System, device and method for anchoring a stent

Patent metadata

Field	Value
Publication number	US-12245959-B2
Application number	US-202318216414-A
Country	US
Kind code	B2
Filing date	Jun 29, 2023
Priority date	Oct 15, 2019
Publication date	Mar 11, 2025
Grant date	Mar 11, 2025

Abstract

The present disclosure relates generally to stents, systems, and methods for anchoring devices within a body lumen by cooperation between the device and the body musculature. A device comprising an elongate tubular member may be deployed within a body lumen, where the body lumen includes a sphincter that regulates flow through the body lumen. The elongate tubular member includes a sleeve formed from a flexible membrane and one or more stents disposed at either or both ends of the sleeve. In some embodiments, the stents may be treatment stents configured to treat a portion of the body lumen. The elongate tubular member may be deployed within the body lumen such that the flexible membrane aligns with and moves in coordination with the sphincter, thereby increasing retention forces acting upon the elongate tubular member when the sphincter is closed to minimize treatment stent migration.

First claim

What is claimed is:

1. A device comprising an elongate tubular body configured for positioning across an anatomical constriction portion that regulates flow between a first anatomical flow path and a second anatomical flow path, the device comprising:
a proximal stent having an elongate tubular wall having a proximal end, a distal end, a longitudinal extent therebetween the proximal end and the distal end configured to anchor the proximal stent with respect to anatomical structure proximal to the anatomical constriction portion, and a flare disposed at the distal end;
a distal stent having an elongate tubular wall having a proximal end and a distal end and a longitudinal extent therebetween configured to anchor the distal stent with respect to anatomical structure distal to the anatomical constriction portion; and
a sleeve more flexible than the proximal stent and the distal stent and coupled to the distal end of the proximal stent and the proximal end of the distal stent;
wherein:
the sleeve is configured to extend through and to conform to the anatomical constriction portion, and to transition in coordination with the anatomical constriction portion between an expanded configuration enabling flow through the sleeve and a constricted configuration wherein flow through the sleeve is restricted while the proximal stent remains anchored to anatomical structure proximal to the anatomical constriction portion and the distal stent remains anchored to anatomical structure distal to the anatomical constriction portion; and
the proximal stent, the distal stent, and the sleeve together define a central lumen providing a flow path through the elongate tubular body resistant to migration.

2. The device of claim 1 , wherein the device comprises an additional flare on at least one of the proximal stent or the distal stent.

3. The device of claim 2 , wherein both the proximal stent and the distal stent each comprise at least one flare, wherein at least two of the flares have different diameters.

4. The device of claim 1 , wherein the elongate tubular wall of the proximal stent and the elongate tubular wall of the distal stent each comprise a rigid or semi-rigid structure which is not pulled into the anatomical constriction portion as the flexible sleeve constricts with the anatomical constriction portion.

5. The device of claim 1 , wherein the sleeve is formed of a material more flexible than the proximal stent and the distal stent to maintain efficacy of the anatomical constriction portion without causing the proximal stent and the distal stent to migrate.

6. The device of claim 5 , wherein the proximal stent and the distal stent are configured to not be pulled into the anatomical constriction portion as the flexible sleeve constricts with the anatomical constriction portion.

7. The device of claim 1 , wherein the sleeve has a length selected to extend between a proximal side of the anatomical constriction portion and the distal side of the anatomical constriction portion with the proximal stent affixed to tissue at the proximal side of the anatomical constriction portion, and the distal stent affixed to tissue at the distal side of the anatomical constriction portion.

8. The device of claim 1 , wherein the sleeve is comprised of a material configured to transition from the expanded configuration to the constricted configuration in response to forces applied thereto by the anatomical constriction portion, thereby anchoring the device with respect to the anatomical constriction portion.

9. The device of claim 1 , wherein:
the sleeve is configured to conform to an anatomical constriction portion comprising a sphincter;
the proximal stent is configured to engage tissue at a proximal end of the sphincter;
the distal stent is configured to engage tissue at a distal end of the sphincter; and
the sleeve is configured to transition from the expanded configuration when the sphincter is opened to the constricted configuration when the sphincter is closed, thereby maintaining sphincter efficacy, without affecting the positions of proximal stent and the distal stent surrounding and at each end of the sphincter.

10. The device of claim 9 , wherein the sleeve is configured to move in coordination with the sphincter and to be compressed and anchored by the sphincter to secure the device against migratory forces resulting from the peristaltic motion of the sphincter.

11. The device of claim 1 , wherein at least one of the proximal stent or the distal stent comprises one of a metal, a metal alloy, a polymer, a metal-polymer composite, a ceramic, or a combination thereof.

12. The device of claim 1 , wherein the sleeve comprises a flexible silicone membrane.

13. The device of claim 1 , wherein the sleeve comprises a tube having one of a fixed or variable thickness, ranging from between 20 microns and 150 microns.

14. The device of claim 1 , wherein at least one of the proximal stent or the distal stent comprises a treatment portion comprising one of a tubular scaffold, a coating, a mesh or combination thereof.

15. A system including:
a first elongate body positioned across a first anatomical constriction portion and comprising:
a first tubular wall defining a proximal retention end of the first elongate body and extending longitudinally to define an elongate exterior configured to anchor with respect to an anatomical structure proximal to the first anatomical constriction portion;
a second tubular wall defining a distal retention end of the first elongate body and extending longitudinally to define an elongate exterior configured to anchor with respect to an anatomical structure distal to the first anatomical constriction portion; and
a flexible sleeve coupled between the first tubular wall and the second tubular wall;

wherein:
the flexible sleeve is configured to extend across the first anatomical constriction portion to transition in coordination with application of a retention force from the first anatomical constriction portion on the flexible sleeve between an expanded configuration enabling flow through the flexible sleeve when the first anatomical constriction portion is open and a constricted configuration when the first anatomical constriction portion constricts;
the first tubular wall and the second tubular wall are configured to be anchored to anatomical structure on either side of the first anatomical constriction portion across which the flexible sleeve therebetween extends;
the first tubular wall and the second tubular wall and the flexible sleeve cooperate with the first anatomical constriction portion to retain the first elongate body in place with respect to the first anatomical constriction portion; and
the first tubular wall includes a flare disposed adjacent the flexible sleeve, the flexible sleeve extending distally from the flare.

16. The system of claim 15 , further comprising:
a second elongate body positioned across a second anatomical constriction portion and comprising:
a first tubular wall defining a proximal retention end of the second elongate body and extending longitudinally to define an elongate exterior configured to anchor with respect to an anatomical structure proximal to the second anatomical constriction portion;
a second tubular wall
defining a distal retention end of the second elongate body and extending longitudinally to define an elongate exterior configured to anchor with respect to an anatomical structure distal to the second anatomical constriction portion; and
a flexible sleeve coupled between the first tubular wall and the second tubular wall; and

a bypass

Assignees

• Boston Scient Scimed Inc

Inventors

• Tuck Daniel
• Folan Martyn G
• Keating Thomas M
• Burke Martin

Classifications

• A61F5/0079

  Pyloric or esophageal obstructions · CPC title

• A61F2/07 Primary

  Stent-grafts · CPC title

• A61F2220/0008

  Fixation appliances for connecting prostheses to the body · CPC title

• A61F2002/044

  Oesophagi or esophagi or gullets · CPC title

• A61F2/90

  characterised by a net-like or mesh-like structure · CPC title