Devices and methods for gastrointestinal bypass

• US 9,675,489 B2
• Filed: 06/26/2014
• Issued: 06/13/2017
• Est. Priority Date: 05/31/2012
• Status: Active Grant

• Current Assignee: ValenTx, Inc.
• Original Assignee: ValenTx, Inc.
• Inventors: Neisz, Johann, Chen, Cole, Smith, C. Daniel, St. Germain, Jon
• Primary Examiner(s): Deak, Leslie
• Application Number:
  US14/315,330
• Publication Number:
  US 20150018745A1
• Time in Patent Office: 1,083 Days
• Field of Search: 604 8, 604 9
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 5/0036 : Intragastrical devices
• CPC Class Codes: A61F 5/0076 : preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

Devices and methods for gastrointestinal bypass are described. A gastrointestinal bypass device includes a gastrointestinal cuff and a gastrointestinal sleeve. The cuff may be configured to be attached in the esophagus, and may be sufficiently flexible to expand and collapse to conform with the inside of the esophagus to allow the esophagus to function substantially normally. The sleeve is configured to be coupled to the cuff, and may be made of a material that is floppy or flaccid but does not substantially expand radially.

Claims

1. A gastrointestinal bypass device, comprising:

a gastrointestinal cuff configured to be at least partially positioned in an esophagus; and

a gastrointestinal sleeve coupled to the cuff, the sleeve having a flexible tube configured to be at least partially positioned in a stomach and a small intestine;

wherein the cuff and the sleeve are configured to allow a bypassed portion of food to be bypassed past the stomach and into the small intestine, and wherein the cuff and/or the sleeve include one or more side wall openings configured to allow a nonbypassed portion of food to pass through the openings and into the stomach.

2. The device of claim 1, wherein the cuff includes a liner configured to allow the nonbypassed portion of food to pass from an inside of the liner to an outside of the liner.

3. The device of claim 2, wherein the liner is at least partially made of a woven material having openings.

4. The device of claim 2, wherein the liner is at least partially made of a mesh material having openings.

5. The device of claim 2, wherein the liner includes one or more, or any combination of, openings, slits, holes, channels, valves, and/or flaps.

6. The device of claim 1, wherein the cuff includes a liner configured to allow an amount of the nonbypassed portion of food to be adjusted in situ.

7. The device of claim 6, wherein the liner includes one or more temporary or removable portions and/or layers.

8. The device of claim 1, wherein the cuff includes a liner having a proximal portion that allows the nonbypassed portion of food to pass into the stomach.

9. The device of claim 8, wherein the proximal portion of the liner includes a scalloped edge.

10. The device of claim 9, wherein the scalloped edge includes a plurality of peaks and valleys configured to allow the nonbypassed portion of food to pass through the valleys to an outside of the liner and into the stomach.

11. The device of claim 1, wherein the sleeve includes a tube configured to allow the nonbypassed portion of food to pass from an inside of the tube to an outside of the tube.

12. The device of claim 11, wherein the tube includes one or more, or any combination of, openings, slits, holes, channels, valves, and/or flaps.

13. The device of claim 1, wherein the sleeve includes a tube configured to allow an amount of the nonbypassed portion of food to be adjusted in situ.

14. The device of claim 13, wherein the tube includes one or more temporary or removable portions and/or layers.

15. A method of providing adjustable gastric bypass, the method comprising:

positioning at least a portion of a gastrointestinal cuff in an esophagus;

positioning at least a portion of a gastrointestinal sleeve in a stomach and a small intestine, wherein the cuff and the sleeve are configured to allow a bypassed portion of food to be bypassed past the stomach and into the small intestine, and wherein the cuff and/or the sleeve include one or more side wall openings configured to allow a nonbypassed portion of food to pass through the openings and into the stomach; and

adjusting an amount of the nonbypassed portion of food allowed to pass into the stomach.

16. The method of claim 15, wherein the cuff includes a liner, and wherein adjusting an amount includes removing one or more temporary or removable portions of the liner.

17. The method of claim 15, wherein the sleeve includes a tube, and wherein adjusting an amount includes removing one or more temporary or removable portions of the tube.