Patent Publication Number: US-9414824-B2

Title: Closure devices, systems, and methods

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This U.S. Patent Application is a divisional of U.S. patent application Ser. No. 12/688,065, filed Jan. 15, 2010, which claims the benefit of and priority to U.S. Provisional Patent Application having Ser. No. 61/145,468, filed on Jan. 16, 2009, the disclosures of which are incorporated herein by reference in their entireties. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates generally to medical devices, systems, and methods. In particular, the present disclosure relates to vessel closure devices, systems, and methods. 
     2. Technology 
     Catheterization and interventional procedures, such as angioplasty or stenting, generally are performed by inserting a hollow needle through a patient&#39;s skin and tissue into the patient&#39;s vascular system. A guidewire may be advanced through the needle and into the patient&#39;s blood vessel accessed by the needle. The needle is then removed, enabling an introducer sheath to be advanced over the guidewire into the vessel, e.g., in conjunction with or subsequent to a dilator. 
     A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guidewire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure. 
     Upon completing the procedure, the devices and introducer sheath are removed, leaving a puncture site in the vessel wall. Traditionally, external pressure is applied to the puncture site until clotting and wound sealing occur; however, the patient must remain bedridden for a substantial period after clotting to ensure closure of the wound. This procedure, however, may be time consuming and expensive, requiring as much as an hour of a physician&#39;s or nurse&#39;s time. It is also uncomfortable for the patient and requires that the patient remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs. 
     BRIEF SUMMARY 
     The present disclosure includes vessel closure devices, systems, and methods. In particular, the devices, systems, and methods of the present disclosure may allow a medical service provider to efficiently and quickly close an opening in a body lumen in a cost effective manner. In addition, the devices, systems, and methods of the present disclosure may allow for the closing of smaller body lumen openings using fewer parts than prior devices and systems. 
     According to one embodiment of the present disclosure, a closure device configured to close an opening in a body lumen may include an elongate member having a distal end and a proximal end. In addition, an anchor member may be disposed on the elongate member proximate the distal end of the elongate member. A cap member may also be disposed on the elongate member a distance from the distal end of the elongate member. 
     These and other advantages 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 advantages and features of the present disclosure, a more particular description of the disclosure will be rendered by reference to example embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only example embodiments of the disclosure and are therefore not to be considered limiting of its scope. The example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  illustrates an example closure device for closing an opening in a body lumen or other tissue; 
         FIG. 2  illustrates an another example closure device for closing an opening in a body lumen or other tissue; 
         FIG. 3A  illustrates an example closure system for closing an opening in a body lumen or other tissue; 
         FIG. 3B  illustrates an additional example closure system; 
         FIG. 3C  illustrates a further example closure system; and 
         FIGS. 4-11  illustrate an example method of closing a lumen opening. 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure includes devices, systems, and methods for closing an opening in a body lumen or other tissue. In particular, an example closure system may allow for at least one of reduced production costs, ease of use, and more effective hemostasis. In addition, embodiments of the closure system disclosed herein may allow for the closure of smaller openings in body lumens or other tissue. 
     In one embodiment, the closure system may include a closure device. The closure device may include an elongate member, such as a suture or shaft, an anchor member (or foot), and a cap member. The closure device may be disposed within or deployed by the closure system. The closure system may include an outer member, an inner member, an intermediate member, or combinations thereof configured to deploy a closure device from the closure system. 
     Reference is now made to  FIG. 1 , which illustrates an example closure device  100 . The closure device  100  may include a plurality of closure members  110  coupled to an elongate member  120 . In particular, the plurality of closure members  110  may include an anchor member  110   a  and/or a cap member  110   b . In one embodiment, the anchor member  110   a  may be disposed near a distal end of the elongate member  120 . In a further embodiment, the cap member  110   b  may be proximate the anchor member  110   a  and/or spaced a distance away from the distal end of the elongate member  120 . 
     The anchor member  110   a  may be configured to be deployed through an opening in a body lumen in order to secure the closure device  100  from a point distal to the lumen opening. For example, the anchor member  110   a  may be configured to move from a compressed, folded, or compacted first position having a dimension smaller than a lumen opening to a deployed, unfolded, or expanded second position having a dimension larger than the lumen opening. As a result, the anchor member  110   a  may pass through the lumen opening while in the first position and thereafter may move to the second position and provide an anchor against the distal side of the lumen wall proximate the lumen opening. 
     The elongate member  120  may extend proximally from the deployed anchor member  110   a  and/or may be tensioned to secure the anchor member  110   a  proximate the lumen opening and/or against a distal surface of a lumen wall once deployed. In a further embodiment, the elongate member  120  may pass through the cap member  110   b , which may be deployed at a position proximal of the lumen wall. Once deployed, the cap member  110   b  may be moved in a distal direction and/or may engage the proximal surface of the lumen wall. As a result, the anchor member  110   a  and/or cap member  110   b  may at least partially close the lumen opening. 
     The closure device  100  including, but not limited to, the anchor member  110   a  and/or cap member  110   b , may include one or more biocompatible, bioabsorbable, bioresorbable, other materials, or combinations thereof. Examples of such materials may include a suitable hydrogel, hydrophilic polymer, biodegradable polymers, bioabsorbable polymers and bioneutral polymers. Examples of such polymers may include poly(alpha-hydroxy esters), polylactic acids, polylactides, poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lactide, polyglycolic acids, polyglycolide, polylactic-co-glycolic acids, polyglycolide-co-lactide, polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, polyanhydrides, polyanhydride-co-imides, polyesters, polyorthoesters, polycaprolactones, polyesters, polyanydrides, polyphosphazenes, polyester amides, polyester urethanes, polycarbonates, polytrimethylene carbonates, polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates), polyfumarates, polypropylene fumarate, poly(p-dioxanone), polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines, poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids, combinations thereof, and/or the like. 
     In one embodiment, the closure device  100 , including, but not limited to, the anchor member  110   a  and/or cap member  110   b , may be coated with an active pharmaceutical ingredient with or without a polymeric carrier. The active pharmaceutical ingredient can be any drug. In one embodiment, the pharmaceutical ingredient may increase tissue growth. 
     The polymeric coating and drug may be configured to cooperate so as to form a diffusion pathway (e.g., lipophilic, hydrophilic, and/or amphipathic) with tissue when at least a portion of the closure device  100  engages tissue. This may facilitate diffusion into the tissue instead of into a body fluid passing over the closure device  100 . 
     The closure device  100  or any portion thereof may be loaded with and deliver beneficial agents or drugs, such as therapeutic agents, pharmaceuticals and radiation therapies. Accordingly, the closure device  100  and/or coating material may contain a drug or beneficial agent to improve the use of the closure device  100 . Such drugs or beneficial agents may include antithrombotics, anticoagulants, antiplatelet agents, thrombolytics, antiproliferatives, anti-inflammatories, hemostatic agents, agents that inhibit hyperplasia, inhibitors of smooth muscle proliferation, antibiotics, growth factor inhibitors, or cell adhesion inhibitors, as well as antineoplastics, antimitotics, antifibrins, antioxidants, agents that promote endothelial cell recovery, antiallergic substances, radiopaque agents, viral vectors having beneficial genes, genes, siRNA, antisense compounds, oligionucleotides, cell permeation enhancers, and combinations thereof. Another example of a suitable beneficial agent is described in U.S. Pat. Nos. 6,015,815 and 6,329,386 entitled “Tetrazole-containing rapamycin analogs with shortened half-lives”, the entireties of which are herein incorporated by reference. 
     The anchor member  110   a  and/or cap member  110   b  may include any shape configured to facilitate obstruction of a lumen opening. In one embodiment, the anchor member  110   a  and/or cap member  110   b  may have a disc-like shape. For example, the anchor member  110   a  and/or cap member  110   b  may include a generally flat piece of material that may be circular or oval in shape. The anchor member  110   a  and/or cap member  110   b  may incorporate other shapes and/or configurations. For example, the anchor member  110   a  and/or cap member  110   b  may have an elliptical and/or polygonal shape. In a further embodiment, the closure members  110  may be rectangular in shape along the length thereof with rounded and/or triangular ends or corners. 
     In one implementation, the thickness of the anchor member  110   a  and/or cap member  110   b  may be continuous throughout the anchor member  110   a  and/or cap member  110   b . In further implementations, however, the thickness of the anchor member  110   a  and/or cap member  110   b  may vary as desired for a particular application. For example, the thickness of the anchor member  110   a  and/or cap member  110   b  may be greater near the center than along the outer edge of the anchor member  110   a  and/or cap member  110   b . In a yet further example, the thickness of the anchor member  110   a  and/or cap member  110   b  may be greater along a first axis extending through the center of the anchor member  110   a  and/or cap member  110   b  and progressively thinner extending away from the first axis. As a result, the anchor member  110   a  and/or cap member  110   b  may allow bending about the first axis but may resist bending about an axis perpendicular to or different from the first axis. In yet further implementations, the thickness of the anchor member  110   a  and/or cap member  110   b  may vary as desired to achieve a particular strength, rigidity, flexibility, and/or other mechanical property. 
     In one implementation, the anchor member  110   a  and cap member  110   b  may have the same shape, size, coating, and/or other characteristics, and/or combinations thereof. In a further embodiment, the shape, size, coating, and/or other characteristics of the anchor member  110   a  may be different than those of the cap member  110   b.    
     As mentioned, the closure device  100  may include an elongate member  120 . In one embodiment, the anchor member  110   a  may be coupled to a distal end of the elongate member  120  and/or the cap member  110   b  may be disposed on the elongate member  120  at a position along the length of the elongate member  120 . The elongate member  120  may include one or more bioabsorbable materials and/or beneficial agents, such as any bioabsorbable material and/or beneficial agents disclosed herein. In a further embodiment, the elongate member  120  may include a bioabsorbable metal, alloy, polymer, plastic, composite, other materials, or combinations thereof. The elongate member  120  may include a single limb, such as disclosed in  FIG. 1 , or may include a plurality of limbs, such as disclosed in  FIG. 2 . In one example embodiment, the elongate member  120  may include a suture or a plurality of sutures. In a further embodiment, the elongate member  120  may include an elongate shaft or a plurality of elongate shafts. In a yet further embodiment, at least a portion of the elongate member  120  may be generally tubular or hollow. 
     The closure device  100  may be configured to resist proximal movement of the cap member  110   b  and/or distal movement of the anchor member  110   a  after deployment. For example, in one embodiment, a knot may be disposed on the elongate member  120  proximal of the cap member  110   b  to secure the cap member  110   b  and/or anchor member  110   a  in place. In a further embodiment, a cleat, such as a bioabsorbable plastic cleat, may be positioned to secure the cap member  110   b  and/or anchor member  110   a  in place. For example, the cleat may be positioned along the elongate member  120  proximal of and/or abutting the cap member  110   b . The cleat may maintain sufficient tension in the elongate member  120  to maintain the cap member  110   b  and anchor member  110   a  securely in a deployed position, such as in apposition with the lumen wall and/or lumen opening therebetween. In particular, the anchor member  110   a  and cap member  110   b  may sandwich the lumen wall surrounding a lumen opening to achieve closure of the lumen opening. 
     In a further embodiment, the closure device  100  may include a mechanism to lock and/or secure the anchor member  110   a  and cap member  110   b  in place. In one example embodiment, the elongate member  120  may have a uniform thickness along its length and/or pass through an aperture in the cap member  110   b  configured to produce sufficient frictional force between the cap member  110   b  and elongate member  120  to resist relative movement between the elongate member  120  and cap member  110   b . In particular, this configuration may allow the cap member  110   b  to be deployed by sliding the cap member  110   b  in a distal direction along the elongate member  120  to secure the cap member  110   b  and anchor member  110   a  in place. Once deployed, the frictional force between the elongate member  120  and the cap member  110   b  may prevent and/or resist further movement by the cap member  110   b  and/or anchor member  110   a.    
     In a further embodiment, the closure device  100  may include a barbed and/or ratchet design to secure the cap member  110   b  and anchor member  110   a  in the deployed configuration. For example, the elongate member  120  may include a plurality of projections  125  disposed along the length thereof. The projections  125  may include barbs, teeth, ridges, and/or other similar projections. The projections  125  may be configured to allow the cap member  110   b  to move in a distal direction but may resist/prevent movement by the cap member  110   b  in a proximal direction. For example, the projections  125  may be angled and/or extend in a distal direction to allow the cap member  110   b  to pass over the projections  125  in a distal direction but to prevent the cap member  110   b  from then passing back over the projections  125  in a proximal direction. Accordingly, once the anchor member  110   a  is deployed and/or secured against the distal surface of the lumen wall, the cap member  110   b  may be advanced along the elongate member  120  over the projections  125 . The cap member  110   b  may be secured against the proximal surface of the lumen wall and/or held in place by one or more of the projections  125  of the elongate member  120 . 
     In yet a further embodiment, the locking mechanism (i.e., knot, cleat, projections, etc.) may be independent of the cap member  110   b . In particular, decoupling the locking mechanism from the cap member  110   b  may allow for the independent optimization of the locking mechanism and/or the cap member  110   b . For example, the closure device  100  may further include a sliding collet that may be advanced along the elongate member  120  and/or lock the cap member  110   b  in place once deployed. The collet may incorporate one or more locking features that may be otherwise incorporated in the cap member  110   b  as explained in more detail herein. 
     In a further embodiment, the cap member  110   b  may be secured in place using a hollow elongate member  120  and a plug configured to be inserted into the elongate member  120 . Once the anchor is deployed, the cap member  110   b  may be moved along the hollow elongate member  120  into apposition with the anchor member  110   a , thereby applying pressure to opposite sides of the lumen wall near the lumen opening. A plug may be driven into the hollow elongate member  120  to expand the elongate member  120  proximal of the cap member  110   b . As a result, the expanded portion of the hollow elongate member  120  may secure the cap member  110   b  in place by limiting movement by the cap member  110   b  in a proximal direction. 
     Reference is now made to  FIG. 2  which illustrates another example closure device. The example closure device  200  of this configuration may be functionally similar to the example closure device  100  previously described above and shown in  FIG. 1  in most respects. Certain features will not be described in relation to this configuration where those components may function in the manner as described above and are hereby incorporated into this additional configuration described below. Like structures and/or components may be given like reference numerals. 
     In one embodiment, the closure device  200  may include a plurality of closure members  210  coupled to a plurality of elongate members  220   a ,  220   b . The plurality of closure members  210  may include an anchor member  210   a  and/or a cap member  210   b . In particular, the anchor member  210   a  may be coupled to the distal ends of the elongate members  220   a ,  220   b  and/or the cap member  210   b  may be disposed on the elongate members  220   a ,  220   b  proximal of the anchor member  210   a.    
     In one embodiment, the elongate members  220   a ,  220   b  may include plurality of sutures extending together along at least a portion of the length of the closure device  300 . In a further example, the elongate members  220   a ,  220   b  may include shafts and/or sutures. The elongate members  220   a ,  220   b  may be coupled together and/or to the anchor member  210   a  at their distal ends. For example, the elongate members  220   a ,  220   b  may be coupled together and/or coupled to the anchor member  210   a  using a distal knot  230   a . In particular, the distal knot  230   a  may be a heat formed knot. In a yet further embodiment, the elongate members  220   a ,  220   b  may form a proximal knot  230   b  at a position proximal of the cap member  210   b . The proximal knot  230   b  may be configured to be advanced in a distal direction and/or secure the cap member  210   b  in apposition to the anchor member  210   a  on opposite sides of a lumen wall. The elongate members  220   a ,  220   b  may be flexible and include surgical silk or thread, which may be bioabsorbable. Alternatively, the elongate member  120  (in  FIG. 1 ) may be relatively stiff. 
     Reference is now made to  FIG. 3A , which illustrates an example closure system  1000  for closing an opening in a body lumen or other tissue. In one embodiment, the closure system  1000  may include a closure device  300 , a generally tubular outer member  1010 , a generally tubular inner member  1030 , and a generally tubular intermediate member  1020 . The example closure device  300  included in the closure system  1000  of this configuration may be functionally similar to the example closure devices  100 ,  200  previously described above and shown in  FIGS. 1-2  in most respects, where certain features will not be described in relation to this configuration wherein those components may function in the manner as described above and are hereby incorporated into this additional configuration described below. Like structures and/or components may be given like reference numerals. 
     In one embodiment, the closure device  300  may include an anchor member  310   a , a cap member  310   b , and an elongate member  320 . The closure device  300  may be disposed at least partially within the outer member  1010  proximate a distal opening  1015  of the outer member  1010 . The intermediate member  1020  may be disposed at least partially within the outer member  1010  proximal of the closure device  300 . In particular, the distal end of the intermediate member  1020  may be disposed within the proximal end of the outer member  1010 . The proximal end of the intermediate member  1020  may also extend out of the proximal end of the outer member  1010  for operation by a medical practitioner. The inner member  1030  may be disposed at least partially within the outer member  1010  and/or the intermediate member  1020 . In a further embodiment, the closure device  300  may be disposed on or along side the inner member  1030 . In particular, the anchor member  310   a  and/or cap member  310   b  may fold or wrap at least partially around the inner member  1030 . The elongate member  320  of the closure device  300  may extend through a distal opening in the inner member  1030  and out a proximal opening in the inner member  1030  for operation by a medical practitioner. 
     The outer member  1010  may be configured to advance to a lumen opening while carrying the other components of the closure system  1000 . In one embodiment, the outer member  1010  may have a generally tapered distal end to facilitate entry into a body lumen through a lumen opening. The outer member  1010  may have a distal opening  1015  through which the inner member  1030  may pass and through which the closure device  300  may be deployed. In one example embodiment, the outer member  1010  may include a non-rigid catheter. 
     In further implementations, the outer member  1010  may have any dimensions desired. For example, as shown in  FIG. 3A , the outer member may have a substantially constant diameter along a majority of its length. However, in further implementations, the outer member  1010  may have a varying diameter. In a yet further implementation, the thickness of the outer member  1010  may vary along its length. For example, the thickness of the outer member may increase near the distal end. As a result, the inner diameter of the outer member may decrease near the distal end, creating a conical or funnel-like interior surface of the outer member  1010 . The reduced inner diameter of the outer member  1010  may allow for a reduction of setting of the anchor member  310   a  and/or cap member  310   b  from age and/or sterilization. In a yet further implementation, the anchor member  310   a  and/or cap member  310   b  may be disposed with the outer member proximate its proximal end or within a handle portion of the closure system  1000  prior to deployment through the distal opening  1015  of the outer member  1010 . 
     The intermediate member  1020  may be configured to deploy the anchor member  310   a  and/or cap member  310   b  of the closure device  300  through the distal opening  1015  in the outer member  1010 . For example, the intermediate member  1020  may be disposed within the outer member  1010  and positioned proximal of and/or abutting the closure device  300 . The intermediate member  1020  may be configured to translate in a distal direction relative to the outer member  1010  in order to push at least a portion of the closure device  300  through the distal opening  1015  of the outer member  1010  and/or to deploy the anchor member  310   a  and/or cap member  310   b . For example, once a distal end of the outer member  1010  has advanced through a lumen opening into a lumen, the intermediate member  1020  may be advanced in a distal direction relative to the outer member  1010  to deploy the anchor member  310   a  from the distal end of the outer member  1010  and/or into the lumen. 
     In one embodiment, the intermediate member  1020  may be configured to limit its range of movement in order to reduce instances of inadvertent deployment of the cap member  310   b  within the lumen. For example, the distance that the proximal end of the intermediate member  1020  extends beyond the proximal end of the outer member  1010  may be equal to the distance necessary to deploy the anchor member  310   a . In a further embodiment, the intermediate member  1020  may be configured to limit further distal movement of the intermediate member  1020  relative to the outer member  1010  once the relative movement necessary to deploy only the anchor member  310   a  has been achieved. For example, the proximal end of the intermediate member  1020  may include one or more flanges at its proximal end configured to abut the proximal end of the outer member once the relative movement necessary to deploy only the anchor member  310   a  has been achieved. 
     The inner member  1030  may pass through the intermediate member  1020  and/or outer member  1010  and extend out the distal and/or proximal ends of the outer member  1010  and/or intermediate member  1020 , respectively. In one embodiment, the distal end of the inner member  1030  may be configured to at least partially close the distal opening  1015  in the outer member  1010  in order to reduce instances of premature and/or inadvertent deployment of the closure device  300 . In a further embodiment, the inner member  1030  may include an inner lumen. For example, the inner lumen of the inner member  1030  may operate as a guidewire lumen, such that the closure system  1000  may advance over a guidewire into a body lumen through an opening in the body lumen wall. As explained above, the elongate member  320  of the closure device  300  may also be at least partially disposed through the inner member  1030 . In addition, the inner member  1030  may be configured to operate as and/or include a marker port and/or a flow back lumen, such as blood mark race and/or bleed back lumen, to indicate when the distal end of the closure system  1000  has entered the body lumen. 
     Reference is now made to  FIG. 3B , which illustrates an additional example closure system  1000 ′ in accordance with an implementation of the present invention. The closure system  1000 ′ of this configuration may be functionally similar to the example closure system  1000  previously described above and shown in  FIG. 3A  in most respects, wherein certain features will not be described in relation to this configuration where those components may function in the manner as described above and are hereby incorporated into this additional configuration described below. Like structures and/or components may be given like reference numerals. 
     In particular, the closure system  1000 ′ may differ from the closure system  1000  of  FIG. 3A  by integrating the intermediate member  1020  and inner member  1030  into a single component, namely intermediate member  1020 ′. For example, the intermediate member  1020 ′ may include a proximal portion  1020   a ′ and a distal portion  1020   b ′. In one implementation, the proximal portion  1020   a ′ may have a larger diameter than the distal portion  1020   b ′. The anchor member  310   a ′ and/or cap member  310   b ′ of the closure device may be disposed on or proximate to the distal portion  1020   b ′ of the intermediate member  1020 ′ within the outer member  1010 ′ and distal of the proximal portion  1020   a ′ of the intermediate member  1020 ′. When the intermediate member  1020 ′ is advanced in a distal direction, the proximal portion  1020   a ′ may assist in pushing or deploying the anchor member  310   a ′ and/or cap member  310   b ′ through a distal opening  1015 ′ in the outer member  1010 ′. The intermediate member  1020 ′ may also define a lumen through which the elongate member  320 ′, a guidewire, or body fluid may pass. As a result, the closure system  1000 ′ may have less moving parts than the closure system  1000  of  FIG. 3A  but may, nonetheless, operate similarly to deploy the closure device  300 ′ to close a body lumen opening. 
     Reference is now made to  FIG. 3C , which illustrates an additional example closure system  1000 ″ in accordance with an implementation of the present invention. The closure system  1000 ″ of this configuration may be functionally similar to the example closure systems  1000 ,  1000 ′ previously described above and shown in  FIGS. 3A-3B  in most respects, wherein certain features will not be described in relation to this configuration where those components may function in the manner as described above and are hereby incorporated into this additional configuration described below Like structures and/or components may be given like reference numerals. 
     As shown in  FIG. 3C , in addition to or in conjunction with the closure device  300 ″, the closure system  1000 ″ may include a plug  400 . The plug  400  may be configured to close an opening in a body lumen or a corresponding tissue tract. The plug  400  may be disposed within the closure system  1000 ″ and configured for deployment proximate the body lumen opening. In particular, the plug  400  may be disposed within the closure system  1000 ″ on the inner member  1030 ″ and distal of the intermediate member  1020 ″. In a further implementation, the plug  400  may be disposed on the elongate member  320 ″ of the closure device  300 ″ proximal of the anchor member  310   a ″ and/or cap member  310   b ″. The plug  400  may comprise any material known or used for closing a body lumen opening or tissue tract, including biodegradable materials, bioerodible materials, bioabsorbable materials, bioresorbable materials, other materials, or combinations thereof. In one implementation, the plug  400  may comprise collagen and/or polyethylene glycol. 
     Reference is now made to  FIGS. 4-11  which illustrate an example method of deploying the closure device  300  using the closure system  1000  of  FIG. 3 . For example,  FIG. 4  illustrates that the closure system  1000  may be advanced through a tissue tract and at least partially into a body lumen through a lumen opening to be obstructed or closed. As shown, the closure system  1000  may be advanced into the lumen over a guidewire  1040 . In particular, the guidewire may pass through the inner member  1030  of the closure system  1000 . The inner member  1030  may include and/or operate as a fluid mark race and/or flow back lumen in order to indicate to a user that the distal end of the closure system  1000  has entered the body lumen. For example, the closure system  1000  may be advanced in an artery, until a pulsatile blood mark is indicated at the proximal end of the inner member  1030 . 
     Once the closure system  1000  is in position with the distal end thereof disposed within the lumen, the inner member  1030  and/or guidewire  1040  may be retracted as illustrated in  FIG. 5 . In particular, the inner member  1030  may be removed by pulling on the inner member  1030  while stabilizing the remaining components of the closure system  1000 . In one embodiment, removing the inner member  1030  from the closure system  1000  may facilitate deployment of the closure device  300  through the distal opening  1015  of the outer member  1010 . 
     Once the inner member  1030  has been removed, the intermediate member  1020  may be advanced in a distal direction to deploy the anchor member  310   a  of the closure device  300  into the lumen as illustrated in  FIG. 6 . In one embodiment, the anchor member  310   a , which may have been folded and/or otherwise compacted while disposed within the outer member  1010 , may expand into a deployed state. 
     After the anchor member  310   a  is deployed, the outer member  1010  may be retracted and/or the elongate member  320  of the closure device  300  may be tensioned for the anchor member  310   a  to engage the distal surface of the lumen wall proximate the lumen opening as illustrated in  FIG. 7 . The outer member  1010  may continue to retract, and the resulting tension in the elongate member  320  caused by the secured anchor member  310   a  may deploy the cap member  310   b  from the distal opening  1015  of the outer member  1010  as illustrated in  FIGS. 8-9 . In a further embodiment, the intermediate member  1020  may be used to deploy the cap member  310   b.    
     Once the cap member  310   b  is deployed within the tissue tract proximal of the lumen wall, it may then be advanced into apposition with the anchor member  310   a , as illustrated in  FIG. 10 , in order to engage the anchor member  310   a  and/or cap member  310   b  with opposing surfaces of the lumen wall. During this process, the position of the anchor member  310   a  may be retained by maintaining tension in the elongate member  320  as the outer member  1010  is withdrawn and/or as the cap member  310   b  is advanced. In a further embodiment, a knot and/or cleat  330  may be advanced along the elongate member  320  of the closure device  300  and/or secure the cap member  310   b  against the anchor member  310   a  with the lumen wall sandwiched at least partially therebetween, thereby further securing the closure members in place. In a further embodiment, the elongate member  320  may include a plurality of projections (i.e.,  125 ,  FIG. 1 ) extending from a surface thereof and configured to secure the cap member  310   b  in place and prevent proximal movement of the cap member  310   b  relative to the elongate member  320 . Once the cap member  310   b  and anchor member  310   a  are secured, the elongate member  320  may be trimmed proximal of the cap member  310   b , such as by using a suture trimmer  340 , and then retracted, as shown in  FIG. 11 . In a further embodiment, one or more additional locking mechanisms as disclosed in more detail herein may be used to secure the cap member  310   b  and/or anchor member  310   a  in place. 
     Once deployed, the cap member  310   b  and the anchor member  310   a  can close or substantially close an opening in a body lumen. The vessel or tissue adjacent the opening can be disposed at least partially between the cap member  310   b  and the anchor member  310   a . As the cap member  310   b  is advanced, the cap member  310   b  and the anchor member  310   a  can apply pressure to the tissue or vessel to hold the tissue in place and close the opening. Further, the cap member  310   b  and the anchor member  310   a  may be configured to also bond or become connected to the tissue to further close the opening. Also, the cap member  310   b  and the anchor member  310   a  may slightly deform as tension is applied to accommodate the tissue that is between the cap member  310   b  and the anchor member  310   a.    
     The embodiments of 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 disclosure 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.