# US 12,109,103 B2 · Methods and devices for treating sphincter disorders

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- Number: US 12,109,103 B2
- Document ID: US12109103B2
- Status: Granted
- Kind: B2
- Application number: 18/404,655
- Filed: 2024-01-04
- Published: 2024-05-02
- Granted: 2024-10-08
- Earliest claimed: 2019-08-26
- Assignees: Eschara Medical, LLC
- Applicants: Eschara Medical, LLC
- Inventors: Robert A. Ganz; Gabriel L. Ganz; Ryan Timothy Balko; Justin James Herbert; Brett Allyn Williams
- Web page: https://patentgrep.com/patent/US12109103B2

## CPC

- A61F 2/04: Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts (A61F2/18, A61F2/20 take precedence; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95)
- A61B 17/12013: {for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61F 2/0036: {implantable (A61F2/0018 takes precedence)}
- A61B 2017/00827: {Treatment of gastro-esophageal reflux}
- A61F 2002/044: {Oesophagi or esophagi or gullets}
- A61F 2210/0004: bioabsorbable
- A61F 2220/0033: made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
- A61F 2230/0065: toroidal, e.g. ring-shaped, doughnut-shaped
- A61F 2250/003: differing in adsorbability or resorbability, i.e. in adsorption or resorption time
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Devices and methods for treatment of bodily lumens and sphincters are disclosed. Some embodiments include methods and devices for inducing an inflammatory response and development of fibrosis, collagen, and/or scar tissue. In some embodiments, scaffolds may be composed of a matrix of filaments. Application of the methods and devices disclosed herein to treat Gastroesophageal Reflux Disease (GERD) and other sphincter disorders are discussed. Biodegradable scaffolds configured to induce an inflammatory response are also disclosed.

## Claims

### Claim 1

A bioabsorbable scaffold, comprising:
a matrix comprising:
a first bioabsorbable filament; and
a second bioabsorbable filament,
wherein the matrix is configured to be disposed at least partially around a body portion or a sphincter of a patient,
wherein the matrix is configured to induce a formation of collagen tissue about a portion of the sphincter,
wherein the first bioabsorbable filament has a first bioabsorption rate and the second bioabsorbable filament has a second bioabsorption rate that is different from the first bioabsorption rate, and
wherein the matrix is configured to couple the body portion or the sphincter of the patient to an adjacent body portion.

### Claim 2 (depends on 1)

The bioabsorbable scaffold of claim 1, wherein the second bioabsorbable filament is wound about the first bioabsorbable filament.

### Claim 3 (depends on 2)

The bioabsorbable scaffold of claim 2, wherein the first bioabsorbable filament comprises a shape selected from the group consisting of a cylindrical shape, a hollow tubular shape, and combinations thereof.

### Claim 4 (depends on 1)

The bioabsorbable scaffold of claim 1, wherein the first bioabsorbable filament and the second bioabsorbable filament are woven together.

### Claim 5 (depends on 4)

The bioabsorbable scaffold of claim 4, wherein the matrix comprises a shape selected from the group consisting of a cylindrical shape, a hollow tubular shape, and combinations thereof.

### Claim 6 (depends on 4)

The bioabsorbable scaffold of claim 4, wherein the matrix comprises a flat woven shape.

### Claim 7 (depends on 1)

The bioabsorbable scaffold of claim 1, wherein the matrix consists of 100% bioabsorbable material.

### Claim 8 (depends on 1)

The bioabsorbable scaffold of claim 1, wherein the matrix further comprises a third bioabsorbable filament having a third bioabsorption rate that is different from each of the first bioabsorption rate and the second bioabsorption rate.

### Claim 9

A bioabsorbable scaffold, comprising:
a matrix comprising:
a first end;
a second end opposite the first end; and
a bioabsorbable filament extending from the first end to the second end,
wherein the matrix is configured to be disposed at least partially around a body portion or a sphincter of a patient,
wherein the matrix is configured to induce a formation of collagen tissue about a portion of the sphincter,
wherein the first end and the second end remain in non-touching relation to one another, and
wherein the matrix is configured to couple the body portion or the sphincter of the patient to an adjacent body portion.

### Claim 10 (depends on 9)

The bioabsorbable scaffold of claim 9, wherein the matrix is configured to be disposed around portions of the sphincter in a manner selected from the group consisting of partially circumferentially, a piecemeal fashion, and combinations thereof.

### Claim 11 (depends on 9)

The bioabsorbable scaffold of claim 9, wherein the matrix is configured to be disposed fully circumferentially around the sphincter.

### Claim 12 (depends on 9)

The bioabsorbable scaffold of claim 9, wherein the matrix is configured to expand in response to a natural expansion of the sphincter.

### Claim 13 (depends on 9)

The bioabsorbable scaffold of claim 9, wherein the bioabsorbable filament comprises a constant filament density along a length of the matrix.

### Claim 14

A bioabsorbable scaffold, comprising:
a matrix comprising a bioabsorbable filament,
wherein the matrix is configured to be disposed at least partially around a body portion or a sphincter of a patient,
wherein the matrix is configured to induce a formation of collagen tissue about a portion of the sphincter,
wherein the matrix is configured to be disposed helically about the sphincter, and
wherein the matrix is configured to couple the body portion or the sphincter of the patient to an adjacent body portion.

### Claim 15 (depends on 14)

The bioabsorbable scaffold of claim 14, wherein the matrix comprises a first matrix, the bioabsorbable scaffold further comprising:
a second matrix comprising a bioabsorbable filament,
wherein the second matrix is configured to be disposed on or adjacent to the body portion or the sphincter of the patient, and
wherein the second matrix is configured to be disposed helically about the sphincter.

### Claim 16 (depends on 15)

The bioabsorbable scaffold of claim 15, wherein the second matrix is disposed concentrically within the first matrix.

### Claim 17 (depends on 15)

The bioabsorbable scaffold of claim 15, wherein the first matrix and the second matrix are stacked with respect to one another.

### Claim 18 (depends on 14)

The bioabsorbable scaffold of claim 14, wherein the matrix is configured to be disposed about the sphincter in a non-overlapping manner.

### Claim 19 (depends on 14)

The bioabsorbable scaffold of claim 14, wherein the matrix is configured to be disposed about the sphincter in an overlapping manner.

### Claim 20 (depends on 14)

The bioabsorbable scaffold of claim 14, wherein the matrix is configured to be completely absorbed into the body portion or the sphincter of the patient.
