Methods and devices for removing heart valve therapy

Abstract

A retrieval catheter and method of use for removing a heart valve therapy, such as a leaflet clip or artificial leaflet chord, is described. The retrieval catheter can include a cutting element and basket, a piercing element, a clamping mechanism or similar grasping device. The method includes delivering the catheter to the area of the heart valve therapy, then manipulating the catheter and associated instruments as needed to cut the tissue, then remove the heart valve therapy and withdraw the catheter.

Description

[0001] Related Applications

[0002] This application claims priority to provisional application U.S. Provisional Application No. 62 / 872,139, filed July 9, 2019, entitled “Method and Apparatus for Removing Leaflet Positioning Therapy,” and provisional application U.S. Provisional Application No. 62 / 977,021, filed February 14, 2020, entitled “Mitral Valve Clip Removal,” the entire contents of which are hereby incorporated by reference herein. TECHNICAL FIELD

[0003] The present disclosure relates to novel and advantageous transcatheter devices and methods for facilitating valve repair and / or replacement. More particularly, the devices and methods herein relate to removing therapy that interacts with heart valve leaflets. BACKGROUND

[0004] Heart valve disease occurs when the leaflets of a patient’s valve fail to fully close, which causes blood to flow backward or abnormally. Referring to FIG. 1, mitral valve 20 regurgitation is particularly common when anterior leaflet 22 fails to properly coapt with posterior leaflet 24. When the ventricle of heart 10 contracts, some blood flows from left ventricle 14 back into left atrium 12 instead of into aorta 11. Similar regurgitation can occur with tricuspid valve 15, causing blood to flow from right ventricle 13 back into right atrium 16. Figure 1

[0005] One common treatment for valve regurgitation is to use a therapy device to appose or permanently connect the leaflets together. Such heart valve therapy hardware can be placed using a surgical, transcatheter, or minimally invasive approach. For example, the hardware or therapy for removal can be a MitraClip (Abbott Structural Heart, Santa Clara, CA), a PASCAL device (Edwards Lifesciences, Irvine, CA), a surgical suture (such as an Alfieri suture), or similar heart valve therapy. Other heart valve therapies can be the result of techniques that target leaflets as part of the therapy and require removal of some or all of the leaflets. Other examples include chordae replacement techniques performed with transcatheter or surgical approaches to compensate for malpositioned, interrupted, or misaligned existing chords. For purposes of this application, the term “heart valve therapy” shall be defined as any device and / or method used for heart valve treatment, such as a leaflet clip, suture, artificial chord, or any other device or method related to heart valve and associated leaflet therapy.

[0006] Figure 2 ​An exemplary transcatheter delivery procedure for a leaflet clip 40 (e.g., a mitral clip) of a mitral valve 20 for treating regurgitation is shown. A delivery catheter 41 is passed through the right atrium 16, through the atrial septum 18, and into the left atrium 12. As shown, the interior of the catheter 41 A, which includes the leaflet clip 40, is passed through the mitral valve 20 into the left ventricle 14. In this example, the leaflet clip 40 includes two outer arms 40A positioned below the leaflets 22, 24 and two inner arms 40B positioned vertically between the two leaflets 22, 24. As shown, the catheter 41 includes control wires that can cause the outer arms 40A to be brought close to the inner arms 40B to squeeze or engage the leaflet tissue. Barbs or similar structures on the arms 40B help the leaflet clip 40 anchor within the tissue of the leaflets 22, 24, as shown. Finally, the catheter 41 is removed, as shown. As shown in the top view, the leaflet clip 40 is generally positioned near the center of the valve 20, preventing the central portion from opening, and creating two smaller valve openings on either side of the clip 40. The smaller diameter of these openings generally allows for better coaptation of the leaflets and prevention of regurgitation. Figure 3 Figure 3 Figure 4 Figure 5 Figure 6

[0007] In some cases, it is desirable to remove these structures to facilitate other valve treatments, such as recurrent or residual regurgitation that needs to be addressed. For example, the valve can require placement of other leaflet technologies, annuloplasty or rings, chords or chordae, positioning devices, or replacement valves, many of which can not be suitable for previously performed heart valve therapies.

[0008] In some cases, these treatments require removal from one or more attachment points on the leaflets, but not complete removal, in order to facilitate other valve treatments, leaving the structure in the heart but enabling it to be moved from the area of interest and apply the desired treatment.

[0009] However, these heart valve therapies are often excised through open-heart surgery, which can cause particularly great trauma to the patient and present a relatively high risk of complications. Thus, what is needed is a less traumatic way to remove heart valve therapies, thereby reducing the risk of complications. SUMMARY

[0010] The present invention relates to systems and methods for removing heart valve therapies used to position valve leaflets. Such removal can be necessary when additional treatment of the valve disease is required (e.g., a different repair method, valve replacement surgery), when the heart valve therapy is causing or potentially causing harm to the patient (e.g., stenosis, infection), when the heart valve therapy is not believed to have clinical benefit, or when it is generally desired not to treat.

[0011] ​​​​​The present invention relates to systems and methods for removal of heart valve therapies used to position leaflets, and which can have been placed using surgical, transcatheter, or minimally invasive means. In at least one embodiment, the hardware or therapy for removal can be the MitraClip (Abbott Structural Heart, Santa Clara, CA), the PASCAL device (Edwards Lifesciences, Irvine, CA), surgically placed sutures (e.g., Alfieri sutures), or similar positioning devices and techniques. In at least one embodiment, such positioning devices that require removal can be a result of the technology that has involved leaflets as part of the therapeutic target, and partial or full leaflet involvement requires removal. An example of such a device is a heart valve replacement technology performed with transcatheter methods or surgery. In some cases, the chordae or chordae are ineffective due to malpositioning, breakage, misplacement, or defects in the repair material.

[0012] The methods of the present invention include a tool for cutting native valve tissue attached to a heart valve therapy, with or without a capture tool to hold the hardware to be removed as it is exteriorized from the human body. In at least one embodiment, the cutting method includes an adjustable snare that wraps around the heart valve therapy, and can mechanically cut the native tissue from the heart valve therapy, or by heating the tissue with radiofrequency electrosurgical equipment, rapidly bringing the intracellular temperature of the electrosurgical cutting equipment to 100°C, the intracellular contents undergo a liquid-gas transition, a large-scale volume expansion, and ultimately vaporization. In at least one embodiment, the capture tool is an adjustable basket, bag, or box. The capture tool can be used to cut, release, compress, modify, or completely remove the heart valve therapy from the human body.

[0013] In some embodiments, the method for removing a previously placed heart valve therapy includes a steerable catheter that has been inserted into the patient using a transseptal, transatrial, or transventricular approach. The steerable catheter contains a delivery catheter that can place a tool for cutting and capturing the heart valve therapy.

[0014] In some embodiments, the capture of the heart valve therapy is performed by directly inserting and embedding the tool into, on, and / or around the heart valve therapy. In this method, the native tissue is cut from the heart valve therapy by using an electrosurgical cutting device (radiofrequency electric or similar device) or similar energy or force delivered from the embedded tool. A basket or bag for capturing the heart valve therapy can not be needed when removing the target material. Thus, in at least one embodiment, the cutting tool is used alone without the need for a capture basket.

[0015] In at least one embodiment, a loop structure is pushed onto the tissue bridge, chordal implant, or fixation method created by the heart valve therapy. The loop structure can be used to cut electrically or mechanically. The loop structure can be circular, oval, or multi-segmented, and can fully or not fully encapsulate the cut and removal area. The loop structure can be used to loop around the heart valve therapy and tissue for resection, then externalized.

[0016] In at least one embodiment, a tool is used to expand the heart valve for removal. This expansion can be mechanical, electrical, pneumatic, hydraulic, or similar, to deploy or change the shape of the heart valve, thereby removing it.

[0017] The elements of the tool can be fixed onto the heart valve therapy to reduce the risk of embolization. This fixation can be done by straight anchors, helical anchors, barbed anchors, or combinations of these methods.

[0018] In at least one embodiment, a catheter, patch, balloon, or other device can be used in conjunction with the removal device to manage the blood flow or regurgitation of the valve after the heart valve therapy is removed. If the removed heart valve therapy and basket can be retracted through a steerable catheter, this operation can be performed quickly, and then the sealing device can be delivered through the same delivery catheter.

[0019] While several embodiments have been disclosed, other embodiments of the application will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure. As will be realized, the various embodiments of the disclosure are capable of modifications in various obvious respects, all without departing from the spirit and scope of the application. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature, and not restrictive. BRIEF DESCRIPTION OF DRAWINGS

[0020] These and other aspects, features, and advantages of which the application embodiments are capable of will be apparent and elucidated from the following description, reference being made to the accompanying drawings, of which

[0021] Figure 1 Anatomy of the heart is shown;

[0022] Figure 2 A side view of a procedure to implant a leaflet heart valve therapy device is shown;

[0023] Figure 3 A side view of a procedure to implant a leaflet heart valve therapy device is shown;

[0024] Figure 4 A side view of a procedure to implant a leaflet heart valve therapy device is shown;

[0025] Figure 5A side view of the procedure of implanting a leaflet heart valve therapy device is shown;

[0026] Figure 6 A top view of the procedure of implanting a leaflet heart valve therapy device is shown;

[0027] Figure 7 A side view of a removal catheter according to the present invention is shown;

[0028] Figure 8 A side view of a removal catheter according to the present invention is shown;

[0029] Figure 9 A side view of a removal catheter according to the present invention is shown;

[0030] Figure 10 A side perspective view of a removal catheter according to the present invention is shown;

[0031] Figure 11 A side view of a removal catheter according to the present invention is shown;

[0032] Fig. 12 shows a cross-sectional view of a removal catheter according to the present invention;

[0033] Fig. 13 shows an exploded view of a removal catheter according to the present invention;

[0034] Figure 14 A perspective view of a cutting ring according to the present invention is shown;

[0035] Figure 15 A perspective view of a cutting ring according to the present invention is shown;

[0036] Figure 16 A perspective view of a cutting ring according to the present invention is shown;

[0037] Figure 17 A perspective view of a cutting ring according to the present invention is shown;

[0038] Figure 18 A perspective view of a cutting ring according to the present invention is shown;

[0039] Figure 19 A perspective view of a cutting ring according to the present invention is shown;

[0040] Figure 20 A top view of a cutting ring according to the present invention is shown;

[0041] Figure 21 A top view of a cutting ring according to the present invention is shown;

[0042] Figure 22 A perspective view of a cutting ring according to the present invention is shown;

[0043] Figure 23 A cross-sectional view of a cutting ring according to the present application is shown;

[0044] Figure 24 A cross-sectional view of a cutting ring according to the present application is shown;

[0045] Figure 25 A cross-sectional view of a cutting ring according to the present application is shown;

[0046] Figure 26 shows a cross-sectional view of a cutting ring according to the present application;

[0047] Figure 27 shows a cross-sectional view of a cutting ring according to the present application;

[0048] Figure 28 A cross-sectional view of a cutting ring according to the present application is shown;

[0049] Figure 29 A cross-sectional view of a cutting ring according to the present application is shown;

[0050] Figure 30 A cross-sectional view of a cutting ring according to the present application is shown;

[0051] Figure 31 A side view of a basket according to the present application is shown;

[0052] Figure 32 A side view of a basket according to the present application is shown;

[0053] Figure 33 A side view of a removal catheter according to the present application is shown;

[0054] Figure 34 A side perspective view of a removal catheter according to the present application is shown;

[0055] Figure 35 shows a side perspective view of a removal catheter according to the present application;

[0056] Figure 36 shows a side perspective view of a removal catheter according to the present application;

[0057] Figure 37 shows a side view of a removal catheter according to the present application;

[0058] Figure 37 shows a side view of a removal catheter according to the present application;

[0059] Figure 39 shows a side view of a removal catheter according to the present application;

[0060] Figure 40 shows a side view of a basket according to the present application;

[0061] Figure 41 shows a side view of a basket according to the present application;

[0062] Figure 42 shows a side view of a basket according to the present application;

[0063] Figure 43 shows a side view of a basket according to the present application;

[0064] Figure 44 Figure 44 shows a side view of a handle according to the present application;

[0065] Figure 45 Figure 45 shows a side view of a handle according to the present application;

[0066] Figure 46 Figure 46 shows a side view of a removal catheter according to the present application;

[0067] Figure 47 Figure 47 shows a side view of a removal catheter according to the present application;

[0068] Figure 48 shows a side view of a removal catheter according to the present application;

[0069] Figure 49 shows a side view of a removal catheter according to the present application;

[0070] Figure 50 Figure 50 shows a side view of a removal catheter according to the present application;

[0071] Figure 51 shows a side view of a removal catheter according to the present application;

[0072] Figure 52 shows a side view of a removal catheter according to the present application;

[0073] Figure 53 Figure 53 shows a side view of a removal catheter according to the present application;

[0074] Figure 54 Figure 54 shows a side view of a removal catheter and guide catheter according to the present application;

[0075] Figure 55 Figure 55 shows a side view of a removal catheter and guide catheter according to the present application;

[0076] Figure 56 Figure 56 shows a side view of a removal catheter procedure according to the present application;

[0077] Figure 57 Figure 57 shows a side view of a removal catheter procedure according to the present application;

[0078] Figure 58 Figure 58 shows a side view of a removal catheter procedure according to the present application;

[0079] Figure 59 Figure 59 shows a side view of a removal catheter procedure according to the present application;

[0080] Figure 60A side view of a removal catheter procedure according to the present application is shown;

[0081] Figure 61 A side view of a removal catheter procedure according to the present application is shown;

[0082] Figure 62 A side view of a removal catheter procedure according to the present application is shown;

[0083] Figure 63 A side view of a removal catheter procedure according to the present application is shown;

[0084] Figure 64 A side view of a removal catheter procedure according to the present application is shown;

[0085] Figure 65 A side view of a removal catheter procedure according to the present application is shown;

[0086] Figure 66 A side view of a removal catheter procedure according to the present application is shown;

[0087] Figure 67 A side view of a removal catheter procedure according to the present application is shown;

[0088] Figure 68 A side view of a removal catheter procedure according to the present application is shown;

[0089] Figure 69 A side view of a removal catheter procedure according to the present application is shown;

[0090] Figure 70 A side view of a removal catheter procedure according to the present application is shown;

[0091] Figure 71 A side view of a removal catheter procedure according to the present application is shown;

[0092] Figure 72 A side view of a removal catheter procedure according to the present application is shown;

[0093] Figure 73 A side view of a removal catheter procedure according to the present application is shown;

[0094] Figure 74 A side view of a removal catheter procedure according to the present application is shown;

[0095] Figure 75 A side view of a removal catheter procedure according to the present application is shown;

[0096] Figure 76 A side view of a removal catheter procedure according to the present application is shown;

[0097] Figure 77 shows a side view of a removal catheter procedure in accordance with the present application;

[0098] Figure 78 shows a side view of a removal catheter procedure in accordance with the present application;

[0099] Figure 79 shows a side view of a removal catheter procedure in accordance with the present application;

[0100] Figure 80 Figure 80 shows a side view of a removal catheter procedure in accordance with the present application;

[0101] Figure 81 shows a side view of a removal catheter procedure in accordance with the present application;

[0102] Figure 82 shows a side view of a removal catheter procedure in accordance with the present application;

[0103] Figure 83 Figure 83 shows a side view of a removal catheter procedure in accordance with the present application;

[0104] Figure 84 shows a side view of a removal catheter procedure in accordance with the present application;

[0105] Figure 85 shows a side view of a removal catheter procedure in accordance with the present application;

[0106] Figure 86 shows a side view of a removal catheter procedure in accordance with the present application;

[0107] Figure 87 shows a side view of a removal catheter procedure in accordance with the present application;

[0108] Figure 88 shows a side view of a removal catheter procedure in accordance with the present application;

[0109] Figure 89 Figure 89 shows a side view of a removal catheter procedure in accordance with the present application;

[0110] Figure 90 Figure 90 shows a side view of a removal catheter procedure in accordance with the present application;

[0111] Figure 91 shows a side view of a removal catheter procedure in accordance with the present application;

[0112] Figure 92 shows a side view of a removal catheter procedure in accordance with the present application;

[0113] Figure 93 shows a side view of a removal catheter procedure in accordance with the present application;

[0114] Figure 94 shows a side view of a removal catheter procedure in accordance with the present application;

[0115] Figure 95 shows a side view of a removal catheter procedure in accordance with the present application;

[0116] Figure 96 shows a side view of a removal catheter procedure in accordance with the present application;

[0117] Figure 97 shows a side view of a removal catheter procedure according to the present application;

[0118] Figure 98 shows a side view of a removal catheter procedure according to the present application;

[0119] Figure 99 shows a side view of a removal catheter procedure according to the present application;

[0120] Figure 100 shows a side view of a removal catheter procedure according to the present application;

[0121] Figure 101 Figure 101 shows a perspective view of a removal catheter device according to the present application;

[0122] Figure 102 Figure 102 shows a perspective view of a removal catheter device according to the present application;

[0123] Figure 103 Figure 103 shows a perspective view of a removal catheter device according to the present application;

[0124] Figure 104 Figure 104 shows a perspective view of a removal catheter device according to the present application;

[0125] Figure 105 Figure 105 shows a perspective view of a removal catheter device according to the present application;

[0126] Figure 106 Figure 106 shows a perspective view of a removal catheter device according to the present application;

[0127] Figure 107 Figure 107 shows a perspective view of a valve cutting example;

[0128] Figure 108 Figure 108 shows a perspective view of a removal catheter device according to the present application;

[0129] Figure 109 Figure 109 shows a perspective view of a removal catheter device according to the present application. DETAILED DESCRIPTION

[0130] Specific embodiments of the present application will now be described with reference to the accompanying drawings. However, the present application can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and fully convey the scope of the application to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the present application. In the drawings, like numbers refer to like elements.

[0131] The present invention generally relates to devices and methods for removing heart valve therapies via catheter-based procedures. While current methods for removing heart valve therapies require open-heart surgery, the techniques and devices of the present invention utilize catheter-based devices and procedures that are less invasive and can provide better patient outcomes.

[0132] Figure 1 to 1 3 illustrates various aspects of one embodiment of a removal catheter 100 for removing leaflet heart valve therapies, such as a valve clip 40 or similar heart valve therapy device, in accordance with the present invention. The removal catheter 100 generally includes an expandable capture basket 102 and a cutting loop 104 disposed near the top opening of the basket 102. As Figure 7 and Figure 8 The basket 102 is placed over the implanted valve clip 40 such that the top of the basket 102 and the cutting loop 104 are between the clip 40 and the leaflets 22, 24 on the atrial side of the leaflets 22, 24. Next, the top opening of the basket 102 is closed or reduced in diameter and the cutting loop 104 is activated to cut the leaflet tissue surrounding the valve clip 40 (e.g., by providing RF energy) to release the valve clip 40 from the valve 20. Finally, the capture basket 102 containing the valve clip 40 is withdrawn and removed from the patient. Further details and variations of the removal catheter 100 are discussed below, followed by example ways and methods of removing various heart valves (e.g., the mitral valve 20 or the tricuspid valve 15).

[0133] As Figure 9 to 11 illustrated, the removal catheter 100 includes an inner control member 108 (as Figure 11 illustrated) positioned within an outer tubular sheath 110. The inner control member 108 can be a solid wire or tube that extends between the distal and proximal ends of the sheath 110. The basket 102 and the cutting loop 104 are connected to the distal end of the inner control member 108 such that when the inner control member 108 is moved longitudinally or rotationally relative to the outer tubular sheath 110, the basket 102 and the cutting loop 104 move similarly.

[0134] Referring to Figure 11 In one embodiment, a plurality of loops 102A are positioned around the circumference of the top opening of the basket 102 and a tightening loop 106 is disposed through the loops 102A. As shown in FIG. 13, the tightening loop 106 can be composed of a looped wire (e.g., circular, elliptical, etc.) and an elongated straight portion 106A that can be connected to the control member 108 through a connection sleeve 112. The connection sleeve 112 can be clamped, welded, glued / epoxied, or any combination thereof, to secure the sleeve 112 to the control member 108. Alternatively, the tightening loop 106 can be connected to the control member 108 by welding or adhesive alone.

[0135] Cutting loop 104 can similarly be formed in a general loop shape (e.g., circular, oval, saddle-shaped, etc.) and can include an elongated straight portion 104E that can also be connected to control member 108 by a connecting sleeve 112. In this regard, as shown in the cross-sectional view of FIG. 12, both elongated straight portions 106A and 104E are located within connecting sleeve 112.

[0136] In one embodiment, cutting loop 104 cuts tissue when it is supplied with radiofrequency energy. In one example, a radiofrequency power source is connected to the proximal end of control member 108, which is composed of an electrically conductive metal, thus delivering radiofrequency energy to its distal end, and then to connected cutting loop 104. To complete the radiofrequency energy circuit using cutting loop 104, a second radiofrequency electrode can be connected to the radiofrequency power source, and can be connected to another location on the patient through an electrode pad (monopolar radiofrequency system), a second electrode can be included on removal catheter 100 (bipolar radiofrequency system) at another location, or, a second insulated wire can be included on control member 108 (bipolar radiofrequency system).

[0137] It can be desirable to isolate the radiofrequency energy circuit of cutting loop 104 from both tightening loop 106 and basket 102 to prevent damage to other tissue in the heart. This can be accomplished by using electrical insulation as a specific location on the device. For example, a wire insulation layer 114 can be placed on elongated straight portion 106A (or optionally the entire tightening loop 106) to electrically isolate tightening loop 106 from the radiofrequency current of control member 108, as shown in the cross-sectional view of FIG. 12 and the exploded view of FIG. 13.

[0138] In Figure 14 to 30 other examples shown, cutting loop 104 can have different structures, shapes, and electrical insulation to help reduce the risk of non-insulated portion 104B (i.e., the portion that cuts the leaflet tissue) contacting any portion of tightening wire 106 or basket 102. For example, Figure 14 cutting loop 104 is shown with non-insulated portion 104B located opposite elongated straight portion 104E, adjacent to insulated portions 104A on each side. In this example, non-insulated portion 104B can extend completely around the circumference of the wire, as shown in Figure 21 or can be exposed only along the inside of loop 104, as shown in Figure 20

[0139] As shown in Figure 14 non-insulated portion 104B can include only a single area (e.g., between about 1 mm to 5 mm) of wire 104C exposed therein, or as shown in Figure 22 non-insulated portion 104B can include a relatively small length (e.g., between about 1 mm to 5 mm) of multiple discrete non-insulated portions 104B (e.g., 2 to 10 portions 104B).

[0140] ​In all cutting ring embodiments, the majority of the surface of the cutting ring 104 is insulated. To create the non-insulated portion 104B, the cutting ring insulation 104A can be selectively removed (for wires with existing insulation) to expose the cutting ring conductor 104C in a manner that would allow it to contact and deliver radiofrequency cutting energy to the leaflet tissue bridge upon contact with tissue near the heart valve therapy. Alternatively, insulation 104A can be added (e.g., by impregnation, spraying, or similar techniques), and the non-insulated portion 104B can be created by masking the intended area prior to insulation application.

[0141] It should be understood that the non-insulating portion 104B can be oriented in any number of ways, for example, on the inner / outer surface of the cutting ring 104 and on the bottom (i.e., atrium) side of the ring 104.

[0142] The lower wire 104C of the cutting ring 104 may be composed of a shape memory metal (e.g., nickel-titanium alloy) or a similar conductive metal (e.g., stainless steel or copper). Figure 23 , 24 As shown in the cross-sectional diagram of 25, the line 104C below can have rectangular cross-sections, circular cross-sections, triangular cross-sections, and square cross-sections, respectively.

[0143] The cut ring 104 can also consist of one or more wires, such as a first wire 104C and a second wire 104D. Both wires can be made of similar materials (such as nickel-titanium alloy, stainless steel, copper, silver, or similar materials), or each wire can be made of different materials. For example, one wire 104C can be made of a metal that conducts current better (such as stainless steel, silver, or copper), while another wire 104D can be made of a material that maintains its shape between compression and expansion configurations (e.g., shape memory metals such as nickel-titanium alloy). Multiple wires can be electrically isolated or insulated from each other or independently. Different cross-sectional shapes can be further used for the same or different materials, such as... Figure 16 to 18 As shown in Figures 26 to 28.

[0144] In another example, the cutting ring 104 may be composed of a single wire comprising multiple strands of different wire materials. For example, Figure 19 and Figure 29 A core 104D composed of shape memory stranded wire is shown, which has multiple conductive strands 104C located around the core 104D. In another example, Figure 30 This includes alternating shape memory stranded wire 104D and conductive stranded wire 104C. In this respect, the different strands can provide the desired current conduction and the ability to expand from a compressed configuration to a predetermined loop shape. Multiple wires can be electrically isolated or insulated from each other or independently. Either of these two cable examples can have 2 to 49 strands or more.

[0145] The cutting loop can have a variety of different shapes, structures, and electrical insulation patterns to facilitate tissue removal around the clip 104, for example the cutting loop can provide additional length and / or a predetermined path or geometry. Figure 101 One alternative example of a cutting loop 316 having a "saddle" or wave shape is shown, where each side 314, 315 of the loop is angled downward (i.e., in the direction toward the proximal end of the catheter 100) and its free end 311 is curved upward (i.e., in the direction away from the distal end of the catheter 100). The side portions 314 and 315 can be insulated, and the middle portion 311 and the end portions 312 and 313 can be insulated. The middle portion 311 contacts or engages tissue on one side of the loop 316, while the end portions 312 and 313 contact or engage tissue on the other side. The side portions 315 and 316 can be curved outward to increase the width of the loop 316, curved inward to decrease the width of the loop 316, or can be relatively straight to maintain a uniform width (i.e., circular or elliptical) of the loop 316.

[0146] Many different tissue engagement methods can be facilitated by the cutting loop 316, for example the end portions 312 and 313 can be activated first simultaneously, while the cutting loop 316 applies axial tension to the tissue structure, effectively cutting the tissue in contact with these portions 312, 313, and partially releasing the leaflet clip 40. Next, the free end portion 311 can be activated to cut the tissue connected thereto and complete the excision of the leaflet clip 40 from the leaflet. Alternatively, all three portions 311, 312, and 313 can be activated simultaneously. The axial tension on the loop 316 can be applied before, during, or intermittently during the engagement of the loop 316. This example shows three non-insulated cutting regions or portions 311, 312, and 313, but there can be any number of cutting elements (e.g., from 1 to 100), including the entire loop 316 as one continuous non-insulated cutting element.

[0147] The additional length included along the side portions 314 and 315 can accommodate other tissue structures that exist around the leaflet clip 40. The additional length of the side portions 314 and 315 can also be deformable, such that when the elongated straight portion 317 applies tension, the side portions 314 and 315 will straighten and lengthen the loop 316 to an approximate axial configuration. During this stretching and elongation, the axial distance between the free end portion 311 and the proximal end portions 312, 313 increases, thereby accommodating greater variations in diameter and angle of approach to the clip. Any such non-linear path can also accomplish this, and is therefore contemplated in the present invention, but is not shown herein for the sake of brevity.

[0148] Figure 102A delivery mechanism is shown, having a previously described cutting ring 316 and an outer tubular sheath 320 generally similar to the previously described sheath 110. However, the outer tubular sheath 320 also includes a sheath cutting section 321 disposed at the distal end of the sheath 320 and circumferentially arranged around the distal end of the sheath 320. This sheath cutting section 321 may have a structure and features similar to the non-insulated portion of the existing cutting ring previously described, and may be similarly electrically activated to provide an additional area of ​​cuttable tissue. The outer tubular sheath 320 can be used in conjunction with any other disclosed device and in a manner most advantageous for flap clip removal surgery. Similarly, all non-insulated cutting sections 311, 312, 313, and 321 may be activated individually at different times or all together simultaneously.

[0149] Figure 103 It shows Figure 102 An embodiment within a heart valve tissue model 330, which includes chordae tendineae 13 and leaflet positioning clips 40. The figure illustrates an example of how devices 320 and 316 engage tissue on each side of clip 40 in a manner positioned to detach attached tissue structures from clip device 40.

[0150] exist Figure 104 Another example embodiment of the cut ring 350 can be seen, wherein each side ring portion 314, 315 is bent upward (i.e., in the distal direction) and its free end is bent downward (i.e., in the proximal direction). Furthermore, the side ring portions 314, 315 are shown to be bent laterally outward, increasing the width of the ring 350. The ring 350 can have various different insulating and non-insulating portions, such as... Figure 101 to 103 The portion described in the text (i.e., several discrete non-insulating parts or the entire ring is non-insulating).

[0151] Figure 105 and 106 Another embodiment of the removal device 360 ​​is shown, which is generally similar to the removal device 100 but also includes a first cutting ring 104 and a second cutting ring 316. In some cases, it may be difficult for a physician to accurately see which tissue should be cut to completely remove the cardiac therapy device. Two or more rings can allow for a first series of cuts to the valve tissue, followed by one or more second cuts (e.g., by tightening the first cutting ring) to completely remove the cardiac therapy without requiring major repositioning of the rings. Conversely, it may be necessary to move, longitudinally reposition, and / or rotate a single cutting ring to completely sever the cardiac therapy.

[0152] In the present example, the first cutting ring 104 has a slightly larger diameter (e.g., similar to the opening of the basket 104), and the second cutting ring 316 has a smaller diameter than the first cutting ring 104 and is further from the basket 104. Thus, the second ring 316 can be placed in close proximity to the valve leaflets and / or chordae tendinae (e.g., Figure 107 In the present example, the first cutting ring 104 has a slightly larger diameter (e.g., similar to the opening of the basket 104), and the second cutting ring 316 has a smaller diameter than the first cutting ring 104 and is further from the basket 104. Thus, the second ring 316 can be placed in close proximity to the valve leaflets and / or chordae tendinae (e.g., Figure 107 In the present example, the first cutting ring 104 has a slightly larger diameter (e.g., similar to the opening of the basket 104), and the second cutting ring 316 has a smaller diameter than the first cutting ring 104 and is further from the basket 104. Thus, the second ring 316 can be placed in close proximity to the valve leaflets and / or chordae tendinae (e.g.,

[0153] While specific implementations of the cutting rings 104 and 316 are shown, for example, in FIGS. 1-3, any combination of any of the rings described in this specification can be used in this manner. For example, Figure 105 and 106 and Figure 108 An embodiment 180 is shown having two rings 316 that are similar in shape and configuration. Thus, either ring can have a different number and pattern of cutting portions, and these cutting portions can be activated simultaneously or at different times / patterns. In one example, the cutting rings 104 and 316 are both connected to the same electrical circuit (e.g., the internal control component 108). Alternatively, each ring 104, 316 (or each set of cutting portions) can have its own electrical circuit (e.g., separate wires) that allows for activation independent of the other cutting ring. Further, three or four cutting rings can be used interchangeably. The cutting rings can all be connected to the same removal catheter, or one or more rings can be connected to a catheter that is separate from the other cutting rings and / or the basket 104. In some embodiments, one or more cutting rings can be located on the ventricular side of the valve, while one or more cutting rings can be located on the atrial side of the valve.

[0154] If the cinching ring 106 has an insulating coating along its entire length, the cutting ring 104 can be positioned directly on top of the cinching ring 106, in contact with the ring. The cutting ring 104 can also be longitudinally spaced apart from the cinching ring 106, for example, between about 0 mm and about 15 mm.

[0155] Preferably, the internal control component 108 (as Figure 11 to 13) flexible enough to pass through the vasculature while having enough column strength to push the basket 102 and cutting loop 104 out of the outer tubular sheath 110; the inner control member is effective to transfer radio frequency energy from the proximal handle to the cutting loop; the inner control member is insulated to prevent current leakage into the blood stream; and the inner control member has good torque response so that the user can rotate the basket and loop while deploying inside and around the valve.

[0156] In a preferred embodiment, the inner control member 108 comprises an inner control tube core connected or welded to a more flexible inner control cable, which is then connected to the cutting loop wire tail using a distal coupler. In a preferred embodiment, the inner control needle, inner control cable, cutting loop wire, and distal coupler are the same material (e.g., a steel alloy) to achieve a strong welded joint and effective current transfer. The inner control cable can be a laser cut tube, a stranded cable, a stranded cable tube, a coil, or a combination thereof. In another embodiment, the inner control cable can extend from the proximal handle to the cutting loop 104 and does not require an inner control needle.

[0157] In an alternative embodiment, the inner control member 108 can be two separate wires; one connected to the cinching loop 106 and the other connected to the cutting loop 104. In the case where both inner control members are disposed in the same single lumen of the outer tubular sheath 110, the basket 102 can be deployed first by advancing the inner basket control member distally until the basket cinching loop 106 is fully exposed. Then, the inner cutting loop control member can be advanced distally to deploy the cutting loop 104. Each loop can be rotated, advanced, or retracted by the respective control member. This provides the operator with more degrees of freedom. The heart valve therapy can first be captured or encircled by the cutting loop 104, then the basket cinching loop 106 and basket 102 can follow. Then, the cutting loop 104 can be closed onto the leaflet tissue bridge by retracting the inner cutting loop control member. Once the cutting loop is closed on the tissue bridge, one of the following two steps can be taken: 1) the basket cinching line 104 and basket 102 can then be closed by retracting the inner basket control member proximally; or 2) if the cutting loop 104 cannot reach the base of the heart valve therapy, radio frequency (RF) cutting energy can be applied to cut one side of the device to reach the base of the clip 40; then the basket 102 can be closed. Once both loops are properly closed on the tissue on the atrial side of the heart valve therapy, the inner cutting loop control member is energized with radio frequency power as the inner cutting loop control member is retracted proximally into the outer delivery sheath 110. The inner cutting loop control member transfers cutting energy to the cutting element only through the cutting loop 104.

[0158] The internal control components described above can be alternately disposed in separate lumens in a single outer tubular sheath or in the same sheath 110. The design of the system can be such that each sheath can be placed in a separate orifice (i.e., on opposite sides of the heart valve therapy). Once both loops have captured the heart valve therapy, the same synchronization steps described above will be followed.

[0159] The control component insulation covering the outer surface of the internal control tube core and the internal control components is preferably flexible enough not to interfere with the navigation of the delivery catheter through the valve orifice. It is also desirable to be as lubricious as possible in order to minimize the friction between the internal control components and the delivery catheter as the internal control components are pushed distally to deploy the basket and cutting loop in the left ventricle. For example, the insulation can include a hydrophilic coating, a silicone coating, a Teflon-like coating, a polyolefin coating, a thermoform or thermoset coating, or a fluoropolymer.

[0160] Returning to the basket 102, the length and diameter of the basket 102 can depend on the size of the heart valve therapy device or clip 40. For example, the length of the basket 102 can be in the range of about 20 mm to about 50 mm, and the diameter can be in the range of about 10 mm to 20 mm. The diameter of the basket 102 can be adjusted accordingly depending on the size of the leaflet clip 40 and the angle at which the basket 102 is intended to capture the clip 40. For example, the larger the angle taken with respect to the top surface of the basket 102 opening, the larger the diameter of the basket 102 should be. In other words, unless the basket 102 is intended to be positioned substantially directly under the clip 40, the basket 102 should expand to a diameter much larger than the diameter of the clip 40.

[0161] In Figure 31 In one embodiment, the basket 102 can be composed of a plurality of braided wires. The wires can be composed of a shape memory material, such as Nitinol, or a non-shape memory material, such as stainless steel, and can be braided over a mandrel of the desired basket size and then heat set so that the braided shape reverts to the expanded basket structure upon compression. The wires can also have an insulating coating, such as ethylene tetrafluoroethylene (ETFE), polyimide, polyethylene terephthalate, silicone, or similar materials. The benefit of a braided basket is that its behavior / performance can be altered by changing the basket wire diameter, basket wire material, and / or braiding density (i.e., basket hole size) while keeping the basket diameter and length constant. The basket diameter and length design is primarily dictated by the size of the heart valve to be removed. The size, spacing, and number of the braided basket eyelets can also be adjusted and optimized. In one example, the basket 102 holes 102B are in the range of about 100 μιη to about 4 mm in diameter when expanded.

[0162] The wire size is preferably small enough to allow it to be easily folded into the delivery catheter and unfolded from the delivery catheter during the procedure, but also large enough to give the basket some rigidity so that it can open sufficiently in the presence of valve chords or other structures. The pore size of the woven basket can vary depending on the design intent. In general, the pore size should be smaller than the length, width, or height of the heart valve therapy to avoid it from being embolized after it is excised. Woven baskets with very small pores help to filter and capture any debris generated during the tissue cutting process.

[0163] One benefit of coating the metal basket is to ensure that the electrical energy is concentrated in the cutting element and not distributed throughout the metal structure of the basket and into the blood pool. A second benefit of the coating is that it can also reduce friction and thus make it easier to capture the heart valve therapy inside the basket. If the basket is too rough or has too many interior edges, the heart valve therapy can not be able to be fully secured inside the basket. Adding a layer of lubricious coating or smoothing to the interior surface of the capture basket can make it easier to capture the heart valve therapy.

[0164] In Figure 32 , 33 and 34, the removal catheter 150 includes a basket 152 that is composed of a polymer such as silicone, polyethylene terephthalate (PET), polyester, nylon, polypropylene, Kevlar (a new material for fiber optic cables and electrical cables), or similar material that can be folded or collapsed into a radially compressed configuration. The basket 152 can be formed with a plurality of pore sizes that are sized to prevent the passage of leaflet clips 40 and other biological material that can be dislodged from the procedure (e.g., about 100 pm to about 4 mm in diameter). The basket 152 can be similar in size to the basket 102 discussed earlier. The top opening of the basket 152 can also include a plurality of rings or channels 152B that are sized to allow the passage of the cinch ring 106 so that the basket 152 can be closed during the procedure.

[0165] The construction of the polymer basket 152 can be done using a weave, mesh, braid, knit, or by injection molding. The potential basket shapes and material combinations are infinite and only a few are described here. It is important to select a polymer material that has high heat resistance, low moisture absorption, is durable enough to be folded into the outer sheath multiple times. Silicone tends to best meet all of these performance requirements. If the basket is made from silicone, it can be molded into a basket shape as a standalone component or molded directly onto the ring structure. If the basket is made from a silicone flat sheet, it can be cut into the designed pattern and then sewn onto the ring to form the desired shape.

[0166] The size and spacing of the holes 152A can be adjusted depending on the material chosen. Generally, the hole diameter can be smaller than the length, width, or height of the heart valve therapy to avoid its being clogged after being cut open. Using a basket with very small pores can help filter and capture any debris generated during the tissue cutting process. Designing a basket with pores can also allow some blood to flow through; this helps improve the operator’s control of the basket by minimizing the force exerted on the basket when pumping blood (i.e., minimizing the “parachute effect”). The polymer basket can or can not be configured with eyelets; if there are eyelets as shown, they would be slidably mounted on the basket tightening ring. If there are no eyelets, they should be securely fixed to the basket tightening ring.

[0167] Since the polymer basket 152 does not conduct current, other embodiments can be employed in which the cutting ring 104 of the catheter 160 also acts as the tightening ring, as shown in FIGS. 35 and 36. The basket 152 can be directly connected to the insulated portion 104A of the cutting ring 104 (or an insulated portion can also be formed directly around the uninsulated wire), leaving the uninsulated portion 104B to perform the leaflet cutting.

[0168] Similar “single loop” embodiments can also be used for other shapes and materials. For example, FIG. 37 shows multiple polymer or fabric filaments woven together to form a flexible basket shape and relatively large pore size (e.g., about 0.5 mm to about 4 mm). FIG. 38 shows multiple polymer or fabric fibers woven into a fabric basket 164 with a relatively small pore size (e.g., about 0.5 mm to about 4 mm). FIG. 39 shows a polymer sheet stitched to form a basket 166. In any of these embodiments, the cutting ring 104 can be exposed so that the uninsulated portion 104B can cut through the valve leaflets after being tightened.

[0169] In other embodiments, the basket can be partially or entirely composed of a laser-cut basket. For example, FIGS. 40 and 41 show multiple vertical, laser-cut ribs with eyelets arranged along their length to allow weaving or braiding of multiple wires or polymer filaments. FIGS. 42 and 43 show a laser-cut basket shape entirely composed of a laser-cut shape memory metal (e.g., a shape memory metal tube or sheet).

[0170] An advantage of a laser-cut basket is that its performance / properties can be changed by varying the tube size and / or cutting pattern / density (i.e., basket pore size) while keeping the basket's diameter and length constant. The basket's diameter and length design is primarily dictated by the size of the heart valve to be removed. The size, spacing, and number of laser-cut pores can also be adjusted and optimized. The material used is preferably one with shape memory properties, such as Nitinol, to allow the laser-cut portion of the tube to expand and shape. The use of a material with shape memory functionality can allow the basket to be repeatedly folded and opened to the same shape. The wire size is preferably small enough to allow it to be easily folded into and deployed from a delivery catheter during the procedure, but large enough to give the basket some rigidity so that it can open sufficiently in the presence of valve chords or other structures.

[0171] In a laser-cut design, the basket pore size can be varied by changing the cutting pattern to achieve the desired result. For example, the pore size can vary from about 100 pm to about 4 mm. Generally, the pore size should be smaller than the length, width, or height of the heart valve therapy to avoid its embolization through the basket after being cut out. One unique advantage of a laser-cut basket is that the pore size and spacing can be different throughout the length of the basket. For example, the proximal open side of the basket can have large pores with a particular pattern density. The pore size and pattern density can become smaller and denser toward the distal end of the basket.

[0172] Any of the basket embodiments described in this specification can further include a shell to help collect any debris or embolic material released during the procedure. Such a shell can include a solid or porous polymer sheet, a braid, a tubular formed from relatively small, fine braided wire, or the like. In one particular embodiment, the interior of the basket can have a non-conductive liner, film, or coating (e.g., silicone) on its inner surface to help prevent conduction with the cutting element 104.

[0173] In one embodiment, the removal catheter 100 can include a proximal handle portion 170, as shown in FIGS. 1 and 2. The handle 170 can include an outer housing 172 and a sliding member 174 configured to slide within a longitudinal slot within the housing 172. When the sliding member 174 is connected to the inner control member 108, the housing 172 can be connected to the outer tubular sheath 110, thereby allowing a user to adjust the position of the sliding member 174 with a thumb to cause corresponding longitudinal movement of the inner control member 108, the basket 102, and the cutting loop 106. Figure 44 and 45

[0174] ​Optionally, handle 170 can also include a fluid connection port 176 (e.g., a luer port) that is in communication with the interior of the internal passageway of outer tubular sheath 110, so that an electrically neutral solution (e.g., a dextrose solution) can be delivered to the area near the cutting ring, enhancing the tissue cutting effect and minimizing energy loss in the area surrounding the blood pool. The amount and timing of this fluid can be determined by the physician (e.g., via a syringe) or by an electrically powered pump mechanism based on the position of cutting ring 106 (i.e., when the cutting ring is outside the outer tubular sheath and in good contact with the desired tissue 110).

[0175] As shown in FIG. 17, handle 170 can also include a locking mechanism 173 near the distal end of housing 172 that locks internal control member 108 in position relative to outer tubular sheath 110. For example, locking mechanism 173 can include a knob 177 that is configured to rotate a cam member 178 around the proximal end of internal control member 108. When knob 177 rotates member 178, cam member 178 forms an interference fit with the interior of housing 172, locking control member 108 in its longitudinal position. When knob 177 rotates cam member 178 in the opposite direction, it releases the interference fit between cam member 178 and housing 172 to release internal control member 108, enabling it to slide longitudinally within handle 170. Figure 45

[0176] An embodiment of removal catheter 100 is shown with an overflow hole 111 in outer tubular sheath 110. This embodiment is most advantageous for embodiments with a single tightening and cutting ring and a polymeric or minimally conductive basket 102. When cutting element 104 and fixed basket 102 are retracted within outer sheath 110 to begin cutting the leaflet tissue, the distal end of outer sheath 110 can become isolated from the blood pool. If this occurs after the tissue has been cut, the electrical current delivered to cutting element 104 is no longer transmitted to the tissue or blood, but rather is transmitted as heat and / or current through basket 102, potentially damaging basket 102. An electrical current overflow hole 111 in outer tubular sheath 110 can ensure that cutting element 104 is always in communication with the blood pool, even after cutting is complete. In this way, the electrical current will preferentially flow through the blood to the opposing radiofrequency electrode connected at the other part of the patient, rather than the basket. Figure 46

[0177] ​Optionally, a wire 113 can be connected to the internal control member 108 to ensure that the current path always involves the blood pool even after the cut is complete. The wire 113 is preferably designed to be long enough to always protrude from the distal end of the outer tube sheath 110 even when the basket 102 is fully collapsed within the outer tube sheath 110. It is best to have a very small exposed metal area at the very distal tip, with the rest being insulated. This way, when the cut is complete, the current will preferentially flow through the wire, which has a lower resistance, and to the blood, rather than through the basket 102 (e.g., silicone), which has a higher resistance.

[0178] Figures 48-53 show side views of the removal catheter 100 as it deploys and cinches its basket 102. In Figure 48, the basket 102, the cinch ring 106, and the cutting ring 104 are all within the outer tube sheath 110. As shown, these components are radially compressed to a relatively small diameter to allow passage through the patient's blood vessel (the compression within the outer sheath enables passage through a smaller orifice and between the plurality of clips).

[0179] In Figure 49, the internal control member 108 is advanced distally (e.g., by the sliding member 174) so that the basket 102 begins to exit the outer tube sheath 110 and radially expand. This distal movement continues until the basket 102 and the cutting ring 104 are both deployed and fully expanded outside of the sheath 110, as shown in Figure 50. Figure 50

[0180] Figures 51 and 52 illustrate the retraction of the internal control wire 108, which causes the cinch ring 106 and the cutting wire 104 to retract and radially close the diameter. Typically, during this time, radio frequency energy will be activated so that as the cutting wire 104 closes, it cuts the tissue of the leaflet. When the cutting ring 104 is fully pulled into the outer tube sheath 110, the radio frequency current is deactivated. This can be accomplished in a variety of different ways. For example, the sliding member 174 of the handle 170 described earlier can include a position switch that turns the radio frequency energy on / off at a predetermined longitudinal position. Alternatively, a manual on / off switch can be included on the handle 170 or the radio frequency power source.

[0181] ​To help determine when to manually turn off the radiofrequency energy, a radiopaque marker can be placed at the distal end of the outer tubular sheath 110. When the physician makes the tissue bridge cut, their eyes will be on the fluoroscopy screen. Since tissue is not typically visible on fluoroscopy, it can be useful to provide the operator with a visual indicator on the catheter 100 that the tissue bridge has been cut. During the cutting process, the inner control member 108 and cutting loop 104 are retracted into the sheath 110, and the positioning of the radiopaque marker is such that when the operator sees the entire cutting loop 104 proximal to the radiopaque marker on the fluoroscopy screen, the tissue bridge has been cut. This is not only a useful visual indicator for the operator, but also makes the procedure safer. Once the cutting loop 104 passes the radiopaque marker, the operator can immediately terminate the radiofrequency cutting energy to prevent any inadvertent heating by applying power beyond the necessary time.

[0182] Finally, the opening of the basket 102 is almost completely closed, and the positioning of the inner control member 108 can optionally be locked in place (e.g., locking mechanism 173 on handle 170). The basket 102 can remain outside of the outer tubular sheath 110 and be pulled into the larger catheter used during the procedure.

[0183] The present invention includes different methods or approaches to remove cardiac valve therapies such as the valve clip 40. For example, Figure 56 to 61 A removal procedure is illustrated in which access is made through the atrial septum 18 to the mitral valve 20. While example access methods and procedures are described, it should be understood that variations can occur based on known catheter access techniques. In addition, these access techniques can be used with any embodiment of the present specification.

[0184] In one embodiment, Figure 56 to 61 A mitral valve access procedure in Figure 54 can be seen individually in Figure 55 together in and are discussed further below. The three nested but independent curved and axial connection catheters enable the removal device to be placed anywhere in the heart regardless of size or procedure positioning. However, other tools, sheaths, catheters, and similar devices can be used alternatively to guide the removal catheter 100 as described below.

[0185] First turning to Figure 56The interatrial septum can be accessed by advancing a transseptal lead or needle into the interatrial septum 18 (e.g., through the inferior vena cava 17 or superior vena cava 19), using the lead through the interatrial septum 18, and finally moving the lead to the left atrium. Next, a relatively large-diameter external transseptal catheter 182 can be passed through the lead and through the interatrial septum 18 so that its distal end is located within the left atrium 12. Alternatively, the transseptal guide catheter 182 can be advanced through the interatrial septum 18 without using any transseptal lead. The external transseptal guide catheter 182 may optionally have a predetermined curve or bend, which can help it tilt from the inferior vena cava 17 toward the interatrial septum 18.

[0186] The lead can be removed, and then the internal steerable guide catheter 180 can be advanced through the external transseptal guide catheter 182 so that its distal end is located within the left atrium 12. The distal end of the internal steerable guide catheter 180 can be “steered” or deflected so that its distal opening faces the desired position of the mitral valve 20. Because the guide catheter is independent of the transseptal guide catheter 182, the physician can guide the internal steerable guide catheter 180 to any position on the mitral valve 20, allowing it to rotate, advance / retract, or change the degree of deflection while keeping the transseptal guide catheter 182 in the same position.

[0187] In the example of the mitral valve 20 with leaflet clips 40, the internal steerable guide duct 180 preferably points to either of the two valvular openings on each side of the central clip 40 (see [link]). Figure 6 (Top view). Once the desired target location is indicated, remove catheter 100 through the internally steerable guide catheter 180 and from its distal end into the left atrium 12, and through one lateral opening of the mitral valve 20 into the left ventricle 14, as shown. Figure 56 As shown.

[0188] like Figure 57 and 58As shown, the internal control component 108 is advanced distally through the outer sheath 110 of the removal catheter 100, thereby disengaging the capture basket 102, tightening ring 106, and cutting ring 104 from the outer sheath 110. Preferably, the capture basket 102, tightening ring 106, and cutting ring 104 are connected to the internal control component 108 such that they expand so that the openings of the basket 102 and the cutting ring 104 face or point toward the leaflet clamp 40. For example, the plane 103A of the openings of the basket 102 and the cutting ring 104 can be an angle 103C between 45 and 135 degrees relative to the axis 103B (e.g., 90 degrees) of the internal control component 108. The internal control component 108 can be rotated relative to the outer sheath 110 (or the entire removal catheter 100 can be rotated alternately) so that the capture basket 102, tightening ring 106, and cutting ring 104 also rotate within the left ventricle 14. In this way, the doctor can align or orient the basket 102 to the desired position directly below the leaflet clip 40.

[0189] Once the capture basket 102, tightening ring 106, and cutting ring 104 are deployed, the internal control component 108 (or optionally the external tubular sheath 110) can be withdrawn proximally so that the leaflet clamp 40 is positioned inside the basket 102, as... Figure 59 As shown. Preferably, both the cutting ring 104 and the tightening ring 106 are located above the leaflet clamp 40; that is, between the leaflet clamp 40 and the bottom adjacent surfaces of the leaflets 22 and 24.

[0190] Turning Figure 60 The internal control component 108 retracts proximally to partially retract the tightening ring 106 and the cutting ring 104. This causes the top opening of the basket 102 to close diametrically above the leaflet clip 40, and also causes the cutting ring 104 to decrease in diameter and engage between the atrial side portions of the leaflets 22, 24 and the leaflet clip 40.

[0191] like Figure 61 As shown, radiofrequency energy is applied to the cutting ring 104 as it is withdrawn proximally and its diameter decreases. The non-insulated portion 104B presses against the portions of leaflets 22 and 24 closest to the leaflet clip 40, thereby cutting the tissue and releasing the leaflet clip 40 from the mitral valve 20. Radiofrequency energy is cut off to the cutting ring 104. Preferably, the transseptal guide catheter 182 has a sufficiently large diameter to allow the basket 102 containing the leaflet clip 40 to be placed within it. However, if necessary, the removal catheter 100, the internal steerable catheter 180, and the transseptal guide catheter 182 can be removed from the patient as a single unit.

[0192] It is further contemplated that after removal of the leaflet clip 40, a prosthetic valve can be installed at the location of the mitral valve 20. If a guide wire is used during the removal procedure, the guide wire can also be used to advance and orient a valve delivery catheter to deliver and implant the prosthetic valve. One example of such a prosthetic valve replacement can be found in U.S. Patent 8,579,964 entitled Transcatheter Mitral Valve Prosthesis, the contents of which are incorporated herein by reference.

[0193] It is further contemplated that after removal of the leaflet clip, a blood flow management device (e.g., a spacer, a catheter, a balloon, or other device) is advanced and expandable at the valve location to manage flow through the valve until additional therapy such as replacement of the valve can be provided.

[0194] Figure 62 to 65 Another method of removing a leaflet positioning device (e.g., leaflet clip 40) through a transapical approach is shown. First, an incision is made over the sternum (e.g., between the manubrium and the body of the sternum), and a transapical sheath 184 is passed through the incision, through the apex 10, and into the left ventricle 14, as shown. Figure 62 The catheter 100 is then removed through the transapical sheath 184 such that the distal end of the outer tubular sheath 110 extends into the left ventricle 14.

[0195] Turning to Figure 63 , the inner control member 108 is advanced distally within the outer tubular sheath 110 so as to release and expand the basket 102 and cutting loop 104 into the left ventricle 14. The cinch loop 106 and cutting loop 104 preferably have a predetermined bend (e.g., heat set bend / curve) that orients the top opening of the basket 102 and the opening of the cutting loop 104 toward the leaflet clip 40. For example, the plane of the top opening of the basket 102 and the opening of the cutting loop 104 can be in the range of 135 degrees to 225 degrees (e.g., about 180 degrees) relative to the axis of the inner control member 108. The inner control member 108 can be further rotated by the physician (or the entire removal catheter 100 can be rotated) to best align the cutting loop 104 and basket 102 with the leaflet clip 40.

[0196] As shown in Figure 64 , the outer tubular sheath 110 is further extended out of the transapical sheath 184 so that the leaflet clip 40 is entirely within the basket 102. As shown in Figure 65 , the inner control member 108 is proximally retracted so as to reduce the diameter of the cinch loop 106 and cutting loop 104. As the diameter of the loops 104 and 106 is reduced, the top opening of the basket 102 is reduced so as to confine the leaflet clip 40 therein. In addition, as the cutting loop 104 is reduced, radiofrequency energy is activated and delivered to the loop 104 so as to allow the non-insulated portion 104B to cut the leaflet tissue immediately above the leaflet clip 40.

[0197] Preferably, the capture basket 102, the cinch ring 106, and the cutting ring 104 are connected to the inner control member 108 so that they expand to the direction in which the openings of the basket 102 and the cutting ring 104 are oriented or pointed toward the direction of the leaflet clip 40. For example, the planes 103A of the basket 102 openings and the cutting ring 104 openings can be at an angle 103C between 25 degrees and 135 degrees relative to the axis 103B of the inner control member 108 (e.g., 90 degrees).

[0198] If the trans-septal sheath 184 has a large enough diameter, the outer sheath 110 can be proximally retracted, and the basket 102 containing the leaflet clip 40 can be retracted into the channel of the trans-septal sheath 184 for removal. If the basket 102 and the leaflet clip 40 are too large for the trans-septal sheath 184, the sheath 184 and the removal catheter 100 can be pulled out simultaneously.

[0199] Figure 66 and 67 Another method of removing a heart valve therapy, such as the leaflet clip 40, through an aortic approach is illustrated. Referring to Figure 66 The aortic catheter 186 is first positioned in the aorta 11 and then into the left ventricle 14. The aortic catheter 186 can have a fixed curve / shape to help the physician guide the distal end of the catheter 186 under the leaflet clip 40. Alternatively or additionally, the aortic catheter 186 can include a steerable mechanism to allow deflection in different directions.

[0200] Next, the removal catheter 100 is passed through the aortic guide catheter 186 so that the distal end of the outer tubular sheath 110 extends from the distal end of the catheter 186 into the left ventricle 14. The inner control member 108 is further advanced distally relative to the outer tubular sheath 110 so that the basket 102 and the cutting ring 104 are deployed, expanded, and positioned in the left ventricle 14. The openings of the basket 102 and the cutting ring 104 are both or oriented so that they face the leaflet clip 40. For example, the opening faces of the basket 102 and the cutting ring 104 can be in the range of about 300 degrees and 45 degrees relative to the axis of the inner control member 108 (e.g., about 320 degrees).

[0201] Referring to Figure 67The aortic guide catheter 186 (in the case of a steerable catheter) is moved or deflected to position the cutting loop 104 and basket 102 above the leaflet clip 40. The inner control member 108 is proximally retracted into 110, causing the diameter of the tightening loop 106 and cutting loop 104 to decrease, thereby closing the top opening of the basket 102. As the diameter of the cutting loop 104 decreases, radiofrequency energy is delivered to the loop 104, thereby allowing the non-insulated portion 104 to cut the region of leaflet tissue adjacent to the leaflet clip 40, thereby releasing the leaflet clip 40 from the mitral valve 20. The basket 102 and leaflet clip 40 can be retracted through the aortic guide catheter 186, or all catheters can be removed simultaneously as a single unit.

[0202] The present invention also contemplates use of the removal catheter 100 (or any of the variations described in this specification) on the tricuspid valve 15, as shown in Figure 68 and Figure 69 Referring first to Figure 68 , an outer tricuspid guide catheter 188 is first passed through the inferior vena cava 17 or superior vena cava 19 into the right atrium 16. The tricuspid guide catheter 188 can include a fixed curve at its distal end to help direct the distal opening of the catheter toward the tricuspid valve 15, or can include a steering mechanism that performs the same operation. Then, an inner intermediate catheter 189 can be passed through the outer tricuspid guide catheter 188 to provide a better angle to the tricuspid valve 15. For example, the inner intermediate catheter 189 can have a fixed curve toward the tricuspid valve 15, or can include a steerable catheter mechanism to allow the physician to deflect the distal end of the catheter 189 toward the tricuspid valve 15.

[0203] Next, the removal catheter 100 is passed through the inner intermediate catheter 189 so that it exits the distal end of the inner intermediate catheter 189 into the right atrium 16, through the tricuspid valve 15 into the right ventricle 13. Since the leaflet clip 40 is typically positioned in the middle of the valve 15 (e.g., similar to the top view of the mitral valve in Figure 6 , the removal catheter 100 is preferably positioned on both sides of the leaflet clip 40, creating a contralateral valve opening.

[0204] The inner control member 108 is further distally advanced relative to the outer tubular sheath 110 so that the basket 102 and cutting loop 104 are deployed, expanded, and positioned in the right ventricle 13. The openings of the basket 102 and cutting loop 104 are both or oriented so that they face the leaflet clip 40. For example, the plane 103A of the surface of the openings of the basket 102 and cutting loop 104 can be at an angle 103C in the range of about 0 degrees to 90 degrees relative to the axis 103B of the inner control member 108 (e.g., about 45 degrees). The removal catheter 100 is proximally retracted relative to the inner intermediate catheter 189 so that the cutting loop 104 and basket 102 are positioned above and beyond the leaflet clip 40.

[0205] The internal control component 108 retracts proximally, causing a reduction in the diameter of the tightening ring 106 and the cutting ring 104, thereby closing the top opening of the basket 102. As the diameter of the cutting ring 104 decreases, radiofrequency energy is delivered to the ring 104, allowing the non-insulated portion 104 to cut the leaflet tissue region adjacent to the leaflet clip 40, thereby releasing the leaflet clip 40 from the tricuspid valve 15. The basket 102 and the leaflet clip 40 can be retracted via the internal intermediate conduit 189, or all conduits can be removed simultaneously as a single unit.

[0206] It should be understood that any embodiment of this specification can be used in accordance with the access and delivery methods described in this application. Furthermore, further methods can be used in conjunction with these access and delivery methods, such as the delivery and implantation of artificial valves (mitral or tricuspid valves).

[0207] While the previously described embodiments of catheter removal include baskets or similar devices for capturing heart valve therapy, such as leaflet clips 40, different capture methods and devices are also considered.

[0208] Figure 70 to 72 A removal catheter 200 for removing a cardiac valve therapy leaflet clip 40 is shown. The removal catheter 200 includes an elongated perforated portion 202 for inserting a device and an external cutting catheter 204 disposed above the perforated portion 202. The elongated perforated portion 202 may be a wire, catheter, or similar elongated device with a sharpened, helical, expandable barb, or rotating element at its distal end, such that, Figure 70 As shown, the elongated perforated member 202 can be pressed into the top of the leaflet clip 40 (and optionally rotated or unfolded) to initially engage or capture the leaflet clip 40.

[0209] like Figure 71 As shown, the external cutting conduit 204 is advanced distally onto the elongated perforated component 202 until its distal end contacts the top surface of the leaflet, as... Figure 71 As shown. The external cutting catheter 204 can be configured to cut valve leaflet tissue using various different mechanisms, such as mechanical (e.g., rotational or anterior pressure) and / or electrosurgical cutting devices (i.e., electrocautery or cryo-cautery). Figure 72 As shown, once released from the leaflet tissue, the leaflet clip 40 can be removed by the elongated perforated component 202.

[0210] Figure 73 to 75 The image shows the removal catheter 210, which is similar to the aforementioned catheter 200, except that the cutting catheter 212 also includes a gripping mechanism with two hinged jaw plate components connected by a connector. Figure 76 The leaflet clip 40 has been joined to the elongated perforated component 202. Figure 73 After that, the outer cutting component 212 is pushed upward onto the elongated perforating component 202 until it contacts the top surface of the leaflet.Figure 74 The hinged jaw component preferably includes a tissue cutting mechanism at its end, such as a blade or electro / cryosurgical cutting device mechanism, allowing cutting of the leaflet tissue around the leaflet clip 40. Finally, in Figure 75 In the middle, the jaw components of the cutting catheter 212 approach each other to engage and grasp the tissue clip 40.

[0211] Figures 77 to 82 illustrate another embodiment of a removal catheter 220 embedded in a previously placed leaflet clip 40, followed by a passageway for a ring-based tool 224 for encapsulating, cutting, and removing the clip 40. In Figure 77, the ring-based removal catheter 220 includes an anchoring mechanism 226 connected to a central push rod 227, side push rods 223, and a pushability element 225.

[0212] Figure 78 shows an end view of the loop-based removal catheter 220, which can be circular, elliptical, multi-segmented, or a combination of these shapes and elements. Side rods 223 push the pushable element 225, while a central push rod 227 applies force to the anchoring mechanism 226. In Figure 79, the entire loop-based removal catheter 220 is folded and placed within the delivery catheter sheath 221. Figure 80 In this process, the anchoring mechanism 226 is advanced into the heart valve therapy hardware (i.e., the leaflet clip 40) using the central pusher 227 and the pushable element 125. In Figures 78 and 79, the pushable element 225 is then pushed using the side pusher 223 to completely or partially enclose the ring-based removal catheter 220 around the leaflet clip 40. Cutting is then performed mechanically or electrically, and the target tissue is removed.

[0213] Figure 83 to 8 Figure 8 illustrates a removal catheter 230 embedded in a previously placed cardiac valve (e.g., leaflet clip 40), followed by removal of the hardware via a tool that dilates the leaflet clip 40. Figure 83 In Figure 80, a maneuverable guide catheter 231 is used to position a removal catheter 232, which includes a dilation tool 234 for dilating the leaflet clip 40. The dilation tool 234 may have barbs, anchoring, or embedding mechanisms to remove or grasp native or foreign leaflet or tissue material from the tissue clip 40. In Figure 84, an anchor 235 is advanced and implanted. In Figure 85, the dilation tool 234 is advanced within the leaflet clip 40. In Figure 86, the dilation tool 235 is mechanically dilated to dilate the leaflet clip 40. Dilation can be assisted by electricity, heating, hydraulic pressure, rotation, internal or external ultrasound, or energy. Tissue is cut from the leaflet clip 40. Figure 89 In the middle, close the expansion tool 235 and then remove it from the leaflet. Figure 88 shows a similar method for the balloon expandable element 129.

[0214] Figure 89 and 90is a cross-sectional view of the mitral valve 20 that has been treated with a heart valve therapy comprising one or more heart valve structures 50. The heart valve structure 50 typically includes a chord or chordae 52 that is connected to a leaflet by an anchor 54 and to the left ventricle. The chord 52 can be fixed to the ventricular side of the leaflet 24 Figure 89 ) or the atrial side of the leaflet 24 Figure 90 ). As further described in the examples below, similar devices can be used to remove the heart valve structure 50 as for the leaflet clip 40.

[0215] Figures 91-92 show a removal tool 240 for cutting and capturing a previously placed heart valve therapy involving implantation of a leaflet spine or heart valve structure. In Figure 91, the procedure is performed using a cutting catheter 212 with open, close, energize, and remove hardware capabilities previously described, similar to Figure 73 to 76 the above description of other heart valve therapies in

[0216] In Figures 93-97, the procedure is performed by a loop-based tool 250 that encapsulates, cuts, and removes hardware, similar to the above description of Figures 77-82.

[0217] In Figures 98-100, the procedure is performed using a cutting catheter 260, similar to Figure 70 to 72 the above description of other heart valve therapies in

[0218] In addition, flow restrictors can be used to help limit flow in any of the procedures described in this specification. For example, Figure 109 shows an embodiment of the removal catheter 100 with an additional flow restriction device 341 in Figure 60 The flow restriction device 341 can be positioned in the area of the valve 20 (e.g., through the valve 20) before, during, or after the removal of the clip 40 and remains in the valve area to manage the patient's blood flow by restricting blood flow. The flow restriction device 341 can be any flow restrictor known to those skilled in the art, such as but not limited to a balloon, a stent with a covering, or a catheter. Any or all of these examples are configured or capable of expanding to occupy a clinically suitable space to manage blood flow by itself or in combination with the valve structure. As shown, the flow restriction device 341 can be introduced individually through delivery catheters 342 and 343. In addition, the flow restriction device 341 can be integrated into the delivery mechanism, such as the internal steerable catheter 180. Alternatively, the flow restriction device 341 can be the delivery system for another therapy, such as but not limited to a heart valve.

[0219] Although different embodiments and examples have been discussed in the specification, any of the features described can be mixed, exchanged, or added to other embodiments in the specification. In other words, each embodiment described is not intended to be limited in its features, and any feature described in any other embodiment can be explicitly added to that embodiment.

[0220] As used herein, the term "substantially" or "generally" refers to a complete or nearly complete range or degree of an act, feature, attribute, state, structure, item, or result. For example, a "substantially" or "generally" enclosed object means that the object is either completely enclosed or nearly completely enclosed. In some cases, the exact degree of allowance for absolute completeness can depend on the particular context. However, in general, the nearness of the degree of completion will be such that the overall result is essentially the same as if absolute completion were obtained. The use of "substantially" or "generally" is also applicable in instances in which an act, feature, attribute, state, structure, item, or result that is not entirely absent is intended. For example, an element, composition, embodiment, or composition that is "substantially free" or "generally free" of a component or element can still actually contain such item, so long as it does not generally have a measurable effect.

[0221] As used herein, any reference to "one embodiment" or "the embodiment" means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearance of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment.

[0222] As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. Further, unless otherwise expressly specified, "or" means any one or any combination of the alternatives. For example, a condition A or B is satisfied by any of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), both A and B are true (or present), or both A and B are false (or not present).

[0223] Also, the use of "a" or "an" to describe elements and components herein is merely for convenience and is not intended to confer a meaning of singularity where one would not otherwise exist. The description herein of any element or component also is intended to provide support for a conjunctive term when applied to two or more such elements and components unless otherwise indicated.

[0224] Furthermore, the drawings are for illustrative purposes only and represent preferred embodiments. Alternative embodiments of the structures and methods illustrated herein will be readily apparent to those skilled in the art from this disclosure.

[0225] Upon reading this disclosure, those skilled in the art will appreciate still additional alternative structural and functional designs for a customized urn. Accordingly, while particular embodiments and applications have been illustrated and described, it is to be understood that the disclosed embodiments are not limited to the precise construction and components disclosed herein. Various modifications, changes and variations, which will be obvious to those skilled in the art, can be made in the arrangement, operation and details of the methods and apparatus disclosed herein without departing from the spirit or scope defined in the following claims.

[0226] While the application has been described in terms of particular embodiments and applications, those skilled in the art will recognize that additional embodiments and modifications are possible within the spirit and scope of the claimed application. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature and not as restrictive.

Claims

1. A system for removing a heart valve, comprising: Outer tubular sheath; A cutting element comprising a first cutting ring connected to a first internal control component, the cutting element being movable from a first compression structure within the outer tubular sheath to a second expansion structure outside the outer tubular sheath; wherein in the second expansion structure of the cutting element, a plane aligned across the opening of the first cutting ring forms an angle between 45 and 135 degrees with respect to the longitudinal axis of the first internal control component, and the first cutting ring is disposed on one side of the longitudinal axis of the first internal control component; as well as A basket connected to a second internal control component, the basket being movable from a first compression structure within an outer tubular sheath to a second expansion structure outside the outer tubular sheath; wherein in the second expansion structure of the basket, a plane aligned across the opening of the basket forms an angle between 45 and 135 degrees relative to the longitudinal axis of the second internal control component, and the basket is arranged on one side of the longitudinal axis of the first internal control component and opens towards the proximal end; and The opening of the first cutting ring and the opening of the basket are rotatable within the outer tubular sheath to align with the heart valve therapy.

2. The system of claim 1, wherein the plane of the opening of the first cutting ring is at an angle of approximately 90 degrees relative to the longitudinal axis of the first internal control component.

3. The system of claim 1, wherein the plane of the opening of the basket is at an angle of approximately 90 degrees relative to the longitudinal axis of the second internal control component.

4. The system of claim 1, wherein the first cutting ring is wave-shaped, and wherein the side portion of the first cutting ring is bent relative to the free end of the first cutting ring.

5. The system according to claim 1, wherein the first cutting ring is circular, elliptical, or saddle-shaped.

6. The system of claim 1, wherein the second expansion structure of the first cutting ring comprises a wire having one or more insulating portions and one or more non-insulating portions, the insulating portions being positioned to contact valve tissue.

7. The system according to claim 1, wherein the first cutting ring comprises a single wire made of a single conductive material, two or more wires each made of different conductive materials, or a multi-strand wire made of different conductive materials.

8. The system according to claim 1, wherein, The first cutting ring has one or more uninsulated portions that are confined only to the radial inner surface of the second expansion structure of the cutting element.

9. The system of claim 1, wherein the basket further comprises a plurality of rings positioned around the opening and a tightening line positioned through the plurality of rings; wherein moving the tightening line proximally into an outer tubular sheath closes the opening of the basket.

10. The system of claim 1, wherein the basket further comprises a plurality of rings positioned around the opening, wherein the cutting element is positioned through the plurality of rings, and wherein moving the cutting element proximally into the outer tubular sheath closes the opening of the basket.

11. The system of claim 1, wherein the basket is composed of multiple braided threads, each braided thread being composed of shape memory material.

12. The system of claim 11, further comprising an electrically insulating coating on the outer surface of the plurality of braided wires.

13. The system of claim 1, wherein the basket is composed of silicone, PET, polyester, nylon, polypropylene or Kevlar.

14. The system of claim 1, wherein the basket is composed of a woven fabric, mesh, woven material, or knitted polymer.

15. The system of claim 1, wherein the basket is made of metal having a plurality of holes.

16. The system of claim 1, wherein the cutting element further comprises a second cutting ring located near the first cutting ring.

17. The system of claim 1, wherein the cutting ring has a saddle-shaped side portion.

18. The system of claim 17, wherein the side portion is inclined downward and upward in a wave pattern.

19. The system of claim 1, wherein the cutting element comprises a plurality of non-insulated regions, the plurality of non-insulated regions being electrically activated at different times or simultaneously at the same time.

20. The system of claim 1, wherein the cutting element is electrically insulated from the basket.

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