procedure. One of ordinary skill in the art will appreciate that provided device is useful for closing a perforation in any lumen of a mammal, including the gastrointestinal tract (e.g., the stomach, intestines, colon, etc.), heart, peritoneal cavity, esophagus, vagina, trachea, bronchi, or a blood vessel. 
         [0181]    Although certain figures and embodiments relate to use of a provided device for closure of a perforation associated with vascular surgery, one of ordinary skill in the art will appreciate that components of a provided device are not size dependent (i.e., are scalable) and are therefore useful for closure of any perforation in a lumen of a mammal. 
         [0182]    In some embodiments, the present invention is directed to a closure system and method of percutaneous closure of an arteriotomy following an endovascular/intra-arterial procedures. 
         [0183]    One of ordinary skill in the art will recognize that many mammalian lumina are comprised of one or more friable tissues. Thus, a common difficulty associated with surgical closure of a perforation in such lumina is that suture material typically causes tears in the friable tissue. Such tearing of the luminal tissue impedes healing and causes scarring. Indeed, such tearing of the friable tissues of the internal lumina of blood vessels can lead to scarring, dislodgment of tissue particles, blockage, or even eventual death of the patient. In view of the fragile nature of luminal tissues, an aspect of the present invention is to provide a device that affords dispersal of tension in suture material across the surface of a luminal tissue thereby allowing for closure of a perforation with minimum damage to the tissue. 
         [0184]    With regards to the arterial wall morphology, the fibrous adventitial layer of an artery (i.e., the outer layer) is relatively tough, whilst the intimal and endothelial layers are friable. Because of the morphology of the arterial wall, an arteriotomy will normally be circumferential in nature and perpendicular to the longitudinal axis of the artery. In accordance with the present disclosure, a provided intra-arterial foot prevents trauma and/or damage to the friable inner layer of the arterial wall by minimizing the amount of direct contact the sutures have with the inner layer. In addition, the intra-arterial foot distributes the tension in the sutures across the luminal surface. This closure configuration, i.e. controlling the alignment of the wound edges, and the absence of any transluminal impediments, ensures that the wound will heal expeditiously with minimal granulation tissue or scaring. 
         [0185]    In certain embodiments, the present invention provides a closure system and method of percutaneous closure of arteriotomies following endovascular/intra-arterial procedures. In some embodiments, a closure device includes an intra-arterial foot positioned against a luminal surface of an arteriotomy; at least one suture positioned within the intra-arterial foot for securing the intra-arterial foot into position, the at least one suture having a proximal end and a distal end; at least one extra-arterial bolster attached to the proximal end of the at least one suture, the at least one extra-arterial bolster secured on an adventitial surface of the arteriotomy; and at least one needle attached to the distal end of the at least one suture, the at least one needle anchored on a posterior portion of the intra-arterial foot such that a tensile force is applied to the suture, the suture securing the intra-arterial foot into position. In some embodiments, the suture is doubled up within the intra-arterial foot. The at least one needle delivers the at least one suture through an arterial wall to a posterior side of the intra-arterial foot. In some embodiments, the intra-arterial foot, the suture, the bolster and the needle are all bio-absorbable. 
         [0186]    In some embodiments, a closure device includes: a foot positionable against a luminal surface of an arteriotomy, the foot having an internal channel; a suture positionable within the foot for securing the foot against the luminal surface; and a bolster attached to a proximal end of the suture, the bolster positionable on an adventitial surface of the arteriotomy, the suture is fitted within the internal channel by a tensile force applied to the suture. In certain embodiments, a provided device further includes a needle on a distal end of the suture. The needle guides the suture through the internal channel and to the posterior side of the foot. Moreover, the bolster tethers the foot against the luminal surface in response to the tensile force. Either some or all of the components of this embodiment of the closure device, namely the foot, the suture and the bolster, is biodegradable. 
         [0187]    As described in detail herein below, the closure system of the present disclosure includes two principal subassemblies, namely, a delivery device and a closure device. The delivery device is introduced via a delivery sheath that is already in situ after a given procedure. The delivery device delivers and positions the closure device in the arteriotomy, closing the arteriotomy. The closure device includes an intra-arterial foot component, tethering sutures, needle tips and extra-arterial bolsters. In accordance with the present disclosure, in the final closure dynamic of the closure device, the intra-arterial foot is positioned against a luminal surface juxtaposed to the arteriotomy of a vessel. The sutures reside within an interference fit (e.g. a channel) of the intra-arterial foot, and secure the intra-arterial foot into position (i.e. against the luminal surface of the vessel). The bolsters are positioned on the adventitial or external surface of the artery and the needle tips are positioned on the underside of the intra-arterial foot and, in some embodiments, oblique to the intra-arterial foot surface to provide an anchor for the sutures. 
         [0188]    The delivery device includes a foot anchor initially anchored to the intra-arterial foot during the delivery of the intra-arterial foot into the internal lumen of the artery, a wound spreader for spreading the wound edges of the arteriotomy and needle drivers to drive the needle/suture subassembly into a capture and release ribbon component. The capture and release ribbon components are adapted for tensioning the suture securely within the channel in the intra-arterial foot and for releasing the suture after the tensioning, in a manner described in detail herein below. 
         [0189]    In one embodiment, the wound spreader component is oriented transverse to the artery and is positioned adjacent to the foot anchor. In particular, the wound spreader includes an elliptical configuration, with the major axis corresponding to an outermost diameter of the intra-arterial foot. In addition the major axis of the elliptical configuration is at least the same as the circumference of the delivery sheath. During delivery of the intra-arterial foot, the wound spreader aids the spreading of the wound edges of the arteriotomy, guiding the arteriotomy to conform to its elliptical configuration. Thus, the wound spreader controls the geometry of the arteriotomy, helping minimize blood loss into the surrounding tissue. 
         [0190]    In some embodiments, a provided closure system comprises a foot portion, a wing portion, a suture, one or more bolsters, and a needle/shuttle, and various combinations thereof. In certain embodiments, a provided closure system further comprises a handle and deployment mechanism. Details of components associated with a provided closure system are set forth, infra, and, in certain embodiments, as depicted in the accompanying Figures. 
       2. Components of a Provided Device 
       [0191]    a. Foot 
         [0192]    As used herein the term “foot”, used alone or in combination, for example as “intra-arterial foot,” refers to a component of a provided closure system that can act as an anchor for securing other components of the system. For example, a provided foot can secure a suture and support a wing component (further described below). In certain embodiments, a provided intra-arterial foot supports wound edges and minimizing the amount of direct contact the sutures have with a luminal surface of an artery. In some embodiments, a provided intra-arterial foot distributes suture tension across a luminal surface of an arteriotomy. 
         [0193]    In some embodiments, a provided intra-arterial foot can be a tamponade for controlling bleeding during a delivery of the closure device. The arteriotomy includes a wound having at least two edges. The intra-arterial foot helps maintain the two wound edges in apposition via the suture assembly securing the foot in place with respect to the wound edges. The suture resides, and is substantially retained, within the intra-arterial foot and thus limits suture contact with the tissue in the proximity of the arteriotomy. 
         [0194]    In another embodiment, a provided foot includes a channel that locks the suture into place. Alternatively, an interference fit between the suture and the intra-arterial foot locks the suture into place. 
         [0195]    In some embodiments, a provided foot includes a first portion having at least one opening for facilitating delivery of a suture; and a flexible second portion associated with the first portion, where the first portion and the second portion create a tamponade effect on a wound (e.g., of an arteriotomy). The first portion is a central core component for providing structural integrity of the foot and the second portion is a flexible wing component. The suture tethers the first and the second component against a luminal surface of a vessel. 
         [0196]    In some embodiments, a first portion of the intra-arterial foot includes a diameter that is less than a diameter of the arteriotomy and a second portion includes a diameter that is greater than the diameter of the arteriotomy. In one embodiment, the first and the second portions include an absorbable porous material, where the absorbable porous material may include electrospun polyglycolic acid (PGA), polyglycolic/lactic acid (PGLA), Polyurethane (PUR) and polydioxanone (PDO). In other embodiments, the first and the second portions are radiopaque. 
         [0197]    In certain embodiments, the first and the second portions have a circular configuration. In other embodiments, the first and second portions are manufactured as a single component. In some embodiments where the first and the second portions have circular configurations, the first portion includes a uniform thickness and a flat profile. Alternatively, the first portion may include a circular profile and uniform thickness or varying thickness. In some specific embodiment, the first portion includes a circular profile and varying thickness having at least one hollowed out portion. 
         [0198]    In a second embodiment of the intra-arterial foot, the foot includes a central core having at least one opening for facilitating delivery of a suture, the central core having a diameter less than a diameter of an arteriotomy; and a flexible wing associated with the central core, the flexible wing positionable on a luminal surface of an arteriotomy and the flexible wing creating a tamponade. 
         [0199]    The step of deploying the flexible portion of the foot includes disposing the flexible portion from a substantially folded first position to a deployed second position. In one particular embodiment, the flexible portion of the foot is substantially larger than a diameter of the arteriotomy. 
         [0200]    In one embodiment of the present disclosure, the intra-arterial foot functions as a tamponade to control bleeding during the delivery of the closure system. In addition, the intra-arterial foot protects the friable intimal and endothelial layers of the artery from the sutures. In particular, the intra-arterial foot retains the suture substantially within itself, thus limiting suture contact with any tissue in the proximity of the arteriotomy. In accordance with the present disclosure, the intra-arterial foot maintains the alignment of the arteriotomy wound edges and acts as a scaffold to accurately hold (and align) the wound edges into apposition during and after tightening of the sutures. That is, the intra-arterial foot in concert with the suture assembly brings and maintains the two wound edges together in substantial alignment, as opposed to avert (i.e. turned out), invert (i.e. turned in) or overlap of the wound edges as the suture assemblies secure the foot in place. The apposition of the wound edges is advantageous to promote primary intent wound healing (i.e. healing by first intention). As is well known, primary intent healing is full thickness healing which results in minimal scaring or granuloma within the healing wound. However, in accordance with the present disclosure, direct apposition of the wound edges is not necessary for effective closure since apposition may not occur in all instances due to many factors including, for example, the disease state of the vessel. 
         [0201]    Intra-arterial foot houses the sutures once tensioned. In particular, the sutures are partially positioned within a slot of the intra-arterial foot in a folded manner such that each one is at least twofold within the intra-arterial foot. Moreover, the tensioned, folded suture occludes the slot of the intra-arterial foot thereby assisting in the prevention of blood loss through the slots. The distal end of each of the sutures is attached to a corresponding needle tip and the proximal end is attached to a corresponding bolster. As such, the needle tip acts as an anchor to allow tensioning of the bolsters. More in particular, the suture and bolster together securely tether the intra-arterial foot to the luminal surface of the artery. The bolster, in particular, distributes a tensile force applied to the suture laterally across the arterial surface and parallel to the wound edges of the arteriotomy, thus ensuring an evenly distributed force along each wound edge of the arteriotomy to effect a secure closure of the arteriotomy as and after the wound edges are brought into apposition at least in part by the force exerted through the bolster. Moreover, the intra-arterial foot distributes the resulting force of the suture tension on the luminal surface of the artery. The distal needle tip is adapted to deliver the suture through the arterial wall to the posterior side of the intra-arterial foot and to anchor the distal end of the suture to the intra-arterial foot. In particular, the distal end of the suture is attached to a central portion of the needle tip thus forming a “T” configuration. 
         [0202]    Thus, the closure system of the present disclosure provides an active and secure closure of wound edges of an arteriotomy. Healing of the arteriotomy is expedited because the wound edges are aligned and because the transluminal components are minimized and in some embodiments non-existent. Moreover, all friable tissues are shielded from any tension on the sutures. With regards to the sutures, the suture-based closure accommodates infinitely different anatomies. The closure system exploits arterial wall morphology and uses the adventitial layer for anchoring. In the final closure dynamics, all intra-arterial components are tethered to arterial wall. 
         [0203]    b. Wing 
         [0204]    In certain embodiments, a provided device includes a flexible wing component. In some embodiments, the wing is substantially circular. In certain embodiments, the wing is elliptical. In certain embodiments, the wing is positionable against a provided foot for use as a wound occluder. In such embodiments, the wing is positionable against a luminal surface and the foot is positionable against the internal surface of the wing. 
         [0205]    In one embodiment, the foot includes a flexible wing, the wing movable from a folded first position within a delivery device to a deployed second position within an artery. It will be appreciated that a flexible wing component can be integrally formed with a provided foot or can be a separate component used in conjunction with a provided foot. 
         [0206]    In some embodiments, the second portion of the intra-arterial foot forms a seal with a portion of an arteriotomy. In addition, the second portion is adapted for movement between a first position substantially folded about the first component and a second position that is at least partially deployed. Alternatively, the second portion is adapted for movement from a substantially folded first position to a deployed second position. In particular, the second portion is at least partially folded within a delivery sheath and at least partially open when the second portion is advanced through the delivery sheath. In one embodiment, the second portion is elliptical in shape, where the second portion is wider in the latitudinal or transverse direction relative to a longitudinal axis of the artery. In this particular embodiment, the minor diameter of the ellipse is larger than a diameter of the arteriotomy. 
         [0207]    In some embodiments, a provided wing includes a plurality of patterned holes or, alternatively, slots and a midsection. In other embodiments, a provided wing includes a plurality of latitudinal parallel slots and a non-porous midsection. In one particular embodiment, a provided wing includes a plurality of longitudinal parallel slots and a midsection. In another particular embodiment, a provided wing includes a plurality of profiled patterned openings and a non-porous midsection. In yet another embodiment, a provided wing includes a plurality of profiled slots and a non-porous midsection. Alternatively, a provided wing may include a plurality of patterned holes and a non-porous border about an edge thereof. A provided wing having a plurality of patterned holes and a solid non-porous midsection is also envisioned. 
         [0208]    c. Suture Bolster 
         [0209]    As used herein, the term “bolster” refers to a device component attached to a proximal end of a suture. The bolster ultimately is positioned at the outer surface of the vessel for closure. For example, in the case of an arteriotomy, a bolster is positionable at a fibrous adventitial layer of an artery (i.e., the outer layer). 
         [0210]    In certain embodiments, an extra-arterial bolster is tethered to an adventitial surface of an arterial wall. In addition, the at least one needle is tethered to the intra-arterial foot and the intra-arterial foot is tethered to the luminal surface of the arterial wall. 
         [0211]    In accordance with the present invention, a tensile force is applied to the suture, generating suture tension. In some embodiments, the suture tension effects active closure of the arteriotomy. In particular, the intra-arterial foot secures the suture in response to the tensile force. Moreover, the tension on the suture causes the extra-arterial bolster to securely tether the intra-arterial foot to the luminal surface layer of the artery. In one embodiment, the extra-arterial bolster distributes the suture tension laterally across the arterial surface and parallel to the at least two wound edges of the arteriotomy. In particular, the extra-arterial bolster evenly distributes the tensile force along each of the plurality of wound edges of the arteriotomy to effect a secure closure. In addition, the extra-arterial bolster distributes the suture tension on the adventitial surface of the artery with a resulting force aligning the at least two wound edges. In one particular embodiment, the suture tension on the adventitial surface of the artery results in a force bringing the at least two wound edges into direct apposition. The needle-tip acts as an anchor in response to the suture tension such that tension is applied between the at least one extra-arterial bolster and the intra-arterial foot. 
         [0212]    In one particular embodiment, the method includes effecting, by the tensile force, closure of an arteriotomy. The tensile force tethers the at least one suture. In addition, the foot, which may include distinct wing and core components, helps seal and reinforce the arteriotomy in response to the tensile force. 
         [0213]    d. Needle and Suture Shuttle 
         [0214]    The needle, suture, and shuttle may take on various configuration in various embodiments disclosed herein. Generally, the needle will reference the mechanism piercing and/or penetrating one or more of the vessel wall, the intra-arterial foot, and any ribbons disposed therein. The shuttle generally references the item attached to an end of the suture. In some embodiments, the tip of a needle may be the shuttle, and hence may be attached to the suture. In other embodiments the shuttle may be distinct from the needle and/or housed within, or on the needle and may be separated from the needle after penetrating the intra-arterial foot. 
         [0215]    In one particular embodiment, the suture includes a tapered section. In addition, the suture is, inter alia, either a single monofilament or a braided suture. The suture, tapered or not, and the needle form a “T” configuration. In particular, the needle is rotatable to and from a “T” configuration with the suture. More in particular, the needle rotates to form a “T” configuration with the suture when the needle is ejected from a driving member. 
         [0216]    The needle includes a body and a proximal spherical tip. The body includes an opening for receiving a portion of the suture therewithin. In one embodiment, the opening includes a conical shape having a first diameter smaller than a second diameter, the smaller diameter securing the suture. In another embodiment, the needle includes a shoulder and the body includes a raised portion tapering from the shoulder to a proximal end of the needle. In this particular embodiment, the raised portion is engageable with a slot within the driving member. Moreover, the raised portion is tapered to reduce the profile of the needle and the suture. 
         [0217]    In another embodiment, the needle includes a shoulder and a penetrating tip, where the shoulder is positionable on a distal portion of the driving member. In this embodiment, the suture shelters behind the shoulder. 
         [0218]    In yet another embodiment, the needle includes an elliptical profile. In this particular embodiment, the elliptical profile reduces a profile of the needle in a longitudinal axis. In addition, the elliptical profile increases a surface area of the needle for securing the needle to the posterior side of the intra-arterial foot. 
         [0219]    The needle includes a body having an opening for receiving a portion of a suture; and a conical distal end attached to the body. A portion of the body and the conical distal end is tapered flat. In some embodiments, the needle includes one of an elliptical profile and a cylindrical profile. Alternatively, the needle includes a flat edge. The conical end includes a shoulder, the shoulder resting in a distal portion of a driving member. The conical end may sometimes include a penetrating tip. In one particular embodiment, the conical end of the needle includes a shoulder and a penetrating tip, the shoulder resting on a distal portion of a driving member. In another embodiment, the conical end includes a raised portion tapering from the conical distal end to a proximal end of the body. 
         [0220]    The needle drivers are positioned parallel to the foot anchor and are advanced distally to drive the needle/suture subassembly through an opening of a capture and release ribbon component. The capture and release ribbon component captures the needle/suture subassembly and applies a tensile force to move and secure the suture into the channel of the intra-arterial foot. The “T” configuration of the needle/suture subassembly needle anchors the needle tip to the underside of the intra-arterial foot while the suture is secured within the channel. After the suture is secured within the channel, the ribbon component releases the suture and retracts into the delivery device. 
       3. Aspects of the Invention Embodied by the Figures 
       [0221]    Other aspects, features and advantages of the presently disclosed closure system and methods of percutaneous closure of arteriotomies following endovascular/intra-arterial procedures will become apparent from the following detailed description taken in conjunction with the accompanying drawing, which illustrate, by way of example, the presently disclosed system and method. 
         [0222]    Referring now to the drawing figures, wherein like references numerals identify similar, identical or corresponding elements, an embodiment of the presently disclosed closure system is described. The closure system, in accordance with the present disclosure, provides for a minimally invasive, percutaneous mechanical closure of arteriotomies, while substantially reducing the length of time needed to perform the closure. 
         [0223]      FIGS. 1 and 2  illustrate an exemplary closure device  100  in the final closure position with respect to an arteriotomy  202  of a sectioned artery  200 . Closure device  100  includes an intra-arterial foot component  102 , tethering sutures  104 , extra-arterial bolsters  106  and needle tips  108 . Closure device  100  is adapted for active and secure closure of wound edges of an arteriotomy  202 , in a manner described in detail herein below. 
         [0224]    In some embodiments, the intra-arterial foot is a single-piece foot, as depicted by foot  102 . Foot  102  is tethered into position by two independent sutures  104 , two extra-arterial bolsters  106 , and two needle tips  108 . In particular, each suture  104  includes an extra-arterial bolster  106  attached to its proximal end and a needle tip  108  attached to its distal end. During the delivery of closure device  100 , the needle tips  108  are inserted through an arterial wall  204  such that sutures  104  penetrate the wall and pass through to the posterior side of the single-piece intra-arterial foot  102 . Additionally, needle tips  108  anchor the distal end of sutures  104  to an underside of intra-arterial foot  102 , in a manner described in detail herein below. As illustrated by the figures, when the sutures are situated in their final position according to some embodiments of the present invention the two sutures are oriented in a mirrored configuration. 
         [0225]      FIGS. 3 and 4  illustrate a suture  104  having a needle tip  108  on a distal end of suture  104  and a bolster  106  on the proximal end of suture  104 . Needle tip  108  and bolster  106  are attached to suture  104  using techniques well known in the art, such as, for example, bonding, using a glue/adhesive, heat staking, tying off the suture behind the particular component, over-molding, or a combination of these processes. Suture  104  is continuous between bolster  106  and needle tip  108 . In accordance with embodiments of the present invention, bolster  106  secures the suture to the arterial wall  204  and needle  108  secures the suture to the intra-arterial foot  102 , thus securing intra-arterial foot  102  to luminal surface of the arteriotomy site. In particular, applying tension to the suture  104  brings the wound edges  203   a  and  203   b  into alignment and tethers the intra-arterial foot  102  to the lumen  206  of artery  200  to effect closure of arteriotomy  202 . 
         [0226]    In some embodiments, suture  104  includes a regular section  105   a , a tapered section  105   b  and an enlarged section  105   c . Section  105   b  is tapered to increase the interference fit within the intra-arterial foot  102 , in a manner described in detail herein below. In some embodiments, suture  104  includes a single monofilament and tapered section  105   b  may be achieved by means of a bump-extrusion, coating or sleeve. In other embodiments, suture  104  is a braided suture, where tapered section  105   b  is attained by reducing the strands in the braid or by braiding over a tapered mandrel. One method of anchoring the tensioned sutures within the intra-arterial foot  102  is by forming a channel  111  and by using an interference fit between the suture and cavities (e.g. channel  111 ) within the intra-arterial foot  102  ( FIGS. 9-11 ). The compression of the interference fit can be increased by means of a tapered suture, as illustrated by  FIG. 3 . As discussed herein, some embodiments of the present invention incorporate a suture having a uniform thickness. 
         [0227]    Suture  104  provides flexibility with respect to differing arterial wall thickness and other variations in anatomy. Additionally, suture  104  infers variability of tensioned length, that is, suture  104  provides flexibility to all sizes of artery  200 . By contrast, a purely mechanical application of intra-arterial foot  102  would fit some arteries, but may be excessively loose or tight on other arteries. Moreover, as suture  104  is continuous, it does not require tying or cutting thus eliminating an extra process step. Also, the continuous suture  104  securely anchors the intra-arterial foot  102  to the luminal or internal surface  206  of arteriotomy  202  in a fail-safe manner. 
         [0228]    With reference to  FIG. 5 , in conjunction with  FIGS. 3 and 4 , bolster  106  is attached to a proximal end of suture  104 . The function of bolster  106  is to securely tether intra-arterial foot  102  to the luminal layer  206  of artery  200 . In some embodiments of the present invention, bolster  106  is designed to distribute a tensile force applied on suture  104  over a large surface area and parallel to the wound edges  203   a  and  203   b  of the arteriotomy  202 . Distributing the pressure resulting from the tension applied to the suture ensures that the adventitial or external surface  208  of artery  200  is not damaged. Furthermore, the tension in the suture actively and securely brings the wound edges  203   a  and  203   b  into alignment with the intra-arterial foot to ensure proper alignment of the opposing edges without requiring insertion of any foreign material between the wound edges. As illustrated by the figure, bolster  106  includes an opening  107  for receiving the proximal portion of suture  104  and a profiled, arched section  109  for engaging the exterior surface  208  of artery  200 . 
         [0229]    With reference to  FIGS. 6 and 7 , in conjunction with  FIGS. 1 and 2 , during closure of arteriotomy  202 , needle tip  108  drives suture  104  through a channel  111  within intra-arterial foot  102 , in a manner described in detailed herein below with reference to  FIGS. 64 and 65 . Extra-arterial bolsters  106  are positioned on the adventitial surface  208  of artery  200  by applying a tensile force on suture  104 , which pulls suture  104  into channel  111  of intra-arterial foot  102  and secures the intra-arterial foot to lumen  206 . As illustrated by the figures, suture  104  is doubled up within the channel  111 . As such, when tension is applied to the suture  104  to position extra-arterial bolster  106  in place, this tensing movement brings wound edges  203   a  and  203   b  into alignment and maintains the alignment as channel  111  in intra-arterial foot  102  locks sutures  104  into place. 
         [0230]    With particular reference to  FIG. 6 , as bolster  106  makes contact with the adventitial surface  208  of the artery  200  and tension is constantly applied to both sutures  104  they actively pull the edges  203   a  and  203   b  of arteriotomy  202  into alignment (depicted by the directional arrows), with the intra-arterial foot  102  providing a scaffold to ensure accurate alignment of the wound edges. This securely closes the arteriotomy and provides the optimal closure for primary intent healing of the arteriotomy. It is noted that  FIG. 6  illustrates bolster  106  in their final position on the surface of artery  200 , where the arteriotomy  202  is effectively closed. 
         [0231]      FIG. 8  describes an alternative configuration with respect to the distribution of the suture tension to affect an active closure of the arteriotomy  202 . In this particular embodiment, the basic configuration of closure device  100  is similar to that shown in  FIGS. 1 and 2 ; however, the sutures within intra-arterial-foot  102  include the bolsters attached to the proximal ends, but do not include the needle-tips. As shown by the figures, a bolster is attached to the proximal end of each suture and the distal end of each suture resides within intra-arterial foot  102 . An interference fit between suture  104  and intra-arterial-foot  102  secures the sutures to maintain tension on each one of the extra-arterial bolster  106 . It is noted that the sutures  104  do not contact the inner lumen surface except for at the point of penetration or transluminal tissue across the arteriotomy in some embodiments, thereby eliminating the risk of damaging the tissue around the incision site due to point loading of a suture directly contacting the tissue. In some embodiments, the folded suture loops may be pulled through an opening at the top of the foot and out of arteriotomy. Although the closure device in the embodiment shown in  FIG. 8  does not include a needle tip, embodiments of the present invention include a needle tip that guides the suture into place. In such embodiments, the needle tip is maneuvered through the delivery shaft and removed from the distal end of the suture. 
         [0232]    The materials used in the components of the presently disclosed closure system generally include materials that are bioabsorbable. In the following description, any details regarding specific materials are for exemplary purposes only and are not intended to be limiting. Therefore, it is to be understood that the recitation of any material or material property in this disclosure is not to be limited to those precise materials or properties. 
         [0233]    Suture  104  may be a standard polyglycolic acid (PGA), polydioxanone (PDO) or a polyglycolic/lactic acid (PGLA)  9010  copolymer. Monofilament and multifilament sutures may be utilized. Alternatively, suture  104  may be composed of many off the shelf absorbable suture. However, it is noted that the material should allow the suture to be flexible. 
         [0234]    Bolster  106  may be manufactured from the same absorbable material as suture  104 . In one particular embodiment, for example, the material is a blend of 82:18 PLA/PGA or a blend of 15% 5050 DLG 1A and 85% of 8218 LG 13E. In other embodiments, bolster  106  may be a standard PGA, PGLA, Polyurethane (PUR) and polydioxanone (PDO). 
         [0235]    With reference to  FIGS. 9-12 , another embodiment of intra-arterial foot  102  will now be described in detail. In this particular embodiment, intra-arterial foot  102  is a two-piece foot having two functional elements, namely a central core component  110  and a flexible wing  112 . In accordance with the present disclosure, flexible wing  112  folds within a delivery sheath for ease of delivery of intra-arterial foot  102  into the lumen of the artery  200 . 
         [0236]      FIGS. 11 and 12  illustrate each of the two components of intra-arterial foot  102 , with  FIG. 11  illustrating central core component  110  and  FIG. 12  illustrating flexible wings  112 . 
         [0237]    Flexible wing  112  increases the surface area of the intra-arterial foot contacting the inner surface of an artery and hence, increases the tamponade effect of intra-arterial foot  102 . As such, bleeding from arteriotomy  202  is increasingly controlled during the delivery and securing of the closure device  100 . Central core component  110  provides intra-arterial foot  102  with additional structural integrity. Additionally, central core  110  facilitates the delivery of sutures  104  and maintains the engagement of the sutures after tensioning of the sutures. In particular, as shown by  FIG. 9  and particularly  FIG. 11 , central core component  110  includes a plurality of openings or slots for receiving sutures  104 . More particularly, needles  108  are ejected from their driving member and pass through channel  111 . Providing flexible wing  112  separate and independent from the central core component  110  further facilitates the longitudinal flexibility of flexible wing  112 . 
         [0238]    With reference to  FIGS. 13-16 , a method of delivering the intra-arterial foot  102  of  FIGS. 9-10  is described. During delivery of the two-piece intra-arterial foot  102 , flexible wing  112  is folded to fit within a procedural or delivery sheath  150 . Upon exiting delivery sheath  150 , flexible wing  112  intrinsically spreads open during deployment.  FIGS. 15 and 16  illustrate isometrically the flexible wing folded within delivery sheath  150  and opened once the intra-arterial foot  102  is advanced through the delivery sheath  150  into artery  200 . After exiting the delivery sheath, at least a portion of the delivery device, automatically or under direct control of the operator, is partially retracted thereby positioning wing  112  of foot  102  on the inner lumen surface directly below the arteriotomy site. In embodiments including a wound spreader (for example, would spreader  304  in  FIG. 57 ), this retraction may place the wound spreader within the arteriotomy, thereby shaping the wound as discussed further below and assisting with the occlusion of the wound to provide a hemostatic effect. In concert with the wound spreader shaping and occluding the arteriotomy the deployed flexible wing  112  creates a tamponade on the arteriotomy  202 , immediately controlling arterial bleeding. As such, flexible wing  112  takes advantage of hydraulic forces within artery  200  to create a seal as the foot in its entirety is secured in place. It is noted that the intrinsic opening of wings  112  is by way of the elastic properties of the wing materials. 
         [0239]    In other embodiments, flexible wing  112  may be actively spread, once deployed from the delivery sheath  150 , by applying tension to sutures that are attached to the lateral extremities of wing  112 . In this particular embodiment (not shown by the figures), the lateral sutures would also retract the lateral wound edges  203   a ,  203   b  of arteriotomy  202  during applied tension to the structures. Controlling the positioning of the wound edges  203   a ,  203   b  in this manner is significant in (1) aiding the tamponade of the winged intra-arterial foot, (2) facilitating the ability to accurately deploy the needle  108  and suture system  104  relative to the controlled position of the wound edges, and (3) centralizing the device relative to the arteriotomy  202 . Mechanically, positioning the wound edges once the delivery sheath  150  has been removed from the arteriotomy has particular relevance to large arteriotomies (e.g. above 10 French units), which loose their intrinsic ability to contract the wound edges. 
         [0240]    With reference to  FIG. 63 , an alternative to actively spreading flexible wing  112  and retracting wound edges  203   a  and  203   b  is illustrated. In this particular embodiment, the stored energy in a spring clips  308  is used to spread wing  112 . Spring clips  308  may be, for example, a stainless steel wire or a nitinol clip. In some embodiments, each spring clip  308  is flexible enough to allow flexible wing  112  to fold within delivery sheath  150 , actively spread the wing and simultaneously retract the lateral edges of arteriotomy  202 . Each clip  308  is attached to either side of flexible wing  112 , as illustrated by the figure. Clips  308  may be released from flexible wing  112 , after intra-arterial foot  102  is implanted about arteriotomy  202 , by pulling clips  308  in an upward direction relative to the plane of the intra-arterial foot  102 , and using arterial wall  204  to provide counter traction to allow clip  308  to release from flexible wing  112  wing spreader recess. Clip housing  309  houses the proximal end of each clip  308 , leading and aiding the control the movement of the clips  308  during the pulling action. In some embodiments, clips  308  are adapted for spreading the wound edges of the arteriotomy. 
         [0241]    With reference to the embodiment shown in  FIG. 12 , the geometry of wing  112  is elliptical in shape, i.e. wider in the latitudinal or transverse to the longitudinal axis of the artery. In some embodiments, the minor diameter of the ellipse is larger than the diameter of the arteriotomy by at least (π)×(diameter)/2. This particular dimensioning of wing  112  is necessary to form an effective seal. Typically, arteriotomy  202  is formed by progressive dilation. In addition, and as a consequence of the morphology of arterial wall  204 , the arteriotomy is generally of a transverse nature, and hence the width of the arteriotomy (in its natural state) is given by (π)×(diameter)/2, where “diameter” is the outer diameter of the dilator (not shown by the figures) used to create the arteriotomy. An elliptically shaped wing oriented with its major diameter transverse to the longitudinal axis of the artery offers an advantageous seal over a circular profile with respect to the transverse nature of the arteriotomy since the material needed to create the seal is reduced. That is, although a circular wing could create a seal, a larger surface area would be required. 
         [0242]    As shown in  FIG. 12 , wing  112  may be curved in profile to match the profile of the lumen of artery  200 . Alternatively, wing  112  may be flat ( FIGS. 31-39 ) to increase its shape memory (i.e. spring-back). 
         [0243]    Wing  112  may include a central opening  126  ( FIG. 17 ), which may be circular to allow the wing to freely rotate independent of the foot core. Alternatively, wing  112  may include a plurality of openings  128  ( FIG. 18 ) that correspond to a plurality of openings in central core  110  (not shown) in a specific alignment. 
         [0244]    The flexibility of wing  112  is not just important in a lateral configuration to facilitate collapse during delivery ( FIGS. 13-16 ), but it is also important to have flexibility in a longitudinal plane. Flexibility in both lateral and longitudinal planes is important for some embodiments to ensure an effective tamponade of arteries in differing disease states with different surface topographies and varying anatomical configurations. Independent flexibility in different planes may be achieved with elastomeric materials such as polydioxanone, polyurethane films, or by very thin films produced by extrusion, solvent casting, or compression molding, etc. Wing geometry, perforations, slots, etc. can also be utilized to infer independent flexibility in different directions. It is also advantageous that the wing be porous in some embodiments to allow nutrient exchange to the luminal surface  206  of artery  200 , whilst maintaining sufficient tamponade effect. This facilitates blood coagulation on the wing surface and creates a seal. 
         [0245]      FIGS. 19-26  illustrate various embodiments of different types of wing designs to increase the flexibility and the porosity of wing  112 , in accordance with various embodiments of the present invention. With particular reference to  FIGS. 25 and 26 , the solid broader silhouette  129  is designed to stiffen the wing&#39;s perimeter to prevent the potential of the wing to folding-back-on-itself during deployment within the artery  200  and during the natural blood flow of the artery. It is noted that porosity of the wing may also be achieved by use of absorbable porous materials, such as, for example, electrospun Polyglycolic acid (PGA) or the addition of soluble materials to the polymer during processing. 
         [0246]    With reference to  FIGS. 27-29 , in conjunction with  FIGS. 9 and 10 , central core component  110  may be circular in geometry and of a higher stiffness, relative to wing  112 . In some embodiments, central core component  110  is sized to be less than the diameter of the arteriotomy  202  ( FIG. 29 ). This ensures that central core component  110  fits comfortably within the delivery sheath  150 . As illustrated by  FIG. 29 , central core component  110  may include a curvature for suiting the luminal curvature of the artery (see, for example,  FIG. 7 ). This curvature imparts an elliptical surface area on central core component  110 , similar to wing  112 , with a major diameter transverse to the longitudinal axis of artery  200 . The shape of central core component  110  (equivalent to that of wing  112 ) helps to ensure wing  112  unfolds when deployed from within the delivery sheath  150 . Additionally, the shape of central core component  110  supports flexible wing  112  once positioned against the arterial lumen  206  and helps to prevent wing  112  from folding back on itself during deployment. 
         [0247]    With continued reference to  FIG. 29 , central core component  110  includes a diameter “L” that is smaller than the arteriotomy  202  and the outside diameter “OD” of delivery sheath  150 . Moreover, flexible wing  112  includes a diameter larger than the arteriotomy  202  and the outside diameter of delivery sheath  150 . In such embodiments, and as described herein, flexible wing  112  is deployable from a folded first position to a deployed second position. 
         [0248]      FIGS. 30-39  illustrate alternative embodiments of central core component  110  and flexible wing  112 . These embodiments illustrate central core component  110  and wing  112  as circular in the plan view. Central core component  110  and wing  112  may include the same material. Moreover, wing  112  is independent from central core component  110 , where wing  112  is larger than the diameter of arteriotomy  202  and central core component  110  is smaller than the diameter of arteriotomy  200 . 
         [0249]    With reference to  FIGS. 40-49 , alternative embodiments of intra-arterial foot  102  are illustrated. In these embodiments, intra-arterial foot  102  is a single piece configuration (i.e. central core component  110  and wing  112  are one unit) manufactured from one material. These embodiments illustrate designs that are circular in the plan view. The outer diameter of the intra-arterial foot  102  of  FIGS. 40-49  is larger than the diameter of arteriotomy  202 . This design concept requires that the intra-arterial foot material be elastomeric so that, the one piece intra-arterial foot can be deformed during insertion into the delivery sheath and will open out to its original diameter without any plastic deformation, once deployed within the artery. By way of example, for an 18 French arteriotomy, these designs would typically have an intra-arterial foot diameter of 10 mm in the plan view. 
         [0250]    In accordance with embodiments of the present invention, closure device  100  is bio-absorbable. In particular, closure device  100  has a functional requirement with structural integrity in the order of approximately 1 to 100 days to allow clinical healing of the arterial wall and absorption should be complete within approximately 1 to 300 days. As known in the art, complete absorption is defined as less than approximately 10% of the original mass. 
         [0251]    In some embodiments, material for the intra-arterial foot is the same for both the flexible wing and the central core to ensure consistent, more predictable biocompatibility and ease of manufacturing. These materials are required to be both haemocompatible and biocompatible in some embodiments. The materials may be non-absorbable, however, the preferred material would be synthetic absorbable polymer. Selection of the appropriate absorbable material is based on haemocompatibility, biocompatibility functional and physical characteristics and absorption profile. 
         [0252]    The haemo- and biocompatibility requirements of the material, in accordance with embodiments of the present invention, include, but are not limited to materials that do not cause adverse tissue reaction, haemolysis, and severe thrombogenesis or occluding emboli formation. During absorption of the material, the breakdown products from the absorbable material should not result in producing emboli, which would cause downstream occlusion. This is achieved by surface erosion which produces particles of less than 8 μm (to allow them to pass through a capillary bed), or by encouraging encapsulation of the intra-arterial implant to anchor all fragmented particles from the absorbing implant to the arterial wall  204 . 
         [0253]    Moreover, the functional and physical characteristics of the material should allow elastic deformation of the flexible wing (to allow it to fold within the delivery sheath  150  and conform to the luminal surface of the artery once delivered), and provide sufficient strength, stiffness or rigidity to the central-core to allow correct positioning, suture capture and locking during the delivery process. 
         [0254]    In one particular embodiment, the absorption profile should allow structural integrity of the implant for at least 20 days to allow clinical healing of the arterial wall  204  and absorption should be complete within approximately 90 days, in which time the arterial wall will have completely remodeled to its original condition. Complete absorption is defined as less than 10% of the original mass. Intra-arterial foot  102  may be manufactured with bio-degradable plastic and elastomeric materials such as, for example, PGA, PGLA, PUR and PDO. 
         [0255]    In one particular embodiment, the intra-arterial foot  102  is radiopaque such as to locate intra-arterial foot  102  in situ, after implantation by means of a radiograph or fluoroscopy or other x-ray imaging modality. Radiopacity of the intra-arterial foot can be achieved by the addition of contrast agents to the polymer such as, for example, barium sulphate. An alternative method is to incorporate the addition of an absorbable radiopaque metal alloy such as, for example, bioabsorbable magnesium alloy. 
         [0256]    In accordance with embodiments of the present invention, intra-arterial foot provides numerous advantages over the prior art. For example, flexible wing  112  allows the sealing component of intra-arterial foot  102  to fold for delivery. In addition, flexible wing  112  allows large surface area sealing member (greater than the diameter of the arteriotomy) to be delivered into the artery for effective tamponade of the arteriotomy. Moreover, the flexible and independent wing  112  allows the sealing member to conform to the topology of the arterial luminal surface. Furthermore, flexible wing  112  may be made from porous material to aide nutrient exchange to the luminal surface beneath the wing. Because flexible wing  112  is wider in the latitudinal plane, it reduces the surface of the sealing member without compromising the effectiveness of the seal. Moreover, an active wound retraction (on the lateral edges) controls the wound edges position for better control of bleeding, ensuring the intra-arterial foot  102  is centrally aligned relative to the arteriotomy, and increases the distance from the wound edge to the suture penetration point. 
         [0257]    The central core component  110  facilitates both delivery and securing of the closure device. In addition, the central core component  110  in circular plan-view profile aids in supporting the flexible wing within the artery, to ensure the wings  112  unfold and help to prevent fold-back of the wings. Moreover, intra-arterial foot  102  can be made from absorbable material, leaving no permanent implant once healing is complete. 
         [0258]    With reference to  FIGS. 50-56 , needle tip  108  includes a body portion  130  having a proximal spherical end  132 . In accordance with some embodiments of the present invention, needle tip  108  and suture  104  form a “T” configuration (See, for example,  FIG. 75 ). In particular, the proximal spherical end  132  facilitates rotation of the needle tip  108  to and from the “T” configuration with suture  104  upon ejection from its driver (not shown). Body portion  130  includes an opening  134  for receiving a portion of suture  104  therein. In one particular embodiment, opening  134  is conical with a first diameter substantially smaller than a second diameter, where the first diameter is adjacent to the suture side so as to increase security of the attached suture  104 . As discussed herein, suture  104  may be secured to body portion  130  by conventional means including adhesives, bonding, etc. 
         [0259]    With continued reference to  FIGS. 50-56 , in one embodiment, needle tip  108  includes a shoulder  136  and a penetrating tip  138  ( FIGS. 51 ,  55  and  56 ). In this particular embodiment, shoulder  136  is adapted such that it rests on a distal portion of a driving member (i.e. the delivery system). In other embodiments, the distal end of needle tip  108  includes a penetrating tip  138  but no shoulder ( FIGS. 50 ,  52  and  53 ). In yet other embodiments, the body portion  130  includes a raised portion  140  tapering from shoulder  136  to a proximal end of needle tip  108  ( FIGS. 51 and 56 ). In this particular embodiment, raised portion  140  is designed to engage with a slot within a needle driver  312  ( FIGS. 70 ,  71  and  73 ) to prevent needle tip  108  from rotating relative to the driver  312  and damaging suture  104 . Moreover, raised portion  140  may taper to reduce the profile of both the needle and the emanating suture during penetration. Thus, suture  104  is permitted to shelter behind shoulder  136 . In some embodiments, needle  108  includes a cylindrical profile ( FIG. 53 ). In other embodiments, needle  108  includes an elliptical profile ( FIG. 54 ). The elliptical profile reduces the needle profile along the long axis to provide increased surface area for securing the needle tip on the posterior side of the intra-arterial foot  102 . In other embodiments, needle  108  includes a cylindrical profile having a flat edge ( FIG. 55 ). In yet other embodiments of needle tip  108  includes shoulder  136  and body portion  130  includes a flat edge ( FIG. 56 ). 
         [0260]    With reference again to  FIGS. 15 and 16 , in conjunction with  FIGS. 1 and 2 , a method of use and operation of closure system  100  will be described in detail. Closure system  100  is positioned on a distal end of a delivery system  300  and advanced within the lumen of artery  200  via a delivery sheath  150 . As illustrated by  FIG. 15 , flexible wing  112  of intra-arterial foot  102  is folded within delivery sheath  150  and is deployed as it emerges from delivery sheath  150  within the lumen of artery  200  ( FIG. 16 ). Intra-arterial foot  102  is tethered in position by two independent sutures  104  and bolsters  106 . Each suture  104  includes a bolster  106  at its proximal end and a needle  108  at its distal end. In accordance with the present disclosure, delivery system  300  drives needle  108 , and therefore suture  104 , to move distally in a straight, linear pathway through arterial wall  204 . Such movement drives needle tip  108  (and suture  104 ), through intra-arterial foot  102  and is ejected on the posterior side of intra-arterial foot  102 . A shear force is then applied to suture  104 , pulling sutures  104  into a channel  111  within intra-arterial foot  102  and generating a tensile force within the suture. The tensile force in suture  104  secures the intra-arterial foot  102  on the luminal surface  206  of artery  200 . This tensile force additionally pulls bolsters  106  against the adventitial surface  208  of artery  200 . Moreover, needle tips  108  are anchored against the posterior surface of intra-arterial foot  102  in response to the applied tension on the sutures  104 . The tension applied to the sutures  104  bring about a closure of the arteriotomy  202 . In particular, bolsters  106  distribute the tension on the suture such that the wound edges  203   a  and  203   b  are brought into alignment and/or apposition. Delivery system  300  is then removed leaving behind the secured closure system  100  with arteriotomy  202  sealed by the intra-arterial foot  102 . 
         [0261]    With reference to  FIGS. 66 and 67 , an exemplary delivery device and method will now be described in detail. Delivery device  300  includes generally a wound spreader, a ribbon capture and release component and a needle driver having an ejection pin. As already described herein above, the closure device  100 , in accordance with the present disclosure, is attached to the distal end of the delivery device  300  and is driven into position via a delivery sheath  150 . When the intra-arterial foot component  102  exits procedural sheath  150 , it expands, spreading open to effect a tamponade affect of the intra-arterial foot  102  to control arterial bleeding ( FIGS. 15 and 16 ). In one embodiment, the spreading of intra-arterial foot  102  is a result of the elastic properties of intra-arterial foot  102 . In an alternative embodiment, intra-arterial foot  102  may be actively spread, once deployed from the procedural sheath, by applying tension to spring clips  308 , which are attached to the lateral extremities of the flexible wings  112  ( FIG. 63 ). Clips  308  attached to a lateral flexible wing  112  performs a second important function of retracting the lateral wound edges  203   a  and  203   b  of arteriotomy  202 . 
         [0262]    Typically, dilated arteriotomies are configured in a circumferential orientation, transverse to the longitudinal axis of artery  200 . Thus, applying lateral traction to the wound edges  203   a ,  203   b  of arteriotomy  202  has the effect of bringing the wound edges towards apposition. In accordance with the present disclosure, a wound spreader component controls the positioning of the wound edges  203   a ,  203   b  aids the tamponade of flexible wings  112  of intra-arterial foot  102 . This positioning of wound edges  203   a  and  203   b  helps to facilitate the ability to accurately deploy needle  108  and sutures  104  relative to the controlled position of wound edges  203   a  and  203   b . Furthermore, it centralizes the closure device  100  relative to the arteriotomy. 
         [0263]    With reference to  FIGS. 57-59 , a portion of an exemplary delivery device  300  is illustrated, in accordance with one embodiment of the present disclosure. Delivery device  300  includes a foot anchor  358  and a wound spreader component  304  adjacent to foot anchor  358 . Delivery device  300  is adapted for delivering closure device  100  for closing wound edges  203   a  and  203   b  of an arteriotomy  202 , in a manner described in detail herein below. 
         [0264]    In some embodiments, wound spreader component  304  includes a flexible member forming an elliptical profile. The spreader component  304  may be oriented in the direction relevant to the appropriate or desired wound refraction. In some particular embodiments, the major diameter of wound spreader  304  may be substantially the same as the outermost diameter of intra-arterial foot  102 . Moreover, the major diameter of wound spreader  304  may be substantially the same diameter as the diameter of delivery sheath  150 . In other embodiments the major diameter of the wound spreader is substantially larger than the diameter of delivery sheath  150 . In such embodiments, the compressible nature of the spreader allows the spreader to fit within the sheath. 
         [0265]    With continued reference to  FIGS. 57-59 , foot anchor  358  is releasably attached to intra-arterial foot  102 . More specifically, foot anchor  358  anchors intra-arterial foot  102  during its delivery and positioning against the arteriotomy. As illustrated by these figures, wound spreader  304  is adjacent to foot anchor  358 , wherein a distal end of the wound spreader  304  is substantially abutting a portion of intra-arterial foot  102 . Thus, when the closure system of the present disclosure is used in arterial application, wound spreader  304  helps minimize blood loss into the surrounding soft tissues. In particular, when the introducer sheath  150  is removed from artery  200  prior to deploying the intra-arterial foot  102 , spreader component  304  functions as a temporary seal, prior to securing the intra-arterial foot on the arteriotomy. As delivery sheath  150  is removed from the arteriotomy, the arteriotomy conforms substantially to the geometry and shape of wound spreader  304 . 
         [0266]    With reference to  FIGS. 58 and 59 , in operation, wound spreader  304  and intra-arterial foot  102  are advanced through delivery sheath  150  and into the lumen of an artery. Wound spreader  304  and foot anchor  358  are then retracted proximally such that the wound spreader  304  controls the wound edges  203   a  and  203   b  of arteriotomy  202  and intra-arterial foot  102  is positioned against the internal wall of the artery. A needle housing (not shown), housing needle drivers and positioned within delivery sheath  150 , is then positioned against the exterior wall of the artery. Once intra-arterial foot  102  is positioned in the internal surface of the arterial lumen  206  juxtaposed with arteriotomy  202 , a “sandwich” is created, wherein arterial wall  204  is held between intra-arterial foot  102  and the needle housing ( FIG. 59 ). 
         [0267]    In accordance with the embodiment illustrated by  FIGS. 29 ,  59 , and  68  the intra-arterial foot is held in its correct position against the internal arterial surface (i.e. internal wall), centrally located relative to the arteriotomy. Additionally, the needle/suture subassembly and needle driver assembly  312  have unobstructed and direct passage through arterial wall  204  into intra-arterial foot  102 . 
         [0268]    Wound spreader component  304  may be manufactured from a semi compliant material such as polyisoprene, silicone, Pebax, PTFE, that it can deform to fit within delivery sheath  150  during delivery through the percutaneous tissue (not shown by the figures) and into arterial lumen  206 . Once positioned in arterial lumen  206 , wound spreader  304  is exposed distally relative to delivery sheath  150  and deploys into its initial profile. Delivery sheath  150  is then withdrawn until the delivery sheath is no longer within the arteriotomy, and is replaced by the geometry of wound spreader  304 . As such, arteriotomy  202  moves from a first geometry (e.g. circular) to a second geometry (e.g. elliptical) to conform to the shape of spreader component  304 . It is noted that bleeding is controlled during this withdrawal and transition between geometries by the tamponade of both delivery sheath  150  and spreader  304 . 
         [0269]      FIG. 60  illustrates a perspective view of a wound spreader according to embodiments of the present invention. The wound spreader  601  is a magnified view of wound spreader  304  depicted in  FIG. 57 . Like wound spreader  304 , wound spreader  601  may be incorporated with the anchor assembly of a delivery device. The spreader assists with spreading the wound edges and additionally assists in minimizing blood loss into the surrounding soft tissue when the introducer sheath of the delivery device is removed from the artery, but prior to the intra-arterial foot being secured in place. In some embodiments, the spreader occupies substantially the entire wound space once the sheath is removed. Spreader  601  is geometrically designed such that the shoulders  603  of the spreader are spread further apart than the neck  602  of the spreader. The increased width of the spreader in the shoulder region is designed to be substantially as wide as the diameter of the introducer sheath delivering an intra-arterial foot in some embodiments. The width of the spreader maintains a lateral tension in a wound such that the edges of the wound, for example edges  203   a  and  203   b  shown in  FIG. 2 , are drawn closer together. By occupying the space of the wound and by drawing the edges of the wound together the wound spread helps minimize fluid flow through the wound. The shape of the wound spreader may be an elliptical shape, and the spreader may be composed of a compressible material. 
         [0270]      FIG. 61  illustrates a perspective view of the wound spreader of  FIG. 60  from below the spreader, and  FIG. 62  illustrates a bottom view of the wound spreader of  FIG. 60 . As demonstrated in  FIGS. 61 and 62 , spreader  601  may include arcuate edges  604  and  615 , conforming to the shape of the intra-arterial foot assembly. Edges  604  and  615  may recede to different depths into respective surfaces of the spreader such that face  611  of the spreader is at an angle or taper. Additionally, the wound spreader generally includes an opening  610 , which provides a passageway through which an object such as a foot anchor, ribbons or other objects interacting with the intra-arterial foot may pass. The spreader is generally coupled to an extension of the anchor assembly  606  at the neck  602  of the spreader in a co-axial alignment. In some embodiments the axial extension  606  of the anchor assembly is coupled to an interior region of spreader  601 . In other embodiments, the extension may be coupled to an exterior portion of the anchor assembly. However, as demonstrated, the extension  606  and spreader  601  maintain a passageway for entry and exiting of various elements. 
         [0271]    With reference to  FIGS. 64 and 65 , an alternative method of spreading and orienting wound edges  203   a ,  203   b  is illustrated wherein delivery device  300  includes spreader tangs  310  having a length and a distal end positioned on a side portion of delivery sheath  150 . In this particular embodiment, delivery sheath  150  is a tri-lumen extrusion (not shown): a large inner lumen for providing access to various surgical instruments and delivery device  300 , and two smaller lumens for housing spreader tangs  310 . During delivery, spreader tangs  310  are retracted back inside procedural sheath  150 . Once positioned inside artery  200 , tangs  310  are advanced out to the front end of delivery sheath  150  then sprung outwardly such that once they exit distally from delivery sheath  150 , the distance between them would be greater than the distance between them when contained inside delivery sheath  150 . This added width assists to actively retract and spread the wound edges  203   a  and  203   b.    
         [0272]    In one embodiment, tangs  310  include a floppy, atraumatic tip at the distal end. An atraumatic tip ensures that tangs  310  are advanced into internal lumen  206  like guide wires, with minimal trauma to the lumen during delivery and use. The length of tangs  310  eliminates the risks of tangs  310  accidentally being pulled out of arteriotomy  202  during the spreading and orientation of wound edges  203   a  and  203   b . In other embodiments, tangs  310  include a mating feature for securing them to procedural sheath  150  such that when tangs  310  exit from the front end of sheath  150 , their orientation is fixed to one plane, not free to rotate. This configuration ensures that tangs  310  apply traction to wound edges  203   a  and  203   b  in the transverse plane only. 
         [0273]    With reference now to  FIGS. 66-68 , delivery device  300  may include needle drivers  312  for driving needle  108  and suture  104  through intra-arterial foot  102 . Each needle driver  312  includes an ejector pin, such as pin  314  depicted in  FIG. 77 , contained within needle driver  312  for disengaging the needle/suture ( FIGS. 69 and 77 ). In some embodiments, needle tip  108  is adapted to be re-oriented from a first concentric alignment with needle driver  312  to a second horizontal position once free from driver  312 . More in particular, and as described herein above, needle tip  108  forms a “T” configuration with suture  104 . 
         [0274]    With particular reference to  FIGS. 67 and 68 , in conjunction with  FIGS. 73 and 74 , after the intra-arterial foot  102  is in position, needle drivers  312  are advanced through the arterial wall and a portion of the intra-arterial foot to drive the needle/suture subassembly to a posterior side of the intra-arterial foot. More in particular,  FIG. 68  illustrate needle divers  312  in an advanced position passing through a profiled opening  316  of a capture and release strip, shown in the form of a capture and release ribbon component  313  (component  313  shown in  FIGS. 73 and 74 ). As shown in various figures, including  FIGS. 66-69  and  71 , the delivery device may deploy a pair of ribbons  313  through the channel in the intra-arterial foot. The distal end of the ribbons, particularly tab  315 , may project in opposing directions, such that one ribbon forms an acute angle with respect to the anchor and sheath and the other ribbon forms an obtuse angle with respect to the sheath. In some embodiments, the acute angle is about 40 degrees. In certain embodiments, the obtuse angle is about 140 degrees. Once needle/suture subassembly passes through opening  316  on tab  315  of ribbon  313 , ejector pin  314  ejects the needle tip  108  ( FIG. 69 ). After ejecting needle tip  108 , each needle driver  312  and ejector pin  314  are retracted from the intra-arterial foot  102  (i.e. moved in a proximal direction) into the needle housing. Moreover, each needle tip  108  has a length substantially larger than any diameter of the profiled opening  316  of capture ribbon component  313 . Thus, once needle tip  108  is ejected from needle driver  312  through profiled opening  316 , the needle tip  108  cannot be removed back because of its dimension. Thus, suture  104  remains threaded through the profile opening  316  of capture ribbons  313  ( FIG. 75 ). Furthermore, once a significant amount of the suture extends beyond the capture ribbon, the suture may have enough slack to ensure that the shuttle does not slip back through the hole in the capture ribbon. Accordingly, some embodiments of the present invention may be provided without a T configuration. This is discussed in further detail below. 
         [0275]    With reference to  FIGS. 70-72 , and  FIGS. 73-75 , delivery device  300  further includes at least one capture and release ribbon component  313  extending laterally for capturing, retracting and locking the deployed needle/suture subassembly. Capture and release ribbon component  313  includes a first longitudinal portion attached to a movable mount (not shown) and a second tab portion  315  extending from the first longitudinal portion. Second tab portion  315  includes the profiled opening  316 . As described hereinabove, profile opening  316  is adapted for receiving and engaging the needle/suture subassembly. 
         [0276]    Second tab portion  315  may include a lock ribbon (e.g. an aperture) (not shown) for receiving and locking a longitudinal member for holding the intra-arterial foot in place during the driving of the needle/suture subassembly. 
         [0277]    In operation, during actuation of delivery system  300 , each needle driver  312  advance distally to drive each needle/suture subassembly through arterial wall  206 , intra-arterial foot components and through profile opening  316  of capture and release ribbon component  313  to a posterior side of intra-arterial foot. Each ejector pin  314  then ejects shuttle-suture subassembly  108   a  out through the side of needle driver  312  leaving the shuttle-suture subassembly remaining threaded through capture ribbons  313  ( FIG. 75 ). In one embodiment, the timing of this movement could be configured to retract driver  312  and partially retract capture ribbon  313  back up through the center of intra-arterial foot  102 . 
         [0278]    With particular reference to  FIG. 71 , the second tab portion of capture and release ribbon component  313  is moved laterally through channel  111  of intra-arterial foot  102  in response to a longitudinal retraction of the first longitudinal portion of capture ribbons components  313 . This retracting action pulls a portion of the suture/needle subassembly into channel  111 . The re-oriented needle tip  108  acts as an anchor and abuts against the underside and edge of intra-arterial foot  102  ( FIG. 70 ). As noted above, some embodiments of the present invention may be provided without a T configuration and the suture slack may be relied upon to prevent the shuttle from slipping back through the hole in the capture ribbon. Once needle tip  108  is effectively stationary (i.e. blocked from further travel), suture  104  connected to extra-arterial bolster  106  outside artery  200  will continue to pull into the artery  200  as capture and release ribbon component  313  continue to retract into channel  111 . This action will also pull extra-arterial bolster  106  down onto the external surface  208  of artery  200  ( FIG. 72 ). As illustrated by  FIGS. 71 and 72 , retraction of ribbon components  313  will pull suture  104  into channel  111  and double suture  104  on itself. More in particular, suture  104  is partially pulled into the space (i.e. channel  111 ) previously occupied by the retracting ribbon capture components  313 . 
         [0279]    More in particular, and with continued reference to  FIGS. 71 and 72 , when capture and release ribbons component  313  pull the needle/suture subassembly, needle  108  is secured against a surface of intra-arterial foot  102  while suture  104  is doubled-up and secured within channel  111  of intra-arterial foot  102 . Because the distal end of suture  104  (i.e. needle  108 ) is anchored against intra-arterial foot  102 , when ribbon component  313  is retracted, a portion of suture  104  is advanced (i.e. pulled) and doubled within channel  111 . This action creates an interference fit between suture  104  and channel  111  of intra-arterial foot  102 .  FIG. 72  illustrates intra-arterial foot  102  implanted in artery  200  with doubled up sutures  104  tethered into position, needle tips  108  anchored against the intra arterial foot, and external bolster  106  tightened onto the outer wall (i.e. external surface  208 ) of artery  200 . 
         [0280]    To accommodate variations in arterial morphology and wall thickness dimensions between patient populations, it is envisioned that the capture and release ribbon components  313  will disengage from suture  104  after the suture is positioned within channel  111  and/or when a predetermined load is reached. It is noted that the release will not be reached until the interference lock with the doubled up suture  104  is reached on both sides of intra-arterial foot  102 . In view of the variations in arterial morphology the interference lock with the doubled up suture may be reached at various points in different patients or in vessels with different thicknesses and more arterial tissue with respect to other vessels. 
         [0281]    With reference to  FIGS. 76 and 77 , in conjunction with  FIG. 51 , one embodiment of needle/suture subassembly is illustrated attached to a distal end of a driver  312 . In this particular embodiment, needle tip  108 , with suture  104  attached thereto, punctures the vessel wall during an operation and penetrates the foot and ribbons. This embodiment also incorporates a keying feature, which engages with a slot in the needle driver tube. This feature ensures orientation of the needle-tip and suture relative to the needle driver and prevents damage to the suture or suture/needle junction during assembly, deployment and ejection. The ramped back profile on the needle tip is designed to allow room for the suture to fold down to protect it from any shearing action during the firing through arterial wall and intra-arterial foot  102 . Folding of the suture should also help to minimize the penetration force when passing through the arterial wall. 
         [0282]    With reference to  FIGS. 79-86 , one embodiment of a needle-shuttle-suture subassembly attached to a distal end of pusher  314 , in accordance with the present disclosure, is described. In the particular embodiment illustrated in  FIGS. 79-86  and  74 , pusher  314  is pointed to engage needle-shuttle suture subassembly  108   b . In operation, pusher  314  is advanced to deploy through arterial wall  206  and into a recess (i.e. channel  111  within intra-arterial foot  102 . During this actuation, pusher  314  and needle-shuttle/suture subassembly also pass through capture and release ribbon component  313  housed in intra-arterial foot  102 , as described herein above with reference, for example, to  FIGS. 74 and 75 . 
         [0283]      FIG. 87  illustrates a needle in accordance with embodiments of the present invention. The needle demonstrates an embodiment that may be used as an alternative to the needle embodiments demonstrated in  FIGS. 73 ,  76 , and  79 . The needle embodiment depicted in  FIG. 87  may be used in combination with various delivery system embodiments of the present invention. The needle design depicted in  FIG. 87 , like the embodiment shown in  FIGS. 76 and 79  engage a suture configured to extend axially from the needle. However, the needle embodiment depicted in  FIG. 87  has a tubular needle  870  that is distinct and detachable from suture  872 . Needle tube  870  may be ejected from the sheath of a delivery system, thereby piercing the vessel wall of an artery. Because the suture  872  is engaged with the needle  870  via shuttle  871  attached to suture  872 , the suture will enter the vessel wall as the needle pierces the wall, in a manner similar to a thread attached to a sewing needle piercing a piece of fabric. 
         [0284]      FIG. 88  illustrates the needle of  FIG. 87  during actuation. After needle  870  has penetrated a vessel wall, carrying suture  872  and shuttle  871  with it through the wall, pusher rod  880  may be translated through the hollow tube of needle  870  to eject and hence detach the suture and shuttle from the needle tube  870 . 
         [0285]    As demonstrated in  FIG. 89  pusher rod  880  may extend beyond the tip of needle  870  to effect complete ejection and detachment of suture  872  and shuttle  871  from needle  870 . During an operating procedure, once the suture penetrates the vessel wall and is detached from the needle, the needle may be withdrawn from the artery. As previously demonstrated the needle may be aligned within the sheath of the delivery system so that it will penetrate a portion of the intra-arterial foot. In some embodiments, the needle penetrates a portion of the intra-arterial foot and a ribbon engaged with the foot through coaxially aligned apertures in the foot and ribbon. Accordingly, once the shuttle and suture are released from the needle and the needle is extracted, the shuttle and suture remain engaged with the foot and ribbon. The shuttle will assist in anchoring the suture to the intra-arterial foot when the suture is pulled taught. 
         [0286]      FIG. 90  illustrates a cross-sectional side view of the needle of  FIG. 87 . As indicated above and depicted in  FIG. 90 , the engagement of shuttle  871 , which is attached to suture  872 , with tubular needle  870 , maintains the attachment of the suture to the needle and assures that the suture is pulled through any surfaces that the needle penetrates. The pointed edge of the tubular needle assist the needle in piercing an extra-arterial surface. 
         [0287]      FIG. 91  illustrates a cross-sectional side view of the needle of  FIG. 87  ejecting a suture. As shown the ejection of the suture is effected by the interaction of the pusher rod  880  with the shuttle  871  attached to suture  872 . 
         [0288]      FIG. 92  illustrates an embodiment of a suture assembly in accordance with embodiments of the present invention. The suture assembly depicted in  FIG. 92  is engageable with various needle assembly embodiments. Unlike the suture assembly depicted in  FIGS. 3 and 4 , the suture assembly depicted in  FIG. 92  includes a shuttle that is co-axial with the extended suture  921 . The assembly includes a bolster  922  positioned along the suture  921 . Bolster  922 , although generally stationary, may be movably attached to the suture in some embodiments so that when the shuttle and suture are inserted into a vessel and an intra-arterial foot via a needle and ejected from the needle, the bolster  922  may be adjusted to contact the exterior surface of the vessel and fixed on the suture at a location that maintains the suture taught and thereby holds the intra-arterial foot in place. 
         [0289]      FIG. 93  illustrates a side view of the suture assembly of  FIG. 92 . As demonstrated the shuttle  920  is tapered in accordance with various embodiments of the present invention. However as demonstrated in  FIGS. 94 and 95 , the shuttle may take on other geometric shapes and properties. Specifically, the shuttle may have a uniform cross section, such as the tubular cross-section depicted by shuttle  940  of  FIG. 94  and the cylindrical cross section depicted by shuttle  950  of  FIG. 95 . As further demonstrated by  FIGS. 94 and 95 , shuttles according to embodiments of the present invention may be hollow like shuttle  940  or may be solid like shuttle  950 . A hollow shuttle or partially hollow, such as shuttle  940 , allows the suture to be knotted and the knot may be maintained within the shuttle while keeping the suture affixed to the shuttle. The shuttle may be fixed to the suture through various means such as by knotting or tying of the suture, by bonding, using a glue/adhesive, by heat staking, by over-molding, or a combination of these processes. In some embodiments the shuttle may be movable, at least temporarily, along the suture. 
         [0290]      FIG. 96  depicts a perspective view of the central core of an intra-arterial foot in accordance with embodiments of the present invention. Central core  960  may be coupled with a wing according to various embodiments of the present invention. Core  960  includes various apertures engageable for delivery of the core to a vessel and for coupling the core to a vessel via sutures. Core  960  has a central opening  961 . Opening  961  does not extend through the bottom side of core  960 . Opening  961  allows the foot to be anchored to an anchor assembly as will be further discussed. Opening  961  may be shaped to correspond to the base of an anchor such that the base of the anchor fits in core  960  in a lock and key configuration (i.e. the shape of the anchor base may correspond to at least a portion of the opening. Core  960  also includes openings  962  and  963 , which receive the needle, suture, and shuttle provided by embodiments of the present invention. Each of openings  961 - 963  may be tapered or angled in accordance with various embodiments of the present invention. The angular aspect of opening  961  allows core  960  to be maintained at a particular orientation on the base of an anchor. Core  960  also includes a channel  964  extending through the core. 
         [0291]      FIG. 97  shows a cross-sectional view of the central core depicted in  FIG. 96 . As shown in  FIG. 97  channel  964  may extend an entire span of core  960 . As further demonstrated in  FIG. 96 , core  960  may include openings  970  and  971 , which may be aligned with parts of opening  961 . Openings  970  and  971  may be configured as either through holes or blind holes. 
         [0292]      FIG. 98  shows another cross-sectional view of the central core depicted in  FIG. 96 . As shown in  FIG. 98 , the region on core  960  directly below the center of opening  961  is solid such that a portion of the opening does not penetrate the entire depth of core  960 . 
         [0293]      FIG. 99  illustrates a top view of the central core depicted in  FIG. 96 . While a central region of opening  961  may not penetrate the entire depth of core  960 , other opening such as opening  971  may provide a channel aligned with opening  961  such that the channel penetrates the entire depth of core  960 .  FIG. 99  further demonstrates an exemplary shape of core  960  in accordance with various embodiments of the present invention. 
         [0294]      FIG. 100  illustrates a bottom perspective view of the central core depicted in  FIG. 96 .  FIG. 100  shows openings  962  and  963  as penetrating the entire depth of core  960 . As described above, these openings receive the shuttle portion of suture assemblies via the insertion of needles into the openings. 
         [0295]      FIG. 101  provides a view of  FIG. 100  from the opposite end of the central core. Channel  964  shown on one side of core  960  in  FIG. 100  is shown to extend to the other side of core  960  in  FIG. 101 . 
         [0296]      FIG. 102  shows a bottom view the central core of  FIG. 96 . The perimeter of the core  960  is illustrated as having a distinct geometry on the bottom of core  960  that differs from the geometry on the top of core  960 . 
         [0297]      FIG. 103  shows a side view of the central core of  FIG. 96 . The top surface of core  960  may not be planar as demonstrated in  FIG. 103 . Additionally, the entry/exit point of openings  970  and  971  may be offset from opening  961  such that a channel extending from one of openings  971  or  970  to opening  961  is angular with respect to core  960 . 
         [0298]      FIGS. 104 and 105  illustrate end views the central core of  FIG. 96  with channel  964  extending from one end to the other end. As discussed with previous embodiments, in some embodiments the core may have an arcuate upper surface to conform to an intra-arterial surface. 
         [0299]      FIG. 106  illustrates a central core prior to insertion of a ribbon wire engageable with a ribbon in accordance with embodiments of the present invention. In accordance with some example embodiments of the present invention, a single ribbon  1061  may be engaged with a central core  960  of an intra-arterial foot. The ribbon, which may be used to affix one or more sutures to central core  960  in a prescribed manner, such as the manner illustrated by sutures  104  in  FIG. 1 , is engageable with ribbon wire  1060 . Engaging ribbon wire  1060  with ribbon  1061  requires—in some example embodiments—inserting ribbon wire  1060  into opening  961  before inserting ribbon  1060  completely in channel  964 . 
         [0300]      FIG. 107  illustrates the central core of  FIG. 106  after insertion of the ribbon wire into opening  961  in preparation to receive ribbon  1061  through the loop formed by wire  1060 . Ribbon  1060  includes grooves  1062  configured to engage and maintain engagement with ribbon wire  1060 . 
         [0301]    Although  FIGS. 107 and 108  include a ribbon wire  1060  configured to actuate the ribbon  1061 , it should be understood that any suitable actuation mechanism may be provided as an alternative or in addition to the wire/ribbon configuration of the illustrated example. 
         [0302]      FIG. 108  illustrates the central core of  FIG. 106  after the ribbon wire engages the ribbon inserted into the central core. As shown in  FIG. 106  wire  1060  engages grooves  1062  of ribbon  1061  according to various embodiments of the present invention. Additionally openings  963  and  962  are aligned with openings  1101  and  1100  of ribbon  1060 . The alignment of the openings on ribbon  1060  and core  960  allows penetration of needle assemblies and suture assemblies according to various embodiments of the present invention. 
         [0303]      FIG. 109  illustrates&#39; the central core of  FIG. 106  prior to insertion of an anchor assembly. The anchor assembly  1090  may be moved axially, the assembly travelling parallel to the ribbon wire. Anchor assembly may include prongs  1091  geometrically shaped to fit in a keyed portion of opening  961 . 
         [0304]      FIG. 110  shows a cross-sectional view of  FIG. 109 . As shown in  FIG. 109 , ribbon  1061  may include a plurality of apertures, engageable with various components of the delivery device and securing members, such as the suture assemblies. Openings  1100  and  1101  are aligned with openings  962  and  963  in core  960 . 
         [0305]      FIG. 111  illustrates a cross-sectional view of the central core shown in  FIG. 106  with the ribbon inserted into the core and with the ribbon wire and anchor engaging the ribbon wire. The prongs of the anchor assembly  1091  traverse openings  1102  and  1103  of ribbon  1061  in core  960 , thereby helping to maintain the core of the intra-arterial foot anchored to the anchor assembly for movably deploying the foot from a sheath through an arteriotomy and into the interior of an artery or vessel. 
         [0306]      FIG. 112  illustrates a cross-sectional view of the central core shown in  FIG. 106  during removal of a ribbon from the central core via the ribbon wire. In the context of an operation, once sutures are deployed and extend through apertures  1101  and  1100  of ribbon  1061  and apertures  963  and  962  of core  960  and core  960  is positioned as desired, anchor assembly  1090  and ribbon wire  1060  may be retracted. The retraction of these components may occur independently of one another. The retraction of ribbon wire  1060  will cause ribbon  1061  to be drawn out of core  960  through central opening  961 . As shown in  FIG. 112 , ribbon  1061  may be made sufficiently flexible, via material and/or geometric properties, to achieve such a withdrawal. As apertures  1101  and  1100  are withdrawn from core  960  they will pull any suture extending there through towards the center of the core  960 , whereby the sutures may become affixed within channel  964  of core  960 . 
         [0307]      FIG. 113  illustrates a cross-sectional view of the central core shown in  FIG. 106  after the ribbon has been removed from the core via the ribbon wire. As the ribbon wire is retracted further, the ribbon  1061  may be completely removed from core  960  through opening  961 . The sutures may be cut in accordance with some embodiments in order to allow complete withdrawal of the ribbon from core  960 . However, as discussed further below, the ribbon may be configured to release the sutures extending through the apertures of the ribbons without cutting the sutures. 
         [0308]    With reference to  FIGS. 114-118 , after suture  104  is positioned within channel  111 , in a manner described hereinabove, capture and release ribbon component  313  will disengage and release suture  104 . In some embodiment, the disengagement of suture  104  from capture and release ribbons  313  may be a cutting action. In other embodiments, the disengagement of suture  104  involves a release mechanism  317  wherein the suture loop is knocked off from ribbon component  313 . In particular, the disengagement and release of sutures  104  will occur at/or above an exit hole on a potion of intra-arterial foot  102 . Following release of suture  104 , capture and release ribbon components  313  will retract completely from closure device  200 . 
         [0309]    With continued reference to  FIGS. 114-118 , various embodiments of the release mechanism  317  of ribbon components  313 , in accordance with the present disclosure, are illustrated. Release mechanism  317  may be, for example, a cut detail, which allows ribbon  313  open and/or un-link from the captured suture  104  (for example, in response to exceeding a particular, e.g., predetermined, load exerted between the captured suture  104  and the release mechanism). In one particular embodiment, capture ribbon  313  includes a laser cut nitinol ribbon with a fold out tab folding on itself and extendable in the longitudinal direction ( FIGS. 114 ,  116  and  117 ). 
         [0310]    Referring to  FIG. 118 , the release mechanism is provided in the form a structurally weakened portion  318  configured to break or open (for example, in response to exceeding a particular, e.g., predetermined, load exerted between the captured suture  104  and the release mechanism). In the example illustrated in  FIG. 18 , the weakened portion  318  is in the form of a notch cut into the end portion of the ribbon  313 , such that upon the suture  104  exerting a load in the general location of the notch that exceeds a predetermined load, the end loop of the ribbon  313  breaks at the location of the notch, thereby releasing the suture  104  from the loop and allowing separation of the ribbon  313  from the suture  104 . Although the weakened portion  318  is shown as a notch, it should be understood that any other suitable mechanism may be provided. For example, the material properties could be varied at particular locations. 
         [0311]    With reference for  FIG. 119 , ribbon component  313  is illustrated within a sleeve having a cut-out portion. The cut-out portion is adapted for allowing release mechanism  317  to release suture  104  in the event that the suture is not release by the methods described hereinabove. In particular, when the ribbon component pulls the suture, the load on the release mechanism  317  will cause the release mechanism to deploy open thus releasing the suture. The cut-out portion on the sleeve, as illustrated by the figure, will ensure that the suture is released when the suture attempts to pass through the sleeve, since the suture will apply an increased load on the mechanism  317  until the mechanism releases the suture. The sleeve is no longer retaining the capture ribbon loop. 
         [0312]    Capture and release ribbon component  313  is a flexible member for permitting movement in and refraction from intra-arterial foot  102 . In one embodiment, capture and release ribbon components  313  may be manufactured from a flexible but non-compliant plastic material, such as, for example, Polyether ether ketone (PEEK) or a metal such as, for example, nitinol or stainless steel. 
         [0313]    While  FIGS. 1-119  illustratively describe exemplary components of the exemplary closure system, according to specific embodiments of the present invention, it is to be understood that a person ordinarily skilled in the art can readily modify the demonstrated system consistent with the above descriptions. For example, although the closure system  100  is described herein as application to the an artery, it is the intent of the present disclosure that the closure system described herein will also apply to other applications, such as, for example, NOTES SILS and the closure of many surgically induced openings. It should therefore be recognized that the present disclosure is not limited to the specific embodiments illustrated herein above, but rather extends in utility to many other modification, variation, application, and embodiment, and accordingly, all such modifications, variations, applications, and embodiments are to be regarded within the scope of the present disclosure. 
       4. Uses and Procedures 
       [0314]    As described generally above, a provided device is useful for closing a perforation (i.e., a hole, puncture, tear, rip, or cut) in any hollow vessel associated with a mammalian surgical procedure. One of ordinary skill in the art will appreciate that provided device is useful for closing a perforation in any lumen of a mammal, including the gastrointestinal tract (e.g., the stomach, intestines, colon, etc.), the heart, the peritoneal cavity, or a blood vessel. 
         [0315]    In some embodiments, a provided device is useful for closing a perforation (i.e., a hole, puncture, tear, rip, or cut) in any hollow vessel associated with a human surgical procedure. In some embodiments, a provided device is suitable for closing a perforation in a veterinary surgical procedure. In certain embodiments, a veterinary surgical procedure is an equine surgical procedure. 
         [0316]    In one embodiment, the closure system is adapted for percutaneous closure of an arteriotomy following endovascular/intra-arterial procedures. Although the closure system is described as one directed to the closure of an arteriotomy of the common femoral artery or vein, the closure system described herein is equally applicable to closure of openings in any membrane, wall, septum or vessel. Similarly, although the closure system of the present disclosure is for large hole arteriotomy (in the size range of approximately 10 to approximately 30 French units), closure system  100  is equally application to smaller hole ranges (e.g. approximately 5 to 10 French units). One particular application of the presently described closure system is of the closure of remote openings during minimal invasive surgery, such as, for example, Natural Orifice Transluminal Endoscopic Surgery (NOTES), closure of the visceral surface being crossed and the closure of patent foramen ovale. 
         [0317]    One of ordinary skill in the art will appreciate that a variety of surgical procedures result in a perforation in a lumen of the patient. In some embodiments, the surgical procedure is SILS (single incision laparoscopic surgery, also known as “belly-button surgery”), NOTES, or laparoscopic surgery. 
         [0318]    In some embodiments, the present invention is directed to a closure system and method of percutaneous closure of an arteriotomy following an endovascular/intra-arterial procedures. 
         [0319]    A method of closing an arteriotomy is also described. The method includes advancing a closure system into a lumen of an artery, the closure system including a foot, at least one suture, at least one bolster attached to a proximal end of the at least one suture, and a needle/shuttle attached to a distal end of the at least one suture; deploying a flexible portion of the foot within the lumen of the artery; driving the needle through the foot to a posterior surface of the foot; and applying a tensile force on the at least one suture, the at least one bolster is secured against a adventitial surface of the artery in response to the tensile force and the foot is secured against a luminal surface of the artery in response to the tensile force. At least one of the foot, the suture, the bolster and the needle are bio-degradable. The method further includes anchoring the needle/shuttle against the posterior surface of the foot in response to the tensile force. In addition, the method further includes aligning, by the intra-arterial foot, at least two wound edges of an arteriotomy. In one embodiment, the foot is secured against a luminal surface of the artery in response to the tensile force. In addition, the foot forms a seal with a portion of the arteriotomy. 
         [0320]    Although the present invention has been described with reference to particular examples and embodiments, it should be understood that the present invention is not limited to those examples and embodiments. Moreover, the features of the particular examples and embodiments may be used in any suitable combination. The present invention therefore includes variations from the various examples and embodiments described herein, as will be apparent to one of skill in the art.