Apparatus and methods for forming and securing gastrointestinal tissue folds

• US 20050075653A1
• Filed: 11/18/2004
• Published: 04/07/2005
• Est. Priority Date: 06/25/1999
• Status: Abandoned Application

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Ewers, Rich C., Michlitsch, Kenneth Jerome, Brenneman, Rodney, Chen, Eugene, Rothe, Chris, Saadat, Vahid C., Lam, Cang
• Application Number:
  US10/994,101
• Publication Number:
  US 20050075653A1
• 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 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 system for suturing tissue, comprising:

a needle adapted to suture an area of tissue, the needle being removable from a distal end of an endoscopic device;

an urging mechanism adapted to move the needle from a deployment configuration to a suturing configuration in which the needle is angled relative to the endoscopic device; and

wherein the needle defines at least one opening through which a suture is passed from a first side of tissue to a second side of tissue.

2. The system of claim 1 wherein the needle defines a lumen with the at least one opening defined near or at a distal end of the needle.

3. The system of claim 1 wherein the needle defines a slot along a length of the needle.

4. The system of claim 1 further comprising an anchor assembly removably disposed within the needle.

5. The system of claim 1 wherein the suture is disposed within the needle.

6. The system of claim 1 wherein the urging mechanism comprises a flexible delivery tube through which the needle is movable, the flexible delivery tube having a bendable section adapted to angle the needle relative to the endoscopic device.

7. The system of claim 1 wherein the urging mechanism further comprises an elongate pusher adapted to slide through the needle.

8. The system of claim 1 wherein the urging mechanism is adapted to move the needle from the deployment configuration where the needle is parallel with the endoscopic device to the suturing configuration where the needle is perpendicularly angled relative to the endoscopic device.

9. An endoscopic system for suturing tissue, comprising:

a needle adapted to travel a curved path to suture an area of tissue, the needle being removable from a distal end of an endoscopic device;

a transmission mechanism adapted to move the needle from a deployment configuration to a curved suturing configuration in which the needle is angled relative to the endoscopic device; and

wherein the needle defines at least one opening through which a suture is passed from a first side of tissue to a second side of tissue.

10. The system of claim 9 wherein the needle defines a lumen with the at least one opening defined near or at a distal end of the needle.

11. The system of claim 9 wherein the needle defines a slot along a length of the needle.

12. The system of claim 9 further comprising an anchor assembly removably disposed within the needle.

13. The system of claim 9 wherein the suture is disposed within the needle.

14. The system of claim 9 wherein the urging mechanism comprises a flexible delivery tube through which the needle is movable, the flexible delivery tube having a bendable section adapted to angle the needle relative to the endoscopic device.

15. The system of claim 9 wherein the urging mechanism further comprises an elongate pusher adapted to slide through the needle.

16. The system of claim 9 wherein the urging mechanism is adapted to move the needle from the deployment configuration where the needle is parallel with the endoscopic device to the suturing configuration where the needle is perpendicularly angled relative to the endoscopic device.

17. A method of suturing tissue within a hollow body organ, comprising:

positioning an endoscopic device relative to a tissue region within the hollow body organ;

piercing the tissue whereby a needle assembly travels a curved path through a flexible tubular member, the needle assembly being removable from a distal end of the endoscopic device; and

passing a length of suture through the tissue via a needle body at a distal end of the needle assembly, the needle body defining at least one opening through which the suture is passed through the tissue.

18. The method of claim 17 wherein positioning an endoscopic device comprises passing the endoscopic device through an esophagus and into a stomach of a patient.

19. The method of claim 17 wherein positioning an endoscopic device comprises positioning the distal end of the endoscopic device adjacent to the tissue region.

20. The method of claim 17 further comprising moving the needle assembly from a deployment configuration to a curved suturing configuration in which the needle assembly is angled relative to the endoscopic device prior to piercing the tissue.

21. The method of claim 17 further comprising grasping the tissue via a grasper extending from the distal end of the endoscopic device prior to piercing the tissue.

22. The method of claim 17 wherein piercing the tissue comprises passing the needle assembly into or through the tissue.

23. The method of claim 17 wherein passing a length of suture comprises delivering the suture within the needle assembly for deployment through the at least one opening.

24. The method of claim 17 further comprising deploying the length of suture from the at least one opening.

25. The method of claim 17, further comprising securing the tissue via the length of suture deployed from the needle assembly.

26. An endoscopic treatment apparatus, comprising:

an endoscopic device having a proximal end, a distal end, and a flexible length therebetween;

a needle assembly which is adapted to travel a curved path to suture an area of tissue, the needle assembly being actuatable from the proximal end of the endoscopic device to direct the needle assembly to the curved path; and

a tissue stabilizing member projecting pivotally and translationally from the distal end of the endoscopic device, the stabilizing member being adapted to hold onto the tissue when the tissue is pierced by the needle assembly.

27. The apparatus of claim 26 further comprising a tissue anchoring assembly deployable from the needle assembly.

28. The apparatus of claim 27 wherein the tissue anchoring assembly is adapted to be disposed within the needle assembly.

29. The apparatus of claim 26 wherein the needle assembly comprises a needle body which defines at least one opening therein.

30. The apparatus of claim 29 wherein the needle body defines a slot along a length thereof.

31. The apparatus of claim 26 further comprising a length of suture disposed within the needle assembly.

32. The apparatus of claim 26 further comprising an urging mechanism adapted to move the needle assembly from a deployment configuration to a suturing configuration in which the needle is angled relative to the endoscopic device.

33. The apparatus of claim 32 wherein the urging mechanism comprises a flexible delivery tube through which the needle assembly is movable, the flexible delivery tube having a bendable section adapted to angle the needle assembly relative to the endoscopic device.

34. The apparatus of claim 26 further comprising a transmission mechanism adapted to move the needle assembly from a deployment configuration to a curved suturing configuration in which the needle assembly is angled relative to the endoscopic device.

35. The apparatus of claim 26 wherein the tissue stabilizing member comprises a tissue grasper.

36. The apparatus of claim 26 wherein the tissue stabilizing member is adapted to pivotally angle relative to the endoscopic device.

37. The apparatus of claim 26 wherein the tissue stabilizing member is adapted to pivot when translated proximally relative to the endoscopic device.

38. A system for endoscopic treatment of tissue, comprising:

an endoscopic device having a proximal end, a distal end, and a flexible length therebetween;

a needle assembly which is adapted to suture an area of tissue, the needle assembly being actuatable from the proximal end of the endoscopic device to direct the needle assembly over a curved path;

a tissue stabilizing member projecting pivotally and translationally from the distal end of the endoscopic device, the stabilizing member being adapted to stabilize the tissue when the tissue is pierced by the needle assembly; and

a tissue anchoring assembly adapted to be deployed from the needle assembly for securing the tissue.

39. The system of claim 38 wherein the needle assembly comprises a needle body which defines at least one opening therein.

40. The system of claim 39 wherein the needle body defines a slot along a length thereof.

41. The system of claim 38 wherein the tissue stabilizing member comprises a tissue grasper.

42. The system of claim 38 wherein the tissue stabilizing member is adapted to pivotally angle relative to the endoscopic device.

43. The system of claim 38 wherein the tissue stabilizing member is adapted to pivot when translated proximally relative to the endoscopic device.

44. The system of claim 38 further comprising an urging mechanism adapted to move the needle assembly from a deployment configuration to a suturing configuration in which the needle assembly is angled relative to the endoscopic device.

45. The system of claim 44 wherein the urging mechanism comprises a flexible delivery tube through which the needle assembly is movable, the flexible delivery tube having a bendable section adapted to angle the needle assembly relative to the endoscopic device.

46. The system of claim 38 further comprising a transmission mechanism adapted to move the needle assembly from a deployment configuration to a curved suturing configuration in which the needle assembly is angled relative to the endoscopic device.

47. The system of claim 38 wherein the tissue anchor assembly comprises a length of suture disposed within the needle assembly.

48. A method of endoscopically treating tissue within a hollow body organ, comprising:

positioning a distal end of an endoscopic device relative to a region of tissue within the hollow body organ;

stabilizing the tissue via a stabilizing member projecting pivotally and translationally from the distal end of the endoscopic device;

piercing the tissue with a needle assembly which is adapted to suture the tissue by actuating the needle assembly from a proximal end of the endoscopic device such that the needle assembly is directed over a curved path; and

passing a length of suture through the tissue via the needle assembly.

49. The method of claim 48 wherein positioning a distal end of an endoscopic device comprises advancing the endoscopic device through an esophagus and into a stomach of a patient.

50. The method of claim 48 wherein stabilizing the tissue via a stabilizing member comprises articulating the stabilizing member proximally while grasping the tissue.

51. The method of claim 48 wherein stabilizing the tissue via a stabilizing member comprises pulling the tissue proximally and pivoting the stabilizing member relative to the tissue.

52. The method of claim 48 wherein piercing the tissue comprises passing a needle body positioned at a distal end of the needle assembly into or through the tissue.

53. The method of claim 48 further comprising flexing a portion of a tubular member through which the needle assembly is translatable to form the curved path prior to piercing the tissue.

54. The method of claim 48 wherein passing a length of suture comprises deploying the suture from the needle assembly after piercing the tissue.

55. The method of claim 48 further comprising deploying a tissue anchor assembly from the needle assembly.

56. The method of claim 55 further comprising securing the tissue via the tissue anchor assembly.