US20100185234A1 - Closure devices, systems, and methods - Google Patents

Abstract

The present disclosure includes vessel closure devices, systems, and methods. 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. 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. The anchor member and the cap member cooperate to close the opening in the body lumen.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This U.S. patent application claims the benefit of and priority to U.S. Provisional Patent Application having Ser. No. 61/145,468, filed on Jan. 16, 2009, the disclosure of which is incorporated herein by reference in its entirety.
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's skin and tissue into the patient's vascular system. A guidewire may be advanced through the needle and into the patient'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's or nurse'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 toFIG. 1, which illustrates anexample closure device100. Theclosure device100 may include a plurality ofclosure members110 coupled to anelongate member120. In particular, the plurality ofclosure members110 may include ananchor member110aand/or acap member110b. In one embodiment, theanchor member110amay be disposed near a distal end of theelongate member120. In a further embodiment, thecap member110bmay be proximate theanchor member110aand/or spaced a distance away from the distal end of theelongate member120.
• Theanchor member110amay be configured to be deployed through an opening in a body lumen in order to secure theclosure device100 from a point distal to the lumen opening. For example, theanchor member110amay 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, theanchor member110amay 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.
• Theelongate member120 may extend proximally from the deployedanchor member110aand/or may be tensioned to secure theanchor member110aproximate the lumen opening and/or against a distal surface of a lumen wall once deployed. In a further embodiment, theelongate member120 may pass through thecap member110b, which may be deployed at a position proximal of the lumen wall. Once deployed, thecap member110bmay be moved in a distal direction and/or may engage the proximal surface of the lumen wall. As a result, theanchor member110aand/orcap member110bmay at least partially close the lumen opening.
• Theclosure device100 including, but not limited to, theanchor member110aand/orcap member110b, 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, theclosure device100, including, but not limited to, theanchor member110aand/orcap member110b, 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 theclosure device100 engages tissue. This may facilitate diffusion into the tissue instead of into a body fluid passing over theclosure device100.
• Theclosure device100 or any portion thereof may be loaded with and deliver beneficial agents or drugs, such as therapeutic agents, pharmaceuticals and radiation therapies. Accordingly, theclosure device100 and/or coating material may contain a drug or beneficial agent to improve the use of theclosure device100. 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. No. 6,015,815 and U.S. Pat. No. 6,329,386 entitled “Tetrazole-containing rapamycin analogs with shortened half-lives”, the entireties of which are herein incorporated by reference.
• Theanchor member110aand/orcap member110bmay include any shape configured to facilitate obstruction of a lumen opening. In one embodiment, theanchor member110aand/orcap member110bmay have a disc-like shape. For example, theanchor member110aand/orcap member110bmay include a generally flat piece of material that may be circular or oval in shape. Theanchor member110aand/orcap member110bmay incorporate other shapes and/or configurations. For example, theanchor member110aand/orcap member110bmay have an elliptical and/or polygonal shape. In a further embodiment, theclosure members110 may be rectangular in shape along the length thereof with rounded and/or triangular ends or corners.
• In one implementation, the thickness of theanchor member110aand/orcap member110bmay be continuous throughout theanchor member110aand/orcap member110b. In further implementations, however, the thickness of theanchor member110aand/orcap member110bmay vary as desired for a particular application. For example, the thickness of theanchor member110aand/orcap member110bmay be greater near the center than along the outer edge of theanchor member110aand/orcap member110b. In a yet further example, the thickness of theanchor member110aand/orcap member110bmay be greater along a first axis extending through the center of theanchor member110aand/orcap member110band progressively thinner extending away from the first axis. As a result, theanchor member110aand/orcap member110bmay 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 theanchor member110aand/orcap member110bmay vary as desired to achieve a particular strength, rigidity, flexibility, and/or other mechanical property.
• In one implementation, theanchor member110aandcap member110bmay 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 theanchor member110amay be different than those of thecap member110b.
• As mentioned, theclosure device100 may include anelongate member120. In one embodiment, theanchor member110amay be coupled to a distal end of theelongate member120 and/or thecap member110bmay be disposed on theelongate member120 at a position along the length of theelongate member120. Theelongate member120 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, theelongate member120 may include a bioabsorbable metal, alloy, polymer, plastic, composite, other materials, or combinations thereof. Theelongate member120 may include a single limb, such as disclosed inFIG. 1, or may include a plurality of limbs, such as disclosed inFIG. 2. In one example embodiment, theelongate member120 may include a suture or a plurality of sutures. In a further embodiment, theelongate member120 may include an elongate shaft or a plurality of elongate shafts. In a yet further embodiment, at least a portion of theelongate member120 may be generally tubular or hollow.
• Theclosure device100 may be configured to resist proximal movement of thecap member110band/or distal movement of theanchor member110aafter deployment. For example, in one embodiment, a knot may be disposed on theelongate member120 proximal of thecap member110bto secure thecap member110band/oranchor member110ain place. In a further embodiment, a cleat, such as a bioabsorbable plastic cleat, may be positioned to secure thecap member110band/oranchor member110ain place. For example, the cleat may be positioned along theelongate member120 proximal of and/or abutting thecap member110b. The cleat may maintain sufficient tension in theelongate member120 to maintain thecap member110bandanchor member110asecurely in a deployed position, such as in apposition with the lumen wall and/or lumen opening therebetween. In particular, theanchor member110aandcap member110bmay sandwich the lumen wall surrounding a lumen opening to achieve closure of the lumen opening.
• In a further embodiment, theclosure device100 may include a mechanism to lock and/or secure theanchor member110aandcap member110bin place. In one example embodiment, theelongate member120 may have a uniform thickness along its length and/or pass through an aperture in thecap member110bconfigured to produce sufficient frictional force between thecap member110bandelongate member120 to resist relative movement between theelongate member120 andcap member110b. In particular, this configuration may allow thecap member110bto be deployed by sliding thecap member110bin a distal direction along theelongate member120 to secure thecap member110bandanchor member110ain place. Once deployed, the frictional force between theelongate member120 and thecap member110bmay prevent and/or resist further movement by thecap member110band/oranchor member110a.
• In a further embodiment, theclosure device100 may include a barbed and/or ratchet design to secure thecap member110bandanchor member110ain the deployed configuration. For example, theelongate member120 may include a plurality ofprojections125 disposed along the length thereof. Theprojections125 may include barbs, teeth, ridges, and/or other similar projections. Theprojections125 may be configured to allow thecap member110bto move in a distal direction but may resist/prevent movement by thecap member110bin a proximal direction. For example, theprojections125 may be angled and/or extend in a distal direction to allow thecap member110bto pass over theprojections125 in a distal direction but to prevent thecap member110bfrom then passing back over theprojections125 in a proximal direction. Accordingly, once theanchor member110ais deployed and/or secured against the distal surface of the lumen wall, thecap member110bmay be advanced along theelongate member120 over theprojections125. Thecap member110bmay be secured against the proximal surface of the lumen wall and/or held in place by one or more of theprojections125 of theelongate member120.
• In yet a further embodiment, the locking mechanism (i.e., knot, cleat, projections, etc.) may be independent of thecap member110b. In particular, decoupling the locking mechanism from thecap member110bmay allow for the independent optimization of the locking mechanism and/or thecap member110b. For example, theclosure device100 may further include a sliding collet that may be advanced along theelongate member120 and/or lock thecap member110bin place once deployed. The collet may incorporate one or more locking features that may be otherwise incorporated in thecap member110bas explained in more detail herein.
• In a further embodiment, thecap member110bmay be secured in place using a hollowelongate member120 and a plug configured to be inserted into theelongate member120. Once the anchor is deployed, thecap member110bmay be moved along the hollowelongate member120 into apposition with theanchor member110a, thereby applying pressure to opposite sides of the lumen wall near the lumen opening. A plug may be driven into the hollowelongate member120 to expand theelongate member120 proximal of thecap member110b. As a result, the expanded portion of the hollowelongate member120 may secure thecap member110bin place by limiting movement by thecap member110bin a proximal direction.
• Reference is now made toFIG. 2 which illustrates another example closure device. Theexample closure device200 of this configuration may be functionally similar to theexample closure device100 previously described above and shown inFIG. 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, theclosure device200 may include a plurality ofclosure members210 coupled to a plurality ofelongate members220a,220b. The plurality ofclosure members210 may include ananchor member210aand/or acap member210b. In particular, theanchor member210amay be coupled to the distal ends of theelongate members220a,220band/or thecap member210bmay be disposed on theelongate members220a,220bproximal of theanchor member210a.
• In one embodiment, theelongate members220a,220bmay include plurality of sutures extending together along at least a portion of the length of theclosure device300. In a further example, theelongate members220a,220bmay include shafts and/or sutures. Theelongate members220a,220bmay be coupled together and/or to theanchor member210aat their distal ends. For example, theelongate members220a,220bmay be coupled together and/or coupled to theanchor member210ausing adistal knot230a. In particular, thedistal knot230amay be a heat formed knot. In a yet further embodiment, theelongate members220a,220bmay form aproximal knot230bat a position proximal of thecap member210b. Theproximal knot230bmay be configured to be advanced in a distal direction and/or secure thecap member210bin apposition to theanchor member210aon opposite sides of a lumen wall. Theelongate members220a,220bmay be flexible and include surgical silk or thread, which may be bioabsorbable. Alternatively, the elongate member120 (inFIG. 1) may be relatively stiff.
• Reference is now made toFIG. 3A, which illustrates anexample closure system1000 for closing an opening in a body lumen or other tissue. In one embodiment, theclosure system1000 may include aclosure device300, a generally tubularouter member1010, a generally tubularinner member1030, and a generally tubularintermediate member1020. Theexample closure device300 included in theclosure system1000 of this configuration may be functionally similar to theexample closure devices100,200 previously described above and shown inFIGS. 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, theclosure device300 may include ananchor member310a, acap member310b, and anelongate member320. Theclosure device300 may be disposed at least partially within theouter member1010 proximate adistal opening1015 of theouter member1010. Theintermediate member1020 may be disposed at least partially within theouter member1010 proximal of theclosure device300. In particular, the distal end of theintermediate member1020 may be disposed within the proximal end of theouter member1010. The proximal end of theintermediate member1020 may also extend out of the proximal end of theouter member1010 for operation by a medical practitioner. Theinner member1030 may be disposed at least partially within theouter member1010 and/or theintermediate member1020. In a further embodiment, theclosure device300 may be disposed on or along side theinner member1030. In particular, theanchor member310aand/orcap member310bmay fold or wrap at least partially around theinner member1030. Theelongate member320 of theclosure device300 may extend through a distal opening in theinner member1030 and out a proximal opening in theinner member1030 for operation by a medical practitioner.
• Theouter member1010 may be configured to advance to a lumen opening while carrying the other components of theclosure system1000. In one embodiment, theouter member1010 may have a generally tapered distal end to facilitate entry into a body lumen through a lumen opening. Theouter member1010 may have adistal opening1015 through which theinner member1030 may pass and through which theclosure device300 may be deployed. In one example embodiment, theouter member1010 may include a non-rigid catheter.
• In further implementations, theouter member1010 may have any dimensions desired. For example, as shown inFIG. 3A, the outer member may have a substantially constant diameter along a majority of its length. However, in further implementations, theouter member1010 may have a varying diameter. In a yet further implementation, the thickness of theouter member1010 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 theouter member1010. The reduced inner diameter of theouter member1010 may allow for a reduction of setting of theanchor member310aand/orcap member310bfrom age and/or sterilization. In a yet further implementation, theanchor member310aand/orcap member310bmay be disposed with the outer member proximate its proximal end or within a handle portion of theclosure system1000 prior to deployment through thedistal opening1015 of theouter member1010.
• Theintermediate member1020 may be configured to deploy theanchor member310aand/orcap member310bof theclosure device300 through thedistal opening1015 in theouter member1010. For example, theintermediate member1020 may be disposed within theouter member1010 and positioned proximal of and/or abutting theclosure device300. Theintermediate member1020 may be configured to translate in a distal direction relative to theouter member1010 in order to push at least a portion of theclosure device300 through thedistal opening1015 of theouter member1010 and/or to deploy theanchor member310aand/orcap member310b. For example, once a distal end of theouter member1010 has advanced through a lumen opening into a lumen, theintermediate member1020 may be advanced in a distal direction relative to theouter member1010 to deploy theanchor member310afrom the distal end of theouter member1010 and/or into the lumen.
• In one embodiment, theintermediate member1020 may be configured to limit its range of movement in order to reduce instances of inadvertent deployment of thecap member310bwithin the lumen. For example, the distance that the proximal end of theintermediate member1020 extends beyond the proximal end of theouter member1010 may be equal to the distance necessary to deploy theanchor member310a. In a further embodiment, theintermediate member1020 may be configured to limit further distal movement of theintermediate member1020 relative to theouter member1010 once the relative movement necessary to deploy only theanchor member310ahas been achieved. For example, the proximal end of theintermediate member1020 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 theanchor member310ahas been achieved.
• Theinner member1030 may pass through theintermediate member1020 and/orouter member1010 and extend out the distal and/or proximal ends of theouter member1010 and/orintermediate member1020, respectively. In one embodiment, the distal end of theinner member1030 may be configured to at least partially close thedistal opening1015 in theouter member1010 in order to reduce instances of premature and/or inadvertent deployment of theclosure device300. In a further embodiment, theinner member1030 may include an inner lumen. For example, the inner lumen of theinner member1030 may operate as a guidewire lumen, such that theclosure system1000 may advance over a guidewire into a body lumen through an opening in the body lumen wall. As explained above, theelongate member320 of theclosure device300 may also be at least partially disposed through theinner member1030. In addition, theinner member1030 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 theclosure system1000 has entered the body lumen.
• Reference is now made toFIG. 3B, which illustrates an additionalexample closure system1000′ in accordance with an implementation of the present invention. Theclosure system1000′ of this configuration may be functionally similar to theexample closure system1000 previously described above and shown inFIG. 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, theclosure system1000′ may differ from theclosure system1000 ofFIG. 3A by integrating theintermediate member1020 andinner member1030 into a single component, namelyintermediate member1020′. For example, theintermediate member1020′ may include aproximal portion1020a′ and a distal portion1020b′. In one implementation, theproximal portion1020a′ may have a larger diameter than the distal portion1020b′. Theanchor member310a′ and/orcap member310b′ of the closure device may be disposed on or proximate to the distal portion1020b′ of theintermediate member1020′ within theouter member1010′ and distal of theproximal portion1020a′ of theintermediate member1020′. When theintermediate member1020′ is advanced in a distal direction, theproximal portion1020a′ may assist in pushing or deploying theanchor member310a′ and/orcap member310b′ through adistal opening1015′ in theouter member1010′. Theintermediate member1020′ may also define a lumen through which theelongate member320′, a guidewire, or body fluid may pass. As a result, theclosure system1000′ may have less moving parts than theclosure system1000 ofFIG. 3A but may, nonetheless, operate similarly to deploy theclosure device300′ to close a body lumen opening.
• Reference is now made toFIG. 3C, which illustrates an additionalexample closure system1000″ in accordance with an implementation of the present invention. Theclosure system1000″ of this configuration may be functionally similar to theexample closure systems1000,1000′ previously described above and shown inFIGS. 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 inFIG. 3C, in addition to or in conjunction with theclosure device300″, theclosure system1000″ may include aplug400. Theplug400 may be configured to close an opening in a body lumen or a corresponding tissue tract. Theplug400 may be disposed within theclosure system1000″ and configured for deployment proximate the body lumen opening. In particular, theplug400 may be disposed within theclosure system1000″ on theinner member1030″ and distal of theintermediate member1020″. In a further implementation, theplug400 may be disposed on theelongate member320″ of theclosure device300″ proximal of theanchor member310a″ and/orcap member310b″. Theplug400 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, theplug400 may comprise collagen and/or polyethylene glycol.
• Reference is now made toFIGS. 4-11 which illustrate an example method of deploying theclosure device300 using theclosure system1000 ofFIG. 3. For example,FIG. 4 illustrates that theclosure system1000 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, theclosure system1000 may be advanced into the lumen over aguidewire1040. In particular, the guidewire may pass through theinner member1030 of theclosure system1000. Theinner member1030 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 theclosure system1000 has entered the body lumen. For example, theclosure system1000 may be advanced in an artery, until a pulsatile blood mark is indicated at the proximal end of theinner member1030.
• Once theclosure system1000 is in position with the distal end thereof disposed within the lumen, theinner member1030 and/orguidewire1040 may be retracted as illustrated inFIG. 5. In particular, theinner member1030 may be removed by pulling on theinner member1030 while stabilizing the remaining components of theclosure system1000. In one embodiment, removing theinner member1030 from theclosure system1000 may facilitate deployment of theclosure device300 through thedistal opening1015 of theouter member1010.
• Once theinner member1030 has been removed, theintermediate member1020 may be advanced in a distal direction to deploy theanchor member310aof theclosure device300 into the lumen as illustrated inFIG. 6. In one embodiment, theanchor member310a, which may have been folded and/or otherwise compacted while disposed within theouter member1010, may expand into a deployed state.
• After theanchor member310ais deployed, theouter member1010 may be refracted and/or theelongate member320 of theclosure device300 may be tensioned for theanchor member310ato engage the distal surface of the lumen wall proximate the lumen opening as illustrated inFIG. 7. Theouter member1010 may continue to retract, and the resulting tension in theelongate member320 caused by thesecured anchor member310amay deploy thecap member310bfrom thedistal opening1015 of theouter member1010 as illustrated inFIGS. 8-9. In a further embodiment, theintermediate member1020 may be used to deploy thecap member310b.
• Once thecap member310bis deployed within the tissue tract proximal of the lumen wall, it may then be advanced into apposition with theanchor member310a, as illustrated inFIG. 10, in order to engage theanchor member310aand/orcap member310bwith opposing surfaces of the lumen wall. During this process, the position of theanchor member310amay be retained by maintaining tension in theelongate member320 as theouter member1010 is withdrawn and/or as thecap member310bis advanced. In a further embodiment, a knot and/orcleat330 may be advanced along theelongate member320 of theclosure device300 and/or secure thecap member310bagainst theanchor member310awith the lumen wall sandwiched at least partially therebetween, thereby further securing the closure members in place. In a further embodiment, theelongate member320 may include a plurality of projections (i.e.,125,FIG. 1) extending from a surface thereof and configured to secure thecap member310bin place and prevent proximal movement of thecap member310brelative to theelongate member320. Once thecap member310bandanchor member310aare secured, theelongate member320 may be trimmed proximal of thecap member310b, such as by using asuture trimmer340, and then retracted, as shown inFIG. 11. In a further embodiment, one or more additional locking mechanisms as disclosed in more detail herein may be used to secure thecap member310band/oranchor member310ain place.
• Once deployed, thecap member310band theanchor member310acan close or substantially close an opening in a body lumen. The vessel or tissue adjacent the opening can be disposed at least partially between thecap member310band theanchor member310a. As thecap member310bis advanced, thecap member310band theanchor member310acan apply pressure to the tissue or vessel to hold the tissue in place and close the opening. Further, thecap member310band theanchor member310amay be configured to also bond or become connected to the tissue to further close the opening. Also, thecap member310band theanchor member310amay slightly deform as tension is applied to accommodate the tissue that is between thecap member310band theanchor member310a.
• 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.

Claims (28)

1. A closure device configured to close an opening in a body lumen, the closure device comprising:

an elongate member having a distal end and a proximal end;

an anchor member disposed on the elongate member proximate the distal end of the elongate member; and

a cap member disposed on the elongate member a distance from the distal end of the elongate member, wherein the anchor member and the cap member are positioned to close the opening in the body lumen.

2. The closure device ofclaim 1, wherein the elongate member comprises a metal or plastic shaft.

3. The closure device ofclaim 1, wherein the elongate member comprises a suture.

4. The closure device ofclaim 3, further comprising a second elongate member disposed substantially in parallel with the first elongate member, the second elongate member comprising a suture.

5. The closure device ofclaim 1, wherein the elongate member comprises a hollow shaft and the closure device further comprises a plug configured to be inserted into the hollow shaft to expand the hollow shaft.

6. The closure device ofclaim 1, wherein the elongate member comprises one or more projections disposed along the length thereof.

7. The closure device ofclaim 6, wherein the one or more projections are chosen from a group comprising teeth, barbs, and ridges.

8. The closure device ofclaim 6, wherein the one or more projections are configured to permit movement by the cap member in a distal direction and resist movement by the cap member in a proximal direction.

9. The closure device ofclaim 1, wherein the cap member is slidably disposed on the elongate member.

10. The closure device ofclaim 1, wherein the anchor member or cap member comprises a biodegradable material.

11. The closure device ofclaim 1, wherein the anchor member or cap member is disc shaped.

12. The closure device ofclaim 1, wherein the anchor member or cap member has a varying thickness.

13. The closure device ofclaim 1, wherein the elongate member comprises a bioabsorbable monofilament.

14. The closure device ofclaim 1, wherein the anchor member is coupled to the elongate member proximate a knot.

15. The closure device ofclaim 1, further comprising a cleat, collet, or knot disposed on the elongate member proximal of the cap member.

16. A closure system comprising:

a generally tubular outer member having a distal opening and a proximal opening;

a generally tubular intermediate member disposed at least partially within the outer member; and

a closure device disposed at least partially within the outer member, the closure device comprising:

an elongate member having a distal end and a proximal end, the elongate member being disposed at least partially through the intermediate member;

an anchor member disposed on the elongate member proximate the distal end of the elongate member, the anchor member being further disposed within the outer member distal of the intermediate member; and

a cap member disposed on the elongate member a distance from the distal end of the elongate member, the cap member being further disposed within the outer member proximal of the anchor member.

17. The closure system ofclaim 16, wherein the outer member comprises a non-rigid catheter.

18. The closure system ofclaim 16, further comprising a generally tubular inner member disposed at least partially within the outer member and/or intermediate member.

19. The closure system ofclaim 18, wherein the inner member comprises a guidewire lumen, fluid marker port, and/or flow back lumen.

20. The closure system ofclaim 18, wherein the inner member and the intermediate member are integrated together into a single component.

21. The closure system ofclaim 16, wherein the intermediate member comprises a pusher tube.

22. The closure system ofclaim 16, wherein the intermediate member is movable relative to the outer member.

23. The closure system ofclaim 22, wherein the distal movement of the intermediate member relative to the outer member is limited to the movement necessary deploy the anchor member from the distal opening of the outer member.

24. The closure system ofclaim 16, further comprising a collagen or polyethylene glycol plug configured to at least partially obstruct a tissue tract proximate a body lumen opening.

25. A method of closing an opening in a lumen wall, the method comprising:

advancing the distal end of a closure system over a guidewire into a body lumen, the closure system comprising:

a generally tubular outer member having a distal opening and a proximal opening;

a generally tubular intermediate member disposed at least partially within the outer member; and

a closure device disposed at least partially within the outer member, the closure device comprising:

an elongate member having a distal end and a proximal end, the elongate member being disposed at least partially through the intermediate member;

an anchor member disposed on the elongate member proximate the distal end of the elongate member, the anchor member being further disposed within the outer member distal of the intermediate member; and

a cap member disposed on the elongate member a distance from the distal end of the elongate member, the cap member being further disposed within the outer member proximal of the anchor member.

deploying the anchor member into the lumen;

tensioning the elongate member to engage the anchor member with a distal surface of the lumen wall; and

deploying the cap member and advancing the cap member in a distal direction along the elongate member to engage a proximal surface of the lumen wall.

26. The method ofclaim 25, further comprising positioning a knot, collet, or cleat on the elongate member proximal of the cap member.

27. The method ofclaim 25, further comprising retracting the outer member in a proximal direction to deploy the cap member.

28. The method ofclaim 25, wherein the closure system further comprises a generally tubular inner member disposed at least partially within the intermediate member.

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