NON-INFLATABLE GASTRIC IMPLANTS AND SYSTEMS

• US 20120095497A1
• Filed: 10/19/2011
• Published: 04/19/2012
• Est. Priority Date: 10/19/2010
• Status: Abandoned Application

• Current Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Babkes, Mitchell H., Dominguez, Zachary, Schwab, Justin, Hoover, Jason
• Application Number:
  US13/276,904
• Publication Number:
  US 20120095497A1
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

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:

an elongated member having a relaxed configuration that forms a non-uniform diameter helix, with a middle coil of maximum diameter and end coils that are smaller than the middle coil, the relaxed configuration having a length and maximum diameter that generally fits within the stomach of an adult patient so as to span between the antrum and cardia walls and apply pressure to surrounding walls upon contraction thereof, the elongated member being formed of a material which permits it to be stretched 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 non-uniform diameter helix in a relaxed state has a superior end adapted to be implanted at the cardia region and an inferior end adapted be implanted at the antrum region, and the middle coil of maximum diameter is offset so as to be closer to the superior end.

3. The implant of claim 1, wherein the elongated member comprises a hollow plastic tube forming the non-uniform diameter helix.

4. The implant of claim 1, wherein the elongated member comprises a thin metal wire core covered with a soft outer layer.

5. The implant of claim 1, wherein opposite ends of the elongated member are slightly bent back inward toward an axis of the helix to avoid irritating pressure to stomach walls.

6. The implant of claim 1, further including a tab melt-molded into one end of the elongated member to serve as a grasping point for device removal

7. A passive intragastric obesity treatment implant, comprising:

an elongated member having a relaxed configuration that forms a non-uniform diameter helix, with end coils and a middle region that is substantially without coils, the relaxed configuration having a length that generally fits within the stomach of an adult patient so as to span between the antrum and cardia walls and apply pressure surrounding walls upon contraction thereof, the elongated member being formed of a material which permits it to be stretched into a substantially linear 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 non-uniform diameter helix in a relaxed state has a superior end adapted be implanted at the cardia region and an inferior end adapted to be implanted at the antrum region, and the coil diameter of the superior end is larger than the coil diameter of the inferior end.

9. The implant of claim 7, wherein the elongated member comprises a hollow plastic tube forming the non-uniform diameter helix.

10. The implant of claim 7, wherein the elongated member comprises a thin metal wire core covered with a soft outer layer.

11. The implant of claim 7, wherein opposite ends of the elongated member are slightly bent back inward toward an axis of the helix to avoid irritating pressure to stomach walls.

12. The implant of claim 7, further including a tab melt-molded into one end of the elongated member to serve as a grasping point for device removal.

13. 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.

14. The implant of claim 13, 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.

15. The implant of claim 13, wherein the members are no wider than 20 mm.

16. The implant of claim 13, 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.

17. The implant of claim 16, 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.

18. The implant of claim 17, wherein the axes aligned with the cavity and nipple define an obtuse included angle of between about 120-150°

.

19. The implant of claim 13, wherein the rotational orientation of any one member relative to another is unrestricted.

20. The implant of claim 13, wherein each member may only join together in a particular rotational orientation with another member.

21. The implant of claim 13, 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.

22. A passive intragastric obesity treatment implant, comprising:

an expandable net-like body formed of a plurality of struts, the body having a relaxed configuration with a size sufficient to contact the interior stomach walls upon contraction thereof, the body including a generally tubular outer portion connected to two invertible end portions terminating in cups, one of the cups including structure for mating with a delivery tube, and the other cup being solid,

the implant being capable of being stretched open into a substantially linear delivery configuration and being formed of a material that will resist degradation over a period of at least six months within the stomach.

23. The implant of claim 22, wherein the relaxed diameter of the body is slightly larger than the average obese patient'"'"'s upper stomach interior, and larger than the lower stomach.

24. The implant of claim 22, wherein the relaxed shape of the body defines an outer cylindrical periphery and an hourglass-shaped inner profile.

25. The implant of claim 24, wherein the cups are shaped similarly to nest together in the center of the structure.

26. A passive intragastric obesity treatment implant, comprising:

an elongated solid member having a relaxed configuration that forms a coil, opposite free ends of the coil being adapted to connect together to form a continuous loop, the coil assuming a three-dimensional shape upon implant in the stomach having a size that generally fits within the stomach of an adult patient so as to contact the interior stomach walls upon contraction thereof, the member being formed of a material which permits it to be stretched into a substantially linear delivery configuration and that will resist degradation over a period of at least six months within the stomach.

27. The implant of claim 26, further including a plurality of necked-down sections along the length of the elongated member providing areas for cutting the elongated member.

28. The implant of claim 26, wherein the elongated member has a distal end connector with a lumen, and a proximal end connector with a lumen and a side aperture spaced from the proximal end connector, the implant further including a tether that extends through the hollow lumen on the distal end connector and is secured therein, and passes in through the proximal end connector lumen and outward through the side aperture, the proximal and distal end connectors being brought together upon pulling the tether taut.

29. A intragastric device for the treatment of obesity, the device comprising:

an elongated member having a relaxed configuration that forms a non-uniform diameter helix, with a middle coil of the helix having a maximum diameter, and at least one end coil of the helix having a diameter which is less than the diameter of the middle coil, the relaxed configuration of the elongated member having a length and a maximum diameter such that the device can be placed in and fit within the stomach of a patient so that the device once implanted in the stomach of the patient span or occupies along at least one axis the distance or span between the antrum and cardia walls of the stomach and thereat make contact with and apply a pressure to the stomach walls, the elongated member being formed of a material which permits it to be stretched into a substantially linear delivery configuration and wherein the device can substantially resist degradation over a period of at least six months while the device is implanted in the stomach.