Devices, systems, and methods for closing openings in vessel walls

Abstract

Devices, systems, and methods for treating vessel openings are disclosed herein. According to some embodiments, a system for closing a vessel opening in a blood vessel wall comprises an elongate shaft, a patch configured to be implanted over the vessel opening with at least a portion of the patch positioned against an inner surface of the vessel wall, a flexible anchor with a first end fixed to the patch, and a tubular sheath. The elongate shaft is configured to be positioned within a lumen of the sheath. When the system is in a pre-delivery configuration, the patch is positioned between an outer surface of the elongate shaft and an inner surface of the sheath with the anchor extending distally from the patch, then proximally through the lumen of the elongate shaft until the second end of the anchor exits the lumen of the elongate shaft at the proximal portion.

Description

DEVICES, SYSTEMS, AND METHODS FOR CLOSING OPENINGS IN VESSELWALLSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from U.S. Provisional Patent Application 63 / 619,389 filed 10 January 2024, the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The present technology relates generally to tissue puncture closure devices, and more particularly, to devices and methods for closure of openings in vessel walls.BACKGROUND

[0003] Traditionally, cardiovascular procedures have been performed as open surgical procedures in which one or more large incisions are made through the patient’s skin to visualize the treatment site. Open cardiac surgical procedures further require cutting through the patient’s breastbone and spreading the patient’s ribcage to access the heart. More recently, transcatheter procedures have been developed that inflict significantly less trauma on the patient’s body. Transcatheter procedures involve percutaneously accessing a blood vessel through a patient’s skin and inserting a catheter into the lumen of the blood vessel. The catheter can be navigated through the patient’s vasculature to deliver a medical device to a treatment site within the cardiovascular system. As one example, a distal end of the catheter can be navigated into the patient’s heart and a leadless pacemaker can be delivered through the catheter into the patient’s heart. In some procedures, such as balloon angioplasty, for example, the catheter itself can perform the medical intervention. In any case, by accessing the patient’s vascular system with a small puncture or incision through the patient’s skin, transcatheter procedures are less invasive, safer, and more efficient than open surgical procedures.

[0004] Upon completion of a transcatheter procedure, the catheter is removed from the patient’s vasculature, leaving an opening in the wall of the blood vessel and the subcutaneous tissue through which the vessel was accessed. The opening allows blood to exit the vessel and presents a risk of bleeding. Thus, a need exists for devices and methods to close vessel openings and / or to prevent bleeding through vessel openings created during transcatheter procedures.SUMMARY

[0005] The subject technology is illustrated, for example, according to various aspects described below, including with reference to FIGS. 1-5C. Various examples of aspects of the subject technology are described as numbered examples (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology.[00061 In a first aspect, a system for closing a vessel opening in a blood vessel wall is provided. The system comprises an elongate shaft defining a lumen therethrough and having a proximal portion and a distal portion, the lumen terminating distally at an opening in the elongate shaft, wherein the distal portion is configured to be positioned within the blood vessel lumen via insertion through the vessel opening in the blood vessel wall; a patch configured to be implanted over the vessel opening in the blood vessel lumen with at least a portion of the patch positioned against an inner surface of the blood vessel wall; a flexible anchor extending between a first end and a second end, wherein the first end of the anchor is fixed to the patch, and wherein the anchor is configured to be positioned within cutaneous and subcutaneous tissue when the patch is implanted in the blood vessel lumen; and a tubular sheath defining a lumen extending therethrough, wherein the elongate shaft is configured to be positioned within the lumen of the sheath, wherein, when the system is in a pre-delivery configuration, the patch is positioned between an outer surface of the elongate shaft and an inner surface of the sheath with the anchor extending distally from the patch along the elongate shaft, through the opening in the elongate shaft, and through the lumen of the elongate shaft until the second end of the anchor exits the lumen of the elongate shaft at the proximal portion of the elongate shaft.

[0007] In another aspect, a system for closing a vessel opening in a blood vessel wall is provided. The system comprises a delivery system comprising: a delivery device comprising an elongate shaft defining a lumen therethrough and having a proximal portion and a distal portion, the lumen terminating distally at an opening in the elongate shaft, wherein the distal portion is configured to be positioned within the blood vessel lumen via insertion through the vessel opening in the blood vessel wall; a closure device configured to be secured to the delivery device for delivery to the vessel lumen, the closure device comprising: a patch configured to be implanted over a vessel opening with at least a portion of the patch positioned against an inner surface of the blood vessel wall; a flexible anchor extending between a first end and a second end, wherein the first end of the anchor is fixed to the patch, and wherein the anchor is configured to be positioned within cutaneous and subcutaneous tissue when the patch is implanted in the blood vessel; and a tubular sheath defining a lumen extending therethrough,wherein the elongate shaft is configured to be positioned within the lumen of the sheath, wherein, when the delivery system is in a pre-delivery configuration, the patch is positioned between an outer surface of the elongate shaft and an inner surface of the sheath with the anchor extending distally from the patch along the elongate shaft, through the opening in the elongate shaft, and through the lumen of the elongate shaft until the second end of the anchor exits the lumen of the elongate shaft at the proximal portion of the elongate shaft.{0008] In yet a further aspect, a method for closing an opening in a blood vessel wall is provided. The method comprises inserting a delivery system through an elongate tubular member into the blood vessel lumen such that a distal portion of the delivery system is distal of a distal end of the tubular member, the delivery system comprising: a delivery device comprising an elongate shaft defining a lumen therethrough and having a proximal portion and a distal portion, the lumen terminating distally at an opening in the elongate shaft; and a closure device coupled to the delivery device, the closure device comprising a patch and a flexible anchor coupled to and extending away from the patch, wherein, during insertion through the tubular member, the patch is positioned between the outer surface of the elongate shaft and an inner surface of the tubular member with the anchor extending distally from the patch along the elongate shaft, then proximally through the opening in the elongate shaft and through the lumen of the elongate shaft until exiting the lumen at the proximal portion of the elongate shaft; advancing the delivery system distally until the patch is distal of the tubular member; and withdrawing the tubular member and elongate shaft together through the vessel opening and tissue channel leading to the vessel opening such that the patch is positioned over the opening with a portion of the patch abutting an inner surface of the vessel wall surrounding the opening, thereby preventing egress of blood to an extravascular space.BRIEF DESCRIPTION OF THE DRAWINGS(00091 Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.

[0010] FIG. 1 illustrates a delivery system configured in accordance with several embodiments of the present technology, shown in a pre-delivery state.

[0011] FIG. 2 is an enlarged view of a distal portion of the delivery system shown inFIG. 1A.

[0012] FIG. 3 A is an introducer sheath configured in accordance with several embodiments of the present technology.

[0013] FIG. 3B is a schematic cross-sectional view of the delivery system of FIG. 1 being inserted through the hub of the introducer sheath of FIG. 3 A.

[0014] FIG. 4 is a top view of a patch configured in accordance with several embodiments of the present technology.

[0015] FIGS. 5A-5C show an example method of closing an opening in a vessel wall using the patch and associated delivery system of the present technology.DETAILED DESCRIPTION

[0016] The present technology relates to devices, systems, and methods for closing an opening in a blood vessel wall. The present technology can include a closure device comprising a bioabsorbable patch configured to be implanted within the blood vessel lumen, over the opening in the blood vessel wall, with at least a portion of the patch positioned against the inner surface of the vessel wall surrounding the opening. The closure device can further include a flexible, bioabsorbable anchor having a first end coupled to the patch. When the patch is positioned over the opening within the vessel, the body of the anchor extends away from the patch, through the corresponding tissue puncture tract with a second end of the anchor secured at the patient’s skin. The anchor helps secure the patch over the opening until the opening is healed.

[0017] According to some embodiments, the present technology includes a delivery system for delivering the closure device to the opening through the lumen of another medical device, such as a catheter, sheath, introducer or other tubular device used to gain access to the blood vessel and / or perform a vascular intervention. The patch, for example, can be positioned over an elongate member with the anchor extending distally along an outer surface of the elongate member, through an opening at a distal end of the elongate member, then proximally through a lumen of the elongate member to an extracorporeal location. In this delivery configuration, the closure device and elongate member can be pushed through a lumen of a medical device already positioned through the puncture tract and vessel opening. In some cases, the delivery system includes a cover positioned over the patch and configured to facilitate passage of the patch through any valves or other internal structure of the medical device on which the patch may catch. In contrast to conventional systems that require removal of the existing medical device(s) from the puncture tract prior to inserting and deploying a separatevessel closure device, the delivery devices of the present technology enable closure of a vessel opening while the medical device(s) remains within the opening and / or puncture tract, preventing the outflow of blood. This beneficially reduces the time and steps for the physician while reducing the risk of hematoma formation. The delivery devices herein can be configured for delivery through a wide range of medical device diameters, including inner diameters of at least 23 French.

[0018] FIG. 1 shows a delivery system 100 (or “system 100”) configured in accordance with several embodiments of the present technology. The delivery system 100 has a proximal portion 100a configured to be positioned at an extracorporeal location during a closure procedure and a distal portion 100b configured to be positioned within a vessel lumen. The delivery system 100 can include an implantable closure device 102 (or “device 102”) coupled to a delivery device 108. The closure device 102 can comprise a patch 104 and a flexible, elongate anchor 106. The anchor 106 has a first end 106a (FIG. 2) coupled to the patch 104, a second end 106b (FIG. 1), and a body extending therebetween. As described herein, the patch 104 is configured to cover an opening in a blood vessel wall and prevent and / or reduce blood flow therethrough to an extravascular space.

[0019] The delivery device 108 can comprise, for example, a catheter, a dilator, an introducer, and / or any other medical device configured to extend from an extracorporeal location through a puncture tract and vessel opening to a location within a vessel lumen. As shown in FIGS. 1 and 2, in some embodiments the delivery device 108 comprises a hub 110 and an elongate shaft 112 extending between a proximal end portion 112a at the hub 110 and a distal end portion 112b configured to be positioned within the vessel lumen. The elongate shaft 112 defines a lumen extending therethrough that terminates distally at an opening 105 (FIG. 2) at the distal tip of the elongate shaft 112. The elongate shaft 112 can have a substantially constant outer diameter or may have a tapered distal portion (as shown in FIGS. 1 and 2).

[0020] In any case, the elongate shaft 112 is configured to be slidably received within a lumen of a medical device already positioned through the vessel opening (e.g., a catheter, a sheath, an introducer, etc.). An example medical device 300 is shown in FIG. 3A. The medical device 300 may be a component of the delivery system 100 or may be provided separately. As depicted in FIG. 3A, the medical device 300 can include a hub 302 and an elongate shaft 304 extending distally from the hub 302 and defining a lumen therethrough. In some embodiments,the medical device 300 has an inner diameter of at least 23 Fr. It will be appreciated that other sizes are possible.

[0021] The delivery system 100 is shown in a pre-insertion configuration in FIGS. 1 and 2. In this configuration, the patch 104 may be positioned at an outer surface of a distal region of the elongate shaft 112 with the anchor 106 extending distally away from the patch 104 along the outer surface 115 of the elongate shaft 112 to and / or beyond the distal tip. The anchor 106 then turns and extends proximally through the opening 105 at the distal tip, through the lumen of the elongate shaft 112, and exits the delivery device 108 proximally through the hub 110.

[0022] In some embodiments, the delivery system 100 includes a sheath 114 positioned over a portion of the elongate shaft 112, the patch 104, and at least a portion of the anchor 106 such that the portion of the elongate shaft 112, the patch 104, and the at least a portion of the anchor 106 are positioned within a lumen 116 of the sheath 114. The inner diameter of the sheath 114 can be sized such that the patch 104 is held in place and / or forced to conform to the outer surface of the elongate shaft 112. Depending on the size and flexibility of the patch 104, the sheath 114 may force the patch 104 to wrap and / or curl around all or a portion of the circumference of the elongate shaft 112 when in the pre-insertion configuration.

[0023] FIG. 3B is a schematic cross-sectional view of the delivery system 100 being inserted through the 302 hub of the medical device 300. As shown, the sheath 114 can be configured to facilitate insertion of the elongate shaft 112 and closure device 102 through a valve 303 within the hub 302 of the medical device 300. For example, during insertion of the delivery system 100 through the hub 302, the outer surface of the sheath 114 can engage the valve 303 and prevent the patch 104 from catching on the valve 303. The friction between the outer surface of the sheath 114 and the valve 303 is greater than the distal advancement forces on the sheath 114 such that the sheath 114 then remains within or proximal of the valve 303 (and thus at least partially within the hub 302) while the patch 104 moves distally beyond the hub 302 as the elongate shaft 112 is advanced. Accordingly, the sheath 114 holds the valve 303 open while the patch 104 is advanced therethrough. As shown in FIGS. 1 and 2, the sheath 114 can have a length shorter than that of the elongate shaft 112, so long as the sheath 114 extends the length of the patch 104.

[0024] FIG. 4 shows a top view of the patch 104 with the anchor 106 removed. With reference to FIGS. 1, 2, and 4, the patch 104 can comprise a bioabsorbable or non-absorbablematerial of any symmetrical or asymmetrical shape, including but not limited to a circle (as shown), ellipse, square, rectangle, oval, and / or any polygon or other shape suitable for covering the opening in the vessel. In some embodiments, the patch 104 has a cross-sectional area of about 100 mm2to about 130 mm2. In some examples, the patch 104 is an ellipse with a major axis length of between about 12 and 16 mm, or about 15 mm, and a minor axis length of about 8 to 12 mm, or about 10 mm.

[0025] The anchor 106 (not shown in FIG. 4) may be fixed to the patch 104 at a central location (such as location 120 in FIG. 4), or may be offset from the center, biased towards a particular side of the patch 104. In some embodiments, the patch 104 can comprise a mesh and / or fabric structure defining a plurality of pores 118. The pore size may be the same or vary across the surface of the patch 104. In some examples, the patch 104 comprises a solid resorbable structure, such as a bioabsorbable polymer film, and does not include any pores. In those cases where the patch 104 is absorbable, the patch 104 may absorb within 30 to 90 days post-implantation.

[0026] The patch 104 has a thickness measured between its top and bottom sides. The thickness can be the same across the patch 104, or may vary. For example, in some embodiments it may be beneficial for the thickness of the patch 104 to be greater in the region where the first end 106a of the anchor 106 attaches to the patch 104. In any case, the patch 104 can be sufficiently thin (e.g., less than 1 mm) to maintain a low-profile within the blood vessel lumen and avoid occluding the blood vessel and / or creating a nidus for clot formation once implanted. The patch material can comprise one or more layers of cellulose (including but not limited to oxidized cellulose), a knitted and / or woven mesh formed of bioabsorbable polymer fibers, and other suitable materials. In some embodiments, the patch 1104 comprises a fabric and / or textile. One or both of the top and bottom sides of the patch 104 may include a coating. For example, in some embodiments at least the top side (facing the vessel wall) may include a coating configured to promote thrombosis at the extravascular side of the opening and / or at least the bottom side (facing the vessel lumen) may include a coating configured to prevent thrombosis. When more than one layer of material is used to form the patch 104, the edges of the layers can be weaved together and / or bonded with a medical adhesive or absorbable resin.

[0027] The anchor 106 can comprise one or more flexible, bioabsorbable strands of material, such as a suture material. As best shown in FIG. 2, in some embodiments the anchor 106 optionally includes a plurality of barbs 107 (only one barb labeled in FIG. 2) extending radially away from a longitudinal axis of the anchor 106. One, some, or all of the barbs 107can extend away from the body of the anchor 106 along a line that is perpendicular to the anchor 106, or may extend away at a non-90 degree angle. As shown in FIG. 2, in some embodiments one, some, or all of the barbs 107 can point towards the first end 106a of the anchor 106 (e.g., the free ends of the individual barbs 107 are closer to the first end 106a of the anchor 106 than the ends of the barbs 107 fixed at the anchor body) such that, when the closure device 102 is implanted, the barbs 107 extend distally into the subcutaneous tissue surrounding the puncture tract and thus resist distal movement of the closure device 102 towards the vessel lumen. In other embodiments, one, some, or all of the barbs 107 can point towards the second end 106b of the anchor 106 (e.g., the free ends of the individual barbs 107 are closer to the second end 106b of the anchor 106 than the ends of the barbs 107 fixed at the anchor body). In some embodiments, the anchor may be constructed as a barbed suture.

[0028] In some embodiments, the anchor 106 comprises a braided and / or twisted suture. In these and other examples, the second end 106b of the anchor 106 may include a securing member (not shown) for securing the anchor 106 to the skin following implantation of the patch 104. The securing member can comprise, for example, a needle, a cinching member, a ratcheted guide (like a zip tie), and / or an elastic member for tensioning. As but one example, a cinching member could comprise a disc (such as a silicone disc or other material) having a slot extending across at least a portion of its diameter. The disc can be positioned at skin level, and an extracorporeal end region of the anchor 106 can be inserted into the slot. The barbs 107 of the anchor 106 can fixate within the disc as well to help hold tension in addition to the barbs 107 that are fixated in the tissue.

[0029] FIGS. 5A-5C illustrate an example method of closing an opening in tissue proximate a puncture site in a blood vessel using the delivery system 100. To begin the procedure, a needle (not shown) is inserted through the skin S, subcutaneous tissue T, and vessel wall W to provide access to the vessel lumen L. In some cases, the needle may be inserted at a non-perpendicular angle to the vessel. In some procedures, the vessel can be accessed via a cut-down procedure in which an incision is made through the patient’s skin and subcutaneous tissue. In any case, a guidewire (not shown) can be inserted through a lumen of the needle into the vessel lumen (thereby creating an opening VO in the vessel wall W) to provide and maintain access to the vessel lumen. The needle can be retracted proximally over the guidewire and removed from the subcutaneous tissue and skin, leaving a channel C extending through the subcutaneous tissue T and skin S surrounding the guidewire.

[0030] The elongate shaft 304 of the medical device 300 can be fed over the guidewire through the tissue channel C and vessel opening O and into the lumen L of the targeted blood vessel. The blood vessel can be any artery or vein, including but not limited to the internal jugular vein, external jugular vein, subclavian vein, etc. A medical procedure (e.g., placement of a pacemaker, heart valve repair or replacement, etc.) can then be performed with the distal portion of the elongate shaft 304 positioned within the vessel lumen L.

[0031] At the conclusion of the medical procedure, prior to removal of the medical device 300, the physician can insert the delivery system 100 in the pre-insertion configuration into the hub 302 (not shown) of the medical device 300. As the delivery system 100 is advanced distally, the sheath 114 contacts a valve within the hub 302, thereby allowing passage of the patch 104 through the valve while leaving the sheath 114 behind at the hub 302. As shown in FIG. 5 A, the clinician can continue to push the delivery system 100 distally through the elongate shaft 304 of the medical device 300 such that a distal end portion 112b of the elongate shaft 112 of the delivery device 108 is within the vessel lumen L, distal of the distal tip of the elongate shaft 304 of the medical device 300. The elongate shaft 112 is pushed distally until the patch 104 clears the distal end of the elongate shaft 304 of the medical device 300 and is thereby free to move away from the elongate shaft 112. At this point, the patch 104 remains operatively coupled to the elongate shaft 112 via the anchor 106 extending through the lumen of the elongate shaft 112 to an extracorporeal location.

[0032] As shown in FIG. 5B, the delivery system 100 and medical device 300 are withdrawn simultaneously from the vessel lumen L, through the opening VO in the vessel wall W and through tissue channel C. Withdrawal of the delivery system 100 pulls the patch 104 proximally through the vessel lumen L until a top side of the patch 104 abuts an internal surface of the vessel wall W surrounding the vessel opening VO, as shown in FIG. 5C. The elongate shaft 112 continues to be withdrawn over the anchor 106, which extends proximally from the patch 104 through the vessel opening VO, tissue channel C, and opening TO in the skin S to an extracorporeal location. The elongate shaft 112 is then removed from the anchor 106 / closure device 102.

[0033] With the larger diameter medical device 300 removed, the tissue surrounding the tissue channel C contracts, thereby shrinking the diameter of the channel C and bringing the tissue into contact with the anchor 106. As previously mentioned, the anchor 106 may optionally include barbs 107 that engage the tissue and prevent and / or resist distal movement of the closure device 102 once implanted, thereby keeping the patch 104 over the opening VOin the vessel. In some embodiments, the barbs 107 extend distally from the longitudinal axis of the anchor 106, as shown in FIG. 5C.

[0034] With or without inclusion of the barbs 107, the second end 106b of the anchor 106, now extending into an extracorporeal space from the skin S, can be secured at the skin S via one or more securing means. In some embodiments, for example, the second end 106b of the anchor 106 includes a needle and / or becomes coupled to a needle so that the anchor 106 can be sutured into the skin S. In these and other examples, the anchor 106 can be secured to a surface anchor (not shown) that sits on the surface of the skin S after implantation. The surface anchor can comprise, for example, a bandage, patch, silicone button and / or disc, etc. In some embodiments, the means for securing the anchor 106 additionally serve to pull together the skin S at the opening TO.

[0035] In some embodiments of the present technology, a bioadhesive may optionally be delivered to the tissue channel C and / or opening TO in the skin S to help adhere the tissue and close the channel and opening. Such adhesive can comprise, for example, any composition suitable for facilitating adhesion of cutaneous and / or subcutaneous tissue to itself. Example adhesives include an n-butyl cyanoacrylate, such as VenaSeal™ adhesive, sold by Medtronic, Inc., a biological glue such as a bovine serum albumin-gluteraldehyde combination (e.g., BIOGLUE, Cryolife, Atlanta, Ga.), PV A, Biogard, collagen, fibrinogen, fibronectin, vitronectin, laminin, thrombin, gelatin, combinations thereof, or other biocompatible adhesives. Once the adhesive has been delivered to the tissue opening and / or channel, the clinician may hold pressure on the tissue opening to bring the opposing portions of the subcutaneous tissue together. Pressure may be held for 2-3 minutes until the adhesive sets and the opening is closed.

[0036] Although many of the embodiments are described above with respect to systems, devices, and methods for delivering material to extravascular spaces proximate vessel wall openings, the technology is applicable to other applications and / or other approaches, such as delivering material to other wounds or anatomical regions. Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above with reference to FIGS. 1-5C.

[0037] Example 1. A system for closing a vessel opening in a blood vessel wall, the system comprising: an elongate shaft defining a lumen therethrough and having a proximal portion and a distal portion, the lumen terminating distally at an opening in the elongate shaft, wherein the distal portion is configured to be positioned within the blood vessel lumen via insertion through the vessel opening in the blood vessel wall; a patch configured to be implanted over the vessel opening in the blood vessel lumen with at least a portion of the patch positioned against an inner surface of the blood vessel wall; a flexible anchor extending between a first end and a second end, wherein the first end of the anchor is fixed to the patch, and wherein the anchor is configured to be positioned within cutaneous and subcutaneous tissue when the patch is implanted in the blood vessel lumen; and a tubular sheath defining a lumen extending therethrough, wherein the elongate shaft is configured to be positioned within the lumen of the sheath, wherein, when the system is in a pre-delivery configuration, the patch is positioned between an outer surface of the elongate shaft and an inner surface of the sheath with the anchor extending distally from the patch along the elongate shaft, through the opening in the elongate shaft, and through the lumen of the elongate shaft until the second end of the anchor exits the lumen of the elongate shaft at the proximal portion of the elongate shaft.

[0038] Example 2. The system of Example 1, wherein a diameter of the elongate shaft tapers along the distal portion of the elongate shaft.

[0039] Example s. The system of Example 1 or Example 2, wherein the anchor further comprises a barbed suture.

[0040] Example 4. The system of any one of Examples 1 to 3, wherein at least some for the barbs are oriented to inhibit distal movement of the anchor when the anchor is implanted within the cutaneous and subcutaneous tissue.

[0041] Example 5. The system of any one of Examples 1 to 4, wherein a portion of the anchor is positioned between the outer surface of the elongate shaft and the inner surface of the sheath when the system is in a pre-delivery configuration.

[0042] Example 6. The system of any one of Examples 1 to 5, wherein the at least a portion of the patch configured to be positioned against the inner surface of blood vessel wall includes a thrombotic agent.

[0043] Example 7. The system of any one of Examples 1 to 6, wherein a surface of the patch configured to face towards the vessel lumen when the patch is implanted over the vessel opening comprises an anti -thrombotic agent.

[0044] Example 8. The system of any one of Examples 1 to 7, wherein the second end of the anchor includes a securing member, all or a portion of which is configured to be positioned on the skin when the patch is implanted.

[0045] Example 9. The system of any one of Examples 1 to 8, wherein the patch comprises a bioabsorbable mesh structure.

[0046] Example 10. A system for closing a vessel opening in a blood vessel wall, the system comprising: a delivery system comprising: a delivery device comprising an elongate shaft defining a lumen therethrough and having a proximal portion and a distal portion, the lumen terminating distally at an opening in the elongate shaft, wherein the distal portion is configured to be positioned within the blood vessel lumen via insertion through the vessel opening in the blood vessel wall; a closure device configured to be secured to the delivery device for delivery to the vessel lumen, the closure device comprising: a patch configured to be implanted over a vessel opening with at least a portion of the patch positioned against an inner surface of the blood vessel wall; a flexible anchor extending between a first end and a second end, wherein the first end of the anchor is fixed to the patch, and wherein the anchor is configured to be positioned within cutaneous and subcutaneous tissue when the patch is implanted in the blood vessel; and a tubular sheath defining a lumen extending therethrough, wherein the elongate shaft is configured to be positioned within the lumen of the sheath,wherein, when the delivery system is in a pre-delivery configuration, the patch is positioned between an outer surface of the elongate shaft and an inner surface of the sheath with the anchor extending distally from the patch along the elongate shaft, through the opening in the elongate shaft, and through the lumen of the elongate shaft until the second end of the anchor exits the lumen of the elongate shaft at the proximal portion of the elongate shaft.

[0047] Example 11. The system of Example 10, further comprising a medical device comprising a hub and an elongate tubular member extending distally from the hub, wherein a distal portion of the tubular member is configured to be positioned within the vessel lumen, and wherein the delivery system is configured to be delivered through a lumen of the tubular member to the vessel lumen.

[0048] Example 12. The system of Example 11, wherein, during insertion of the delivery system through the hub of the medical device, the sheath engages an internal structure of the hub such that the sheath remains within the hub while the patch passes through the hub and into the lumen of the tubular member.

[0049] Example 13. The system of Example 11 or Example 12, wherein the tubular member has an inner diameter of at least 23 Fr.

[0050] Example 14. The system of any one of Examples 11 to 13, wherein the medical device is an introducer and the delivery device is a dilator.

[0051] Example 15. A method for closing an opening in a blood vessel wall, the method comprising: inserting a delivery system through an elongate tubular member into the blood vessel lumen such that a distal portion of the delivery system is distal of a distal end of the tubular member, the delivery system comprising: a delivery device comprising an elongate shaft defining a lumen therethrough and having a proximal portion and a distal portion, the lumen terminating distally at an opening in the elongate shaft; and a closure device coupled to the delivery device, the closure device comprising a patch and a flexible anchor coupled to and extending away from the patch, wherein, during insertion through the tubular member, the patch is positioned between the outer surface of the elongate shaft and an inner surface ofthe tubular member with the anchor extending distally from the patch along the elongate shaft, then proximally through the opening in the elongate shaft and through the lumen of the elongate shaft until exiting the lumen at the proximal portion of the elongate shaft; advancing the delivery system distally until the patch is distal of the tubular member; and withdrawing the tubular member and elongate shaft together through the vessel opening and tissue channel leading to the vessel opening such that the patch is positioned over the opening with a portion of the patch abutting an inner surface of the vessel wall surrounding the opening, thereby preventing egress of blood to an extravascular space.

[0052] Example 16. The method of Example 15, further comprising implanting the anchor within the puncture tract.

[0053] Example 17. The method of Example 15 of Example 16, wherein the delivery system further comprises a tubular sheath defining a lumen extending therethrough, and wherein, prior to insertion of the delivery device within the tubular member, the sheath is positioned over the elongate shaft and patch such that the patch is positioned between the outer surface of the elongate shaft and an inner surface of the sheath.

[0054] Example 18. The method of Example 17, wherein a proximal end of the tubular member is coupled to a hub, and wherein during insertion of the delivery system through the hub, the sheath engages an internal structure of the hub such that the sheath remains within the hub while the patch passes through the hub and into the lumen of the tubular member.

[0055] Example 19. The method of any one of Examples 15 to 18, further comprising securing an end of the anchor at the skin.

[0056] Example 20. The method of any one of Examples 15 to 19, wherein the tubular member is an introducer and the elongate shaft is a dilator.

[0057] The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps arepresented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0058] As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art. The term “at least partially” includes both a partial and complete relationship between the parts being described. For example, in the phrase “the outer wall at least partially circumferentially surrounds the inner wall,” means the outer wall may surround only a portion of the circumference of the inner wall, or may surround the entirety of the circumference of the inner wall.

[0059] Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMSI / We claim:

1. A system for closing a vessel opening in a blood vessel wall, the system comprising: an elongate shaft defining a lumen therethrough and having a proximal portion and a distal portion, the lumen terminating distally at an opening in the elongate shaft, wherein the distal portion is configured to be positioned within the blood vessel lumen via insertion through the vessel opening in the blood vessel wall; a patch configured to be implanted over the vessel opening in the blood vessel lumen with at least a portion of the patch positioned against an inner surface of the blood vessel wall; a flexible anchor extending between a first end and a second end, wherein the first end of the anchor is fixed to the patch, and wherein the anchor is configured to be positioned within cutaneous and subcutaneous tissue when the patch is implanted in the blood vessel lumen; and a tubular sheath defining a lumen extending therethrough, wherein the elongate shaft is configured to be positioned within the lumen of the sheath, wherein, when the system is in a pre-delivery configuration, the patch is positioned between an outer surface of the elongate shaft and an inner surface of the sheath with the anchor extending distally from the patch along the elongate shaft, through the opening in the elongate shaft, and through the lumen of the elongate shaft until the second end of the anchor exits the lumen of the elongate shaft at the proximal portion of the elongate shaft.

2. The system of Claim 1, wherein a diameter of the elongate shaft tapers along the distal portion of the elongate shaft.

3. The system of Claim 1 or Claim 2, wherein the anchor further comprises a barbed suture.

4. The system of any one of Claims 1 to 3, wherein at least some for the barbs are oriented to inhibit distal movement of the anchor when the anchor is implanted within the cutaneous and subcutaneous tissue.

5. The system of any one of Claims 1 to 4, wherein a portion of the anchor is positioned between the outer surface of the elongate shaft and the inner surface of the sheath when the system is in a pre-delivery configuration.

6. The system of any one of Claims 1 to 5, wherein the at least a portion of the patch configured to be positioned against the inner surface of blood vessel wall includes a thrombotic agent.

7. The system of any one of Claims 1 to 6, wherein a surface of the patch configured to face towards the vessel lumen when the patch is implanted over the vessel opening comprises an anti -thrombotic agent.

8. The system of any one of Claims 1 to 7, wherein the second end of the anchor includes a securing member, all or a portion of which is configured to be positioned on the skin when the patch is implanted.

9. The system of any one of Claims 1 to 8, wherein the patch comprises a bioabsorbable mesh structure.

10. A system for closing a vessel opening in a blood vessel wall, the system comprising: a delivery system comprising: a delivery device comprising an elongate shaft defining a lumen therethrough and having a proximal portion and a distal portion, the lumen terminating distally at an opening in the elongate shaft, wherein the distal portion is configured to be positioned within the blood vessel lumen via insertion through the vessel opening in the blood vessel wall; a closure device configured to be secured to the delivery device for delivery to the vessel lumen, the closure device comprising:a patch configured to be implanted over a vessel opening with at least a portion of the patch positioned against an inner surface of the blood vessel wall; a flexible anchor extending between a first end and a second end, wherein the first end of the anchor is fixed to the patch, and wherein the anchor is configured to be positioned within cutaneous and subcutaneous tissue when the patch is implanted in the blood vessel; and a tubular sheath defining a lumen extending therethrough, wherein the elongate shaft is configured to be positioned within the lumen of the sheath, wherein, when the delivery system is in a pre-delivery configuration, the patch is positioned between an outer surface of the elongate shaft and an inner surface of the sheath with the anchor extending distally from the patch along the elongate shaft, through the opening in the elongate shaft, and through the lumen of the elongate shaft until the second end of the anchor exits the lumen of the elongate shaft at the proximal portion of the elongate shaft.

11. The system of Claim 10, further comprising a medical device comprising a hub and an elongate tubular member extending distally from the hub, wherein a distal portion of the tubular member is configured to be positioned within the vessel lumen, and wherein the delivery system is configured to be delivered through a lumen of the tubular member to the vessel lumen.

12. The system of Claim 10 or Claim 11, wherein, during insertion of the delivery system through the hub of the medical device, the sheath engages an internal structure of the hub such that the sheath remains within the hub while the patch passes through the hub and into the lumen of the tubular member.

13. The system of any one of Claims 10 to 12, wherein the tubular member has an inner diameter of at least 23 Fr.

14. The system of any one of Claims 11 to 13, wherein the medical device is an introducer and the delivery device is a dilator.

Images