Patent Publication Number: US-2015066055-A1

Title: Redundant tissue closure methods and apparatuses

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional application of U.S. patent application Ser. No. 12/559,377, filed 14 Sep. 2009, entitled “REDUNDANT TISSUE CLOSURE METHODS AND APPARATUSES, which claims the benefit of and priority to U.S. Provisional App. No. 61/097,072, filed 15 Sep. 2008, entitled “REDUNDANT TISSUE CLOSURE METHODS AND APPARATUSES.” U.S. patent application Ser. No. 12/559,377 is a continuation of U.S. patent application Ser. No. 12/365,397, filed 4 Feb. 2009, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES,” now U.S. Pat No. 8,048,108, which is a continuation of U.S. patent application Ser. No. 11/316,775, filed 23 Dec. 2005, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES,” now abandoned, which claims the benefit of and priority to U.S. Provisional App. No. 60/711,279, filed 24 Aug. 2005, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES.” U.S. patent application Ser. No. 12/559,377 is a continuation-in-part of U.S. patent application Ser. No. 11/508,656, filed 23 Aug. 2006, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES,” now U.S. Pat. No. 8,758,397, which claims the benefit of and priority to U.S. Provisional Pat. App. No. 60/711,279, filed 24 Aug. 2005, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES,” and which is a continuation-in-part of U.S. patent application Ser. No. 11/316,775, filed 23 Dec. 2005, entitled, “VASCULAR CLOSURE METHODS AND APPARATUSES,” now abandoned, which claims the benefit of and priority to U.S. Provisional Pat. App. No. 60/711,279, filed 24 Aug. 2005, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES.” U.S. patent application Ser. No. 12/559,377 is a continuation-in-part of U.S. patent application Ser. No. 11/508,715, filed 23 Aug. 2006, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES,” which claims the benefit of and priority to U.S. Provisional Pat. App. No. 60/711,279, filed 24 Aug. 2005, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES,” and which is a continuation-in-part of U.S. patent application Ser. No. 11/316,775, filed 23 Dec. 2005, entitled, “VASCULAR CLOSURE METHODS AND APPARATUSES,” now abandoned, which claims the benefit of and priority to U.S. Provisional Pat. App. No. 60/711,279, filed 24 Aug. 2005, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES.” U.S. patent application Ser. No. 12/559,377 is a continuation-in-part of U.S. patent application Ser. No. 11/508,662, filed 23 Aug. 2006, entitled “VASCULAR OPENING EDGE EVERSION METHODS AND APPARATUSES,” which claims the benefit of and priority to U.S. Provisional Pat. App. No. 60/711,279, filed 24 Aug. 2005, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES,” and claims benefit of and priority to U.S. Provisional Pat. App. No. 60/726,985, filed 14 Oct. 2005, entitled “SEALANT PLUG SYRINGES, TUBES, AND PENCILS,” and which is a continuation-in-part of U.S. patent application Ser. No. 11/316,775, filed 23 Dec. 2005, entitled, “VASCULAR CLOSURE METHODS AND APPARATUSES,” now abandoned, which claims the benefit of and priority to U.S. Provisional Pat. App. No. 60/711,279, filed 24 Aug. 2005, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES,” the disclosures of which are hereby incorporated by reference in their entireties. 
    
    
     BACKGROUND 
     1. The Field of the Invention 
     The present disclosure relates to tissue closure apparatuses and methods. 
     2. The Relevant Technology 
     During intravascular and other related procedures, catheters are typically inserted through an incision or puncture in the skin and underlying tissues to access an artery or vein, typically in the groin, neck, or subclavian areas of a patient. The catheter can be inserted through a puncture in the blood vessel and guided to the desired site to perform interventional procedures such as angiography, angioplasty, stent delivery, plaque removal, and infusion of a therapeutic substance. After the procedure is completed and the catheter is removed from the patient, however, the access hole must be closed to prevent massive hemorrhage. This is typically achieved by applying pressure over the blood vessel manually and then by applying a pressure bandage or a compressive weight. With conventional methods, the rate of post-puncture hemorrhage is high, which can cause considerable complications. This complication is exacerbated by the concomitant use of anticoagulant medications such as heparin or warfarin and by anti-platelet drugs, which are commonly used following a procedure in order to prevent clot formation and thrombus and/or to treat vascular disease. 
     It is generally recognized that many currently employed vascular sealing methods and devices and other tissue closure methods and devices have an inherent failure rate due to incomplete sealing of holes or wounds in vascular or other tissue. Achieving complete wound closure is particularly important in sealing arterial punctures, which are relatively high pressure systems. For example, under normal blood pressure, the arterial system has a pressure of about 120/80 mmHg or more. Failure to completely close arterial holes can result in hematoma, exsanguination, and other catastrophic consequences, including limb amputation and death. Moreover, many currently employed vascular devices employ methods and materials that remain on the intravascular endothelial surface or otherwise in the sealed vessel. Materials that remain intravascularly can be a nidus for thrombus or intravascular mural hyperplasia with later spontaneous and catastrophic closure of the vessel. 
     BRIEF SUMMARY 
     The present disclosure provides methods and apparatuses that are suitable for closure of vascular punctures or other openings in bodily tissues. The apparatuses and methods disclosed herein provide a redundancy of closure, which enhances wound healing and patient safety. The devices and methods described herein are configured for wound closure on the external surface of the wound, which allows wound healing with little endothelial disruption thereby reducing the chances of intravascular thrombosis or embolism or intimal hyperplasia. 
     The present disclosure describes a closure device for closing an opening in a tissue. An exemplary tissue closure device according to the present disclosure includes at least one tubular member, a tissue eversion apparatus configured to form an everted tissue region around the opening in the tissue, a first closure element, which can be deployed over the tissue opening around the portion of everted tissue, and a second, redundant closure element that is applied in addition to the first closure element to ensure efficient closure. Combining a first closure and a second, redundant closure provides for wound closure with a failure rate and/or complication rate lower than either acting alone. The devices described herein can be supplied in different diameters (e.g., French sizes) to accommodate different sizes of catheters and different sizes of puncture holes. 
     The tissue eversion apparatus, the first closure element, and the second closure element are typically disposed in a lumen of one or more tubular members and deployable therefrom. The tubular members can be sheaths having various shapes and/or be formed from various materials, as examples a solid walled or porous walled cylinder or other shape, or a plurality of guide rods or bars mounted relative to each other. 
     The present disclosure also describes methods for closing an opening in a tissue using, for example, an embodiment of an apparatus as described above. Tissue openings can include openings in a body lumen such as an opening in a blood vessel. An exemplary method for closing an opening in a tissue includes (a) deploying a tissue eversion apparatus into the opening in the body lumen, the tissue eversion apparatus having a plurality of elongate tissue engaging members capable of approximating and everting edges of the opening to form an everted tissue region, (b) deploying a first closure element in a first configuration to the everted tissue region around the opening in the body lumen, (c) transitioning the first closure element that was disposed around the portion of everted tissue to a second, smaller configuration so as to close the opening in the body lumen, (d) retracting the tissue eversion apparatus so as to release the everted edges, and (e) deploying a second closure element over or around the first closure element so as to redundantly close the opening in the body lumen. 
     According to the present disclosure, the act of deploying a second closure element over or around the first closure element can be performed either before or after retracting the tissue eversion apparatus so as to release the everted edges. 
     According to the present disclosure, the first closure element can include a cincture element having a first size and a second size that is smaller than the first size. Accordingly, the first size is configured to surround a portion of the everted tissue region around the opening and the second size is configured to capture a portion of the everted tissue region and close the opening when the cincture element is transitioned from the first size towards and/or to the second size. 
     In one embodiment, the cincture element includes a loop of suture having at least one pre-tied knot, such that the loop can be tightened by pulling on a free-end so as to close the loop and close the tissue opening. In one embodiment, the pre-tied knot can be, for example, a slip knot. In one embodiment, the loop of suture can include at least one dentate configured to maintain the cincture element in a closed position. That is, the at least one dentate can permit the loop to be pulled closed while simultaneously functioning to prevent re-opening of the loop. 
     In one embodiment, the cincture element can be formed from a shape memory material having an expanded delivery configuration and a contracted deployed configuration. For instance, the shape memory cincture element can be a ring-like structure formed from a metallic material (e.g., NiTi) or a polymeric material (e.g., a rubber-like material) that resiliently closes the opening when the first closure element is deployed around the everted tissue region. The shape memory cincture element may be biased towards the contracted deployed configuration. 
     Suitable examples of second closure elements that can be applied to the wound after the first closure element is placed can include, but are not limited to, sealant plugs, adhesive glues, occlusive substances, extraluminal clips, RF energy, thermal energy, electrical induction, infrared light, ultrasonic vibration, microwave or laser irradiation, sutures, and combinations thereof. 
     These and other objects and features of the present disclosure will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       To further clarify the above and other advantages and features of the present disclosure, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIGS. 1A-1D  illustrate schematic views of a tissue eversion apparatus according to one embodiment of the present disclosure. 
         FIGS. 2A-2D  illustrate schematic views of a tissue eversion apparatus according to several embodiments of the present disclosure. 
         FIGS. 3A and 3B  illustrate a tissue cincture apparatus according to one embodiment of the present disclosure. 
         FIGS. 4A and 4B  illustrate a tissue cincture apparatus according to one embodiment of the present disclosure. 
         FIGS. 5A and 5B  illustrate a tissue cincture apparatus according to one embodiment of the present disclosure. 
         FIGS. 6A-6G  schematically illustrate closure of an opening in a body lumen using a tissue eversion apparatus and a tissue cincture apparatus according to one embodiment of the present disclosure. 
         FIGS. 7A-7H  schematically illustrate a number of tissue cinctures that can be used to close an opening according to one embodiment of the present disclosure. 
         FIGS. 8A-8F  illustrate closure of an opening in a body lumen using a redundant closure system according to one embodiment of the present disclosure. 
         FIGS. 9A-9E  illustrate closure of an opening in a body lumen using a redundant closure system according to one embodiment of the present disclosure. 
         FIGS. 10A-10C  illustrate closure of an opening in a body lumen using a redundant closure system according to one embodiment of the present disclosure. 
         FIGS. 11A-11H  illustrate closure of an opening in a body lumen using a redundant closure system according to one embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure provides apparatuses and methods for closing a vascular puncture wound or any tissue aperture, for example those resulting from the insertion of a vascular catheter or surgical instrument, trauma or disease. The apparatuses and methods disclosed herein provide a redundancy of closure, which enhances wound healing and patient safety. The devices and methods described herein are configured for wound closure on the external surface of the wound, which allows wound healing with little endothelial disruption and thereby reducing the chances of intravascular thrombosis or embolism or intimal hyperplasia. 
     The description included herein refers to “vessels” for convenience; the present disclosure is applicable to facilitate closure of various types of tissue openings. 
     The present disclosure describes a closure device for closing an opening in a tissue. An exemplary tissue closure device according to the present disclosure includes at least one tubular member, a tissue eversion apparatus configured to form an everted tissue region around the opening in the tissue, a first closure element, which can be deployed over the tissue opening around the portion of everted tissue, and a second, redundant closure element that is applied in addition to the first closure element to ensure efficient closure. 
     Referring now to  FIGS. 1A-1D , schematic illustrations of a tissue eversion apparatus  100  according to one embodiment of the present disclosure are shown.  FIG. 1A  is a lateral, cutaway view of a tissue eversion apparatus  100  in a closed or undeployed state. A plurality of tissue engaging members  102   a  are shown in a retracted state disposed in an elongate tubular sheath member  104 . As shown in a non-limiting example in  FIG. 1A , two tissue engaging members  102   a  are disposed in the sheath  104 . However, any practical number of tissue engaging members  102   a  can be disposed in the sheath  104  such that the tissue engaging members  102   a  can engage with or otherwise grasp tissue surrounding an opening when the tissue engaging members  102   a  are deployed. The elongate tubular sheath member  104  is configured to accommodate a guidewire, or in another embodiment can be inserted through a sheath or a closure device and used like a guidewire. 
       FIG. 1B  is a lateral, cutaway view of the tissue eversion apparatus  100  in an extended or deployed state, where the tissue engaging members  102   b  are extended. As shown in  FIG. 1B , the tissue engaging members  102   b  can curl up when they are in the extended position. In one embodiment, the tissue engaging members can be formed from a shape-memory material such as a nickel-titanium alloy to facilitate the shape change from the retracted to the deployed state. 
     In another embodiment, the tissue engaging members can be formed from a deformable material, such that the tissue engaging members can bent for disposal in the delivery sheath. For example, the tissue engaging members can include a sharp bend that directs the distal ends of the tissue engaging members toward the proximal end of the delivery sheath. When the tissue engaging members are deployed out of the delivery sheath, the pre-bent shape allows the tissue engaging members to engage with the vessel walls. In yet another embodiment, the tissue engaging members can include hinged members near the distal ends of the engaging members. The hinges can be configured to allow the tissue engaging members to be folded for disposal in the delivery sheath and the hinges can be configured to allow the distal ends of the engaging members to splay out and engage with the vessel walls when the engaging members are deployed into the vessel lumen. 
       FIG. 1C  is a lateral view showing the tissue eversion apparatus  100  in the retracted state with a plunger mechanism  106  that can be used to extend the tissue engaging members  102   a  and finger flanges or rests  108  to control the device.  FIG. 1D  is a lateral view showing the tissue eversion apparatus  100  in the deployed state. 
     The tissue eversion apparatus  100  shown in  FIGS. 1A-1D  can be guided or placed into a puncture wound by means of a guidewire that can be accommodated within the sheath  104 . The tissue eversion apparatus shown in  FIGS. 1A-1D  can be placed into the puncture wound by means of a sheath that can accommodate the everter device  100  internally. The tissue eversion apparatus shown in  FIGS. 1A-1D  can be placed into the puncture wound using other methods. Regardless, once the tissue eversion apparatus  100  is in the vessel, the tissue engaging members  102  can be deployed and used to evert the tissue around the opening or wound. 
       FIGS. 2A-2D  illustrate alternative embodiments of a tissue eversion apparatus  200 , according to the present disclosure.  FIG. 2A  is a lateral cutaway view of a tissue eversion apparatus  200   a  with tissue engaging members  202   a  in a retracted state. In the embodiment shown in  FIG. 2A , tissue engaging members  202   a  are retracted within internal lumens  206  that are disposed within lumen  204 . 
       FIG. 2B  is a lateral view of a tissue eversion apparatus  200   b  in the extended or opened state, where the tissue engaging members  202   b  are extended, and curl up to allow engagement with a vessel wall.  FIG. 2C  is another schematic illustration of a tissue eversion apparatus  200   c.  As shown in  FIG. 2C , the tissue engaging members  202   c  extend in a cross-wise function across the sheath  204 , the purpose being that the wound edges can be more efficiently and mechanically brought into apposition by the tissue engaging members  202   c  when members  200   c  engage with the tissue around the wound and the device  200   c  is retracted from the wound in order to draw the tissue up and form a portion of everted tissue.  FIG. 2D  is another schematic illustration of a tissue eversion apparatus  200   d.  As shown in  FIG. 2D , the tissue engaging members  202   d  extend towards one another towards the central axis of the sheath  204 , the purpose being that the wound edges can be more efficiently and mechanically brought into apposition by the tissue engaging members  202   d  when members  200   d  engage with the tissue around the wound and the device  200   d  is retracted from the wound in order to draw the tissue up and form a portion of everted tissue. 
     In the embodiments illustrated herein the plurality of tissue engaging members are shown as separate elongate members. One will appreciate, however, that the plurality of members can be coupled together at a point proximal to the distal ends of each of the individual tissue engaging members. For example, the plurality of members can be coupled to an elongate columnar member that can allow the tissue engaging members to be deployed and retracted. Coupling the tissue engaging members proximal to their ends can also be advantageous in that it can reduce the diameter of the tissue region everted by the engaging members in a manner similar to what is shown in  FIG. 2D . 
       FIGS. 1A-2D  present for illustration purposes two tissue engaging members; the devices shown can include as few as two tissue engaging members, but can include any plurality, and as many as are practical within applicable design considerations. The tissue engagement features (e.g.,  102   a ), shown as sharp hook-like portions of the active members in the figure, can include textured portions or attachments, mating portions with apposing feet, penetrating devices, hooks, teeth, or other adaptations to allow firm engagement of the tissue. 
     Additional discussion of tissue eversion apparatuses that can be adapted for use in the devices and methods discussed herein can be found in U.S. patent application Ser. No. 11/316,775, filed 23 Dec. 2005, now abandoned, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES” and U.S. patent application Ser. No. 11/508,662, filed 23 Aug. 2006, entitled “VASCULAR OPENING EDGE EVERSION METHODS AND APPARATUSES,” the entireties of which are incorporated herein by reference. 
       FIGS. 3A and 3B  illustrate a cincture apparatus  300  according to one embodiment of the present disclosure. The cincture apparatus  300  includes a tubular member  302  (e.g., a delivery sheath) and a cincture (shown as  304   a  in  FIG. 3A and 304   b  in  FIG. 3B ) disposed in the lumen of tubular member  302 . The cincture shown in  FIGS. 3A and 3B  is transitionable from an open configuration  304   a  to a contracted or closed configuration  304   b.  The cincture apparatus  300  shown in  FIGS. 3A and 3B  can be used in conjunction with the tissue eversion apparatuses discussed above to deliver a closure element (such as cincture  304   a,    304   b ) to a portion of everted tissue according to the devices and methods disclosed herein. 
     Referring to  FIG. 3A , the interior wall of the delivery sheath  302  delivers a cincture  304   a,  which can be held in place in the sheath  302  by a retention structure  306 . The retention structure  306  can prevent the cincture  304   a  from malpositioning and/or from prematurely contracting. The cincture  304   a,  which can be held by the retention structure  306 , can be sufficiently rigid to not readily change position and/or can be temporarily held in place by a wax-like or other semi-solid biocompatible material that will give way with contraction of the cincture  304   a.    
     The cincture  304   a  can be attached to a retractable suture loop  310 , which is contained in a lumen  308 , shown in the Figure as a cylindrical structure. The lumen  308  can include a narrowed portion  312  that permits the cincture material to pass, but prevents a tightening feature (e.g., a functional slipknot) from passing. Thus when the suture loop  310  is pulled, the cincture  304   a  is reduced in diameter and transitioned towards and/or to the smaller diameter  304   b.  When the suture loop  310  is pulled in its entirety, the cincture loop  304   b  completely closes, effecting closure around a portion of everted tissue around an opening (e.g., a puncture wound). 
       FIGS. 4A and 4B  illustrate a cincture apparatus  400  according to another embodiment of the present disclosure. The cincture apparatus  400  includes a tubular member  402  (e.g., a delivery sheath) and a cincture (shown as  404   a  in  FIG. 4A and 404   b  in  FIG. 4B ) disposed on the outer surface of the tubular member  402 . The cincture shown in  FIGS. 4A and 4B  is transitionable from an open configuration  404   a  to a contracted or closed configuration  404   b.  The cincture apparatus  400  shown in  FIGS. 4A and 4B  can be used in conjunction with the tissue eversion apparatuses discussed above to deliver a closure element (such as cincture  404   a,    404   b ) to a portion of everted tissue according to the devices and methods disclosed herein. 
     The delivery sheath  402  delivers a cincture  404   a,  which can be held in place on the sheath  402  by a retention structure  406 . The retention structure  406  can prevent the cincture  404   a  from malpositioning and/or from prematurely contracting. In some embodiments, the retention structure  406  can be slidably positioned on the sheath  402 , such that the retention structure  406  can be slid distally on the sheath  402  to act as an actuator to slide the cincture  404   a  off the sheath  402 . The cincture  404   a,  which can be held by the retention structure  406 , can be sufficiently rigid to not readily change position and/or can be temporarily held in place by a wax-like or other semi-solid biocompatible material that will give way, allowing the cincture  404   a  to slide off the sheath  402  and contract. 
     The cincture  404   a  can be attached to a retractable suture loop  410 , which is contained in a lumen  408 , shown in the Figure as a cylindrical structure. The lumen  408  can comprise a narrowed portion  412  that permits the cincture material to pass, but prevents a tightening feature (e.g., a functional slipknot) from passing. Thus when the suture loop  410  is pulled, the cincture  404   a  is reduced in diameter and transitioned to the smaller diameter  404   b.  When the suture loop  410  is pulled in its entirety, the cincture loop  404   b  completely closes, effecting closure around a portion of everted tissue around an opening (e.g., a puncture wound). 
       FIGS. 5A and 5B  illustrate a cincture apparatus  500  according to yet another embodiment of the present disclosure. The cincture apparatus  500  includes a tubular member  502  (e.g., a delivery sheath) and a cincture (shown as  504   a  in  FIG. 5A and 504   b  in  FIG. 5B ) disposed on the outer surface of the tubular member  502 . The cincture shown in  FIGS. 5A and 5B , which in this embodiment is formed from a resilient or shape-memory material, can transition from an open configuration  504   a  to a contracted or closed configuration  504   b  when the cincture  504   a  is removed from the tubular member  502 . The cincture apparatus  500  shown in  FIGS. 5A and 5B  can be used in conjunction with the tissue eversion apparatuses discussed above to deliver a closure element (such as cincture  504   a,    504   b ) to a portion of everted tissue according to the devices and methods disclosed herein. 
     The delivery sheath  502  delivers a cincture  504   a,  which can be held in place on the sheath  502  by a retention structure  506 . The retention structure  506  can prevent the cincture  504   a  from malpositioning and/or from prematurely contracting. In some embodiments, the retention structure  506  can be slidably positioned on the sheath  502 , such that the retention structure  506  can be slid distally on the sheath  502  to act as an actuator to slide the cincture  504   a  off the sheath  502 . The cincture  504   a,  which can be held by the retention structure  506 , can be sufficiently rigid to not readily change position and/or can be temporarily held in place by a wax-like or other semi-solid biocompatible material that will give way, allowing the cincture  504   a  to slide off the sheath  502  and contract. 
     The cincture  504   a  can be attached to a retractable suture loop  510 , which is contained in a lumen  508 , shown in the Figure as a cylindrical structure. The retractable suture loop  510  can be used to pull the cincture  504   a  past the end of the sheath  502 . If the retention structure  506  is slidably disposed on the sheath  502 , or otherwise has the ability to move the cincture past the end of the sheath  502 , then the suture loop  510  may not be might not be necessary (although it can still be useful for retrieving misplaced cinctures). When the self contracting cincture  504   a  is moved past the end of the sheath  502 , by action of the suture loop  510  or the retention device  506 , the cincture contracts adopting configuration  504   b,  reducing its radius, effecting closure around a portion of everted tissue around an opening (e.g., a puncture wound). 
       FIGS. 6A-6G  schematically illustrate steps in a method of closing a tissue opening using at least one tubular member, a tissue eversion apparatus, and as cincture closure according to the present disclosure. In  FIG. 6A , a sheath  602 , for example a sheath like that described in relation to  FIG. 1 , is guided into an opening in a vessel  620  with the aid of a guidewire  608 . The sheath  602  includes elongate tissue engaging members  604   a  disposed in the lumen of the sheath  620 . 
     As shown in  FIG. 6B , the elongate tissue engaging members  604   b  are deployed so that they can engage the edges of the opening  606 . In a non-limiting example, the tissue engaging members  604   b  curve back away from sheath  602  when they are deployed so that the tissue engaging members  604   b  are positioned to engage the tissue around the opening and evert the tissue when the sheath  602  is retracted. As shown in  FIG. 6C , once the elongate tissue engaging members  604   b  are engaged with the tissue edges  606 , the sheath  602  can be retracted creating an everted tissue region  606   a.    
     As shown, the elongate tissue engaging members  604   b  pierce a portion of the everted tissue region  606   a.  Nonetheless, one will appreciate that the tissue engaging members  604   b  need not pierce the tissue in order to engage the tissue to form the everted tissue region  606   a.  For example, any known gripping means such as apposing feet, hooks, teeth, adhesive devices and the like can be used to engage the tissue around the opening to form the everted tissue region. 
     Referring now to  FIGS. 6D-6G , a cincture  612   a  can be advanced from a second sheath  610 , and tightened  612   b  over the everted edges of the opening, as shown in  FIG. 6E . As shown in  FIGS. 6D-6E , the cincture  612   a,    612   b  is placed around the everted tissue region  606   a  below the portion of the everted region  606   a  that is punctured by the tissue engaging members. This ensures that the portions of the vessel that are punctured by the tissue engaging members do not cause additional bleeding after the cincture  612   a,    612   b  is placed. Moreover, placing the cinture  612   a,    612   b  below the portion of the tissue engaged by the tissue engaging members can prevent the tissue engaging members from interfering with complete closure of the opening and/or can facilitate good contact between the vascular epithelial layers to facilitate wound healing. 
     After the cincture  612   b  is placed, the second sheath  610  can be removed, leaving the opening closed by the cincture  612   b,  as shown in  FIG. 6F . The tissue engaging members  604   a  can also be retracted into the sheath  602 , all as shown in  FIG. 6F . The suture loop  614  (if required), tissue engaging members  604   a  and sheath  602 , the second sheath  610 , and the guidewire  608  can all be removed, leaving the cincture  612   b  in place closing the opening in the vessel  620 , as shown in  FIG. 6G . As will be discussed below in reference to  FIGS. 8A-11H , a number of second, redundant closure elements may be applied following placement of the first closure element (e.g., the cincture) in order to provide redundant closure to the opening. 
       FIGS. 7A-7H  illustrate various cincture configurations that can be adapted for use with the devices and methods disclosed herein. Cincture  11 , shown in  FIG. 7A , illustrates a simple cincture in an open configuration and cincture  12  is the simple cincture of  11  in a closed position. Cinctures  11  and  12  include a slip-knot with only one suture end to be pulled and distal loop for the pulling suture. Cinctures  21  and  22 , shown in  FIG. 7B , illustrate a cincture configuration with a slip-knot device, with both suture ends to be pulled through the slip-knot device, resulting in a loop of material when the cincture is completely closed. Cinctures  31  and  32 , shown in  FIG. 7C , illustrate a cincture configuration that includes a loop and the pulling suture is functionally internal to the cincture initially, resulting in very little trailing material when the cincture is completely closed. Cinctures  41  and  42 , shown in  FIG. 7D , illustrate a cincture configuration that includes dentates on the suture. When cinctures  41  and  42  are closed, the dentates act to lock the suture in the closed position. Cinctures  51  and  52 , shown in  FIG. 7E , illustrate a cincture configuration that includes multiple strands of material, resulting in a multiple level complex closed cincture. Cinctures  61  and  62 , shown in  FIG. 7F , illustrate a cincture configuration that includes beads or other geometric structures or grippers that fit together and hold the wound closed when the cincture is closed. Cinctures  71  and  72 , shown in  FIG. 7G , illustrate a cincture made of memory material, so that when the cincture is released from the delivery sheath it contracts to effect closure of the opening. Cinctures  81  and  82 , shown in  FIG. 7H , illustrate a cincture made of a rubber-like or memory material, that when pushed off of the delivery sheath, can contract more-or-less uniformly to close the cincture and thereby close the opening or wound. 
     Additional discussion of cincture apparatuses that can be adapted for use with the devices and methods discussed herein can be found in U.S. patent application Ser. No. 11/508,715, filed 23 Aug. 2006, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES,” the entirety of which is incorporated herein by reference. 
       FIGS. 8A-8F  illustrate a schematic depiction of a typical embodiment of a hemostatic plug that can be used in combination with a cincture to provide a redundant closure to further reduce the potential failure rate.  FIG. 8A  demonstrates a typical hemostatic plug  901  made of a biocompatible material preferably shaped as a columnar structure with a cylindrical or toroidal cross section with an internal lumen  902  that permits movement of a grasper device and guidewire. Other cross sectional configurations are possible, with or without a central hole.  FIG. 8B  demonstrates the hemostatic plug after hydration, where it may assume a larger volume  903  and may decrease the internal diameter of the lumen  904 . 
       FIG. 8C  demonstrates the cincture delivery device with the hemostatic plug  905  and a pushing device  906  which permits expulsion of the hemostatic plug out the suture delivery device onto the closed puncture wound  907  and onto the tines of the tissue engaging members  908 .  FIG. 8D  shows the hemostatic plug  909  being pushed by the expulsion device  910  while the tissue engaging members  908  and cincture delivery device  911  are withdrawn to permit the plug to seat on the puncture wound and the cincture  912 .  FIG. 8E  shows the expulsed hemostatic plug  913  seated directly over the cinctured puncture wound  914 .  FIG. 8F  shows the expulsed hemostatic plug  915  after it has assumed its fully hydrated shape applying pressure to and/or further sealing the cinctured puncture  916 . It is to be understood the cincture could be temporary to achieve immediate hemostasis while the plug is adhering to local tissues, and then the cincture could be removed using a number of methods leaving the plug as the primary hemostatic instrument. 
       FIG. 9A-9F  illustrate a schematic depiction of a typical embodiment of a cincture closure device combined with a biocompatible injectable adhesive or occluding material to provide redundant wound closure. The biocompatible injectable adhesive or occluding material may be bioabsorbable and/or bioresorbable or not.  FIG. 9A  depicts the cincture delivery device  1001  with a cincture seated  1002  on the puncture wound and a tissue eversion apparatus  1010  with tissue engaging members  1012  engaged with the everted tissue.  FIG. 9B  demonstrates injectable or extrudable adhesive or occluding material  1003  being injected through the cincture delivery device  1001  and around the tissue eversion apparatus  1010 . In the alternative,  FIG. 9C  demonstrates an injectable or extrudable adhesive or occluding material  1004  being injected through the lumen of the tissue eversion apparatus  1010 .  FIG. 9D  depicts the injected adhesive or occlusive material  1005  surrounding the cincture  1002 .  FIG. 9E  depicts the injected adhesive or occlusive material  1006  surrounding, sealing, and/or further binding the puncture wound and cincture  1002 . Note that the cincture  1002  can prevent the adhesive or occlusive material  1006  from entering the blood vessel. 
       FIGS. 10A-10C  illustrate a schematic depiction of the application of an extramural clip over a cincture device in order to provide redundant closure.  FIG. 10A  illustrates a tissue eversion apparatus  1110  with tissue engagement members  1112  engaged with a portion of everted tissue, a cincture delivery device  1101 , a clip  1102  riding on the cincture delivery device  1101 , a device  1103  that pushes the clip  1102 , a cincture  1108  over the puncture wound  1104 .  FIG. 10B  represents the clip  1106  being pushed off the cincture delivery device  1101  by the pushers  1107 .  FIG. 20C  shows a representation of the clip  1109  residing on the closed puncture  1104 , providing redundancy for the cincture closure  1108 . It is to be understood the cincture  1108  could be temporary to achieve immediate hemostasis. 
     The clip  1102  shown in  FIGS. 10A-10C  can include a base member shaped to allow passage of the clip over the delivery sheath  1102 , and a plurality of grasping members that are configured to engage with the everted tissue region (e.g.,  606   a  in  FIG. 6A ). The base member can be shaped as a ring or a complete circular or cylindrical band, or the base member can be a discontinuous circle to better accommodate the delivery sheath  1102 . The base member can also include shape memory materials to better accommodate the delivery sheath  1102  and to assume a lower profile when delivered (e.g., clip  1109 ). The clip  1102  can include as few as two grasping members and as many as are practical within applicable design considerations. The grasping members can include textured portions or attachments, mating portions with apposing feet, penetrating devices, hooks, teeth, or other adaptations to allow firm grip of the everted tissue region proximal to the tissue cincture. 
       FIGS. 11A-11H  illustrate a schematic depiction of an alternate design of an extramural clip  1200  that can be used to provide redundant closure over a cincture.  FIG. 11A  represents a typical wafer clip  1200  or collar consisting of a disk-like structure with inwardly protruding members  1201  having sharpened or compressive ends, and a space  1202  between the members  1201 .  FIG. 11B  is an oblique of the typical wafer clip  1200  demonstrating the members  1203  and intermember spaces  1204 .  FIG. 11C  represents an important property of the hemostatic adherent wafer clip  1200 , that the members  1201 , although sharp and rigid or semi-rigid, can be displaced  1205  under force, but are resilient and return to the planar low energy state as shown in  FIG. 11B . 
       FIG. 11D  demonstrates the interaction of the hemostatic adherent wafer clip  1200  and its intermember spaces  1202  with a tissue eversion apparatus  1207 , the tissue engaging members  1208  have engaged the wound edges  1209  of the puncture. In  FIG. 11E , tissue engaging members  1208  have been pulled through the intermember spaces  1202  of the wafer clip  1200 , pulling the wound edges  1211  through the hemostatic clip  1200 , and members  1208  engaging and holding the puncture wound edges in opposition and closing the wound. 
       FIG. 11F  shows a hemostatic clip  1200  engaging puncture wound tissues after a cincture  1214  has been placed.  FIG. 11G  shows the hemostatic wafer clip  1200  providing redundant closure in addition to the cincture  1214 .  FIG. 11H  shows the hemostatic wafer clip members  1200  seated on the wound edges  1218  providing redundant closure to the cincture  1214 . 
     Additional discussion of clip apparatuses that can be adapted for use with the devices and methods discussed herein can be found in U.S. patent application Ser. No. 11/508,656, filed 23 Aug. 2006, entitled “VASCULAR CLOSURE METHODS AND APPARATUSES,” the entirety of which is incorporated herein by reference. 
     Additional examples of second, redundant closure elements that can be applied to or around the wound after placing the first closure element can include, but are not limited to, RF energy, thermal energy, electrical induction, infrared light, ultrasonic vibration, microwave or laser irradiation, sutures, and combinations thereof. For example, heat (i.e., thermal energy) can be applied to the wound region after applying the first closure element to cauterize the wound and provide redundant closure. 
     The embodiments shown in the Figures presented herein show the tissue eversion apparatus and the first and second closure elements being delivered by separate elongate members (i.e., sheaths). One will appreciate, however, that the figures are presented for illustrative purposes, and that the tissue eversion apparatus and the first and second closure elements can be delivered by a single elongate member. 
     Examples of knots that can be suitable for use with the present disclosure include, but are not limited to, the overhand knot or half knot, the double overhand knot, the multifold-overhand-knot, the Flemish eight, hitches (single simple, half, clove, two half, buntline, rolling Magnus, midshipman&#39;s tautline, adjustable jamming, cow, reversed half, lobster buoy), single loops (bowline, Dutch marine bowline, cowboy bowline, double figure-of-eight loop, Flemish eight, bowstring knot, tucked double overhand, butterfly loop, lineman&#39;s loop, artillery loop, pendant hitch), clove hitch, reef knot, square knot, noose (simple noose, strangle-snare, scaffold knot, gallows knot, hangman&#39;s knot, reverse eight-noose), monkey fist, the dolly, fisherman&#39;s bend, surgeon&#39;s knot, sheet bend knot, timber hitch, fisherman&#39;s knot, reef knot, square knot, DuraKnot, sliding knots, simple sliding knot, Nicky&#39;s knot, Roeder&#39;s knot, Seoul Medical Centre knot, Smith &amp; Nephew&#39;s knot, Tennesee&#39;s knot, purse string, surgical knot with extra loop, other knots and/or cincture devices or combinations thereof could also be used and are anticipated. Endoscopic knot tying devices and suture cutting devices can also be used to create the cincture for this device and are also anticipated. 
     Examples of suture material at can be suitable for use with the present disclosure include, but are not limited to, absorbable, non-absorbable, braided, monofilament, pseudo-monofilament, multifilament, barbed, smooth, directional, and bidirectional. The suture material can be composed of but not limited to polyglycolic acid, polydioxanon, polylactate, polycaprone, silk, linen, cotton, treated and non-treated collagen, “catgut”, chromic, Vicryl, Monocyrl, PDS, polyesther, polypropylene, polyamide, stainless steel, and others. The cincture device can be made from other suitable materials, including typical suture materials, flexible polymeric materials with elastomeric properties including polyurethane, polyethylene, polyestenurethane, polyimide, olyethreimide, polycarbonate, polysiloxane, polyvinyls, hydroxyethylmethacrylate, related polymers, co-polymers of these or other polymers, or drug-embedded or drug-eluting polymers to prevent coagulation or intimal hyperplasia (such as Taxol), also which can be made radiopaque by markers and addition of appropriate radiopaque materials. 
     The tines or gripping portion of a the tissue engaging members or components of the sheath or cincture device can be made from any number of suitable materials, including radiopaque materials and materials coated to be made radiopaque, including bioabsorbable polymers or compounds, non-absorbable alloys and compounds including stainless steel, MP35, Nitinol, Nickel-Titanium alloy, Kevlar, nylon polyester acrylic, gold, platinum, tantalum, niobium, molybdenum, rhodium, palladium silver, hafnium, tungsten, iridium. Materials with memory can be useful to allow tines to spontaneously open after extended from the sheath. These can be made in the form of wires, fibers, filaments, small beams, and other extruded, woven, or formed shapes. Piano wire, super elastic memory wire, chromium allows, alloys of titanium and nickel, and other elastic memory materials previously mentioned as well as others can be used as well. 
     The sealant plug, injected sealant, and injected occlusive material can be composed of an appropriate biocompatible materials including but not limited to fibrin and cross-linked fibrin autologous blood clot formed by blood mixed with topical thrombin, the above clot treated with epsilon-aminocaproic acid providing a more stable clot and delaying lysis; Gelfoam, Ivalon, Oxycel and other particulate materials, biocompatible polymer including an alginate, chitosan and poly-L-amino acid, sodium alginate, potassium alginate, strontium alginate, barium alginate, magnesium alginate or any other alginate or a mixture thereof; poly-L-lysine, poly-L-arginine, poly-L-glutamic acid, poly-L-histidine, poly-a-D-glutamic acid or a mixture thereof; platelet-rich plasma and a biocompatible polymer; mixture of fibrin and fibrinogen; fibrin microbeads, collagen, cross-linked collagen and other collagen-derivatives, polysaccharides, cellulosics, polymers (natural and synthetic), inorganic oxides, ceramics, zeolites, glasses, metals, and composites; dextran beads; microporous polysaccharide beads; tackified natural rubbers; synthetic rubbers such as butyl rubber; and tackified linear, radial, star, and branched and tapered styrene block copolymers, such as styrene-butadiene, styrene-ethylene/butylene and styrene-isoprene; polyurethanes; polyvinyl ethers; acrylics, especially those having long chain alkyl groups; poly-a-olefins; and silicones; a platelet glue (platelets-fibrinogen-fibrinogen activator) wound sealant; pressure glues, polymer glues, polyglycolic acid, polydioxanon, polylactate, polycaprone; flexible polymeric materials with elastomeric properties including polyurethane, polyethylene, polyestenurethane, polyimide, olyethreimide, polycarbonate, polysiloxane, polyvinyls, hydroxyethylmethacrylate, related polymers, co-polymers of these or other polymers, or drug-embedded or drug-eluting polymers to prevent coagulation or intimal hyperplasia (such as Taxol), also which can be made radiopaque by markers and addition of appropriate radiopaque materials. 
     The extraluminal clip and/or hemostatic wafer clip could be constructed of any of the above absorbable or non-absorbable materials but also any number of suitable materials, including radiopaque materials and materials coated to be made radiopaque, including bioabsorbable polymers or compounds, non-absorbable alloys and compounds including stainless steel, MP35, Nitinol, Nickel-Titanium alloy, Kevlar, nylon polyester acrylic, gold, platinum, tantalum, niobium, molybdenum, rhodium, palladium silver, hafnium, tungsten, iridium. 
     The present disclosure may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.