Methods and apparatus for securing and deploying tissue anchors

• US 20060271074A1
• Filed: 04/26/2006
• Published: 11/30/2006
• Est. Priority Date: 05/26/2005
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Ewers, Richard C., Lam, Cang C.
• Granted Patent: US 8,298,291 B2
• Time in Patent Office: Days
• US Class Current: 606/148
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• 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 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• 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 2017/2927 the angular position of the head being adjustable with respect to the shaft

Abstract

Methods and apparatus for securing and deploying tissue anchors are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member. A reconfigurable launch tube is also pivotably coupled to the tissue manipulation assembly, which may be advanced through a shape-lockable endoscopic device, a conventional endoscope, or directly by itself into a patient. A second tool can be used in combination with the tissue manipulation assembly to engage tissue and manipulate the tissue in conjunction with the tissue manipulation assembly. A deployment assembly is provided for securing engaged tissue via one or more tissue anchors, the deployment assembly also being configured to disengage the anchors endoluminally or laparoscopically by applying thermal energy through at least one suture cutting element disposed along the deployment assembly.

Claims

1. A tissue anchor deployment system, comprising:

a housing having a guide defined along a length of the housing;

an elongate flexible shaft with a lumen defined therethrough and having a proximal end attached to the housing and a distal end having a piercing body attached thereto;

an elongate pusher member slidably disposed at least within the elongate shaft;

a retraction control member removably connected to the housing; and

a release wire slidably disposed within the elongate shaft and secured at a proximal end to the retraction control member.

2. The system of claim 1 wherein the guide defined along the length comprises a channel.

3. The system of claim 1 wherein the guide further defines at least a first locking position along the housing.

4. The system of claim 3 wherein the guide further defines at least a second locking position along the housing.

5. The system of claim 1 further comprising an actuation member translatable along the guide and attached to a proximal end of the elongate pusher member.

6. The system of claim 5 wherein the actuation member comprises a carriage slidably positioned within the housing, the carriage defining a lumen through which the release wire is disposed.

7. The system of claim 1 wherein the elongate flexible shaft comprises a catheter shaft.

8. The system of claim 1 wherein the piercing body comprises a needle body having a lumen defined therethrough.

9. The system of claim 1 wherein the elongate pusher member comprises a hollow tubular member having a length.

10. The system of claim 9 wherein the elongate pusher member further comprises a coiled body which is adapted to provide column support when pushed or pulled through the elongate flexible shaft.

11. The system of claim 1 further comprising a stop fixedly attached to a portion of the release wire.

12. The system of claim 11 wherein the stop has a diameter sized to inhibit movement through at least part of the elongate pusher member.

13. The system of claim 11 further comprising a plug member slidably located along the release wire proximal to the stop.

14. The system of claim 13 wherein the plug member comprises one or more expandable arms projecting radially from a plug body in an expanded configuration and over or around the stop in a low-profile configuration.

15. The system of claim 14 wherein the one or more expandable arms are positionable around the stop such that distal ends of the one or more expandable arms are constrained within a proximal end of a carriage positioned within the housing.

16. The system of claim 1 wherein the retraction control member comprises a threaded attachment for connection to the housing.

17. The system of claim 1 wherein the release wire comprises a nitinol wire.

18. The system of claim 1 wherein the release wire forms a loop through the elongate shaft.

19. The system of claim 18 wherein the release wire forms a loop through a length of the elongate pusher member.

20. The system of claim 1 further comprising a deployable tissue anchor assembly slidably positioned within a portion of the elongate shaft distally of the elongate pusher member.

21. The system of claim 20 wherein the tissue anchor assembly comprises at least a first tissue anchor and a second tissue anchor connected by a length of suture.

22. The system of claim 21 wherein a terminal end of the length of suture is passed at least partially through or around the release wire within the elongate shaft.

23. The system of claim 21 further comprising a locking mechanism slidably positioned along the length of suture between the tissue anchor assembly and the elongate pusher member.

24. The system of claim 1 further comprising a tissue grasping tool pivotably coupled to a distal end of an outer flexible shaft and adapted to be advanced endoluminally into a body lumen, wherein the elongate flexible shaft with the distal end having a piercing body is sized for advancement through the outer flexible shaft and through the tissue grasping tool.

25. The system of claim 24 wherein the tissue grasping tool comprises a first jaw member pivotably coupled to a distal end of the outer flexible shaft, a second jaw member pivotably coupled along the first jaw member, and a launch tube member adapted to urge the first and second jaw members between a low-profile delivery configuration and an expanded grasping configuration.

26. The system of claim 24 further comprising a tissue engagement device having a helical tissue engager adapted to reversibly engage tissue and further adapted to be positioned endoluminally within the body lumen adjacent to the tissue grasping tool.

27. The system of claim 24 further comprising an endoluminal elongate body adapted to transition between a flexible state and a rigid state, wherein the tissue grasping tool and the elongate flexible shaft are removably advanceable therethrough.

28. The system of claim 27 wherein the endoluminal elongate body comprises a steerable distal portion.

29. A method of securing tissue within a hollow body organ, comprising:

endoluminally advancing through engaged tissue an elongate flexible shaft having a proximal end attached to a housing and a distal end having a piercing body attached thereto;

actuating an actuation member on the housing to urge an elongate pusher member distally through the elongate flexible shaft such that a first tissue anchor is urged from the piercing body into or against a first side of the engaged tissue;

retracting the elongate flexible shaft to a second side of the engaged tissue;

further actuating the actuation member on the housing to urge the elongate pusher member further distally through the elongate flexible shaft such that a second tissue anchor is urged from the piercing body into or against a second side of the engaged tissue;

tensioning a release wire proximally through the elongate flexible shaft such that a suture element connecting the first and second tissue anchors is tensioned and a stop attached to a portion of the release wire is freed from a plug member located along the release wire proximally of the stop;

retracting the elongate pusher member relative to the elongate flexible shaft such that a distal looped portion of the release wire is exposed to release a terminal end of the suture element.

30. The method of claim 29 wherein endoluminally advancing comprises advancing the elongate flexible shaft trans-esophageally into a stomach.

31. The method of claim 29 wherein actuating an actuation member comprises distally advancing a slide mechanism along the housing to urge the elongate pusher member relative to the elongate flexible shaft.

32. The method of claim 31 further comprising unlocking the actuation member from a first locking position along the housing prior to actuating an actuation member.

33. The method of claim 31 further comprising locking the actuation member into a second locking position along the housing prior to tensioning a release wire.

34. The method of claim 29 wherein further actuating comprises distally advancing a slide mechanism along the housing to a distal position to urge the elongate pusher member relative to the elongate flexible shaft.

35. The method of claim 29 wherein tensioning comprises pulling the release wire proximally through the elongate flexible shaft and housing.

36. The method of claim 29 wherein tensioning comprises approximating the first and second tissue anchors towards one another to secure the engaged tissue therebetween.

37. The method of claim 29 wherein tensioning further comprises uni-directionally advancing a locking mechanism along the suture element proximal to the first and second tissue anchors.

38. The method of claim 29 wherein retracting comprises distally passing the stop at least partially into the elongate pusher member to expose the distal looped portion of the release wire.

39. The method of claim 29 further comprising grasping the tissue within the hollow body organ with a tissue grasping instrument prior to actuating an actuation member.

40. The method of claim 39 wherein endoluminally advancing comprises advancing the elongate flexible shaft through the tissue grasping instrument.

41. The method of claim 40 further comprising advancing the tissue grasping instrument along or through a flexible body with a steerable distal section, wherein the flexible body is adapted to be rigidized to maintain an arbitrary shape.