SUPPORT DEVICE FOR GASTROINTESTINAL IMPLANT

• US 20170035594A1
• Filed: 08/02/2016
• Published: 02/09/2017
• Est. Priority Date: 08/06/2015
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Hardy, Greg James, Sigmon, John Crowder Jr., Gittard, Shaun D., McLawhorn, Tyler Evans, Martinez, Michelle D., Surti, Vihar C.
• Granted Patent: US 10,045,870 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0069 in the wall of the stomach
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

The present disclosure provides a support device for a gastrointestinal implant. The support device may include a lumen configured to extend through a submucosal tunnel and a mouth located at a proximal end of the lumen and in fluid communication with the lumen. The mouth may be configured to face proximally within a gastrointestinal tract to receive GI contents, and the mouth may be configured to direct the GI contents into the lumen. The support device may further include a support structure, where the lumen extends through the support structure, and where the support structure is configured to apply an outward radial force on an inner wall of the gastrointestinal tract. An artificial tunnel may extend distally from the support structure, may form at least a portion of the lumen, and may be configured to extend through the submucosal tunnel.

Claims

1. A support device for a gastrointestinal implant, the support device comprising:

a lumen configured to extend through a submucosal tunnel;

a mouth located at a proximal end of the lumen and in fluid communication with the lumen, wherein the mouth is configured to face proximally within a gastrointestinal tract to receive GI contents, and wherein the mouth is configured to direct the GI contents into the lumen;

a support structure, wherein the lumen extends through the support structure, and wherein the support structure is configured to apply an outward radial force on an inner wall of the gastrointestinal tract; and

an artificial tunnel extending distally from the support structure and forming at least a portion of the lumen, wherein the artificial tunnel is configured to extend through the submucosal tunnel.

2. The support device according to claim 1, wherein the support structure includes a first portion and a second portion located distally of the first portion, and wherein a diameter of the first portion is larger than a diameter of the second portion.

3. The support device according to claim 2, wherein the first portion is configured to be located within a native lumen of the gastrointestinal tract, and wherein the second portion is configured to be located in a submucosal tunnel.

4. The support device according to claim 1, wherein the artificial tunnel is semi-permeable.

5. The support device according to claim 1, wherein the artificial tunnel includes an outer surface with a surface characteristic configured to facilitate tissue ingrowth.

6. The support device according to claim 1, wherein the support structure includes a stent.

The support device according to claim 1, further comprising:

a feeding tube including the lumen and the mouth; and

a balloon including the support structure;

wherein the feeding tube extends substantially through the balloon.

7. The support device according to claim 1, wherein the support structure is configured to apply a pressure to a flap of submucosal tissue placed in contact with an opposite-side wall of the gastrointestinal tract.

8. A method for providing a submucosal tunnel, the method comprising:

forming the submucosal tunnel within an inner wall of a native lumen of a gastrointestinal tract; and

deploying a support device configured to maintain the submucosal tunnel, the support device including a support structure, a lumen extending through the support structure, and a mouth located at a proximal end of the lumen and in fluid communication with the lumen,

wherein deploying the support device includes locating at least a portion of the lumen within the submucosal tunnel.

9. The method of claim 8, wherein deploying the support device includes locating at least a portion of the support structure proximally of the submucosal tunnel such that the support structure applies an outward radial force on an inner wall of the native lumen of the gastrointestinal tract.

10. The method of claim 8, wherein deploying the support structure includes maneuvering the support structure through the gastrointestinal tract in a collapsed state and then expanding the support structure to an expanded state such that the support structure contacts the inner wall of the native lumen.

11. The method of claim 8, wherein the support device includes an artificial tunnel extending distally from the support structure and forming at least a portion of the lumen, and wherein deploying the support device includes locating the artificial tunnel such that it extends through at least a portion of the submucosal tunnel.

12. The method of claim 11, wherein the artificial tunnel includes a distal mouth configured to discharge GI contents into a native portion of the gastrointestinal tract.

13. The method of claim 8, wherein forming the submucosal tunnel includes displacing a flap of submucosal tissue from a wall of the native lumen of the gastrointestinal tract and adhering the flap to the opposite-side wall of the native lumen.

14. The method of claim 13, wherein forming the submucosal tunnel further includes forming an injury site on the opposite-side wall of the native lumen and placing the flap in contact with the injury site.

15. A method for forming a bypass of a portion of a gastrointestinal tract, the method comprising:

injecting a fluid beneath a first layer to separate the first layer from a second layer, thereby forming a fluid-filled pocket;

forming a first incision at a proximal end portion of the fluid-filled pocket; and

forming a second incision in a distal end portion of the fluid-filled pocket,

wherein the first incision, second incision, and pocket define a tunnel.

16. The method of claim 15, wherein the fluid is injected at a plurality of locations.

17. The method of claim 15, the method further comprising deploying a reinforcement device within the tunnel.

18. The method of claim 17, the method further comprising expanding the reinforcement device within the tunnel.

19. The method of claim 15, wherein the first incision is located in an esophagus of a patient, and wherein the second incision is located in a stomach of a patient.

20. The method of claim 15, wherein the pocket extends from an esophagus of a patient and bypasses at least a portion of a stomach of the patient.