Non-Inflatable Gastric Implants and Systems

• US 20150142044A1
• Filed: 01/29/2015
• Published: 05/21/2015
• Est. Priority Date: 10/19/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Inventors: Schwab, Justin J., Babkes, Mitchell H., Metzner, Jason, Dominguez, Zachary P.
• Granted Patent: US 9,801,747 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• 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 5/0073 in the abdominal cavity, e.g. not attached to the stomach
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: Y10T 24/44342 having rigid linking arm pivotally connected to each gripping member
• CPC Class Codes: Y10T 24/4453 with position locking-means for gripping members
• CPC Class Codes: Y10T 24/44564 having specific surface material or irregularity on or along engaging face

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, or the greater and lesser curvatures in the middle of the stomach, to stimulate satiety-inducing nerves. Some devices may 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:

a series of non-inflatable members each having a through bore, the members each having a male and a female mating connector which permits each member to connect with another member, each of the members being sized such that it can be easily implanted and removed through the esophagus, the members together taking up volume within the stomach of at least 400 ml and being made of a material that will resist degradation over a period of at least six months within the stomach; and

a tether sized to pass through the through bores of the non-inflatable members, a distal end of the tether attaching to a distal one of the non-inflatable members such that the members can be pulled together by pulling the tether taut to cause the male and female mating connectors to couple, thus forming a relatively solid structure.

2. The implant of claim 1, wherein the male and female mating connectors of the members are configured such that the relatively solid structure formed after pulling the tether taut is a helix.

3. The implant of claim 1, wherein the members are no wider than 20 mm.

4. The implant of claim 1, wherein each of the non-inflatable members comprises a spherical body having an opening on one side centered about a radial axis and leading to an internal cavity, and a nipple projecting from another side.

5. The implant of claim 4, wherein the cavity is stepped and narrows into the internal through bore that angles within the spherical body and continues outward through the nipple along a different radial axis, the nipple being stepped to fit within a stepped cavity of another of the members.

6. The implant of claim 5, wherein the axes aligned with the cavity and nipple define an obtuse included angle of between about 120-150°

.

7. The implant of claim 1, wherein the rotational orientation of any one member relative to another is unrestricted.

8. The implant of claim 1, wherein each member may only join together in a particular rotational orientation with another member.

9. The implant of claim 1, wherein each of the non-inflatable members comprises a body having an opening on one side centered about a radial axis and leading to an internal cavity that narrows into the internal through bore that angles within the spherical body and continues outward through a nipple projecting from another side along a different radial axis, wherein each nipple fits within a cavity of another of the members, and wherein each cavity has a helical ledge that terminates in a small notch, while the nipple has a single protrusion along its length, such that when a nipple is introduced into a cavity and forced together, the members will rotate until the protrusion on the nipple seats in the notch.

10. A passive intragastric obesity treatment implant, comprising:

a plurality of rounded non-inflatable members linked in series, each of the members being sized such that it can be easily implanted and removed through the esophagus, and being made of a material that will resist degradation over a period of at least six months within the stomach, wherein the series of members are configured to assume a particular non-straight shape when the series is placed under serial compression.

11. The implant of claim 10, wherein the non-inflatable members each a male mating connector and a female mating connector which permits each member to connect with another member.

12. The implant of claim 10, wherein the members together take up a volume of at least 400 ml within the stomach.

13. The implant of claim 10, further comprising a tether having a proximal and distal ends, wherein the non-inflatable members each having a through bore, the tether is sized to pass through the through bores of the non-inflatable members, a distal end of the tether attaching to a distal one of the series of non-inflatable members such that the members can be pulled together into serial compression by pulling the tether taut to cause the male and female mating connectors to couple.

14. The implant of claim 13, wherein when the tether is taut, the non-straight shape is a relatively solid structure.

15. The implant of claim 13, wherein the non-straight shape comprises a helix.

16. The implant of claim 13, wherein the throughbore angles within the non-inflatable member.

17. The implant of claim 16, wherein the non-inflatable member comprises a spherical body.

18. The implant of claim 10, wherein adjacent non-inflatable members in the series include features that cause the adjacent non-inflatable members to mate with each other in a specific orientation relative to each other.

19. The implant of claim 10, wherein the non-inflatable members are identical in shape.