Minimally invasive mitral valve repair method and apparatus

• US 7,758,595 B2
• Filed: 11/15/2005
• Issued: 07/20/2010
• Est. Priority Date: 10/21/1999
• Status: Expired due to Fees

• 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
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US11/274,877
• Publication Number:
  US 20060064116A1
• Time in Patent Office: 1,708 Days
• Field of Search: 606/139, 606/141, 606/148
• 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. A method of connecting suture to a heart valve having at least two leaflets, the method using one or more catheters, each catheter having a releasable capturing apparatus configured to releasably capture one or more heart valve leaflets, each catheter further having a suture deploying apparatus configured to deploy one or more sutures through one or more heart valve leaflets, the method comprising;

positioning a first catheter in a patient'"'"'s body so that the releasable capturing apparatus and suture deploying apparatus of the first catheter are adjacent a first heart valve leaflet;

releasably capturing the first heart valve leaflet with the releasable capturing apparatus;

deploying a first suture line through the first heart valve leaflet with the suture deploying apparatus;

deploying a second suture line through the first heart valve leaflet with the suture deploying apparatus, wherein the first and second suture lines are deployed simultaneously through the first heart valve leaflet;

releasing the first heart valve leaflet from the releasable capturing apparatus; and

drawing the first and second suture lines through the first heart valve leaflet.

2. The method of claim 1, wherein the first and second suture lines are opposing ends of a first common suture line.

3. The method of claim 1, further comprising:

releasably capturing the second heart valve leaflet;

deploying a third suture line through the second heart valve leaflet;

deploying a fourth suture line through the second heart valve leaflet; and

releasing the second heart valve leaflet; and

drawing the third and fourth suture lines through the second heart valve leaflet.

4. The method of claim 3, wherein the first and second suture lines are opposing ends of a first common suture line, and the third and fourth suture lines are opposing ends of a second common suture line.

5. The method of claim 4, wherein the third and fourth suture lines are deployed via the first catheter simultaneously with the deployment of the first and second suture lines.

6. The method of claim 5, further comprising:

securing the first suture line to the third suture line.

7. The method of claim 6, wherein securing the first suture line to the third suture line comprises remotely tying and advancing a knot to secure the first suture line to the third suture line.

8. The method of claim 6, further comprising:

securing the second suture line to the fourth suture line.

9. The method of claim 5, further comprising:

securing the first suture line, second suture line, third suture line, and fourth suture line together to form a generally x-shaped suture assembly.

10. A method of connecting suture to a heart valve having at least two leaflets using a catheter having a releasable capturing apparatus configured to releasably capture one or more heart valve leaflets, the catheter further having a suture deploying apparatus configured to deploy one or more sutures through one or more heart valve leaflets, the method comprising;

positioning the catheter in a patient'"'"'s body so that the releasable capturing apparatus and suture deploying apparatus are adjacent a first heart valve leaflet;

releasably capturing the first heart valve leaflet with the releasable capturing apparatus;

deploying a first suture line through the first heart valve leaflet with the suture deploying apparatus;

positioning the catheter in a patient'"'"'s body so that the releasable capturing apparatus and suture deploying apparatus are adjacent a second heart valve leaflet;

releasably capturing the second heart valve leaflet with the releasable capturing apparatus;

deploying a second suture line through the second heart valve leaflet with the suture deploying apparatus, wherein the first and second suture lines are deployed simultaneously through the first and second heart valve leaflets, respectively;

releasing the first heart valve leaflet and the second heart valve leaflet from the releasable capturing apparatus; and

drawing the first and second suture lines through the first and second heart valve leaflets, respectively.

11. The method of claim 10, wherein drawing the first and second suture lines through the first and second heart valve leaflets includes withdrawing the catheter from the area adjacent the first and second heart valve leaflets.

12. The method of claim 10, wherein the first and second suture lines are opposing ends of a first common suture line.

13. The method of claim 12, further comprising:

securing the first suture line to the second suture line.

14. The method of claim 13, wherein securing the first suture line to the second suture line comprises tying a knot in the first and second suture lines.

15. A method of connecting suture to a heart valve having at least two leaflets using a catheter having a releasable capturing apparatus configured to releasably capture one or more heart valve leaflets, the catheter further having a suture deploying apparatus configured to deploy one or more sutures through one or more heart valve leaflets, the method comprising;

positioning the catheter in a patient'"'"'s body so that the releasable capturing apparatus and suture deploying apparatus are adjacent a first heart valve leaflet;

releasably capturing the first heart valve leaflet with the releasable capturing apparatus;

deploying a first suture line through the first heart valve leaflet with the suture deploying apparatus;

positioning the catheter in a patient'"'"'s body so that the releasable capturing apparatus and suture deploying apparatus are adjacent a second heart valve leaflet;

releasably capturing the second heart valve leaflet with the releasable capturing apparatus;

deploying a second suture line through the second heart valve leaflet with the suture deploying apparatus;

deploying a third suture line through the first heart valve leaflet with the suture deploying apparatus;

deploying a fourth suture line through the second heart valve leaflet with the suture deploying apparatus;

releasing the first heart valve leaflet and the second heart valve leaflet from the releasable capturing apparatus; and

drawing the first and second suture lines through the first and second heart valve leaflets, respectively.

16. The method of claim 15, wherein the third and fourth suture lines are deployed simultaneously.

17. The method of claim 15, wherein the first and second suture lines are opposing ends of a first common suture line, and the third and fourth suture lines are opposing ends of a second common suture line.

18. The method of claim 17, further comprising:

securing the first suture line to the second suture line, and securing the third suture line to the fourth suture line.

19. The method of claim 18, wherein securing the first suture line to the second suture line comprises remotely tying and advancing a first knot to secure the first suture line to the second suture line, and wherein securing the third suture line to the fourth suture line comprises remotely tying and advancing a second knot to secure the third suture line to the fourth suture line.