Bariatric sleeve

• US 9,155,609 B2
• Filed: 02/21/2012
• Issued: 10/13/2015
• 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:
  US13/401,258
• Publication Number:
  US 20120215152A1
• Time in Patent Office: 1,330 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.13, 623/1.25, 623/1.26, 604/8
• US Class Current: 1/1
• 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 2220/0008 : 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 delivery system for placing a gastrointestinal implant device comprising:

the gastrointestinal implant device including an anchor and a sleeve that extends from the anchor, the sleeve being an unsupported flexible sleeve;

an outer sheath storing the anchor;

an inner shaft within the outer sheath and extending distally beyond the outer sheath;

a sleeve release mechanism that releasably retains the sleeve near a distal end of the inner shaft as the anchor is stored within the outer sheath; and

an anchor release mechanism to release the anchor from the outer sheath.

2. The delivery system of claim 1 further comprising an atraumatic element coupled to a distal tip of the inner shaft.

3. The delivery system of claim 2 wherein the atraumatic element is a spherical ball.

4. The delivery system of claim 1 further comprising a ball coupled to a distal tip of the inner shaft.

5. The delivery system of claim 1 further comprising a retention wire extending through the inner shaft and out of the inner shaft about the sleeve to releasably retain the sleeve on the inner shaft.

6. The delivery system of claim 5 wherein the retention wire extends through the sleeve and back into the inner shaft, and the sleeve is released by pulling the retention wire back from the sleeve.

7. The delivery system of claim 6 wherein the retention wire extends through a first hole in the inner shaft, through the sleeve, and back through a second hole in the inner shaft.

8. The delivery system of claim 5 wherein the retention wire is a snare wire that forms a loop around a portion of the sleeve, and the sleeve is released by pushing the retention wire distally.

9. A delivery system for placing a gastrointestinal implant device comprising:

the gastrointestinal implant device, including an anchor and a sleeve that extends from the anchor, the sleeve being conformable to collapse in the intestine to a small volume, and the sleeve extending at least about 1.5 feet beyond the anchor;

an outer sheath storing the anchor;

an inner shaft within the outer sheath and extending distally beyond the outer sheath;

a sleeve release mechanism that releasably retains a distal end of the sleeve near a distal end of the inner shaft as the anchor is stored within the outer sheath and the sleeve extends from the anchor and from the outer sheath; and

an anchor release mechanism to release the anchor from the outer sheath.

10. The delivery system of claim 9 further comprising an atraumatic element coupled to a distal tip of the inner shaft.

11. The delivery system of claim 10 wherein the atraumatic element is a spherical ball.

12. The delivery system of claim 9 further comprising a ball coupled to a distal tip of the inner shaft.

13. The delivery system of claim 9 further comprising a retention wire extending through the inner shaft and out of the inner shaft about the sleeve to releasably retain the sleeve on the inner shaft.

14. The delivery system of claim 13 wherein the retention wire extends through the sleeve and back into the inner shaft, and the sleeve is released by pulling the retention wire back from the sleeve.

15. The delivery system of claim 14 wherein the retention wire extends through a first hole in the inner shaft, through the sleeve, and back through a second hole in the inner shaft.

16. The delivery system of claim 13 wherein the retention wire is a snare wire that forms a loop around a portion of the sleeve, and the sleeve is released by pushing the retention wire distally.