Apparatus and methods for forming and securing gastrointestinal tissue folds

• US 20040162568A1
• Filed: 12/12/2003
• Published: 08/19/2004
• Est. Priority Date: 06/25/1999
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical Incorporated
• Inventors: Brenneman, Rodney, Chen, Eugene, Rothe, Chris, Saadat, Vahid C., Lam, Cang, Ewers, Rich C., Michlitsch, Kenneth Jerome
• Granted Patent: US 8,574,243 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• 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
• 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
• 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
• CPC Class Codes: A61B 2017/061 : hollow or tubular
• 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
• 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 forming a tissue fold in a tissue wall of a patient'"'"'s hollow body cavity, the apparatus comprising:

a catheter having a flexible tube with a distal region configured for insertion into the cavity;

a tissue engaging assembly disposed on the distal region, the tissue engaging assembly defining a first tissue contact point;

a second tissue contact point disposed at a location initially proximal of, or in line with, the first tissue contact point; and

means for moving the first tissue contact point to a position proximal of the second tissue contact point to form the tissue fold.

2. The apparatus of claim 1 further comprising a third tissue contact point disposed at a location initially proximal of, or in line with, the first tissue contact point, wherein the means for moving moves the first tissue contact point to a position proximal of the third tissue contact point to form the tissue fold, so that the second and third tissue contact points are disposed on opposing sides of the tissue fold.

4. The apparatus of claim 1 further comprising an anchor delivery system adapted to deliver and secure the tissue fold with an anchor assembly.

5. The apparatus of claim 4, wherein the anchor delivery system comprises a flexible delivery catheter adapted for insertion into the cavity.

6. The apparatus of claim 5, wherein the flexible delivery catheter is configured to buckle into transverse alignment with the tissue fold.

7. The apparatus of claim 6, wherein the anchor delivery system further comprises a needle configured for advancement through the flexible delivery catheter and for transverse passage through the tissue fold.

8. The apparatus of claim 7, wherein the anchor assembly is configured for delivery through the needle.

9. The apparatus of claim 1, wherein the tissue engaging assembly is configured to engage mucosa, thereby defining the first tissue contact point.

10. The apparatus of claim 1, wherein the tissue engaging assembly is configured to engage muscularis, thereby defining the first tissue contact point.

11. The apparatus of claim 1, wherein the tissue engaging assembly is configured to engage serosa, thereby defining the first tissue contact point.

12. The apparatus of claim 4, wherein the tissue fold comprises serosa-to-serosa tissue contact and the anchor assembly is adapted to secure the serosa-to-serosa tissue contact.

13. The apparatus of claim 1 further comprising a shape-lockable guide tube.

3. The apparatus of claim 3, wherein the means for moving linearly displaces the first tissue contact point relative to the second and third tissue contact points.

14. A method of forming a tissue fold in a tissue wall of a patient'"'"'s hollow body cavity, the method comprising:

endoscopically engaging the tissue wall at a first tissue contact point;

endoscopically contacting the tissue wall at a second tissue contact point; and

moving the first tissue contact point from a position initially distal to, or in line with, the second tissue contact point to a position proximal of the second tissue contact point, thereby forming the tissue fold.

15. The method of claim 14 wherein moving the first tissue contact comprises linearly displacing the first tissue contact point relative to the second tissue contact point.

16. The method of claim 14 further comprising:

endoscopically contacting the tissue wall at a third tissue contact point; and

moving the first tissue contact point from a position initially distal to, or in line with, the third tissue contact point to a position proximal of the second and third tissue contact points, so that the second and third tissue contact points are disposed on opposing sides of the fold.

17. The method of claim 14 wherein the tissue fold comprises a serosa-to-serosa tissue fold, the method further securing the serosa-to-serosa tissue fold.

18. The method of claim 17, wherein securing the serosa-to-serosa tissue fold further comprises placing a needle transversely across the tissue fold.

19. The method of claim 18, wherein securing the serosa-to-serosa tissue fold further comprises deploying an anchor assembly from within the needle.

20. The method of claim 19, wherein placing a needle transversely across the tissue fold further comprises:

advancing the needle through a delivery catheter; and

buckling the delivery catheter into transverse alignment with the tissue fold.

21. A method for endoscopically performing gastric reduction, the method comprising:

endoscopically engaging a tissue wall within a patient'"'"'s stomach at a first tissue contact point;

endoscopically contacting the tissue wall at a second tissue contact point;

moving the first tissue contact point from a position initially distal to, or in line with, the second tissue contact point to a position proximal of the second tissue contact point, thereby forming a first tissue fold; and

forming at least one additional tissue fold within the stomach.

22. The method of claim 21 wherein the first tissue fold comprises a serosa-to-serosa tissue fold, the method further securing the serosa-to-serosa tissue fold.

23. The method of claim 22, wherein securing the serosa-to-serosa tissue fold further comprises placing a needle transversely across the first tissue fold.

24. The method of claim 23, wherein securing the serosa-to-serosa tissue fold further comprises deploying an anchor assembly from within the needle.

25. The method of claim 23, wherein placing a needle transversely across the first tissue fold further comprises:

advancing the needle through a delivery catheter; and

buckling the delivery catheter into transverse alignment with the first tissue fold.

26. Apparatus for performing a medical procedure within a hollow body organ of tortuous or unpredictably supported anatomy, the apparatus comprising:

an overtube having a flexible state that facilitates insertion of the overtube into the hollow body organ, and a rigid state wherein the overtube resists bending forces exerted on the overtube; and

a mechanism selectively operable to reversibly transition the overtube between the flexible and rigid states,

wherein at least a portion of the overtube is configured to be manipulated from outside the hollow body organ.

27. The apparatus of claim 26, wherein at least one section of the overtube is adapted to remain in the flexible state upon transition of the overtube to the rigid state.

28. The apparatus of claim 26, wherein at least one section of the overtube comprises varied rigidity relative to a different section of the overtube when the overtube is disposed in the rigid state.

29. The apparatus of claim 26, wherein at least one section of the overtube comprises varied flexibility relative to a different section of the overtube when the overtube is disposed in the flexible state.

30. The apparatus of claim 26, wherein at least one section of the overtube comprises is steerable.