Attachment system for transmural attachment at the gastroesophageal junction

• US 7,892,214 B2
• Filed: 05/09/2006
• Issued: 02/22/2011
• 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:
  US11/430,677
• Publication Number:
  US 20060206063A1
• Time in Patent Office: 1,750 Days
• Field of Search: 604/96.01, 604/164.01, 604233-284, 604523-525, 623 11- 12, 623/2, 623/23.64, 606/151, 606/108, 606/153, 606/154, 606/215
• US Class Current: 604/264
• 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 5/0036 : Intragastrical devices
• 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 endoluminal gastrointestinal device, such as an artificial stoma device, a gastrointestinal bypass sleeve device or an attachment cuff, within a patient'"'"'s digestive tract for treatment of obesity.

Claims

1. An attachment system for attaching a device to the mucosal side of a wall of the gastrointestinal tract, the wall comprising a muscularis layer and a serosal layer, the system comprising:

a gastrointestinal attachment cuff having a tubular body, a proximal end and a distal end;

at least one tissue anchor for transmural attachment of the cuff to the mucosal side, the anchor comprising a tension element having a proximal end and a distal end for extending through the wall and at least one transverse retention surface configured for positioning in contact with serosal tissue, wherein the retention surface is attached near the distal end of the tension element, wherein the retention surface is transformable from a first, transversely reduced profile to a second, transversely enlarged profile;

a gastric bypass tube for connection to the cuff, the bypass tube having a length of at least about 50 cm; and

a first coupler on the attachment cuff configured for removably coupling to a second, complementary coupler on the gastric bypass tube.

2. An attachment system as in claim 1, wherein the tension element comprises suture.

3. An attachment system as in claim 1, wherein the tension element comprises a proximal end for extending through the mucosal layer and a distal end for carrying the transverse retention surface, wherein the transverse retention surface comprises a proximal surface of a serosal anchor.

4. An attachment system as in claim 3, wherein the serosal anchor comprises a T-tag.

5. An attachment system as in claim 3, wherein the serosal anchor comprises a disc.

6. An attachment system as in claim 3, wherein the serosal anchor is inflatable.

7. An attachment system as in claim 3, wherein the tension element has a length between the cuff and the transverse retention surface, and the length is from about 2 mm to about 6 mm.

8. An attachment system as in claim 3, wherein the tension element has a length between the cuff and the transverse retention surface, and the length is at least about 10 mm.

9. An attachment system as in claim 1, comprising at least six tissue anchors.

10. An attachment system as in claim 1, comprising at least ten tissue anchors.

11. An attachment system as in claim 1, wherein the tension element comprises a first material and the transverse retention surface comprises a second, different material.

12. An attachment system as in claim 1, wherein the at least one transverse retention surface comprises a first transverse retention surface extending in a first generally transverse direction with respect to a longitudinal axis of the tension element and a second transverse retention surface extending in a second generally transverse direction with respect to the longitudinal axis of the tension element after passing transmurally through the wall.

13. An attachment system as in claim 1, wherein the cuff comprises a lumen for passage of ingested contents therethrough, wherein the lumen has a diameter at the proximal end of the cuff that is substantially similar to a luminal diameter at the distal end of the cuff.

14. An attachment system as in claim 1, wherein the tension element is flexible.

15. An attachment system as in claim 1, wherein the first coupler comprises a retention surface of the cuff and the second coupler comprises a retention surface of the bypass tube.

16. An attachment system as in claim 15, wherein the retention surface of the cuff is a radially inwardly-extending surface and the retention surface of the bypass tube is a radially outwardly-extending surface.

17. An attachment system as in claim 16, wherein the inwardly-extending surface is an inwardly-extending lip.

18. An attachment system as in claim 1, wherein the first coupler interlocks with the second coupler with an overlapping interference fit.

19. An attachment system as in claim 1, wherein at least one of the first coupler and the second coupler comprises a hook.

20. An attachment system as in claim 1, wherein the first coupler forms a friction fit with the second coupler.