Apparatus and methods for forming and securing gastrointestinal tissue folds

• US 20040225305A1
• Filed: 12/12/2003
• Published: 11/11/2004
• Est. Priority Date: 06/25/1999
• Status: Active Grant

• Current Assignee: USGI Medical, Inc., USGI Medical Incorporated
• Original Assignee: USGI Medical Incorporated
• Inventors: Brenneman, Rodney, Chen, Eugene, Rothe, Chris, Saadat, Vahid C., Michlitsch, Ken, Ewers, Rich, Lam, Cang
• Granted Patent: US 7,744,613 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/0055 Constructional details of insertion parts, e.g. vertebral elements
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/2736 Gastroscopes
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• 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 17/0218 for minimally invasive surgery A61B17/0281, 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 17/0469 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 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• 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 17/062 Needle manipulators
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/295 combined with cutting implements
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00269 : endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/003 : Steerable
• CPC Class Codes: A61B 2017/00353 : one mechanical instrument performing multiple functions, e.g. cutting and grasping channel for multiple instruments A61B2017/3445; instrument channel A61B2017/22072; replaceable heads A61B2017/2931; suction A61M1/00
• CPC Class Codes: A61B 2017/00827 : Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0404 : Buttons
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• 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 2017/0451 : Cams or wedges holding the suture by friction
• 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 2017/0461 : with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• 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 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61B 2017/2905 : flexible
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2943 : Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/3445 : used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like

Abstract

Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies; as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites; are also provided.

Claims

1. Apparatus for endoscopically forming, approximating and securing a plurality of tissue folds within a patient, the apparatus comprising:

a device adapted to endoscopically form the plurality of tissue folds;

means for approximating the plurality of tissue folds;

at least one anchor assembly; and

an anchor delivery system configured to endoscopically deploy the at least one anchor assembly across the plurality of tissue folds to secure the plurality of tissue folds.

2. The apparatus of claim 1, wherein the anchor delivery system comprises a flexible delivery catheter.

3. The apparatus of claim 2, wherein the flexible delivery catheter is configured to buckle into transverse alignment with at least one of the plurality of tissue folds.

4. The apparatus of claim 2, wherein the anchor delivery system further comprises a needle configured for advancement through the flexible delivery catheter and for transverse passage through the plurality of tissue folds.

5. The apparatus of claim 4, wherein the anchor assembly is configured for delivery through the needle.

6. The apparatus of claim 1, wherein the device comprises a tissue engaging assembly configured to engage a mucosal layer of a patient'"'"'s stomach.

7. The apparatus of claim 1, wherein the device comprises a tissue engaging assembly configured to engage a muscularis layer of a patient'"'"'s stomach.

8. The apparatus of claim 1, wherein the devices comprises a tissue engaging assembly configured to engage a serosal layer of a patient'"'"'s stomach.

9. The apparatus of claim 1, wherein the plurality of tissue folds comprise serosa-to-serosa tissue contact and the anchor assembly is adapted to secure the serosa-to-serosa tissue contact.

10. The apparatus of claim 1 wherein the device further comprises a shape-lockable guide tube.

11. A method of endoscopically forming, approximating and securing a plurality of tissue folds within a patient, the method comprising:

endoscopically forming a first tissue fold;

placing a first anchor across the first tissue fold;

endoscopically forming at least one additional tissue fold, thereby forming the plurality of tissue folds;

placing at least one additional anchor across the at least one additional tissue fold;

approximating the plurality of tissue folds; and

securing the approximated plurality of tissue folds with the anchors.

12. The method of claim 11, wherein the first tissue fold and the at least one additional tissue fold are not attached to one another.

13. The method of claim 11, wherein the first tissue fold is formed from an anterior segment of the patient'"'"'s stomach and at least one additional tissue fold is formed from a posterior segment of the patient'"'"'s stomach opposite the anterior segment.

14. The method of claim 11, wherein the first tissue fold and the at least one additional tissue fold are disposed inferior to a patient'"'"'s gastroesophageal junction.

15. A method of performing gastric reduction procedure comprising:

endoscopically forming, approximating and securing a first plurality of tissue folds in a first plane within a patient'"'"'s stomach; and

endoscopically forming, approximating and securing at least one additional plurality of tissue folds in at least one additional plane within the patient'"'"'s stomach.

16. The method of claim 15, wherein the first plane and the at least one additional plane are substantially parallel to one another.

17. The method of claim 15, wherein the first plurality of tissue folds and the at least one additional plurality of tissue folds are not attached to one another.

18. The method of claim 15, wherein the first plurality of tissue folds and the at least one additional plurality of tissue folds each comprise at least one tissue fold from an anterior segment of the patient'"'"'s stomach and at least one tissue fold from an opposing posterior segment of the patient'"'"'s stomach.

19. The method of claim 15, wherein the first plurality of tissue folds and the at least one additional plurality of tissue folds are disposed inferior to the patient'"'"'s gastroesophageal junction.