Devices and methods for endolumenal gastrointestinal bypass

• US 7,837,669 B2
• Filed: 04/07/2006
• Issued: 11/23/2010
• 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:
  US11/400,724
• Publication Number:
  US 20070010794A1
• Time in Patent Office: 1,691 Days
• Field of Search: 604/283, 604500-522, 604275-279, 604/96.01, 604/164.01, 604/523
• US Class Current: 604/514
• 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. A method of treating a patient, comprising the steps of:

providing a gastrointestinal sleeve device having an elongate tubular body, with a first end, a fold point where the sleeve inverts proximally within itself, and a second end;

positioning the gastrointestinal sleeve device in the patient'"'"'s digestive tract such that the second end is positioned proximally to the fold point and within the sleeve;

everting the sleeve distally to position the second end distal to the pylorus so that the second end advances distally past the fold point, removing the fold;

positioning the first end at the gastroesophageal junction to receive ingested material from the patient'"'"'s esophagus; and

securing the first end at the gastroesophageal junction.

2. A method of treating a patient as in claim 1, wherein the securing step comprises advancing at least four tissue anchors through a tissue wall and positioning a retention surface on each tissue anchor in contact with a serosal surface of the tissue wall.

3. A method of treating a patient as in claim 2, wherein the tissue anchor comprises a connecting element for connecting the retention surface to the sleeve device, and the length of the connecting element is at least about 75% of the uncompressed tissue wall thickness.

4. A method of treating a patient as in claim 3, wherein the length of the connecting element is at least about 95% of the uncompressed tissue wall thickness.

5. A method of treating a patient as in claim 3, wherein the length of the connecting element is at least about 125% of the uncompressed tissue wall thickness.

6. A method of treating a patient as in claim 1, wherein the tubular body is impermeable such that the tubular body acts as an internal intestinal bypass.

7. A method of treating a patient as in claim 1, wherein the providing step comprises providing the tubular body with a stoma in the vicinity of the first end.

8. A method of treating a patient as in claim 1, wherein the everting step comprises everting the tubular body such that the second end is positioned at least as far as the patient'"'"'s jejunum.

9. A method of treating a patient as in claim 1, wherein the everting step comprises everting the tubular body such that the second end is positioned at least about 100 cm past the pylorus.

10. A method of treating a patient as in claim 1, wherein the providing step comprises providing a sleeve having a substantially constant diameter throughout its length.

11. A method of treating a patient as in claim 1, wherein the providing step comprises providing a sleeve having a funnel-shaped entry on the proximal end.

12. A method of treating a patient as in claim 1, wherein everting the sleeve distally to position the second end distal to the pylorus comprises positioning the second end into the duodenum.

13. A method of treating a patient as in claim 1, wherein everting the sleeve distally to position the second end distal to the pylorus comprises positioning the second end into the jejunum.

14. A method of treating a patient as in claim 1, wherein everting the sleeve distally to position the second end distal to the pylorus comprises positioning the second end into the ileum.

15. A method of treating a patient as in claim 1, wherein the securing step comprises securing the first end of the sleeve to a cuff.

16. A method of treating a patient as in claim 15, comprising the steps of first inserting the cuff, and second advancing the distal end of the sleeve through the cuff.

17. A method of treating a patient as in claim 15, wherein the sleeve is removably secured to the cuff.

18. A method of treating a patient as in claim 1, wherein a pull line is releasably secured to the distal end of the sleeve.

19. A method of treating a patient as in claim 18, further comprising temporarily occluding the distal end of the sleeve during deployment of the sleeve.