UPPER STOMACH GASTRIC IMPLANTS

• US 20120095499A1
• Filed: 10/17/2011
• Published: 04/19/2012
• Est. Priority Date: 10/19/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Babkes, Mitchell H., Dominguez, Zachary
• Granted Patent: US 9,198,790 B2
• Time in Patent Office: Days
• US Class Current: 606/198
• CPC Class Codes: A61F 5/0033 with more than one chamber
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions

Abstract

A variety of passive intragastric implant devices for obesity treatment are disclosed. Such passive devices do not autonomously change shape, but instead react within the stomach to induce satiety. The devices may provide slowed entry into the stomach, thus reducing the intake capacity. Additionally, the devices may contact areas within the stomach, such as the cardia surrounding the esophageal sphincter, to stimulate satiety-inducing nerves. Some devices combine two or more of these satiety-inducing features. Methods of implant are disclosed including compressing the devices within a delivery tube and transorally advancing the devices through the esophagus to be deployed within the stomach. Removal of the devices occurs in the reverse. The implants are formed of materials that permit the implant to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach

Claims

1. A passive intragastric obesity treatment implant, comprising:

an esophageal stent sized to anchor within the esophagus just above the esophageal sphincter;

a shallow conical ring sized to contact the interior stomach walls adjacent to the esophageal sphincter with a central through hole centered at the esophageal sphincter;

a thin, flexible tether connecting the esophageal stent to the conical ring;

a plurality of thin anchor legs extending from a distal rim of the conical ring, the legs made of a resilient material; and

a shallow cup member attached to the anchor legs opposite from the conical ring and sized to create large spaces between the conical ring and the cup member, the anchor legs having a sufficient length such that the cup member contacts an interior stomach wall opposite the esophageal sphincter,

the implant being formed of materials that permit it to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach.

2. The implant of claim 1, wherein there are four anchor legs.

3. The implant of claim 1, wherein the tether is relatively flexible while the anchor legs are relatively stiffer to transmit compressive forces from the cup member to the conical ring.

4. A passive intragastric obesity treatment implant, comprising:

an esophageal stent sized to anchor within the esophagus just above the esophageal sphincter;

a cardia-stimulating pillow having perforations and a central opening that aligns with the esophageal sphincter to permit food to pass therethrough;

a flexible tether securing cardia-stimulating pillow to the esophageal stent;

a balloon-like pillow smaller than the cardia-stimulating pillow having perforations therein; and

a thin relatively stiff tube connecting the cardia-stimulating pillow and the balloon-like pillow, the tube having a length sufficient to maintain contact of the cardia-stimulating pillow against the cardia and the balloon-like pillow against the stomach wall opposite the esophageal sphincter,

the implant being formed of materials that permit it to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach.

5. The implant of claim 4, wherein the cardia-stimulating pillow comprises a substantially disk-shaped member having large spoke-like through holes for passage of food.

6. The implant of claim 4, wherein the cardia-stimulating pillow further includes a central hub connected to both the tube and tether.

7. The implant of claim 4, wherein the esophageal stent comprises a coil of elastic material.

8. The implant of claim 7, wherein the coil material is Nitinol.

9. The implant of claim 4, wherein the cardia-stimulating pillow and the balloon-like pillow are molded with relatively thick walls to maintain their as-molded shape without inflation, and each includes holes to allow stomach juices to freely flow in and out.

10. A passive intragastric obesity treatment implant, comprising:

an esophageal stent sized to anchor within the esophagus just above the esophageal sphincter;

an enlarged cardia-stimulating pillow tethered to the esophageal stent to abut the esophageal opening and being open to the esophagus, the pillow including an artificial stoma opening to the stomach cavity; and

a plurality of balloon-like pillows having perforations stacked against the cardia-stimulating pillow so as to reach the interior stomach wall opposite the esophageal sphincter and thus maintain contact of the cardia-stimulating pillow against the cardia; and

the implant being formed of materials that permit it to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach.

11. The implant of claim 10, wherein the artificial stoma comprises an aperture in a flexible diaphragm such that the artificial stoma has a variable diameter.

12. The implant of claim 10, further comprising an anti-rotation leg attached to an outer one of the balloon-like pillows.

13. The implant of claim 10, wherein there are two balloon-like pillows each having a substantially hemispherical shape and arranged so that their equatorial planes abut.

14. The implant of claim 10, wherein the balloon-like pillows are molded with relatively thick walls to maintain their as-molded shape without inflation, and each includes holes to allow stomach juices to freely flow in and out.

15. The implant of claim 10, wherein the cardia-stimulating pillow is tethered to the esophageal stent by a collapsible tubular connector between the esophageal stent and the cardia-stimulating pillow, the tubular connector permitting food to flow therethrough from the esophagus into the interior of the pillow.

16. A passive intragastric obesity treatment implant, comprising:

an esophageal mounting stent sized to anchor within the esophagus just above the esophageal sphincter, the stent has a configuration that allows it to change its outer diameter while maintaining an inner diameter aperture substantially constant; and

an enlarged cardia-stimulating umbrella tethered to the esophageal stent having a contracted columnar shape for delivery and an expanded splayed out shape that abuts against the cardia surrounding the esophageal sphincter,

the implant being formed of materials that permit it to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach.

17. The implant of claim 16, wherein the esophageal mounting stent has an accordion-like spiral structure include a plurality of triangular membranes that are each bordered on two sides by an upper strut and a lower strut, with an outer edge being free.

18. The implant of claim 16, wherein the cardia-stimulating umbrella comprises a plurality of strips splayed outward from a central hub, and flexible webbing extending between the strips.

19. The implant of claim 18, wherein the strips are relatively stiff in comparison to the webbing.

20. The implant of claim 18, wherein the central hub is an open ring for food to pass therethrough.