STOMACH-SPANNING GASTRIC IMPLANTS

• US 20120095384A1
• Filed: 10/17/2011
• Published: 04/19/2012
• Est. Priority Date: 10/19/2010
• Status: Abandoned Application

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Babkes, Mitchell H., Dominguez, Zachary
• Application Number:
  US13/275,170
• Publication Number:
  US 20120095384A1
• Time in Patent Office: Days
• US Class Current: 604/9
• 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 implants do not autonomously change shape, but instead react within the stomach to induce satiety. The implants may take up volume within the stomach, thus reducing the digestive capacity. Additionally, the implants may contact areas within the stomach, such as the cardia surrounding the esophageal sphincter, to stimulate satiety-inducing nerves. Also, a number of implants slow gastric emptying by blocking or otherwise impeding flow through the pyloric sphincter. Other implants delay digestion by providing a duodenal sleeve. A number of implants combine two or more of these satiety-inducing features. Methods of implant are disclosed including compressing the implants within a delivery tube and transorally advancing the implants through the esophagus to be deployed within the stomach. Removal of the implants occurs in the reverse.

Claims

1. A passive intragastric obesity treatment implant, comprising:

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

a tubular body having a length sufficient to extend between the esophageal sphincter and the pyloric sphincter upon implant in the stomach, the tubular body having perforations therein to permit ingress of stomach juices;

a duodenal tube extending in series from the tubular body;

collapsible tubular connectors between the esophageal stent and the tubular body, and between the tubular body and the duodenal tube, the connectors each having longitudinal slits therein; and

a bulbous flange surrounding and connected to the distal end of the tubular body, the bulbous flange having a size that prevents passage through the pyloric 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, further including:

an enlargement surrounding the duodenal tube and sized to prevent passage through the pyloric sphincter.

4. The implant of claim 1, further including perforations along the tubular body to allow ingress of digestive stomach juices.

5. The implant of claim 1, wherein the bulbous flange is molded with relatively thick walls to maintain its as-molded shape without inflation.

6. The implant of claim 1, wherein the entire implant is made of silicone.

3. The implant of claim 3, wherein the duodenal tube and enlargement extend only up to 5-10 cm in length.

7. A passive intragastric obesity treatment implant, comprising:

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

a tubular body having a length sufficient to extend between the esophageal sphincter and the pyloric sphincter upon implant in the stomach, the tubular body having perforations therein to permit ingress of stomach juices, the esophageal stent attaching to a proximal end of the tubular body with a first tether;

a duodenal sleeve extending distally from the tubular body, the duodenal sleeve attaching to a distal end of the tubular body with a second tether;

proximal and distal circular shelves surrounding free ends of the tubular body, the shelves having sizes that resist passage through the esophageal sphincter and the pyloric sphincter, respectively; and

a plurality of positioning rings attached to mid-portions of the tubular body, the positioning rings having a sufficient diameter so as to contact the interior stomach walls upon contraction thereof,

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.

8. The implant of claim 7, wherein the esophageal stent comprises a helical coil of plastic wire.

9. The implant of claim 8, wherein the first tether comprises an extension of the helical coil of plastic wire.

10. The implant of claim 7, wherein there are positioning rings on both sides of the tubular body to maintain spacing of the tubular body with walls of the stomach and ensure the tubular body tracks a gradual arc from the esophageal sphincter to the pylorus rather than taking the shortest path.

11. The implant of claim 7, wherein the tubular body and positioning rings are molded together from the same material.

12. The implant of claim 7, wherein the entire implant is made of silicone.

14. The implant of claim 11, wherein the cardia flange is a flexible, flat partial conical ring that includes a central through hole.

15. The implant of claim 11, wherein the cardia flange is formed by a braided Nitninol wire mesh covered with a soft silicone.

16. The implant of claim 11, wherein the antrum stent is formed by a braided Nitninol wire mesh covered with a soft silicone.

17. The implant of claim 11, further comprising a narrow neck region attached to a distal end of the antrum stent that fits within the pylorus.

18. The implant of claim 11, further comprising a duodenal stent connected in series with the antrum stent at a narrow neck region such that a generally hourglass shape of the antrum stent, neck region, and duodenal stent conforms closely to the antrum, pylorus and upper end of the duodenum.

19. The implant of claim 11, wherein the entire implant is made of silicone and Nitinol.

13. A passive intragastric obesity treatment implant, comprising:

a cardia flange sized and shaped to conform to a cardia region of the stomach and resist passage through the esophageal sphincter and having a central through hole centered at the esophageal sphincter through which food passes;

an antrum stent sized and shaped to conform closely to the antrum; and

a plurality of struts connecting the cardia flange and antrum stent that are flexible enough to straighten out and be passed transorally down an access tube, while also being somewhat stiff to provide light pressure to both the cardia flange and antrum stent on each end;

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.