Apparatus and methods for forming and securing gastrointestinal tissue folds

• US 20050245945A1
• Filed: 11/17/2004
• Published: 11/03/2005
• Est. Priority Date: 06/25/1999
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Brenneman, Rodney, Chen, Eugene, Rothe, Chris, Saadat, Vahid C., Michlitsch, Ken, Ewers, Rich, Lam, Cang
• Granted Patent: US 7,704,264 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. An endoscopic apparatus, comprising:

an elongate endoscopic device having a proximal end, a distal end, and a length therebetween, wherein at least a portion of the length is adapted to lock its configuration;

an end effector positioned at the distal end of the endoscopic device, the end effector having an outer surface and being provided with at least one recess opening onto the outer surface and an internal passageway communicating with the recess whereby when a suction source is coupled to the endoscopic device a suction is created in the recess to draw a portion of tissue wall into the recess; and

a needle slidably disposed in the endoscopic device, the needle being actuatable from a proximal end of the needle for movement from a retracted position in which a distal end of the needle is out of the recess to an extended position in which the distal end of the needle extends into the recess whereby the needle can be extended into the portion of tissue wall drawn into the recess.

2. The apparatus of claim 1 wherein the endoscopic device has a lumen extending from the proximal end to the distal end, the suction source being coupled to the lumen in a vicinity of the proximal end of the endoscopic device.

3. The apparatus of claim 1 wherein the endoscopic device has a lumen extending from the proximal end to the distal end, the needle being slidably disposed in the lumen.

4. The apparatus of claim 1 wherein the endoscopic device is comprised of a plurality of adjacent links.

5. The apparatus of claim 1 wherein the endoscopic device is adapted to have an endoscope advanced through the internal passageway.

6. The apparatus of claim 1 further comprising an endoscopic visualization device adapted to be advanced within the internal passageway.

7. The apparatus of claim 1 wherein the needle is positioned proximally of the recess when in the retracted position.

8. The apparatus of claim 1 further comprising an anchor assembly adapted to be deployed via the needle through the tissue wall drawn into the recess.

9. A method of forming a tissue fold, comprising:

positioning a distal end of an elongate endoscopic device relative to a portion of tissue wall, the endoscopic device having a length adapted to lock its configuration;

drawing tissue into at least one recess opening defined on an outer surface of an end effector positioned at the distal end of the endoscopic device;

advancing a needle slidably disposed in the endoscopic device from a retracted position in which a distal end of the needle is out of the recess to an extended position in which the distal end of the needle extends into the recess; and

securing the portion of tissue wall drawn into the recess.

10. The method of claim 9 wherein positioning a distal end of an elongate endoscopic device comprises advancing the endoscopic device into a stomach of a patient.

11. The method of claim 9 wherein drawing tissue into at least one recess opening comprises pulling the portion of tissue wall into the recess opening via a suction force.

12. The method of claim 9 wherein advancing a needle comprises manipulating a proximal end of the needle such that its distal end is advanced from a position proximal of the recess opening.

13. The method of claim 9 wherein advancing a needle further comprises piercing the portion of tissue wall within the recess opening via the needle.

14. The method of claim 9 wherein securing the portion of tissue wall comprises deploying an anchor assembly against the tissue such that a configuration of the tissue wall is maintained.

15. A tissue suturing system, comprising:

an endoscopic sheath adapted to have a flexible state and a rigid state, a distal portion of the endoscopic sheath defining a side opening and a lumen through which an endoscope is advanceable;

a needle disposed in the endoscopic sheath and adapted to move from a first position to a second position; and

a suction device adapted to create a negative pressure on an interior of the endoscopic sheath to suck tissue through the opening to an interior of the opening.

16. The system of claim 15 further comprising an endoscope for advancement through the endoscopic sheath.

17. The system of claim 16 further comprising at least one tool having an end effector adapted for advancement through the endoscope.

18. The system of claim 15 further comprising an anchor assembly adapted to be deployed into or against the tissue via the needle.

19. The system of claim 15 wherein the lumen extends from a proximal portion to the distal portion and is in fluid communication with the side opening.

20. The system of claim 19 wherein the suction device is fluidly coupled to the lumen at the proximal portion.

21. The system of claim 15 wherein the endoscopic sheath defines a needle lumen extending from a proximal portion to the distal portion, wherein the needle is slidably disposed within the needle lumen.

22. The system of claim 15 wherein the endoscopic sheath is comprised of a plurality of adjacent links.

23. The system of claim 15 further comprising an endoscopic visualization device adapted to be advanced within the lumen.

24. The system of claim 15 wherein the needle is positioned proximally of the side opening when in the first position.

25. The system of claim 24 wherein the needle is positioned within or distally of the side opening when in the second position.

26. A method of manipulating tissue, comprising:

advancing a distal portion of an endoscopic sheath to a tissue region, the endoscopic sheath having a length adapted to have a flexible state and a rigid state;

positioning a side opening defined in the distal portion relative to the tissue region, the side opening being in fluid communication with a lumen defined through the endoscopic sheath;

drawing the tissue region into the side opening; and

piercing the tissue region within the side opening with a needle disposed within the endoscopic sheath.

27. The method of claim 26 wherein advancing a distal portion of an endoscopic sheath comprises advancing the endoscopic sheath into a stomach of a patient.

28. The method of claim 26 further comprising positioning an endoscope within the endoscopic sheath proximal of the side opening prior to piercing the tissue region within the side opening.

29. The method of claim 26 wherein drawing the tissue region comprises pulling the tissue region into the side opening via a suction force.

30. The method of claim 26 wherein piercing the tissue region comprises manipulating a proximal end of the needle such that its distal end is advanced from a position proximal of the side opening.

31. The method of claim 26 further comprising securing the tissue region such that the tissue maintains a folded configuration.

32. The method of claim 31 wherein securing the tissue region comprises deploying an anchor assembly against the tissue such that a configuration of the tissue wall is maintained.