# US 10,441,256 B2 · Devices and methods useful for sealing bodily openings

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- Number: US 10,441,256 B2
- Document ID: US10441256B2
- Status: Granted
- Kind: B2
- Application number: 15/062,749
- Filed: 2016-03-07
- Published: 2016-09-15
- Granted: 2019-10-15
- Earliest claimed: 2010-05-19
- Assignees: Cook Medical Technologies LLC; Cook Biotech Incorporated
- Applicants: Cook Medical Technologies LLC; Cook Biotech Incorporated
- Inventors: Ram H. Paul, Jr.; Cleon Stanley; Brian L. Bates; F. Joseph Obermiller; Thomas A. Osborne; Sean D. Chambers
- Web page: https://patentgrep.com/patent/US10441256B2

## 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 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00597: {Implements comprising a membrane}
- A61B 2017/00623: {Introducing or retrieving devices therefor}
- A61B 2017/00628: {T-shaped occluders}
- A61B 2017/00641: {for closing fistulae, e.g. anorectal fistulae}
- A61B 2017/00659: {located only on one side of the opening}
- A61B 2017/00663: {the implement being a suture}
- A61B 2017/0496: {for tensioning sutures}
- A61B 2017/06176: {with protrusions, e.g. barbs}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Among other things, there are disclosed apparatuses and methods for medically sealing an opening in a vessel or wall. For example, in medical applications, a delivery tube is provided for insertion through a sheath into a vessel (e.g. a blood vessel). A dome-shaped seal fixed to a filament, an absorbent and/or compressible buffer, and a locking member are provided in the delivery tube. The delivery tube is configured so that it can be inserted into the vessel through a sheath. Tension is maintained on the filament to hold the seal against the tube or sheath. The sheath is pulled out, which pulls out the tube at the same time, leaving the seal over the opening in the vessel wall. The locking member compresses the buffer against the outside of the vessel and with the filament holds the seal in place against the inside of a vessel.

## Claims

### Claim 1

A system for use in closing an opening in a vessel wall, comprising:
a sheath having an insertion portion with a distal end for insertion into the vessel and a proximal head portion, said head portion having a proximal opening of a first diameter and a second opening into said insertion portion having a second diameter smaller than the first diameter;
a delivery tube having a proximal end, a distal end, and a longitudinal lumen between said ends, the delivery tube being at least partially within said sheath; and
a seal within said delivery tube, wherein a filament is fixed to said seal, the seal member being dome-shaped in a relaxed configuration and deformable under tension applied through said filament to at least partially flatten and urge a peripheral region having a rim against an interior surface of the vessel wall, and further including a mass of compressible material connected to said filament proximal of said seal, and a locking member proximal of said mass of compressible material, with said filament extending through said locking member and the locking member having a central opening and slidable along said filament so as to compress said compressible material against an external surface of the vessel and separate the locking member from the external surface of the vessel when the system is in a locked condition.

### Claim 2 (depends on 1)

The system of claim 1, wherein said seal includes at least one bead along an edge of said seal, said at least one bead configured to engage the inner surface of the vessel.

### Claim 3 (depends on 1)

The system of claim 1, wherein said compressible material comprises an extracellular matrix material.

### Claim 4 (depends on 1)

The system of claim 1, wherein said seal, said filament, said compressible material and said locking member are biodegradable.

### Claim 5 (depends on 1)

The system of claim 1, wherein said filament includes protuberances that are monolithic with and of the same biodegradable material as said filament.

### Claim 6 (depends on 1)

The system of claim 1, wherein the delivery tube includes a first boss slidably attached to the outside of the tube, and a second boss fixed with respect to said tube at a position proximal of said first boss, said first boss being slidable between said distal end of said tube and said second boss, said first boss having a distal portion with a diameter less than that of said proximal opening and forming a close fit with said second opening, said first boss having a flared proximal portion, at least part of which is larger than said proximal opening of said head portion.

### Claim 7 (depends on 6)

The system of claim 6, wherein said first boss forms a seal with a portion of said sheath.

### Claim 8 (depends on 6)

The system of claim 6, wherein said first and second bosses each have a respective substantially cylindrical distal portion and an outwardly flared proximal portion, wherein a portion of said second boss is adapted to enter within said flared proximal portion of said first boss, so that said second boss blocks travel by said first boss along said body portion beyond said second boss.

### Claim 9 (depends on 1)

The system of claim 1, further comprising a pusher member having a longitudinal passage, said filament extending through said passage and said pusher member being proximal of said locking member.

### Claim 10 (depends on 1)

The system of claim 1, wherein said compressible material has a length substantially greater than its width and surrounds said filament, said compressible material being adapted for compression by said locking member to reduce said length and increase said width to a width greater than that of said body of said delivery tube.

### Claim 11 (depends on 1)

The system of claim 1, wherein said compressible material comprises a folded or rolled sheet of extracellular matrix material, with a central passage allowing said compressible material to travel along said filament.

### Claim 12 (depends on 1)

The system of claim 1, wherein said compressible material comprises a ribbon or sheet of extracellular matrix material and said filament is woven or threaded into said compressible material.

### Claim 13 (depends on 1)

The system of claim 1, wherein the head portion has an open passage surrounded by a side wall and an inwardly-directed end surface and between the proximal opening and the second opening, the second opening being through the inwardly-directed end surface.

### Claim 14 (depends on 1)

The system of claim 1 wherein the seal has a relaxed configuration with a domed shape having a convex exterior surface, an opposite open concave interior surface, the seal adapted to contact the interior of a vessel, and wherein the filament includes a plurality of protuberances around which the locking member can travel toward the seal but which resist travel back through the locking member.