SPACE-FILLING INTRAGASTRIC IMPLANTS WITH FLUID FLOW

• US 20120095495A1
• 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, Schwab, Justin
• Granted Patent: US 9,095,405 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0013 Implantable devices or invasive measures
• CPC Class Codes: A61F 5/003 inflatable
• 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
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like

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 take up volume within 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. Also, certain devices slow gastric emptying by blocking or otherwise impeding flow through the pyloric sphincter. A number of 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.

Claims

1. A passive intragastric obesity treatment implant, comprising:

an inflatable body having a length sufficient to extend between the esophageal sphincter at a superior end and the pyloric sphincter at an inferior end upon implant in the stomach, and a width sufficient to contact the interior stomach walls upon contraction thereof, the body being rounded and slightly tapered so as to generally conform to the volume of an adult stomach cavity, the body including a series of chambers fluidly connected so as to be capable of simultaneous inflation and deflation, wherein two chambers at the superior end are separated by an annular recess that is positioned to open to the esophageal sphincter, and wherein apertures in the annular recess open to a central flow channel that extends from the annular recess to the inferior end of the body, and some of the chambers surround the central flow channel, the implant being formed of a material which permits it to be compressed into a substantially linear 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 the central flow channel has a star-shaped cross-section.

3. The implant of claim 1, further including a plurality of circumferential grooves extending around the body and between adjacent chambers, and radial passages connecting the circumferential grooves to the central flow channel.

4. The implant of claim 1, wherein the chambers gradually decrease in diameter from the superior to the inferior ends of the body.

5. The implant of claim 1, wherein the body includes a rounded superior end that mimics the shape of the surrounding cardia and defines a proximal chamber therein.

6. A passive intragastric obesity treatment implant, comprising:

a foam body having a sufficient diameter so as to contact the interior stomach walls upon contraction thereof, the foam body defining a central throughbore; and

a radially expandable and compressible stent lining the central throughbore, the stent having a tubular wall and struts across a proximal end to filter larger food particles,

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

7. The implant of claim 6, wherein the struts at the proximal end of the stent are formed in a web of angled struts that extend inward from the tubular wall and are joined together by a ring.

8. The implant of claim 6, wherein the foam body has a diameter of between about 10-20 cm.

9. A passive intragastric obesity treatment implant, comprising:

a collapsible body defining a large bowl-shaped proximal end having a diameter sufficient to contact the interior stomach walls upon contraction thereof, the proximal end having an artificial stoma opening through a bottom of the bowl shape, the body further including a tapered hollow leg extending distally from the proximal end and an enlarged pyloric member on the distal end of the leg,

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

10. The implant of claim 9, wherein the body has an ear-horn shape narrowing from the bowl-shaped proximal end along the leg to the pyloric member.

11. The implant of claim 9, wherein the leg includes a plurality of large apertures to permit ingress of stomach juices to the interior of the leg.

12. The implant of claim 9, wherein the body is inflatable, and the stoma opening communicates with a flow-through passage that extends to the outside of the leg.

13. A passive intragastric obesity treatment implant, comprising:

a hollow flexible tether having a lumen and a length sufficient to extend substantially the entire length of the stomach cavity from the pyloris to the esophageal/stomach junction and for a distance into the esophagus;

a detention tray affixed to a proximal section of the tether and having a size that impedes free passage of food boluses entering the stomach from the esophagus; and

a series of inflatable balloons affixed to the tether and being in fluid communication with the lumen so as to be able to receive fluid from and be filled by fluid in the tether, the inflatable balloons including a pyloric balloon at a distal end of the tether having a size that will not pass through the pyloric sphincter, wherein the detention tray is positioned on the tether relative to the pyloric balloon so as to be located adjacent the cardia,

wherein the device is made of a material that will resist degradation over a period of at least six months within the stomach.

14. The implant of claim 13, wherein the detention tray is non-inflatable.

15. The implant of claim 13, wherein the detention tray is bowl-shaped with a concave proximal side.

16. The implant of claim 13, wherein one of the inflatable balloons is a positioning balloon and is sized larger than the others and positioned on the tether just distal to the detention tray so that it contacts the surrounding cardia and centers the tether and tray below the esophageal/stomach junction.

17. The implant of claim 16, wherein the positioning balloon has an arcuate outer section connected by spokes to a middle portion through which the tether passes.

18. The implant of claim 17, wherein the outer section defines a full circle.

19. The implant of claim 13, wherein the pyloric balloon is shaped like a donut with a central through hole that permits passage of chyme from the stomach to the pyloric sphincter.

20. The implant of claim 13, wherein the inflatable balloons includes the pyloric balloon and a pair of spherical intermediate balloons between the pyloric balloon and the detention tray, the intermediate balloons maintaining a space between the tether and the stomach wall.

21. The implant of claim 13, further including a fill valve fitted to a proximal end of the tether, the fill valve having structure for mating with a fill tube nipple.