Devices and methods for preparing valves for transcatheter valve replacement procedures

Abstract

Aspects of the present disclosure include methods, systems, and devices for severing and optionally removing at least a portion of a heart valve leaflet. The leaflets may be partially or completely removed, or otherwise removed, and the leaflets may be severed or opened in a manner that avoids coronary occlusion, LVOT occlusion, or access challenges in a procedure in which a prosthetic valve is to be implanted within a previously implanted prosthetic valve. Aspects of the present disclosure also relate to various devices and methods for disabling one or more valve ligation devices to provide an unobstructed valve opening so that a prosthetic heart valve can be implanted within the opening. The one or more ligation devices are disabled by removing the one or more ligation devices or severing a leaflet so that the ligated leaflet can be separated. In some embodiments, the one or more ligation devices are severed to disable the one or more ligation devices.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This non-provisional patent application claims the benefit of the filing dates of U.S. Provisional Patent Application Serial No. 62 / 829,234, filed on April 4, 2019; U.S. Provisional Patent Application Serial No. 62 / 767,025, filed on November 14, 2018; and U.S. Provisional Patent Application Serial No. 62 / 767,026, filed on November 14, 2018, the entire teachings of which are incorporated herein by reference. Technical Field

[0003] The present technology generally relates to devices and methods for severing and optionally removing at least a portion of one or more heart valve leaflets, including disabling and / or removing one or more valve fastening devices (if present), so that (if desired) the valve is prepared for a subsequent procedure, such as implanting a stented prosthetic heart valve into the opening of the treated valve. Background Art

[0004] Prior to implantation of a surgical aortic valve implant, the native aortic leaflets are surgically removed. However, in a transcatheter aortic valve (TAV) procedure, the native leaflets (or graduated valve leaflets in a prosthetic valve in a prosthetic valve procedure) are retained. When the TAV is placed in position, the remaining leaflets fold upward into the aortic wall. Depending on the specific patient anatomy (e.g., coronary height), valve placement, and other factors, the displaced leaflets may become positioned against the aorta such that they block the coronary orifice and severely obstruct flow or provide challenging access to the coronary for future percutaneous coronary intervention procedures. Additionally or alternatively, a large portion of the native leaflets (or graduated valve leaflets in a prosthetic valve in a prosthetic valve procedure) may reduce the effective orifice area (EOA) of the TAV and may therefore adversely affect the gradient across the valve (particularly, for patients with small annuli).

[0005] Clinicians have begun to address this problem by segmenting the displaced leaflets so that they open when pinned against the aorta, thereby allowing full opening of the native valve for replacement.

[0006] Prior to implantation of a surgical mitral valve implant, the native mitral valve leaflets are surgically removed. However, in a transcatheter mitral valve (TMV) procedure, the native leaflets (or the indexed valve leaflets in a prosthetic valve in a prosthetic valve procedure) are retained. The remaining anterior mitral valve leaflets (especially if the leaflets are unusually long) can fold anteriorly into the left ventricular outflow tract (LVOT), causing obstruction of systolic anterior motion (SAM), or posteriorly lie beneath the TMV device, thereby affecting valve performance (transvalvular flow obstruction). Various means of cutting and / or removing the leaflets or portions thereof to manage this problem are described herein.

[0007] Various types of clips and surgical sutures (e.g., Alfieri stitches) are used to provide edge-to-edge mitral valve repair. These techniques are used to reduce regurgitation of a diseased mitral valve by clamping the anterior and posterior leaflets together at one or more locations. Although such devices and methods are generally clinically successful in reducing regurgitation, there are situations in which such devices and methods do not adequately reduce regurgitation or the devices fail over time and require subsequent intervention. As transcatheter mitral valve replacement (TMVR) advances and gains regulatory approval and is therefore more widely used, there will be situations in which repair patients will benefit from the placement of a TMVR. However, prior to placement of a TMVR, the previously implanted clip or surgical repair suture needs to be removed or disabled to allow full opening of the native valve for replacement.

[0008] The present disclosure provides devices and methods for severing and optionally removing at least a portion of one or more heart valve leaflets in preparation for a transcatheter valve replacement procedure. In addition, the present disclosure provides devices and methods for disabling and / or removing valve ligation devices in preparation for a transcatheter valve replacement procedure. Further, the present disclosure addresses the problems and limitations associated with the related art. Summary of the invention

[0009] Aspects of the present disclosure are generally directed to valve preparation devices, systems, and methods suitable for severing and optionally removing cusp or leaflet tissue in preparation for implantation of an artificial heart valve. The leaflets may be severed and retained, partially removed, or completely removed, or otherwise removed, and the leaflets may be severed or opened in a manner that avoids coronary occlusion, LVOT occlusion, or access challenges during a procedure in which the artificial valve is to be implanted within a native or previously implanted artificial valve. It is believed that once an artificial heart valve is implanted within a leaflet prepared by the disclosed devices and methods, such devices and methods will reduce coronary flow or LVOT occlusion.

[0010] Aspects of the present disclosure also generally relate to valve preparation devices, systems and methods suitable for removing / disabling valve fastening devices and / or releasing fastened valve leaflets. In this way, an artificial heart valve can be implanted in the opening of a previously fastened valve between the released leaflets (or another intervention procedure can be performed).

[0011] One aspect of the present disclosure includes a valve preparation device, comprising an outer catheter; an inner catheter that can slide coaxially within the outer catheter; a balloon that is fixed to the inner catheter; and an electrode that extends along the length of the balloon. In one embodiment, the device further includes a plurality of electrodes that extend along the length of the balloon.

[0012] Aspects of the present disclosure further include methods of preparing a heart valve having a plurality of leaflets and a valve opening. The method includes providing a valve preparation device, the valve preparation device including an outer catheter; an inner catheter, the inner catheter being coaxially slidable within the outer catheter; a balloon, the balloon being secured to the inner catheter; and an electrode, the electrode extending along the length of the balloon. The method includes delivering the valve preparation device to a first leaflet of the plurality of leaflets and aligning the electrode with an area of ​​the first leaflet to be severed. The balloon is at least partially inflated and the electrode is actuated to create a first slit in the first leaflet.

[0013] Another aspect of the present disclosure includes a valve preparation device comprising an inner catheter coaxially aligned and at least partially positioned within the outer catheter; and a first jaw pivotally connected to a second jaw. The first and second jaws extend from the inner catheter. Each jaw defines an edge. The first and second jaws have a closed arrangement in which the edges contact and an open arrangement in which the first and second jaws are open relative to each other. The device further includes a first cutting element connected to the second jaw.

[0014] Aspects of the present disclosure further include a method for preparing a heart valve of a patient, the heart valve having a plurality of leaflets and a valve opening. The method includes providing a valve preparation device, the valve preparation device including an outer catheter; an inner catheter, the inner catheter coaxially aligned and at least partially positioned within the outer catheter; and a first jaw, the first jaw pivotally connected to a second jaw. The first and second jaws extend from the inner portion, and each jaw defines an edge. The first and second jaws have a closed arrangement in which the edges are in contact and an open arrangement in which the first and second jaws are open relative to each other. The device further includes a cutting element connected to the second jaw. The method further includes delivering the valve preparation device to the heart valve, and then proximally retracting the outer catheter and converting the first and second jaws to an open arrangement. The method includes inserting one of the first and second jaws into the valve opening to position a first leaflet of the plurality of leaflets between the first jaw and the second jaw and cutting at least a portion of the first leaflet with the cutting element.

[0015] In one aspect, the present disclosure provides valve preparation devices and methods for grasping and severing the anterior mitral valve leaflet or a portion thereof before or after deployment of a TMVR.

[0016] In one aspect, the present disclosure provides a valve preparation device comprising an outer catheter; an inner catheter coaxially aligned and at least partially positioned within the outer catheter; and a first jaw pivotally connected to a second jaw. The first and second jaws extend from the inner catheter, and each jaw defines an edge. The first and second jaws have a closed arrangement in which the edges are in contact and an open arrangement in which the first and second jaws are open relative to each other.

[0017] In another aspect, the present disclosure provides a valve preparation device, comprising a catheter; a U-shaped hook positioned in the catheter; and an electrode assembly positioned at least partially in the catheter. The electrode assembly comprises a first arm and a second arm; each arm comprises a curved portion and an electrode positioned at the curved portion.

[0018] In another aspect, the present disclosure provides a valve preparation device comprising a catheter having a distal end. In addition, the device comprises a plurality of loops for positioning and orienting the cutting element relative to the leaflet to be cut. The loop has a delivery arrangement in which the loop has a first diameter. The loop also has a deployment arrangement in which the loop has a second diameter and extends from the distal end. The device further comprises a plurality of detectors, thereby allowing multiple simultaneous cuts to be made in each leaflet. The detectors have a delivery arrangement in which the detectors are positioned proximally relative to the distal end and a deployment arrangement in which the detectors extend distally relative to the distal end. Each detector is a tube in which a cutting element is positioned.

[0019] In yet another aspect, the present disclosure provides a method for removing a portion of at least one leaflet of a heart valve. The method may include providing a device as disclosed herein and guiding the device to the leaflet. In some embodiments, a gripper is used to guide a catheter of the device. Once the device is in place, the method includes cutting off the leaflet. The method may further include implanting a stented artificial heart valve into the treated valve.

[0020] In yet another aspect, the present disclosure relates to a valve preparation device comprising a catheter having a distal end and a proximal end, the catheter further comprising an inflation lumen. The device further comprises a balloon positioned at the distal end of the catheter and in fluid communication with the inflation lumen. The balloon has one or more electrodes for cutting leaflet tissue.

[0021] In yet another aspect, the present disclosure relates to a method for treating a calcified leaflet. The method comprises providing a valve preparation device comprising a catheter having a distal end and a proximal end, the catheter further comprising an inflation lumen. The device further comprises a balloon positioned at the distal end of the catheter and in fluid communication with the inflation lumen. The balloon has one or more electrodes for cutting leaflet tissue. The method comprises: delivering the balloon in a deflated arrangement to a valve; at least partially inflating the balloon; and energizing the electrodes to create a slit in at least one leaflet of the valve. The method may further comprise implanting a stented prosthetic heart valve within the treated valve.

[0022] In yet another aspect, the present disclosure provides a valve preparation device comprising a catheter comprising a first lumen, a second lumen, a third lumen, and a fourth lumen. The device further comprises: a first positioning arm extending within the first lumen and extending distally out of the catheter; and a second positioning arm extending within the second lumen and extending distally out of the catheter. The device further comprises a wire extending through both the third and fourth lumens, wherein the lumens maintain electrodes positioned distally of the catheter. The present disclosure comprises many other devices suitable for severing leaflet tissue to release a ligation device or removing the ligation device from a patient's body.

[0023] In yet another aspect, the present disclosure provides a method for treating a patient with a ligation device (such as a clip or suture) that interconnects a pair of heart valve leaflets (e.g., an anterior mitral leaflet and a posterior mitral leaflet of a mitral valve). The method includes providing a device that includes a catheter from which a cutting element extends, and the catheter guides the cutting element to the proximal side of the ligation device. The valve is cut with the cutting element proximal to the ligation device until the ligation device no longer blocks the opening. In some embodiments, the ligation device remains fixed to a leaflet in the patient's body, and in other embodiments, the ligation device is removed from the patient's body. The method may further include implanting a stented artificial heart valve into the opening.

[0024] The details of one or more aspects of the disclosure are set forth in the drawings and description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1A It is a partial perspective view of a valve preparation apparatus.

[0026] Figure 1B Includes optional rotary cutting mechanism Figure 1A A partial perspective view of a valve preparation apparatus.

[0027] Figure 1C Has an optional U-shaped channel for accommodating the rotary cutting mechanism Figure 1A A partial perspective view of a valve preparation apparatus.

[0028] Figure 2 Delivered to the aortic valve Figure 1A A partial perspective view of the device.

[0029] Figure 3 is a partial elevation view of a grasper that may be used to deliver the various devices disclosed herein.

[0030] Figure 4 is operably positioned proximal to the leaflets of a heart valve Figure 3 A partial image of the gripper.

[0031] Figure 5 is a partial perspective view of an alternative valve preparation device in an open configuration to engage a leaflet.

[0032] Fig. 6A is in a closed arrangement so that the leaflets are coapted Figure 5 A partial perspective view of the device.

[0033] Figure 6B With optional slidable cut-off element Figure 5-6A A partial perspective view of the device.

[0034] Figure 7 is in a closed configuration and rotated so that the leaflets wrap around the device Figure 5-6A A partial perspective view of the device.

[0035] Figure 8 yes Figure 5-6A and Figure 7 A partial perspective view of a device of , showing the outer catheter of the device in a distally advanced position with a cutting element passing through a leaflet to cut the leaflet.

[0036] Fig. 9 is a partial perspective view of an alternative valve preparation device including an outer catheter and an electrode assembly.

[0037] Fig.10 is advanced distally to puncture a leaflet Fig. 9 A partial perspective view of the guidewire of the device.

[0038] Fig.11 yes Figure 9-10 A partial perspective view of the device in which the outer catheter is advanced over the guidewire to the leaflet.

[0039] Fig.12 yes Figure 9-11 A partial perspective view of the device in which the U-shaped hook is advanced distally from the outer catheter to engage the leaflet.

[0040] Fig.13 yes Figure 9-12 A partial perspective view of a device in which the outer catheter has been withdrawn proximally to expose the electrode assembly.

[0041] Fig.14 yes Figure 9-13 A partial perspective view of the device in which the electrode assembly has severed the lobule tissue and the severed tissue is held by the U-shaped hook.

[0042] Fig.15 is used to Figure 9-14 A partial perspective view of a containment sheath advanced distally over the device to enclose the device as the device is withdrawn from the patient's body.

[0043] Fig.16 is a partial perspective view of an alternative valve preparation device including a loop extending distally from an outer catheter.

[0044] Fig.17 yes Fig.16 A partial perspective view of a device showing multiple detectors extending from an outer catheter.

[0045] Fig.18 yes Figure 16-17 A partial perspective view of the device.

[0046] Fig.19 yes Figure 16-19 A partial bottom view of a device is shown and illustrates a cutting element (such as a blade) that can be set within each detector in the detector.

[0047] Fig. 20 is a schematic illustration of one possible result of the process of the present disclosure, wherein Figure 16-19 The device forms slits in all three leaflets.

[0048] Fig.21A is a perspective view of an alternative valve preparation device.

[0049] Figures 21B-21C yes Fig.21B Perspective view of the distal end of a valve preparation device.

[0050] Fig.21D Is in delivery confirmation Figures 21A-21C Perspective view of a valve preparation apparatus.

[0051] Figures 22A-22F Demonstrated the use of Figures 21A-21C An example method of an apparatus.

[0052] Fig.23 is included Figure 1A Schematic illustration of a valve preparation apparatus and a system for supporting a frame of leaflets positioned within a valve opening during a procedure of the present disclosure.

[0053] Fig.24A is a partial perspective view of an alternative valve preparation apparatus having a catheter and a balloon in a deflated arrangement, the balloon containing at least one electrode.

[0054] Fig. 24B is a device having a balloon in an inflated configuration Fig.24A A partial perspective view of the device.

[0055] Fig.24C yes Fig.24A Schematic illustration of an enlarged cross-section of a balloon.

[0056] Figures 25A-25D Demonstrated the use of Figures 24A-24C An example method of an apparatus.

[0057] Fig.26 is a partial side schematic illustration of an alternative balloon having a plurality of electrodes arranged longitudinally along and around the circumference of the balloon.

[0058] Fig. 27 yes Fig.24A An example of the internal configuration of a catheter of the device.

[0059] Fig.28 yes Fig.24A An optional helical configuration of the balloon of the device.

[0060] Figures 29A-29C Alternative devices comprising a balloon with electrodes and methods of treating leaflets with the electrodes are presented.

[0061] Fig.30 is a partial perspective illustration of an alternative device.

[0062] Fig.31 is a schematic illustration of a mitral valve in which a ligation device (clip) has been implanted that connects the anterior mitral valve leaflet to the posterior mitral valve leaflet.

[0063] Fig.32 yes Fig.31 Schematic illustration of a mitral valve showing placement of an incision or slit to be made in the mitral valve to separate the anterior and posterior leaflets according to various embodiments.

[0064] Fig.33 yes Fig.31 Schematic illustration of a mitral valve showing the placement of an incision or slit to be made in the mitral valve to remove a clip or other ligation device from the mitral valve according to various embodiments.

[0065] Fig.34 yes Fig.31 Schematic illustration of a mitral valve showing the placement of an incision or slit to be made in a ligation device to separate the anterior and posterior leaflets.

[0066] Fig.35 A portion of a disabling device and a method of disabling a clip or other ligation device by removing the ligation device from a patient's body using the disabling device are schematically illustrated.

[0067] Fig.36 A portion of a disabling device and a method of disabling a clip or other ligation device by removing the ligation device from a patient's body using the disabling device are schematically illustrated.

[0068] Fig.37 is a partial schematic illustration of an alternative disabling device having an inner catheter and first and second jaws, the disabling device being in a position to remove a ligation device from Fig.31 during the process of mitral valve removal.

[0069] Fig.38 The ligation device has been connected Fig.37 Schematic illustration of a disabling device.

[0070] Fig.39 yes Figure 37-38 Schematic illustration of a disabling device further comprising an outer catheter having a distal end with a cutting element positioned over the inner catheter.

[0071] Fig.40A The device is advanced through both the anterior and posterior leaflets of the mitral valve, and an incision is formed around the ligation device to surround 360 degrees so that the ligation device can be removed from the mitral valve. Figure 37-39 Schematic illustration of a shut-off element of a disabling device.

[0072] Fig.40B The ligation device is disabled by advancing through one leaflet of the mitral valve and forming an incision around the ligation device that encompasses approximately 180 degrees. Figure 37-39 Schematic illustration of a shut-off element of a disabling device.

[0073] Fig.41 are flow charts illustrating various methods of the present disclosure.

[0074] Fig.42 is a perspective view of an alternative device including a handle assembly and two jaws, one of which includes a cutting element.

[0075] Fig.43 yes Fig.42 A cross-sectional view of a handle assembly.

[0076] Fig.44 yes Fig.42 A perspective view of the jaws of the device.

[0077] Fig.45 yes Fig.44 Cross-sectional view of.

[0078] Fig.46 yes Fig.42 A partial side view of the device showing the jaws in an open arrangement.

[0079] Fig.47 yes Fig.46 A partial side view of the device showing the jaws in a closed arrangement.

[0080] Fig.48 With the jaws in an open configuration Fig.46 A perspective view of the device.

[0081] Fig.49 yes Fig.46 A cross-sectional view of one jaw of the device.

[0082] Figure 50-56 Demonstrated the use of Figure 42-49 An example method of an apparatus.

[0083] Fig.57 is a partial perspective view of an alternative device.

[0084] Figure 58-59 Demonstrated the use of Fig.57 An example method of an apparatus.

[0085] Fig.60 It is a partial perspective view of the positioning device.

[0086] Fig.61 is a partial perspective view of an alternative positioning device.

[0087] Fig.62 is a partial perspective view of an alternative device including a balloon and electrodes.

[0088] Fig.63 yes Fig.62 Schematic representation of the electrodes.

[0089] Figures 64-67 Demonstrated the use of Fig.62 An example method of an apparatus. DETAILED DESCRIPTION

[0090] Specific embodiments of the present disclosure are now described with reference to the accompanying drawings, wherein similar reference numerals indicate identical or functionally similar elements. In the following description, the terms "distal" and "proximal" are used with respect to a position or direction relative to a treating clinician. "Distal" or "distally" is a position away from a clinician or in a direction away from a clinician. "Proximal" and "proximally" are positions close to a clinician or in a direction toward a clinician.

[0091] Figure 1A-21 and 2 show a valve preparation device 100 and its variations. The valve preparation device 100 includes an inner catheter 102 and an outer catheter 104 coaxially arranged to slide over the inner catheter 102. At the distal end 106 of the inner catheter 102, first and second jaws 110, 112 are provided. The first jaw 110 is pivotally connected to the second jaw 112 so that the jaws 110, 112 can be selectively transformed from an open arrangement to a closed arrangement. In the open arrangement, the first jaw 110 is pivoted away from the second jaw 112, as shown in FIG. Figure 1A . In the closed arrangement, the first jaw 110 is oriented generally parallel to the second jaw 112, thereby minimizing the profile of the common jaws 110, 112. Actuating the first jaw 110 to the open arrangement can be accomplished in a variety of ways. For example, the first jaw 110 can be biased into the open arrangement with a spring or the like (not shown). An elongated member (e.g., a suture, a wire, etc., not shown) can be connected to the first jaw 110 to pull the first jaw 110 into the closed arrangement. When the tension in the elongated member is released, the first jaw 110 is transformed into the open arrangement due to the bias. The catheters 102, 104 are connected to a handle assembly 120 opposite the distal end 106. The handle assembly 120 can take a variety of forms capable of guiding the catheters 102, 104 during a vascular access procedure and include one or more actuators 122, 124 for controlling the movement of the valve preparation device 100 (e.g., the jaws 110 / 112 of the device 100, the catheters 102 / 104, the elongated member, or other elements) as desired.

[0092] To assist the valve preparation or disabling device 100 in severing a heart valve leaflet or cusp (referred to herein as L, L1, L2, AL, or PL), each jaw 110, 112 includes a body 130, 132 defining an edge 134, 136 having a cutting element 138, 140. In some embodiments, the edges 134, 136 and the jaws 110, 112 together form a clamshell shape defining a receiving area 142 therebetween. The cutting elements 138, 140 may span all or a portion of the respective edges 134, 136 as desired. In various embodiments, in a closed arrangement, the cutting elements 138, 140 contact. Each cutting element 138, 140 may be an electrode, a plasma electrode, a high frequency ultrasound, a resistive heating element, a cryoablation element, or a microwave energy element, or may be a mechanical cutter such as a blade. Optionally, to reduce the profile of device 100, the body 130, 132 of one or more jaws 110, 112 can be made of a shape memory foldable material (eg, nitinol wire mesh) and the corresponding edge 134, 136 can contain a wire (eg, nitinol wire).

[0093] In some embodiments ( Figure 1Band, unless expressly stated, are not Figure 1A The same), mechanical energy driven grinding of the leaflets captured within the receiving area 142 can be used as an alternative to removing large pieces of leaflets. For example, within the receiving area 142, the rotary cutter 115 can be slid distally and proximally within the receiving area 142 at one time by actuation of a pusher 117 having first and second plates 119a, 119b supporting the rotary cutter 115. When the jaws 110, 112 are in a closed arrangement, the rotary cutter 115 contacts the leaflets, and the grinding of the leaflets is caused by the rotational actuation of the pusher 117 in combination with the traverse. Optionally, the plates 119a, 119b can terminate at one or V-shaped sections 121. In one example, the rotary cutter 115 can include a plurality of cutting teeth 125 (generally referred to as) extending around its circumference.

[0094] Alternatively, in Figure 1C , the channel 113 of the second jaw 112 forms a U-shape within the body 132, thereby generally reflecting the path of the edge 136. The rotation and longitudinal movement of the rotary cutter 115' / pushers 117' grinds the section of the leaflet held by the jaws 110, 112. In one example, the rotary cutter 115' is positioned around a track 123, which is used to guide the rotary cutter 115' around the channel 113 when the rotary cutter 115' is pushed. In this embodiment, the rotary cutter 115' / pushers 117' are guided within the channel 113. The leaflet grinds can be pulled into one of the catheters 102, 104 by suction applied from the inner or outer catheters 102, 104, or can be captured by a filter (not shown) mounted on the periphery of one of the catheters 102, 104. In some embodiments, a portion of the removed leaflet can then be removed along with the removal of the jaws 110, 112. In one example, as with Figure 1B The rotary cutter 115' includes cutting teeth 125' (generally referred to as ) on its surface, as compared to the embodiment of the embodiment of the present invention around its circumference. It should be understood that unless expressly stated otherwise, Figure 1C Examples and Figure 1A The embodiments are configured identically.

[0095] use Figure 1A Valve preparation device 100 and Figure 1B or any modified device of 1C can be accomplished as follows. The device 100 is delivered to a heart valve V comprising a plurality of leaflets L1, L2, etc., via a retrograde approach with the jaws 110, 112 in a closed configuration. The heart valve V can be, for example, Figure 21 , and the like (for ease of illustration, only two valve leaflets L1 , L2 are visible). The first jaw 110 is pivoted away from the second jaw 112 to an open arrangement. The second jaw 112 is then inserted through the opening O of the heart valve V, through the leaflets L1 and L2, while the first jaw 110 remains on the opposite side of the leaflet L1. In this manner, the first jaw 110 and the second jaw 112 are positioned on opposite sides of the leaflet L1 so that the leaflet L1 is positioned in the receiving area 142. In various embodiments, when the electrodes or cutting elements 138, 140 span the entire respective edges 134, 136, the first and second jaws 110, 112 together define the receiving area 142, which is the area of ​​the leaflet L1 to be removed. Therefore, the first and second jaws 110, 112 are positioned around the leaflet L1 accordingly. Once in position, the jaws 110, 112 are brought into a closed arrangement together with the handle assembly 120 or otherwise. If necessary, the cutting elements 138, 140 are stimulated or otherwise actuated to achieve cutting / severing of the leaflet L1 at the area where one or more cutting elements 138, 140 or the first and second jaws 110, 112 contact. In some embodiments, where applicable, the rotary cutter 115 / pushers 117 (or 115', 117') are actuated to grind the leaflet L1. The device 100 can then be withdrawn from the patient's body in the same manner as the delivery device 100 with the cut portion of the leaflet L1 fixed between the two jaws 110, 112. The process can be repeated until one or more leaflets L1, L2, etc. are fully removed as desired. In some optional embodiments, a guide wire (not shown) is provided with the device 100 to stabilize and / or capture the edge of the leaflet L1 that is severed during use of the device 100.

[0096] Optionally, the valve preparation device 100 can be delivered to the heart valve V using a grasper or positioning device 150, the grasper or positioning device comprising a Figure 3-4154 are depicted in the figures with two jaws / arms 152, 154 associated with guidewires 156, 158, respectively (the arms 152 / 154 otherwise function the same as the jaws 110, 112 or any other jaws disclosed herein with respect to alternative embodiments). The two guide wires 156 and 158 serve as positioning rails on which the outer catheter 104 slides. The first arm 152 has a through lumen (not visible) from the proximal end (not shown) of the outer catheter 104 to the distal end of the first arm 152 that receives the first guidewire 156. The second arm 154 is associated with a rapid exchange lumen (not visible) mounted on the second arm 154 and extending along a portion of the second arm 154 and receiving the second guidewire 158. Alternatively, the second arm 154 is associated with a through lumen as is the first arm 152. In one embodiment, in order to use the grasper 150, the first guidewire 156 is advanced across the heart valve V and embedded in the ventricle VGW. The second guide wire 158 is placed in the coronary artery CA associated with the leaflet L1 to be severed. Figure 4 154) is advanced over the first and second guidewires 156, 158 and guides the outer catheter 104 so that the leaflet L1 is positioned between the two arms 152, 154 of the grasper 150. By actuating the grasper 150, the leaflet L1 is captured by the device as disclosed with respect to any valve preparation and disabling device embodiment of the present disclosure and is ready for manipulation (e.g., removal and / or cutting). An advantage of using the grasper 150 in the method of the present disclosure is that using the first and second arms 152, 154 together with the guidewires 156, 158 allows the device to be aligned with the leaflet L1 and ensures grasping of the leaflet with minimal reliance on imaging techniques. The positioning of the guidewire 158 in the coronary artery CA further ensures that the associated slit or removed leaflet material is rotationally aligned with the associated coronary ostium of the associated coronary artery CA. In addition, a slight proximal pull on the outer catheter 204 by the clinician after grasping the corresponding leaflet L1 with the grasper 150 can provide the clinician with tactile feedback that the leaflet L1 is actually captured.

[0097] Now also refer to Figure 5-8 , which shows an alternative valve preparation or disabling device 200 comprising an inner catheter 202 and an outer catheter 204 coaxially arranged to slide over the inner catheter 202. Similar to the previous embodiments, at the distal end 206 of the inner catheter 202, first and second jaws 210, 212 are provided with a receiving area 242 defined therebetween. The first jaw 210 is pivotally connected to the second jaw 212 so that the jaws 210, 212 can be selectively moved from an open position ( Figure 5 ) into a closed arrangement ( Fig. 6A). In the open arrangement, the first jaw 210 is pivoted away from the second jaw 212 so that the leaflet L can be received between the jaws 210, 212. In the closed arrangement, the first jaw 210 is oriented generally parallel to the second jaw 212. Actuating the first jaw 210 to the open arrangement can be accomplished in a variety of ways, including with respect to Figure 1A-2 , etc., described in the manner of the previous embodiments of the present invention. Optionally, the first and / or second jaws 210, 212 can include a plurality of teeth for engaging the leaflet L and can each include a cutting element (not visible) that can be similarly configured as the cutting elements 138, 140. The outer catheter 204 includes a cutting element 260 at the distal end 206, etc. The cutting element 260 can include a mechanical cutter, such as a cork boring knife edge (as shown), an electrode, or any of the cutting elements disclosed with respect to the previous embodiments. Distal advancement of the outer catheter 204 relative to the inner catheter 202 can sever tissue, as will be discussed in more detail below.

[0098] In one example, use of the valve preparation or disabling device 200 can be accomplished as follows. Figure 2 The first jaw 210 is pivoted away from the second jaw 212 to an open position. The second jaw 212 is then inserted through the valve opening O, through the leaflet L, while the first jaw 210 remains on the opposite side of the leaflet L. In this manner, the first jaw 210 and the second jaw 212 are positioned on opposite sides of a single leaflet L (see also FIG. Figure 2). The first and second jaws 210, 212 are positioned proximal to the section of the leaflet L to be cut or removed. Once in position, the jaws 210, 212 are brought together into a closed arrangement. If the desired amount of tissue to be removed exceeds the amount of tissue positioned between the first jaw 210 and the second jaw 212, the inner catheter 202 is rotated and the first and second jaws 210, 212 are thereby rotated to wrap the leaflet L around the outer surfaces of the jaws 210, 212. In one embodiment, the inner catheter 202 is rotated at least 1 degree to 360 degrees around the central axis of the device 200. In another embodiment, the inner catheter 202 is rotated within a range of 10 degrees to 180 degrees around the central axis of the device 200. Once the desired amount of the leaflet L to be removed is wrapped around the first and second jaws 210, 212, the outer catheter 204 is advanced distally over the inner catheter 202 and the jaws 210, 212 so that the cutting element passes through the leaflet L, thereby severing the leaflet L along the path. If necessary or in the case where the leaflet L is not wrapped around the jaws 210, 212, one or more cutting elements 138, 140 are actuated to achieve cutting of the leaflet L at the junction where the one or more cutting elements 138, 140 or the first and second jaws 210, 212 contact. The device 200 can then be withdrawn from the patient's body with the severed leaflets L fixed around the jaws 210, 212 and / or within the storage area 242 in the same manner as the delivery device 200. The process can be repeated until one or more leaflets L are sufficiently removed and / or severed as desired. In some optional embodiments, a guide wire (e.g., see other embodiments disclosed herein) is provided with the valve preparation device 200 to stabilize and / or capture the edges of the leaflets L that are severed during use of the device 200. In other embodiments, the valve preparation device 200 is provided with a grasper 150 and used in combination with the grasper as discussed above.

[0099] In yet another embodiment, the valve preparation device 200 is provided with a second slidable cutting element 263 ( Figure 6B ), the second slidable cutting element is configured to cut the leaflet L on one side of the jaws 210, 212 after the jaws 210, 212 initially engage the leaflet L ( Fig. 6A). In this case, the cross-section of the cutting element 262 is a semicircular or flat blade positioned on one side of the outer catheter 204 so that only tissue on one side of the leaflet L relative to the closed jaws 210, 212 is cut. After cutting, the cutting element 263 is retracted proximally to a position substantially (if not entirely) proximal to the jaws 210, 212. By rotating the device 200 about the central axis, the uncut side of the leaflet will be free to roll up onto the jaws 210, 212. This approach may be beneficial in situations where the leaflet L is calcified, because calcified leaflets may have a low degree of elasticity and therefore require a high force to gather onto the jaws 210, 212. In addition, if a high force is required to gather the leaflet L onto the jaws 210, 212 by twisting, it may be difficult to transmit such a high force to the distal end of the inner catheter 202. By cutting the leaflet L before rotating the device 200, the required force should be reduced. In this method, the device 200 can be provided with the grasper 150 and optionally used in combination with the grasper 150 as discussed above. Once the valve preparation device 200 has been rotated, the cutting element 263 is again advanced to make a second cut, first ensuring that the cutting element 263 is rotationally aligned with the uncut, gathered leaflet L tissue.

[0100] Now also refer to Figure 9-15 , which shows yet another valve preparation or disabling device 300. The device 300 includes an external delivery catheter 304 and an electrode assembly 360. The electrode assembly 360 includes first and second arms 362, 364 made of a shape memory material (e.g., a shape memory metal such as Nitinol). Each arm 362, 364 terminates and joins at a distal end 366 that may include a cap 366 that joins the two arms 362, 364. The arms 362, 364 are biased to Fig. 9 364, wherein the arms 362, 364 flare outwardly relative to the delivery catheter 304 and change direction at the bends 368, 370. At each bend 368, 370, an electrode 372, 374 may be provided.

[0101] In one embodiment, use of the valve preparation device 300 may be accomplished as follows. A guide catheter (not shown) may be passed through a retrograde approach to the corresponding leaflet L1 and advanced through the guide catheter to the leaflet L1 and guided through the leaflet L1 as shown in FIG. Fig.10The guidewire 376 may be delivered by puncturing leaflet L1 (i.e., creating a hole in the leaflet) via the approach generally depicted in FIG. 1 . The guidewire 376 may be a standard guidewire, or may be a charged guidewire having an exposed electrode tip that may be introduced, for example, via a guide catheter. The guide catheter may be a separate catheter, or the delivery catheter 304 may be provided with a guidewire lumen and provide the same functionality as the guide catheter described. In an alternative embodiment, a radiofrequency ("RF") tip catheter (not shown) may be used to create the leaflet L1 hole or puncture P. The heart valve V may be, for example, as Figure 10-15 . In one embodiment, the guide catheter and / or the charged guidewire 376 create a puncture P in the leaflet L1 to be cut. Once the puncture P is made, several options for placing the device 300 are possible. In one embodiment, both the guidewire 376 and the guide catheter are removed, and the delivery catheter 304 is advanced and brought to (or even passed through) the puncture P in the corresponding leaflet. L1 In another embodiment, the guidewire 376 is maintained in place through the leaflet L1, and the guide catheter is removed. The delivery catheter 304 is then delivered over the charged guidewire to ensure that the delivery catheter 304 is in the proper position at the leaflet puncture P. In yet another embodiment, the guide catheter is advanced (or through the puncture P), and the guidewire 376 is removed. The delivery catheter 304 is then delivered through the guide catheter that is then removed, and the delivery catheter 304 is then in the proper position. In yet another embodiment, the delivery catheter 304 provides the guide catheter function, and thus eliminates the need to exchange the guide catheter with the delivery catheter 304.

[0102] Other alternative methods include forming the puncture P with the electrode assembly 360. In a first method, the delivery catheter 304 is pushed upward against the leaflet L1 so that as the electrode assembly 360 is advanced distally, the leading edge of the electrode assembly 360 includes two electrodes 372 and 374. Because the two electrodes are constrained by the delivery catheter 304 when they first exit the catheter at the distal end 306 of the catheter 304, they behave like a single electrode and can be energized to create the puncture P. In a second alternative, the electrode assembly 360 is loaded so that the leading edge includes an end cap 366, which can include a sharp mechanical puncture element or an electrode that can be energized to puncture the leaflet L1 to form the puncture P.

[0103] In some embodiments, after puncture P is formed, delivery catheter 304 is delivered over guidewire 376 to the location of puncture P such that distal end 306 of delivery catheter 304 is adjacent to leaflet L1 ( Fig.11In the delivery arrangement, the electrode assembly 360 is completely positioned within the delivery catheter 304 (i.e., the electrode assembly 360 including the electrodes 372, 374 is completely positioned proximally relative to the distal end 306 of the delivery catheter 304). Once the delivery catheter 304 is in position ( Fig.11 ), so that the distal end 306 of the delivery catheter 304 contacts the corresponding leaflet L1, the guide wire 376 is removed and the U-shaped hook 378 is advanced through the delivery catheter 304 to pierce the leaflet slit and engage the portion of the leaflet L1 to be cut / removed ( Fig.12 Alternatively, the guidewire 376 may be left in place during this step ( Fig.12 304 is then retracted proximally to provide sufficient space for the electrode assembly 360 to be withdrawn distally from the distal end 306 of the delivery catheter 304, as shown. Fig.13 . The electrode assembly 360 is advanced distally through the delivery catheter 304 until the electrodes 372, 374 contact the leaflet L1. The electrodes 372, 374 are then energized to cut the leaflet L1, and further optionally guided along the leaflet L1 to enlarge the incision in the direction of the valve opening O. Due to the offset nature of the arms 362, 364, the portion of the leaflet L1 surrounding the segment SEC enlarges as the incision becomes larger ( Fig.14 ), because the shape memory material of the arms 362, 364 biases the electrodes 372, 374 further and further apart as the electrodes 372, 374 are deployed further distally relative to the delivery catheter 304. Alternatively, the electrodes 372, 374 may be advanced through the same cutout surrounded by the U-shaped hook 378 before the incision is enlarged. In one embodiment, the resulting leaflet segment SEC that is cut away is tapered or generally triangularly shaped ( Fig.14 Once the segment SEC of the leaflet L1 is cut away, the U-shaped hook 378 is positioned between the first and second arms 362, 364 and can lift the segment of the leaflet L1 proximally for removal ( Fig.14 In some embodiments, a coaxially positioned delivery catheter 304 is provided ( Fig.15 , however, the delivery catheter 304 is Fig.15304). The retrieval sheath 380 can have a distal portion 382 that is enlarged in diameter compared to the proximal portion 384 of the delivery catheter 304. The distal portion 382 of the retrieval sheath 380 is advanced over the exposed electrode assembly 360 and U-shaped hook 378 to compress and cover those elements for removal in the same manner as they were delivered. The process can be repeated until one or more leaflets L1, L2, etc. are sufficiently removed as desired.

[0104] Now also refer to Figure 16-20 , which shows yet another embodiment of a valve preparation or disabling device 400. In this embodiment, the valve preparation device 400 includes an outer catheter 404 containing a plurality of loops 490 (e.g., three loops). The loops 490 are maintained within the outer catheter 404 in a delivery arrangement and can be as Fig.16 404 to protrude from the distal end 406 of the outer catheter 404. The loop 490 can be formed, for example, of a wire material such as nitinol and is configured to align with the leaflets (cusps) L ​​of a heart valve V (e.g., an aortic valve). In this manner, as the loop 490 extends from the distal end 406, its diameter D expands. In one embodiment, one end of each wire forming each loop is fixed and the second end is advanced distally, causing the loop 490 to bend outward and its diameter D to expand. Once the loop 490 expands to Fig.16 In the arrangement shown in , the loops are each gently advanced and seated in the leaflets L, one loop 490 for each leaflet L. In another embodiment, one loop 490 may be advanced and seated in one leaflet L, and then the other two loops 490 may be advanced and seated in their respective leaflets L. In other words, the loops 490 may be seated sequentially.

[0105] The valve preparation device 400 further comprises an inner catheter 402 coaxial with the outer catheter 404. Associated with each loop 490 is a Figure 18-19 ( Fig.18 As best shown in FIG. 4A and FIG. 4B , one or more probes 492 (e.g., two) can be advanced from within the inner catheter 402 from the corresponding orifice 401 (generally referenced) within the corresponding loop 490. Each probe 492 is a tube containing a lumen 494 through which a cutting element 496 can be guided to puncture and sever or cut the corresponding leaflet L. Fig.19 Only one cut-off element 496 is shown in the figure, however, the other corresponding cut-off elements 496 can be configured in the same manner. As indicated by similar reference numerals, all detectors 492 are configured in the same manner. In the illustrated embodiment, the cut-off element 496 is as shown in FIG. Fig.19Examples of suitable cutting elements 496 include, but are not limited to, a sharp wire with a formed curl or barb that can puncture the leaflet L and then anchor through the leaflet, a wire connected to an RF energy source for puncturing the leaflet and cutting the leaflet, a rod or wire with a blade section that will remain in place in the leaflet once the wire has punctured and anchored through the respective leaflet.

[0106] A plurality of probes 492 extend from the distal end 406 and are directed to each leaflet L where it is desired to be cut. The probes 492 may have a pre-set curve or include a steering mechanism to direct them to the desired position on the respective leaflets. In one exemplary embodiment, one probe 492 is directed to the left coronary cusp / leaflet and one probe is directed to the right coronary cusp / leaflet. For each probe 18-19, the device 400 includes an inner catheter 402 nested within an outer catheter 404. As indicated above, the inner catheter 402 ensures that once the loop 490 is extended and seated within the leaflet L, the probes 492 are also directed within the respective leaflet L. Once seated in one or more leaflets L, each probe 492 delivers a cutting element 496.

[0107] Once all of the cutting elements 496 have punctured through the desired leaflets L (e.g., two punctures P are made per leaflet / cusp L), the inner catheter 402 is retracted, thereby causing simultaneous severing of the leaflets L. Severing / cutting may also be accomplished by RF energy or mechanical cutting with a sharp section 497 (e.g., a blade, etc.) of the cutting elements 496. Fig. 20 Slits S are shown in all three valve leaflets L of the valve V. However, it should be understood that more or fewer slits S may be formed while adequately ensuring coronary flow. It should also be understood that the slits S may be formed in only one or two leaflets L (specifically, the leaflets associated with the right and / or left coronary orifices) instead of all three leaflets. The slits S define a tissue flap F in the leaflets L that allows each leaflet L to be folded and / or pushed downward during deployment of the artificial heart valve. In another embodiment, as previously described, the leaflets L do not fold downward when pinned against the aorta but instead open. It should be understood that any of the devices of the present disclosure may be configured as described above. Fig. 20 The one shown in FIG. 1 is used to form slits and flaps in one or more leaflets.

[0108] Now also refer to Figures 21A-22F, which shows another embodiment of a valve preparation or disabling device 500. In this embodiment, the valve preparation device 500 has an inner catheter 502 and an outer catheter 504. The outer catheter 504 is coaxially aligned with the inner catheter 502 and is arranged to slide over the inner catheter. At the distal end 506 of the inner catheter 502 are a first jaw 510 and a second jaw 512, wherein the jaws 510, 512 can pivot relative to each other. In one example, the jaws 510, 512 are made of a flexible material (e.g., a plastic such as polyetheretherketone, nylon, etc.), which is optionally blended or coated with an opaque material. Attached to the second jaw 512 is a cutting element 538. In the embodiment shown, the cutting element 538 is an electrode 538 that can be energized to puncture and cut the corresponding leaflet L1 when the device 500 engages with the leaflet L1 and is pulled along the leaflet. In some embodiments, the cutting element 538 is spring biased to Fig.21B The electrode 538 is positioned at a position substantially parallel to the second jaw 512 (i.e., extending outwardly at an angle relative to the second jaw 512) and can be delivered in a delivery arrangement substantially parallel to the second jaw 512 and maintained in the delivery arrangement with compressive pressure applied from the first jaw 510. In some embodiments, severing or cutting is achieved by generating plasma on the electrode 538 via an external power source (not shown). For a monopolar design, an external counter electrode 539 (at Fig.21A ) is mounted on the patient's skin via a patch. For a bipolar design, a counter electrode 539 is mounted on the device 500. The first and second jaws 510, 512 can be made of, for example, a polymeric material or a mixture of a polymer and a metal. One purpose can be to balance the material of the jaws 510, 512 to have enough metal to be visible under fluoroscopy, but not so much metal that it interferes with the echogenicity of the device. In some embodiments, only a portion of the jaws 510, 512 that captures leaflet L1 is the distal portion containing the puncturing electrode 538, thereby allowing the electrode 538 to cut the leaflet L1 when it is pulled proximally relative to the leaflet L1 (in other words, if the device 500 does not clamp the leaflet L1 at a certain location, the jaws / electrodes 510, 512, 538 can only move relative to the leaflet L1).

[0109] An example method of using the valve preparation device 500 may include a closed arrangement in which the first and second jaws 510, 512 are drawn together into a cylindrical configuration and covered by an outer catheter 504 for delivery via a retrograde approach to a heart valve V having multiple leaflets L1, L2, etc. Fig.21D ) delivery device 500. With respect to the proximal side of leaflets L1, L2, jaws 510, 512 are transformed into, for example Fig. 21CThe jaws 510, 512 are shifted by retracting the outer catheter 504 so that the jaws 510, 512 spring into their natural biased positions. The second jaw 512 is then inserted through the valve opening O, passing through the leaflets L1, L2, while the first jaw 510 remains on opposite sides of the corresponding leaflet L1. In this way, the first jaw 510 and the second jaw 512 are positioned on opposite sides of a leaflet L1. Once the cutting element 538 is in the proper position, the cutting element 538 is actuated to first pierce the leaflet L1, and then the cutting element 538 can be pulled across the leaflet L1 to create a slit in the leaflet L1. The process can be repeated until one or more leaflets L1, L2 are sufficiently removed and / or severed as desired. In some embodiments, the valve preparation device 500 is delivered to a leaflet together with the grasper 150, as described above with respect to similar embodiments. In some embodiments, as Figures 22A-22C As shown in FIG. 5 , the device 500 can be guided by guide wires 156, 158. Fig.22A As shown in , one coronary guidewire 158 is placed in the right or left coronary artery and then the LV guidewire 156 is inserted into the left ventricle. The device 500 is then advanced over the two guidewires 156, 158 to the ascending aorta. Alternatively, the device 500 can be advanced over the coronary guidewire 158 to the ascending aorta, and the LV guidewire 156 can then be positioned (particularly if the device is combined with a steering mechanism). In addition, the device 500 can be advanced over the LV guidewire 156 without the use of the coronary guidewire 158. In this example, the outer catheter 504 can be used to inject contrast agent in order to determine the position of the jaws 510, 5132 within the aortic root. Specific reference Fig. 22C Once the device 500 is advanced into the aortic root so that the distal end of the first jaw 510 (the jaw on the proximal coronary side) is located in the belly of the leaflet L1, the positioning of the device 500 is configured by positioning and orienting the guidewires 156, 158. Fig.22D In the embodiment, the cutting element 538 (eg, electrode) is activated, thereby Fig.22E The cutting element 538 is activated again and retracted proximally to cut the corresponding leaflet L, as shown in FIG. Fig.22F As shown in .

[0110] Any of the devices disclosed herein may be configured to further include Fig.23Schematically shown in the figure is a part of a system 1 for stabilizing a frame 701 of leaflets L1, L2. Frame 701 can be a stented artificial heart valve to be implanted at the patient's failing heart valve, or can be any type of stent frame known in the art (such as a stent frame for an artificial heart valve) and is typically a metal mesh cylinder. Such a frame 701 has a compression arrangement and an expansion arrangement. Frame 701 can be made of a shape memory material to be biased to an expanded position, or can be mechanically expanded by a balloon or the like. In such a system 1 and related methods, frame 701 is positioned within the valve opening O and partially or fully expanded in any known manner. The partially expanded or expanded frame 701 limits and stops the movement of leaflets L1, L2, etc. to allow cutting or similar leaflet removal procedures to be completed. Therefore, during use, the valve preparation device 100 is positioned radially outward relative to both the frame 701 and the valve opening O. Once the leaflet severing and optional removal procedure is completed according to any of the embodiments disclosed above, the frame 701 is removed or can be implanted as a replacement stented prosthetic heart valve (if applicable). In some embodiments, the frame 701 can be deployed with a suture loop and then recaptured or deployed from approximately 2 / 3 of the capsule and then recaptured within the capsule for removal. In various embodiments, the inflow end of the frame includes a temporary valve to control blood flow during the procedure. In other various embodiments, the frame 701 can include positioning arms (not shown) to help position and / or grasp the leaflets L1, L2 for severing. In all disclosed methods, the temporary valve can be optionally deployed (not shown, for example in a mid-field position (Hufnagel position)) to provide blood flow management during the procedure. Although Fig.23 The valve preparation device 100 is shown in FIG. 1 , but it should be understood that the frame 701 can be used in conjunction with any of the valve preparation devices disclosed herein as part of the system 1 .

[0111] Now except Figures 24A-28 , which collectively illustrate components of another valve preparation or disabling device 800 and optional modifications to its components. The device 800 includes a catheter 802 (only a short length of which is shown) that can be used to deliver a valve to a handle (e.g., see Figure 1A Handle 120 or Fig.21A The catheter 802 extends proximally of the handle 501. At the distal end 806 of the catheter 802 is a balloon 810 made of a compliant elastic material. The balloon 810 has a deflation arrangement ( Fig.24A ) and inflation arrangement ( Fig. 24B). The device 800 further includes an inflation lumen 804a for connecting to an inflation source (not shown). The inflation lumen 804a can extend within the catheter 802 to the balloon 810 and can extend through the handle assembly or otherwise connect to the inflation source. The balloon 810 includes one or more cutting elements 838, such as electrodes, that longitudinally span the length of the balloon 810. In the case where the cutting elements 838 are electrodes, each electrode can include a lead (not visible) extending to the handle assembly. In one embodiment, when the balloon 810 is in an inflated arrangement, the balloon 810 (and therefore the electrodes 838) can be advanced and rotationally aligned to a desired position within the valve V (e.g., adjacent to the leaflet L, see Figures 25A-25D ), and can be selectively energized to sever one or more leaflets L so that slits are formed in the leaflets to cut or remove the leaflets. Optionally, balloon 810 can be partially inflated, then electrode 838 can be energized, and then balloon 810 can be further inflated so that outward movement of balloon 810 helps cut leaflet tissue.

[0112] There are many advantages to using one or more electrodes 838 for cutting / severing leaflets L. When one or more electrodes are used, the cutting function can be controlled independently of balloon inflation and the cutting function can be positioned by independently turning on the appropriate electrodes (one or more of 838), and the power of each electrode can be independently controlled. Additionally, because the electrodes can be turned off, safety can be further improved during introduction, delivery, and removal of the device, while the mechanical cutter maintains its cutting edge during introduction, delivery, and removal.

[0113] As in Fig.24C , each electrode 838 may optionally have a circular cross-section, and in addition, each electrode 838 may be provided with an insulator 840 spanning a portion of the circumference of the electrode 838 to direct the plasma outward rather than toward the interior of the balloon 810. In one embodiment, each insulator 840 spans approximately 180 degrees of the circumference of a respective electrode 838 along the full length of the electrode 838. Optionally, the electrode 838 may be constructed of a flat wire having a rectangular cross-section or a wire having an elliptical cross-section.

[0114] In embodiments where the balloon 810 includes a plurality of cutting elements 838 (i.e., electrodes), the electrodes 838 may be radially distributed around the circumference of the balloon 810. In one embodiment, six electrodes 838 are provided (see Fig.24C). Fewer or more electrodes 838 are also contemplated. If all are powered together, the electrodes 838 will provide six incisions in the treated valve V. Alternatively, the electrodes 838 can be powered individually and selectively energized in any amount and pattern desired. In this way, the catheter 802 will not need to be rotated to achieve multiple cuts or otherwise oriented.

[0115] Further imagine that Figures 24A-24B Each electrode 838 may be segmented by insulation or other means. Fig.26 As schematically shown in , each electrode 938 of the balloon 910 used in the device of the present disclosure (e.g., device 800) can be longitudinally subdivided into individually powered elements that can be selectively energized. In one illustrative example, a 9 mm long electrode 938 can be subdivided into three individually powered 3 mm long electrodes to allow 3, 6, 9 mm cuts to be made by energizing the appropriate number of electrodes depending on the anatomical needs.

[0116] The catheter 802 can take a variety of configurations. Fig. 27 In one optional configuration shown in , the catheter 802 includes three lumens 804a, 800b, 800c. The first lumen 804a can be used as an inflation lumen, the second lumen 804b can be configured to receive a guidewire, and the third lumen 804c can be used to provide blood flow when the balloon 810 is in an inflated arrangement and is otherwise configured to not block blood flow. The third lumen 804c communicates with the patient's blood vessels on both sides of the balloon 810 and thus allows blood to enter one side and exit the other side, thereby providing blood flow through the blood vessels during inflation of the balloon when the balloon might otherwise block blood flow.

[0117] The balloons of embodiments of the present disclosure may take on a variety of configurations. Fig.28 An alternative example is shown in FIG. 1010. In this example, the balloon 1010 can have a spiral shape when in the inflated arrangement. In this way, blood can flow from the proximal end of the balloon to the distal end in a spiral manner, and thus allow perfusion when the balloon 1010 is in the inflated arrangement. The balloon 1010 can include a plurality of Figures 24A-24B 26 show one or more cutting elements or electrodes similar to those described and, for example, other cutting elements or electrodes disclosed herein.

[0118] use Figures 24A-28 An example method of an embodiment of can include delivering a valve preparation device 800 in a deflated arrangement in which a balloon 810, 910, 1010 is deflated via a retrograde approach to a heart valve V having multiple leaflets L1, L2, etc. (see also Figures 25A-25D). Once the one or more cutting elements 838, 938 are in place, the one or more cutting elements 838, 938 are energized or otherwise activated to pierce the one or more leaflets and form slits in the one or more leaflets. The process may be repeated until the one or more leaflets L1, L2 are sufficiently removed and / or severed as desired. Optionally, the severance may be a partial severance that does not extend the full thickness of the leaflet but is sufficient to increase the flexibility or compliance of the corresponding leaflet. Figures 24A-28 The device can be further used with the grasper or positioning device disclosed herein.

[0119] In yet another embodiment, the cutting elements disclosed herein may be biased outwardly from the balloon. Figures 29A-29C 100. In this embodiment, the device 1100 includes an outer catheter 1102 that receives an inner catheter 1104 that supports a balloon 1110 having one or more cutting elements 1138. The balloon 1110 is made of a compliant material and operates similarly to those other balloons disclosed herein. The one or more cutting elements 1138 can be wire-form electrodes made of a memory shape material to bias outward relative to the balloon 1110 to enhance engagement with one or more leaflets L1, L2, etc. In one embodiment, at least one cutting element 1138 includes a proximal attachment ring 1140a attached to the inner catheter 1104 and a distal attachment ring 1140b positioned on the inner catheter 1104 distal to the balloon 1110. The distal attachment ring 1140b can slide along the inner catheter 1104 to account for the forward retraction of the cutting element 1138 when the balloon 1110 is expanded due to inflation. In one embodiment, only a certain section of the length of the cutting element 1138 is active or non-insulated (by an insulating coating). In one example, the section of the active cutting element is approximately half of the full length of the balloon 1110.

[0120] An exemplary method of the present disclosure includes puncturing a hole in leaflet L1 by any preferred method disclosed herein. Then, guidewire 1150 is positioned through a puncture / hole in leaflet L1, which may be formed in any manner disclosed herein, for example. In one example, outer catheter 1102 is tracked around the aortic arch to a position in the ascending aorta. Inner catheter 1104, which maintains balloon 1110, is pushed distally out of outer catheter 1102 and then advanced through the hole in leaflet L1 to a depth such that the active portion of cutting element 1138 extends from below the hole to above leaflet L1. In other words, balloon 1110 is positioned so that the active portion of cutting element 1138 is in contact with leaflet L1 or very close to the leaflet. In some examples, balloon 1110 may be rotationally oriented so that the cutting element is adjacent to the center of leaflet L1. Once cutting element 1138 is oriented as desired, cutting element 1138 may be activated to cut the corresponding leaflet L1. The procedure may be repeated on the same or any remaining leaflet as desired.

[0121] In one approach, the valve preparation devices disclosed herein can be used to manage the anterior mitral valve leaflet during a TMVR procedure, particularly where the leaflet is unusually long. If the leaflet is not properly managed, it can fold anteriorly into the LVOT, causing obstruction of systolic anterior motion (SAM), or posteriorly beneath the TMVR device, thereby affecting valve performance (transvalvular flow obstruction). Therefore, removal of the leaflet or portion thereof before or after the TMVR procedure would be advantageous for TMV function. For the mitral valve leaflet, some embodiments herein may reverse the mounting of the grasper / cutting element relative to the delivery catheter or outer catheter. For example, the jaws of any disclosed device may be configured for an apical approach relative to, for example, Figure 3-4 The catheter body shown in FIG. 1 is mounted, and the jaws of any disclosed device can be directed to, for example, Fig.30 The transseptal or aortic approach shown in FIG. 1 is reversed (so that the jaw opening faces the proximal end of the external catheter relative to the distal end). Specifically, Fig.30 A valve preparation or disabling device 1200 is shown and, unless otherwise specified, may be used in much the same manner as described herein. Figure 1A-2 The device 1200 includes a first jaw 1210 and a second jaw 1212 pivotally connected at a pivot point 1206 located at the distal end of the device 1200, distal to the outer catheter 1204. In this manner, the jaws 1210, 1212 can grasp the leaflets in the storage area 1242 during a transseptal or aortic approach. The jaws 1210, 1212 can be otherwise connected to the outer catheter 1204. Figure 1A-2 The jaws in the same configuration and perform the same function.

[0122] Another alternative is to align the grasper perpendicular to the centerline of the outer catheter. Compared to cutting or severing the aortic valve leaflets before the TAVR procedure, cutting or severing the mitral valve leaflets before the TMVR procedure may provide the advantage of reducing motion of the native valve leaflets, thereby allowing for easier grasping and severing of the leaflets. In one embodiment, as shown in FIG. Figure 5-8 As shown in FIG. 2 , a valve preparation apparatus 200 can be used to modify the anterior mitral valve leaflet to help prevent LVOT obstruction during a TMVR procedure.

[0123] Now except Fig.31 With reference to the invention, it is common to treat a diseased valve (e.g., mitral valve V) by fixing a pair of leaflets (e.g., the anterior leaflet AL and the posterior leaflet PL of the mitral valve) together in one or more locations with a fastening device C. Examples of the fastening device C include, but are not limited to, Or any other ligating clip, suture, etc. for securing to a valve (e.g., a mitral valve) for the purpose of preventing regurgitation. Similarly, the leaflets (e.g., AL, PL) can be surgically attached using an Alfieri needle (also known as a "bowtie procedure" or "edge-to-edge repair"). Although such clips C or other ligating devices are generally clinically successful in reducing regurgitation through the valve opening O, there are situations in which the ligating device does not adequately reduce regurgitation and requires subsequent intervention. As transcatheter mitral valve replacement (TMVR) advances, gains regulatory approval, and is therefore more widely used, there will be situations in which patients with ligating devices will benefit from the placement of a TMVR or some other interventional procedure by which the repair is effectively reversed. However, prior to placement of a TMVR, one or more previously implanted ligating devices C need to be removed or otherwise disabled to allow full opening of the native valve to implant a replacement (or perform another interventional procedure). Aspects of the present disclosure relate to disabling devices and methods for removing such a ligation device C and / or disabling a ligation device C spanning an opening O to interconnect valve leaflets (eg, mitral valve leaflets AL, PL).

[0124] Now except Fig.32 With reference to the above, in various embodiments, generally, the transcatheter valve preparation or disabling device of the present disclosure is used to sever / cut the anterior leaflet AL of the mitral valve V in a manner that releases a previously implanted clip C (or other ligation device) only from the anterior leaflet AL and attaches the clip C to the posterior leaflet PL. Conversely, the valve preparation or disabling device can be used to sever or cut only the posterior leaflet PL in a manner that attaches the clip C to the anterior leaflet AL. Fig.32Region A is shown where the anterior leaflet AL is to be severed to release the leaflets AL, PL and disable the clip C. In effect, severed region A transfers a small portion of the AP of the anterior leaflet AL (and the clip C) to the posterior leaflet PL, effectively "disabling" the clip C and allowing the opening O to fully open, thereby allowing a prosthetic heart valve (not shown) to be subsequently implanted within the opening O. In this manner, a portion of the AP effectively becomes part of the posterior leaflet PL after region A has been severed (or vice versa if the posterior leaflet PL is severed). In other words, after disabling the clip C or other ligation device, the opening O is unobstructed and ready to receive a replacement prosthetic mitral heart valve or to perform an interventional procedure on the mitral valve V.

[0125] Typically, in one variation or embodiment, a region A' surrounding the entire clip C is removed from the patient using a valve preparation or disabling device, said region including a portion AP and a portion PP of the posterior leaflet PL within region A' (see Fig.33 ). Therefore, the clip C is also removed from the patient's body. In this case, the valve preparation or disabling device further includes a device for grasping the leaflets AL, PL or the clip C before cutting off the leaflets AL, PL, so that the clip C can be removed from the patient's body after cutting off the leaflets AL, PL. Examples of suitable devices (not shown) include snares, spiral anchoring devices, etc. and other leaflet engagement elements disclosed herein. This embodiment may increase the complexity of the entire valve preparation or disabling device or system, but provides the benefit of completely removing the clip C from the mitral valve V for removal from the patient's body.

[0126] In yet another variation or embodiment, the valve preparation or disabling device may be used as Fig.34 Schematically shown in FIG. 4 is the cut ligation device C itself. In this way, the ligation device C (e.g., clip, suture, etc.) is cut into two pieces so that although a piece of the ligation device C remains connected to each leaflet AL, PL, the opening O is unobstructed so that a replacement artificial heart valve (not shown) can be implanted in the opening O.

[0127] exist Fig.35Schematically shown is a distal end of a suitable valve preparation or disabling device 10 for performing the methods of the present disclosure. The valve preparation or disabling device 10 includes a catheter 12 that can be relatively rigid to approach the clip C from the ventricle (e.g., a transatrial approach) or can be more flexible for a transseptal approach. The catheter 12 includes lumens 14, 16 for receiving two positioning posts 30, 32. The catheter 12 further includes lumens 18, 20 for receiving a lunar or circular shaped wire 36 having a cutting element (e.g., an electrode 38 configured to generate plasma), the wire 36 being installed between the two positioning posts 30, 32. It is contemplated that the electrode 38 can be replaced with other cutting elements capable of cutting the leaflets AL, PL to disable the clip C. In addition, the valve preparation or disabling device 10 includes another lumen 22 in which the clamp 40 can be positioned. The forceps 40 can be retracted proximally within the lumen 22 during valve preparation or delivery of the disabling device 10 and can be at least partially advanced distally out of the lumen 22 to grasp the clip C and any severed leaflet portions AP, PP proximal to the clip C for removal from the patient.

[0128] In one example, a patient has a mitral valve V that includes one or more clips C bridging the two "leaflets" AL, PL together near the midpoint of the opening O. In other embodiments, multiple clips C may be provided along the length of the opening O. Two positioning posts 30, 32 are slid through the opening O, one on either side of the opening O, with one clip C located between the positioning posts 30, 32. Once in position, the electrodes 38 are energized (e.g., with an FT10 power supply or other suitable RF generator, not shown) to produce a signal such as Fig.33 severing plasma on one side of the opening O at region A, as generally shown in FIG. Thus, in various embodiments, the electrode 38 extends more than 180 degrees and in some embodiments approximately 360 degrees around the wire 36 to effectively release portions of the AP, PP from the mitral valve V. It should be understood that many patients have more than one clip implanted along the length of the opening O and therefore the valve preparation or disabling device 10 can be used sequentially to remove all existing ligation devices in a similar manner.

[0129] Similarly, if Fig.36 The valve preparation or disabling device 10 ′ shown in FIG. Fig.35 The valve preparation or disabling device 10 of FIG. 1 is configured identically, except that a half-moon shaped wire 36' and electrode 38' replace the moon shaped wire 36 and electrode 38. In this example, two positioning posts 30, 32 are slid through the opening O, one on either side of the opening O, with one clip C located between the positioning posts 30, 32. Once in place, the electrode 38' is energized to produce a pressure drop as is generally described with respect to FIG. Fig.32The plasma shown and described cuts off one side of the opening O at region A. Therefore, the conduit 12' need not include Fig.35 The lumen 22 and clamp 40 of the embodiment are shown in FIG. 1 because the clip C will remain in the patient after being disabled. It should be understood that many patients have more than one ligation device implanted along the length of the opening O and therefore the valve preparation or disabling device 10 can be used sequentially to remove all ligation devices in a similar manner.

[0130] Further imagine that Figures 1A-1C The valve preparation or disabling device 100 disclosed above is suitable for use with the method for disabling the ligation device C. The valve preparation or disabling device 100 includes an inner catheter 102 and an outer catheter 104 coaxially arranged to slide over the inner catheter 102. At the distal end 106 of the inner catheter 102, first and second jaws 110, 112 are provided. The pivotally connected jaws 110, 112 can be selectively transformed from an open arrangement to a closed arrangement. In the open arrangement, the jaws 110, 112 are pivoted away from each other, such as Figure 1A . In the closed arrangement, the first jaw 110 is oriented generally parallel to the second jaw 112, thereby minimizing the profile of the common jaws 110, 112. Actuating the first jaw 110 to the open arrangement can be accomplished in a variety of ways. For example, the first jaw 110 can be biased into the open arrangement with a spring or the like (not shown). An elongated member (e.g., a suture, a wire, etc., not shown) can be connected to the first jaw 110 to pull the first jaw 110 into the closed arrangement. When the tension in the elongated member is released, the first jaw 110 is transformed into the open arrangement due to the bias. The catheters 102, 104 are connected to a handle assembly 120 opposite the distal end 106. As indicated above, the handle assembly 120 can take a variety of forms capable of guiding the catheters 102, 104 during a vascular access procedure and include one or more actuators 122, 124 for controlling the movement of the valve preparation or disabling device 100 (e.g., the jaws 110 / 112 of the valve preparation or disabling device 100, the catheters 102 / 104, the elongated member, or other elements) as desired.

[0131] To assist the valve preparation or disabling device 100 in severing one or more heart valve leaflets (referred to as L, L1, L2, AL, or PL) to release the valve leaflets that have been connected to the ligation device C, each jaw 110, 112 includes a body 130, 132 defining an edge 134, 136 having a cutting element 138, 140. In some embodiments, the edges 134, 136 and the jaws 110, 112 together form a clamshell shape defining a receiving area 142 therebetween. The cutting elements 138, 140 may span all or a portion of the respective edges 134, 136 as desired. In various embodiments, in a closed arrangement, the cutting elements 138, 140 contact. Each cutting element 138, 140 may be an electrode, a plasma electrode, a high frequency ultrasound, a resistive heating element, a cryoablation element, or a microwave energy element, or may be a mechanical cutter such as a blade. Optionally, to reduce the profile of the valve preparation or disabling device 100, the bodies 130, 132 of one or more jaws 110, 112 can be made of a memory shape foldable material (e.g., a nitinol wire mesh) and the corresponding edges 134, 136 can contain wires (e.g., nitinol wires).

[0132] exist Figure 1C In a variation of , channel 113 forms a U-shape within body 132, thereby generally reflecting the path of edge 136 of second jaw 112, and distal movement and actuation of rotary cutter 115' / pushers 117' grinds up a segment of the leaflet that is held by jaws 110, 112 and that can be removed with removal of jaws 110, 112 and optionally clip C (e.g., leaflet portions AP, PP). In one embodiment, pushers 117' are attachable to handle assembly 120 ( Figure 1A ) in the handle assembly 120 that can actuate the rotation of the pusher 117' and, correspondingly, the rotational cutter 115'. In this embodiment, the rotating cutter 115' / pusher 117' is guided within the channel 113. In one embodiment, a second motor (not shown) in the handle assembly 120 or, alternatively, an operator of the device 100 can pull the pusher 117' proximally to keep the rotating cutter 115' around the channel 113. The pusher 117' can optionally include a flexible sleeve (not shown) approximately the length of the channel 113 to maintain the pusher 117 in the channel 113. The leaflet abrasives can be pulled into one of the catheters 102, 104 by suction applied from the inner or outer catheters 102, 104, or can be captured by a filter (not shown) mounted on the periphery of one of the catheters 102, 104. It should be understood that unless expressly stated, the pusher 117' can be pulled into one of the catheters 102, 104 by suction applied from the inner or outer catheters 102, 104. Figure 1C The embodiments can be used with Figure 1AThe embodiments of are configured identically and can be used in a similar manner thereto. It should be further understood that Figure 1B The device can be used to disable the clip in a similar manner.

[0133] Use the valve preparation or disabling device 100 to produce Figure 31-34 One or more of the cut areas A, A' can be accomplished as follows. The valve preparation or disabling device 100 is delivered to the mitral valve V containing the first and second leaflets AL, PL in a closed arrangement via a transapical, transatrial approach or a transseptal or transapical approach. The jaws 110, 112 are pivoted away from each other to an open arrangement. The second jaw 112 is then inserted through the opening O, adjacent to a ligation device C, through the leaflets AL, PL, while the first jaw 110 remains on opposite sides of the leaflets AL, PL. In this manner, the first jaw 110 and the second jaw 112 are positioned on opposite sides of the leaflets AL, PL so that the ligation device C is positioned in the storage area 142. Once in position, the jaws 110, 112 are brought together into a closed arrangement in contact with one or more leaflets AL, PL. If necessary, the cutting elements 138, 140 are energized or otherwise actuated to effectuate cutting of the leaflets AL, PL at the area where one or more cutting elements 138, 140 or the first and second jaws 110, 112 contact. The valve preparation or disabling device 100 can then be withdrawn from the patient in the same manner as the delivery of the disabling device 100 in a closed arrangement with one or more severed portions of the leaflets AP, PP and the ligating device C secured between the areas of the two jaws 110, 112. The process can be repeated until the ligating device C is removed as desired.

[0134] Optionally, Figures 1A-1C The valve preparation or disabling device 100 may be equipped with a through lumen in each of the jaws / arms 152 and 154 (which otherwise function the same as jaws 110, 112), depicted as Figure 31. A valve preparation or disabling device 100 is provided in the embodiment of the present invention. Two guide wires 156 and 158 are associated with the jaws 152 and 154, respectively. The two guide wires 156 and 158 serve as positioning rails on which the outer catheter 104 slides. The first arm 152 has a through lumen (not visible) from the proximal end (not shown) of the outer catheter 104 to the distal end of the first arm 152 that receives the first guide wire 156. The second arm 154 is associated with a rapid exchange lumen mounted on the second arm 154 and extending along a portion of the second arm 154 and receiving the second guide wire 158. Alternatively, the second arm 154 is associated with a through lumen like the first arm 152. In one embodiment, to use the valve preparation or disabling device 100, two guide wires 156 and 158 are slid through the opening O, one guide wire on either side of the opening O, with one ligation device C located between the guide wires 156 and 158. The outer catheter 104 is then advanced over the first and second guidewires 156, 158 and directed to the ligation device C. Once the respective valve preparation or disabling device 100 is in place, the method of disabling the ligation device C may continue as described herein.

[0135] Return to reference Figures 21A-22F , which collectively illustrate a valve preparation or disabling device 500 that can be used to disable the ligation device C. Unless otherwise specified, the valve preparation or disabling device 500 can be used with Figures 1A-1C . In this embodiment, the valve preparation or disabling device 500 includes a handle assembly 501, an inner catheter 502 and an outer catheter 504. The outer catheter 504 is coaxially aligned with the inner catheter 502 and is arranged to slide over the inner catheter. At the distal end 506 of the inner catheter 502 are a first jaw 510 and a second jaw 512, wherein the jaws 510, 512 can pivot relative to each other. In one embodiment, the jaws 510, 512 and the inner catheter 502 are non-movably attached to each other proximal to the handle assembly 501. In one embodiment, the jaws 510, 512 include a mating feature 511 (generally referred to as ) that may include grooves and teeth, which cooperate when the jaws 510, 512 are opened and closed to help align the jaws 510, 512 when the jaws move. In some embodiments, the cutting element 538 includes a first end 539a and a second end 539b (see specifically Figures 22D-22F In one embodiment, the cut-off element 538 is spring biased to Fig.21B The position of the first end 539a (i.e., the first end 539a extends away from the second jaw 512, wherein the second end 539b is maintained within the jaw 512). In one embodiment, the biasing function is provided by the spring portion 539c formed by the cutting element 538. The pin 541 ( Figures 22D-22F) can be disposed within spring portion 539c to maintain and bias cutting element 538. Jaws 510, 512 can be in a delivery arrangement ( ) in which jaws 510, 512 are substantially parallel to each other and at least 90% of the length of jaws 510, 512 is sheathed by outer catheter 504. Fig.21D ) for delivery. In the delivery arrangement, compressive pressure is applied from the outer catheter 504 to compress the jaws 510, 512 toward each other and into a cylindrical arrangement. In one embodiment, the handle assembly 501 includes an actuator knob 505 / actuator 562. The handle assembly 501 is configured so that the rotational movement of the actuator 562 translates to the movement of the actuator 562, which causes the outer catheter 504 to move to / away from the handle assembly 501 to sheath and extract the jaws 510, 512 ( Fig.21D ). Handle assembly 501 is provided as one example of a suitable handle assembly, and it is contemplated that many other handle assembly designs may be configured to operate device 500 in the manner described above.

[0136] In one embodiment, the handle assembly 501 includes a body 560 that supports an actuation knob 505. As indicated above, rotational movement of the actuation knob 505 translates to an actuator positioned within the body 560, which in turn moves the outer catheter 504 to and away from the body 560. In an example, the handle assembly 501 includes an orifice 564 for a hemostatic valve (e.g., a three-way hemostatic valve, not shown) for optional two guidewires 156, 158 and a conductive wire 568 interconnecting the electrode 538. It should be noted that in some embodiments, the channel 513 ( Fig.21B ) is disposed in the jaws 512 supporting the electrode 538, and the conductive wire 568 can be routed through this channel 513 and welded to the second end 539b of the electrode 538 and potted with an adhesive or the like. However, for ease of description, Fig.21B The conductive wire 568 is not shown.

[0137] In some embodiments, the severing or cutting is achieved by generating plasma on the electrode 538 via an external power source (not shown). For a monopolar design, an external counter electrode 539 (schematically shown) is mounted on the skin via a patch. For a bipolar design, the counter electrode 539 is mounted on a valve preparation or disabling device. The first and second jaws 510, 512 can be made of, for example, a polymeric material or a mixture of a polymer and a metal. One purpose can be to balance the material of the jaws 510, 512 to have enough metal to be visible under fluoroscopy, but not too much metal to interfere with the echogenicity of the disabling device. In some embodiments, only a portion of the capture leaflet L1, L2 of the jaws 510, 512 is a distal portion containing the puncture electrode 538, thereby allowing the electrode 538 to cut the leaflet L1, L2 when it is pulled proximally relative to the leaflet L1, L2 (in other words, if the disabling device C does not clamp the leaflet AL, PL at a certain location, the jaws / electrodes 510, 512, 538 can only move relative to the leaflet L1, L2). In various methods, the jaws 510 and 512 of the valve preparation or disabling device 500 are associated with the guidewires 156, 158 to facilitate interfacing with the valve preparation or disabling device 500 having the guidewires 156, 158 and also as described above. Figures 22A-22C The valve preparation or disabling device 100 is positioned in a manner similar to that shown in FIG.

[0138] Another method of disabling the ligation clip using the valve preparation or disabling device 500 (see Figure 31-33 and related disclosures) can include delivering a valve preparation or disabling device 500 in a closed arrangement in which first and second jaws 510, 512 are pulled together to a mitral heart valve V having a plurality of leaflets L1, L2 via a transatrial or transseptal approach. The jaws 510, 512 are pivoted away from each other to open relative to the proximal side of the leaflets L1, L2. One jaw 510, 512 is slid through the opening O, one jaw on either side of the opening O, with one ligation device C located between the jaws 510, 512. In this manner, the first jaw 510 and the second jaw 512 are positioned on opposite sides of the clip C. The jaws 510, 512 are then pivoted to a closed arrangement, the cutting element 538 is activated, and the entire device 500 is pulled distally to sever / cut the corresponding leaflet L1 / AL / PL or the ligation device C (if applicable). Typically, this technique will be more effective with an Alfieri needle, as severing suture ligation devices are typically better suited to this technique than severing / cutting metal clip ligation devices. The process may be repeated until all existing ligation devices are sufficiently disabled or the leaflets are otherwise sufficiently severed or removed as desired.

[0139] Now except Figure 37-39Reference is made to yet another valve preparation or disabling device 1400 and method for disabling one or more ligation devices. Unless otherwise specified, the valve preparation or disabling device 1400 may be used with Figure 1A-1B The valve preparation or disabling device 1400 is substantially similar. Typically, the valve preparation or disabling device 1400 includes an inner catheter 1402 and an outer catheter 1404 coaxially aligned with the inner catheter 1402 and slidably positioned above the inner catheter. The inner catheter 1402 includes first and second jaws 1410, 1412 that can be configured identically to the jaws 110, 112. The main difference in this embodiment is that the outer catheter 1404 has a distal end 1406 that includes a cutting element 1438. The cutting element 1438 can be, for example, a cork boring knife edge, welded on a tip, or configured to generate radiofrequency plasma. In this way, the tissue to be cut can be grasped with the jaws 1410, 1412 to hold the tissue (e.g., leaflets AL, PL) in place while the outer catheter 1404 is advanced distally to bring the cutting element 1438 into contact with the leaflets AL, PL. If applicable, the cutting element 1438 is energized or otherwise actuated to sever the leaflets so that the outer catheter 1404 extends through the leaflets AL, PL. In one embodiment, the ligation device C is captured between the jaws 1410, 1412 before the outer catheter is advanced distally to sever the leaflets AL, PL. In this manner, the ligation device C can be removed from the patient's body by retracting the valve preparation or disabling device 1400 proximally in the same manner as the valve preparation or disabling device 1400 is delivered. The portion of the leaflet AL, PL captured within the jaws 1410, 1412 will also be removed thereby. In effect, this method removes the ligation device C obstruction within the opening O so that an artificial heart valve can be implanted within the opening or an alternative intervention procedure can be performed.

[0140] exist Fig.40A In the embodiment of the present invention, the cutting element 1438 is configured to cut the leaflets AL, PL approximately 360 degrees around the ligation device C so that the ligation device C can be removed from the patient's body (see, for example, Fig.33 However, in the Fig.40B In the embodiment of the present invention, the cutting element 1438' can be configured to cut less than 360 degrees, about 180 degrees, of the leaflets AL, PL around the ligation device C (see, for example Fig.32 region A), so that the clip C is merely disabled, leaving the opening O unobstructed and retained in the patient's body. It should be noted that for the sake of clarity, Fig.40B The distal portion of the outer catheter 1404 is omitted from the view of FIG. Fig.40BAfter being severed as shown in FIG. 14 , the jaws 1410 , 1412 can be transformed into an open arrangement to release the leaflets AL, PL and / or the fastening device C. The valve preparation or disabling device 1400 is then proximally retracted in the same manner in which it was delivered.

[0141] In yet another embodiment, the jaws 1410 and 1412 of the valve preparation or disabling device 1400 are associated with a guidewire to aid in positioning in a manner similar to that of the valve preparation or disabling device 100 with guidewires 156 , 158 .

[0142] exist Fig.41 Many of the aforementioned methods of the present disclosure are summarized in the flowchart of Fig.41 As generally indicated in , in any of the methods of the present disclosure, the method may further include implanting a prosthetic heart valve (e.g., an aortic heart valve) into the opening such that the prosthetic mitral heart valve is implanted after all applicable fastening devices are disabled and the valve opening is unobstructed (i.e., wherein one or more previously implanted fastening devices have been removed from the patient, one of the leaflets has been severed, or one or more fastening devices have been disabled). In some methods, the prosthetic mitral heart valve is implanted adjacent to one or more previously disabled fastening devices. The prosthetic mitral heart valve may be of any type known in the art for replacing a mitral valve, and the method of delivering and implanting a stented prosthetic heart valve may be any of the methods known in the art for replacing a mitral valve.

[0143] Specifically, the method 1490 of the present disclosure may include providing a patient having a mitral valve with at least one ligation device spanning the anterior and posterior leaflets 1491. The method may then include disabling one or more ligation devices with a disabling device of the present disclosure 1492. Optionally, the disabling device may be removed with the ligation device 1493, or the disabling device may be removed from the patient without the ligation device 1494. Once the disabling device is removed, the method may then include delivering a replacement prosthetic mitral heart valve and implanting it within the opening of the mitral valve 1495.

[0144] Now except Figure 42-561500, which together discloses yet another valve preparation or disabling device 1500 that can be used in the aforementioned procedures. Device 1500 includes a handle assembly 1502, a catheter 1504, and a tip assembly 1506 extending from the proximal end 1508 of the catheter 1504. The tip assembly 1506 includes a tip body 1507 supporting a cutting element 1510, which can be otherwise referred to as a jaw. In some embodiments, the cutting element 1510 can be used as a blade. In other embodiments, the cutting element 1510 can be used as an electrode. In some embodiments, the cutting element 1510 is used as both a blade and an electrode. In the case where the cutting element 1510 can be used as an electrode, the handle assembly 1502 is configured to be connected to a radio frequency (RF) energy source 1512 that can be applied by the cutting element 1510 to, for example, cut off leaflet tissue. The handle assembly 1502 shown is only one example of a suitable handle assembly. It is conceivable that other handle assemblies that perform similar functions to operate the tip assembly 1506 can be provided.

[0145] In one example, the cutting element 1510 includes a body 1514 having a sharpened cutting edge 1516 terminating at a tip 1511 that can be used to pierce and then tear the leaflet. In one embodiment, the cutting edge 1516 is configured to be sharp, wherein all other edges of the body 1514 are rounded. The cutting element 1510 further includes a solder tab 1518 to attach a wire 1520 to conduct energy from the RF source 1512 to the cutting element 1510 and also push and pull to pivot the cutting element 1510 from the folded position to the deployed position. In embodiments where the cutting element 1510 is not used as an electrode, the wire 1520 does not need to be conductive or connected to the RF source. The wire 1520 interconnects the cutting element 1510 with a corresponding actuator 1522 of the handle assembly 1502 for control by the user. In one embodiment, the cutting element 1510 further includes an aperture 1524 to receive a pin 1526 (omitted in some views for ease of illustration) about which the cutting element 1510 can pivot. In one example, the element body 1514 is made of stainless steel, and the body 1514 is partially coated with an insulating material 1528, such as ceramic, glass, polytetrafluoroethylene, etc. In the case where the cutting element 1510 can be used as an electrode, at least a portion of the solder tab 1518 is not coated with an insulating material to allow for conductive positioning and connection with the wire 1520. The wire 1520 connected to the cutting element 1510 has a single strand conductor portion 1530 and is stripped to a great length so that it is flexible. With a certain length of shrink tubing 1532 or other insulating material covering the conductor portion 1530, the pushing and pulling action of the wire 1520, such as achieved by the actuator 1522 of the handle assembly 1502, causes the cutting element 1510 to pivot from the folded position to the deployed position. Typically, when device 1500 is used in a conductive environment (e.g., in blood), it may be important to insulate wire 1520 and cutting element 1510, and so (if applicable) the electrical path of device 1500 from RF source 1512 to cutting element 1510 may also be sealed and prevented from dispersing energy into the fluid to focus the RF energy at cutting edge 1516 so that its effectiveness is not reduced.

[0146] Cutting element 1510 is configured to rotate toward and away from upper surface 1534 of tip body 1507, as shown in FIG. Figures 46-49 In the folded position, the tip assembly 1506 can be introduced into the heart via a femoral artery approach. Once the cutting element 1510 is in the heart and through the aortic valve, the cutting element 1510 is moved to the expanded position to prepare for cutting the leaflets, as will be discussed in further detail below.

[0147] In one example of the device 1500, the upper surface 1534 of the tip body 1507 is planar to receive a first or outer arm 1540 in position. The first outer arm 1540 may otherwise be referred to as a jaw. The outer arm 1540 is configured to pivot relative to the upper surface 1534 and may optionally be made of a non-conductive material so that energy from the cutting element 1510 (if applicable) cannot pass through the outer arm 1540. The movement of the outer arm 1540 is controlled by a wire 1542 extending from the outer arm 1540 to the handle assembly 1502, and the wire is configured to push and pull the wire 1542 through a corresponding actuator 1544 to control the movement of the outer arm 1540 accordingly. For example, when the wire 1542 is pushed in the direction of the tip assembly 1506 by the actuator 1544, the outer arm 1540 is transformed into a jaw. Fig.45 In some embodiments, the outer arm 1540 is biased to the open position by molding the outer arm into a generally S-shaped configuration, such as Figures 45-46 . When the guide wire 1542 is pulled in a direction away from the tip assembly 1506 by the actuator 1544, the outer arm 1540 is pulled toward the upper surface 1534 of the tip body 1507 into a closed position in which the outer arm 1540 is generally flattened into a linear arrangement. In the closed position, the outer arm 1540 can be configured so that the tip assembly 1506 has a generally uniform diameter along its length, which reduces the profile of the tip assembly 1506 for delivery. The guidewire channel 1548 can extend from the handle assembly 1502 through the catheter 1504 and through the tip body 1507. The tip body 1507 can include a circular distal cap 1552 at its distal-most end, proximal to the cutting element 1510. In one embodiment, the tip body 1507 includes a longitudinal slot 1554 in the upper surface 1534 through which the cutting element 1510 can be positioned in a folded position. The entire cutting element 1510 may fit within slot 1554 to provide a more compact tip assembly 1506 for delivery.

[0148] In some embodiments, tip assembly 1506 further includes a second or inner arm 1560 positioned between outer arm 1540 and tip body 1507 and biased away from upper surface 1534 in an S-shaped configuration in a manner and orientation similar to that of outer arm 1540. Inner arm 1560 can include a slot 1562 through which cutting element 1510 can pass when cutting element 1510 is in the deployed position. In some embodiments, inner arm 1560 is made of metal or an alternative radiopaque material. Once cutting element 1510 is confirmed to be in the desired position by fluoroscopy, cutting element 1510 can then be activated and, due in part to the pressure of spring-loaded or biased outer arm 1540, cutting element 1510 pierces the leaflet by pushing the leaflet over tip 1511, which may or may not be assisted by RF energy applied at tip 1511. In one embodiment, wire 1542 is connected to inner arm 1560 and outer arm 1540 so that they can move with an actuator 1544. When the wire 1542 is pulled, both the outer arm 1540 and the inner arm 1560 fold into the tip body 1507, and when the wire 1542 is pushed, both the outer arm 1540 and the inner arm 1560 pivot out from the tip body 1507 to their natural biased positions.

[0149] The device 1500 can be used in one of the disclosed methods for severing a leaflet and / or severing one or more ligating devices interconnecting two leaflets, etc. The device 1500 is advantageous because it is configured to allow a user to first confirm that the leaflet has been grasped and secondly that the leaflet has been pierced by the electrode before a slit is formed in the leaflet. Specifically, the device 1500 can be configured so that the user will see the position of certain radiopaque elements of the device (e.g., radiopaque cutting element 1510, radiopaque inner arm 1560) under fluoroscopy and be able to make, for example, these confirmations.

[0150] exist Figure 50-56 An example method of using the apparatus 1500 is shown in FIG. Fig.50 In the embodiment, the device 1500 is introduced into the valve V of the human heart in a delivery configuration via a steerable catheter through a femoral artery access. The device 1500 is positioned above the aortic valve. A guidewire 1570 is pushed through the guidewire channel 1548 and through the aortic valve.

[0151] Then, if Fig.51, by pushing the guide wire 1542 in the direction of the tip assembly 1506 via the respective actuators 1544, the outer arm 1540 and the inner arm 1560 of the device 1500 are pushed apart and released to transition to their biased positions. Due to the radiopaque properties of both the cutting element 1510 and the inner arm 1560, the tip assembly 1506 can be rotated and aligned into the desired position using fluoroscopy. The guide wire 1570 is then used to push the tip assembly 1506 into the opening of the aortic valve, as shown in FIG. Figure 52-53 As shown in .

[0152] Cutting element 1510 is moved from a folded position to an expanded position by a corresponding actuator 1522. Using fluoroscopy, cutting element 1510 is positioned on the interior of leaflet L where the incision is desired ( Figure 52-53 ). The outer arm 1540 and the inner arm 1560 are retained on the outside of the leaflet L.

[0153] Inner arm 1540 and inner arm 1560 are pulled toward cutting element 1510 to provide pressure from cutting element 1510 onto leaflet L. Inner arm 1560 remains positioned proximal to tip 1511 , contacting the leaflet at tip 1511 .

[0154] Once the position of the cutting element 1510 is confirmed, the cutting element 1510 is activated. Because the inner arm 1560 contains the slot 1562 and is biased away from the upper surface 1534, when the leaflet L is pierced, the inner arm 1560 slides over the cutting element 1510 ( Figure 54-55 ). Using fluoroscopy, puncture of leaflet L is confirmed by viewing the position of cutting element 1510 relative to inner arm 1560. It should be noted that during this step, outer arm 1540 is positioned to cover tip 1511 and protect any surrounding tissue (e.g., aortic wall) from being inadvertently processed.

[0155] like Fig.56 As generally depicted in FIG, cutting element 1510 is activated again and device 1500 is retracted to form a slit S in leaflet L that generally corresponds to the distance tip assembly 1506 is retracted or until device 1500 is released from leaflet L. If there is a potential blockage of other coronary arteries, the process may optionally be repeated on the corresponding leaflet. In other examples of the present disclosure, it should be understood that the same Fig.41 The method is similar to the method to use device 1500.

[0156] Now Figure 57-59 Reference is made to another embodiment of the present invention, which shows another positioning device 1600 of the present invention for the above-mentioned procedure and the Figure 3-4In other words, device 1600 can be used as a replacement for grasper 150 when desired, or can be otherwise omitted from any of the aforementioned methods of using the device of the present disclosure. In one example, positioning device 1600 can be used to position a piercing wire, electrode, blade, etc. in front of the coronal ostium.

[0157] In one example, the positioning device 1600 includes a positioning catheter 1602. A positioning balloon 1606 is positioned at the distal tip 1604 of the catheter 1602. The positioning balloon 1606 is made of a compliant material that can be delivered in a deflated arrangement and can be inflated by an inflation path that is interconnected with an inflation source (not shown) provided in the catheter 1602 to expand the diameter of the positioning balloon 1606. In one example, the balloon includes a portion (e.g., a line) of an adhesive 1608 or the like that extends axially along one side of the positioning balloon 1606 along the length of the positioning balloon 1606. A portion of the adhesive 1608 prevents the region proximal to a portion of the adhesive 1608 from expanding during inflation, thereby resulting in a balloon having an irregular kidney shape in its inflated state. The kidney-shaped, inflated positioning balloon 1606 advances to the cusp of the leaflet L to be cut or severed. It may be necessary to manipulate the catheter 1602 to bring the distal end 1604 of the catheter 1602 close to the desired positioning. In some embodiments, the positioning balloon 1606 can be provided with radiopaque markers (not shown) to assist in rotational directional alignment. When inflated, the positioning balloon 1606 serves to center the catheter 1602 in the corresponding cusp of the leaflet L. Additionally, the kidney shape of the inflated positioning balloon 1606 provides an opening to the coronary artery to ensure proper blood flow to the heart. Once the clinician is satisfied with the position of the distal end 1604 of the catheter 1602, a little forward pressure is applied to the catheter 1602 and a guide wire 1610 can be inserted through the catheter 1602 and used to puncture the leaflet L ( Fig.59 ). In one example, the guide wire is an RF powered guide wire. In other embodiments, the guide wire may be sharpened so that it is suitable for puncturing the leaflet. Once the hole or puncture in the leaflet L is formed, any guide wire can be tracked from the catheter 1602 and passed through the leaflet L for guiding any valve preparation or disabling device of the present disclosure to its location.

[0158] Now except Fig.60 Reference is made to the locating device 1700, which is shown in the figure, and unless otherwise specified, the locating device is similar in configuration and use to the locating device 1700. Figure 57-59The positioning device 1700 is largely similar to the positioning device of the present invention. The positioning device 1700 includes a positioning catheter 1702 having a distal end 1704. In this embodiment, the positioning device 1700 includes a first and a second positioning balloon 1706a, 1706b positioned adjacent to each other. Compared to the positioning balloon 1606 described above, each positioning balloon 1706a, 1706b can be configured and operated similarly. In one example, the positioning balloons 1706a, 1706b are positioned 180 degrees from each other. In one example, the catheter 1702 includes a semi-rigid extension tube 1703 extending from the distal end 1704 to guide a wire 1710, which is equivalent to the wire 1610 described above.

[0159] Now except Fig.61 Reference is made to the locating device 1800, which is shown in FIG. 1 , and unless otherwise specified, the locating device is similar in configuration and use to the locating device 1800. Figures 57-60 The positioning device 1800 comprises a positioning catheter 1802 having a distal end 1804. At the distal end 1804, a frame 1803 supports a positioning balloon 1806 defined in two segments 1812a, 1812b separated by an adhesive strip 1814 at opposite quadrants of the distal end 1804 of the catheter 1802, which will be in the same Fig.60 In one example, catheter 1802 provides separate first and second lumens 1816a, 1816b for delivering saline or another inflation medium to balloon segments 1812a, 1812b, respectively. One advantage of a segmented balloon configuration is that a clinician can align the puncture point with the coronal even if the coronal is not centered on the belly of the corresponding leaflet.

[0160] Now except Figure 62-67 Reference is made to the foregoing, which collectively illustrate a valve preparation or disabling device 1900 that can be used in the aforementioned procedures. The device 1900 comprises an outer catheter 1902 ( Fig.64 ). Inner catheter 1904 supports balloon 1906 made of compliant material. Cutting element 1908 is positioned above balloon 1906, but may not be directly connected to the balloon. In one embodiment, cutting element 1908 is an electrode. Cutting element 1908 has a delivery configuration ( Fig.66 ) and the cutting element also has a deployed configuration activated by inflation of balloon 1906 ( Fig.67). In the deployed configuration, the cutting element 1908 extends at least partially away from the balloon 1906 (i.e., protrudes from the balloon) and extends at a certain angle relative to the inner catheter 1904. In one embodiment, the cutting element 1908 includes a distal ring 1910a and a proximal ring 1910b interconnected by a body 1912. The body 1912 includes a split connection point 1914 defining a first and second portion 1916a, 1916b, the first portion 1916a being a portion of the cutting element 1908 extending outward from the balloon 1906 in the deployed position. The proximal ring 1910b is non-movably fixed to the inner catheter 1904, and the distal ring 1910a can be slidably connected to the inner catheter 1904 to account for shortening of the cutting element 1908 when in the deployed position. In one embodiment, the cutting element 1908 is made of an elastic material so that the distal ring 1910a can be non-movably fixed to the inner catheter. Where cutting element 1908 is an electrode, the electrode may be at least partially coated with a non-conductive material to limit the area of ​​the electrode that may be activated. In one example, all surfaces of cutting element 1908 except for the surface designated at 1913 are coated with an insulating material. These surfaces 1913 are both in the delivery configuration (see Fig.63 ) in the contact and in the expanded configuration ( Fig.62 ) The split junction 1914 is positioned closer to the distal end of the balloon 1906 to allow the electrodes 1908 to be separated as shown.

[0161] like Figures 64-67 As shown in FIG. 1 , an exemplary method of using the device 1900 is described as follows. A hole is punctured through a leaflet L1 (by any preferred means, examples disclosed herein). A guide wire 1920 is placed through the hole in the leaflet L1 ( Fig.64 ). The outer catheter 1902 is tracked around the aortic arch to a position in the ascending aorta. In the deflated state, the balloon 1906 is advanced out of the outer catheter 1902 through the inner catheter 1904, as shown in FIG. Fig.65 Then, the balloon 1906 is advanced through the hole, as shown in FIG. Fig.66 When the balloon is beneath leaflet L1, balloon 1906 and inner catheter 1904 may optionally be rotated so that cutting element 1908 is oriented in the direction of the desired leaflet incision (this may be done before or after cutting element 1908 is moved to the deployed position). Balloon 1906 is inflated ( Fig.67 ), which forces cutting element 1908 to transition to an expanded arrangement such that first portion 1916a extends away from balloon 1906. Cutting element 1908 can be activated and balloon 1906 can be pulled proximally to create an incision in leaflet L1. The process can be repeated until all desired incisions are formed in all desired leaflets.

[0162] One aspect of the present disclosure includes a valve preparation device comprising an outer catheter; an inner catheter that can slide coaxially within the outer catheter; a balloon that is fixed to the inner catheter; and an electrode that extends along the length of the balloon. In one embodiment, the device further includes a plurality of electrodes that extend along the length of the balloon. In one embodiment, the electrode is segmented. In one embodiment, the device further includes a first attachment ring that interconnects the electrode with the inner catheter; and a second attachment ring that interconnects the electrode with the inner catheter. In one embodiment, the first and second attachment rings are slidable along the inner catheter. Optionally, the valve preparation device further includes a positioning device that is configured to align the puncture element in front of the coronary ostium. In some embodiments, the positioning device includes a positioning catheter and a positioning balloon; wherein the valve preparation device can be delivered by the positioning catheter. The electrode includes a first portion and a second portion that are interconnected at a split connection point; wherein when the balloon is inflated, the first portion is configured to extend away from the second portion at the split connection point. In one embodiment, the electrode comprises an insulator spanning a portion of the circumference of the electrode.

[0163] Aspects of the present disclosure further include a method for preparing a heart valve having a plurality of leaflets and a valve opening. The method includes providing a valve preparation device, the valve preparation device including an outer catheter; an inner catheter, the inner catheter being coaxially slidable within the outer catheter; a balloon, the balloon being fixed to the inner catheter; and an electrode, the electrode extending along the length of the balloon. The method includes delivering the valve preparation device to a first leaflet of the plurality of leaflets and aligning the electrode with the region of the first leaflet to be cut. The balloon is at least partially inflated and the electrode is actuated to create a first slit in the first leaflet. The method may further include providing a positioning device and using the positioning device to guide the valve preparation device to the first leaflet. In some embodiments, the positioning device includes a positioning catheter and a positioning balloon. In some variations, the method includes guiding the positioning catheter to the first leaflet, thereby inflating the positioning balloon and guiding the valve preparation device to the first leaflet through the positioning catheter. In some embodiments, the positioning device comprises first and second guide wires; wherein the first guide wire is inserted into one of the right or left coronary arteries and the second guide wire is inserted into the left ventricle of the heart. In some embodiments, the balloon is delivered through a puncture in the first leaflet before being inflated. In some embodiments, the electrode comprises a first portion and a second portion interconnected at a split connection point; wherein, when the balloon is at least partially inflated, the first portion extends away from the second portion at the split connection point. In some methods, when the balloon is at least partially inflated, the electrode slides relative to the inner catheter. In some embodiments, a second slit is created in the first leaflet to define a flap in the first leaflet. In some embodiments, the balloon is inserted into the valve opening. In some embodiments, the device comprises a plurality of electrodes spaced around the circumference of the balloon, and the method comprises creating a plurality of slits in the plurality of leaflets with the plurality of electrodes. The method may optionally include stabilizing the plurality of leaflets with a frame positioned in the valve opening during the step of actuating the electrodes.

[0164] Another aspect of the present disclosure includes a valve preparation device, comprising an inner catheter, the inner catheter is coaxially aligned and at least partially positioned within the outer catheter; and a first jaw, the first jaw is pivotally connected to a second jaw. The first and second jaws extend from the inner catheter. Each jaw defines an edge. The first and second jaws have a closed arrangement in which the edges are in contact and an open arrangement in which the first and second jaws are open relative to each other. The device further includes a first cutting element, the first cutting element is connected to the second jaw. In one embodiment, the first jaw includes a second cutting element. In one embodiment, the first and second cutting elements are selected from the group consisting of: an electrode, a plasma electrode, a high-frequency ultrasound, a resistive heating element, a cryoablation element, a microwave energy element, or a mechanical cutter. In one embodiment, the first cutting element is positioned in a receiving area between the first jaw and the second jaw. Optionally, the device further includes a positioning device, and the outer catheter slides on the positioning device. In some embodiments, the first jaw is configured to receive a first guidewire and the second jaw is configured to receive a second guidewire. In various embodiments, the first cutting element is a rotary cutter. In one embodiment, the outer catheter can be positioned over the first and second jaws to fold the first and second jaws into a cylindrical configuration. In one embodiment, the first cutting element comprises an electrode biased into a position away from the second jaw. In some embodiments, the electrode defines a cutting edge. In some embodiments, the first cutting element comprises a blade. In various embodiments, the inner arm is positioned between the first jaw and the second jaw. In one embodiment, the inner arm comprises a slot through which the first cutting element extends.

[0165] Aspects of the present disclosure further include a method of preparing a heart valve of a patient, the heart valve having a plurality of leaflets and a valve opening. The method includes providing a valve preparation device, the valve preparation device including an outer catheter; an inner catheter, the inner catheter coaxially aligned and at least partially positioned within the outer catheter; and a first jaw, the first jaw pivotally connected to a second jaw. The first and second jaws extend from the inner portion, and each jaw defines an edge. The first and second jaws have a closed arrangement in which the edges are in contact and an open arrangement in which the first and second jaws are open relative to each other. The device further includes a cutting element connected to the second jaw. The method further includes delivering the valve preparation device to the heart valve, and then proximally retracting the outer catheter and converting the first and second jaws to an open arrangement. The method includes inserting one of the first and second jaws into the valve opening to position a first leaflet of the plurality of leaflets between the first jaw and the second jaw and cutting at least a portion of the first leaflet with the cutting element. In one embodiment, the method includes closing the first and second jaws and removing the cut leaflet from the patient. In one embodiment, the step of transitioning the first jaw and the second jaw to an open arrangement comprises pushing a wire interconnected to the first jaw in a distal direction. In one embodiment, the method comprises rotating the cutting element from a folded position to an expanded position prior to the cutting step. In one embodiment, the rotating step comprises pushing a wire interconnected to the cutting element in a distal direction. In one embodiment, the valve preparation device comprises an intermediate arm positioned between the first jaw and the second jaw; wherein the method comprises positioning the first leaflet between the intermediate arm and the first jaw. In one embodiment, the cutting element comprises an electrode.

[0166] One aspect of the present disclosure includes a delivery device for delivering a stented prosthesis to a target site. The delivery device has at least one elongated tensile member that can compressively hold the stented prosthesis to the delivery device; and a shaft assembly having a lumen and a cutting assembly positioned within the lumen. In one embodiment, the cutting assembly includes a blade configured to selectively cut the at least one elongated tensile member. In one example, the blade is flexible. In one example, the cutting assembly includes a blade holder that defines a jog through which the blade can travel. In one embodiment, the delivery device further includes a handle assembly, and the cutting assembly actuates movement of the cutting assembly. In some embodiments, each of the elongated tensile members includes a first and second end; wherein the first and second ends are connected to the cutting assembly. In some embodiments, each of the elongated tensile members is interconnected with a loop that can be cut by the cutting assembly. In one embodiment, the blade is a circular blade that circumscribes an orifice in the cutting assembly. In some embodiments, the elongated tensile member is positioned within the orifice prior to being severed. In one embodiment, the cutting assembly can be moved within the lumen. In one example, the cutting assembly comprises: a pin through which the elongated tensile member is threaded; and a cutting blade, the cutting blade being fixed to the lumen; wherein the pin can be moved relative to the cutting blade. In another example, the cutting assembly comprises a cutting blade; and a rope looped around the elongated tensile member, the rope being configured to pull the elongated tensile member toward the cutting blade. In one embodiment, the cutting blade can be actuated to extend out of the lumen to sever the elongated tensile member.

[0167] In one example, the cutting assembly includes a pair of resilient blades extending out of a hollow shaft; wherein the blades are configured to be actuated by compressing the blades against the hollow shaft. Optionally, the shaft is hollow and the elongated tensile member is threaded through the hollow shaft. In one embodiment, the delivery device has a loaded state in which a stented prosthetic heart valve is loaded into the delivery device; wherein the blade is positioned distal to the elongated tensile member in the loaded state. In one example, the cutting assembly includes a pull pin positioned within the lumen; wherein the blade is fixed to the pull pin. In one example, the cutting assembly includes a sleeve having a plurality of windows; wherein the blade is positioned at an edge of at least one of the plurality of windows; wherein the sleeve can move along the shaft assembly. In one embodiment, the cutting assembly includes a plurality of blades such that each window edge includes a blade. In one example, the blade can travel along a path defined by an inner diameter of the lumen. In one embodiment, movement of the blade is limited by a separator. In one example, the blade rotates within the shaft assembly. In one example, the blade rotates about the central axis of the shaft assembly. In one embodiment, the cutting assembly includes a torque shaft, a fixed disk, and an interface disk; wherein the blade is positioned on an edge of an aperture in one of the fixed disk or the interface disk. In one embodiment, the cutting assembly includes a pull pin, the pull pin including a plurality of protrusions on which a blade is positioned; the protrusions are arranged and configured to engage and sever the elongated tensile member at the blade. In one example, the cutting assembly includes a pull pin, and the blade extends from a distal end of the pull pin; wherein actuation of the blade is accomplished with movement of the pull pin. In one embodiment, the shaft assembly includes first, second, and third lumens; wherein at least one tensile member is routed through the first and second lumens and the cutting assembly is at least partially positioned within the third lumen; wherein a gap interconnects the second and third lumens and the blade of the cutting assembly can travel through the gap to the second lumen.

[0168] Another aspect of the present disclosure provides a valve preparation device, which includes a catheter having a distal end and a proximal end. The catheter further includes an inflation lumen and a balloon, which is positioned at the distal end of the catheter and is in fluid communication with the inflation lumen. The balloon includes an electrode. In one embodiment, the balloon includes a plurality of electrodes. In one embodiment, the plurality of electrodes are circumferentially spaced around the balloon. In one embodiment, each electrode is longitudinally subdivided into individually powered elements. In one embodiment, the catheter includes a guidewire lumen and a blood flow lumen. In one embodiment, the balloon has a spiral helical shape when in an inflated arrangement. In one embodiment, an insulator is provided between the balloon and each electrode. In one embodiment, the electrode is biased outward from the outer surface of the balloon.

[0169] Aspects of the present disclosure include a method for treating calcified aortic leaflets, the method including providing a valve preparation device including a catheter having a distal end and a proximal end. The catheter further includes an inflation lumen and a balloon, the balloon being positioned at the distal end of the catheter and in fluid communication with the inflation lumen. The balloon includes an electrode. The method further includes: delivering the balloon in a deflated arrangement to an aortic valve; at least partially inflating the balloon; and energizing the electrode to create a slit in at least one leaflet of the aortic valve. In one embodiment, the method includes the step of rotationally aligning the balloon prior to the step of energizing the electrode. In one embodiment, the step of energizing the electrode is performed while the balloon is in a partially inflated arrangement, and the method further includes further inflating the balloon during the step of energizing the electrode. In one embodiment, the balloon includes a plurality of electrodes, and the step of energizing the electrode includes selectively energizing one of the plurality of electrodes. In one embodiment, the catheter includes a lumen that allows perfusion during the steps of inflating the balloon and energizing the electrode. In one embodiment, the electrode is biased outwardly relative to an outer surface of the balloon. In one embodiment, the electrode comprises an insulator positioned between the balloon and the electrode.

[0170] Aspects of the present disclosure include a disabling device comprising a catheter comprising a first lumen, a second lumen, a third lumen, and a fourth lumen. The device further comprises: a first positioning arm extending within the first lumen and extending distally out of the catheter; a second positioning arm extending in the second lumen and extending distally out of the catheter; and a guide wire extending through both the second and third lumens, wherein the lumens maintain an electrode positioned distal to the catheter. In one embodiment, the first lumen and the second lumen are on opposite sides of the catheter. In one embodiment, the device comprises a fifth lumen in the catheter and a clamp extending from the fifth lumen. In one embodiment, the grasper comprises two arms each associated with a guidewire; wherein the catheter slides over the two arms. Optionally, the fifth lumen is sized to accommodate a ligation device. In one embodiment, the device comprises a sheath coaxially aligned with the catheter and slidably positioned over the catheter. Optionally, the electrode has a half-moon shape. In one embodiment, the electrode spans approximately 360 degrees.

[0171] Embodiments of the present disclosure further include a method for treating a patient having a ligation device that interconnects an anterior mitral leaflet and a posterior mitral leaflet of a mitral valve and thereby obstructs an opening of the mitral valve. The method includes providing a disabling device, the disabling device including a first catheter, a cutting element extending from the first catheter, and the first catheter guiding the cutting element to the proximal side of the ligation device. The method further includes cutting the mitral valve proximal to the clip until the ligation device no longer obstructs the opening. In one example, the anterior mitral leaflet is cut. In one embodiment, after the cutting step, the ligation device remains in the patient's body. Some embodiments include removing multiple ligation devices from the mitral valve. Some embodiments include the step of implanting an artificial heart valve into the opening. In one example, the disabling device further includes a guide disposed within the lumen of the first catheter, the guide including first and second arms. In one embodiment, the first catheter comprises a first lumen, a second lumen, a third lumen, and a fourth lumen; and a first positioning arm extending within the first lumen and extending distally out of the first catheter; a second positioning arm extending in the second lumen and extending distally out of the first catheter; and a guide wire extending through both the second and third lumens, wherein the lumens maintain an electrode positioned distal to the first catheter. In one example, the step of guiding the cutting element comprises: advancing the first catheter to the left atrium; rotating the catheter so that the first and second positioning arms are aligned with the anterior leaflet and the posterior leaflet of the mitral valve; and advancing the first catheter distally so that the first and second positioning arms penetrate the anterior leaflet and the posterior leaflet of the mitral valve on either side of the ligation device. In one embodiment, the device comprises a forceps, and the method further comprises grasping the ligation device with the forceps. In one example, the method comprises removing the ligation device from the patient with the forceps. In one embodiment, the device further comprises a sheath coaxially aligned with the first catheter and slidably positioned over the first catheter, wherein after the ligation device is captured by the forceps, the sheath is slid distally over the ligation device. Optionally, the forceps are disposed in a fifth lumen. In one embodiment, the size of the fifth lumen is configured to accommodate the ligation device. In one embodiment, the device further comprises a second catheter positioned within the first catheter, wherein the second catheter comprises first and second jaws. In one embodiment, the method comprises capturing the ligation device in the first and second jaws. In one example, the ligation device is cut together with the disabling device. In one embodiment, the ligation device is a suture. In another embodiment, the ligation device is a clip. In one example, the cutting element has a half-moon shape.In one embodiment, the cutting element spans approximately 360 degrees.

[0172] In view of the present disclosure, it should generally be understood that any "cutting" or "severing" to create an incision or slit will generally be through the entire thickness of one or more leaflets AL, PL, such that the ligation device C is sufficiently disabled and / or can be removed by disabling the device. However, if the ligation device does not extend through the entire thickness of one or more leaflets AL, PL, the "severing" or "cutting" may not necessarily have to extend through the entire thickness of one or more leaflets to effectively disable and / or remove the ligation device.

[0173] If not specifically mentioned above, any of the above-mentioned devices may optionally include radiopaque markers (e.g., Fig.24A Markers 815) can be provided to help confirm the positioning of the device through fluoroscopy techniques. In one example, the inner and / or outer catheters contain one or more radiopaque markers. In some embodiments, markers 815 can be positioned adjacent to the beginning and end of the corresponding cutting element.

[0174] Any of the above-mentioned devices may also be configured so that the inner catheter and / or the outer catheter may be twisted to aid in the alignment of the respective devices. Twisting may be achieved, for example, by rotating the handle assembly at the proximal end of the respective catheter or by selectively actuating one or more catheter shafts through a rotation mechanism in the handle assembly (e.g., if only the inner catheter is desired to be rotated, but not the outer catheter).

[0175] Any of the above-mentioned devices may also be configured with a steering mechanism (such as a pull wire) to assist in positioning the distal ends of the inner and / or outer catheters.

[0176] It should be understood that the various aspects disclosed herein can be combined in different combinations other than those specifically presented in the specification and drawings. It should also be understood that, according to examples, the actions or events of any process or method described herein can be performed in different orders, can be added, merged, or completely excluded (for example, all described actions and events may not be necessary for performing the technology). In addition, although for the purpose of clarity, certain aspects of the present disclosure are described as being performed by a single module or unit, it should be understood that the technology of the present disclosure can be performed by a combination of units or modules associated with, for example, a medical device.

Claims

1. A valve preparation device, comprising: External catheter; an inner conduit coaxially aligned and at least partially positioned within the outer conduit; a first jaw pivotally connected to a second jaw, the first and second jaws extending from the inner conduit; wherein each jaw defines an edge; wherein the first and second jaws have a closed arrangement in which the edges are adjacent to each other and an open arrangement in which the first and second jaws are open relative to each other; wherein the first jaw is S-shaped in the open arrangement and is linear in the closed arrangement; as well as A first cutting element is connected to the second jaw, the first cutting element having a delivery arrangement in which the first cutting element is parallel to the second jaw and a deployed arrangement in which the first cutting element extends outwardly from the second jaw.

2. The valve preparation device according to claim 1, wherein the first cutting element is selected from the group consisting of: an electrode, a plasma electrode, high-frequency ultrasound, a resistive heating element, a cryoablation element, a microwave energy element or a mechanical cutter. 3 . The valve preparation device according to claim 1 , wherein the first cutting element is positioned in a receiving area between the first jaw and the second jaw. 4 . The valve preparation device according to claim 1 , further comprising a positioning device on which the outer catheter slides.

5. The valve preparation device of claim 1, wherein the first jaw is configured to receive a first guide wire and the second jaw is configured to receive a second guide wire.

6. A valve preparation device according to claim 1, wherein the outer catheter can be positioned above the first and second jaws to fold the first and second jaws into a cylindrical configuration.

7. The valve preparation device according to claim 1, wherein the first cutting element comprises an electrode.

8. The valve preparation device of claim 1, comprising an inner arm positioned between the first jaw and the second jaw.

9. The valve preparation device of claim 8, wherein the inner arm comprises a slot through which the first cutting element extends.

Images