# US 2013/0158595 A1 · Enteric fistula treatment devices

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- Number: US 2013/0158595 A1
- Document ID: US20130158595A1
- Status: Published application
- Kind: A1
- Application number: 13/769,164
- Filed: 2013-02-15
- Published: 2013-06-20
- Earliest claimed: 2008-09-04
- Assignees: Curaseal Inc.
- Inventors: Akshay MAVANI; Kenton FONG; Leif Erik BANSNER; Nathan Christopher MAIER; Dean HU; Moshe PINTO; Harold Francis CARRISON; Eliot KIM
- Web page: https://patentgrep.com/patent/US20130158595A1

## 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 2017/00579: {Barbed implements}
- A61B 2017/00588: {Rigid or stiff implements, e.g. made of several rigid parts linked by hinges}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00597: {Implements comprising a membrane}
- A61B 2017/00601: {Implements entirely comprised between the two sides of the opening}
- A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening}
- A61B 2017/0061: {Implements located only on one side of the opening}
- A61B 2017/00623: {Introducing or retrieving devices therefor}
- A61B 2017/00641: {for closing fistulae, e.g. anorectal fistulae}
- A61B 2017/0065: {the implement being an adhesive}
- A61B 2017/00898: {expandable upon contact with fluid}
- A61B 2017/00902: {transparent or translucent}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Disclosed herein is a non-vascular fistula treatment system. The system may include a collapsible member, at least one tether, and a bioresorbable material. The collapsible member may be configured for positioning through a fistula tract and may comprise first and second disc members. The outer perimeter of the second disc member may be larger than the outer perimeter of the first disc member, and the first disc member may comprise a tether attachment structure. The at least one tether may be attached to the tether attachment structure. The bioresorbable material may be configured for placement in the fistula tract and may comprise a coupling structure configured to couple to the at least one tether. The second disc member may be configured to seal to a surface of a body lumen at a distal opening of the fistula tract and occlude the fistula tract at the distal opening.

## Claims

### Claim 1

A non-vascular fistula treatment system, comprising:
a collapsible member configured for positioning through a fistula tract and comprising a first disc member and a second disc member, wherein an outer perimeter of the second disc member is larger than an outer perimeter of the first disc member, and wherein the first disc member comprises a tether attachment structure;
at least one tether attached to the tether attachment structure; and
a bioresorbable material configured for placement in the fistula tract and comprising a coupling structure configured to couple to the at least one tether,
wherein the second disc member is configured to seal to a surface of a body lumen at a distal opening of the fistula tract and occlude the fistula tract at the distal opening.

### Claim 2 (depends on 1)

The system of claim 1, wherein the collapsible member has a circular shape.

### Claim 3 (depends on 1)

The system of claim 1, wherein the collapsible member is non-resorbable.

### Claim 4 (depends on 1)

The system of claim 1, wherein the collapsible member comprises an expandable frame supporting a webbing material.

### Claim 5 (depends on 4)

The system of claim 4, wherein the expandable frame comprises a star or petal-like configuration.

### Claim 6 (depends on 1)

The system of claim 1, wherein the collapsible member has an arcuate channel.

### Claim 7 (depends on 6)

The system of claim 6, wherein the collapsible member further comprises at least one radial channel in communication with the arcuate channel.

### Claim 8 (depends on 1)

The system of claim 1, wherein the coupling structure is attached to a loop structure configured to slidably couple to the at least one tether.

### Claim 9 (depends on 1)

The system of claim 1, wherein the coupling structure is configured to couple to the at least one tether such that the bioresorbable material is positioned off-axis from the at least one tether.

### Claim 10 (depends on 1)

The system of claim 1, wherein the bioresorbable material comprises a plurality of resorbable members and the plurality of resorbable members are serially attached.

### Claim 11 (depends on 1)

The system of claim 1, wherein the bioresorbable material comprises a porosity of at least 90%.

### Claim 12 (depends on 11)

The system of claim 11, wherein the bioresorbable material comprises a cross-linking agent.

### Claim 13 (depends on 1)

The system of claim 1, wherein the bioresorbable material comprises a plurality of foam members, each foam member comprising a first end, a second end, and a body therebetween.

### Claim 14 (depends on 13)

The system of claim 13, wherein each foam member is an elongate foam member.

### Claim 15 (depends on 14)

The system of claim 14, wherein the coupling structure comprises a looped structure.

### Claim 16 (depends on 1)

The system of claim 1, further comprising a proximal anchor attachable to the at least one tether, wherein the proximal anchor is configured to maintain tension in the at least one tether, and wherein the proximal anchor comprises a skin contact surface.

### Claim 17 (depends on 16)

The system of claim 16, wherein the proximal anchor further comprises vacuum openings.

### Claim 18 (depends on 1)

The system of claim 1, further comprising a delivery tool with an inflation channel, wherein the delivery tool is configured for detachable coupling to an inflation lumen of the collapsible member.

### Claim 19 (depends on 18)

The system of claim 18, further comprising a delivery cannula configured to permit insertion of the delivery tool.
