IP Library Granted Patent US 11,376,146
Granted Patent B2
US 11,376,146 · App. 16/221,722 · Granted Jul 5, 2022

Tissue interface features for implantable sphincter assistance device

Inventors: Kevin M. Fiebig (Cincinnati, OH); Frederick E. Shelton, IV (Hillsboro, OH)
Assignee: Cilag GmbH International
A61F5/0063A61B17/12099A61F2/04A61B2017/00818A61B2018/00553A61F2002/044A61F2210/009
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Quick Facts
Patent No.
US 11,376,146
App. No.
16/221,722
Granted
Jul 5, 2022
Kind
B2
Abstract

An implantable sphincter assistance device is configured to surround an exterior wall of an esophagus. The implantable sphincter assistance device includes a plurality of beads, at least one connector, and secondary material. Each of the beads has an exterior surface. The connector is configured to serially connect the beads to form a ring. The secondary material is configured to be disposed between the exterior surface of at least one of the beads and the exterior wall of the esophagus. The secondary material is configured to control remodeling of tissue surrounding the exterior wall of the esophagus.

Claims (31)

1. An implantable sphincter assistance device configured to surround an exterior wall of an esophagus, wherein the implantable sphincter assistance device comprises:

(a) a plurality of beads, wherein each of the beads has an exterior surface;

(b) at least one connector configured to serially connect the beads to form a ring; and

(c) a secondary material including a bioabsorbable casing that is configured to be disposed between the exterior surface of at least one of the beads and the exterior wall of the esophagus, wherein the bioabsorbable casing includes a tapered lead in portion and a raised body portion surrounding a primary circumference of a majority of the beads, wherein the tapered lead in portion is configured to resist movement of the implantable sphincter assistance device, wherein the secondary material is configured to control remodeling of tissue surrounding the exterior wall of the esophagus.

2. The implantable sphincter assistance device of claim 1 , wherein the secondary material is configured to be disposed between the exterior surface of the majority of the beads and the exterior wall of the esophagus.

3. The implantable sphincter assistance device of claim 2 , wherein the bioabsorbable casing is coupled with the exterior surface of the majority of the beads, wherein the bioabsorbable casing is configured to be absorbed by the exterior wall to form a tissue capsule, wherein the tissue capsule is configured to have an inner wall that is separated a distance from the beads allowing the majority of the beads to freely move around inside the tissue capsule.

4. The implantable sphincter assistance device of claim 3 , wherein the bioabsorbable casing extends radially outwardly from the exterior surface of the majority of the beads, wherein the bioabsorbable casing is configured to be absorbed by the exterior wall to form the tissue capsule.

5. The implantable sphincter assistance device of claim 2 , wherein the secondary material includes a bioabsorbable scaffold, wherein the bioabsorbable scaffold is configured to encapsulate the majority of the beads, wherein the bioabsorbable scaffold is configured to expand and contract.

6. The implantable sphincter assistance device of claim 5 , wherein the bioabsorbable scaffold is formed from absorbable polymer that includes PGA, PDS, PCL, or PLA or a copolymer blend of PGA, PDS, PCL, or PLA, wherein the bioabsorbable scaffold is configured to encourage cellular in growth.

7. The implantable sphincter assistance device of claim 5 , wherein the bioabsorbable scaffold includes a tight weave, a loose weave, and a frayed edge, wherein the bioabsorbable scaffold transitions from the tight weave, to the loose weave, to the frayed edge moving away from the exterior surface of the majority of the beads.

8. The implantable sphincter assistance device of claim 5 , wherein the bioabsorbable scaffold is configured to encourage tissue encapsulation of the implantable sphincter assistance device without restricting movement of the implantable sphincter assistance device.

9. The implantable sphincter assistance device of claim 1 , wherein the connector comprises a flexible cord, wherein the beads are configured to be individually moveable along the flexible cord, wherein the flexible cord and the beads include a coating configured to discourage bonding with the tissue.

10. The implantable sphincter assistance device of claim 1 , further comprising first and second clasps that are configured to transition from an unlocked configuration allowing for insertion and removal of the implantable sphincter assistance device and a locked configuration that radially surrounds the esophagus, wherein the first and second clasps include exterior surfaces, wherein the exterior surfaces of the first and second clasps include a coating to encourage bonding with the tissue that is configured to be anchored to the exterior wall.

11. The implantable sphincter assistance device of claim 1 , wherein the beads are titanium beads, wherein the secondary material includes a coating coupled with the exterior surface of the titanium beads.

12. The implantable sphincter assistance device of claim 1 , wherein at least one of the beads is formed from polycrystalline titanium, wherein the secondary material is configured to oxidize the polycrystalline titanium.

13. The implantable sphincter assistance device of claim 1 , wherein each of the beads includes plurality of annular or toroidal rare-earth permanent magnets configured to impart a radially inwardly oriented magnetic bias to the ring, wherein the implantable sphincter assistance device is sized and configured to fit around a lower esophageal sphincter of the esophagus, wherein the magnets of the beads are configured to magnetically bias an opening of the lower esophageal sphincter to a closed configuration, wherein the magnets of the beads are configured to permit separation of the beads to thereby permit passage of a bolus through the opening of the lower esophageal sphincter.

14. The implantable sphincter assistance device of claim 1 , wherein at least one of the plurality of beads is configured to move along the at least one connector relative to the connector.

15. The implantable sphincter assistance device of claim 1 , wherein the bioabsorbable casing is configured to extend completely around a perimeter formed by the exterior surface of at least one of the beads and the exterior wall of the esophagus.

16. The implantable sphincter assistance device of claim 15 , wherein the perimeter defines a circumference, wherein the bioabsorbable casing is configured to extend completely around the circumference formed by the exterior surface of at least one of the beads and the exterior wall of the esophagus.

17. A method of implanting a sphincter assistance device, comprising:

(a) providing a sphincter assistance device comprising:

(i) a plurality of beads, wherein each of the beads has an exterior surface,

(ii) at least one connector configured to serially connect the beads to form a ring, and

(iii) bioabsorbable secondary material coupled to the exterior surface of a majority of the beads; and

(b) inserting the sphincter assistance device around an exterior wall of an esophagus so that the bioabsorbable secondary material contacts the exterior wall of the esophagus, wherein the bioabsorbable secondary material is absorbed by an exterior wall of an esophagus creating a tissue capsule having a greater volume than the sphincter assistance device, wherein the greater volume allows for movement of the majority of the beads.

18. The method of claim 17 , wherein the bioabsorbable secondary material includes a bioabsorbable casing coupled with the exterior surface of a majority of the beads or a bioabsorbable scaffold, wherein the bioabsorbable secondary material is configured to control remodeling of the tissue surrounding the exterior wall of the esophagus.

19. A method of implanting a sphincter assistance device, comprising:

(a) coupling a bioabsorbable reinforcement buttress around at least a portion of an exterior wall of an esophagus;

(b) waiting a period of time for the exterior wall of the esophagus to bioabsorb the bioabsorbable reinforcement buttress producing scar tissue; and

(c) inserting the sphincter assistance device around the exterior wall of the esophagus by coupling first and second clasp members of the sphincter assistance device together to serially connect a plurality of beads of the sphincter assistance device, wherein the scar tissue prevents the sphincter assistance device from causing tissue erosion.

20. The method of claim 19 , wherein each of the beads comprises a plurality of annular or toroidal rare-earth permanent magnets configured to impart a radially inwardly oriented magnetic bias to the beads to reinforce a sphincter to transition between a closed configuration and an open configuration.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2021
From: ETHICON LLC
To: CILAG GMBH INTERNATIONAL
Reel/Frame 056601/0339 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2019
From: FIEBIG, KEVIN M.; SHELTON, FREDERICK E., IV
To: ETHICON LLC
Reel/Frame 048502/0156 →