Methods of treatment using a bariatric sleeve

• US 7,935,073 B2
• Filed: 10/29/2007
• Issued: 05/03/2011
• Est. Priority Date: 12/02/2002
• Status: Expired due to Fees

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Cvinar, John, Levine, Andy H.
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US11/978,327
• Publication Number:
  US 20080103604A1
• Time in Patent Office: 1,282 Days
• Field of Search: 623/23.64, 623/23.65, 623/23.66, 623/23.7, 623/1.15, 623/1.16, 623/1.11, 623/1.17, 604/8
• 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 of treating type 2 diabetes comprising:

anchoring a flexible sleeve within a non-obese diabetic patient, the sleeve being open at both ends; and

extending the flexible sleeve into the duodenum, thereby having a therapeutic effect on diabetes.

2. The method of claim 1, wherein the flexible sleeve is anchored in the stomach.

3. The method of claim 1, wherein the flexible sleeve is anchored distal to the pylorus.

4. The method of claim 1, wherein the flexible sleeve is floppy.

5. The method of claim 1, wherein the 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.

6. The method of claim 1, wherein the sleeve is coated with silicone.

7. The method of claim 1, wherein the sleeve is coated with polyurethane.

8. The method of claim 1, wherein the sleeve is formed of polyethylene.

9. The method of claim 1, wherein the distal end of the sleeve is directionally textured.

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

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

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

13. The method of claim 10, wherein the barbs are bi-directional.

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

15. The method of treatment of claim 10, wherein a first plurality of barbs are oriented in a proximal direction and a second plurality of barbs are oriented in a distal direction.

16. The method of claim 10, wherein the barbs are configured to anchor the flexible sleeve to muscle.

17. The method of claim 1, wherein the sleeve causes enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

18. The method of claim 1, comprising inserting the flexible sleeve endoscopically with a catheter.

19. The method of claim 1, wherein the flexible sleeve is configured to be removed endoscopically with a removal device.

20. The method of treatment of claim 1, wherein the sleeve has a coefficient of friction of less than 0.2.

21. The method of claim 1, wherein the method results in complete reversal of Type-2 Diabetes.