Devices and methods for endolumenal gastrointestinal bypass

• US 10,350,101 B2
• Filed: 05/21/2012
• Issued: 07/16/2019
• Est. Priority Date: 11/01/2002
• Status: Active Grant

• Current Assignee: ValenTx, Inc.
• Original Assignee: ValenTx, Inc.
• Inventors: Dann, Mitchell, Butters, Joshua, Fluet, Greg, Guterman, Lee, Kagan, Jonathan, Swain, Paul, von Hoffmann, Gerard, Wright, James
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US13/476,884
• Publication Number:
  US 20120232459A1
• Time in Patent Office: 2,612 Days
• Field of Search: 604275, 604514, 604516, 604909-910, 604 9601
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• 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 hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• 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 2002/044 : Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 5/0036 : Intragastrical devices
• CPC Class Codes: A61F 5/0076 : preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like

Abstract

The present invention provides devices and methods for attachment of an endolumenal gastrointestinal device, such as an artificial stoma device, a gastrointestinal bypass sleeve or other therapeutic or diagnostic device, within a patient'"'"'s digestive tract. In one application of the invention, an endolumenal bypass sleeve is removably attached in the vicinity of the gastroesophageal junction to treat obesity and/or its comorbidities, such as diabetes. The bypass sleeve may be at least partially deployed by eversion.

Claims

1. An endolumenal gastric bypass system, comprising:

an elongate, flexible filler tube, having a proximal end and a distal end; and

an elongate, flexible gastric bypass sleeve, having a proximal end, a distal end, and a central lumen in fluid communication therebetween and configured for the passage of ingested materials therethrough and configured to deliver the ingested materials from the esophagus to the intestine, bypassing the stomach;

wherein the central lumen is in fluid communication with the filler tube and the proximal end of the bypass sleeve is removably attached with a fluid-tight seal to the distal end of the filler tube.

2. The endolumenal gastric bypass system as in claim 1, wherein the filler tube is at least about 30 cm long.

3. The endolumenal gastric bypass system as in claim 1, wherein the filler tube is at least about 50 cm long.

4. The endolumenal gastric bypass system as in claim 2, wherein the bypass sleeve is at least about 75 cm long.

5. The endolumenal gastric bypass system as in claim 1, wherein the distal end of the bypass sleeve is proximally retracted into the filler tube.

6. The endolumenal gastric bypass system as in claim 5, further comprising a source of inflation media.

7. The endolumenal gastric bypass system as in claim 6, further comprising an attachment cuff, configured for attachment in the vicinity of the squamocolumnar junction.

8. The endolumenal gastric bypass system as in claim 7, wherein the attachment cuff comprises a first connector and the bypass sleeve comprises a second connector for facilitating connection between the bypass sleeve and the cuff.

9. The endolumenal gastric bypass system as in claim 7, wherein the attachment cuff comprises a plurality of apertures configured for receiving tissue anchors therethrough.

10. The endolumenal gastric bypass system as in claim 9, wherein the plurality of apertures are located proximate a proximal end of the attachment cuff.

11. The endolumenal gastric bypass system as in claim 9, further comprising reinforcing structures surrounding each of the plurality of apertures.

12. The endolumenal gastric bypass system as in claim 7, wherein the cuff comprises a compliant and stretchable material configured to accommodate motion of the esophagus and the stomach.

13. An endolumenal gastric bypass system, comprising:

an elongate, flexible filler tube, having a proximal end and a distal end; and

an elongate, flexible gastric bypass sleeve, having a proximal end, a distal end, and a central lumen in fluid communication therebetween and configured for the passage of ingested materials therethrough;

wherein the central lumen is in fluid communication with the filler tube and the proximal end of the bypass sleeve is removably attached with a fluid-tight seal to the distal end of the filler tube,

wherein the distal end of the bypass sleeve is proximally retracted into the filler tube.

14. The endolumenal gastric bypass system as in claim 13, wherein the filler tube is at least about 30 cm long.

15. The endolumenal gastric bypass system as in claim 13, wherein the filler tube is at least about 50 cm long.

16. The endolumenal gastric bypass system as in claim 13, wherein the bypass sleeve is at least about 75 cm long.

17. The endolumenal gastric bypass system as in claim 13, further comprising inflation media.

18. The endolumenal gastric bypass system as in claim 17, further comprising an attachment cuff, configured for attachment in the vicinity of the squamocolumnar junction.

19. The endolumenal gastric bypass system as in claim 18, wherein the attachment cuff comprises a first connector and the bypass sleeve comprises a second connector for facilitating connection between the bypass sleeve and the cuff.

20. The endolumenal gastric bypass system as in claim 18, wherein the attachment cuff comprises a plurality of apertures configured for receiving tissue anchors therethrough.

21. The endolumenal gastric bypass system as in claim 20, wherein the plurality of apertures are located proximate a proximal end of the attachment cuff.

22. The endolumenal gastric bypass system as in claim 20, further comprising reinforcing structures surrounding each of the plurality of apertures.

23. The endolumenal gastric bypass system as in claim 18, wherein the cuff comprises a compliant and stretchable material configured to accommodate motion of the esophagus and the stomach.