Intestinal sleeve

• US 9,744,061 B2
• Filed: 12/08/2015
• Issued: 08/29/2017
• Est. Priority Date: 12/09/2003
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Meade, John C., Levine, Andy H., Melanson, David A., Cvinar, John F.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/962,610
• Publication Number:
  US 20160089257A1
• Time in Patent Office: 630 Days
• Field of Search: 623 2365- 237
• 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 17/12 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 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
• 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 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics

Abstract

A gastrointestinal implant device is anchored in the duodenum and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for attaching the device to the duodenum and an unsupported flexible sleeve. The anchor can include a stent and/or a wave anchor and is collapsible for catheter-based delivery and removal.

Claims

1. A gastrointestinal implant device comprising:

a flexible sleeve configured to carry chyme from a proximal end of the sleeve to a distal end of the sleeve and adapted to extend into the duodenum; and

a collapsible self-expanding anchor coupled to the proximal end of the sleeve and adapted to be retained entirely within the duodenal bulb, the anchor having a relaxed diameter of at least about 40 millimeters.

2. The gastrointestinal implant device of claim 1, wherein the anchor is attached to the surrounding anatomy with a mechanical fastener.

3. The gastrointestinal implant device of claim 2, wherein the mechanical fastener is a suture.

4. The gastrointestinal implant device of claim 2, wherein the mechanical fastener is a surgical staple.

5. The gastrointestinal implant device of claim 2, wherein the mechanical fastener is a barb.

6. The gastrointestinal implant device of claim 5, wherein the barb is bi-directional.

7. The gastrointestinal implant device of claim 1, wherein the anchor is attached to the surrounding anatomy with a chemical fastener.

8. The gastrointestinal implant device of claim 7, wherein the chemical fastener is a surgical adhesive.

9. The gastrointestinal implant device of claim 1, wherein the sleeve comprises an anti-buckling mechanism extending along a length of the sleeve.

10. The gastrointestinal implant device of claim 1, wherein the sleeve is impregnated with a drug that reduces hunger.

11. The gastrointestinal implant device of claim 10, wherein the drug that reduces hunger is selected from the group consisting of Leptin, Glucagon-Like Peptide-1 (GLP-1), Cholecystokinin (CCK), peptide YY (PYY), insulin, and ghrelin.

12. The gastrointestinal implant device of claim 1, wherein the sleeve is impregnated with a drug that reduces inflammation.

13. The gastrointestinal implant device of claim 12, wherein the drug that reduces inflammation is selected from the group consisting of aminosalicylates, corticosteroids, immune modifiers, and antibiotics.

14. The gastrointestinal implant device of claim 1, wherein a plurality of distal sections of the sleeve are coated to form a plurality of dissolvable pills.

15. The gastrointestinal implant device of claim 14, wherein the dissolvable pills are configured to dissolve at different times.

16. The gastrointestinal implant device of claim 14, wherein the dissolvable pills have a biodegradable coating.

17. The gastrointestinal implant device of claim 16, wherein the biodegradable coating comprises polyethylene glycol.

18. The gastrointestinal implant device of claim 17, wherein the biodegradable coating comprises polylactic acid.

19. The gastrointestinal implant device of claim 17, wherein the biodegradable coating comprises polycaprolactone.