Abstract:
A method of locating a vessel lumen to enable placement of a vascular hole closure device comprising the steps of providing a syringe containing a fluid therein, connecting the syringe to an elongated instrument, exerting a force on the syringe plunger as it is inserted through the tissue towards the vessel wall, and detecting movement of the syringe to eject the fluid to determine entry of the elongated instrument into the vessel lumen.

Description:
[0001]    This application claims priority from provisional patent application serial No. 60/355,526, filed Feb. 6, 2002 and is a continuation-in-part of U.S. patent application Ser. No. 09/659,648, filed Sep. 12, 2000 which claims priority from provisional patent application serial No. 60/153,736, filed Sep. 13, 1999. 
     
    
     
       BACKGROUND  
         [0002]    1. Technical Field  
           [0003]    This application relates to a vascular device and more particularly to a device for closing openings in vessel walls.  
           [0004]    2. Background of Related Art  
           [0005]    During certain types of vascular surgery, catheters are inserted through an incision in the skin and underlying tissue to access the femoral artery in the patient&#39;s leg. The catheter is then inserted through the access opening made in the wall of the femoral artery and guided through the artery to the desired site to perform surgical procedures such as angioplasty or plaque removal. After the surgical procedure is completed and the catheter is removed from the patient, the access hole must be closed. This is quite difficult not only because of the high blood flow from the artery, but also because there are many layers of tissue that must be penetrated to reach the femoral artery.  
           [0006]    Several approaches to date have been used to close femoral access holes. In one approach, manual compression by hand over the puncture site is augmented by a sandbag or weight until the blood coagulates. With this approach, it can take up to six hours for the vessel hole to close and for the patient to be able to ambulate. This inefficiency increases the surgical procedure time as well as the overall cost of the procedure since the hospital staff must physically maintain pressure and the patient&#39;s discharge is delayed because of the inability to ambulate.  
           [0007]    In another approach to close the vessel puncture site, a clamp is attached to the operating table and the patient&#39;s leg. The clamp applies pressure to the vessel opening. The patient, however, must still be monitored to ensure the blood is coagulating, requiring additional time of the hospital staff and increasing the cost of the procedure.  
           [0008]    To avoid the foregoing disadvantages of manual pressure approaches, suturing devices have been developed. One such suturing device, referred to as “the Closer” and sold by Perclose, advances needles adjacent the vessel wall opening and pulls suture material outwardly through the wall adjacent the opening. The surgeon then ties a knot in the suture, closing the opening. One difficulty with the procedure involves the number of steps required by the surgeon to deploy the needles, capture the suture, withdraw the suture, and tie the knot and secure the suture. Moreover, the surgeon cannot easily visualize the suture because of the depth of the femoral artery (relative to the skin) and essentially ties the suture knot blindly or blindly slips a pre-tied knot into position. Additionally, the ability to tie the knot varies among surgeons; therefore success and accuracy of the hole closure can be dependent on the skill of the surgeon. Yet another disadvantage of this suturing instrument is that the vessel opening is widened for insertion of the instrument, thus creating a bigger opening to close in the case of failure to deliver the closure system. It is also difficult to pass the needle through calcified vessels.  
           [0009]    U.S. Pat. No. 4,744,364 discloses another approach for sealing a vessel puncture in the form of a device having an expandable closure member with a filament for pulling it against the vessel wall. The closure member is held in place by a strip of tape placed on the skin to hold the filament in place. However, the closure device is still subject to movement which can cause leakage through the puncture. Additionally, if the suture becomes loose, the closure member is not retained and can flow downstream in the vessel. Moreover, since the suture extends through the skin, a potential pathway for infection is created. The closure device in U.S. Pat. No. 5,545,178 includes a resorbable collagen foam plug located within the puncture tract. However, since coagulation typically takes up to twenty minutes and blood can leak in between the plug and tissue tract, manual pressure must be applied to the puncture for a period of time, until the collagen plug expands within the tract.  
           [0010]    It would therefore be advantageous to provide a device which would more quickly and effectively close openings (punctures) in vessel walls. Such device would advantageously avoid the aforementioned time and expense of applying manual pressure to the opening, simplify the steps required to close the opening, avoid widening of the opening, and more effectively retain the closure device in the vessel.  
         SUMMARY  
         [0011]    The present invention overcomes the disadvantages and deficiencies of the prior art. The present invention provides a device for closing an aperture in a vessel wall comprising an elongated member positionable inside the vessel against an internal opening of the aperture and having a dimension at least substantially equal to a dimension of the internal opening to prevent egress of fluid through the aperture, and at least two curved legs positionable outside the vessel to help retain the elongated member in position.  
           [0012]    The at least two curved legs are preferably wires composed of shape memory material. In one embodiment, a connecting member in the form of a flexible wire couples the curved legs to the elongated member. Preferably, a retaining member in the form of a collar secures the curved legs therein.  
           [0013]    In one embodiment, a tube having a series of slots for flexibility and an opening to receive the curved legs is connected to the elongated member for moving the elongated member toward the internal opening of the aperture.  
           [0014]    In one embodiment, the elongated member has a lengthwise dimension exceeding the widthwise dimension, and the widthwise dimension has an enlarged dimension at a region between first and second ends of the elongated member. In another embodiment, the elongated member has an enlarged width region at one end and an adjacent reduced width region at another end. The elongated member, in one embodiment, is composed of a resorbable material. In a preferred embodiment, the elongated member is biased to a position transverse to an axis extending from the external opening to the internal opening.  
           [0015]    The present invention also provides an apparatus for closing an aperture in a vessel comprising a closure device having an aperture covering member and at least one leg connected to the covering member wherein the covering member and the at least one leg are movable between an insertion position and a deployed position. In the insertion position, the covering member is substantially parallel to a longitudinal axis of the aperture and in the deployed position the covering member is substantially perpendicular to the longitudinal axis of the aperture on a first side of the aperture. In the insertion position, the at least one leg is in a substantially straightened position and in the deployed position has a curved configuration to grasp tissue on a second side of the aperture.  
           [0016]    In one embodiment, a plurality of curved legs are provided, composed of wire elements which extend downwardly toward the vessel and inwardly toward the aperture in the deployed position. The aperture covering member preferably has an enlarged width portion. In one embodiment, the aperture covering member is composed of a resorbable material.  
           [0017]    The present invention also provides an apparatus for closing an aperture in a vessel comprising a patching member and a retaining member, wherein the patching member is positioned inside the vessel in contact along a portion of the inner vessel wall and has a dimension at least substantially equal to a dimension of the aperture to cover the aperture and prevent blood flow through the aperture. The retaining member is positioned outside the vessel wall and includes at least one gripping element which extends inwardly toward the aperture and directs tissue towards the aperture.  
           [0018]    A system for closing an aperture in a vessel wall is also provided comprising a closure device and a delivery instrument for delivering the closure device. The closure device has an aperture covering member and a retaining member, wherein the aperture covering member is positionable inside the vessel and dimensioned to cover an internal side of the aperture and the retaining member has a plurality of curved legs engaging tissue outside the vessel. The delivery instrument has a holding member releasably engagable with the closure device to position and to release the closure device.  
           [0019]    In one embodiment, the holding member comprises a slotted tube releasably positioned over a portion of the closure device. The slotted tube can be positioned over a collar which retains the curved legs.  
           [0020]    The present invention further provides a system for closing an aperture in a vessel wall comprising:  
           [0021]    a) a closure device having an aperture covering member and a retaining member, the aperture covering member positionable inside the vessel and dimensioned to cover an internal side of the aperture in the vessel wall, and the retaining member having a plurality of curved legs engaging tissue outside the vessel; and  
           [0022]    b) a delivery instrument for delivering the closure device, the delivery instrument having an outer tube and a pusher slidably disposed within the outer tube, wherein the pusher engages the retaining member to advance the covering member from the outer tube.  
           [0023]    The delivery instrument is preferably insertable through an introducer sheath, and snap fitted thereon, such that a distal end of the outer tube remains proximal of a distal end of the introducer sheath. The pusher in one embodiment has a plurality of longitudinal slots to receive the curved legs when in a straightened position within the delivery instrument. A retention mechanism is preferably provided for retaining the pusher in an initial position and in an advanced position to deploy the retaining member. In one embodiment, a portion of the outer tube has a diameter less than a lengthwise dimension of the aperture covering member so that the portion of the outer tube bulges outwardly when the covering member is positioned therein.  
           [0024]    The present invention also provides a method for closing an aperture in a vessel wall comprising:  
           [0025]    providing a closure device having an elongated member and a plurality of retention legs;  
           [0026]    deploying the elongated member in the vessel to cover a first internal side of the aperture; and  
           [0027]    deploying the retention legs outside the vessel wall wherein the legs assume a curved configuration to grasp tissue on a second external side of the aperture.  
           [0028]    The step of deploying the elongated member preferably comprises the step of actuating a pusher to advance the elongated member distally. The method may further comprise the steps of placing an introducer sheath through the aperture into the vessel and connecting a delivery instrument containing the closure device to the sheath. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0029]    Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:  
         [0030]    [0030]FIG. 1 is a perspective view of a first embodiment of the closure device of the present invention showing the clip legs in their memorized position;  
         [0031]    [0031]FIG. 2 is a bottom view of the closure device of FIG. 1;  
         [0032]    FIGS.  3 - 5  are front views of the closure device of FIG. 1 (the suture not shown for clarity) showing movement of the clip legs to their memorized position wherein:  
         [0033]    [0033]FIG. 3 shows the clip legs in a partially deflected (curved) position;  
         [0034]    [0034]FIG. 4 shows the clip legs in a further deflected position; and  
         [0035]    [0035]FIG. 5 shows the clip legs in their memorized position;  
         [0036]    [0036]FIG. 6 is a side view illustrating the closure device of FIG. 1 partially deployed from the introducer sheath wherein the elongated member is retained in a longitudinal position;  
         [0037]    [0037]FIG. 7 is a view similar to FIG. 6 except showing the closure device further deployed from the introducer sheath to enable the elongated member to rotate to its transverse position;  
         [0038]    [0038]FIG. 8 is a transverse cross-sectional view showing the positioning of the connecting wire and the clip legs within the collar of the closure device;  
         [0039]    [0039]FIG. 9A is a perspective view of a second embodiment of the closure device of the present invention having an alternately configured elongated member;  
         [0040]    [0040]FIG. 9B is a perspective view of a third embodiment of the closure device of the present invention having a paddle shaped elongated member;  
         [0041]    [0041]FIG. 9C is an exploded view of the closure device of FIG. 9B;  
         [0042]    [0042]FIG. 9D is a side view of the closure device of FIG. 9B;  
         [0043]    [0043]FIG. 9E is a transverse cross-sectional view showing the positioning of the connecting wire and clip legs of FIG. 9B within the collar of the closure device;  
         [0044]    [0044]FIG. 10A is a perspective view of a Fourth embodiment of the closure device of the present invention having clip legs formed of independent flat wire sections;  
         [0045]    [0045]FIG. 10B is a perspective view of a fifth embodiment of the closure device of the present invention having clip legs integrally formed from rectangular tubing;  
         [0046]    [0046]FIG. 11A is a perspective view of a sixth embodiment of the closure device of the present invention having a connecting wire extending through an eyelet of the elongated member;  
         [0047]    [0047]FIG. 11B is a perspective view of a seventh embodiment of the closure device of the present invention having a connecting wire insert molded in the elongated member;  
         [0048]    [0048]FIG. 11C is a perspective view of an eighth embodiment of the closure device of the present invention having flattened clip legs with a retaining mechanism engagable with the collar;  
         [0049]    [0049]FIG. 11D is a schematic representation of an elongated member with varying regions of resorbability;  
         [0050]    FIGS.  12 A- 12 E are perspective views, with a portion of the vessel cut away, illustrating a first method of delivery of the closure device of FIG. 1 wherein:  
         [0051]    [0051]FIG. 12A shows the dilator and sheath inserted over the guidewire into the target vessel;  
         [0052]    [0052]FIG. 12B shows the delivery instrument positioned within the introducer sheath inserted through the skin opening and through the vessel wall aperture into the interior of the vessel;  
         [0053]    [0053]FIG. 12C illustrates the elongated member of the closure device advanced beyond the distal end of the introducer sheath into the vessel lumen;  
         [0054]    [0054]FIG. 12D illustrates the closure device pulled proximally so the elongated member abuts the internal wall of the vessel to cover the internal opening of the aperture; and  
         [0055]    [0055]FIG. 12E illustrates the introducer sheath and delivery instrument being fully withdrawn to fully deploy the closure device so the clip legs move toward their memorized position to engage the tissue;  
         [0056]    [0056]FIG. 12F is a side view showing the introducer sheath extending through the internal and external openings of the vessel wall aperture;  
         [0057]    FIGS.  13 A- 13 E are perspective views, with a portion of the vessel cut away, illustrating an alternate method of delivery of the closure device of FIG. 1 wherein:  
         [0058]    [0058]FIG. 13A shows the dilator and sheath being inserted over the guidewire into the target vessel;  
         [0059]    [0059]FIG. 13B shows the delivery instrument positioned within the introducer sheath inserted through the skin opening and through the vessel wall aperture into the interior of the vessel to a position where it is desirable to deploy the elongated member;  
         [0060]    [0060]FIG. 13C illustrates the introducer sheath withdrawn proximally in a slot in the delivery instrument to release the elongated member of the closure device into the vessel;  
         [0061]    [0061]FIG. 13D illustrates the closure device pulled proximally so the elongated member abuts the internal wall of the vessel to cover the internal opening of the aperture; and  
         [0062]    [0062]FIG. 13E illustrates the introducer sheath and delivery instrument being fully withdrawn to fully deploy the closure device so the clip legs move toward their memorized position to engage the tissue;  
         [0063]    [0063]FIG. 14 is a perspective view similar to FIGS. 12D and 13D showing the closure device partially deployed so that the elongated member is in its transverse position against the internal wall of the vessel;  
         [0064]    [0064]FIG. 15 is an enlarged perspective view of the region of the closure device outlined in FIG. 14;  
         [0065]    [0065]FIG. 16A is a perspective view of a ninth embodiment of the closure device of the present invention placed by a delivery instrument having a slotted tube overlying the collar;  
         [0066]    [0066]FIG. 16B is a perspective view of the slotted tube of FIG. 16A;  
         [0067]    [0067]FIG. 16C is a transverse cross-sectional view taken through the collar of FIG. 16A;  
         [0068]    [0068]FIG. 16D is a perspective view of an alternate delivery instrument of the present invention for placement of the closure device, the instrument having a pair of jaws engaging the collar (the clip legs removed for clarity);  
         [0069]    [0069]FIG. 17A is a front view of a tenth embodiment of the closure device of the present invention having a mushroom shaped aperture covering member;  
         [0070]    [0070]FIG. 17B is a side view of the closure device of FIG. 17A;  
         [0071]    [0071]FIG. 18 is a side view of another alternate embodiment of the delivery instrument for the closure device having a projecting tip for pivoting the elongated member;  
         [0072]    [0072]FIG. 19 is a side view of the closure device of FIG. 15 with the delivery instrument of FIG. 18;  
         [0073]    [0073]FIG. 20 is a side view of an eleventh embodiment of the closure device of the present invention having a wire offset with respect to the elongated member for biasing the elongated member to the transverse position;  
         [0074]    [0074]FIG. 21 is a perspective view of yet another alternate embodiment of the delivery instrument for the closure device of the present invention having a pair of jaws for grasping and releasing the closure device;  
         [0075]    [0075]FIG. 22 is an enlarged view of the region outlined in FIG. 21 showing the jaws grasping the closure device;  
         [0076]    [0076]FIG. 23A is a perspective view of an insertion tube configured for insertion into the introducer sheath;  
         [0077]    [0077]FIG. 23B is a longitudinal cross-sectional view of the insertion tube positioned within the introducer sheath;  
         [0078]    [0078]FIG. 24A is a side view of the delivery instrument being inserted into the introducer sheath;  
         [0079]    [0079]FIG. 24B is a view taken along lines B-B of FIG. 24A showing the sheath and insertion tube in cross-section and the closure device positioned therein;  
         [0080]    [0080]FIG. 25A is a side view similar to FIG. 24A except showing the delivery instrument inserted further into the introducer sheath;  
         [0081]    [0081]FIG. 25B is a view taken along lines B-B of FIG. 25A showing the introducer sheath in cross section and the closure device positioned therein deflecting the sheath;  
         [0082]    [0082]FIG. 26A is a side view similar to FIG. 24A except showing the delivery instrument fully inserted into the introducer sheath;  
         [0083]    [0083]FIG. 26B is a cross-sectional view taken along lines B-B of FIG. 26A showing the closure device positioned therein and deflecting the sheath;  
         [0084]    [0084]FIG. 26C is a cross-sectional view of the distal end of the introducer sheath of FIG. 26A;  
         [0085]    [0085]FIG. 26D is a cross-sectional view similar to FIG. 26B except showing the closure device of FIG. 11B positioned in the introducer sheath;  
         [0086]    [0086]FIG. 27A is a perspective view of a twelfth embodiment of the closure device of the present invention having a spiral tube;  
         [0087]    [0087]FIG. 27B is a perspective view of the closure device of FIG. 27A positioned to close the aperture in the vessel wall;  
         [0088]    [0088]FIG. 28A is a side view of a thirteenth embodiment of the closure device having a single clip leg shown in a deflected position;  
         [0089]    [0089]FIG. 28B is a side view of the clip of FIG. 28A showing the range of movement of the clip leg;  
         [0090]    [0090]FIG. 29A is a side view of a fourteenth embodiment of the closure device having a single clip leg shown in a partially deflected position;  
         [0091]    [0091]FIG. 29B is a side view of the closure device of FIG. 29A showing the clip leg in a fully deflected position;  
         [0092]    [0092]FIG. 30 is a side view of the closure device of FIG. 29A showing the clip leg in the straightened position within the delivery instrument;  
         [0093]    [0093]FIG. 31 is a perspective view of another alternate embodiment of the delivery instrument of the present invention for placement of the closure device showing the instrument positioned in an introducer sheath, the plunger in the retracted position, and the syringe connected to the extension assembly;  
         [0094]    [0094]FIG. 32 is a cross-sectional view of the proximal end of the delivery instrument of FIG. 31 showing the plunger in the retracted position;  
         [0095]    [0095]FIG. 33 is a transverse cross-sectional view taken along lines C-C of the delivery instrument of FIG. 31 (with the introducer sheath removed for clarity);  
         [0096]    [0096]FIG. 34 is a longitudinal sectional view showing a portion of the delivery instrument of FIG. 31 positioned in an introducer sheath;  
         [0097]    [0097]FIG. 35 is a side view illustrating the distal end of the delivery instrument and the closure device in the introducer sheath; and  
         [0098]    [0098]FIG. 36 is a side view showing the elongated member advanced from the delivery instrument and introducer sheath by the pusher. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0099]    Referring now in detail to the drawings where like reference numerals identify similar or like components throughout the several views, FIG. 1 is a perspective view of first embodiment of the vascular hole (aperture) closure device of the present invention. The device is intended to close an aperture in the vessel wall, typically formed after removal of a catheter previously inserted through the vessel wall into the vessel lumen for performing angioplasty or other interventional procedures. The aperture extends through the patient&#39;s skin and underlying tissue, through the external wall of the vessel, through the wall of the vessel, and through the internal wall of the vessel to communicate with the internal lumen of the vessel. The closure devices of the present invention have a covering member or patch positioned within the vessel pressing against the internal wall of the vessel to block blood flow and a clip positioned external of the vessel wall to retain the covering member. The clip pulls the covering member upwardly towards the aperture.  
         [0100]    Turning first to FIGS.  1 - 5 , a first embodiment of the closure device of the present invention is illustrated. Hole (aperture) closure device  10  has an elongated member  12  and a clip  14  having four legs, preferably in the form of wires,  30   a ,  30   b ,  30   c , and  30   d  retained within a collar  38 . The elongated member  12  is dimensioned and configured for positioning inside the vessel on the internal side of the aperture; the wires  30   a - 30   d  are configured to be positioned outside the vessel wall adjacent the external side of the aperture.  
         [0101]    Elongated member  12  is retained in a longitudinal position for delivery to the vessel, and then pivots to a transverse position within the vessel lumen. This movement is illustrated in FIGS. 6 and 7 wherein elongated member  12  is partially deployed from the introducer sheath  300 , but still retained in a longitudinal position by engagement of the wall at distal end  303  (FIG. 6) with end region  18 . When fully deployed from the introducer sheath  300 , end region  18  of elongated member  12  is also released so it can pivot to the transverse position of FIG. 7 where it&#39;s substantially perpendicular to an axis extending through the aperture. Note that preferably the center of collar  38  is slightly offset from the eyelet  24 , enabling the elongated member  12  to pivot slightly when deployed; the vessel wall can then further pivot the elongated member to a transverse position as it is pulled back against the wall. This movement is described in more detail below in conjunction with the discussion of the method of insertion of closure device  10 . The legs  30   a - 30   e  of the clip  14  are retained in a substantially straightened position for delivery and when released moved to a curved configuration. This is also discussed in detail below.  
         [0102]    The elongated member  12  functions to cover (patch) the internal opening in the vessel wall to prevent the egress of blood. As illustrated in FIGS. 1 and 2, the elongated (covering) member has an enlarged region  20  between the first and second end regions  16 ,  18 . The longitudinal axis defines a lengthwise dimension L and transverse axes define widthwise dimensions. The widthwise dimension w1 at the ends  16  and  18  of the elongated member  12  are preferably substantially equal and preferably range from about 0.025 inches to about 0.035 inches. At the enlarged region  20 , the widthwise dimension progressively increases, so its maximum width w2 preferably ranges from about 0.090 inches to about 0.125 inches. This central enlarged region  20  of elongated member  12  provides a larger area to patch (cover) the internal opening in the vessel. The width w2 preferably is at least substantially equal to the dimension of the internal opening to effectively cover the opening. Other dimensions are also contemplated.  
         [0103]    It should be appreciated that the elongated member could be provided without an enlarged region as long as it has sufficient area to cover the opening (aperture). This is illustrated by way of example in FIG. 9A, wherein closure device  50  has an elongated member  60  which is substantially uniform in width throughout its length. In this embodiment, connecting wire  56  abuts projecting surface  62  of elongated member  60  to tip (pivot) the elongated member  60 . In all other respects, closure device  50  is identical to device  10 , e.g. four legs  52   a ,  52   b ,  52   c  and  52   d  retained within a collar  59  and connected to elongated member  60  by connecting wire  56  extending through the opening in projecting surface  62 .  
         [0104]    The elongated member could also be configured asymmetrically so that the enlarged region is off centered to accommodate widening of the aperture as the member is pulled at an angle. The elongated member can also be configured in a paddle shape with a narrowed region adjacent a wider region as discussed below in conjunction with FIGS.  9 B- 9 E.  
         [0105]    The elongated member can be composed of materials such as polycarbonate or polyurethane, or alternatively can be composed of resorbable materials such as glycolide/lactide polymers which after a period of time resorbs in the body, leaving only the clip portion external of the vessel lumen. If composed of resorbable material, the elongated member could optionally have regions of varying resorbability. One example is shown in FIG. 11D, where region R 1  would be the last to resorb, region R 2  would resorb at a slower rate, and Region R 3  would be the first to resorb. One of more of these regions, e.g. R 1  and R 2 , could optionally not be resorbable.  
         [0106]    With continued reference to the closure device  10  of FIGS.  1 - 5 , the elongated member  12  has an opening or eyelet  24  formed in projecting surface  22 . Opening  24  receives a connecting wire  40  to couple the clip  14  to the elongated member  12 .  
         [0107]    The clip legs  30   a - 30   d  of clip  14  each have a first portion which extends through collar  38 , terminating at ends  33   a - 33   d , respectively, and a second end  32   a - 32   d , respectively, which is configured to engage tissue. In FIG. 1, the ends  32   a - 32   d  are non-penetrating blunt tips. However, it is also contemplated that sharpened or tissue penetrating tips could alternatively be provided. The clip legs  30   a - 30   d  are retained in the collar  38  by laser welding, glue, or other securing means. Alternatively, the clip legs can be welded or otherwise attached to each other (and the connecting wire) without the need for a collar.  
         [0108]    Also fixed within collar  38 , by any suitable means, e.g. laser welding or glue, is connecting wire  40  which loops at region  42  through opening  24 . The two ends of the connecting wire are designated by reference numeral  44 . (Only one end is shown). FIG. 8 illustrates a transverse cross-sectional view taken through collar  38  to illustrate the positioning of the clip legs  30   a - 30   d  and connecting wire  40  within the collar  38 . Suture  45  also extends through eyelet  24  and functions to position the elongated member  12  as described in detail below.  
         [0109]    Clip legs  30   a ,  30   b ,  30   c , and  30   d  are preferably composed of four discrete wire elements composed of shape memory material, such as Nitinol (nickel titanium alloy) with a memorized position of that shown in FIG. 5. In use, the clip legs  30   a - 30   d  are retained in the delivery instrument in a substantially straightened position, and when released, are warmed by body temperature to curve inwardly as shown in FIGS. 3 and 4. The extent to which the clip legs can return to their memorized position will depend on the thickness and resistance of the tissue. Once curved inwardly, the curved clip legs  30   a - 30   d  grasp the tissue to retain the closure device  10  within the tissue. As the legs  30   a - 30   d  curve inwardly, they apply a proximal pulling force on the elongated member  12  to pull it slightly upwardly (proximally) against the vessel wall. The legs may gather and force tissue on the external side of the vessel wall toward the opening.  
         [0110]    [0110]FIG. 10A illustrates an alternate embodiment of the closure device of the present invention, designated by reference numeral  70 . Closure device  70  is similar to closure device  10  except for the shape of the clip legs  78  (only two of which are shown) and the collar  75 . Clip legs  78  (preferably four are provided) are made of wire having a rectangular cross-sectional shape. The clip legs  78 , as shown, are formed into an elongated U-shape. Also, instead of the cylindrical collar  38  of closure device  10 , a rectangular shaped collar  75  is provided. In all other respects, e.g. elongated covering member  72 , connecting wire  73 , etc. closure device  70  is identical to closure device  10 .  
         [0111]    In the embodiment of FIG. 10B, the clip legs  84   a - 84   d  of closure device  80  are initially formed from rectangular (or square) tubing. As shown, tubing  86  is split, preferably by laser cutting to form the four curved legs  84   a - 84   d  which in their closed position form a C-shape configuration. Elongated covering member  85  is identical to elongated member  12  of closure device  10  with an enlarged width region  85  for covering (patching) the internal side of the opening. A connecting wire  83  connects the clip portion to the elongated member via eyelet  88 . Plug  87  is slip fit over connecting wire  83  and has one or more tabs  89  snap fit through window  86   a  in tubing  86  to connect the elongated member  82  to the tubing  86 .  
         [0112]    It should be appreciated that the other embodiments disclosed herein could also have retaining tabs for attachment to the collar portion.  
         [0113]    [0113]FIG. 11A is a perspective view of another alternate embodiment of the closure device. In this embodiment, closure device  90  has four legs  94  (only two of which are shown) as in the embodiment of FIG. 1. Instead of a suture extending through the eyelet  24  as shown in FIGS. 1 and 14, suture  97  is connected to the loop  95  of connecting wire  96 . That is, connecting wire  96  is looped through eyelet  93  of elongated member  92  at one end and receives a suture loop  95  at the opposite end. In this manner, as the suture is pulled proximally, the elongated member (and clip) are pulled proximally. Connecting wire  96  is preferably attached within collar  98  by laser welding, gluing, or other suitable means. Connecting wire  96  can be utilized to bias the elongated member to a transverse position.  
         [0114]    In the embodiment of FIG. 11B, the connecting wire  116  of closure device  110  is embedded, e.g. insert molded, within the elongated member  112 . This reduces the profile of the elongated member  112  since the projecting surface (protrusion) as in the FIG. 11A embodiment is eliminated. Also, the connecting wire  116  is made of material, e.g. shape memory metal, which is designed to be in a substantially straightened position, or alternatively in an angled position such as 45 degrees. This configuration biases the elongated member  112  to the transverse position. Otherwise, device  110  is identical to device  90 , e.g. legs  114  (only two are shown), suture  117  attached to connecting wire  116 , etc.  
         [0115]    FIGS.  9 B- 9 E illustrate an alternate embodiment of the closure device, designated by reference numeral  140 , having a flexible connecting wire  146  attached to elongated covering member  142  by insert molding, mechanical connection or other suitable means. As shown, connecting wire  146 , optionally composed of shape memory material such as Nitinol, is positioned off center of the connecting member  142  to bias it to the transverse position and to facilitate movement of the connecting member  142  to the longitudinal position for delivery to the vessel. The proximal end of connecting wire  146  is attached by suitable means to the collar  148 . Four clip legs  144  as in the embodiment of FIG. 1 are provided. The clip legs  144  can have hooked tips  145  as shown which are positioned within and engage collar  148  to facilitate securement therein.  
         [0116]    The elongated covering member  142  is paddle shaped having an enlarged region  142   a  and a narrowed region  142   b , thereby reducing its profile so the overall amount of material left in the vessel after placement of the closure device  140  is reduced. Narrowed region  142   b  can optionally progressively taper starting from the transition with the enlarged region  142   a.    
         [0117]    In a preferred manufacturing method, the collar  148 , clip legs  144  and connecting wire  146  are laser welded together. The connecting wire  146 , with tag end  147  is subsequently connected to covering member  142  in the orientation shown. In this preferred attachment method, covering member  142  has a longitudinal slot with interference bumps (not shown) dimensioned to receive the tag end  147  of connecting wire  142 . Absorbable or non-absorbable glue could optionally be applied to enhance the attachment of tag end  147  and to provide a seal.  
         [0118]    [0118]FIG. 11C illustrates another alternate embodiment of the closure device, designated by reference numeral  130 . Closure device  130  has clip legs  134   a - 134   d  with planar surfaces formed from wire of rectangular cross-section and is preferably composed of shape memory metal. A connecting strap  136 , or alternatively a connecting wire like wire  96  of FIG. 11A, extends through eyelet  133  of elongated member  132 . Suture  137  is looped through strap  136  for pulling elongated member  132  against the internal opening of the aperture. The clip legs  134   a - 134   d  are retained within collar  138  by engagement of a respective tab  139  on each of the legs extending through a respective window  135  on collar  138 .  
         [0119]    In the closure devices described herein, four discrete wire legs are disclosed spaced approximately 90 degrees apart. However, it is also contemplated that fewer legs, e.g. two legs spaced approximately 180 degrees apart or three legs spaced approximately 120 degrees apart, or more than four legs can be provided to achieve the device retention function. It should be appreciated that in a four clip version, to conserve space, i.e. minimize the size for positioning within the delivery instrument and introducer sheath, the legs need not be symmetrically spaced with respect to one another, but preferably at least the opposing legs would be about 180 degrees apart. (see e.g. FIG. 16C).  
         [0120]    FIGS.  28 - 30  illustrate an example of a single clip leg utilized to retain the elongated member and exert a proximal force on the tissue and elongated member. In FIGS. 28A, 28B, curved clip leg  702 , when deployed from delivery instrument  703  curves inwardly as shown to grasp tissue and secure elongated member  704  against the internal vessel wall. In FIGS. 29 and 30, clip leg  740 , directly connected to elongated member  744 , is retained in a substantially straightened position within the delivery instrument  742  (FIG. 30), and when deployed curves around itself, to form a spring-like element, as shown in FIG. 29B. This clip leg  740  coils to pull up on the elongated member  744  to retain it within the vessel.  
         [0121]    Also, in each of the embodiments described herein, blunt tips or sharpened tips can be provided on the clip legs to perform their gripping function. Although preferably composed of shape memory material, the clip legs can alternatively be composed of stainless steel, resorbable material, or other materials.  
         [0122]    Tuning now to the placement of the closure device of the present invention, FIGS.  12 A- 12 E illustrate a first insertion method. The method illustrated shows placement of closure device  10 , however, it should be understood that the other closure devices described herein can be inserted in a similar manner.  
         [0123]    As shown in FIG. 12A, a dilator  304  is inserted through introducer sheath  300  and over a guidewire  302  into the vessel lumen. Note the sheath and dilator  304  extend through opening “a” in the skin, through the tissue tract to the vessel V, through external opening “b” in the vessel wall, through the aperture in the vessel wall “w”, and through an internal opening “c” on the interior side of the vessel wall into the vessel lumen (see also FIG. 12F).  
         [0124]    Next, the guidewire  302  and dilator  304  are withdrawn, and closure applying (delivery) instrument  310  is inserted through the sheath  300  into the vessel lumen as shown in FIG. 12B. The elongated member  12  extends distally of the delivery instrument  310  and is retained in a longitudinal position by the walls of the introducer sheath  300 ; the clip legs are retained in a substantially straightened position in a martensitic state within the delivery instrument by the infusion of cold saline.  
         [0125]    The delivery instrument  310  is advanced through the introducer sheath  300  and past the distal tip  303  so the elongated member  12  is outside the confines of the wall of the introducer sheath  300  and extends into the vessel lumen sufficiently spaced from the internal opening in the vessel wall. This provides sufficient room for pivotal movement of the elongated member  12 . As the elongated member  12  is released from the confines of the wall, it is enabled to pivot toward a transverse position as shown in FIG. 12C.  
         [0126]    Next, the sheath  300  and delivery instrument  310  are pulled proximally as a unit until the elongated member is seated against the internal opening c in the vessel wall w. (It is contemplated that the sheath  300  and instrument  310  can optionally be fitted (locked) together so they can be moved as a single unit.) Suture  45  extending through eyelet  24  of elongated member  12  (see FIGS. 14 and 15), is attached to the delivery instrument  310  so that pulling the delivery instrument proximally pulls the suture  45  and thus the elongated member  12  proximally. The elongated member  12  is pulled proximally to cover the opening in a patch-like manner with the enlarged region  20  spanning the internal opening c to prevent egress of fluid. Note that the vessel wall further pivots the elongated member to the fully transverse position.  
         [0127]    Once elongated member  12  is seated, the closure device is further ejected from the delivery device  310  by distal movement of a pusher (not shown) against the clip legs, thereby forcing clip  14  from the delivery instrument  310  so the clip legs  30   a - 30   d  are warmed by body temperature and move towards their memorized configuration. FIG. 12E illustrates the closure device  10  in position with elongated member  12  abutting internal opening c on the internal side of the vessel V to cover (patch) the opening and the retention legs  30   a - 30   d  curving downwardly and preferably slightly inwardly towards the tissue tract and aperture to engage the tissue and apply a proximal (upward) force on the elongated member  12 . Tissue can also be forced by the curved clip legs  30   a - 30   d  towards the aperture and tissue tract on the external side of the vessel wall. FIG. 12E also shows the introducer sheath  300  (and delivery device  310 ) being withdrawn from the patient&#39;s body. The suture is withdrawn with the delivery device  310 .  
         [0128]    Note that in one embodiment, the suture would be designed to automatically rip when a sufficient load (exceeding a threshold amount) was placed on the suture, thereby separating the closure device from the delivery instrument.  
         [0129]    In an alternate insertion method, when the delivery instrument  310  is inserted through the introducer sheath  300 , and the elongated member  12  remains within the confines of the wall of the introducer sheath  300  the elongated member is ejected by a pusher rather than by advancement of the delivery instrument. That is, the pusher inside the delivery instrument would be actuated to advance the closure device so the elongated member  12  is moved distally, outside the confines of the introducer sheath wall. In this deployed position of the elongated member  12 , the clip legs  30   a - 30   d  still remain within the delivery instrument  310  and are not yet deployed. Optionally, the delivery instrument  310  can lock into the sheath  300  at a proximal end. After pulling back on the elongated member  12  to cover the internal opening of the vessel, the clip legs  30   a - 30   d  are deployed by moving the delivery instrument  300  proximally to expose the clip legs or by further actuating the pusher to advance the clip legs from the delivery instrument.  
         [0130]    FIGS.  13 A- 13 E illustrate an alternate method of insertion of the closure device  10  of the present invention. It should be understood that the other closure devices disclosed herein could also be delivered with delivery instrument  320 . The delivery method of FIGS.  13 A- 13 E is the same as the method of FIGS.  12 A- 12 E except that instead of advancing the closure device distally to free the elongated member for pivotal movement, the introducer sheath  300  is retracted with respect to delivery instrument  320 .  
         [0131]    More specifically, in this method, the dilator (FIG. 13A) is introduced over the guide wire in the same manner as FIG. 12A. Note FIG. 13A shows partial introduction as the sheath would be advanced further into the vessel corresponding to the position of FIG. 13B. Note also, the introducer sheath  300  is inserted into the vessel, but further into the vessel than in the method of FIG. 12, as shown in FIG. 13B. That is, the distal tip  303  of the introducer sheath  300  is moved to the position where it is desired to release the elongated member  12  into the vessel. Once in position, the introducer sheath  300  is retracted with respect to the delivery instrument  320 , with tubing connector  314  received in a slot  322  of delivery instrument  320 . As the sheath  300  is retracted, the elongated member  312  is exposed as shown in FIG. 13C, thus enabling the elongated member  12  to pivot towards its transverse position as it is no longer retained by the wall of the introducer sheath  300 . The remaining steps for pulling the elongated member  12  proximally and releasing the clip (illustrated in FIGS. 13D and 13E) are identical to the steps described above with respect to FIGS. 12D and 12E.  
         [0132]    To enable movement between an expanded and collapsed configuration in the delivery methods described herein, as noted above, clips legs  30   a - 30   d  are preferably made of shape memory metal material, such as Nitinol, a nickel titanium alloy. To facilitate passage of the clip legs through the lumen of the delivery instrument  320  and into the vessel, cold saline is injected into the delivery instrument  320  and around the legs  30   a - 30   d  in their collapsed position within the delivery instrument  320 . This shape memory material characteristically exhibits rigidity in the austenitic state and more flexibility in the martensitic state. The cold saline maintains the temperature dependent wires  30   a - 30   d  in a relatively softer condition as they are in the martensitic state within the delivery instrument. This facilitates the exit of wires  30   a - 30   d  from the delivery instrument  320  as frictional contact between the wires  30   a - 30   d  and the inner surface of the instrument  320  would otherwise occur if the wires were maintained in a rigid, i.e. austenitic, condition. A stopcock  301  (see e.g. FIG. 24A) can control the flow of saline.  
         [0133]    [0133]FIG. 23A illustrates an insertion tube  500  which can be utilized with the introducer sheath  300  to enable a larger dimensioned delivery instrument and larger dimensioned elongated member  12  to be inserted through the introducer sheath  300 . Insertion tube  500  has a head portion  502  and an elongated tubular portion  504  extending from head portion  502 . A lumen  506  extends through the tube  500 . As shown in FIG. 23B, insertion tube  500  is inserted through the valve  308  and into the lumen  309  of introducer sheath  300 . The tube  500  terminates proximal of the reduced lumen area  307  of sheath  300 . Tube  500  steps down to a smaller internal lumen diameter at region  509 .  
         [0134]    The lumen  506  of insertion tube  500  preferably has a diameter of about 0.096 inches and can preferably step down to about 0.088 inches (region  509 ). The lumen  309  of the introducer sheath  300  preferably has a diameter of about 0.125 inches and the reduced lumen area  307  preferably has a diameter D2 of about 0.087 inches, preferably stepped down to a diameter D3 of about 0.079 inches (see FIG. 26C). Preferably, the outer diameter D1 of the introducer sheath  300  is about 0.105 inches and the outer diameter of the tubular portion  504  of the insertion tube  500  is about 0.114 inches. The delivery instrument preferably has an outer diameter of about 0.079 inches. The elongated member  12  preferably has a lengthwise dimension of about 0.313 inches (8 mm). (Note that the foregoing dimensions are provided by way of example and other dimensions are also contemplated.)  
         [0135]    Due to the use of insertion tube  500 , the elongated member  12  can be positioned outside the delivery instrument  310  and fed into the lumen  506  of tube  500  and lumens  309 ,  307 ,  305  of the sheath  300 . As shown in FIGS.  24 - 26 , when initially inserted, the closure device (collar  38 , elongated member  12 , etc.) fits within the confines of the sheath  300  without deflecting the sheath wall (FIG. 24B). When the delivery instrument  310  is inserted further into the introducer sheath  500  as shown in FIG. 25A, the sheath wall is deflected as shown in FIG. 25B and is deformed as it is deflected beyond its elastic limit since the internal diameter of the tip is smaller. Full insertion shown in FIG. 26A further deflects (deforms) the wall as shown in FIG. 26B, beyond its elastic limit. Without the use of insertion tube  500 , the elongated member  12  would have to be retained within the delivery instrument  310 , which would require either a larger diameter delivery instrument  310  or a smaller (lengthwise) elongated member  12 .  
         [0136]    [0136]FIG. 26D illustrates the closure device of FIG. 11B positioned within the introducer sheath  300  to deflect the wall, corresponding to the position of FIG. 26A.  
         [0137]    FIGS.  16 A- 16 C illustrate an alternate embodiment of the closure device of the present invention which utilizes a slotted tube to retract and release the closure device. Closure device  150  has an elongated member  152  and clip legs  154   a - 154   d  identical to the elongated member  12  and clip legs  30   a - 30   d  of closure device  10  of FIG. 1. Closure device  150  also has a collar  158  identical to the collar  38  of FIG. 1. A connecting wire  156 , insert molded to elongated member  152  in the same manner as FIG. 11B, connects the clip portion of the device to the elongated member  152 . The cross-sectional view of FIG. 16C illustrates how the clip legs  154   a - 154   d  and connecting wire  156  are seated within collar  158  along the perimeter to facilitate manufacture.  
         [0138]    A slotted tube  160  of the delivery instrument, having a series of slots  162 , e.g. four, to create a series of flexible fingers  164  is releasably seated over collar  158  to hold the closure device. Due to this interference fit, when slotted tube  160 , which is fixedly mounted to the delivery instrument  161 , is pulled proximally with the proximal movement of the delivery instrument, the collar  158 , and thus the closure device  150  is pulled proximally to seat the elongated member  152  against the internal wall of the vessel to cover the internal opening of the aperture. When a sufficient load is placed on slotted tube  160 , the fingers  164  flex outwardly and slide over the collar  158 , thereby releasing the closure device  150  from the slotted tube  160  of the delivery instrument.  
         [0139]    In an alternate embodiment (not shown), the release tube, instead of being slotted, has a crimped or swaged tip which is positioned slightly distally of the collar. This tip is flexible so that upon placement of sufficient load on the tube, the tip flexes to ride over the collar to release the closure device. Additionally, dimples could be provided on the interior surface to help retain the tube over the collar, but which would enable release of the collar.  
         [0140]    In the alternate embodiment of FIG. 16D, instead of a slotted tube, a pair of jaws  181 ,  182  are fixed to the delivery instrument  180 . Jaws  181 ,  182  grasp collar  178  of closure device  170 . Closure device  170  is substantially identical to device  160  of FIG. 16A having an elongated member  172 , a connecting wire  176 , collar  178 , and four clip legs  174  (only the ends of two are shown for clarity). When a sufficient load is placed on jaws  181 , 182 , the jaws open and slide off collar  178 , thereby releasing the closure device  170  from the jaws of the delivery instrument.  
         [0141]    In the embodiment of FIGS. 21 and 22, a pair of jaws  191  of delivery instrument  190  grasps one or more of the clip legs  30 . The jaws  191 , e.g. an alligator clamp, are spring biased to an open position and are retained by the wall of the introducer sheath  300  in the closed position as shown in FIG. 22. When the delivery instrument is advanced within introducer sheath  300  past the distal tip  302 , the jaws  191  move to the open position to release the clip legs and closure device.  
         [0142]    FIGS.  31 - 36  illustrate another alternate embodiment of a delivery instrument for placement of the closure device. Although described for placement of closure device  140  of FIG. 9B, other closure devices described herein can be placed in a similar manner.  
         [0143]    Turning first to FIGS.  31 , delivery instrument  800  has a housing  801  having winged grippers  802 , a plunger  804  movable axially with respect to housing  801  to advance the closure device  140 , and locking windows  806   a ,  806   b  to secure the plunger  804  in a retracted and advanced position, respectively. An elongated outer tube  805  extends from housing  801  and is dimensioned to receive the closure device  140  therein. Connected to plunger  804  is a pusher  806  having four longitudinal slots  807  (see FIGS. 33 and 36) to each receive a clip leg in the straightened position within the delivery instrument  800 . The distal end of the pusher  806  abuts a region of the clip legs  144  proximal of the retaining collar  148  as shown in FIG. 35.  
         [0144]    When the plunger  804  is advanced, the pusher  806  is also moved distally, forcing the closure device  140  forward so that elongated member  142  is advanced into the vessel and moves to its transverse position, helped by the biasing force of offset connecting wire  146  described above. Note that advancement of the plunger  804  moves flexible fingers  809  from engagement in opposed locking windows  806   a  to engagement in windows  806   b  to retain the plunger  804  and pusher  806  in the advanced position. Also note the angled surface  809   a  of fingers  809  enable distal movement of the plunger  804  while straight surface  809   b  prevents proximal movement out of windows  806   a  and  806   b  (see FIG. 32).  
         [0145]    The delivery instrument  800  is inserted into the vessel through an introducer sheath, designated by reference numeral  900  in FIGS. 31 and 35. The introducer sheath  900  has a hub  906  with a proximal opening  902  to receive either a conventional dilator or the delivery instrument  800 . Sheath tube  907  extends from hub  906  and has an opening  904  in the side wall at the distal end. The distal end is tapered at region  909  to provide a seal with the dilator. The proximal end of the sheath tube  907  is flared at region  912  to enable a smooth transition for the outer tube  805  of the delivery instrument  800  when it is inserted through the introducer sheath  900  because with the closure device  140  in place, the outer tube  805  bulges outwardly. A strain relief  910  surrounds a portion of the sheath tube  907 .  
         [0146]    The hub  906  of sheath  900  has a 45 degree sidearm  913  having tubing  915 , strain relief  914  and a male luer  916  for mounting extension assembly  920 . A conventional clamp  918  is placed on tubing  915 . The distal end of extension assembly  920  is screwed onto male luer  916  and the proximal end of extension assembly has a mounting assembly  922  with a screw thread for mounting a syringe which is described below.  
         [0147]    Hub  906  further includes a valve assembly at the proximal end having a spacer ring  930 , a cylindrical valve element  932  having a slit arrangement, and a sheath cap  934 . The sheath cap  934  has an opening  936  dimensioned to receive and mount by a snap fit arrangement a dilator (not shown) and the delivery instrument  800 . A distal sheath cap  938  is mounted to the distal end of the hub  906 . A collar  810  mounted in housing  801  of the delivery instrument  800  and has a snap in tip  812  fitted within the opening  936  in the sheath cap  934 .  
         [0148]    Placement of the closure device  140  using delivery instrument  800  will now be described. First, to position the introducer sheath  900  in the vessel, a syringe  950 , filled with fluid such as saline, is threaded onto proximal threads of extension assembly  920 . The introducer sheath  900 , with a conventional dilator (not shown) snapped into sheath cap  934 , is inserted through the tissue tract over a guidewire toward the vessel wall, with the user attempting to depress the syringe plunger  952 . While the sheath  900  is still within the tissue tract, very little saline can be ejected from the syringe  950  through side opening  904 . Thus there is little movement of the plunger  952 . However, once the introducer sheath  900  is advanced through the tissue tract and through the vessel wall into the vessel lumen, saline can freely flow out through side opening  904  (after flowing in the gap between the dilator and the internal wall of the sheath  900 ), thus enabling more rapid depression of the plunger  952 . This provides a visual and tactile feel that the introducer sheath  900  is desirably positioned within the vessel, thus ensuring that the closure device, when inserted through the sheath  900  via delivery instrument  800 , will be inserted into the vessel lumen.  
         [0149]    Once the introducer sheath  900  is in place in the vessel, the dilator is removed. The syringe  950  is either filled with cool saline or is detached from the extension assembly  920  and another syringe with cool saline is attached to threads  922 . This cool saline is applied to the closure device  140  during delivery to maintain the legs  144  and connecting wire  146  in a cooled martensitic state as described above with respect to other embodiments.  
         [0150]    After removal of the dilator, the delivery instrument  800  is ready for insertion through the introducer sheath  900 . The closure device  140  is positioned in the delivery instrument  800  as shown in FIG. 35, with the clip legs  142  contained in longitudinal slots of the pusher  806 . The elongated member  142  is contained within the confines of the outer tube  805 . When inserted through and snapped into the introducer sheath  900 , the outer tube  805  remains proximal of the distal tip of the introducer sheath  900  as shown. Next, the plunger  804  is depressed to move the pusher  806  distally (until fingers  809  are positioned in windows  806   b ) to advance the closure device  140  so the elongated member  142  is moved beyond the confines of the outer tube  805  and beyond the distal tip of the introducer sheath  900 . Once outside the confines of tube  805  and sheath  900 , the elongated member  142  pivots to a transverse position as shown in FIG. 36.  
         [0151]    The sheath  900  and delivery instrument  800  are then pulled proximally, pulling the elongated member  142  against the vessel wall. Once in abutment with the vessel wall, it applies a counterforce against the proximal movement of the sheath  900  and delivery instrument  800 . Consequently, subsequent proximal movement of the sheath  900  and instrument  800  will release the clip legs  144  from the confines of the sheath  900  and instrument  800 , where the clip legs  144  will return to their curved memorized temperature as they are warmed by body temperature. The sheath  900  and delivery instrument  800  are then removed from the body.  
         [0152]    FIGS.  18 - 20  illustrate alternate embodiments of the delivery instrument which facilitate repositioning of the elongated member within the vessel. That is, in these embodiments, the delivery (closure applying) instrument has a projecting distal tip with an abutment surface configured to engage one of the sides of the elongated member. Pressing of the abutment surface against the top surface of the elongated member forces the elongated member to pivot back to a longitudinal position for withdrawal from the vessel if desired. This more easily allows repositioning within the body prior to deployment of the clip.  
         [0153]    More specifically, in FIG. 18, protruding tip  402  of instrument  400  abuts upper surface  99  of elongated member  92 . This figure shows use of the closure device  90  of FIG. 11A with the instrument  300 . In FIG. 19, closure device  10 ′ is similar to closure device  10 ′ of FIG. 1 (and FIG. 15), except for the separate opening for connecting wire  42 ′. Elongated member  12 ′ is pivotable back to the position shown in phantom by the projecting tip  412  of instrument  410 .  
         [0154]    In FIG. 20, the elongated member  102  is biased to a transverse position by the offset suture  104  of closure device  100 . It can be pivoted by the projecting tip of the instrument.  
         [0155]    [0155]FIGS. 17A and 17B show a variation of the elongated member. Closure device  120  has a mushroom shaped saddle  121  which functions to abut the internal wall of the vessel to cover the internal opening of the vessel aperture. The saddle  121  has a circular periphery with two opposing sides  125  curving downwardly. Clip legs  122   a ,  122   b ,  122   c , and  122   d  extending from stem  124  function in the same manner as the clip legs described above. Clip legs  122   a - 122   d  are shown with penetrating tips  124   a - 124   d , respectively, but non-penetrating tips can also be provided. This closure device  210  is described in more detail in commonly assigned patent application Ser. No. 09/659,648, filed Sep. 12, 2000, the entire contents of which are incorporated herein by reference.  
         [0156]    [0156]FIGS. 27 and 28 illustrate an alternative embodiment of the closure member of the present invention utilizing a different approach to connecting the clip legs to the elongated member. This version differs from the foregoing embodiments as it eliminates a component to simplify manufacture and simplify the device as a single element can be utilized to both attach the portions of the closure member as well as to bias the elongated member. More specifically, closure device  600  has four legs  602 , similar to legs  30  of the embodiment of FIG. 1 in that they have a memorized curved configuration. A tube  604  is preferably welded to elongated member  603 , but can be insert molded or attached by other means. Tube  604  is spiral cut to provide flexibility and allow bending of the tube. Extending within the proximal end  606  of the tube  604  are clip legs  602 , which are welded through the tube  604  at region  608 . Other means of attachment could also be utilized. The proximal portion  606  of tube  604  is not cut to provide rigidity at the region of attachment to clip legs  602 . The spiral tube thereby serves several functions: connects the clip legs  602  to the elongated member  603  in a flexible manner, retains the clips legs, and biases the elongated member  603  to a transverse position.  
         [0157]    While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.