Methods of treatment using a bariatric sleeve

• US 8,870,806 B2
• Filed: 05/02/2011
• Issued: 10/28/2014
• Est. Priority Date: 12/02/2002
• Status: Expired due to Fees

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Levine, Andy H., Melanson, David A.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/098,750
• Publication Number:
  US 20110245752A1
• Time in Patent Office: 1,275 Days
• Field of Search: 623/1.11, 623/1.13, 623/1.28, 623/1.29, 623/1.36, 623/23.64, 623/23.65, 623/23.67, 623/23.7, 623/23.68, 623/1.24, 623/1.25, 623/1.26, 623/2.11, 623/2.14, 623/2.18, 604/8, 606/191
• US Class Current: 604/8
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00238 Type of minimally invasive operation A61B2017/00805 takes precedence
• CPC Class Codes: A61B 2017/0084 low friction A61B2017/00853 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0419 H-fasteners
• 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 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• 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 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 : provided on at least one of the ends
• CPC Class Codes: A61F 2002/9528 : for retrieval of stents
• CPC Class Codes: A61F 2210/0076 : multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 5/0076 : preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0089 : Instruments for placement or removal

Abstract

Method and apparatus for limiting absorption of food products in specific parts of the digestive system is presented. A gastrointestinal implant device is anchored in the stomach and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for anchoring the device to the stomach and a flexible sleeve to limit absorption of nutrients in the duodenum. The anchor is collapsible for endoscopic delivery and removal.

Claims

1. A method for placing a gastrointestinal implant device in a body, the method comprising:

introducing a balloon catheter into a proximal opening of the gastrointestinal implant device, the balloon catheter comprising a catheter shaft and a balloon, the gastrointestinal implant device comprising a flexible sleeve and a collapsible sleeve anchor coupled to a proximal end of the flexible sleeve, at least a portion of a distal end of the flexible sleeve being folded inside the flexible sleeve;

inflating the balloon to seal the proximal opening of the gastrointestinal implant device; and

injecting fluid through the catheter shaft into a lumen of the flexible sleeve to push the at least the portion of the distal end of the flexible sleeve distally within an intestinal tract of the body until the flexible sleeve is fully deployed distally within the intestinal tract.

2. A method according to claim 1, wherein a band closes the distal end of the flexible sleeve while the at least the portion of the distal end of the flexible sleeve is folded inside the flexible sleeve, the method further comprising injecting the fluid through the catheter shaft until the band falls off.

3. A method according to claim 1, wherein the at least the portion of the distal end of the flexible sleeve comprises about half of a full length of the flexible sleeve.

4. A method according to claim 1, wherein the gastrointestinal implant device is anchored in the stomach.

5. A method according to claim 1, wherein the gastrointestinal implant device is anchored distal to the pylorus.

6. A method according to claim 1, wherein the gastrointestinal implant device is retained within the pyloric orifice.

7. A method according to claim 1, wherein the method comprises implanting the gastrointestinal implant device without use of a guidewire.

8. A method according to claim 1, wherein the flexible sleeve is floppy.

9. A method according to claim 1, wherein the flexible sleeve is of a length that chyme exiting the stomach funneled through the proximal end of the sleeve exits the sleeve through the distal end below the ligament of Treitz.

10. A method according to claim 1, wherein barbs extend from an exterior surface of the flexible sleeve for anchoring the proximal portion of the sleeve, the barbs being coupled to the collapsible sleeve anchor.

11. A method according to claim 10, wherein the barbs are configured for anchoring the proximal portion of the sleeve to the stomach.

12. A method according to claim 10, wherein the barbs are configured for anchoring the proximal portion of the sleeve distal to the pylorus.

13. A method according to claim 10, wherein the barbs are bi-directional.

14. A method according to claim 13, wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.

15. A method according to claim 10, wherein the barbs are configured to anchor the flexible sleeve to muscle.

16. A method according to claim 1, further comprising inserting the gastrointestinal implant device endoscopically with a delivery catheter prior to introducing the balloon catheter.

17. A method according to claim 16, wherein the delivery catheter includes an outer sheath and an inner sheath disposed therein, the inserting of the gastrointestinal implant device further comprising, prior to introducing the balloon catheter:

storing the collapsible sleeve anchor within the outer sheath and outside of the inner sheath;

securing the flexible sleeve outside of the inner sheath;

guiding through the alimentary canal of the body a ball coupled to a distal end of the delivery catheter;

releasing the flexible sleeve from the inner sheath; and

releasing the collapsible sleeve anchor from the outer sheath and expanding the anchor to anchor the gastrointestinal implant device.

18. A method of delivering a sleeve implant into the intestine comprising:

delivering the sleeve into the intestine with a first end of the sleeve everted into the sleeve, the first end of the sleeve being closed;

deploying the first end of the sleeve out of the sleeve to extend the first end of the sleeve into the intestine; and

anchoring a second end of the sleeve in the gastrointestinal tract.

19. The method of claim 18 wherein the first end of the sleeve is the distal end of the sleeve and the second end of the sleeve is the proximal end of the sleeve, and wherein the distal end of the sleeve is deployed applying fluid pressure to the everted sleeve to push the sleeve distally.

20. The method of claim 19 wherein the sleeve is extended into the intestine after the proximal end of the sleeve is anchored.

21. The method of claim 19 further comprising sealing the distal end of the sleeve prior to applying fluid pressure.

22. The method of claim 21 wherein the distal end of the sleeve is sealed with an elastic band.

23. The method of claim 19 wherein an element seals the end of the sleeve, is released after the sleeve is extended, and then passes through the intestine.

24. The method of claim 23 wherein the element is an elastic band.

25. The method of claim 19 wherein the sleeve implant is anchored in the stomach.

26. The method of claim 19 wherein the sleeve implant is anchored distal to the pylorus.

27. The method of claim 19 wherein the proximal end is anchored with barbs.

28. The method of claim 27 wherein the barbs are bidirectional.

29. The method of claim 27 wherein the barbs are configured to anchor the sleeve implant to muscle.