Minimally invasive mitral valve repair method and apparatus

• US 6,626,930 B1
• Filed: 05/01/2000
• Issued: 09/30/2003
• Est. Priority Date: 10/21/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bachman, Alan, Steckel, Robert R., Adams, Ray, Allen, William J., Reed, Scott
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US09/562,406
• Time in Patent Office: 1,247 Days
• Field of Search: 606/150, 606/153, 606/216, 606/221, 606/219, 606/139, 606/144, 606/148, 606/213-215, 606/217-220, 606/232, 606/123, 606/157, 128/898, 604/171, 604/174-176
• US Class Current: 606/213
• 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 the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach tissue pieces to be joined;

a suture-based tissue fastener coupled to the probe for fastening said two pieces of tissue, the suture based tissue fastener comprising a toggle and a suture thread attached to the toggle;

a needle having a lumen and a pusher slidingly disposed at a proximal end of the needle lumen, tissue toggle and the suture thread being housed within the distal end of the needle lumen, the pusher being capable of urging the toggle and the suture thread from a distal end of the needle;

a delivery lumen having an opening on a distal face of the probe, wherein the delivery lumen receives and deploys the needle, and the distal end of the needle is adapted to pierce through the tissue to be fastened; and

at least one vacuum port adjacent the distal tip of the probe, the at least one port being in fluid communication with a vacuum source via the at least one lumen so as to enable the probe to stabilize adjacent pieces of tissue.

2. An apparatus for the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach tissue pieces to be joined;

a suture-based tissue fastener coupled to the probe for fastening the pieces of tissue wherein the suture-based tissue fastener includes a needle attached to a suture thread;

an extension member having a distally-directed frame coupled to a distal end of the probe, wherein the extension member is extendable and retractable and the fame defines a space, the needle being pivotally coupled to the frame and residing within the space; and

at least one vacuum port adjacent the distal tip of the probe, the at least one port being in fluid communication with a vacuum source via the at least one lumen so as to enable the probe to stabilize adjacent pieces of tissue.

3. An apparatus for the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach tissue pieces to be joined;

a clip coupled to the probe for fastening the tissue pieces, wherein the clip comprises an integral spring portion having two arms, each of the arms having one or more barbs; and

at least one vacuum port adjacent the distal tip of the probe, the at least one port being in fluid communication with a vacuum source via the at least one lumen so as to enable the probe to stabilize adjacent pieces of tissue.

4. The apparatus of claim 3, wherein distal ends of the arms are tapered to enable the clip to pierce the pieces of tissue and the arms are overlapping when in a closed position.

5. An apparatus for the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach tissue pieces to be joined;

a clip coupled to the probe for fastening the tissue pieces, wherein the clip comprises an integral spring portion having two arms having tapered distal ends extending inwardly to pierce and lockingly secure the pieces of tissue, and wherein a gap exists between midportions of the arms when the clip is in a closed position; and

at least one vacuum port adjacent the distal tip of the probe, the at least one port being in fluid communication with a vacuum source via the at least one lumen so as to enable the probe to stabilize adjacent pieces of tissue.

6. An apparatus for the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach tissue pieces to be joined;

a clip coupled to the probe for fastening the tissue pieces;

a pusher slidably received within the at least one lumen of said probe, wherein movement of the pusher in the distal direction causes the clip to pierce the pieces of tissue and wherein the clip automatically springs to a closed position when the clip disengages from the probe causing the pieces of tissue to be compressed together;

a sleeve disposed between the pusher and an internal wall of the at least one lumen, the sleeve capable of housing the clip in an open position; and

at least one vacuum port adjacent the distal tip of the probe, the at least one port being in fluid communication with a vacuum source via the at least one lumen so as to enable the probe to stabilize adjacent pieces of tissue.

7. An apparatus for the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach tissue pieces to be joined;

a staple coupled to the probe for fastening the two pieces of tissue; and

at least one vacuum port adjacent the distal tip of the probe, the at least one port being in fluid communication with a vacuum source via the at least one lumen so as to enable the probe to stabilize adjacent pieces of tissue.

8. The apparatus of claim 7 wherein the staple comprises a bridge portion and at least one gripping arm on either side of the bridge portion.

9. The apparatus of claim 8 further comprising two gripping arms on either side of the bridge portion.

10. The apparatus of claim 8 wherein the gripping arms are curled in a semi-circle upward from the plane of the bridge portion and terminate in sharp points approximately in the plane of the bridge portion.

11. An apparatus for the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach tissue pieces to be joined;

at least one vacuum port adjacent the distal tip of the probe, the at least one port being in fluid communication with a vacuum source via the at least one lumen so as to enable the probe to stabilize adjacent pieces of tissue; and

at least one echogenic member at or near the at least one vacuum port to enhance echo visualization.

12. An apparatus for the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach tissue pieces to be joined;

at least one vacuum port adjacent the distal tip of the probe, the at least one port being in fluid communication with a vacuum source via the at least one lumen so as to enable the probe to stabilize adjacent pieces of tissue; and

a polymer coating which can be wholly or selectively applied at or near the at least one vacuum port to enhance echo visualization.

13. An apparatus for joining two tissue pieces, comprising:

a probe adapted to be advanced through a body vessel into proximity with the tissue pieces, the probe having a distal tip;

a device on the distal tip for fastening the tissue pieces together; and

a pair of vacuum ports adjacent the distal tip of the probe, each suitable for stabilizing one of the tissue pieces, the negative pressure generated at each port being separately controllable.

14. A method of repairing a mitral valve having adjacent leaflets comprising:

providing a catheter having a distal tip, the catheter comprising;

at least one lumen and at least two vacuum ports adjacent the distal tip of the catheter, the at least two ports being in fluid communication with the at least one lumen so as to enable the probe to stabilize adjacent leaflets; and

a tissue fastener coupled to the catheter;

delivering the catheter percutaneously through a peripheral vessel to the mitral valve;

applying suction differentially to the adjacent leaflets;

stabilizing the adjacent leaflets; and

fastening the adjacent leaflets.

15. An apparatus for the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach the tissue pieces to be joined;

two or more vacuum ports adjacent the distal tip of the probe, the ports being in separate fluid communication with a vacuum source via the at least one lumen so as to enable the probe to differentially stabilize adjacent pieces of tissue; and

a tissue fastening device comprising a carrier centrally disposed between the vacuum ports at the distal end of the probe.

16. The apparatus of claim 15 wherein the carrier is configured to be extended from the distal tip and retracted back towards the distal tip so that the tissue fastening device can be placed on a first side of the tissue while the vacuum ports remain on a second side of the tissue.

17. The apparatus of claim 16 wherein the tissue fastening device comprises needles which are pivotably mounted on the carrier.

18. The apparatus of claim 17 wherein the vacuum ports further comprise needle catchers which are configured to retain and store the needles in the vacuum ports.

19. The apparatus of claim 15 wherein the tissue fastening device is a suture based tissue fastening device.

20. An apparatus for the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach the tissue pieces to be joined, the probe having a longitudinal axis;

two or more vacuum ports adjacent the distal tip of the probe, the ports being in separate fluid communication with a vacuum source via the at least one lumen so as to enable the probe to differentially stabilize adjacent pieces of tissue, the two or more vacuum ports having vacuum surfaces which are angled between fifteen and forty degrees relative to a plane normal to the longitudinal axis of the probe.

21. The apparatus of claim 20 wherein the vacuum surfaces are angled at about twenty-five degrees relative to a plane normal to the longitudinal axis.

22. An apparatus for the approximation of two pieces of tissue, comprising:

a cylindrical probe with a distal tip having at least one lumen and adapted to approach the tissue pieces to be joined; and

two or more approximately D shaped vacuum ports adjacent the distal tip of the probe, the ports being in separate fluid communication with a vacuum source via the at least one lumen so as to enable the probe to differentially stabilize adjacent pieces of tissue.

23. The apparatus of claim 22 wherein the comers of the D shaped ports are rounded.

24. The apparatus of claim 22 wherein the vacuum ports include barriers positioned within the perimeter of the D.

25. An apparatus for the approximation of two pieces of tissue, comprising:

a probe with a distal tip having at least one lumen and adapted to approach the tissue pieces to be joined;

two or more vacuum ports adjacent the distal tip of the probe, the ports being in separate fluid communication with a vacuum source via the at least one lumen so as to enable the probe to differentially stabilize adjacent pieces of tissue;

a proximal handpiece portion having individual vacuum port controls, the handpiece portion connecting the vacuum source to the vacuum ports via separate vacuum lines, wherein the handpiece portion further comprises two pinch valves, each pinch valve capable of constricting one of the vacuum lines to permit differential control of access to the vacuum source.

26. The apparatus of claim 25 wherein the handpiece portion further comprises a shaft portion and an intersecting handle portion in pistol grip-type relation and wherein the vacuum port controls are located a top surface of the handle portion there by enabling single-handed operation thereof.

27. The apparatus of claim 25 wherein the handpiece portion further comprises a shaft portion and an intersecting handle portion in a pistol grip-type relation and wherein the vacuum port controls are located bottom surface of the handle portion thereby enabling single-handed operation thereof.

28. A method of repairing a mitral valve having adjacent leaflets comprising:

providing a catheter having a distal tip, the catheter comprising;

at least one lumen and at least one vacuum port adjacent the distal tip of the catheter, the at least one port being in fluid communication with the at least one lumen so as to enable the probe to stabilize adjacent leaflets, wherein the catheter comprises;

at least two vacuum ports; and

a tissue fastener coupled to the catheter;

delivering the catheter to the mitral valve;

applying suction differentially to the adjacent leaflets;

stabilizing the adjacent leaflets; and

fastening the adjacent leaflets.