METHODS AND DEVICES FOR VALVE CLIP EXCISION

Abstract

A system for excising an implanted clip approximating opposed valve leaflets in a heart valve includes a capture catheter configured to be introduced proximate the valve leaflets on one side of the clip, a transfer catheter configured to be introduced proximate the valve leaflets on another side of the clip, and a cutting tool configured to be deployed between the capture and transfer catheters and to be engaged against tissue of at least one of the valve leaflets and to excise the clip. A removal catheter may optionally be used to remove the clip from the heart.

Claims

1. A method for excising a clip approximating an opposed pair of valve leaflets in a heart valve, said method comprising: introducing a capture catheter into a heart chamber adjacent to the valve leaflets on one side of the clip; introducing a transfer catheter into the heart chamber adjacent to the valve leaflets on another side of the clip; deploying a cutting element from the transfer catheter to the capture catheter to place the cutting element against tissue of at least one of the valve leaflets; engaging the cutting member against the valve leaflet tissue; and excising the clip from at least one valve leaflet using the cutting member.

2. A method as in claim 1, wherein the heart chamber is the left atrium and the heart valve is a mitral valve.

3. A method as in claim 1, wherein the heart chamber is the left ventricle and the heart valve is a mitral valve.

4. A method as in claim 1, wherein the heart chamber is the right atrium and the heart valve is a tricuspid valve.

5. A method as in claim 1, wherein the heart chamber is the right ventricle and the heart valve is a tricuspid valve.

6. A method as in claim 1, wherein deploying the cutting element comprises steering a tip of least one of the capture catheter and the transfer catheter to bring tips of both catheters into proximity.

7. A method as in claim 6, wherein deploying the cutting member further comprises engaging a magnetic element on the capture catheter against a magnetic element on the cutting member and drawing the cutting member past the valve.

8. A method as in claim 6, wherein deploying the cutting element further comprises engaging a loop on the capture catheter over a free end on the cutting member and drawing the cutting member past the valve.

9. A method as in claim 6, wherein deploying the cutting element further comprises bringing the tips of the capture catheter and the transfer catheter together to form a path past the valve and advancing the cutting member through the path.sub.—

10. A method as in claim 1, wherein the clip is excised from only one valve leaflet.

11. A method as in claim 1, wherein the clip is excised from both valve leaflets of the opposed pair.

12. A method as in claim 1, wherein excising the clip from at least one valve leaflet comprises delivering radiofrequency current through the cutting member.

13. A method as in claim 1, wherein excising the clip from at least one valve leaflet comprises mechanically cutting or abrading the valve tissue with the cutting member.

14. A method as in claim 1, further comprising introducing a clip removal catheter into the heart chamber and engaging a distal end of the clip removal catheter against the clip while excising the clip from at least one valve leaflet using the cutting member.

15. A method as in claim 1, further comprising excising the clip from both opposed valve leaflets and removing the clip with the clip removal catheter.

16. A method as in claim 1, wherein the capture catheter and the transfer catheter are introduced transseptally.

17. A method as in claim 1, wherein the capture catheter and the transfer catheter are introduced transapically.

18. A system for excising an implanted clip approximating opposed valve leaflets in a heart valve, said system comprising: a capture catheter configured to be introduced into a heart chamber adjacent to the valve leaflets on one side of the clip; a transfer catheter configured to be introduced into the heart chamber adjacent to the valve leaflets on another side of the clip; and a cutting member configured to be deployed from the transfer catheter to the capture catheter to place the cutting element against tissue of at least one of the valve leaflets to excise the clip.

19. A system as in claim 18, wherein at least one of the capture catheter and the transfer catheter has a steerable distal tip.

20. A system as in claim 18, wherein each of the capture catheter and the transfer catheter has a steerable distal tip.

21. A system as in claim 18, wherein the capture catheter has a magnetic distal tip.

22. A system as in claim 21, wherein the cutting member is carried by the transfer catheter and has a magnetic element exposed at a distal end of the transfer catheter so that manipulation of the catheter positions within a heart chamber allows the capture catheter to capture the cutting member.

23. A system as in claim 18, further comprising a clip removal catheter having a distal end configured to engage and capture the clip.

24. A system as in claim 18, wherein the cutting member comprises a radiofrequency electrode for energized cutting of valve tissue.

25. A system as in claim 18, wherein the cutting member comprises a mechanically abrasive or sharpened edge for mechanically cutting valve tissue.

26. A system as in claim 18, wherein the cutting member comprises a cutting zone delineated by radiopaque markers.

27. A system as in claim 18, further comprising a delivery sheath configured to introduce the capture catheter and the transfer catheter to the heart chamber.

28. A system as in claim 18, wherein the delivery sheath has a lumen sized to simultaneously accommodate both the capture catheter and the transfer catheter.

29. A system as in claim 18, wherein the delivery sheath comprises a transseptal sheath.

30. A system as in claim 18, wherein the delivery sheath comprises a transapical sheath.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] FIGS. 1 and 1A illustrate the anatomy of the mitral valve after implantation of a mitral valve clip.

[0031] FIGS. 2A and 2B illustrate a capture catheter constructed in accordance with the principles of the present invention with a steerable distal region shown in its straightened configuration (FIG. 2A) and in deflected configurations (FIG. 2B).

[0032] FIG. 3 illustrates a transfer catheter constructed in accordance with the principles of the present invention.

[0033] FIG. 4 illustrates a cutting member used with the capture and transfer catheters in the methods of the present invention.

[0034] FIGS. 5A through 5E illustrate different embodiments of magnetic tips on the capture catheters and magnetic distal elements on the cutting members.

[0035] FIG. 6 illustrates an alternative system according to the present invention including a capture catheter having a capture loop at its distal end.

[0036] FIGS. 7A through 7F illustrate use of a capture catheter and a transfer catheter in a method for removing a pair of clips implanted in a mitral valve in accordance with the principles of the present invention.

[0037] FIG. 8 illustrates transapical introduction of a capture catheter and a transfer catheter into a left atrium for excising a valve clip in a mitral valve in accordance with the principles of the present invention.

[0038] FIGS. 9A through 9C illustrate use of a capture catheter and a transfer catheter in a method for removing a valve clip from a tricuspid valve in accordance with the principles of the present invention.

[0039] FIGS. 10A through 10E illustrate use of a capture catheter and a transfer catheter in a method for removing a single valve clip from a mitral valve in accordance with the principles of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0040] The present invention provides apparatus and methods for the separation of one or more valve clips from mitral and other heart valve leaflets. The valve clips can be located anywhere along the valve coaptation plane (central, medial, lateral, or commissural), and in some embodiments the valve clips are removed from one of the coapting valve leaflets while being left in placed in the other of the coapting valve leaflets. In other embodiments, the valve clips will be removed from both valve leaflets and be extracted entirely from the heart.

[0041] The technology of the present invention can be deployed from a left atrial aspect (transseptal or direct atrial access), or from the left ventricular aspect (transapical, direct ventricular puncture, or retrograde aortic access). The cutting action can be provided by a “noose,” by a scissor-like device, by a wire-based cutter similar to a “cheese cutter,” by a radiofrequency electrode cutting element, or the like. In some instances, the mitral valve clips may be removed from both anterior and posterior leaflets, and a snare, bioptome-type device, or other removal catheter may be used to completely remove the mitral valve clip from the body. The present invention may be used to remove valve clips from tricuspid valves as well as mitral valves, and the catheters be placed through transseptal and transapical guiding catheter which are typically large enough to accommodate all catheters being used in the procedure simultaneously.

[0042] Referring now to FIGS. 1 and 1A, valve clips C may be implanted in the leaflets of a mitral valve MV as well as a tricuspid valve TV in a heart H. The mitral valve MV separates the left atrium LA from the left ventricle LV, and the tricuspid valve TV separates the right atrium RA from the right ventricle RV. For completeness, it is noted that blood flows from the left ventricle LV through the aortic valve AV into the aorta A. As shown in more detail in FIG. 1A, the clip C in the mitral valve MV may be located near a middle of the valve opening between the anterior leaflet AL and the posterior leaflet PL. The clip C, however, could also be implanted at other locations between the leaflets away from the middle of the valve opening.

[0043] Referring now to FIGS. 2A and 2B, a capture catheter 10 comprises a shaft 12 having a proximal end 14 and a distal end 16. A control handle 18 is attached to the proximal end of the shaft, and a deflection knob 20 is located at the distal of the handle. The capture catheter 10 will typically also include a flush port 22 and will have a central lumen adapted to receive a guidewire 24 having a shapeable tip 26 at its distal end. As shown in particular FIG. 2B, a distal region 28 of the catheter shaft 12 will be actively deflectable or “steerable” so that the region can be deflected by up to 180°, as shown. Such deflection will be controlled by the deflection knob 20, and suitable deflection mechanisms may include pull wires, slotted regions at the distal end of the shaft, or any other conventional catheter deflection technology.

[0044] Referring now to FIG. 3, a transfer catheter 34 includes a shaft 36 having a proximal end 38 and a distal end 40. A control handle 42 is attached to the proximal end of the shaft, and a deflection knob 44 is disposed at the distal end of the control handle 42. The transfer catheter 34 may also include a flush port 46 and will typically have a steerable distal tip 48 similar to that described above for the capture catheter 10.

[0045] Referring now to FIG. 4, a cutting member 50 comprises an elongate body 52 which typically has a wire-like configuration (typically being electrically conductive in the case of electrosurgical cutting members as described below) so that it may be fed through an advancement lumen of the transfer catheter 34. The cutting member 50 further includes a cutting region 54 which typically spans a region near a middle of the length of the elongate body, typically having a length from 0.5 cm to several centimeters, and which typically is bounded on each side by a radiopaque marker 56. In the case of electrosurgical cutting members, the member may comprise an electrically conductive wire where the cutting region uninsulated and the regions on either side of the cutting region are electrically insulated. A magnetic distal element 58 will typically be located at one end of the elongate body 52 and, as shown in FIG. 3, when the cutting member 50 is loaded onto the transfer catheter 34, the magnetic distal element 58 will extend outwardly from the distal tip 40 of the catheter so that it is exposed and available to magnetically attract the magnetic tip 30 of the capture catheter 10 as described below .

[0046] As shown in FIGS. 5A through 5E, the magnetic tip 30 of the capture catheter 10 may take a variety of forms. Magnetic tip 30a (FIG. 5A) has a bullet shape with a through lumen to accommodate the guidewire of the capture catheter. Magnetic tip 30b has a disc-like shape and also has a through lumen to accommodate the guidewire in the capture catheter.

[0047] The magnetic distal element 58 of the cutting member 50 may also have a variety of configurations. Most simply, the magnetic distal element 58 will have a sphere shape as shown in FIG. 5E. Alternatively, the magnetic distal element may have a bullet shape 58a as shown in FIG. 5B or a disc-like shape 58b as shown in FIG. 5D.

[0048] As described thus far, the capture catheter 10 and the cutting member 50 will each have magnetic elements to allow capture of the cutting member by the capture catheter 50. While this is a preferred design, a variety of other capture mechanisms could also be employed. For example, as shown in FIG. 6, a capture catheter 62 may carry a capture loop 66 at its distal end. The capture loop could be used then to capture a free end 70 of a cutting member 72 carried by transfer catheter 64. The use of hooks, barbs, coil targets, and the like, would also be possible to allow for capture of the cutting member by a capture catheter.

[0049] Referring now to FIGS. 7A through 7F, the use of capture catheter 10 and transfer catheter 34 for removing a pair of clips C1 and C2 from a mitral valve MV via a transseptal approach will be described. A steerable distal tip 28 of guidewire 24 is first introduced through a transseptal sheath 74 into a left atrium above the mitral valve. The tip 28 can be advanced between the clips C1 and C2 under fluoroscopic guidance with the heart beating. Optionally, the capture catheter 10 could be used to assist in placing the guide wire 24 between the clips before the catheter 10 is the advanced over the guide wire. The guide wire can be passive or active.

[0050] After the guidewire is placed, as shown in FIG. 7A, the capture catheter 10 can be advanced over the guidewire 24 so that it is positioned above the clips C1 and C2, as shown in FIG. 7B. The distal end of the capture catheter 10 is then advanced between the clips C1 and C2 so that the magnetic tip enters the left ventricle, as shown in FIG. 7C. The transfer catheter 34 may then be introduced through the transseptal sheath 74 in parallel to the capture catheter 10 and steered to advance the magnetic distal element 58b on the cutting member 50 so that it engages the magnetic tip 30 on the capture catheter 10. For example, the steerable distal region 48 of the transfer catheter 34 can be advanced downwardly between the anterior leaflet AL and posterior leaflet PL and manipulated to engage the magnetic distal element 58b against the magnetic tip 30.

[0051] After the cutting member 50 and capture catheter 10 are coupled together, the capture catheter 10 may be pulled back to expose the cutting region 54, and the catheters manipulated to engage the cutting region 54 against the second valve clip C2, as shown in FIG. 7E. The cutting region 54 can then be manipulated to saw through or electrode surgically cut the tissue of the posterior leaflet PL surrounding the clip C2. The procedure may then be repeated to excise the first clip C1 from the posterior leaflet PL, as shown in FIG. 7F, resulting in opening of the mitral valve to allow a prosthetic valve implantation or other intervention to take place. While excision of the posterior leaflet is illustrated in FIGS. 7A-7F, in some instances it would be preferable to excise the anterior leaflet tissue leaving the clip(s) attached to the posterior leaflet.

[0052] Referring now to FIG. 8, excision of valve clip C from the mitral valve MV can also be performed using capture catheter 10 and transfer catheter 34 through a transapical sheath 78. Using the transapical approach, the distal tips of the catheters 10 and 34 will be advanced upwardly from the left ventricle LV to the left atrium LA, and the tissue can then be excised using the catheters as generally as described previously.

[0053] Referring now to FIGS. 9A through 9C, excision of a valve clip C implanted between a anterior leaflet AL and a septal leaflet SL in a tricuspid valve TV will be described. Capture catheter 10 and transfer catheter 34 can be introduced through an access sheath 80 into the right atrium above the tricuspid valve, as shown in FIG. 9B. The catheters 10 and 34 can be used to position the cutting region 54 of the cutting member 50 on a side of the clip C in the septal leaflet SL as shown in FIG. 9C. The cutting member 50 can then be manipulated in any of the ways described previously to excise the tissue of the septal leaflet SL to release the clip C and open the tricuspid valve, as shown in FIG. 9C. The portion of the clip C implanted in the anterior leaflet can also be excised, or the clip can be left in place, prior to performing a subsequent intervention on the valve.

[0054] Referring now to FIGS. 10A through 10E, a single valve clip C can be removed from a mitral valve MV by introducing the capture catheter 10 and the transfer catheter 34 into the left atrium using a transseptal sheath 74, as generally described previously. In addition, a clip removal catheter 90 can be introduced through the transseptal sheath 74 simultaneously with the capture catheter 10 and the transfer catheter 34 in order to engage and stabilize the clip C. As shown in FIG. 10A, a clip capture element 94 at the distal end of a manipulation wire 92 can be delivered through a lumen of the clip removal catheter 90 to capture an upper surface of the clip C. The cutting region 54 of the cutting number 50 is then used to excise the tissue in the anterior leaflet AL, while the clip remains held and stabilized by the clip removal catheter 90, thus freeing the clip from the anterior leaflet, as shown in FIG. 10B (where the capture catheter 10 and transfer catheter 34 are removed for ease of illustration). The capture catheter 34 and transfer catheter 10 may then be repositioned, as shown in FIG. 10C, so that the cutting region 54 of the cutting member 50 is positioned against the posterior leaflet PL, and the cutting region can then be manipulated to excise tissue in the posterior leaflet to release the clip, as shown in FIG. 10D. The clip removal catheter 90, which continues to hold the clip C, can be then be used to withdraw the clip C from the mitral valve, as shown in FIG. 10E. The mitral valve MV is then completely free from implanted clips to receive a mitral valve prosthesis or to have another corrective intervention performed.

[0055] Although certain embodiments of the disclosure have been described in detail, certain variations and modifications will be apparent to those skilled in the art, including embodiments that do not provide all the features and benefits described herein. It will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative or additional embodiments and/or uses and obvious modifications and equivalents thereof. In addition, while a number of variations have been shown and described in varying detail, other modifications, which are within the scope of the present disclosure, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the present disclosure. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the present disclosure. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by the particular disclosed embodiments described above. For all of the embodiments described above, the steps of any methods need not be performed sequentially.