Minimally invasive mitral valve repair method and apparatus

• US 20060064115A1
• Filed: 11/15/2005
• Published: 03/23/2006
• Est. Priority Date: 10/21/1999
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bachman, Alan B., Allen, William J., Adams, Leland R., Steckel, Robert R., Reed, Scott
• Granted Patent: US 7,744,609 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• 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 17/062 Needle manipulators
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0417 T-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 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition

Abstract

The present invention is directed to an apparatus and method for the stabilization and fastening of two pieces of tissue. A single device may be used to both stabilize and fasten the two pieces of tissue, or a separate stabilizing device may be used in conjunction with a fastening device. The stabilizing device may comprise a probe with vacuum ports and/or mechanical clamps disposed at the distal end to approximate the two pieces of tissue. After the pieces of tissue are stabilized, they are fastened together using sutures or clips. One exemplary embodiment of a suture-based fastener comprises a toggle and suture arrangement deployed by a needle, wherein the needle enters the front side of the tissue and exits the blind side. In a second exemplary embodiment, the suture-based fastener comprises a needle connected to a suture. The needle enters the blind side of the tissue and exits the front side. The suture is then tied in a knot to secure the pieces of tissue. One example of a clip-based fastener comprises a spring-loaded clip having two arms with tapered distal ends and barbs. The probe includes a deployment mechanism which causes the clip to pierce and lockingly secure the two pieces of tissue.

Claims

1. An apparatus for stabilizing and treating one or more heart valve leaflets, comprising:

a probe with a distal portion having a first side and a second side;

a leaflet stabilizer comprising a first vacuum port on the first side of the distal portion;

a vacuum port control configured to provide vacuum to the first side of the distal portion via the first vacuum port without simultaneously providing vacuum to the second side of the distal portion; and

a leaflet fastening apparatus configured to be deployable into permanent contact with at least one leaflet, at least a portion of the leaflet fastening apparatus releasably positioned on or in the probe, the leaflet fastening apparatus comprising a first element and a second element, wherein the first element is configured to be deployable to contact leaflet tissue at a first tissue location, and wherein the second element is configured to be deployable to contact leaflet tissue at a second tissue location, wherein the first tissue location and the second tissue location are separate locations on one or more leaflets.

2. The apparatus of claim 1, wherein the leaflet stabilizer further comprises:

a second vacuum port on the second side of the distal portion, and wherein the vacuum port control is configured to selectively provide vacuum to the second side of the distal portion via the second vacuum port without simultaneously providing vacuum to the first side of the distal portion.

3. The apparatus of claim 1, wherein the vacuum port control is configured to selectively provide vacuum to the first side of the distal portion via the first vacuum port while simultaneously providing vacuum to the second side of the distal portion via the second vacuum port.

4. The apparatus of claim 1, wherein the vacuum port control comprises one or more valves.

5. The apparatus of claim 1, wherein the leaflet fastening apparatus comprises suture.

6. The apparatus of claim 1, wherein the leaflet fastening apparatus comprises a clip.

7. The apparatus of claim 1, wherein the leaflet fastening apparatus is selected from the group comprising needles, sutures, staples, gripping arms, clips, and barbs.

8. An apparatus for percutaneously deploying suture through selected tissue in a patient'"'"'s body, comprising:

a generally elongated probe with a distal portion and a proximal portion, the distal portion having a first side and a second side, the generally elongated probe configured to be percutaneously advanced into the patient'"'"'s body with the distal end adjacent the selected tissue and the proximal end outside of the patient'"'"'s body;

a leaflet stabilizer comprising a first vacuum port on the first side of the distal portion;

a vacuum port control configured to provide vacuum to the first side of the distal portion via the first vacuum port without simultaneously providing vacuum to the second side of the distal portion; and

a needle and suture assembly comprising a first suture portion, a second suture portion, a first needle, and second needle, wherein the first needle and second needle are positioned at the distal portion of the generally elongated probe, the first portion of suture is secured to the first needle, and the second portion of suture is secured to the second needle.

9. The apparatus of claim 8, wherein at least a portion of the first line of suture passes within a part of the catheter distal portion, and the catheter distal portion is configured to trail the first line of suture out of the catheter distal portion.

10. The apparatus of claim 8, wherein the first needle is configured to be slidably advanced across at least a portion of the first vacuum port.

11. The apparatus of claim 10, wherein the second needle is configured to be slidably advanced across at least a portion of the first vacuum port.

12. The apparatus of claim 10, wherein the leaflet stabilizer comprises a second vacuum port on the second side of the distal portion.

13. The apparatus of claim 12, wherein the second needle is configured to be slidably advanced across at least a portion of the second vacuum port.

14. A system for deploying suture in selected tissue in a patient'"'"'s body, the system comprising:

a suture deploying catheter comprising a distal end and a proximal end, the suture deploying catheter further comprising a first side and a second side, with a first vacuum port on a first side of the catheter distal portion, and a vacuum port control configured to provide vacuum to the first side of the distal portion via the first vacuum port without simultaneously providing vacuum to the second side of the distal portion, and a first needle and second needle slidably positioned on the catheter distal portion; and

at least one line of suture having a first end secured to the first needle.

15. The system of claim 14, wherein the at least one line of suture has a second end secured to the second needle, wherein the first end is opposite the second end.

16. The system of claim 14, further comprising:

a suture securing catheter configured to secure the suture adjacent the selected tissue.

17. The system of claim 16, wherein the suture securing catheter comprises a knot run-down tool.

18. The system of claim 14, further comprising:

a suture cutting tool configured to remove excess suture.

19. The system of claim 14, wherein the suture securing catheter further comprises an integrated suture cutter.

20. An apparatus for fastening heart tissue, comprising:

a tissue engaging tip;

a tissue stabilizer positioned on the tissue engaging tip;

a deployable fastener positioned on the tissue engaging tip, the fastener comprising first and second fastening elements; and

an actuation system in communication with the grasping mechanism and the fastener, the actuation system having first and second actuation modes;

wherein the actuation system in the first actuation mode is capable of causing the tissue stabilizer to grasp a first tissue portion and causing the first fastening element to deploy into the first tissue portion;

wherein the actuation system in the second actuation mode is capable of causing the tissue stabilizer to grasp a second tissue portion and causing the second fastening element to deploy into the second tissue portion; and

, wherein the actuation system is capable of independently and sequentially operating in the first and second actuation modes.

21. The apparatus of claim 20, wherein the first fastening element comprises a first suture portion, and the second fastening element comprises a second suture portion.

22. The apparatus of claim 21, wherein the first suture portion and second suture portion are portions of a common suture line.

23. The apparatus of claim 20, wherein the first fastening element comprises a first needle and the second fastening element comprises a second needle.

24. The apparatus of claim 23, wherein the first needle is secured to a first suture end, and the second needle is secured to a second suture end.

25. The apparatus of claim 24, wherein the first suture end and second suture end are opposing ends of a common suture line.

26. The apparatus of claim 20, wherein the tissue stabilizer comprises a first clamping device and a second clamping device.

27. The apparatus of claim 20, wherein the first fastening element comprises a first needle positioned on or in the tissue stabilizer.

28. The apparatus of claim 27, wherein the tissue stabilizer comprises a first clamping device, and the first needle is positioned on or in the first clamping device.

29. The apparatus of claim 27, wherein the second fastening element comprises a second needle positioned on or in the tissue stabilizer.