Bariatric sleeve

• US 8,162,871 B2
• Filed: 05/26/2009
• Issued: 04/24/2012
• Est. Priority Date: 12/02/2002
• Status: Expired due to Fees

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Levine, Andy H., Cvinar, John F., Melanson, David A., Meade, John C.
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US12/454,915
• Publication Number:
  US 20090240340A1
• Time in Patent Office: 1,064 Days
• Field of Search: 604/8, 623 2364- 237, 623 113- 115, 623/1.23, 623/1.36, 623/1.37, 606/151, 606/153, 606/213, 606/228
• 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 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 for being removably fastened to a predetermined location within the gastrointestinal tract, the device comprising:

a flexible sleeve, open at both ends, and configured to extend within the intestine;

a radially collapsible sleeve anchor that maintains a cylindrical form in relaxed and collapsed states, the sleeve anchor being coupled to a proximal portion of the sleeve and configured to removably anchor the sleeve within the digestive system at or distal to the pylorus; and

bi-directional barbs extending from the exterior surface of the sleeve anchor, each barb comprising two tines with ends 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 sleeve extends at least about 10 inches.

3. The gastrointestinal implant device of claim 1, wherein the sleeve extends has an extended length greater than 1 foot.

4. The gastrointestinal implant device of claim 1, wherein the sleeve is conformable to collapse in the intestine to a small volume.

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

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

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

8. The gastrointestinal implant device of claim 1, wherein the barbs are configured to anchor the proximal portion of the sleeve to muscle.

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

10. The method of claim 1, wherein anchoring the collapsible sleeve anchor includes using the barbs to anchor the proximal portion of the sleeve to muscle.

11. The method of claim 1, further including:

removing the collapsible sleeve anchor.

12. A method of treatment for removably fastening a gastrointestinal implant device to a predetermined location within the gastrointestinal tract, the method comprising:

providing a flexible sleeve, open at both ends, and configured to extend within the intestine;

removably anchoring a radially collapsible sleeve anchor that maintains a cylindrical form in relaxed and collapsed states, the sleeve anchor being coupled to a proximal portion of the sleeve within the digestive system at or distal to the pylorus, the anchoring using bi-directional barbs extending from the exterior surface of the sleeve anchor, each barb comprising two tines with ends 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.

13. The method of claim 12, wherein the sleeve extends at least about 10 inches.

14. The method of claim 12, wherein the sleeve has an extended length greater than 1 foot.

15. The method of claim 12, wherein the sleeve is conformable to collapse in the intestine to a small volume.

16. The method of claim 12, wherein anchoring the collapsible sleeve anchor includes anchoring the collapsible sleeve anchor distal to the pylorus.

17. The method of claim 12, wherein anchoring the collapsible sleeve anchor includes anchoring the collapsible sleeve anchor within the pyloric orifice.

18. The method of claim 12, wherein each bidirectional barb is formed as a unitary piece.