Method and apparatus for clip excision

Abstract

To provide a system for excising an implanted clip approximating opposed valve leaflets in a heart valve.SOLUTION: This system includes a capture catheter 10 configured to be introduced proximate valve leaflets on one side of a clip C1, C2, a transfer catheter 34 configured to be introduced proximate the valve leaflets on the other 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 strands and to excise the clip. A removal catheter may optionally be used to remove the clip from the heart.SELECTED DRAWING: Figure 7D

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 359,121, filed on July 6, 2016 (Attorney Docket No. 50494-703.101) and U.S. Provisional Patent Application No. 62 / 418,571, filed on November 7, 2016 (Attorney Docket No. 50494-703.102), and claims priority to U.S. Patent Application No. 15 / 642,245, filed on July 5, 2017 (Attorney Docket No. 50494-703.201), the entire disclosures of which are incorporated herein by reference.

Background Art

[0002] 1. Technical Field. The present invention generally relates to medical devices and methods. More specifically, the present invention relates to devices, systems, kits, and methods for removing clips or other implanted prostheses from heart valves.

[0003] Mitral regurgitation is a common valvular disease, and the morbidity rate increases with age. In this condition, blood abnormally regurgitates from the left ventricle into the left atrium during cardiac systole, and this condition can lead to harmful consequences such as heart failure due to left ventricular dysfunction, atrial fibrillation, pulmonary hypertension, and death. Published guidelines recommend surgical or transcatheter correction of mitral regurgitation to improve the clinical condition.

[0004] Transcatheter correction of mitral regurgitation by implantation of a mitral clip (specifically, the Abbott Vascular MitraClip(R) system) has become the standard treatment for patients at high risk of open surgical correction procedures. Such clip implantation surgeries are performed through a guiding catheter inserted into the right femoral vein. One or more mitral clips are delivered through the guiding catheter and implanted to approximate the anterior and posterior leaflets of the mitral valve (often referred to as "edge-to-edge" repair). The MitraClip(R) mitral clip is made of cobalt-chromium alloy and covered with a fabric mesh.

[0005] To date, more than 45,000 surgeries using the MitraClip(R) valve clip have been performed worldwide, and currently nearly 1,000 surgeries are performed monthly. The MitraClip(R) surgery has been found to be a very safe surgery, providing a treatment option for patients at high surgical risk.

[0006] However, conventional mitral clip technology has several significant limitations. First, once a mitral clip is implanted, removal typically requires surgical excision by open surgery. Second, due to technical challenges, not all patients achieve satisfactory reduction of MR during the operation. Finally, up to one in five patients may have recurrence of significant MR or the need for repeat intervention within six months of MitraClip(R) surgery.

[0007] When a patient develops recurrent MR after mitral clip surgery, the current options for additional treatment are limited. One option is to place another mitral clip, but this is often not possible due to the concern of developing mitral stenosis (mitral clips often narrow the valve, preventing the valve from opening properly).

[0008] Other options include various mitral valve repair and replacement techniques that are becoming available. Of great interest is the transcatheter mitral valve replacement, in which a bioprosthetic mitral valve mounted on an expandable frame is deployed within a defective native mitral valve. Such transcatheter "replacement" valves would provide complete elimination of mitral regurgitation and mimic the surgical "gold standard" for mitral valve replacement in selected patients.

[0009] Currently, it may be difficult or impossible to implant a transcatheter mitral valve when previous mitral valve clip procedures have been performed because the mitral valve clip interferes and does not allow complete expansion of the new valve. Thus, it would be desirable to provide devices, systems, kits, and methods for removing clips and other implanted prostheses from the heart valve. It would be particularly desirable for such devices, systems, kits, and methods for removing clips and other implanted prostheses from the heart valve to leave the heart valve in a state to undergo subsequent transcatheter procedures such as prosthetic valve implantation to treat the valve pathology. At least some of these objectives will be achieved by the invention described herein.

[0010] 2. Description of the Background Art. See U.S. Patent Application Publication No. 2014 / 0228871, U.S. Patent Application Publication No. 2015257883, U.S. Patent Application Publication No. 2014135799, U.S. Patent No. 8500768, U.S. Patent No. 7955340, U.S. Patent No. 5895404, and the following guidelines and publications: Nishimura RA, Otto CM, Bonow RO et al. 2014 AHA / ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology / American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:2438-88; Feldman T, Kar S, Elmariah S et al. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II. J Am Coll Cardiol 2015;66:2844-54; and Maisano F, Alfieri O, Banai S et al. The future of transcatheter mitral valve interventions: Competitive or complementary role of repair vs. replacement?, Eur Heart J 2015;36:1651-9.

Prior Art Documents

Patent Documents

[0011]

Patent Document 1

Patent Document 2

[0012] [Non-Patent Document 1] Nishimura RA, Otto CM, Bonow RO et al. 2014 AHA / ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology / American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:2438-88 [Non-Patent Document 2] Feldman T, Kar S, Elmariah S et al. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II. J Am Coll Cardiol 2015;66:2844-54 [Non-Patent Document 3] Maisano F, Alfieri O, Banai S et al. The future of transcatheter mitral valve interventions: Competitive or complementary role of repair vs. replacement?, Eur Heart J 2015;36:1651-9

Summary of the Invention

Means for Solving the Problems

[0013] The present invention provides a transcatheter device and procedure that can be used to separate and optionally remove one or more mitral valve clips from native mitral valve leaflet tissue. In such a procedure, a physician can insert a specially designed catheter either from the left atrium or the left ventricle. A guidewire may be placed around the leaflet and valve tissue adjacent to a previously implanted mitral valve clip. Mechanical cutting or ablation, or the use of high-frequency energy, can be used to excise the mitral valve clip from either the anterior or posterior leaflet, or both, restoring the native valve orifice and enabling future repair or replacement therapy. After separating the mitral valve clip from the native leaflet tissue, the degree of mitral regurgitation is expected to deteriorate rapidly. In contrast, the separation procedure of the present invention can be performed immediately prior to transcatheter valve implantation, or another transcatheter corrective procedure. For example, if a transapical access is used for deployment of a new transcatheter mitral valve, a transseptal access can be used to release the mitral valve clip, and vice versa.

[0014] In a first aspect of the invention, a method for excising a clip approaching a pair of opposing leaflets of a heart valve comprises introducing a capture catheter into the heart chamber adjacent to a leaflet on one side of the clip. A delivery catheter is also introduced into the heart chamber adjacent to the leaflet on the opposite side of the clip, and a cutting member is disposed between the delivery catheter and the capture catheter for positioning or engaging the cutting member against tissue of at least one of the leaflets. The cutting member is then used to excise the clip from at least one of the leaflets to release the fixation and enable separation of the leaflets.

[0015] The excision method of the invention is useful in any heart valve in which a clip has been placed to enhance healing or for other reasons. Most typically, the heart valve is the mitral valve and the catheter may be introduced transseptally into the left atrium above the valve or transapically into the left ventricle below the mitral valve. In other examples, the target heart valve is the tricuspid valve and the catheter may be introduced into the right atrium above the tricuspid valve or into the right ventricle below the tricuspid valve.

[0016] In an exemplary embodiment, the step of deploying the cutting member comprises the step of manipulating at least one, and typically both, of the tip of the capture catheter and the tip of the delivery catheter to bring the tips of both catheters near the valve clip. Typically, at least one of the capture catheter and the delivery catheter may be advanced through an opening between the valve leaflets adjacent to the fixed valve clip, and the advanced catheter may then be manipulated around the opposite side of the valve clip and pulled through the space between the valve leaflets on the opposite side of the valve clip. The cutting member may then be passed between the delivery catheter and the capture catheter so as to span the target area of the valve leaflet to be excised. The catheter may then be manipulated to extend the cutting member through the side of the valve clip such that the cutting member is positioned to excise a portion of the valve leaflet on one side of the valve. As will be described in more detail below, the valve clip may remain implanted within the opposing valve leaflets, and subsequent intervention procedures may be performed with the clip attached to the opposing valve leaflets. Alternatively, the capture and delivery catheters may be used to reposition the cutting member to the opposite side of the valve clip such that the opposing valve leaflets are excised from the clip to allow the clip to be completely released and removed from the heart prior to performing subsequent intervention on the heart valve. When releasing and removing the valve clip, it will of course typically be necessary for the valve clip to be constrained by a removal catheter as described hereinbelow.

[0017] In a further specific example, the cutting member may be deployed by engaging a magnetic element on the capture catheter with a magnetic element on the cutting member. The magnetic elements are typically at the tip of the capture catheter and the end of the cutting member, and one or more catheters may be manipulated to pull the cutting member through one or both sides of the valve clip to excise it from the valve leaflet tissue to release the clip.

[0018] In an alternative embodiment, the cutting element may comprise a loop used to capture the free end of the cutting member, and the capture catheter may then be manipulated to advance the loop over the free end of the cutting member and pass the cutting member through the clip and into the valve tissue.

[0019] In a further embodiment, the step of deploying the cutting member may comprise bringing together the tips of the capture catheter and the delivery catheter to form a path through the valve clip, and advancing an element along the path. After such advancement and positioning of the cutting member, the capture catheter and / or the delivery catheter may be manipulated to operate the cutting member to excise valve tissue to release the clip.

[0020] As described above, in some embodiments of the method of the present invention, one or more clips are left implanted within the opposing valve leaflets and excised from only one valve leaflet. Release of one or more clips from at least one valve leaflet is, in at least some cases, sufficient to release the opposing valve leaflet and enable subsequent valve replacement or other intervention procedures. However, in other instances, it may be preferred to completely remove one or more valve clips from the heart valve prior to performing subsequent valve implantation or other intervention. In such cases, a removal catheter or other device is typically used to restrain or capture one or more clips during excision and withdraw the excised one or more clips from the cardiac chamber prior to any further intervention.

[0021] In yet another specific embodiment of the method of the present invention, one or more clips can be excised from the leaflet tissue in various ways. For example, the cutting member may comprise an electrode segment or a conductive region capable of supplying a radiofrequency (RF) cutting current to the tissue. Specifically, the RF current is supplied in a cutting mode such that the cutting member can excise the leaflet tissue adjacent to the valve clip. In other examples, the cutting member can comprise a sharp or abraded region that can be used to mechanically incise the leaflet tissue. For example, the sharp cutting region or the abraded cutting region can reciprocate to "saw" through the tissue to excise the valve. Other well-known tissue cutting modalities can also be employed.

[0022] As previously described, the capture catheter, the delivery catheter, and the cutting member are used to excise tissue from a single leaflet while leaving the valve clip attached to the opposing leaflet. Removal of the valve from a single leaflet allows for sufficient opening of the leaflet for subsequent prosthetic valve implantation or other corrective surgery, although it may be desirable to remove the valve clip from both opposing leaflets. In such cases, it may be preferable to introduce a clip removal catheter into the heart cavity to stabilize the valve clip to be ultimately removed. The distal end of the clip removal catheter is capable of engaging the clip and is typically attached to the clip while the cutting member is used to excise the clip from one or both leaflets.

[0023] In a further exemplary embodiment, the capture catheter, the delivery catheter, and optionally the clip removal catheter can be introduced transseptally, typically simultaneously through a transseptal catheter or sheath. In yet another specific embodiment, the capture catheter, the delivery catheter, and optionally the clip removal catheter can be introduced transapically, typically simultaneously through a transapical sheath or catheter.

[0024] In a second aspect of the present invention, a system for excising an implanted clip approaching the opposing leaflets of a heart valve comprises a capture catheter, a delivery catheter, and a cutting member. The capture catheter is configured to be introduced into the heart chamber adjacent to one leaflet of the clip. The delivery catheter is configured to be introduced into the heart chamber adjacent to the opposite leaflet of the clip, and the cutting member is configured to be deployed from the delivery catheter to the capture catheter to position a cutting element against at least one of the leaflets to excise the clip.

[0025] In certain aspects of the system, at least one of the capture catheter and the delivery catheter has a steerable tip, and typically both have steerable tips. The capture catheter often has a magnetic distal tip configured to engage and capture a magnetic element provided at the distal end of the cutting member. In this way, the magnetic tip on the capture catheter can be used to attract and engage the magnetic end of the cutting member so that the cutting member can be deployed between the capture catheter and the delivery catheter. Thus, the cutting region of the cutting member can be positioned to engage the leaflet tissue adjacent to the valve clip so that the cutting region can be used to cut the tissue and extract the clip. For example, the cutting region can comprise a sharp or worn region that can be used to mechanically cut the valve tissue. Alternatively, the cutting region can comprise an RF electrode that can be powered by a cutting current to excise the leaflet tissue adjacent to the clip.

[0026] The system of the present invention may further comprise an introducer sheath for delivering the catheter of the present invention into the heart chamber, typically a transseptal sheath or a transapical sheath. Usually, the introducer sheath is sized large enough to accommodate at least the capture catheter and the delivery catheter simultaneously. In many cases, the system further comprises a removal catheter, and the introducer sheath is sized to accommodate each of the capture catheter, the delivery catheter, and the removal catheter simultaneously.

[0027] The clip removal catheter of the present invention typically has a distal end configured to engage and capture a clip. Certain valve clips, such as the MitraClip(R) valve clip, have a unique shape that provides a "docking" function that can be used by the clip removal and optionally other catheters of the present invention to "dock" with either the atrial or ventricular surface of the valve clip. The shape of one or more valve clips is typically easily distinguishable by fluoroscopy, which facilitates removing or otherwise targeting the catheter to dock the catheter with the clip during the removal procedure. Such docking has several advantages. First, docking can stabilize the valve clip with respect to the catheter system, which is advantageous because the valve moves during beating heart surgery. Second, docking facilitates orienting one or more catheters to improve the position of the cutting member, such as by looping the clip using either the magnetic or snare techniques described above. Third, by docking the removal or other catheter with the valve clip, the catheter and cutting member can be stably positioned in close proximity to the valve clip, thus minimizing the risk of the chordal apparatus becoming entangled or caught on the loop wire or other cutting member. Fourth, docking can be performed from either the atrial or ventricular surface. For example, atrial docking can be achieved by docking into a groove at the top of the "Y" portion of the MitraClip(R) clip. Ventricular docking can be achieved by docking at the bottom of the "Y" portion of the MitraClip(R) clip. Docking may be passive, for example, via an interference fit, or active, if the removal or other catheter has a "grasping" function to firmly attach the MitraClip(R) clip. Docking can be performed individually for each valve clip or, by varying the docking function, can be performed simultaneously for several at once.

[0028] The removal catheter of the present invention may be designed to dock with a MitraClip(R) or other valve clip in order to place a snare around the clip. Using the catheter described above, after the clip has been released from both the anterior and posterior leaflets (or the septal leaflet in the case of a tricuspid valve), the clip can be removed from the body through an access sheath by the removal catheter. The removal catheter may have any one of various clip-gripping functions, such as a snare, biopsy forceps, or jaws, to hold the valve clip after it has been released from both valve leaflets so that it can be removed from the body. The capture and / or delivery catheter may also be configured to dock with the valve clip and may have, for example, a distal tip having a shape that complements the shape of the valve clip. The catheter for removing the clip can be placed via a transvenous transseptal approach or a left ventricular transapical approach. In some examples, the removal catheter can be designed to have a funnel shape to allow the valve clip to be drawn into the catheter in the proper orientation.

[0029] The catheter system of the present invention can also be used to surround and remove the lead wire of a pacemaker or defibrillator. For example, by sliding a loop that surrounds the lead wire along the length of the lead wire, the lead wire can be excised from the heart or vascular tissue in which it was embedded. Specifically, the catheter of the present invention can be used to release the lead wire from vascular venous tissues such as the axillary vein, brachiocephalic vein, and / or superior vena cava. The catheter of the present invention can also be used to release the lead wire from the myocardium of the tricuspid valve or the right ventricle. Specifically, the lead wire can be released from the tricuspid valve in situations where the lead wire may cause tricuspid regurgitation (TR). Optionally, the lead wire can be repositioned to reduce TR. The catheter can also be used to release the lead wire so that it can be repositioned within the tricuspid valve orifice, as desired to facilitate the placement of a transcatheter valve in the tricuspid valve position.

[0030] The features considered characteristic of the illustrative examples and novel features are set forth in the appended claims. However, the illustrative examples will be best understood by reference to the following detailed description of the illustrative examples of the present disclosure when read in conjunction with the following accompanying drawings.

Brief Description of the Drawings

[0031]

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DETAILED DESCRIPTION OF THE INVENTION

[0032] The present invention provides an apparatus and method for separating one or more valve clips from the mitral valve and other cardiac valve leaflets. The valve clips can be positioned anywhere along the valve junction plane (central, medial, lateral, or commissural). In some embodiments, the valve clip is removed from one of the joined valve leaflets while remaining at a predetermined position of the other of the joined valve leaflets. In other embodiments, the valve clip is removed from both valve leaflets and completely withdrawn from the heart.

[0033] The device of the present invention can be deployed from the left atrial surface (transseptal or direct atrial access) or from the left ventricular surface (transapical, direct ventricular puncture, or retrograde aortic access). The cutting operation can be provided by a "snare", a scissor-like device, a wire-based cutter similar to a "cheese cutter", a high-frequency electrode cutting element, etc. In some examples, the mitral valve clip may be removed from both the anterior and posterior leaflets, and a snare, biopsy forceps-type device, or other removal catheter can be used to completely remove the mitral valve clip from the body. The present invention may be used to remove valve clips not only from the mitral valve but also from the tricuspid valve, and the catheter can typically be placed through a transseptal and transapical guiding catheter large enough to accommodate all the catheters used in the surgery at the same time.

[0034] Referring now to FIGS. 1 and 1A, a valve clip C is implanted on the leaflets of the mitral valve MV and the tricuspid valve TV within the 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. It should be noted that for completeness, 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 of the mitral valve MV is located near the center of the valve opening between the anterior leaflet AL and the posterior leaflet PL. However, the clip C can also be implanted at other positions between the leaflets away from the center of the valve opening.

[0035] Referring now to FIGS. 2A and 2B, capture catheter 10 includes 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 distally of the handle. Capture catheter 10 typically includes a flush port 22 and has a central lumen adapted to receive a guidewire 24 having a deformable tip 26 at its distal end. As particularly shown in FIG. 2B, the distal region 28 of catheter shaft 12 is actively deflectable or "steerable" such that this region can be deflected up to 180° as shown. Such deflection is controlled by deflection knob 20, and suitable deflection mechanisms may include a pull wire, a slot region at the distal end of the shaft, or any other conventional catheter deflection technique.

[0036] Referring now to FIG. 3, delivery 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 provided distally of control handle 42. Delivery catheter 34 may also include a flush port 46 and typically has a steerable distal tip 48 similar to that described above for capture catheter 10.

[0037] Referring now to FIG. 4, the cutting member 50 typically comprises an elongate body 52 having a wire-like configuration (typically conductive in the case of an electrosurgical cutting member as described below) adapted to be supplied through the forward lumen of the delivery catheter 34. The cutting member 50 typically has a length of from 0.5 cm to several centimeters, extends across a region typically near the center of the length of the elongate body, and further includes a cutting region 54 typically in contact on both sides with a radiopaque marker 56. In the case of an electrosurgical cutting member, this member may comprise a conductive wire where the cutting region is not insulated and the regions on both sides of the cutting region are electrically insulated. The magnetic distal element 58 is typically located at one end of the elongate body 52 and, as shown in FIG. 3, when the cutting member 50 is attached to the delivery catheter 34, the magnetic distal element 58 extends outwardly from the distal tip 40 of the catheter so as to be exposed and available to magnetically attract the magnetic tip 30 of the capture catheter 10 as described below.

[0038] As shown in FIGS. 5A through 5E, the magnetic tip 30 of the capture catheter 10 can take various forms. The magnetic tip 30a (FIG. 5A) has a bullet shape with a through lumen for receiving the guide wire of the capture catheter. The magnetic tip 30b has a disk shape and also has a through lumen for receiving the guide wire of the capture catheter.

[0039] The magnetic distal element 58 of the cutting member 50 may also have various configurations. Most simply, the magnetic distal element 58 has a spherical shape as shown in FIG. 5E. Alternatively, the magnetic distal element may have a bullet shape 58a as shown in FIG. 5B or a disk shape 58b as shown in FIG. 5D.

[0040] As previously explained, the capture catheter 10 and the cutting member 50 each have magnetic elements to enable capture of the cutting member by the capture catheter 50. While this is a preferred design, various other capture mechanisms may also be employed. For example, as shown in FIG. 6, the capture catheter 62 may carry a capture loop 66 at its distal end. Then, the capture loop may be used to capture the free end 70 of the cutting member 72 carried by the delivery catheter 64. The use of hooks, barbs, coil targets, etc. may also be possible to enable capture of the cutting member by the capture catheter.

[0041] Referring now to FIGS. 7A through 7F, the use of the capture catheter 10 and the delivery catheter 34 to remove a pair of clips C1 and C2 from the mitral valve MV via a transseptal approach is described. The steerable distal tip 28 of the guidewire 24 is first introduced into the left atrium above the mitral valve through a transseptal sheath 74. The tip 28 can advance between the clips C1 and C2 under fluoroscopic guidance while the heart is beating. Optionally, the capture catheter 10 can be used to assist in placing the guidewire 24 between the clips before the catheter 10 advances over the guidewire. The guidewire may be passive or active.

[0042] As shown in FIG. 7A, after the guidewire is placed, the capture catheter 10 can advance over the guidewire 24 to be positioned over the clips C1 and C2 as shown in FIG. 7B. Thereafter, the distal end of the capture catheter 10 advances between the clips C1 and C2 such that the magnetic tip penetrates into the left ventricle as shown in FIG. 7C. Thereafter, the delivery catheter 34 is guided within the transseptal sheath 74 parallel to the capture catheter 10 and manipulated to advance the magnetic distal element 58b on the cutting member 50 to engage the magnetic tip 30 on the capture catheter 10. For example, the steerable distal region 48 of the delivery catheter 34 can be advanced downward between the anterior leaflet AL and the posterior leaflet PL and manipulated to engage the magnetic distal element 58b with respect to the magnetic tip 30.

[0043] After the cutting member 50 and the capture catheter 10 are coupled to each other, as shown in FIG. 7E, the capture catheter 10 is retracted to expose the cutting region 54, and the catheter is manipulated to engage the cutting region 54 with the second valve clip C2. The cutting region 54 can then be manipulated to cut the tissue of the posterior leaflet PL surrounding the clip C2 with a saw or electro-surgically. Thereafter, as shown in FIG. 7F, the procedure is repeated to excise the first clip C1 from the posterior leaflet PL, creating an opening in the mitral valve that allows for prosthetic valve implantation or other intervention. The excision of the posterior leaflet is shown in FIGS. 7A - 7F, but in some examples, it may be preferable to excise the anterior leaflet tissue with one or more clips remaining attached to the posterior leaflet.

[0044] Referring now to FIG. 8, the excision of the valve clip C from the mitral valve MV can also be performed using the capture catheter 10 and the delivery catheter 34 through the transapical sheath 78. Using a transapical approach, the distal tips of the catheters 10 and 34 are advanced superiorly from the left ventricle LV to the left atrium LA, and the tissue can then be excised generally using a catheter as described above.

[0045] Referring now to FIGS. 9A through 9C, the excision of the valve clip C implanted between the anterior leaflet AL and the septal leaflet SL of the tricuspid valve TV is described. The capture catheter 10 and the delivery catheter 34 can be introduced into the right atrium above the tricuspid valve through the access sheath 80, as shown in FIG. 9B. The catheters 10 and 34 can be used to position the cutting region 54 of the cutting member 50 against the side of the clip C within the septal leaflet SL, as shown in FIG. 9C. The cutting member 50 can then be operated in any of the methods described above to excise the tissue of the septal leaflet SL in order to release the clip C and open the tricuspid valve, as shown in FIG. 9C. It is also possible to excise a portion of the clip C implanted within the anterior leaflet or to leave the clip in place prior to performing subsequent interventions on the valve.

[0046] Referring now to FIGS. 10A through 10E, generally as described above, a single valve clip C can be removed from the mitral valve MV by introducing the capture catheter 10 and the delivery catheter 34 into the left atrium using the transseptal sheath 74. Additionally, a clip removal catheter 90 can be introduced through the transseptal sheath 74 simultaneously with the capture catheter 10 and the delivery catheter 34 to engage and stabilize the clip C. As shown in FIG. 10A, the clip capture element 94 at the distal end of the operating wire 92 can be delivered through the lumen of the clip removal catheter 90 to capture the upper surface of the clip C. The cutting region 54 of the cutting number 50 is then used to excise tissue within the anterior leaflet AL while the clip is held and stabilized by the clip removal catheter 90, thus releasing the clip from the anterior leaflet. This is as shown in FIG. 10B (where the capture catheter 10 and the delivery catheter 34 are omitted for ease of explanation). The capture catheter 34 and the delivery catheter 10 may be repositioned as shown in FIG. 10C such that the cutting region 54 of the cutting member 50 is positioned relative to the posterior leaflet PL, and the cutting region can then be operated to excise tissue within 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 then be used to withdraw the clip C from the mitral valve, as shown in FIG. 10E. And the mitral valve MV is completely released from the implanted clip to receive a mitral valve prosthesis or to perform another corrective intervention.

[0047] While particular embodiments of the present 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 of the features and advantages 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, as well as their obvious modifications and equivalents. Additionally, while numerous variations have been shown and described in detail, other modifications that are within the scope of the present disclosure will be readily apparent to those skilled in the art based on the present disclosure. Various combinations or sub-combinations of the particular features and aspects of the embodiments may be made, and still be within the scope of the present disclosure, which is also contemplated. Accordingly, it should be understood that the various features and aspects of the disclosed embodiments may be combined or replaced with one another in order to form various modes of the present disclosure. For this reason, it is intended that the scope of the present disclosure as disclosed herein should not be limited by the particular disclosed embodiments described above. For all of the above embodiments, the steps of any method need not be executed continuously.

Claims

1. A system for excising an implanted clip approaching opposing leaflets within a heart valve, the system comprising: A capture catheter configured to be introduced into the heart chamber adjacent to the leaflet on one side of the clip; A delivery catheter configured to be introduced into the heart chamber adjacent to the leaflet on the opposite side of the clip; A cutting member configured to be disposed from the delivery catheter to the capture catheter to place a cutting member against tissue of at least one of the leaflets for excising the clip; Comprising; The system, wherein the cutting member comprises a cutting zone formed of a non-insulated conductive member in contact with both a first radiopaque marker and a second radiopaque marker on both sides.

2. The system according to claim 1, wherein the cutting zone further comprises a high-frequency electrode, a wear region, or a sharp blade region for cutting valve tissue.

3. The system according to claim 2, wherein the high-frequency electrode comprises an elongated body having a wire-like configuration.

4. The system according to claim 1, wherein each of the capture catheter and the delivery catheter has an operable distal tip.

5. The system according to claim 1, wherein the capture catheter has a magnetic distal tip.

6. The system according to claim 5, wherein the cutting member is carried by the delivery catheter and has a magnetic element exposed at the distal end of the delivery catheter such that the capture catheter can capture the cutting member by operating the position of the delivery catheter within the heart chamber.

7. The system according to claim 1, further comprising a clip removal catheter having a distal end configured to engage and capture the clip.

8. The system according to claim 1, further comprising a delivery sheath configured to introduce the capture catheter and the delivery catheter into the heart chamber.

9. The system according to claim 8, wherein the delivery sheath has a lumen sized to simultaneously accommodate both the capture catheter and the delivery catheter.

10. The system according to claim 1, wherein the system further comprises a delivery sheath, and the delivery sheath comprises a transseptal sheath.

11. The system according to claim 1, wherein the system further comprises a delivery sheath, and the delivery sheath comprises a transapical sheath.

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