Apparatus and methods for treatment of morbid obesity

• US 9,839,546 B2
• Filed: 08/02/2016
• Issued: 12/12/2017
• Est. Priority Date: 11/01/2002
• Status: Active Grant

• Current Assignee: ValenTx, Inc.
• Original Assignee: ValenTx, Inc.
• Inventors: Kagan, Jonathan, Dann, Mitchell, Guterman, Lee
• Primary Examiner(s): GRAY, PHILLIP A
• Application Number:
  US15/226,799
• Publication Number:
  US 20170056227A1
• Time in Patent Office: 497 Days
• Field of Search: 604514, 604516, 604500, 604264
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0408 Rivets other bone rivets A61B17/68; rivets for connecting prosthetic parts A61F2002/30433, A61F2220/0041
• CPC Class Codes: A61B 2017/0411 Instruments for removing suture anchors for removing suture clamps, clips or locks A61B2017/049
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0464 for soft tissue
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0083 Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like

Abstract

Apparatus and methods are described for treatment of morbid obesity using minimally invasive techniques. The apparatus includes a system of components that may be used separately or in combination for effectively reducing stomach volume, bypassing a portion of the stomach and/or small intestines, reducing nutrient absorption in the stomach and/or small intestines and/or depositing minimally or undigested food farther than normal into the intestines, thereby stimulating intestinal responses. The components described include an artificial stoma device, a gastric sleeve device, an intestinal sleeve device, a combined gastrointestinal sleeve device and permanent and detachable attachment systems. Also described are devices for delivering and deploying the components of the system.

Claims

1. A method of treating a patient, comprising:

providing a sleeve, having a proximal end, a distal end, and a lumen extending therethrough;

providing a tubular cuff having a proximal end and a distal end, the distal end of the cuff attached to the proximal end of the sleeve;

transesophageally advancing the cuff to position the proximal end of the cuff adjacent an attachment site of a luminal wall in the lower esophagus;

attaching the tubular cuff at the attachment site without creating a serosal to serosal bond, such that the sleeve is configured to deliver food from the lower esophagus into the stomach;

wherein attaching the tubular cuff comprises anchoring at least one tissue anchor having a proximal end and a distal end, said anchoring comprising changing the distal end of the tissue anchor from a transversely reduced configuration used while passing through the muscularis layer of the attachment site to a transversely enlarged configuration used after passing through the attachment site, wherein the distal end of the tissue anchor includes a proximally facing surface which rests against a distally facing surface to retain the tubular cuff, and wherein the enlarged configuration of the tissue anchor is transversely larger than any transverse portion of the tissue anchor when the tissue anchor is passing through the attachment site.

2. A method of treating a patient as in claim 1, wherein the tissue anchor comprises a “

T”

tag.

3. A method of treating a patient as in claim 1, wherein the transversely enlarged configuration is achieved by expanding the anchor after passing through the muscularis tissue.

4. A method of treating a patient as in claim 1, wherein the transversely enlarged configuration is achieved by flexing a portion of the anchor after passing through the muscularis tissue.

5. A method of treating a patient as in claim 1, wherein the cuff and the sleeve do not comprise a valve.

6. A method of treating a patient as in claim 1, wherein the sleeve is porous.

7. A method of treating a patient as in claim 1, wherein the sleeve is nonporous.

8. A method of treating a patient as in claim 1, further comprising positioning the distal end of the sleeve proximate a pylorus of the stomach.

9. A method of treating a patient as in claim 1, further comprising positioning the distal end of the sleeve in an antrum of the stomach.

10. A method of treating a patient as in claim 1, further comprising positioning the distal end of the sleeve in a fundus of the stomach.