# US 12,109,104 B2 · Methods and devices for treating sphincter disorders

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- Number: US 12,109,104 B2
- Document ID: US12109104B2
- Status: Granted
- Kind: B2
- Application number: 18/404,702
- 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/US12109104B2

## 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 method of reinforcing a sphincter, comprising:
disposing a scaffold of bioabsorbable material at least partially around a body organ containing a sphincter;
inducing a formation of collagen tissue around a portion of the body organ containing the sphincter; and
coupling, via the collagen tissue, the body organ containing the sphincter to an adjacent body portion.

### Claim 2 (depends on 1)

The method of claim 1, wherein disposing a scaffold of bioabsorbable material on or adjacent to a body organ containing a sphincter comprises disposing the scaffold on or adjacent to a tubular esophagus.

### Claim 3 (depends on 1)

The method of claim 1, further comprising causing to reinforce the sphincter in response to inducing the formation of collagen tissue.

### Claim 4 (depends on 1)

The method of claim 1, further comprising maintaining, via the collagen tissue, a distance of greater than zero and less than five centimeters between a gastroesophageal junction (GEJ) and a diaphragm.

### Claim 5 (depends on 1)

The method of claim 1, further comprising coupling, via the collagen tissue, a body portion selected from the group consisting of a gastroesophageal junction (GEJ), a portion of an esophagus, and combinations thereof to a diaphragm.

### Claim 6 (depends on 1)

The method of claim 1, further comprising coupling the collagen tissue to a lower esophageal sphincter (LES) or a lumen containing the LES.

### Claim 7 (depends on 1)

The method of claim 1, wherein the scaffold of bioabsorbable material comprises a first bioabsorbable material and a second bioabsorbable material, the first bioabsorbable material having a bioabsorption rate that is different from a bioabsorption rate of the second bioabsorbable material, the method further comprising:
inducing a formation of a first collagen tissue, via the first bioabsorbable material, around the body organ containing the sphincter; and
inducing a formation of a second collagen tissue, via the second bioabsorbable material, around the body organ containing the sphincter.

### Claim 8 (depends on 1)

The method of claim 1, further comprising placing the scaffold, in a non-compressing manner, around at least one of the sphincter and the body organ containing the sphincter.

### Claim 9 (depends on 1)

The method of claim 1, further comprising placing the scaffold, in a compressing manner, around at least one of the sphincter and the body organ containing the sphincter.

### Claim 10 (depends on 1)

The method of claim 1, further comprising permitting an expansion of the scaffold in response to a passage of food through the sphincter.

### Claim 11 (depends on 1)

The method of claim 1, further comprising disposing the scaffold at least partially about the body organ containing the sphincter in a non-overlapping, helical manner.

### Claim 12

A method of reinforcing a sphincter, comprising:
disposing a scaffold of bioabsorbable material at least partially around a body part selected from the group consisting of an esophagus, a gastroesophageal junction (GEJ), a lower esophageal sphincter (LES), and combinations thereof;
coupling, via the scaffold, a body portion selected from the group consisting of the GEJ, a portion of an esophagus, and combinations thereof to a diaphragm; and
inducing a formation of collagen tissue around a portion of the body part.

### Claim 13 (depends on 12)

The method of claim 12, further comprising maintaining, via the scaffold, a distance between the body portion and the diaphragm.

### Claim 14 (depends on 12)

The method of claim 12, wherein inducing the formation of collagen tissue around the body portion comprises inducing a formation of a first collagen tissue and a second collagen tissue, wherein a time of formation of the first collagen tissue is different from a time of formation of the second collagen tissue.

### Claim 15 (depends on 12)

The method of claim 12, wherein the scaffold of bioabsorbable material comprises a first bioabsorbable material and a second bioabsorbable material, the first bioabsorbable material having a bioabsorption rate that is different from a bioabsorption rate of the second bioabsorbable material, the method further comprising:
inducing the formation of a first collagen tissue, via the first bioabsorbable material, around the portion of the body part; and
inducing the formation of a second collagen tissue, via the second bioabsorbable material, around the portion of the body part.

### Claim 16

A method of reinforcing a sphincter, comprising:
disposing a scaffold of bioabsorbable material at least partially around a body part containing at least a portion of a gastroesophageal junction (GEJ);
inducing a formation of collagen tissue around a portion of the GEJ;
coupling the scaffold to the GEJ; and
coupling the GEJ to an adjacent body portion.

### Claim 17 (depends on 16)

The method of claim 16, wherein coupling the scaffold to the GEJ occurs in response to inducing the formation of collagen tissue around the portion of the GEJ.

### Claim 18 (depends on 16)

The method of claim 16, further comprising permitting an expansion of the scaffold with a natural expansion of the sphincter.

### Claim 19 (depends on 16)

The method of claim 16, further comprising disposing the scaffold about the body part in a non-overlapping, helical manner.

### Claim 20 (depends on 16)

The method of claim 16, wherein the scaffold of bioabsorbable material comprises a first bioabsorbable material and a second bioabsorbable material, the first bioabsorbable material having a bioabsorption rate that is different from a bioabsorption rate of the second bioabsorbable material, the method further comprising:
inducing the formation of a first collagen tissue, via the first bioabsorbable material, around the portion of the GEJ; and
inducing the formation of a second collagen tissue, via the second bioabsorbable material, around the portion of the GEJ.
