Attachment cuff for gastrointestinal implant

• US 8,012,135 B2
• Filed: 05/08/2006
• Issued: 09/06/2011
• Est. Priority Date: 11/01/2002
• Status: Active Grant

• Current Assignee: ValenTx, Inc.
• Original Assignee: ValenTx, Inc.
• Inventors: Dann, Mitchell, Guterman, Lee, Swain, Paul, Butters, Joshua, Kagan, Jonathan
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US11/430,278
• Publication Number:
  US 20070010866A1
• Time in Patent Office: 1,947 Days
• Field of Search: 604/264, 604/263, 604275-279, 604533-284, 604/96.01, 604/164.01, 604/523, 604 9501- 9505, 606/153, 623/23.65, 623/23.6
• US Class Current: 604/263
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• 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 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• 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 hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• 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 2002/044 : Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 5/0076 : preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like

Abstract

The present invention provides devices and methods for attachment of an endolumenal gastrointestinal device, such as an artificial stoma device, a gastrointestinal bypass sleeve or other therapeutic or diagnostic device, within a patient'"'"'s digestive tract. In one application of the invention, an endolumenal bypass sleeve is removeably attached in the vicinity of the gastroesophageal junction to treat obesity and/or its comorbidities, such as diabetes. The bypass sleeve may be at least partially deployed by eversion.

Claims

1. An attachment cuff, for attaching an endolumenal bypass tube within a patient'"'"'s gastrointestinal system, comprising:

a flexible, tubular body, having a proximal end and a distal end, and an axial length between the proximal end and the distal end of from about 0.5 inches to about 2.0 inches, wherein the flexible tubular body provides little or no radial support, the flexible body configured to expand and contract with the expansion and contraction of at least portions of the stomach and the esophagus, the flexible body reducing additional stress on attachment points between the cuff and adjacent tissue, the flexible body having a flow lumen therethrough having a substantially constant diameter from the proximal end of the cuff to the distal end of the cuff so as to not restrict ingested contents through the cuff;

a first plurality of apertures near the proximal end of the tubular body, the first plurality of apertures configured to receive tissue anchor tension elements; and

a coupler near the distal end of the tubular body, the coupler configured to removably receive an attachment element on the endoluminal bypass tube for connection to the endoluminal bypass tube.

2. The attachment cuff of claim 1, wherein the cuff comprises an elastomeric material that provides approximately 150% or more stretch in the radial direction.

3. The attachment cuff of claim 1, further comprising a reinforcing structure around each of the first plurality of apertures, the reinforcing ring reinforcing the first plurality of apertures to maintain proper positioning of the cuff and the endolumenal bypass tube attached to the cuff with respect to the tissue anchor tension elements.

4. The attachment cuff of claim 3, wherein the reinforcing structure comprises a ring.

5. The attachment cuff of claim 4, wherein the reinforcing ring comprises stitching around the perimeter of the apertures.

6. The attachment cuff of claim 1, wherein each of the first plurality of apertures is spaced the same distance apart from the proximal end of the tubular body.

7. The attachment cuff of claim 1, wherein the cuff is permeable to body fluids.

8. The attachment cuff of claim 1, wherein the cuff is substantially impermeable to body fluids.

9. The attachment cuff of claim 1, wherein the cuff has an inside diameter that is less than the inside diameter of the esophagus.

10. The attachment cuff of claim 1, wherein the cuff has an inside diameter that is equal to or greater than the inside diameter of the esophagus.

11. The attachment cuff of claim 3, wherein the reinforcing structure comprises a rib.

12. The attachment cuff of claim 1, wherein the coupler comprises a hook.

13. The attachment cuff of claim 1, wherein the coupler comprises a clip.

14. The attachment cuff of claim 1, wherein the coupler comprises a plurality of coupling elements.