# US 11,992,198 B2 · Arteriotomy closure apparatus with slotted shoe for advantageous pressure distribution > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,992,198 B2 - Document ID: US11992198B2 - Status: Granted - Kind: B2 - Application number: 17/697,279 - Filed: 2022-03-17 - Published: 2022-07-14 - Granted: 2024-05-28 - Earliest claimed: 2015-12-15 - Assignees: Vivasure Medical Limited - Applicants: Vivasure Medical Limited - Inventors: Mark McGoldrick; Noelle Barrett; Christopher Martin; Peter Grant; Bartosz Pawlikowski; Gerard Brett - Web page: https://patentgrep.com/patent/US11992198B2 ## CPC - A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)} - A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive} - A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)} - A61B 2017/0053: {Loading magazines or sutures into applying tools} - A61B 2017/00654: {entirely comprised between the two sides of the opening} - A61B 2017/00659: {located only on one side of the opening} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract The disclosed technology provides a device for sealing an aperture in a tissue of a body lumen. The device comprises a flexible support member having a base having (i) a central portion and (ii) one or more lateral support portions, to engage and/or hold a sealable member of the device against an interior surface of the tissue when the device is in the sealing position. The lateral support portions provide additional support surfaces to engage peripheral portions of the sealable member against the interior surface of the tissue. A cage or shoe engaged with the support member on the exterior surface of the tissue can provide additional support and assist sealing the aperture. ## Claims ### Claim 1 A device for sealing an aperture in a tissue of a body lumen comprising: a closure device comprising: (i) a flexible support member comprising a base and a column disposed in the center of the base, the column comprising a centering tab and/or one or more locking tabs; (ii) a sealable member comprising a thin, flexible sheet, a hole in the center of the flexible sheet, wherein the flexible sheet is disposed over the base, and wherein the column passes through the hole; (iii) an extra-arterial shoe comprising one or more engagement elements for engagement with an exterior of the column to secure the closure device; and (iv) a guard member comprising an elongate body, a locking feature, a wedge feature, and a guidewire lumen, wherein the elongate body of the guard member is inserted through a first aperture of the extra-arterial shoe; and a delivery system comprising a delivery shaft, wherein the extra-arterial shoe comprises a hollow cylindrical shape and a centerline configured to be collinear with a centerline of the column of the support member when the extra-arterial shoe is engaged on the column, wherein the longitudinal axis of the column forms an angle between 10 degrees and 70 degrees with a lateral plane of the base, wherein the column is angled over a proximal end of the base, and wherein the one or more engagement elements of the extra-arterial shoe comprises at least one of a notch, a hole, and a groove. ### Claim 2 (depends on 1) The device of claim 1, wherein the entirety of the extra-arterial shoe is disposed between a first radius around the centerline of the extra-arterial shoe and a second radius around the centerline of the extra-arterial shoe, wherein the second radius is larger than the first radius. ### Claim 3 (depends on 2) The device of claim 2, wherein the first radius is large enough to allow the column to be disposed therethrough when the extra-arterial shoe is engaged with the column. ### Claim 4 (depends on 1) The device of claim 1, wherein a body of the extra-arterial shoe is disposed between a first radius around the centerline of the extra-arterial shoe and a second radius around the centerline of the extra-arterial shoe, wherein the second radius is larger than the first radius. ### Claim 5 (depends on 4) The device of claim 4, the extra-arterial shoe further comprising at least one angled prong extending externally away at an angle from the body of the extra-arterial shoe beyond the second radius, wherein the at least one angled prong is attached to the distal end of the body of the extra-arterial shoe, and wherein the distal tip of the at least one angled prong exerts pressure against an exterior surface of the body lumen when the extra-arterial shoe is engaged with the column. ### Claim 6 (depends on 5) The device of claim 5, wherein the extra-arterial shoe comprises 2, 3, 4, 5, or 6 angled prongs spaced around the centerline of the extra-arterial shoe at about 180, 120, 90, 72, or 60 degrees apart, respectively. ### Claim 7 (depends on 1) The device of claim 1, wherein the extra-arterial shoe comprises at least one material selected from the group consisting of ε-Caprolactone and Polyethylene glycol. ### Claim 8 (depends on 1) The device of claim 1, further comprising a shoe pusher, wherein the shoe pusher is mounted on the delivery shaft and is slideably moveable along a longitudinal axis of the delivery shaft, and wherein the shoe pusher is configured to push the extra-arterial shoe distally toward the flexible support member. ### Claim 9 (depends on 1) The device of claim 1, wherein the base comprises a generally circular planar shape and one or more lateral support portions forming a continuous outer ring structure at the circumference of the circular planar shape, wherein the outer ring structure is connected to the center of the base by at least one radial spoke. ### Claim 10 (depends on 9) The device of claim 9, wherein the base comprises at least one space between the one or more lateral support portions and the center of the base. ### Claim 11 (depends on 10) The device of claim 10, wherein the one or more lateral support portions comprise at least one gap, wherein the at least one gap forms a discontinuity in the outer ring structure of the base. ### Claim 12 (depends on 11) The device of claim 11, wherein the one or more lateral support portions comprise two gaps spaced about 180 degrees apart on lateral sides of the base, wherein the two gaps form two discontinuities in the outer ring structure of the base. ### Claim 13 (depends on 11) The device of claim 11, wherein the one or more lateral support portions comprise two pairs of gaps comprising a first pair of gaps disposed at a distal end of the base and a second pair of gaps disposed at a proximal end of the base, the first pair and the second pair spaced about 180 degrees apart, and wherein the two pairs of gaps form discontinuities in the outer ring structure of the base. ### Claim 14 (depends on 13) The device of claim 13, wherein the base comprises: an anterior region extending distally from a distal end of the base outside the outer ring structure, the anterior region disposed between the first pair of gaps; and a posterior region extending proximally from a proximal end of the base outside the outer ring structure, the posterior region disposed between the second pair of gaps. ### Claim 15 (depends on 1) The device of claim 1, wherein the first aperture is located on the cylindrical body of the extra-arterial shoe. ### Claim 16 (depends on 1) The device of claim 1, wherein the flexible support member further comprises a second aperture located on the column and a channel disposed through the center of the column, and wherein the channel runs between a bottom surface of the base and a top surface of the column. ### Claim 17 (depends on 1) The device of claim 1, wherein the first aperture overlaps with the second aperture when the extra-arterial shoe is engaged with the column, wherein the guard member is inserted through the channel of the column, and passes through the second aperture and through the first aperture, and wherein the wedge feature closes the channel. ### Claim 18 (depends on 1) The device of claim 1, wherein the extra-arterial shoe further comprises a shoe connector element to connect the shoe to the shoe pusher or to the delivery shaft. ### Claim 19 (depends on 1) The device of claim 1, wherein the body lumen comprises the inside space of a vein or an artery. ### Claim 20 (depends on 1) The device of claim 1, wherein the column comprises a threaded portion near the base of the column to load the sealable member, wherein the threaded portion comprises a protrusion that encircles the body of the column, and wherein the protrusion comprises a gap in the protrusion.