Methods and devices for removal of heart valve therapy

Abstract

A retrieval catheter and method of use are described for removing a heart valve therapy, such as a leaflet clip or a prosthetic leaflet. The recovery catheter may include a cutting element and basket, a piercing element, a clamping mechanism, or similar gripping device. The method includes delivering a catheter to a heart valve therapy region, then manipulating the catheter and associated instruments to cut tissue as desired, and then removing the heart valve therapy and withdrawing the catheter.

Description

[0001] This application is a divisional application of application number 202080050018.6, filed on July 8, 2020, entitled "Method and apparatus for removing heart valves".

[0002] Related applications

[0003] This application claims priority to U.S. Provisional Application No. 62 / 872,139, filed July 9, 2019, entitled “Method and Apparatus for Removing Leaflet Positioning Therapy”, and 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 herein by reference. Technical Field

[0004] This disclosure relates to novel and advantageous transcatheter devices and methods for facilitating valve repair and / or replacement. More specifically, the devices and methods herein relate to therapies for removing valve leaflets that interact with the heart valve. Background Technology

[0005] Heart valve disease occurs when the leaflets of a heart valve cannot close completely, leading to blood regurgitation or abnormal backflow. (Reference) Figure 1 Mitral regurgitation is particularly common when the anterior leaflet 22 of the mitral valve fails to properly cover the posterior leaflet 24. During ventricular contraction of the heart 10, some blood flows from the left ventricle 14 back to the left atrium 12 instead of the aorta 11. A similar regurgitation can also occur at the tricuspid valve 15, causing blood to flow from the right ventricle 13 back to the right atrium 16.

[0006] A common treatment for valvular regurgitation is the use of a therapeutic device to juxtapose or permanently connect the valve leaflets together. This cardiac valve therapeutic hardware may be placed using surgical, transcatheter, or minimally invasive methods. For example, the hardware or treatment used for removal may be a MitraClip (Abbott Structures, Santa Clara, California), a PASCAL device (Edwards Life Sciences, Irvine, California), surgical sutures (such as Alfieri sutures), or similar cardiac valve therapies. Other cardiac valve therapies may result from techniques that use the valve leaflets as part of the treatment target and require the removal of part or all of the leaflets. Other examples include chordae tendineae replacement techniques performed transcatheterically or surgically to compensate for improper length, interruption, or misalignment of existing chordae tendineae. For the purposes of this application, the term "cardiac valve therapy" should be limited to any device and / or method used for the treatment of cardiac valves, such as leaflet clips, sutures, artificial chordae tendineae, or any other device or method related to the treatment of cardiac valves and associated leaflets.

[0007] Figure 2 An exemplary transcatheter delivery procedure is shown for the valve clip 40 (e.g., a Mitra clip) of the mitral valve 20 for treating regurgitation. The delivery catheter 41 passes through the right atrium 16, through the interatrial septum 18, and into the left atrium 12. Figure 3 As shown, the interior of the catheter 41A, including the valve clip 40, enters the left ventricle 14 through the mitral valve 20. In this example, the leaflet clip 40 includes two outer arms 40A located below the leaflets 22, 24 and two inner arms 40B located perpendicularly between the two leaflets 22, 24. Figure 3 As shown, catheter 41 includes a control line that allows the outer arm 40A to be pressed against the inner arm 40B to compress or engage the leaflet tissue. Barbs or similar structures on arm 40B help anchor the leaflet clip 40 within the tissue of leaflets 22, 24, such as... Figure 4 As shown. Finally, remove catheter 41, as... Figure 5 As shown. Figure 6 As shown in the top view, the leaflet clamp 40 is typically located near the center of the leaflet 20 to prevent the central portion from opening and to form two smaller leaflet openings on either side of the clamp 40. The smaller diameter of these openings typically allows for better leaflet closure and prevents backflow.

[0008] In some cases, these structures need to be removed to facilitate other valvular treatments, such as addressing recurrent or residual regurgitation. For example, the valve may require placement of other leaflet techniques, annuloplasty or rings, chordae tendineae or cords, positioning devices, or valve replacement, many of which may not be suitable for previously performed heart valve therapies.

[0009] In some cases, these treatments require removal from one or more attachment points on the valve leaflet, but not complete removal, in order to facilitate other valve treatments, leaving the structure in the heart but being able to move it from the area of ​​concern and apply the required treatment.

[0010] However, these heart valve removal procedures typically involve open-heart surgery, which can be particularly traumatic for patients and carries a relatively high risk of complications. Therefore, what we need is a less invasive method to remove heart valves, thereby reducing the risk of complications. Summary of the Invention

[0011] This invention relates to systems and methods for removing cardiac valve therapies used to locate valvular leaflets. Such removal may be necessary when additional treatment for valvular disease is required (e.g., different repair methods, valve replacement surgery), when cardiac valve therapies cause harm or potential harm to the patient (e.g., stenosis, infection), when cardiac valve therapies are deemed to have no clinical benefit, or when there is a general desire to avoid treatment.

[0012] This invention relates to systems and methods for removing cardiac valve therapies used to position leaflets, which may have been placed surgically, transcatheterically, or minimally invasively. In at least one embodiment, the hardware or therapy used for removal may be a MitraClip (Abbott Structures, Santa Clara, California), a PASCAL device (Edwards Life Sciences, Irvine, California), surgically placed sutures (e.g., Alfieri sutures), or similar positioning devices and techniques. In at least one embodiment, such positioning devices requiring removal may be the result of techniques that have already involved leaflets as part of the treatment objective, and some or all of the leaflets are involved in requiring removal. Examples of such devices are cardiac valve replacement techniques performed using transcatheter methods or surgery. In some cases, chordae tendineae or chordae tendineae become ineffective due to improper length, breakage, misalignment, or defects in the repair material.

[0013] The method of the present invention includes a tool for cutting natural valve tissue attached to a heart valve therapy, the natural valve tissue being with or without a capture tool to retain the hardware to be removed as it is externalized from the body. In at least one embodiment, the cutting method includes enclosing an adjustable snare around the heart valve therapy and can mechanically cut the natural tissue from the heart valve therapy, or heating the tissue using a radiofrequency electrosurgical device to rapidly reach an intracellular temperature of 100°C, causing the intracellular contents to undergo liquid-gas conversion, large-scale volume expansion, and eventual evaporation. 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 body.

[0014] In some embodiments, methods for removing a previously placed heart valve therapy include using a steerable catheter that has been inserted into the patient via a transseptal, transatrial, or transventricular route. The steerable catheter includes a delivery catheter that can be used to place tools for cutting and capturing the heart valve therapy.

[0015] In some embodiments, capture of the heart valve therapy is performed by directly inserting and embedding a tool into, above, and / or around the heart valve therapy. In this method, natural tissue is cut from the heart valve therapy using an electrosurgical cutting device (radiofrequency electricity or a similar device) or similar energy or force delivered from within the embedded tool. A basket or bag for capturing the heart valve therapy may not be necessary when removing the target material. Therefore, in at least one embodiment, the cutting tool is used alone, without the need for a capture basket.

[0016] In at least one embodiment, the ring structure is pushed onto a tissue bridge, chordae tendineae implant, or fixation method resulting from heart valve therapy. The ring structure can be used for electrocautery or mechanical cutting. The ring structure can be circular, elliptical, or multi-segmented and can completely or partially enclose the cutting and removal area. The ring structure can be used to encircle the heart valve therapy and tissue for resection, followed by externalization.

[0017] In at least one embodiment, a tool is used to dilate the heart valve for removal. This dilation can be mechanical, electrical, pneumatic, hydraulic, or similar in nature, to unfold or change the shape of the heart valve, thereby removing it.

[0018] The tool's components can be secured to heart valve therapy to reduce the risk of embolism. This fixation can be achieved through straight anchors, spiral anchors, barbed anchors, or a combination of these methods.

[0019] In at least one embodiment, a catheter, pad, balloon, or other device may be used in conjunction with a removal device to manage blood flow or regurgitation of the valve after removal of the heart valve therapy. This procedure can be performed quickly if the removed heart valve therapy and basket can be retracted via a steerable catheter, and the sealing device can then be delivered via the same delivery catheter.

[0020] While several embodiments have been disclosed, other embodiments of the invention will become clear to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of this disclosure. As will be seen, various embodiments of this disclosure can be modified in a variety of obvious ways without departing from the spirit and scope of the invention. Therefore, the drawings and detailed description should be considered illustrative rather than restrictive. Attached Figure Description

[0021] These and other aspects, features, and advantages that can be achieved by the embodiments of the present invention will be apparent from and will be explained in the following description of the embodiments of the present invention, with reference to the accompanying drawings, wherein...

[0022] Figure 1 The anatomical structure of the heart is shown;

[0023] Figure 2 A side view of a surgical procedure involving the implantation of a leaflet heart valve therapy device is shown.

[0024] Figure 3 A side view of a surgical procedure involving the implantation of a leaflet heart valve therapy device is shown.

[0025] Figure 4 A side view of a surgical procedure involving the implantation of a leaflet heart valve therapy device is shown.

[0026] Figure 5 A side view of a surgical procedure involving the implantation of a leaflet heart valve therapy device is shown.

[0027] Figure 6 A surgical top view of the implanted leaflet heart valve therapy device is shown;

[0028] Figure 7 A side view of catheter removal according to the present invention is shown;

[0029] Figure 8 A side view of catheter removal according to the present invention is shown;

[0030] Figure 9 A side view of catheter removal according to the present invention is shown;

[0031] Figure 10 A side perspective view of the catheter removal according to the present invention is shown;

[0032] Figure 11 A side view of catheter removal according to the present invention is shown;

[0033] Figure 12 A cross-sectional view of the removal catheter according to the present invention is shown;

[0034] Figure 13 An exploded view of the catheter removal method according to the present invention is shown;

[0035] Figure 14 A perspective view of the cutting ring according to the present invention is shown;

[0036] Figure 15 A perspective view of the cutting ring according to the present invention is shown;

[0037] Figure 16 A perspective view of the cutting ring according to the present invention is shown;

[0038] Figure 17 A perspective view of the cutting ring according to the present invention is shown;

[0039] Figure 18 A perspective view of the cutting ring according to the present invention is shown;

[0040] Figure 19 A perspective view of the cutting ring according to the present invention is shown;

[0041] Figure 20 A top view of the cutting ring according to the present invention is shown;

[0042] Figure 21 A top view of the cutting ring according to the present invention is shown;

[0043] Figure 22 A perspective view of the cutting ring according to the present invention is shown;

[0044] Figure 23 A cross-sectional view of the cutting ring according to the present invention is shown;

[0045] Figure 24 A cross-sectional view of the cutting ring according to the present invention is shown;

[0046] Figure 25 A cross-sectional view of the cutting ring according to the present invention is shown;

[0047] Figure 26 A cross-sectional view of the cutting ring according to the present invention is shown;

[0048] Figure 27 A cross-sectional view of the cutting ring according to the present invention is shown;

[0049] Figure 28 A cross-sectional view of the cutting ring according to the present invention is shown;

[0050] Figure 29 A cross-sectional view of the cutting ring according to the present invention is shown;

[0051] Figure 30 A cross-sectional view of the cutting ring according to the present invention is shown;

[0052] Figure 31 A side view of the basket according to the invention is shown;

[0053] Figure 32 A side view of the basket according to the invention is shown;

[0054] Figure 33 A side view of catheter removal according to the present invention is shown;

[0055] Figure 34 A side perspective view of the catheter removal according to the present invention is shown;

[0056] Figure 35 A side perspective view of the catheter removal according to the present invention is shown;

[0057] Figure 36 A side perspective view of the catheter removal according to the present invention is shown;

[0058] Figure 37 A side view of catheter removal according to the present invention is shown;

[0059] Figure 38 A side view of catheter removal according to the present invention is shown;

[0060] Figure 39 A side view of catheter removal according to the present invention is shown;

[0061] Figure 40 A side view of the basket according to the invention is shown;

[0062] Figure 41 A side view of the basket according to the invention is shown;

[0063] Figure 42 A side view of the basket according to the invention is shown;

[0064] Figure 43 A side view of the basket according to the invention is shown;

[0065] Figure 44 A side view of the handle according to the invention is shown;

[0066] Figure 45 A side view of the handle according to the invention is shown;

[0067] Figure 46 A side view of catheter removal according to the present invention is shown;

[0068] Figure 47 A side view of catheter removal according to the present invention is shown;

[0069] Figure 48 A side view of catheter removal according to the present invention is shown;

[0070] Figure 49 A side view of catheter removal according to the present invention is shown;

[0071] Figure 50 A side view of catheter removal according to the present invention is shown;

[0072] Figure 51 A side view of catheter removal according to the present invention is shown;

[0073] Figure 52A side view of catheter removal according to the present invention is shown;

[0074] Figure 53 A side view of catheter removal according to the present invention is shown;

[0075] Figure 54 A side view of the removal catheter and guide catheter according to the present invention is shown;

[0076] Figure 55 A side view of the removal catheter and guide catheter according to the present invention is shown;

[0077] Figure 56 A side view of a catheter removal procedure according to the present invention is shown;

[0078] Figure 57 A side view of a catheter removal procedure according to the present invention is shown;

[0079] Figure 58 A side view of a catheter removal procedure according to the present invention is shown;

[0080] Figure 59 A side view of a catheter removal procedure according to the present invention is shown;

[0081] Figure 60 A side view of a catheter removal procedure according to the present invention is shown;

[0082] Figure 61 A side view of a catheter removal procedure according to the present invention is shown;

[0083] Figure 62 A side view of a catheter removal procedure according to the present invention is shown;

[0084] Figure 63 A side view of a catheter removal procedure according to the present invention is shown;

[0085] Figure 64 A side view of a catheter removal procedure according to the present invention is shown;

[0086] Figure 65 A side view of a catheter removal procedure according to the present invention is shown;

[0087] Figure 66 A side view of a catheter removal procedure according to the present invention is shown;

[0088] Figure 67 A side view of a catheter removal procedure according to the present invention is shown;

[0089] Figure 68 A side view of a catheter removal procedure according to the present invention is shown;

[0090] Figure 69 A side view of a catheter removal procedure according to the present invention is shown;

[0091] Figure 70 A side view of a catheter removal procedure according to the present invention is shown;

[0092] Figure 71 A side view of a catheter removal procedure according to the present invention is shown;

[0093] Figure 72 A side view of a catheter removal procedure according to the present invention is shown;

[0094] Figure 73 A side view of a catheter removal procedure according to the present invention is shown;

[0095] Figure 74 A side view of a catheter removal procedure according to the present invention is shown;

[0096] Figure 75 A side view of a catheter removal procedure according to the present invention is shown;

[0097] Figure 76 A side view of a catheter removal procedure according to the present invention is shown;

[0098] Figure 77 A side view of a catheter removal procedure according to the present invention is shown;

[0099] Figure 78 A side view of a catheter removal procedure according to the present invention is shown;

[0100] Figure 79 A side view of a catheter removal procedure according to the present invention is shown;

[0101] Figure 80 A side view of a catheter removal procedure according to the present invention is shown;

[0102] Figure 81 A side view of a catheter removal procedure according to the present invention is shown;

[0103] Figure 82 A side view of a catheter removal procedure according to the present invention is shown;

[0104] Figure 83 A side view of a catheter removal procedure according to the present invention is shown;

[0105] Figure 84 A side view of a catheter removal procedure according to the present invention is shown;

[0106] Figure 85 A side view of a catheter removal procedure according to the present invention is shown;

[0107] Figure 86 A side view of a catheter removal procedure according to the present invention is shown;

[0108] Figure 87 A side view of a catheter removal procedure according to the present invention is shown;

[0109] Figure 88 A side view of a catheter removal procedure according to the present invention is shown;

[0110] Figure 89 A side view of a catheter removal procedure according to the present invention is shown;

[0111] Figure 90 A side view of a catheter removal procedure according to the present invention is shown;

[0112] Figure 91 A side view of a catheter removal procedure according to the present invention is shown;

[0113] Figure 92 A side view of a catheter removal procedure according to the present invention is shown;

[0114] Figure 93 A side view of a catheter removal procedure according to the present invention is shown;

[0115] Figure 94 A side view of a catheter removal procedure according to the present invention is shown;

[0116] Figure 95 A side view of a catheter removal procedure according to the present invention is shown;

[0117] Figure 96 A side view of a catheter removal procedure according to the present invention is shown;

[0118] Figure 97 A side view of a catheter removal procedure according to the present invention is shown;

[0119] Figure 98 A side view of a catheter removal procedure according to the present invention is shown;

[0120] Figure 99 A side view of a catheter removal procedure according to the present invention is shown;

[0121] Figure 100 A side view of a catheter removal procedure according to the present invention is shown;

[0122] Figure 101 A perspective view of the catheter removal device according to the present invention is shown;

[0123] Figure 102 A perspective view of the catheter removal device according to the present invention is shown;

[0124] Figure 103 A perspective view of the catheter removal device according to the present invention is shown;

[0125] Figure 104 A perspective view of the catheter removal device according to the present invention is shown;

[0126] Figure 105 A perspective view of the catheter removal device according to the present invention is shown;

[0127] Figure 106 A perspective view of the catheter removal device according to the present invention is shown;

[0128] Figure 107 A perspective view of an example of flap cutting is shown;

[0129] Figure 108 A perspective view of the catheter removal device according to the present invention is shown;

[0130] Figure 109 A perspective view of the catheter removal device according to the present invention is shown. Detailed Implementation

[0131] Specific embodiments of the invention will now be described with reference to the accompanying drawings. However, the invention may be embodied in many different forms and should not be construed as limited to the embodiments described herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments shown in the drawings is not intended to limit the invention. In the drawings, similar numbers denote similar elements.

[0132] This invention generally relates to devices and methods for removing heart valves via transcatheter surgery. While current methods for removing heart valves require open-heart surgery, the techniques and devices of this invention utilize less invasive transcatheter devices and procedures that provide better patient outcomes.

[0133] Figures 1 to 13 Various aspects of one embodiment of a removal catheter 100 for leaflet removal heart valve therapy according to the present invention are shown, such as a valve clip 40 or a similar heart valve therapy device. The removal catheter 100 typically includes an expandable capture basket 102 and a cutting ring 104 disposed near a top opening of the basket 102. Figure 7 and Figure 8As shown, basket 102 is placed on the implanted valve clip 40 such that the top of basket 102 and cutting ring 104 are positioned between the clip 40 and the atrial leaflets 22, 24. Next, the top opening of basket 102 is closed or its diameter is reduced, and cutting ring 104 is activated to cut the leaflet tissue surrounding the valve clip 40 (e.g., by providing radiofrequency energy), thereby releasing the valve clip 40 from the valve 20. Finally, the capture basket 102 containing the valve clip 40 is retrieved and removed from the patient. Further details and variations of the removal catheter 100 are discussed below, followed by example methods and approaches for the removal of various heart valves (e.g., mitral valve 20 or tricuspid valve 15).

[0134] like Figures 9 to 11 As shown, the removal catheter 100 includes an internal control component 108 located within the outer tubular sheath 110 (such as...). Figure 11 (As shown). The internal control component 108 may be a solid wire or tube extending between the distal and proximal ends of the sheath 110. The basket 102 and the cutting ring 104 are connected to the distal end of the internal control component 108 such that when the internal control component 108 moves longitudinally or rotatably relative to the outer tubular sheath 110, the basket 102 and the cutting ring 104 move similarly.

[0135] refer to Figure 11 In one embodiment, a plurality of rings 102A are positioned circumferentially around the top opening of the basket 102, and lines are arranged or rings 106 are tightened via the rings 102A. Figure 13 As shown, the tightening ring 106 may consist of a ring-shaped wire (e.g., circular, elliptical, etc.) and an elongated straight portion 106A that can be connected to the control component 108 via a connecting sleeve 112. The connecting sleeve 112 may be clamped, welded, or coated with adhesive / epoxy resin or any combination thereof to secure the sleeve 112 to the control component 108. Alternatively, the tightening ring 106 may be connected to the control component 108 solely by welding or adhesive.

[0136] The cutting ring 104 can be shaped like a general ring (e.g., circular, elliptical, saddle-shaped, etc.) and can include an elongated straight portion 104E, which can also be connected to the control component 108 via a connecting sleeve 112. In this respect, as... Figure 12 As shown in the cross-sectional view, the slender straight portions 106A and 104E are both located inside the connecting sleeve 112.

[0137] In one embodiment, the cutting ring 104 cuts tissue when radiofrequency energy is supplied to it. In one example, the radiofrequency power supply is connected to the proximal end of the control component 108, which is made of conductive metal, thus delivering radiofrequency energy to its distal end and then to the connected cutting ring 104. To complete the radiofrequency energy circuitry using the cutting ring 104, a second radiofrequency electrode may be connected to the radiofrequency power supply and may be connected to other locations on the patient via an electrode pad (monopolar radiofrequency system), the second electrode may be included at other locations on the removal catheter 100 (bipolar radiofrequency system), or a second insulating wire may be included on the control component 108 (bipolar radiofrequency system).

[0138] It may be necessary to isolate the radio frequency energy circuitry of the cutting ring 104 from both the tightening ring 106 and the basket 102 to prevent damage to other tissues in the heart. This can be achieved by using electrical insulation at specific locations on the device. For example, wire insulation 114 can be placed on the elongated straight portion 106A (or optionally the entire tightening ring 106) to electrically isolate the tightening ring 106 from the radio frequency current of the control component 108, such as... Figure 12 Cross-sectional view and Figure 13 The exploded diagram is shown below.

[0139] exist Figures 14 to 30 In other examples shown, the cutting ring 104 may have different structures, shapes, and electrical insulation to help reduce the risk of the non-insulated portion 104B (i.e., the portion cutting the leaflet tissue) contacting any part of the tightening wire 106 or basket 102. For example, Figure 14 A cut ring 104 is shown, in which the non-insulated portion 104B of the wire is located opposite the elongated straight portion 104E and adjacent to the insulating portion 104A on each side. In this example, the non-insulated portion 104B can be as follows: Figure 21 The circular extension that completely surrounds the line, or as shown Figure 20 As shown, only the inner side of ring 104 can be exposed.

[0140] like Figure 14 As shown, the non-insulating portion 104B may consist only of a single area (e.g., between about 1 mm and 5 mm) in which the underlying wire 104C is exposed, or as... Figure 22 As shown, it may include a plurality of discrete non-insulating portions 104B (e.g., 2 to 10 portions 104B) of relatively small length (e.g., between about 1 mm and 5 mm).

[0141] 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.

[0142] 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.

[0143] 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 , Figure 24 and Figure 25 As shown in the cross-sectional view, the line 104C below can have rectangular cross-sections, circular cross-sections, triangular cross-sections, and square cross-sections, respectively.

[0144] 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… Figures 16 to 18 and Figures 26 to 28 As shown.

[0145] 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.

[0146] The cutting ring can have a variety of different shapes, structures and electrical insulation patterns to facilitate tissue removal around the clip 104. For example, the cutting ring can provide additional length and / or a predetermined path or geometry. Figure 101 An alternative example of a cutting ring 316 with a "saddle" or wave-like shape is shown, wherein each side portion 314, 315 of the ring is inclined downward (i.e., in the proximal direction toward the catheter 100) and its free end 311 is bent upward (i.e., in the distal direction away from the catheter 100). The sides 314 and 315 may be insulated, as may the middle portion 311 and the ends 312 and 313. The middle portion 311 contacts or engages tissue on one side of the ring 316, while the ends 312 and 313 contact or engage tissue on the other side. The sides 315 and 316 may be bent outward to increase the width of the ring 316, bent inward to decrease the width of the ring 316, or may be relatively straight to maintain a uniform width of the ring 316 (i.e., circular or elliptical).

[0147] Many different tissue engagement methods can be facilitated by the cutting ring 316. For example, ends 312 and 313 can be electrically activated simultaneously while the cutting ring 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 311 can be activated to remove the tissue attached to it and complete the removal of the leaflet clip 40 from the leaflet. Optionally, all three portions 311, 312, and 313 can be activated simultaneously. The axial tension on the ring 316 can be applied before, during, or intermittently before engagement of the control ring 316. This embodiment shows three non-insulated cutting regions or portions 311, 312, and 313, but any number of cutting elements (e.g., from 1 to 100) can be included, comprising the entire ring 316 as a continuous non-insulated cutting component.

[0148] The additional lengths along the sides 314 and 315 can accommodate other tissue structures present around the leaflet clip 40. The additional lengths of the sides 314 and 315 are also deformable, such that when tension is applied to the elongated straight portion 317, the sides 314 and 315 will straighten, causing the ring 316 to elongate to an approximate axial configuration. During this stretching and elongation, the axial distance between the free end 311 and the proximal ends 312, 313 increases, thereby accommodating greater variations in the diameter and approach angle of the clip. Any such non-linear path could also achieve this, and is therefore considered in this invention, but is not shown herein for the sake of brevity.

[0149] 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.

[0150] 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.

[0151] 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... Figures 101 to 103 The portion described in the text (i.e., several discrete non-insulated parts or the entire ring is non-insulated).

[0152] Figure 105 and Figure 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.

[0153] In this example, the first cutting ring 104 has a slightly larger diameter (e.g., similar to the opening of basket 104), and the second cutting ring 316 has a smaller diameter than the first cutting ring 104 and is further away from basket 104. Therefore, the second ring 316 can be placed close to the valve leaflet and / or chordae tendineae (e.g., Figure 107 The procedure involves cutting 370A via the anterolateral chordae tendineae and 370B via the posteromedial chordae tendineae, and cutting portions 311, 313, and 313 can be activated to perform a first series of cuts on the tissue. This first series of cuts may not cut all the tissue, but the cutting portion 104B of the first cutting ring 104 can be tightened and then activated to perform one or more second cuts to completely remove any remaining tissue from the cardiac treatment device 40 (e.g., along the chordae tendineae). Figure 107 The incision on the atrial side of the 40-degree clamp is 37°C.

[0154] Although the specific implementations of cutting rings 104 and 316 are, for example Figure 105 and Figure 106 As shown, however, any combination of any rings described in this specification can be used in this manner. For example, Figure 108 An embodiment 180 is shown with two rings 316 of similar shape and configuration. Therefore, either ring can have a different number and pattern of cutting portions, and these cutting portions can be activated simultaneously or at different times / modes. In one example, cutting rings 104 and 316 are both connected to the same circuitry (e.g., internal control unit 108). Alternatively, each ring 104, 316 (or each set of cutting portions) can have its own circuitry (e.g., separate leads), allowing activation independent of the other cutting ring. Furthermore, three or four cutting rings can be used alternately. All cutting rings can be connected to the same removal catheter, or one or more rings can be connected to catheters separate from other cutting rings and / or 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.

[0155] If the tightening ring 106 has an insulating coating that extends all the way along its length, the cutting ring 104 can be located directly on top of the tightening ring 106, in contact with the ring. The cutting ring 104 can also be longitudinally spaced from the tightening ring 106, for example, between about 0 mm and about 15 mm.

[0156] Preferably, the internal control component 108 (such as...) Figures 11 to 13(As shown) It is flexible enough to pass through the vascular system, while having sufficient column strength to push the basket 102 and the cutting ring 104 out of the outer tubular sheath 110; the internal control component is capable of effectively transferring radiofrequency energy from the proximal handle to the cutting ring; the internal control component should be insulated to prevent current leakage into the blood flow; and the internal control component has good torque response so that the user can rotate the basket and ring when deployed inside and around the valve.

[0157] In a preferred embodiment, the internal control component 108 includes an internal control core that is connected or soldered to a more flexible internal control cable, and then connected to the tail of the cut ring conductor using a remote coupler. In a preferred embodiment, the internal control pin, internal control cable, cut ring conductor, and remote coupler are made of the same material (e.g., a steel alloy) to achieve a robust solder joint and efficient current delivery. The internal control cable may be a laser-cut tube, stranded cable, stranded cable tube, coil, or a combination thereof. In another embodiment, the internal control cable may extend from the proximal handle to the cut ring 104, and an internal control pin is not required.

[0158] In an alternative embodiment, the internal control component 108 may be two separate lines; one connected to the tightening ring 106 and the other to the cutting ring 104. With both internal control components arranged in the same single lumen of the outer tubular sheath 110, the basket 102 can be deployed first by advancing the inner basket control component distally until the basket tightening ring 106 is fully exposed. The inner cutting ring control component can then be advanced distally to deploy the cutting ring 104. Each ring can be rotated, advanced, or retracted via its respective control component. This provides the operator with greater freedom. Heart valve therapy can first be captured or surrounded by the cutting ring 104, followed by the basket tightening ring 106 and the basket 102. The cutting ring 104 can then be closed onto the leaflet tissue bridge by retracting the inner cutting ring control component. Once the cutting ring is closed on the tissue bridge, one of two steps can be taken: 1) the basket tightening line 104 and basket 102 can then be closed by retracting the inner basket control component proximally; or 2) if the cutting ring 104 cannot reach the base of the heart valve therapy, radiofrequency (RF) cutting energy can be applied to cut one side of the device to reach the base of the clip 40; the basket 102 can then be closed. Once both rings are properly closed on the atrial side of the heart valve therapy tissue, the inner cutting ring control component is energized with RF power as it retracts proximally into the outer delivery sheath 110. The inner cutting ring control component delivers cutting energy to the cutting element only through the cutting ring 104.

[0159] The aforementioned internal control components can be alternately arranged in a separate outer tubular sheath or in a separate lumen within the same sheath 110. The system is designed so that each sheath can be placed in a separate orifice (i.e., on opposite sides of the heart valve therapy). Once both loops have engaged the heart valve therapy, the same steps described above will be followed.

[0160] The control component insulator covering the outer surface of the internal control die and internal control components preferably has sufficient flexibility to not affect the navigation of the delivery catheter through the valve orifice. It is also desirable to be as lubricated as possible to minimize friction between the internal control components and the delivery catheter when the internal control components are pushed distally to deploy the basket and cutting ring in the left ventricle. For example, the insulation may comprise a hydrophilic coating, a silicone coating, a Teflon-like coating, a polyolefin coating, a thermoformed or thermosetting coating, or a fluoropolymer.

[0161] Returning to basket 102, its length and diameter may depend on the size of the heart valve therapy device or clip 40. For example, the length of basket 102 may range from approximately 20 mm to approximately 50 mm, and its diameter may range from approximately 10 mm to 20 mm. The diameter of basket 102 can be adjusted accordingly based on the size of the leaflet clip 40 and the angle at which basket 102 is intended to capture clip 40. For example, the larger the interception angle relative to the top surface through the opening of basket 102, the larger the diameter of basket 102 should be. In other words, unless basket 102 is expected to be positioned substantially directly below clip 40, basket 102 should be expanded to a diameter much larger than that of clip 40.

[0162] exist Figure 31 In one embodiment shown, basket 102 may consist of multiple braided threads. The threads may be made of shape memory material and may be woven onto a mandrel of the desired basket size, then heat-set to allow the braided shape to recover to the expanded basket structure upon compression. The threads may be made of shape memory materials (such as nickel-titanium alloys) or non-shape memory materials (such as stainless steel). The threads may also have an insulating coating, such as ethylene-tetrafluoroethylene copolymer (ETFE), polyimide, polyethylene terephthalate, silicone, or similar materials. The advantage of a braided basket is that its behavior / performance can be altered by changing the basket thread diameter, basket thread material, and / or braiding density (i.e., basket aperture) while keeping the basket's diameter and length constant. The basket's diameter and length design are primarily determined by the size of the heart valve to be removed. The size, spacing, and number of the braided basket apertures can also be adjusted and optimized. In one example, the aperture 102B of basket 102 has a diameter ranging from approximately 100 μm to approximately 4 mm when expanded.

[0163] The woven basket should ideally be small enough to allow it to easily fold into and unfold from the delivery catheter during surgery, but also large enough to provide sufficient rigidity for proper opening in the presence of chordae tendineae or other structures. The orifice size of the woven basket may vary depending on the design intent. Generally, the orifice size should be smaller than the length, width, or height of the heart valve therapy to prevent embolism through the basket after removal. The very small orifices of the woven basket help filter and capture any debris generated during tissue cutting.

[0164] One advantage of coating the metal basket is that it ensures electrical energy is concentrated in the cutting element, rather than distributed across the entire metal structure of the basket and entering the blood pool. A second benefit of the coating is that it also reduces friction, making it easier to capture the heart valve therapy device within the basket. If the basket is too rough or has too many inner edges, the heart valve therapy device may not be completely secured within it. Adding a lubricating or smoothing coating to the inner surface of the capture basket makes capturing the heart valve therapy device much easier.

[0165] exist Figure 32 , Figure 33 and Figure 34 In the alternative embodiment shown, the removal catheter 150 includes a basket 152 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 a similar material that can be folded or folded into a radially compressed configuration. The basket 152 may be formed with multiple apertures sized to prevent the passage of leaflet clips 40 and other biological materials (e.g., approximately 100 μm to approximately 4 mm in diameter) that may dislodge during the procedure. The size of the basket 152 may be similar to that of the basket 102 discussed earlier. The top opening of the basket 152 may also include multiple rings or channels 152B sized to allow the passage of a tightening ring 106 so that the basket 152 can be closed during the procedure.

[0166] The construction of the polymer basket 152 can be accomplished using woven fabric, mesh, braiding, knitting, or injection molding. The potential combinations of basket shapes and materials are limitless; only a few are described here. It is crucial to select a polymer material that is highly heat-resistant, has low moisture absorption, is sufficiently durable, and can be folded multiple times into an outer sheath. Silicone resins often best meet all these performance requirements. If the basket is made of silicone, it can be molded into a basket shape as a stand-alone component or directly molded onto a ring structure. If the basket is made from silicone sheets, it can be cut into the designed pattern and then sewn onto the ring to form the desired shape.

[0167] The size and spacing of the orifices 152A can be adjusted depending on the material selected. Generally, the orifice diameter may be smaller than the length, width, or height of the heart valve therapy to prevent embolism through the basket after it has been cut. Using a basket with very small pores may help filter and capture any debris generated during tissue cutting. Designing a basket with pores also allows some blood to flow through; this helps improve operator control of the basket by minimizing the forces exerted on it when pumping blood (i.e., minimizing the "parachute effect"). Polymer baskets may or may not have an orifice construction; if they have the orifices shown in the figure, they will slide onto the basket tightening ring. If they do not have orifices, they should be securely fixed to the basket tightening ring.

[0168] Since the polymer basket 152 does not conduct current, other embodiments can be used, in which the cutting ring 104 for removing the conduit 160 also acts as a tightening ring, such as... Figure 35 and Figure 36 As shown. The basket 152 can be directly connected to the insulating part 104A of the cutting ring 104 (or an insulating part can be formed directly around the non-insulated wire), leaving the non-insulated part 104B for performing the leaf cutting.

[0169] Similar "single-loop" embodiments can also be used for other shapes and materials. For example, Figure 37 Multiple polymer or fabric filaments are shown woven together to form a flexible basket shape and relatively large pore size (e.g., about 0.5 mm to about 4 mm). Figure 38 Multiple polymer or fabric fibers are shown woven into a fabric basket 164 having relatively small pore sizes (e.g., about 0.5 mm to about 4 mm). Figure 39 A polymer sheet stitched to form basket 166 is shown. In any of these embodiments, the cutting ring 104 may be exposed, allowing the non-insulating portion 104B to be cut through the valve leaflet after being tightened.

[0170] In other embodiments, the basket may be partially or entirely composed of a laser-cut basket. For example, Figure 40 and Figure 41 Multiple vertical, laser-cut ribs are shown, with eyelets arranged along their length to allow for weaving or braiding multiple lines or polymer filaments. Figure 42 and Figure 43 The image shows a laser-cut basket shape composed entirely of laser-cut shape memory metal (e.g., shape memory metal tubes or plates).

[0171] The advantage of laser-cut baskets is that their performance can be altered by changing the tube size and / or cutting pattern / density (i.e., basket aperture) while keeping the basket's diameter and length constant. The basket's diameter and length design are primarily determined by the size of the heart valve to be removed. The size, spacing, and number of laser cutting apertures can also be adjusted and optimized. The material used preferably has shape memory properties, such as nitinol, to allow the laser-cut portion of the tube to expand and shape. Using a shape memory material allows the basket to be repeatedly folded and unfolded into the same shape. The wire size is preferably small enough to allow it to easily fold into and unfold from the delivery catheter during surgery, but large enough to give the basket sufficient rigidity to allow for adequate opening in the presence of chordae tendineae or other structures.

[0172] In laser cutting design, the basket aperture size can be altered by changing the cutting pattern to achieve the desired results. For example, the aperture diameter can vary from approximately 100 μm to approximately 4 mm. Generally, the aperture diameter should be smaller than the length, width, or height of the heart valve therapy to prevent embolism through the basket after resection. A unique advantage of laser-cut baskets is that the aperture diameter and spacing can vary throughout the basket's length. For example, the proximal opening side of the basket may have large apertures with a specific pattern density. The aperture size and pattern density can become smaller and denser towards the distal end of the basket.

[0173] Any basket embodiment described in this specification may further include a housing to help collect any debris or embolic material released during the procedure. Such a housing may comprise a solid or porous polymer sheet, a braid, a tubular or similar material formed from relatively small, finely braided metal wires. In one specific embodiment, the interior of the basket may have a non-conductive liner, membrane, or coating (e.g., silicone) on its inner surface to help prevent conduction with the cutting element 104.

[0174] In one embodiment, the removal catheter 100 may include a proximal handle portion 170, such as Figure 44 and Figure 45 As shown. The handle 170 includes a housing 172 and a sliding member 174 configured to slide within a longitudinal groove in the housing 172. When the sliding member 174 is connected to the internal control component 108, the housing 172 can be connected to the external tubular sheath 110, thereby allowing the user to adjust the position of the sliding member 174 with their thumb to cause corresponding longitudinal movement of the internal control component 108, the basket 102, and the cutting ring 106.

[0175] Optionally, the handle 170 may also include a fluid connection port 176 (e.g., a Luer port) that communicates internally with an internal channel of the outer tubular sheath 110 so that an electrically neutral solution (e.g., a glucose solution) can be delivered to the area near the cutting ring to enhance tissue cutting and minimize energy loss in the area surrounding the blood pool. The amount and timing of this fluid delivery may be determined by a physician (e.g., via a syringe) or based on the position of the cutting ring 106 (i.e., when the cutting ring is outside the outer tubular sheath and in good contact with the desired tissue 110) via an electric pump mechanism.

[0176] like Figure 45 As shown, the handle 170 may also include a locking mechanism 173 near the distal end of the housing 172, which locks the internal control member 108 in place relative to the outer sheath 110. For example, the locking mechanism 173 may include a handle 177 configured to rotate a cam member 178 about the proximal end of the internal control member 108. When the handle 177 rotates the cam member 178, the cam member 178 forms an interference fit with the interior of the housing 172, locking the control member 108 in its longitudinal position. When the handle 177 rotates the cam member 178 in the opposite direction, it releases the interference fit between the cam member 178 and the housing 172 to release the internal control member 108, thereby allowing it to slide longitudinally within the handle 170.

[0177] Figure 46 An embodiment of a removal catheter 100 with an overflow orifice 111 in an outer tubular sheath 110 is shown. This embodiment is most advantageous for embodiments with a single tightening and cutting ring and a polymer or minimal conductive basket 102. The distal end of the outer sheath 110 can be isolated from the blood pool when the cutting element 104 and the retaining basket 102 are retracted into the outer sheath 110 to begin cutting the leaflet tissue. If this occurs after tissue cutting, the current delivered to the cutting element 104 is no longer transmitted to the tissue or blood, but instead transmits heat and / or current through the basket 102, potentially damaging the basket 102. The current overflow orifice 111 in the outer tubular sheath 110 ensures that the cutting element 104 remains in communication with the blood pool, even after cutting is complete. In this way, the current will selectively flow through the blood to the corresponding radiofrequency electrodes connected to other sites on the patient, rather than the basket.

[0178] Alternatively, wire 113 can be connected to internal control component 108 to ensure that the current path always extends through the blood pool, even after the cutting is complete. Wire 113 is preferably designed to be long enough to always extend from the distal end of the outer sheath 110, even when the basket 102 is completely folded inside the outer sheath 110. It preferably has a very small exposed metal area at a very distal tip, with the remainder being insulated. In this way, when the cutting is complete, the current will selectively flow through the lower-resistance wire and into the blood, rather than through the higher-resistance basket 102 (e.g., silicone).

[0179] Figures 48 to 53 A side view is shown with the tube 100 extended and its basket 102 secured. Figure 48 In this configuration, basket 102, tightening ring 106, and cutting ring 104 are all located within the outer tubular sheath 110. As shown, these components are radially compressed to a relatively small diameter to allow passage through the patient's blood vessels (compressed within the outer sheath to allow passage through a small orifice and between multiple clamps).

[0180] exist Figure 49 In this process, the internal control component 108 is advanced distally (e.g., via the sliding member 174), causing the basket 102 to begin withdrawing from the outer tubular sheath 110 and expanding radially. This distal movement continues until both the basket 102 and the cutting ring 104 are fully extended and expanded beyond the sheath 110, as... Figure 50 As shown.

[0181] Figure 51 and Figure 52 The internal control line 108 retracts, causing the tightening ring 106 and the cutting line 104 to retract and radially close the diameter. Typically, radiofrequency energy is activated during this period so that it cuts the tissue of the leaflet when the cutting line 104 closes. The radiofrequency current is deactivated when the cutting ring 104 is fully pulled into the outer tubular sheath 110. This can be achieved in several different ways. For example, the sliding member 174 of the handle 170 described above may include a position switch that turns the radiofrequency energy on / off at a predetermined longitudinal position. Alternatively, a manual on / off switch may be included on the handle 170 or the radiofrequency power supply.

[0182] To help determine when to manually shut off the radiofrequency energy, a radiopaque marker can be placed at the distal end of the outer tubular sheath 110. When the physician is performing tissue bridge cutting, their eyes will be on a fluoroscopic screen. Since tissue is typically not 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 cutting, the internal control unit 108 and the cutting ring 104 retract into the sheath 110, and the positioning of the radiopaque marker ensures that the tissue bridge has been cut when the operator sees the entire cutting ring 104 proximal to the radiopaque marker on fluoroscopy. This not only serves as a useful visual indicator for the operator but also makes the procedure safer. Once the cutting ring 104 passes the radiopaque marker, the operator can immediately terminate the radiofrequency cutting energy to prevent any accidental heating by applying power beyond what is necessary.

[0183] Finally, the opening of the basket 102 is almost completely closed, and the positioning of the internal control component 108 can be optionally locked in place (e.g., locking mechanism 173 on the handle 170). The basket 102 can be held outside the outer tubular sheath 110 and pulled into the larger catheter used during the procedure.

[0184] This invention includes various methods or approaches for removing heart valves, such as valve clips 40. For example, Figures 56 to 61 A removal procedure is described, in which catheters are inserted through the atrial septum 18 into the mitral valve 20. While example access methods and procedures are described, it should be understood that variations may occur based on known catheter access techniques. Furthermore, these access techniques can be used with any embodiments described in this specification.

[0185] In one embodiment, Figures 56 to 61 The mitral valve access procedure may include an internal control component 108, an external tubular sheath 110, an internal adjustable catheter 180, and an external transseptal guide catheter 182, which can... Figure 54 Seen separately in Figure 55 As seen together and discussed further below, the three nested but independent curved and axially connected catheters allow the removal device to be placed anywhere in the heart, regardless of size or surgical positioning. However, other tools, sheaths, catheters, and similar devices may be used interchangeably to guide the removal catheter 100 as described below.

[0186] First go 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 a 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 helps it to tilt from the inferior vena cava 17 toward the interatrial septum 18.

[0187] 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.

[0188] In an example of a 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 to example]). 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.

[0189] like Figure 57 and Figure 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.

[0190] 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.

[0191] 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.

[0192] 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.

[0193] Further envisioning this, after removing the leaflet clip 40, an artificial valve can be implanted at the location of the mitral valve 20. If a lead is used during removal, a lead advancement and directional valve delivery catheter can also be used to deliver and implant the artificial valve. An example of such artificial 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.

[0194] Further envisioning this, after the leaflet clip is removed, a flow management device (such as a septum, catheter, balloon, or other device) can be inserted and expanded at the valve location to manage flow through the valve until additional treatments such as valve replacement can be provided.

[0195] Figures 62 to 65 Another method for removing a leaflet positioning device (e.g., leaflet clip 40) via a transapical approach is illustrated. First, an incision is made in the sternum (e.g., between the manubrium and the sternum), and the apical sheath 184 passes through the incision, through the apex 10, and into the left ventricle 14, as shown. Figure 62 As shown. Then, the catheter 100 is removed through the transapical sheath 184, so that the distal end of the outer tubular sheath 110 extends into the left ventricle 14.

[0196] Turning Figure 63 The internal control component 108 is advanced distally within the outer tubular sheath 110 to release and expand the basket 102 and cutting ring 104 into the left ventricle 14. The tightening ring 106 and cutting ring 104 preferably have a predetermined bend (e.g., a heat-set bend / curve) that aligns the top opening of the basket 102 and the opening of the cutting ring 104 toward the leaflet clip 40. For example, the planes of the top opening of the basket 102 and the opening of the cutting ring 104 relative to the axis of the internal control component 108 can range from 135 degrees to 225 degrees (e.g., approximately 180 degrees). The internal control component 108 can be further rotated by the physician (or the entire removal catheter 100 can be rotated) to optimally align the cutting ring 104 and basket 102 with the leaflet clip 40.

[0197] like Figure 64 As shown, the outer tubular sheath 110 extends further from the transapical sheath 184, thereby completely positioning the leaflet clamp 40 within the basket 102. Figure 65 As shown, the internal control component 108 retracts proximally to reduce the diameter of the tightening ring 106 and the cutting ring 104. As the diameters of rings 104 and 106 decrease, the top opening of the basket 102 decreases, thereby confining the leaflet clip 40 within it. Additionally, as the cutting ring 104 decreases, radio frequency energy is activated and delivered to the ring 104, allowing the non-insulated portion 104B to cut the leaflet tissue immediately above the leaflet clip 40.

[0198] Preferably, the capture basket 102, tightening ring 106, and cutting ring 104 are connected to the internal control member 108 such that they expand to face or point toward the leaflet clamp 40 through the openings of the basket 102 and the cutting ring 104. For example, the plane 103A of the openings of the basket 102 and the cutting ring 104 can be an angle 103C between 25 and 135 degrees relative to the axis 103B (e.g., 90 degrees) of the internal control member 108.

[0199] If the transapical sheath 184 has a sufficiently large diameter, the outer sheath 110 can be retracted proximally, and the basket 102 containing the leaflet clip 40 can be retracted into the channel of the transapical sheath 184 for removal. If the basket 102 and the leaflet clip 40 are too large for the transapical sheath 184, the sheath 184 and the removal catheter 100 can be pulled out simultaneously.

[0200] Figure 66 and 67 This describes another method of heart valve removal via the aortic route, such as leaflet clip 40. (Reference) Figure 66 The aortic catheter 186 is first positioned in the aorta 11 and then enters the left ventricle 14. The aortic catheter 186 may have a fixed curve / shape to help physicians guide the distal end of the catheter 186 under the leaflet clip 40. Optionally or additionally, the aortic catheter 186 may include a steerable mechanism to allow deflection in different directions.

[0201] Next, catheter 100 is removed through aortic guide catheter 186, such that the distal end of outer tubular sheath 110 extends from the distal end of catheter 186 into left ventricle 14. Internal control member 108 is further advanced distally relative to outer tubular sheath 110, such that basket 102 and cutting ring 104 unfold, expand, and are positioned within left ventricle 14. The openings of basket 102 and cutting ring 104 are both oriented such that they face leaflet clip 40. For example, the opening faces of basket 102 and cutting ring 104 may be within a range of approximately 300 degrees and 45 degrees (e.g., approximately 320 degrees) relative to the axis of internal control member 108.

[0202] refer to Figure 67The aortic guide catheter 186 is moved or deflected (in the case of a steerable catheter) to position the cutting ring 104 and basket 102 above the leaflet clip 40. The internal control component 108 retracts proximally into 110, 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 mitral valve 20. The basket 102 and leaflet clip 40 can be retracted via the aortic guide catheter 186, or all catheters can be removed simultaneously as a single unit.

[0203] The invention also contemplates the use of a removal catheter 100 (or any variant described herein) on the tricuspid valve 15, such as Figure 68 and Figure 69 As shown. First refer to Figure 68 The external tricuspid valve guiding catheter 188 first enters the right atrium 16 via the inferior vena cava 17 or the superior vena cava 19. The tricuspid valve guiding catheter 188 may include a fixed curve at its distal end to help its distal opening face the tricuspid valve 15, or may include a steering mechanism to perform the same operation. An internal intermediate catheter 189 may then pass through the external tricuspid valve guiding catheter 188 to provide a better angle toward the tricuspid valve 15. For example, the internal intermediate catheter 189 may have a fixed curve toward the tricuspid valve 15, or may include a steering catheter mechanism to allow a physician to deflect the distal end of the catheter 189 toward the tricuspid valve 15.

[0204] Next, catheter 100 is removed through the internal intermediate duct 189, allowing it to flow distally from the internal intermediate duct 189 into the right atrium 16, and then through the tricuspid valve 15 into the right ventricle 13. Since the leaflet clip 40 is typically positioned in the middle of valve 15 (e.g., with...), Figure 6 (Similar to the top view of the mitral valve in the image), thereby creating an opening on the opposite side of the valve, preferably with the removal catheter 100 positioned on both sides of the leaflet clip 40.

[0205] The internal control component 108 is further advanced distally relative to the external tubular sheath 110, causing the basket 102 and the cutting ring 104 to unfold, expand, and position within the right ventricle 13. 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 plane 103A of the surfaces of the openings of the basket 102 and the cutting ring 104 can be an angle 103C in the range of approximately 0 to 90 degrees relative to the axis 103B of the internal control component 108 (e.g., approximately 45 degrees). The removal catheter 100 is retracted proximally relative to the internal intermediate catheter 189, such that the cutting ring 104 and the basket 102 are positioned above and outside the leaflet clip 40.

[0206] 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.

[0207] 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).

[0208] 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.

[0209] Figures 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.

[0210] 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.

[0211] Figures 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 elongated perforated component 202 has been joined with the leaflet clip 40. 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, such as a blade or electro / cryosurgical cutting device mechanism, at its end, 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.

[0212] Figures 77 to 82 Another embodiment of a removal catheter 220 embedded in a previously placed leaflet clip 40 is shown, followed by a channel for a ring-based tool 224 for encapsulating, cutting, and removing the clip 40. Figure 77 In the ring-based removal conduit 220, there is an anchoring mechanism 226 connected to a central push rod 227, a side push rod 223, and a pushable element 225.

[0213] Figure 78 An end-face view of a loop-based removal conduit 220 is shown, which can be circular, elliptical, multi-segmented, or a combination of these shapes and elements. Side rods 223 push pushable elements 225, while central push rods 227 apply force to anchoring mechanisms 226. Figure 79 In this configuration, the entire annular base 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 a central push rod 227 and a pushable element 125. Figure 78 and Figure 79 Then, using the side push rod 223, the pushable element 225 is pushed to completely or partially wrap the ring-based removal catheter 220 around the leaflet clip 40. Cutting is then performed mechanically or electrically, and the target tissue is removed.

[0214] Figures 83 to 88 A removal catheter 230 is shown embedded in a previously placed heart valve (e.g., leaflet clip 40), followed by the removal of the hardware via a tool that dilates the leaflet clip 40. Figure 83 In this embodiment, 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. Figure 84 In the middle, anchor 235 was advanced and implanted. Figure 85 In the middle, the unfolding tool 234 is advanced within the leaflet clamp 40. Figure 86 In this process, the dilation tool 235 is mechanically dilated to expand the leaflet clip 40. Dilation can be assisted by electricity, heating, hydraulic pressure, rotation, internal or external ultrasound, or energy. Tissue is then 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 A similar method is shown for the balloon expandable element 129.

[0215] Figure 89 and Figure 90 This is a cross-sectional view of the mitral valve 20, which has been treated with valvular therapy comprising one or more valvular structures 50. The valvular structure 50 typically includes a chordae tendineae or cord 52, which is connected to the leaflet and the left ventricle via an anchor 54. The cord 52 may be secured to the ventricular side of the leaflet 24. Figure 89 ) or the atrial side of leaflet 24 ( Figure 90 As further described in the embodiments below, a similar device can be used to remove the heart valve structure 50, just as it is used to remove the leaflet clip 40.

[0216] Figures 91 to 92 A removal tool 240 is shown for cutting and capturing a previously placed heart valve therapy involving a spinal cord or heart valve structure with an implanted leaflet. Figure 91 In this procedure, the cutting catheter 212, previously described, with the ability to open, close, energize, and remove hardware, is used to perform the surgery, similar to... Figures 73 to 76 The above description refers to other heart valve therapies.

[0217] exist Figures 93 to 97 In this process, the procedure is performed using a ring-based tool 250 that encapsulates, cuts, and removes hardware, similar to... Figures 77 to 82 The above explanation.

[0218] exist Figures 98 to 100 In this procedure, a cutting catheter 260 is used to perform the surgery, similar to... Figures 70 to 72 The above description refers to other heart valve therapies.

[0219] In addition, flow limiters can be used to help limit flow in any of the procedures described in this specification. For example, Figure 109 It shows Figure 60An embodiment of a removal catheter 100 with an additional flow-limiting device 341 is provided. This flow-limiting device 341 can be positioned within the region of valve 20 (e.g., through valve 20) before, during, or after removal clamp 40, and remains within the valve region to manage blood flow to the patient by limiting blood flow. The flow-limiting device 341 can be any flow limiter known to those skilled in the art, such as, but not limited to, a balloon, a covered stent, 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 independently or in combination with valve structures. As shown, the flow-limiting device 341 can be introduced separately via delivery catheters 342 and 343. Furthermore, the flow-limiting device 341 can be integrated into a delivery mechanism, such as an internally steerable catheter 180. Alternatively, the flow-limiting device 341 can be a delivery system for another therapy, such as, but not limited to, a heart valve.

[0220] Although different embodiments and examples have been discussed separately in this specification, any features described may be combined, interchanged, or added to other embodiments of this specification. In other words, each described embodiment is not intended to limit its features, and any feature described in any other embodiment may be explicitly added to that embodiment.

[0221] As used herein, the terms “substantially” or “generally” refer to the extent or degree of completeness or near-completeness of a behavior, characteristic, attribute, state, structure, item, or result. For example, a “substantially” or “generally” closed object means that the object is either completely closed or nearly completely closed. In some cases, the exact permissible deviation of absolute completeness may depend on the specific context. However, in general, a degree of proximity to completion will make the overall result approximately the same as if absolute or complete completion had been achieved. The usage of “substantially” or “generally” also applies to situations where, in a negative sense, a behavior, characteristic, attribute, state, structure, item, or result is completely or nearly completely lacking. For example, an element, combination, embodiment, or composition that is “substantially free” or “substantially free” of a component or element may still substantially contain the item, provided that it generally does not have a measurable effect.

[0222] As used herein, any reference to "an embodiment" or "embodiment" means that a particular element, feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment. The appearance of the phrase "in an embodiment" in various places in the specification does not necessarily refer to the same embodiment.

[0223] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having,” or any other variation thereof are intended to cover non-exclusive inclusion. For example, a process, method, article, or apparatus that includes a list of elements is not necessarily limited to those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. Furthermore, unless expressly stated otherwise, “or” means inclusive or, not exclusive or. For example, condition A or B is satisfied by any of the following: A is true (or exists), B is false (or does not exist); A is false (or does not exist), B is true (or exists); or both A and B are true (or exist).

[0224] Furthermore, the terms "a" or "an" are used to describe elements and components in the embodiments herein. This is done merely for convenience and to give a general meaning to the description. This specification should be understood to include one or at least one, and the singular includes the plural, unless it clearly means otherwise.

[0225] Furthermore, the accompanying drawings depict preferred embodiments for illustrative purposes only. Those skilled in the art will readily recognize from the discussion herein that alternative embodiments of the structures and methods shown herein can be used without departing from the principles described herein.

[0226] Upon reading this disclosure, those skilled in the art will understand alternative structural and functional designs for custom containers (urn). Therefore, while specific embodiments and applications have been illustrated and described, it should be understood that the disclosed embodiments are not limited to the precise constructions and components disclosed herein. Various modifications, alterations, and variations can be made to the arrangement, operation, and details of the methods and apparatus disclosed herein without departing from the spirit and scope defined in the appended claims, as will be apparent to those skilled in the art.

[0227] Although the invention has been described with reference to specific embodiments and applications, those skilled in the art can generate additional embodiments and modifications based on the teachings without departing from the spirit or scope of the claimed invention. Therefore, it should be understood that the accompanying drawings and descriptions herein are provided by way of example to facilitate understanding of the invention and should not be construed as limiting the scope of the invention.

Claims

1. A system for removing a heart valve, comprising: External tubular sheath; A cutting element comprising a first cutting ring connected to a first internal control component and capable of moving from a first compression configuration within the outer tubular sheath to a second expansion configuration outside the outer tubular sheath; In the second expansion configuration of the cutting element, the angle between the plane aligned with the opening of the first cutting ring and the longitudinal axis of the first internal control component is between 45 degrees and 135 degrees, and the first cutting ring is positioned on one side of the longitudinal axis of the first internal control component; and The opening of the first cutting ring is 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 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.

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

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

6. The system of 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 multiple strands of wire made of different conductive materials.

7. The system of claim 1, wherein the first cutting ring has one or more non-insulating portions, the one or more non-insulating portions being confined only to the radially inner surface of the second expanded configuration of the cutting element.

8. The system of claim 1, wherein the cutting element further comprises a second cutting ring positioned adjacent to the first cutting ring.

9. The system of claim 1 further includes a second cutting ring positioned adjacent to the first cutting ring.

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

11. The system of claim 10, wherein the side portion is inclined downward and upward in a wave pattern.

12. The system of claim 1, wherein the first cutting ring comprises a plurality of non-insulating regions, the plurality of non-insulating regions being electrically activated individually or simultaneously at different times.

13. The system of claim 1, wherein the first cutting ring comprises nitinol and stainless steel.

14. The system of claim 1, wherein the first cutting ring comprises one or more nitinol wires and one or more stainless steel wires.

15. The system of claim 1, wherein the first cutting ring includes one or more non-insulating portions positioned opposite the elongated straight portion of the first internal control member.

16. The system of claim 1, wherein the first cutting ring comprises a non-insulated portion in the range of 1 to 5 mm or a plurality of discrete non-insulated portions each in the range of 1 to 5 mm.

17. The system of claim 16, wherein the number of the plurality of discrete non-insulating parts is in the range of 2 to 10 discrete non-insulating parts.

18. The system of claim 1, wherein the first cutting ring at least partially comprises stainless steel; and wherein the first cutting ring comprises an insulating portion and at least one non-insulating portion, the at least one non-insulating portion exposing the stainless steel.

19. The system of claim 1, further comprising a basket connected to a second internal control unit and capable of moving from a first compression configuration within the outer tubular sheath to a second expansion configuration outside the outer tubular sheath.

20. A system for removing a heart valve, comprising: External tubular sheath; A cutting element comprising a first cutting ring connected to a first internal control component and capable of moving from a first compression configuration within the outer tubular sheath to a second expansion configuration outside the outer tubular sheath; The cutting ring has a side portion that forms a saddle shape.

21. The system of claim 20, wherein the side portion is inclined downward and upward in a wave pattern.

22. A system for removing a heart valve, comprising: External tubular sheath; A cutting element comprising a first cutting ring connected to a first internal control component and capable of moving from a first compression configuration within the outer tubular sheath to a second expansion configuration outside the outer tubular sheath; The first cutting ring includes a single wire made of a single conductive material, two or more wires each made of different conductive materials, or multiple strands of wire made of different conductive materials.

23. A system for removing a heart valve, comprising: External tubular sheath; A cutting element comprising a first cutting ring connected to a first internal control component and capable of moving from a first compression configuration within the outer tubular sheath to a second expansion configuration outside the outer tubular sheath; The first cutting ring comprises nickel-titanium and stainless steel.

24. The system of claim 23, wherein the first cutting ring comprises one or more nitinol wires and one or more stainless steel wires.

25. A system for removing a heart valve, comprising: External tubular sheath; A cutting element comprising a first cutting ring connected to a first internal control component and capable of moving from a first compression configuration within the outer tubular sheath to a second expansion configuration outside the outer tubular sheath; The cutting element further includes a second cutting ring positioned adjacent to the first cutting ring.

26. A system for removing a heart valve, comprising: External tubular sheath; A cutting element comprising a first cutting ring connected to a first internal control component and capable of moving from a first compression configuration within the outer tubular sheath to a second expansion configuration outside the outer tubular sheath; The first cutting ring includes one or more insulating portions positioned opposite the elongated straight portion of the first internal control component.

27. The system of claim 26, wherein the first cutting ring comprises a non-insulated portion in the range of 1 to 5 mm or a plurality of discrete non-insulated portions each in the range of 1 to 5 mm.

28. The system of claim 27, wherein the number of the plurality of discrete non-insulating parts is in the range of 2 to 10 discrete non-insulating parts.

29. A system for removing a heart valve, comprising: External tubular sheath; A cutting element comprising a first cutting ring connected to a first internal control member and movable from a first compression configuration within an outer tubular sheath to a second expansion configuration outside the outer tubular sheath; wherein, in the second expansion configuration of the cutting element, a plane aligned with the opening of the first cutting ring is at an angle between 45 degrees and 135 degrees relative to the longitudinal axis of the first internal control member, and the first cutting ring is positioned on one side of the longitudinal axis of the first internal control member; and, A basket, connected to a first internal control component and movable from a first compression configuration within the outer tubular sheath to a second expansion configuration outside the outer tubular sheath; wherein in the second expansion configuration of the basket, the angle between a plane aligned with the opening of the basket and the longitudinal axis of the first internal control component is between 45 degrees and 135 degrees, and the basket is positioned on one side of the longitudinal axis of the first internal control component and opens in a proximal direction.

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