Devices and methods for heart valve repair

• US 20050107810A1
• Filed: 02/10/2004
• Published: 05/19/2005
• Est. Priority Date: 06/13/2002
• Status: Abandoned Application

• Current Assignee: Guided Delivery Systems, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Starksen, Niel F., Morales, Rodolfo A.
• Application Number:
  US10/776,682
• Publication Number:
  US 20050107810A1
• Time in Patent Office: Days
• US Class Current: 606/143
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• 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 17/0401 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 17/0487 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/06023 Multiple eyelets
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 : Inserts in the coronary sinus for correcting the valve shape

Abstract

Methods and devices provide constriction of a heart valve annulus to treat cardiac valve regurgitation and other conditions. Embodiments typically include a device for attaching a cinching or tightening apparatus to a heart valve annulus to reduce the circumference of the annulus, thus reducing valve regurgitation. Tightening devices may include multiple tethered clips, multiple untethered crimping clips, stabilizing devices, visualization devices, and the like. In one embodiment, a plurality of tethered clips is secured circumferentially to a valve annulus, and the tether coupling the clips is cinched to reduce the circumference of at least a portion of the annulus. Methods and devices may be used in open heart surgical procedures, minimally invasive procedures, catheter-based procedures, and/or procedures on beating hearts or stopped hearts.

Claims

1. A device for applying tethered clips to an annulus, the device comprising:

a shaft having a proximal end and a distal end;

a plurality of clips slidably coupled to a tether, the tethered clips delivered by the shaft;

a clip applier at or near the distal end of the shaft for securing the clips to the annulus; and

at least one actuator at or near the proximal end of the shaft for causing the device to advance the clips and for activating the clip applier to secure the clips to the annulus.

2. A device as in claim 1, wherein the clip applier comprises:

a pusher coupled with the actuator for advancing the clips; and

at least one slot in an inner surface of the shaft for guiding the clips.

3. A device as in claim 2, wherein the clip applier further comprises a clip crimping member.

4. A device as in claim 3, wherein the at least one actuator includes means for cinching the tethered clips to reduce the circumference of the valve annulus.

5. A device as in claim 1, wherein the at least one actuator is selected from the group consisting of a trigger, a handle, a plunger, a squeeze-activated device, a syringe-grip device and a foot-operated device.

6. A device as in claim 1, wherein each of the plurality of clips includes at least one eyelet, and the tether passes through the at least one eyelet of each clip.

7. A device as in claim 6, wherein each of the plurality of clips includes two eyelets, and the tether has parallel segments passing through both eyelets of each clip.

8. A device as in claim 6, farther comprising means for crimping the at least one eyelet of any of the plurality of clips such that a clip with a crimped eyelet is secured to the tether.

9. A device as in claim 1, wherein the distal end of the shaft comprises a curved tip.

10. A device as in claim 1, wherein the shaft is introducible into a patient through a minimally invasive incision.

11. A device as in claim 1, further comprising a tether anchor coupled to the tether and carried by the shaft.

12. A device as in claim 11, wherein the tether anchor comprises a rivet.

13. A device as in claim 11, wherein the tether anchor is coupled with at least a last clip of the tethered clips such that crimping the last clip secures the last clip to the tether anchor and the tether anchor to the tether.

14. A device as in claim 13, wherein the tether anchor is further coupled with a penultimate clip, such that crimping the penultimate clip secures the penultimate clip to the tether anchor and the tether anchor to the tether.

15. A device as in claim 1, wherein the tether is selected from the group consisting of a suture material, a Teflon strip, a band, a filament, a wire and a strap.

23. A system comprising:

a device as in claim 1;

and

a stabilization device adapted to capture and immobilize the annulus relative to the remainder of the heart.

24. A system as in claim 23, wherein the stabilization device comprises a pair of rings which are adapted to clamp opposed faces of the annular surface.

25. A system as in claim 24, wherein the device is adapted to clamp over and under a heart valve annulus.

29. A system comprising:

a device as in claim 1;

and

a visualization device adapted to directly view a valve annulus in a heart chamber.

30. A system as in claim 29, wherein the visualization device comprises an ultrasonic imaging transducer.

31. A system as in claim 29, wherein the visualization device comprises an optical viewing element disposed in a transparent element.

32. A system as in claim 31, wherein the transparent element comprises a transparent balloon inflatable with a transparent inflation medium.

16. A device for applying tethered clips to an annulus, the device comprising:

a shaft having a proximal end and a distal end,

a tether having at least two parallel segments;

a plurality of clips which slidably receive both segments of the tether, wherein said clips are arranged successively on said tether, and

a clip applier at or near the distal end of the shaft for securing clips to the annulus while said clips remain on said tether.

17. A device as in claim 16, wherein the clips each include a pair of spaced-apart eyelets, wherein one segment is received in each eyelet of the pair.

18. A device as in claim 17, wherein the clips are deformable in the region of the eyelets to permit crimping.

26. A system comprising:

a device as in claim 16, and

a stabilization device adapted to capture and immobilize the annulus relative to the remainder of the heart.

27. A system as in claim 26, wherein the stabilization device comprises a pair of rings which are adapted to clamp opposed faces of the annulus.

28. A system as in claim 26, wherein the device is adapted to clamp over and under a heart valve annulus.

33. A system comprising:

a device as in claim 16;

and

a visualization device adapted to directly view a valve annulus in a heart chamber.

34. A system as in claim 33, wherein the visualization device comprises an ultrasonic imaging transducer.

35. A system as in claim 33, wherein the visualization device comprises an optical viewing element disposed in a transparent element.

36. A system as in claim 34, wherein the transparent viewing element comprises a transparent balloon inflatable with a transparent inflation medium.

19. An annular fastener comprising:

a tether comprising first and second segments, and

a plurality of clips, each clip comprising first and second tether-receiving elements, wherein one segment is received in each of the tether-receiving elements on each clip.

20. An annular fastener as in claim 19, further comprising a terminal clip which is fixed to a leading end of the tether.

21. An annular fastener as in claim 19, wherein the plurality of clips includes at least three clips.

22. An annular fastener as in claim 19, wherein the clips are deformable in the region of the tether-receiving elements to permit crimping.