Bariatric sleeve

• US 7,608,114 B2
• Filed: 12/13/2005
• Issued: 10/27/2009
• Est. Priority Date: 12/02/2002
• Status: Expired due to Fees

• 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:
  US11/302,944
• Publication Number:
  US 20060161265A1
• Time in Patent Office: 1,414 Days
• Field of Search: 623/23.64, 623/23.65, 623/23.68, 623/23.7, 623 113- 116, 623/1.27, 623/1.31, 623/1.35, 623/1.36, 623/1.44, 623/23.66, 606/194
• US Class Current: 623/23.7
• 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 for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0419 H-fasteners
• 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 2/95 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 2220/0008 : 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 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. When implanted within the intestine, the sleeve can limit the absorption of nutrients, delay the mixing of chyme with digestive enzymes, altering hormonal triggers, providing negative feedback, and combinations thereof. The anchor is collapsible for endoscopic delivery and removal.

Claims

1. A gastrointestinal implant device comprising:

a floppy sleeve, open at both ends, and adapted to extend within the intestine, the sleeve being unsupported at a distal end, and being at least one foot in length, the sleeve being noncompliant and having a coefficient of friction less than about 0.2, the sleeve having a wall thickness of less than 0.001 inches and being conformable to collapse in the intestine to a small volume;

a collapsible sleeve anchor coupled to a proximal portion of the sleeve and adapted to anchor the sleeve-at or distal to the pylorus, in the intestine; and

barbs extending from the collapsible sleeve anchor, the barbs being at the proximal end of the anchor, the barbs being bi-directional and having two tines directed in opposite directions from each other and outwardly from the anchor, of which one tine is so oriented at an oblique angle as to prevent longitudinal movement of the device in a first direction and another tine is so oriented at an oblique angle as to prevent longitudinal movement of the device in a second direction substantially opposite to the first direction.

2. The gastrointestinal implant device of claim 1, wherein the collapsible sleeve anchor is adapted to be retained distal to the pylorus.

3. The gastrointestinal implant device of claim 2, wherein the collapsible sleeve anchor is adapted to be retained proximal to the ampulla of Vater.

4. The gastrointestinal implant device of claim 1, wherein the collapsible sleeve anchor is adapted to be retained within the pyloric orifice.

5. The gastrointestinal implant device 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 gastrointestinal implant device of claim 1, wherein each bidirectional barb is formed as a unitary piece.

7. The gastrointestinal implant device of claim 1, wherein the sleeve is adapted to cause enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

8. The gastrointestinal implant device of claim 1, wherein the device is removable.

9. The implant of claim 1, wherein the barbs are adapted to anchor the proximal portion of the sleeve to muscle.

10. A gastrointestinal implant device comprising:

a flexible, floppy sleeve means open at both ends and adapted to extend within the intestine for altering normal digestion along at least that portion of the intestine containing the sleeve, the sleeve being unsupported at a distal end and the sleeve being at least one foot in length, the sleeve being noncompliant and having a coefficient of friction less than about 0.2, the sleeve having a wall thickness of less than 0.001 inches and being conformable to collapse in the intestine to a small volume;

means coupled to a proximal portion of the sleeve for anchoring the sleeve within the digestive system, the means for anchoring being adapted to anchor the sleeve at or distal to the pylorus, in the digestive system; and

barb means extending from the exterior surface of the anchoring means, the barb means being adapted to anchor the proximal portion of the sleeve to muscle, the barb means being bi-directional barbs, the bi-directional barbs comprising two tines directed in opposite directions from each other and outwardly from the anchor, of which one tine is so oriented at an oblique angle as to prevent longitudinal movement of the device in a first direction and another tine is so oriented at an oblique angle as to prevent longitudinal movement of the device in a second direction substantially opposite to the first direction.

11. The gastrointestinal implant device of claim 10, wherein the sleeve means blocks absorption of nutrients.

12. The gastrointestinal implant device of claim 10, wherein the sleeve means delays the mixing of chyme and digestive enzymes.

13. The gastrointestinal implant device of claim 10, wherein the sleeve means blocks hormonal release within the gastrointestinal tract.

14. The gastrointestinal implant of claim 10, wherein the collapsible sleeve anchor is adapted to be retained within the pyloric orifice.

15. The gastrointestinal implant of claim 10, wherein the collapsible sleeve anchor is adapted to anchor the sleeve distal to the pylorus.

16. The gastrointestinal implant device of claim 10, wherein the barbs are adapted to anchor the sleeve to muscle.