Methods of treatment using a bariatric sleeve

• US 20060161172A1
• Filed: 12/13/2005
• Published: 07/20/2006
• Est. Priority Date: 12/02/2002
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Meade, John C., Levine, Andy H., Cvinar, John F.
• Granted Patent: US 7,695,446 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• 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 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/061 hollow or tubular
• 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 2/95 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 2230/0054 : V-shaped
• 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

Methods of treatment using a gastrointestinal implant device removably anchored within an animal'"'"'s gastrointestinal tract. For example, the implant device includes a collapsible anchor for anchoring the device coupled to a proximal end of a flexible sleeve. The implant device can be anchored within the stomach, within the pyloric orifice, and/or distal to the pylorus and extended into the duodenum. All partially-digested food, or chyme, exiting the stomach is funneled through the device. Methods of treatment include treating obesity by one or more of: limiting the absorption of nutrients within the duodenum; delaying the mixing of chyme with digestive enzymes; alter hormonal triggers; and providing negative feedback. Alternatively or in addition, the desired result includes treating a diseases, such as diabetes, or temporarily shielding a portion of the intestine to promote healing within the intestine.

Claims

1. A method of treating Type-2 diabetes comprising:

anchoring a flexible sleeve open at both ends; and

extending the flexible sleeve into the duodenum.

2. The method of claim 1, wherein the sleeve extends distally through the intestine having an extended length greater than 1 foot.

3. The method of claim 1, further comprising removing the sleeve.

4. A method of treatment comprising the steps of:

securing a collapsible sleeve anchor within the digestive system, the sleeve anchor coupled to a proximal portion of a floppy sleeve, open at both ends; and

extending the floppy sleeve within the intestine.

5. The method of claim 4, wherein the collapsible sleeve anchor is secured distal to the pylorus.

6. The method of claim 5, wherein the collapsible sleeve anchor is secured proximal to the ampulla of Vater.

7. The method of claim 4, 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.

8. The method of claim 4, wherein the step of securing comprises using barbs coupled to the collapsible sleeve anchor.

9. The method of claim 4, wherein the collapsible sleeve anchor is a stent comprising a network of struts.

10. The method of claim 4, wherein the floppy sleeve material has a coefficient of friction of less than 0.2.

11. The method of claim 4, wherein the floppy sleeve material includes a fluoropolymer.

12. The method of claim 4, wherein the floppy sleeve material includes a combination of ePTFE and FEP.

13. The method of claim 4, wherein the floppy sleeve is removable.

14. A method of treatment comprising:

placing in the gastrointestinal tract of a subject a floppy sleeve, the sleeve coupled to at least one barb; and

positioning the sleeve so as to alter normal digestion along in at least a portion of the gastrointestinal tract.

15. The method of claim 14, wherein the positioned sleeve blocks absorption of nutrients.

16. The method of claim 14, wherein the positioned sleeve delays the mixing of chyme and digestive enzymes.

17. The method of claim 14, wherein the positioned sleeve blocks hormonal release within the gastrointestinal tract.

18. The method of claim 14, wherein the barb is bi-directional.

19. A method of treating or preventing a disease or medical condition comprising:

placing within the duodenum of a subject the proximal end of a floppy sleeve; and

extending the sleeve within the duodenum.

20. The method of claim 19, further comprising removing the sleeve.

21. The method of claim 20, wherein the sleeve is removed after obtaining a desired result.

22. The method of claim 21, wherein the desired result is weight loss.

23. The method of claim 19, wherein the sleeve extends distally through the intestine having an extended length greater than 1 foot.

24. A method of placing a device within the gastrointestinal tract of a subject comprising:

placing in the duodenum of a subject the proximal end of a floppy sleeve; and

positioning the sleeve so as to alter normal digestion along in at least a portion of the gastrointestinal tract.

25. The method of claim 24, wherein the positioned sleeve blocks absorption of nutrients.

26. The method of claim 24, wherein the positioned sleeve delays the mixing of chyme with digestive enzymes.

27. The method of claim 24, wherein the positioned sleeve blocks hormonal release within the gastrointestinal tract.