# US 11,026,667 B2 · Devices and methods for treating fistulae and other bodily openings and passageways

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- Number: US 11,026,667 B2
- Document ID: US11026667B2
- Status: Granted
- Kind: B2
- Application number: 15/265,183
- Filed: 2016-09-14
- Published: 2017-01-05
- Granted: 2021-06-08
- Earliest claimed: 2010-09-28
- Assignees: Cook Biotech Incorporated
- Applicants: Cook Biotech Incorporated
- Inventors: Charles W. Agnew; Mark Duncan; Chad E. Johnson
- Web page: https://patentgrep.com/patent/US11026667B2

## 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 17/12099: {characterised by the location of the occluder}
- A61B 17/12159: {Solid plugs; being solid before insertion}
- A61B 17/12181: {formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices}
- A61B 17/1219: {expandable in contact with liquids}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00579: {Barbed implements}
- A61B 2017/00601: {Implements entirely comprised between the two sides of the opening}
- A61B 2017/00628: {T-shaped occluders}
- A61B 2017/00641: {for closing fistulae, e.g. anorectal fistulae}
- A61B 2017/0065: {the implement being an adhesive}
- A61B 2017/00884: {enhancing wound closure}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Some aspects of the present invention are directed to unique products and methods for treating fistulae and other passageways and openings in the body. In some preferred forms, an inventive construct will include an elongate graft body that incorporates a plurality of sheet or sheet-like segments. The plurality of sheet or sheet-like segments, in some arrangements, will be stacked in a generally longitudinal direction along the length of the plug body, and optionally, the segments will be received over one or more elongate elements. Elongate elements of this sort can take a variety of forms including a suture, wire, filament, or other relatively thin-bodied elongate member, although in some forms, an elongate element will be or include a somewhat heftier structure such as a biodegradable or non-biodegradable three-dimensional body.

## Claims

### Claim 1

A medical implant, comprising:
an elongate implant body including a plurality of sheet segments, each sheet segment of the plurality of sheet segments having a top surface, a bottom surface and at least one side edge, the plurality of sheet segments being stacked with the top surface of a first sheet segment facing the bottom surface of an adjacent sheet segment;
wherein sheet segments of the plurality of sheet segments comprise a first plurality of sheet segments formed from a first sheet material and a second plurality of sheet segments formed from a second sheet material having a different material of construction than the first sheet material;
wherein the plurality of sheet segments includes successive sheet segments connected to one another;
wherein said successive sheet segments are provided by a unitary sheet structure folded back and forth upon itself in the elongate implant body;
wherein the elongate implant body is within sterile medical packaging with the plurality of sheet segments; and
wherein said successive sheet segments are connected to one another by at least one connecting portion having a maximum cross-sectional dimension that is less than a maximum cross-sectional dimension of said successive sheet segments.

### Claim 2 (depends on 1)

The medical implant of claim 1, wherein the first sheet material comprises a biological polymer.

### Claim 3 (depends on 2)

The medical implant of claim 2, wherein the biological polymer is collagen.

### Claim 4 (depends on 2)

The medical implant of claim 2, wherein the second sheet material comprises a biodegradable synthetic polymer.

### Claim 5 (depends on 1)

The medical implant of claim 1, wherein:
the first sheet material includes one or more bioactive components.

### Claim 6 (depends on 1)

The medical implant of claim 1, wherein:
the second sheet material includes one or more bioactive components.

### Claim 7 (depends on 1)

The medical implant of claim 1, comprising:
an elongate element over which said plurality of sheet segments are received.

### Claim 8 (depends on 7)

The medical implant of claim 7, wherein:
the elongate element comprises a filament.

### Claim 9 (depends on 1)

The medical implant of claim 1, wherein:
the plurality of sheet segments includes about 2 sheet segments per centimeter to about 30 sheet segments per centimeter along a length of the elongate implant body.

### Claim 10 (depends on 1)

The medical implant of claim 1, comprising:
a capping member having a surface extending laterally away from the side edges of the sheet segments and arranged for contacting portions of a tissue wall adjacent to an opening to a fistula so as to inhibit passage of the capping member through the opening.

### Claim 11 (depends on 1)

The medical implant of claim 1, wherein the side edges of the plurality of sheet segments provide more than 50% of a side exterior surface of the elongate implant body.

### Claim 12 (depends on 1)

The medical implant of claim 1, wherein the side edges of the plurality of sheet segments provide more than 90% of a side exterior surface of the elongate implant body.