Methods of treatment using a bariatric sleeve

• US 7,695,446 B2
• Filed: 12/13/2005
• Issued: 04/13/2010
• 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.
• Primary Examiner(s): Stewart; Alvin J
• Application Number:
  US11/302,946
• Publication Number:
  US 20060161172A1
• Time in Patent Office: 1,582 Days
• Field of Search: 623/23.64, 623/23.65, 623/23.68, 623/23.66, 623/23.67, 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 2017/00867 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 obesity, diabetes or a gastrointestinal condition comprising the steps of:

with a delivery system, delivering an implant within the digestive system, the implant having a collapsible sleeve anchor coupled to a proximal portion of a floppy, flexible sleeve, open at both ends, the sleeve defining a lumen between the two ends and made of a thin and conformable material so that it collapses in the intestine;

positioning the floppy sleeve within the intestine with an extension of the delivery system extending beyond the anchor;

securing the sleeve anchor within the digestive system while the flexible sleeve is unsupported at the distal end; and

withdrawing the extension of the delivery system from the digestive system through the lumen of the floppy sleeve, leaving the floppy sleeve in the digestive system.

2. The method of claim 1, wherein the collapsible sleeve anchor is secured distal to the pylorus.

3. The method of claim 2, wherein the collapsible sleeve anchor is secured proximal to the ampulla of Vater.

4. 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.

5. The method of claim 1, wherein the step of securing comprises using barbs coupled to the collapsible sleeve anchor, the barbs fixed to and extending outwardly from the anchor.

6. The method of claim 1, wherein the collapsible sleeve anchor is a stent comprising a network of struts.

7. The method of claim 1, wherein the floppy sleeve material has a coefficient of friction of less than 0.2.

8. The method of claim 1, wherein the floppy sleeve material includes a fluoropolymer.

9. The method of claim 1, wherein the floppy sleeve is removable.

10. The method of claim 1, wherein the extension is an inner catheter.

11. The method of claim 1, wherein the anchor is within an outer catheter.

12. A method of treating obesity, diabetes or a gastrointestinal condition comprising:

placing in the gastrointestinal tract of a subject an implant within the digestive system, the implant having an anchor coupled to a proximal portion of a flexible, floppy sleeve, the open at both ends, the sleeve defining a lumen between the two ends, anchor comprising at least one barb fixed thereto and extending outwardly therefrom to anchor the proximal portion of the sleeve, the barb being fixed to the anchor prior to placing the anchor in the gastrointestinal tract;

positioning the flexible, floppy sleeve within the intestine, a distal portion of the flexible, floppy sleeve extending beyond the anchor and being unsupported, thin, and conformable so that it collapses in the intestine to a small volume;

anchoring the flexible, floppy sleeve by securing the anchor distal to or within the pylorus so as to alter normal digestion along at least a portion of the gastrointestinal tract and withdrawing an extension of the delivery system from the digestive system through the lumen of the floppy sleeve.

13. The method of claim 12, wherein the positioned sleeve blocks absorption of nutrients.

14. The method of claim 12, wherein the positioned sleeve delays the mixing of chyme and digestive enzymes.

15. The method of claim 12, wherein the positioned sleeve blocks hormonal release within the gastrointestinal tract.

16. The method of claim 12, wherein the barb is bi-directional.

17. The method of claim 12, wherein the collapsible sleeve anchor is secured distal to the pylorus.

18. The method of claim 12, wherein the floppy sleeve material has a coefficient of friction of less than 0.2.

19. The method of claim 12, wherein the floppy sleeve material includes a fluoropolymer.