Upper stomach gastric implants

• US 9,398,969 B2
• Filed: 05/14/2012
• Issued: 07/26/2016
• 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: Babkes, Mitchell H.
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US13/470,940
• Publication Number:
  US 20120323160A1
• Time in Patent Office: 1,534 Days
• Field of Search: 606/191, 606/198, 623/23.65, 604/909
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 5/0089 Instruments for placement or removal

Abstract

A variety of passive intragastric implant devices for obesity treatment are disclosed. Such passive devices may 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 system for the treatment of obesity for implantation along an esophagus at an esophageal sphincter of a patient, comprising:

a tubular stent having, in a delivered configuration, an expanded diameter sufficient to anchor in the esophagus adjacent the esophageal sphincter and having a sidewall with a length configured to extend along the esophagus;

a resilient diaphragm member coupled to the tubular stent at a first position along the length of the tubular stent and extending across the tubular stent in a direction perpendicular to the length of the tubular stent, and having a non-closing, fixed size stoma that is always open to allow food to pass through the diaphragm member; and

an elongated obturator having a stent attachment device and a diaphragm attachment device longitudinally spaced from the stent attachment device,

wherein the stent attachment device releasably attaches to the sidewall of the tubular stent at a second position along the length of the tubular stent that is spaced along the length of the tubular stent from the first position and the diaphragm attachment device releasably attaches within the stoma of the diaphragm member at the first position, and

wherein attachment of the stent and the diaphragm to the respective stent attachment device and the diaphragm attachment device causes the tubular stent and the diaphragm to assume a delivery configuration in which the tubular stent is longitudinally extended and radially compressed and the diaphragm is resiliently deformed.

2. The system of claim 1, wherein the tubular stent is configured to expand and return to its delivered configuration upon being released from the obturator, to cause the tubular stent to anchor against the patient'"'"'s esophagus.

3. The system of claim 1, wherein the obturator is configured to releasably attach to a rim that defines the stoma opening.

4. The system of claim 1, wherein the tubular stent has a first end and an opposing second end, the first end being closer to the patient'"'"'s stomach than the second end when the tubular stent is anchored within the patient'"'"'s esophagus, and the diaphragm member is configured to allow an outer edge of the diaphragm member to fold relative to the stoma opening in a direction away from the second end of the tubular stent when the obturator releasably attaches the tubular stent to compress the tubular stent.

5. The system of claim 1, wherein the diaphragm member is shaped as a substantially flat disk.

6. The system of claim 1, wherein the diaphragm member is connected to the stent along its entire circumference.

7. The system of claim 1, wherein the diaphragm member includes an outer edge, and the outer edge is substantially coplanar with the stoma opening.

8. The system of claim 7, wherein the diaphragm member extends substantially coplanar with the end of the tubular stent.

9. The system of claim 7, wherein the stoma opening is substantially coplanar with the end of the tubular stent.

10. The system of claim 9, wherein the diaphragm member is configured to be retained substantially within the stent when the implant is radially compressed into the delivery configuration which is substantially linear.

11. The system of claim 1, wherein the diaphragm member has a first diameter, and the stent has a second diameter that is substantially the same as the first diameter.

12. the system of claim 1, wherein in one configuration when the obturator is engaged relative to the diaphragm, the obturator retains a portion of the diaphragm member in the interior of the tubular stent.

13. The system of claim 1, wherein at least one of the stent attachment device and the diaphragm attachment device are selectively retractable into the obturator.

14. The system of claim 1, wherein the diaphragm attachment device includes a retractable flange configured to pass through and engage the stoma opening.

15. The system of claim 1, wherein the stent attachment device includes at least one protrusion that extend radially outward from the obturator.

16. The system of claim 1, wherein the obturator includes a release mechanism to releasable detach the stent attachment device from the stent and detach the diaphragm attachment device from the diaphragm.