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 retrieval catheter may include a cutting element and a basket, a piercing element, a gripping mechanism, or a similar gripping device. The method includes delivering the catheter to a heart valve treatment region, then manipulating the catheter and associated instruments to cut tissue if necessary, and then removing the heart valve treatment and retracting the catheter.

Description

[0001] Related Applications

[0002] This application claims the benefit of and priority to U.S. Provisional Application Serial No. 63 / 266,799, filed on January 14, 2022, entitled “Method and Device for Removing Chord and Tissue Surrounding Leaflet Apposition Therapy,” U.S. Provisional Application Serial No. 63 / 362,507, filed on April 5, 2022, entitled “Heart Valve Therapy Clip Removal,” and U.S. Provisional Application Serial No. 63 / 368,588, filed on July 15, 2022, entitled “Electrosurgical Devices and Methods,” the entire contents of which are incorporated herein by reference. Background Art

[0003] Heart valve disease can occur when the leaflets of a patient's valves fail to close completely, allowing regurgitation, or abnormal backflow, of blood. Figure 1 Regurgitation is particularly common at the mitral valve 20, where the anterior mitral valve leaflet 22 fails to close properly with the posterior leaflet 24. When the ventricles of the heart 10 contract, some blood moves from the left ventricle 14 back into the left atrium 12 instead of into the aorta 11. Similar regurgitation can also occur at the tricuspid valve 15, allowing blood from the right ventricle 13 to flow back into the right atrium 16.

[0004] A common treatment for valvular regurgitation is to use a treatment device that juxtaposes or permanently connects the leaflets together. Such heart valve treatment hardware may have been placed using surgery, transcatheter, or minimally invasive means. For example, the hardware or treatment targeted for removal may be a MitraClip (Abbott Structural Company, Santa Clara, California), a PASCAL device (Edwards Life Sciences, Irvine, California), a surgical suture (such as the Alfieri suture), or a similar heart valve treatment. Other heart valve treatments may be the result of a technique that targets the leaflets as part of the treatment target and requires partial or complete removal of the leaflets. Other examples include chord replacement techniques placed transcatheter or surgically to compensate for inappropriate length, breakage, or misalignment of existing chordae. For the purposes of this specification, the phrase "heart valve treatment" or "heart valve treatment device" should be defined as any device and / or method for heart valve treatment, such as a leaflet clip, suture, artificial chord, or any other device or method associated with the treatment of a heart valve and associated leaflets.

[0005] Figure 2 An exemplary transcatheter delivery procedure of a valve clip 40 (eg, a Mitra clip) for treating a regurgitant mitral valve 20 is illustrated. A delivery catheter 41 is advanced through the right atrium 16, through the atrial septum 18, and into the left atrium 12. As in Figure 3 As best seen in FIG. 1 , the inner portion of the catheter 41A including the valve clip 40 is advanced through the mitral valve 20 and into the left ventricle 14. In this example, the leaflet clip 40 includes two outer arms 40A positioned below the leaflets 22, 24 and two inner arms 40B positioned vertically between the two leaflets 22, 24. Figure 3 As shown, catheter 41 includes a control wire that can cause outer arm 40A to close against inner arm 40B to tighten or engage the tissue of the valve leaflets. Barbs or similar structures on arm 40B help anchor leaflet clip 40 in the tissue of leaflets 22, 24, such as Figure 4 Finally, the catheter 41 is removed, as shown. Figure 5 As shown in Figure 6 As seen in the top view of FIG, the leaflet clip 40 is generally positioned near the center of the valve 20, thereby preventing the central portion from opening and creating two smaller valve openings on either side of the clip 40. The smaller diameter of these openings generally allows the leaflets to close better and prevent regurgitation.

[0006] In some cases, it may be necessary to remove these structures to facilitate other valve treatments, such as when there is recurrent or residual regurgitation that needs to be addressed. For example, the valve may require placement of other leaflet techniques, annuloplasty or rings, chordae or cables, positioning devices, or replacement valves, many of which may not be available for the previously performed heart valve treatment.

[0007] In some cases, these treatments require removal from one or more attachment points on the leaflets, but not complete removal, to facilitate other valve treatments, leaving the structure in the heart but being able to move the structure away from the area of ​​concern and apply the desired treatment.

[0008] However, these heart valve therapies are typically removed via open-chest surgery, which can be particularly invasive to the patient and presents a relatively high risk of complications. Therefore, what is needed is a less invasive method of removing heart valve therapies that presents a lower risk of complications. Summary of the invention

[0009] The present disclosure relates to systems and methods for removing a heart valve treatment that has been used to position valve leaflets. Such removal may be necessary when additional treatment is needed to treat the valve disease (e.g., a different repair method, valve replacement), when the heart valve treatment causes harm or potential harm to the patient (e.g., stenosis, infection), when the heart valve treatment is deemed to have no clinical benefit, or when it is generally desirable not to use the treatment.

[0010] The present disclosure relates to systems and methods for removing a heart valve treatment used to position a leaflet that may be placed using surgical, transcatheter, or minimally invasive means. In at least one embodiment, the hardware or therapeutic device to be removed may be a Mitra Clip (Abbott Structural, Santa Clara, CA), a Pascal Device (Edwards Lifesciences, Irvine, CA), a surgical suture (such as an Alfieri suture), or similar positioning devices and techniques. In at least one embodiment, such positioning devices that need to be removed may be the result of a technique that targets the leaflet as part of the treatment and in which a portion or all of the leaflet needs to be removed. An example of such a device is a chord replacement technique that is placed using a transcatheter approach or surgically. In some cases, the cord or chords are ineffective due to improper length, breakage, misalignment, or defects in the prosthetic material.

[0011] The method includes a tool for cutting native valve tissue that has been attached to a heart valve treatment, with or without a capture tool that retains hardware to remove it when it is externalized from the human body. In at least one embodiment, the cutting method includes an adjustable snare that wraps around the heart valve treatment and can cut the native tissue from the heart valve treatment mechanically or using a radiofrequency electrosurgical device, which heats the tissue so that the internal temperature of the electrosurgical cutting device quickly reaches 100 degrees Celsius, and the contents inside undergo a liquid to gas conversion, a large volume expansion, and cause vaporization. In at least one embodiment, the capture tool is an adjustable basket, bag or box. The capture tool can be used to cut, release, compress, modify or completely retrieve the heart valve treatment from the human body.

[0012] In some embodiments, a method for removing a previously placed heart valve treatment includes a steerable catheter that has been inserted into a patient using a transseptal, transatrial, or transventricular approach. The steerable catheter includes a delivery catheter capable of placing a tool for cutting and capturing the heart valve treatment.

[0013] In some embodiments, capture of a heart valve treatment is performed by inserting and embedding a tool directly into, onto, and / or around the heart valve treatment. In this manner, native tissue is cut from the heart valve treatment using an electrosurgical cutting device (radio frequency electricity or similar device) or similar energy or force delivered from within the embedded tool. A basket or bag that captures the heart valve treatment may not be required when removing the target material. Thus, in at least one embodiment, the cutting tool may be used alone without a capture basket.

[0014] In at least one embodiment, the ring structure is pushed over a tissue bridge, chordal implant, or fixation method created by a heart valve treatment. The ring structure can be used to cut with electrical or mechanical means. The ring structure can be circular, oval, or multi-segmented and can completely or partially wrap around an area for cutting and removal. The ring structure can be used to wrap around a heart valve treatment and tissue for removal and then externalized.

[0015] In at least one embodiment, a tool is used to expand the heart valve treatment for removal. Such expansion can be mechanical, electrical, pneumatic, hydraulic or similar means to expand or change the shape of the heart valve treatment for removal.

[0016] Elements of the tool can be fixed to the heart valve for treatment to reduce the risk of embolism. This fixation can be achieved by straight, spiral, barbed or a combination of these anchors.

[0017] In at least one embodiment, a catheter, spacer, balloon or other device can be used with the removal device to manage blood flow or regurgitation of the valve after the heart valve treatment is removed. This can be performed quickly if the removed heart valve treatment and basket can be retracted through a steerable catheter - and then the sealing device is delivered through the same delivery catheter.

[0018] Another embodiment of the present invention is directed to a removal system for a valve clip or similar heart valve treatment that may include a cutting-capture catheter and a snare catheter, both of which may be deployed from the same or separate delivery catheters. The snare catheter may initially be used to grasp the valve clip and pull the valve clip distally (e.g., further into the left ventricle) to create tension or force on the valve leaflets. The cutting ring and basket of the cutting-capture catheter are then placed over the valve clip so that the cutting ring is located on the proximal or atrial side of the heart valve treatment. Finally, the cutting ring is activated, the heart valve treatment device is severed, and the valve clip is finally captured with the basket and removed from the patient. This design enables simultaneous cutting and capturing of the heart valve treatment as the cutting ring is pulled through the tissue and the capture basket is closed around the heart valve treatment device.

[0019] The snare catheter may include a snare ring having a circular or oval, saddle shape, forming an arc shape along each side thereof. The snare ring may have multiple teeth, a friction coating, or may be formed of a coiled wire. The snare catheter may also include a distal tip having an opening in the side wall and having features such as abrupt edges, ridges, grooves or hooks that create friction with the snare valve clip.

[0020] The snare catheter may also include a handle configured to retract the snare loop into the snare catheter. The handle may include a mechanism for ensuring that tension is always applied to the clip and limiting the amount of force that a user can apply to tighten the snare. The handle may include a locking mechanism for locking the snare in a desired retracted position.

[0021] The removal system may also include a wire path through one or both of the cutting-capture catheter and the snare catheter. In a specific example, the wire path may extend through the snare catheter and the basket of the cutting-capture catheter. The wire may traverse the length of the capture basket, or may only pass through the tip of the capture basket and then extend along the outer surface of the capture basket.

[0022] The removal system may also include a chord dilator configured to at least partially occlude the distal opening of the delivery catheter and provide a relatively smooth transition, thereby reducing abrupt surface "hanging" on the chords or other features of the valve.

[0023] The cut-and-capture catheter may also include a stretchable capture basket that can be stretched from a longitudinally compressed configuration to a longitudinally stretched configuration once the valve clip is captured.

[0024] The removal system may also include a catheter configured to push the valve clip from the atrial side of the valve to provide a counter force. Thus, the cutting ring of the cutting-capture catheter may be able to better position between the atrial side of the valve clip and the valve leaflets. The catheter may be configured to only contact or may be configured to positively engage or attach the valve clip.

[0025] The removal system may also include a snare catheter including a cutting element that allows it to engage tissue surrounding the valve clip or other heart valve treatment to facilitate capture and removal.

[0026] In certain aspects, the technology described herein relates to a snare catheter for use in the medical treatment of a patient, comprising: an elongated sheath having a lumen and one or more openings leading into the lumen at a distal portion of the elongated sheath; an internal control member extending within the elongated sheath; a snare ring at a distal end of the internal control member and extending from the one or more openings; and an electrical insulator configured to reduce current transmission between an electrical cutting device within the patient's heart.

[0027] In certain aspects, the technology described herein relates to a snare catheter wherein an electrical insulator is disposed over part or all of the snare loop.

[0028] In certain aspects, the technology described herein relates to a snare catheter wherein the electrical insulator comprises a coating or tube comprising silicone, polyolefin, polyimide, a dielectric material, PTFE, FEP.

[0029] In certain aspects, the technology described herein relates to a snare catheter wherein the snare loop comprises one or more wires comprising nitinol or stainless steel.

[0030] In certain aspects, the technology described herein relates to a snare catheter wherein the elongated sheath further comprises a distal tip member at a distal end of the elongated sheath and forming one or more openings; and wherein the electrical insulator further comprises a layer, coating, or structural material.

[0031] In certain aspects, the technology described herein relates to snare catheters wherein the distal tip member includes a rounded, curved, or blunted shape of one or more opening perimeters to reduce or limit damage to electrical insulators.

[0032] In certain aspects, the technology described herein relates to a snare catheter wherein a rounded, curved, or blunted shape is formed by an insert coupled to a distal tip member, or by the distal tip member.

[0033] In certain aspects, the technology described herein relates to a snare catheter wherein one or more openings are located on a side of a distal tip member relative to an axis of the elongated sheath.

[0034] In certain aspects, the technology described herein relates to a snare catheter for use in patient medical treatment, comprising an elongated sheath having a lumen; an internal control member extending within the elongated sheath; a snare loop at a distal end of the internal control member; and a distal tip member connected at the distal end of the elongated sheath, the distal tip member having a first opening and a second opening that lead into the lumen of the elongated sheath; wherein the snare loop is positioned through the first opening and the second opening such that a structural feature between the first opening and the second opening prevents the snare loop from being completely pulled into the lumen of the elongated sheath.

[0035] In certain aspects, the technology described herein relates to a snare catheter wherein the distal tip member features a rod or a pin.

[0036] In certain aspects, the technology described herein relates to a snare catheter for use in patient medical treatment, comprising an elongated sheath having a lumen and one or more openings leading into the lumen at a distal portion of the elongated sheath; an internal control member extending within the elongated sheath; and a snare loop located at a distal end of the internal control member and extending from the one or more openings; wherein the snare loop is configured to limit deflection of a distal tip of the snare loop to a range of about 0 mm to about 10 mm when a force in a range of about 0 grams to about 3 grams is applied to the snare loop.

[0037] In certain aspects, the technology described herein relates to a snare catheter wherein the snare loop is configured to limit deflection of a distal end of the snare loop to a range of about 0 mm to about 5 mm when a force in a range of about 0 grams to about 3 grams is applied to the snare loop.

[0038] In certain aspects, the technology described herein relates to a snare catheter wherein the snare loop comprises a solid shape memory wire having a diameter in a range of approximately 0.001 inches to 0.03 inches.

[0039] In certain aspects, the technology described herein relates to a tissue cutting catheter for use in patient medical treatment, comprising: a slender catheter body; and a cutting ring extending from a distal portion of the slender catheter body; wherein the cutting ring comprises one or more shape memory wire segments and one or more electrodes comprising a non-shape memory material.

[0040] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein one or more electrodes comprise stainless steel.

[0041] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein one or more electrodes comprise a tube or sleeve connected to one or more shape memory wire segments.

[0042] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein one or more electrodes each include a non-shape memory wire segment.

[0043] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein one or more electrodes are radially larger than one or more shape memory wire segments.

[0044] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein the cutting loop is an open loop or a closed loop.

[0045] In certain aspects, the technology described herein relates to a tissue cutting catheter for use in patient medical treatment, comprising: a slender catheter body; and a cutting ring extending from a distal portion of the slender catheter body; wherein the cutting ring comprises a main ring segment and one or more electrodes; wherein the diameter of the one or more electrodes is larger than the main ring segment.

[0046] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein one or more electrodes have a cylindrical, spherical, cubic, curved, and / or ridged shape.

[0047] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein one or more electrodes are disposed above some of the main cutting ring segments; and wherein one or more electrodes are disposed on top of, below, or adjacent to an insulating layer of the main cutting ring segments.

[0048] In certain aspects, the technology described herein relates to a tissue cutting catheter in which one or more electrodes extend completely around or partially around the circumference of one of the main cutting ring segments.

[0049] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein one or more electrodes are wires connected to adjacent segments of a main cutting loop segment.

[0050] In certain aspects, the technology described herein relates to a tissue cutting catheter for use in patient medical treatment, comprising: a slender catheter body; and a cutting ring extending from a distal portion of the slender catheter body; wherein the cutting ring comprises one or more main ring segments and an electrode; wherein the electrode comprises a wire connected at a first position on the cutting ring and at a second position on the cutting ring so as to form a space or gap with a portion of the cutting ring.

[0051] In certain aspects, the technology described herein relates to a tissue cutting catheter for use in patient medical treatment, comprising: an elongated catheter body; and a cutting ring extending from a distal portion of the elongated catheter body; wherein the cutting ring comprises a plurality of electrodes.

[0052] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein the plurality of electrodes includes a first electrode located at a mid- and distal-most location of the cutting loop.

[0053] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein the plurality of electrodes includes a second electrode and a third electrode located on either side of a first electrode and within a distal half of the cutting ring.

[0054] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein the plurality of electrodes includes a first electrode on a first side of the cutting ring and a second electrode on a second side of the cutting ring.

[0055] In certain aspects, the technology described herein relates to a capture basket catheter for use in patient medical treatment, comprising: a slender catheter body; and a capture basket at a distal portion of the slender catheter body; wherein the capture basket is connected at a first distance from the distal end of the slender catheter body and connected at a second distance from the distal end of the catheter body, wherein the second distance is less than the first distance.

[0056] In certain aspects, the technology described herein relates to a capture basket catheter wherein a capture basket is connected at a first distance by a cinch ring.

[0057] In certain aspects, the technology described herein relates to a capture basket catheter wherein a capture basket is connected at a second distance between a wire of the capture basket and an opening of the elongated catheter body.

[0058] In certain aspects, the technology described herein relates to a capture basket catheter wherein an opening is located within a distal tip of an elongated catheter body.

[0059] In certain aspects, the technology described herein relates to a catheter delivery device for use in patient medical treatment, comprising: an elongated sheath having a sheath lumen extending therethrough; and a sheath hub connected to the proximal end of the elongated sheath; wherein the sheath hub includes a plurality of ports extending into the lumen; and wherein the width of the lumen decreases distally; and wherein the lumen further includes a funnel portion at the distal end of the lumen and extending into the sheath lumen of the elongated sheath.

[0060] In certain aspects, the technology described herein relates to a chord cutting device for use in patient medical treatment, comprising an elongated catheter body having a catheter lumen and an opening into the catheter lumen at a distal portion of the elongated catheter body; a cutting element positioned within the catheter lumen and movable longitudinally therein; and an elongated capture member having a distal end that forms an arcuate shape when unconstrained and is movable by a user to extend out of the opening; wherein the arcuate shape is configured to at least partially surround one or more chordae tendineae within the heart and retract the chordae tendineae into the opening; and wherein the cutting element is capable of moving distally against the chordae tendineae to cut the chordae tendineae within the catheter lumen.

[0061] In certain aspects, the technology described herein relates to chord cutting devices wherein an elongated capture member is positioned within a lumen of a cutting element.

[0062] In certain aspects, the technology described herein relates to chord cutting devices wherein an elongated capture member is positioned within a catheter lumen and outside of a cutting element.

[0063] In certain aspects, the technology described herein relates to chord cutting devices wherein the openings are positioned through a sidewall of a catheter body.

[0064] In certain aspects, the technology described herein relates to chord cutting devices wherein the curved shape is a loop, a spiral, a helix, a hook, or a plurality of loops terminating in a hook.

[0065] In certain aspects, the technology described herein relates to chord cutting devices wherein the capture member comprises one or more wires having a diameter in the range of 0.001 to 0.030 inches.

[0066] In certain aspects, the technology described herein relates to chord cutting devices wherein the working diameter of the curved shape is in a range of about 0.15 inches to about 1.5 inches.

[0067] In certain aspects, the technology described herein relates to chord devices wherein the cutting element has a distal end forming a beveled edge, multiple points, a single point, or a stepped shape.

[0068] In certain aspects, the technology described herein relates to chord devices wherein the cutting element is tubular or solid in shape.

[0069] In certain aspects, the technology described herein relates to chord devices wherein the cutting element is an electrode positioned on the capture member and configured to deliver an electrical current to cut tissue.

[0070] In certain aspects, the technology described herein relates to a chordal medical treatment method, comprising advancing a slender catheter body into the heart; pushing a distal portion of an elongated capture member out of an opening in the elongated catheter body; allowing the distal portion of the elongated capture member to bend around one or more chordae tendineae; moving the distal portion of the elongated capture member and a portion of one or more chordae tendineae proximally into a lumen of the elongated catheter body; and, actuating a cutting element within the lumen of the elongated capture member to cut one or more chordae tendineae.

[0071] In certain aspects, the technology described herein relates to a method wherein actuating the cutting element further comprises moving a cutting edge of the cutting element distally against one or more chordae.

[0072] In certain aspects, the technology described herein relates to a method wherein actuating a cutting element includes supplying radiofrequency power to an electrode on an elongated capture member.

[0073] In certain aspects, the technology described herein relates to a method wherein allowing a distal portion of an elongated capture member to bend about one or more chordae further comprises allowing a distal portion of the elongated capture member to bend about a heart valve clip.

[0074] In certain aspects, the technology described herein relates to a chordal medical method comprising advancing an elongated catheter body into the heart; pushing a distal portion of an elongated capture member out of an opening in the elongated catheter body; allowing the distal portion of the elongated capture member to bend around one or more chordae and a heart valve clamp; moving the distal portion of the elongated capture member and a portion of one or more chordae proximally into the lumen of the elongated catheter body; and, advancing a separate cutting element into the heart and cutting one or more captured chordae.

[0075] In certain aspects, the technology described herein relates to a chordal medical method comprising: advancing an elongated catheter body into the heart; pushing a distal portion of an elongated capture member out of an opening in the elongated catheter body; allowing the distal portion of the elongated capture member to bend around one or more chordae tendineae; and, actuating electrodes on the elongated capture member to cut one or more chordae tendineae.

[0076] In certain aspects, the technology described herein relates to an RF power generator for patient medical treatment, comprising: an RF power generator housing comprising a processor, a memory, and software code executable by the processor; and a user interface controllable by the processor and the software code; wherein the software code is configured to measure electrical signals from a plurality of electrodes on a cutting ring and then display whether each of the plurality of electrodes is in contact with tissue.

[0077] In certain aspects, the technology described herein relates to an RF power generator for patient medical treatment, comprising: an RF power generator housing comprising a processor, a memory, and software code executable by the processor; and a user interface controllable by the processor and the software code; wherein the software code is configured to individually activate or deactivate each of a plurality of electrodes on a cutting ring.

[0078] In certain aspects, the technology described herein relates to a heart valve clip for treating a heart valve, comprising: a clip body; a leaflet connection mechanism configured to connect to leaflet tissue; and a snare engagement feature comprising a channel, groove, or enlarged structure at the bottom of the clip body.

[0079] In certain aspects, the technology described herein relates to a heart valve clip for treating a heart valve, comprising: a clip body; a leaflet connection mechanism configured to connect to leaflet tissue; and electrodes configured to deliver current when the clip body is supplied with current.

[0080] In certain aspects, the technology described herein relates to a tissue cutting catheter for use in patient medical treatment, comprising: a slender catheter body; and, a cutting ring, which extends from a distal portion of the slender catheter body and includes one or more electrodes; wherein the surface area of ​​each of the one or more electrodes is in the range of about 0.003 square inches to about 0.006 square inches.

[0081] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein each of the one or more electrodes has a surface area of ​​approximately 0.00437506 square inches.

[0082] In certain aspects, the technology described herein relates to a tissue cutting catheter wherein one or more electrodes are connected to a power source configured to supply radio frequency power in a range of approximately 5 Watts to 1600 Watts.

[0083] Although multiple embodiments are disclosed, other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the present invention. As will be appreciated, the various embodiments of the present disclosure are capable of modification in various obvious respects, all of which will not depart from the spirit and scope of the present disclosure. Therefore, the drawings and detailed description are to be regarded as illustrative rather than restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0084] These and other aspects, features and advantages of embodiments of the present invention will be apparent from and elucidated in the following description of embodiments of the present invention, with reference to the accompanying drawings, in which:

[0085] Figure 1 Diagram showing the anatomy of the heart.

[0086] Figure 2 A side view of a procedure to implant a leaflet heart valve treatment device is illustrated.

[0087] Figure 3 A side view of a procedure to implant a leaflet heart valve treatment device is illustrated.

[0088] Figure 4 A side view of a procedure to implant a leaflet heart valve treatment device is illustrated.

[0089] Figure 5 A side view of a procedure to implant a leaflet heart valve treatment device is illustrated.

[0090] Figure 6 A top view of a procedure to implant a leaflet heart valve treatment device is illustrated.

[0091] Figure 7 A side view of a removal catheter according to the present invention is shown.

[0092] Figure 8 A side view of a removal catheter according to the present invention is shown.

[0093] Fig. 9 A side view of a removal catheter according to the present invention is shown.

[0094] Fig.10 A side perspective view of a removal catheter according to the present invention is illustrated.

[0095] Fig.11 A side view of a removal catheter according to the present invention is shown.

[0096] Fig.12 A cross-sectional view of a removal catheter according to the present invention is shown.

[0097] Fig.13 An exploded view of a removal catheter according to the present invention is shown.

[0098] Fig.14 A perspective view of a cutting ring according to the invention is shown.

[0099] Fig.15 A perspective view of a cutting ring according to the invention is shown.

[0100] Fig.16 A perspective view of a cutting ring according to the invention is shown.

[0101] Fig.17 A perspective view of a cutting ring according to the invention is shown.

[0102] Fig.18 A perspective view of a cutting ring according to the invention is shown.

[0103] Fig.19 A perspective view of a cutting ring according to the invention is shown.

[0104] Fig. 20 A top view of a cutting ring according to the invention is shown.

[0105] Fig.21 A top view of a cutting ring according to the invention is shown.

[0106] Fig. 22 A perspective view of a cutting ring according to the invention is shown.

[0107] Fig.23 A cross-sectional view of a cutting ring according to the invention is shown.

[0108] Fig.24 A cross-sectional view of a cutting ring according to the invention is shown.

[0109] Fig.25 A cross-sectional view of a cutting ring according to the invention is shown.

[0110] Fig.26 A cross-sectional view of a cutting ring according to the invention is shown.

[0111] Fig. 27 A cross-sectional view of a cutting ring according to the invention is shown.

[0112] Fig.28 A cross-sectional view of a cutting ring according to the invention is shown.

[0113] Fig.29 A cross-sectional view of a cutting ring according to the invention is shown.

[0114] Fig.30 A cross-sectional view of a cutting ring according to the invention is shown.

[0115] Fig.31 A side view of a basket according to the invention is shown.

[0116] Fig.32 A side view of a basket according to the invention is shown.

[0117] Fig.33 A side view of a removal catheter according to the present invention is shown.

[0118] Fig.34 A side perspective view of a removal catheter according to the present invention is illustrated.

[0119] Fig.35 A side perspective view of a removal catheter according to the present invention is illustrated.

[0120] Fig.36 A side perspective view of a removal catheter according to the present invention is illustrated.

[0121] Fig.37 A side view of a removal catheter according to the present invention is shown.

[0122] Fig.38 A side view of a removal catheter according to the present invention is shown.

[0123] Fig.39 A side view of a removal catheter according to the present invention is shown.

[0124] Fig.40 A side view of a basket according to the invention is shown.

[0125] Fig.41 A side view of a basket according to the invention is shown.

[0126] Fig.42 A side view of a basket according to the invention is shown.

[0127] Fig.43 A side view of a basket according to the invention is shown.

[0128] Fig.44 A side view of a handle according to the invention is shown.

[0129] Fig.45 A side view of a handle according to the invention is shown.

[0130] Fig.46 A side view of a removal catheter according to the present invention is shown.

[0131] Fig.47 A side view of a removal catheter according to the present invention is shown.

[0132] Fig.48 A side view of a removal catheter according to the present invention is shown.

[0133] Fig.49 A side view of a removal catheter according to the present invention is shown.

[0134] Fig.50 A side view of a removal catheter according to the present invention is shown.

[0135] Fig.51 A side view of a removal catheter according to the present invention is shown.

[0136] Fig.52 A side view of a removal catheter according to the present invention is shown.

[0137] Fig.53 A side view of a removal catheter according to the present invention is shown.

[0138] Fig.54A side view of a removal catheter and a guide catheter according to the present invention is shown.

[0139] Fig.55 A side view of a removal catheter and a guide catheter according to the present invention is shown.

[0140] Fig.56 A side view of a catheter removal procedure according to the present invention is illustrated.

[0141] Fig.57 A side view of a catheter removal procedure according to the present invention is illustrated.

[0142] Fig.58 A side view of a catheter removal procedure according to the present invention is illustrated.

[0143] Fig.59 A side view of a catheter removal procedure according to the present invention is illustrated.

[0144] Fig.60 A side view of a catheter removal procedure according to the present invention is illustrated.

[0145] Fig.61 A side view of a catheter removal procedure according to the present invention is illustrated.

[0146] Fig.62 A side view of a catheter removal procedure according to the present invention is illustrated.

[0147] Fig.63 A side view of a catheter removal procedure according to the present invention is illustrated.

[0148] Fig.64 A side view of a catheter removal procedure according to the present invention is illustrated.

[0149] Fig.65 A side view of a catheter removal procedure according to the present invention is illustrated.

[0150] Fig.66 A side view of a catheter removal procedure according to the present invention is illustrated.

[0151] Fig.67 A side view of a catheter removal procedure according to the present invention is illustrated.

[0152] Fig.68 A side view of a catheter removal procedure according to the present invention is illustrated.

[0153] Fig.69 A side view of a catheter removal procedure according to the present invention is illustrated.

[0154] Fig.70 A side view of a catheter removal procedure according to the present invention is illustrated.

[0155] Fig.71 A side view of a catheter removal procedure according to the present invention is illustrated.

[0156] Fig.72 A side view of a catheter removal procedure according to the present invention is illustrated.

[0157] Fig.73 A side view of a catheter removal procedure according to the present invention is illustrated.

[0158] Fig.74 A side view of a catheter removal procedure according to the present invention is illustrated.

[0159] Fig.75 A side view of a catheter removal procedure according to the present invention is illustrated.

[0160] Fig.76 A side view of a catheter removal procedure according to the present invention is illustrated.

[0161] Fig.77 A side view of a catheter removal procedure according to the present invention is illustrated.

[0162] Fig.78 A side view of a catheter removal procedure according to the present invention is illustrated.

[0163] Fig.79 A side view of a catheter removal procedure according to the present invention is illustrated.

[0164] Fig.80 A side view of a catheter removal procedure according to the present invention is illustrated.

[0165] Fig.81 A side view of a catheter removal procedure according to the present invention is illustrated.

[0166] Fig.82 A side view of a catheter removal procedure according to the present invention is illustrated.

[0167] Fig.83 A side view of a catheter removal procedure according to the present invention is illustrated.

[0168] Fig.84 A side view of a catheter removal procedure according to the present invention is illustrated.

[0169] Fig.85 A side view of a catheter removal procedure according to the present invention is illustrated.

[0170] Fig.86 A side view of a catheter removal procedure according to the present invention is illustrated.

[0171] Fig.87 A side view of a catheter removal procedure according to the present invention is illustrated.

[0172] Fig.88 A side view of a catheter removal procedure according to the present invention is illustrated.

[0173] Fig.89 A side view of a catheter removal procedure according to the present invention is illustrated.

[0174] Fig.90 A side view of a catheter removal procedure according to the present invention is illustrated.

[0175] Fig.91 A side view of a catheter removal procedure according to the present invention is illustrated.

[0176] Fig.92 A side view of a catheter removal procedure according to the present invention is illustrated.

[0177] Fig.93 A side view of a catheter removal procedure according to the present invention is illustrated.

[0178] Fig.94 A side view of a catheter removal procedure according to the present invention is illustrated.

[0179] Fig.95 A side view of a catheter removal procedure according to the present invention is illustrated.

[0180] Fig.96 A side view of a catheter removal procedure according to the present invention is illustrated.

[0181] Fig.97 A side view of a catheter removal procedure according to the present invention is illustrated.

[0182] Fig.98 A side view of a catheter removal procedure according to the present invention is illustrated.

[0183] Fig.99 A side view of a catheter removal procedure according to the present invention is illustrated.

[0184] Fig.100 A side view of a catheter removal procedure according to the present invention is illustrated.

[0185] Fig.101 A perspective view of a removal catheter device according to the present invention is illustrated.

[0186] Fig.102 A perspective view of a removal catheter device according to the present invention is illustrated.

[0187] Fig.103 A perspective view of a removal catheter device according to the present invention is illustrated.

[0188] Fig.104 A perspective view of a removal catheter device according to the present invention is illustrated.

[0189] Fig.105 A perspective view of a removal catheter device according to the present invention is illustrated.

[0190] Fig.106 A perspective view of a removal catheter device according to the present invention is illustrated.

[0191] Fig.107 A perspective view of an example of valve cutting is shown.

[0192] Fig.108 A perspective view of a removal catheter device according to the present invention is illustrated.

[0193] Fig.109 A perspective view of a removal catheter device according to the present invention is illustrated.

[0194] Fig.110 and Fig.111 Illustrated are views of a snare and removal system according to the present invention.

[0195] Fig.112 and Fig.113 A view of a basket tip according to the present invention is illustrated.

[0196] Fig.114 and Fig.115 Illustrated is a view of a snare loop according to the present invention.

[0197] Fig.116 A snare loop according to the invention is illustrated.

[0198] Fig.117 A snare loop according to the invention is illustrated.

[0199] Fig.118 A portion of a snare loop according to the invention is shown.

[0200] Fig.119 A portion of a snare loop according to the invention is shown.

[0201] Fig.120 and Fig.121 A snare catheter tip according to the present invention is illustrated.

[0202] Fig.122 A snare catheter tip according to the present invention is illustrated.

[0203] Fig.123 A snare catheter tip according to the present invention is illustrated.

[0204] Fig.124 A snare catheter tip according to the present invention is illustrated.

[0205] Fig.125 and Fig.126The handle of a snare catheter according to the present invention is illustrated.

[0206] Fig.127 , Fig.128 , Fig.129 and Fig.130 A snare and a method of removing a valve clip according to the present invention are illustrated.

[0207] Fig.131 , Fig.132 and Fig.133 A removal system configured for via-guidewire access is illustrated.

[0208] Fig.134 , Fig.135 , Fig.136 and Fig.137 A chord expander according to the present invention is illustrated.

[0209] Fig.138A A removal system with an alternative wire path is illustrated.

[0210] Fig.138B A removal system with an alternative wire path is illustrated.

[0211] Fig.139 A removal system is shown with a pigtail line on the distal end of a basket according to the present invention.

[0212] Fig.140 and Fig.141 A stretchable basket according to the present invention is illustrated.

[0213] Fig.142 A method of applying force to a valve clip according to the present invention is illustrated.

[0214] Fig.143A An alternative basket shape according to the invention is illustrated.

[0215] Fig.143B An alternative basket shape according to the invention is illustrated.

[0216] Fig.144 An alternative removal system without a basket according to the present invention is illustrated.

[0217] Fig.145 An alternative removal system according to the present invention is illustrated having a cutting element as part of the snare loop.

[0218] Fig.146 An alternative removal system according to the present invention is illustrated having a cutting element as part of the snare loop.

[0219] Fig.147 A side view of a snare catheter according to the present invention is shown.

[0220] Fig.148 The diagram shows the Fig.147 Front view of the snare catheter.

[0221] Fig.149 The diagram shows the Fig.147 Cross-sectional view of a snare catheter.

[0222] Fig.150 The diagram shows the Fig.147 Side view of the handle of the snare catheter.

[0223] Fig.151 The diagram shows the Fig.147 View of the distal tip of the snare catheter.

[0224] Fig.152 The diagram shows the Fig.147 View of the distal tip of the snare catheter.

[0225] Fig.153 Illustrated is a view of the distal tip of a snare catheter according to the present invention.

[0226] Fig.154 Illustrated is a view of the distal tip of a snare catheter according to the present invention.

[0227] Fig.155 A snare loop and an internal control member according to the present invention are illustrated.

[0228] Fig.156 A front view of a cutting ring catheter according to the present invention is shown.

[0229] Fig.157 The diagram shows the Fig.156 Side view of the cutting ring catheter.

[0230] Fig.158 A front view of a cutting ring catheter according to the present invention is shown.

[0231] Fig.159 The diagram shows the Fig.158 Side view of the cutting ring catheter.

[0232] Fig.160 A cross-sectional view of an electrode according to the present invention is shown.

[0233] Fig.161 A cross-sectional view of an electrode according to the present invention is shown.

[0234] Fig.162 A cross-sectional view of an electrode according to the present invention is shown.

[0235] Fig.163 A cross-sectional view of an electrode according to the present invention is shown.

[0236] Fig.164 A cross-sectional view of an electrode according to the present invention is shown.

[0237] Fig.165 A cross-sectional view of an electrode according to the present invention is shown.

[0238] Fig.166 A perspective view of an electrode according to the present invention is shown.

[0239] Fig.167 A front view of an electrode of a cutting ring according to the present invention is shown.

[0240] Fig.168 A side view of a cutting ring having multiple electrodes according to the present invention is illustrated.

[0241] Fig.169 The diagram shows the Fig.168 Side view of the cutting ring.

[0242] Fig.170 The diagram shows the Fig.168 Top view of the cutting ring.

[0243] Fig.171 A top view of a cutting ring having a plurality of electrodes according to the present invention is shown.

[0244] Fig.172 A side view of an open or hook shaped cutting loop according to the present invention is shown.

[0245] Fig.173 A side view of a capture basket catheter according to the present invention is illustrated.

[0246] Fig.174 The diagram shows the Fig.173 View of the distal tip of the capture basket catheter.

[0247] Fig.175 The diagram shows the Fig.173 View of the distal tip of the capture basket catheter.

[0248] Fig.176 A side view of a catheter hub according to the present invention is shown.

[0249] Fig.177 The diagram shows the Fig.176 Cross-sectional view of a catheter hub.

[0250] Fig.178 A loading tool according to the invention is illustrated.

[0251] Fig.179 The diagram shows the Fig.176 The catheter hub.

[0252] Fig.180 A heart valve therapy removal system according to the present invention is illustrated.

[0253] Fig.181 A side view of a tendon tool according to the present invention is shown.

[0254] Fig.182 A side view of a tendon tool according to the present invention is shown.

[0255] Fig.183 A side view of a tendon tool according to the present invention is shown.

[0256] Fig.184 A side view of a tendon tool according to the present invention is shown.

[0257] Fig.185 A side view of a tendon tool according to the present invention is shown.

[0258] Fig.186 A side view of a tendon tool according to the present invention is shown.

[0259] Fig.187 A side view of a cutting element of a tendon tool according to the present invention is illustrated.

[0260] Fig.188 A side view of a cutting element of a tendon tool according to the present invention is illustrated.

[0261] Fig.189 A side view of a cutting element of a tendon tool according to the present invention is illustrated.

[0262] Fig.190 A side view of a cutting element of a tendon tool according to the present invention is illustrated.

[0263] Fig.191 A method of using a tendon tool according to the present invention is illustrated.

[0264] Fig.192 A method of using a tendon tool according to the present invention is illustrated.

[0265] Fig.193 A method of using a tendon tool according to the present invention is illustrated.

[0266] Fig.194 A method of using a tendon tool according to the present invention is illustrated.

[0267] Fig.195 A method of using a tendon tool according to the present invention is illustrated.

[0268] Fig.196 A method of using a tendon tool according to the present invention is illustrated.

[0269] Fig.197 A method of using a tendon tool according to the present invention is illustrated.

[0270] Fig.198 A method of using a tendon tool according to the present invention is illustrated.

[0271] Fig.199 A method of using a tendon tool according to the present invention is illustrated.

[0272] Fig.200 A method of using a tendon tool according to the present invention is illustrated.

[0273] Fig.201 A power supply and an interface according to the present invention are illustrated.

[0274] Fig.202 A power supply and an interface according to the present invention are illustrated.

[0275] Fig.203 A heart valve clip according to the present invention is illustrated.

[0276] Fig.204 A heart valve clip according to the present invention is illustrated.

[0277] Fig.205 A heart valve clip according to the present invention is illustrated.

[0278] Fig.206 A heart valve clip according to the present invention is illustrated.

[0279] Fig.207 A heart valve clip according to the present invention is illustrated.

[0280] Fig.208 A heart valve clip according to the present invention is illustrated. DETAILED DESCRIPTION

[0281] Specific embodiments of the present invention will now be described with reference to the accompanying drawings. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein; rather, these embodiments are provided so that the present disclosure will be thorough and complete and the scope of the present invention will be fully conveyed to those skilled in the art. The terms used in the detailed description of the embodiments illustrated in the accompanying drawings are not intended to limit the present invention. In the accompanying drawings, the same reference numerals refer to the same elements.

[0282] The present invention generally relates to devices and methods for removing heart valve treatment devices via a transcatheter procedure. While current methods for removing heart valve treatment devices require open-chest surgery, the techniques and devices of the present invention utilize transcatheter devices and procedures that are less invasive and can provide better patient outcomes.

[0283] For purposes of this application, the phrase "heart valve therapy" shall be defined as any device and / or method for therapeutically treating a heart valve, such as a leaflet clip, sutures, artificial chordae, or any other device or method associated with the treatment of a heart valve and associated leaflets. Although particular embodiments may discuss or illustrate specific heart valve therapy devices or methods, such as a heart valve leaflet clip, it should be understood that use with any heart valve therapy is specifically contemplated. Therefore, none of the embodiments discussed in this specification should be limited solely to use with a heart valve leaflet clip.

[0284] Figure 1-Figure 13 Various aspects of one embodiment of a removal catheter 100 for removing a leaflet heart valve treatment device (such as the valve clip 40 or similar heart valve treatment device) according to the present invention are illustrated. The removal catheter 100 generally includes an expandable capture basket 102 and a cutting element or cutting ring 104 disposed near the top opening of the basket 102. Figure 7 and Figure 8 As shown, the basket 102 is placed over the implanted valve clip 40 so that the top of the basket 102 and the cutting ring 104 are positioned between the clip 40 and the leaflets 22, 24 on the atrial side. Next, the top opening of the basket 102 is closed or its diameter is reduced, and the cutting ring 104 is activated to cut the leaflet tissue surrounding the valve clip 40 (e.g., providing radiofrequency energy), thereby releasing the clip 40 from the valve 20. Finally, the capture basket 102 containing the valve clip 40 is retracted and removed from the patient. Further details and variations of the removal catheter 100 are discussed below, followed by exemplary means and methods for removing various heart valves (e.g., the mitral valve 20 or the tricuspid valve 15).

[0285] As in Figure 9-11 As best seen in FIG. 1 , the removal catheter 100 includes an inner control member 108 positioned within an outer tubular sheath 110 (in FIG. Fig.11 10). The inner control member 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 inner control member 108 so that when the inner control member 108 moves longitudinally or rotationally relative to the outer tubular sheath 110, the basket 102 and the cutting ring 104 move similarly.

[0286] Reference Fig.11In one embodiment, a plurality of rings 102A are positioned around the circumference of the top opening of the basket 102, and a wire or lacing ring 106 is arranged to pass through the rings 102A. Fig.13 As best seen in , cinch ring 106 may be comprised of an annular wire (e.g., circular, oval, etc.) and an elongated straight portion 106A that may be connected to control member 108 via a connecting sleeve 112. Connecting sleeve 112 may be clamped, welded, have adhesive / epoxy applied, or any combination thereof to attach sleeve 112 to control member 108. Alternatively, cinch ring 106 may be connected to control member 108 via welding or adhesive alone.

[0287] The cutting ring 104 can similarly be formed into a generally annular shape (e.g., circular, oval, saddle-shaped, etc.) and can include an elongated straight portion 104E, which can also be connected to the control member 108 via a connecting sleeve 112. In this regard, both the elongated straight portions 106A and 104E are located within the connecting sleeve 112, as shown in FIG. Fig.12 as seen in the cross-sectional view.

[0288] In one embodiment, when RF energy is supplied to the cutting ring 104, the cutting ring 104 cuts tissue. In one example, the RF power source is connected to the proximal end of the control member 108, which is composed of a conductive metal and thus transmits RF energy to its distal end and then into the attached cutting ring 104. To complete the RF energy loop with the cutting ring 104, a second RF electrode may be connected to the RF power source and may be attached to the patient elsewhere via an electrode pad (monopolar RF system), the second electrode may be included elsewhere on the removal catheter 100 (bipolar RF system), or a second insulated wire may be included on the control member 108 (bipolar RF system). RF energy is a technical term established to describe high frequency alternating current (having a frequency ranging from about 300 kHz to 3 MHz or more narrowly 100 kHz to 10 MHz).

[0289] It may be desirable to isolate the RF energy loop of the cutting ring 104 from both the cinch ring 106 and the basket 102 to prevent other tissue in the heart from being damaged. This can be accomplished by using electrical insulators as specific locations on the device. For example, a wire insulator 114 can be placed on the elongated straight portion 106A (or optionally the entire cinch ring 106) to electrically isolate the cinch ring 106 from the RF current of the control member 108, such as Fig.12 The cross-sectional view and Fig.13 As seen in the exploded view of .

[0290] exist Figure 14-Figure 30In other examples as seen in , the cutting ring 104 may have different structures, shapes, and electrical insulators to help reduce the risk of the non-insulated portion 104B (i.e., the portion that cuts the leaflet tissue) contacting the tightening wire 106 or any portion of the basket 102. For example, Fig.14 The cutting ring 104 is illustrated wherein the non-insulated portion 104B of the wire is positioned opposite the elongated straight portion 104E, adjacent the insulating portion 104A on each side. In this example, the non-insulated portion 104B may be as shown. Fig.21 extends completely around the circumference of the line as seen in Fig. 20 Only the inner side of the ring 104 is exposed as seen in FIG.

[0291] like Fig.14 As seen, the non-insulating portion 104B may include only a single area (e.g., between about 1 mm and 5 mm) where the underlying line 104C is exposed, or may include multiple discrete non-insulating portions 104B (e.g., 2-10 portions 104B) having relatively small lengths (e.g., between about 1 and 5 mm).

[0292] In all cutting ring embodiments, a majority of the surface of the cutting ring 104 is insulated. To create the non-insulated portion 104B, the cutting ring insulator 104A can be selectively removed (for wires with existing insulation) to expose the cutting ring conductive wire 104C in a manner that will allow the cutting ring conductive wire 104C to contact and deliver RF cutting energy to the leaflet tissue bridge when the cutting ring conductive wire 104C contacts tissue near the heart valve treatment. Alternatively, the insulator 104A can be added (e.g., by dipping, spraying, or similar techniques), and the non-insulated portion 104B can be created by masking the desired area before the insulator is applied.

[0293] It will be appreciated that the non-insulated portion 104B may be oriented in any number of ways, such as, for example, on the inner / outer surface of the cutting ring 104 and on the bottom (ie, atrial) side of the ring 104 .

[0294] The lower wire 104C of the cutting ring 104 may be made of a shape memory metal (e.g., Nitinol) or a similar conductive metal (e.g., stainless steel or copper). Fig.23 , Fig.24 and Fig.25 As seen in the cross-sectional view of , the lower line 104C may have a rectangular cross-section, a circular cross-section, a triangular cross-section, and a square cross-section, respectively.

[0295] The cutting ring 104 can also be made of one or more wires, such as a first wire 104C and a second wire 104D. The two wires can be made of similar materials (e.g., nitinol, stainless steel, copper, silver, or the like), or each wire can be made of a different material. For example, one wire 104C can be made of a metal that conducts electrical current better (e.g., stainless steel, silver, or copper), while the other wire 104D can be made of a material that maintains its shape between a compressed configuration and an expanded configuration (e.g., a shape memory metal such as nitinol). The multiple wires can be electrically isolated or insulated from each other or independently electrically isolated or insulated. Different cross-sectional shapes can further be used with the same or different materials, such as Figure 16-18 and Figure 26-Figure 28 As seen in.

[0296] In another example, the cutting loop 104 can be formed from a single wire that includes multiple strands of different wire materials. Fig.19 and Fig.29 A core 104D composed of shape memory strands is illustrated, with a plurality of conductive strands 104C positioned circumferentially around the core 104D. In another example, Fig.30 Includes alternating shape memory strands 104D and conductive strands 104C. In this regard, the different strands can provide the desired current conduction and the ability to expand from a compressed configuration to a predetermined loop shape. The multiple wires can be electrically isolated or insulated from each other or independently electrically isolated or insulated. Either of these two cable examples can have 2-49 or more strands therein.

[0297] The cutting ring may have a variety of different shapes, structures, and electrically insulating patterns to facilitate tissue removal around the clip 104, which may, for example, provide additional length and / or a predetermined path or geometry. Fig.101 An alternative example of a cutting ring 316 having a "saddle" or wavy shape is illustrated, wherein each side portion 314, 315 of the ring sinks downward (i.e., in a proximal direction toward the catheter 100) and its free end 311 curves upward (i.e., in a distal direction away from the catheter 100). The side portions 314, 315 can be insulated, and the middle portion 311 and end portions 312, 313 can be insulated. The middle portion 311 contacts or engages tissue on one side of the ring 316, while the end portions 312, 313 contact or engage tissue on the other side. The side portions 315, 316 can curve outward to increase the width of the ring 316, curve inward to decrease the width of the ring 316, or can be relatively straight to maintain a uniform width (i.e., a circular or oval shape) of the ring 316.

[0298] Many different tissue engagement methods can be facilitated by the cutting ring 316, such as the end portions 312, 313 can first be electrically activated in unison while the cutting ring 316 applies axial tension to the tissue structure, thereby effectively cutting the tissue in contact with those portions 312, 313 and partially releasing the leaflet clip 40. Next, the free end portion 311 can be activated to cut tissue adjacent to it and complete the cutting of the leaflet clip 40 from the leaflet. Alternatively, all three portions 311, 312 and 313 can be activated simultaneously. Axial tension on the ring 316 can be applied before, during, or intermittently to control the engagement of the ring 316. This embodiment illustrates three non-insulated cutting areas or portions 311, 312 and 313, but there can be any number of cutting elements (e.g., 1-100), including the entire ring 316 as a continuous non-insulated cutting member.

[0299] The additional length included along the side portions 314, 315 can accommodate other tissue structures present around the leaflet clip 40. The additional length of the side portions 314, 315 can also be deformable so that when tension is applied through the elongated straight portion 317, the side portions 314, 315 will straighten and cause the ring 316 to stretch into an approximately axial configuration. During this stretching and elongation, the axial distance between the free end portion 311 and the proximal end portions 312, 313 increases, thereby accommodating greater changes in both diameter and the angle of approach to the clip. Any such non-linear path can also achieve this and is therefore contemplated in the present disclosure, but is not shown herein for the sake of brevity.

[0300] Fig.102 A delivery mechanism is illustrated having a previously described cutting ring 316 and an outer tubular sheath 320 that is generally similar to the outer tubular sheath of the previously described sheath 110. However, the outer tubular sheath 320 also includes a sheath cutting portion 321 disposed at and circumferentially around the distal end of the sheath 320. The sheath cutting portion 321 can have a similar construction and properties as the non-insulated portion of the previous cutting ring previously described, and can be similarly electrically actuated to provide an additional area of ​​tissue that can be cut. The outer tubular sheath 320 can be used in conjunction with any other device disclosed and can be used in conjunction with the method that best facilitates the leaflet clip removal procedure. Similarly, all of the non-insulated cutting portions 311, 312, 313, and 321 can be activated individually at different times or simultaneously together.

[0301] Fig.103 The heart valve tissue model 330 with the tendon 21 and the leaflet positioning clip 40 is shown. Fig.102This figure illustrates one example of how devices 320, 316 engage tissue on all sides of clip device 40 in a manner positioned to sever attached tissue structures from clip device 40.

[0302] exist Fig.104 Another exemplary embodiment of a cutting ring 350 can be seen in FIG. 1 , 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). In addition, the side ring portions 314, 315 are shown as being bent laterally outward, thereby increasing the width of the ring 350. The ring 350 can have a variety of different insulating and non-insulating portions, such as Figure 101-Figure 103 Those described in (i.e., multiple discrete non-insulated sections or the entire ring is non-insulated).

[0303] Fig.105 and Fig.106 Another embodiment of a removal device 360 ​​is illustrated that is substantially similar to removal device 100, but further includes a first cutting ring 104 and a second cutting ring 316. In some cases, it may be difficult for a physician to see exactly what tissue should be cut to completely remove the cardiac treatment device. Two or more rings may allow a first series of cuts to be made to valve tissue, and then allow one or more second cuts (e.g., via tightening the first cutting ring) to completely remove the cardiac treatment without requiring significant repositioning of the rings. In contrast, a single cutting ring may need to be moved, longitudinally repositioned, and / or rotated to completely remove the cardiac treatment.

[0304] In this example, the first cutting ring 104 has a slightly larger diameter (e.g., similar to the opening of the basket 104), and the second cutting ring 316 has a smaller diameter than the first cutting ring 104 and is positioned further away from the basket 104. Thus, the second ring 316 can be placed against the valve leaflets and / or chordae tendineae (e.g., at Fig.107 370A through the anterolateral chordae tendineae and 370B through the posteromedial chordae tendineae), and the cutting portions 311, 313, and 314 can be activated to perform a first series of cuts on the tissue. This first series of cuts may not cut all of the tissue, however, 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 Fig.107 Cut 370C on the atrial side of clip 40).

[0305] Although in Fig.105 and Fig.106 Specific embodiments of cutting rings 104, 316 are shown in FIG, but any combination of any rings described in this specification may be used in this manner. For example, Fig.108 An embodiment 180 is shown with two rings 316 having similar shapes and configurations. Thus, either ring may have a different number and pattern of cutting portions, and those cutting portions may all be activated simultaneously or at different times / patterns. In one example, both cutting rings 104, 316 are connected to the same circuit (e.g., internal control member 108). Alternatively, each ring 104, 316 (or alternatively each set of cutting portions) may have its own circuit (e.g., separate conductive wires) that allows activation independent of another cutting ring. Alternatively, three or four cutting rings may be used alternately. The cutting rings may all be connected to the same removal catheter, or one or more rings may be connected to a catheter independent of the other cutting rings and / or basket 104. In some embodiments, one or more cutting rings may be located on the ventricular side of the valve, while one or more cutting rings may be located on the atrial side of the valve.

[0306] If the cinch ring 106 has an insulating coating completely along its length, the cutting ring 104 can be directly on top of the cinch ring 106, thereby contacting the ring. The cutting ring 104 can also be longitudinally spaced apart from the cinch ring 106, such as between about 0 mm and about 15 mm.

[0307] Preferably, the internal control member 108 (in Figure 11-13 The inner control member 108 is preferably a proximal handle (best seen in Figure 1) that is flexible enough to navigate through the vasculature while having sufficient column strength to push the basket 102 and cutting ring 104 out of the outer tubular sheath 110, capable of effectively delivering RF energy from the proximal handle to the cutting ring, is insulated to prevent leakage of current to the blood stream, and has good torque response so the user can rotate the basket and ring as the inner control member 108 is deployed in and around the valve.

[0308] In a preferred embodiment, the internal control member 108 consists of an internal control probe that is bonded or welded to a more flexible internal control cable, which is then joined to the cutting ring conductive wire tail using a distal connector. In a preferred embodiment, the internal control probe, the internal control cable, the cutting ring conductive wire, and the distal connector are the same material (e.g., a steel alloy) to enable a secure welded joint and always effective current delivery. The internal control cable can be a laser cut tube, a stranded cable, a stranded cable tube, a coil, or a combination thereof. In another embodiment, the internal control cable can extend from the proximal handle to the cutting ring 104, and no internal control probe is required.

[0309] In the alternative, the inner control member 108 can be two separate wires; one of which is connected to the cinch ring 106 and the other to the cutting ring 104. With both inner control members disposed in the same single lumen of the outer tubular sheath 110, the basket 102 can first be deployed by advancing the inner basket control member distally until the basket cinch ring 106 is fully exposed. Then, the inner cutting ring control member can be advanced distally to deploy the cutting ring 104. Each ring can be rotated, advanced, or retracted by its respective control member. This provides greater freedom to the operator. The heart valve treatment can first be captured or surrounded by the cutting ring 104, and then the basket cinch ring 106 and basket 102 can follow. The cutting ring 104 can then be closed onto the leaflet tissue bridge by retracting the inner cutting ring control member. Once the cutting rings are closed on the tissue bridge, one of two steps can be taken: 1) the basket cinch wires 104 and basket 102 can then be closed by retracting the inner basket control member proximally, or 2) if the cutting ring 104 cannot reach the base of the heart valve treatment, 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 tissue on the atrial side of the heart valve treatment, the inner cutting ring control member is energized with RF power as it is retracted proximally into the outer delivery sheath 110. The inner cutting ring control member delivers cutting energy through the cutting ring 104 to only the cutting element.

[0310] The aforementioned internal control members may alternately be disposed in separate outer tubular sheaths or in separate lumens in the same sheath 110. This system may be designed so that each sheath may be placed in a separate orifice (i.e., on opposite sides of the heart valve treatment). Once both rings have captured the heart valve treatment, the same steps as described above are followed.

[0311] The control member insulator covering the outer surface of the inner control probe and the inner control member is preferably flexible enough so as not to interfere with the navigation of the delivery catheter through the valve orifice. It is also desirable to be as smooth as possible so that friction between the inner control member and the delivery catheter is minimized when the inner control member is pushed distally to deploy the basket and cutting ring within the left ventricle. For example, such an insulator may include a hydrophilic coating, a silicone coating, a Teflon-type coating, a polyolefin coating, a thermoformed or thermoset coating, or a fluoropolymer.

[0312] Returning to the basket 102, the length and diameter of the basket 102 can depend on the size of the heart valve treatment device or clip 40. For example, the basket 102 can have a length in the range of about 20 mm to about 50 mm and a diameter in the range of about 10 mm and 20 mm. Depending on the size of the leaflet clip 40 and the angle at which the basket 102 is intended to capture the clip 40, the diameter of the basket 102 can be adjusted accordingly. For example, the larger the interception angle relative to the top plane of the opening across the basket 102, the larger the diameter of the basket 102 should be. In other words, unless the basket 102 is intended to be located substantially directly below the clip 40, the basket 102 should expand to a diameter that is much larger than the diameter of the clip 40.

[0313] exist Fig.31 In one embodiment as seen in FIG. 1 , the basket 102 can be constructed of a plurality of braided wires. The wires can be constructed of a shape memory material and can be braided on a mandrel of the desired basket size and then heat set so that the braided shape returns to an expanded basket configuration after being compressed. The wires can be constructed of a shape memory material such as Nitinol or a non-shape memory material such as stainless steel. The wires can also have an insulating coating such as ETFE, polyimide, parylene, silicone, or the like. The benefit of a woven basket is that its behavior / performance can be changed by changing the wire diameter of the basket, the wire material of the basket, and / or the weave density (i.e., the pore size of the basket) while keeping the diameter and length of the basket fixed. The diameter and length design of the basket is primarily determined by the size of the intended heart valve treatment to be removed. The size, spacing, and number of the woven basket eyelets can also be adjusted and optimized. In one example, the holes 102B of the basket 102 have a diameter in the range of about 100 microns to about 4 millimeters when expanded.

[0314] The size of the wire is preferably small enough to allow it to be easily collapsed into and deployed from the delivery catheter during the procedure, but large enough to give the basket some rigidity so that it can be fully opened in the presence of valve chordae or other structures. The pore size of the basket can vary on a woven basket, depending on design intent. Generally, the pore size should be smaller than the length, width, or height of the heart valve treatment to avoid embolization through the basket after the heart valve treatment is cut. Weaving a basket with very small pores can help filter and capture any debris generated during the tissue cutting process.

[0315] One benefit of coating the metal basket is to ensure that the electrical energy is concentrated in the cutting element and not distributed across the entire metal structure of the basket and not distributed into the blood pool. A second benefit of coating is that it can also reduce friction and therefore can facilitate easier capture of the heart valve therapy within the basket. If the basket is too rough or there are too many edges inside the basket, the heart valve therapy may not be fully located within the basket as desired. Adding a slippery coating or lubricious layer to the inner surface of the capture basket can enable easier capture of the heart valve therapy.

[0316] exist Fig.32 , Fig.33 and Fig.34 , the removal catheter 150 includes a basket 152 constructed of a polymer such as silicone, PET, polyester, nylon, polypropylene, Kevlar, or a similar material that can be folded or pleated into a radially compressed configuration. The basket 152 can be formed with a plurality of apertures sized to prevent passage of both the leaflet clip 40 and other biological material (e.g., about 100 microns to about 4 millimeters in diameter) that may be detached from the procedure. The basket 152 can have similar dimensions to the basket 102 discussed previously. The top opening of the basket 152 can also include a plurality of loops or channels 152B sized to allow passage of the cinch ring 106 so that the basket 152 can be closed during the procedure.

[0317] Construction of the polymer basket 152 can be accomplished using a braid, mesh, woven, knitted, or via injection molding. The possible basket shapes and material combinations are endless, and only a few are described here. It is important to select a polymer material that has high heat resistance, low moisture absorption, and is durable enough to collapse into the outer sheath multiple times. Silicone tends to best meet all of these performance requirements. In the case where the basket is made of silicone, it can be molded into the basket shape as a separate component, or molded directly onto the ring structure. If the basket is made from a flat sheet of silicone, it can be cut into the designed pattern and sewn to the ring to form the desired shape.

[0318] Depending on the material selected, the size and spacing of the holes 152A can be adjusted. Typically, the hole diameter can be smaller than the length, width, or height of the heart valve treatment to avoid embolization of the heart valve treatment through the basket after it is cut. Using a basket with very small holes can help filter and capture any debris generated during the tissue cutting process. Designing a basket with holes also allows some blood to flow through the basket; this helps improve operator control of the basket by minimizing the forces applied to the basket due to pumping blood (i.e., it minimizes the "parachute effect"). The polymer basket can be constructed with or without eyelets; if eyelets are present as shown, it will be slidably mounted to the basket tightening ring. If there are no eyelets, it will be securely fixed to the basket tightening ring.

[0319] Because the polymer basket 152 is non-conductive, other embodiments are possible in which the cutting ring 104 of the removal catheter 160 also acts as a cinch ring, such as Fig.35 and Fig.36 The basket 152 may be attached directly to the insulating portion 104A of the cutting ring 104 (or alternatively, the insulating portion may be formed directly around the non-insulated wire), thereby leaving the exposed, non-insulated portion 104B open where the leaflet cutting is performed.

[0320] Similar "single ring" embodiments are possible for other shapes and materials. For example, Fig.37 Illustrated are multiple polymer or fiber filaments braided together to form a flexible basket shape and relatively large pores (eg, about 0.5 mm to about 4 mm). Fig.38 Illustrated are a plurality of polymer or fiber fabrics woven into a fabric basket 164 having relatively small pores (eg, about 0.5 mm to about 4 mm). Fig.39 Illustrated are polymer sheets sewn to form basket 166. In any of these embodiments, cutting ring 104 can be exposed so that non-insulated portion 104B can cut through valve leaflets after being cinched.

[0321] In other embodiments, the basket may be partially or completely constructed from a laser cut basket. Fig.40 and Fig.41 A plurality of vertical, laser-cut ribs are illustrated having eyelets disposed along their length to allow a plurality of wires or polymer filaments to be braided or woven through the eyelets. Fig.42 and Fig.43 A laser cut basket shape constructed entirely of laser cut shape memory metal (eg, shape memory metal tube or sheet) is illustrated.

[0322] The benefit of laser cutting the basket is that its behavior / performance can be changed by changing the tube size and / or the cutting pattern / density (i.e., the aperture of the basket) while keeping the diameter and length of the basket fixed. The diameter and length design of the basket is primarily determined by the size of the intended heart valve treatment to be removed. The size, spacing, and number of laser cut eyelets can also be adjusted and optimized. The material used preferably has shape memory properties (like Nitinol) to allow the laser cut portion of the tube to be expanded and shaped. The use of a material with shape memory is to enable the basket to be repeatedly collapsed and opened back to the same shape. The wire size is preferably small enough to allow it to be easily collapsed into and deployed from the delivery catheter during surgery, but large enough to give the basket some rigidity so that it can be fully opened in the presence of valve chordae or other structures.

[0323] The pore size of the basket can be varied in the laser cut design by changing the cutting pattern to achieve the desired result. For example, the pore size can vary from about 100 microns to about 4 millimeters. Generally, the pore size should be smaller than the length, width, or height of the heart valve treatment to avoid embolization of the heart valve treatment through the basket after it is cut. A unique benefit of laser cutting the basket is that the pore size and spacing can vary throughout the length of the basket. For example, the proximal open side of the basket can have large pores with a certain pattern density. The pore size and pattern density can become smaller and denser towards the distal end of the basket.

[0324] Any of the embodiments of the basket described in this specification may further include an outer covering to help collect any debris or embolic material released during the procedure. Such an outer covering may include a solid or perforated polymer sheet, a woven fabric, a tubular shape formed from relatively small, finely woven metal wires, or similar materials. In a particular embodiment, the interior of the basket may have a non-conductive lining, film, or coating (e.g., silicone) on its inner surface to help prevent electrical conduction with the cutting element 104.

[0325] In one embodiment, the removal catheter 100 may include a proximal handle portion 170, such as Fig.44 and Fig.45 The handle 170 includes an outer housing 172 and a slide member 174 configured to slide within a longitudinal slot within the housing 172. The housing 172 can be connected to the outer tubular sheath 110, while the slide member 174 is connected to the inner control member 108, thereby allowing the user to adjust the position of the slide member 174 with their thumb to cause corresponding longitudinal movement of the inner control member 108, the basket 102, and the cutting ring 106.

[0326] Optionally, the handle 170 may also include a fluid connection port 176 (e.g., a Luer port) that communicates with the interior of the 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, thereby amplifying the tissue cutting effect and minimizing energy loss to the blood pool around the area. The amount and timing of such fluid can be determined by the physician (e.g., via a syringe) or via an electrically actuated pump mechanism 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).

[0327] like Fig.45 As shown, the handle 170 may also include a locking mechanism 173 near the distal end of the housing 172 that locks the inner control member 108 in place relative to the outer tubular sheath 110. For example, the locking mechanism 173 may include a handle 177 that is configured to rotate a cam member 178 that surrounds the proximal end of the inner control member 108. When the handle 177 rotates the member 178, the cam member 178 creates an interference fit with the interior of the housing 172, thereby 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 inner control member 108 so that it can slide longitudinally within the handle 170.

[0328] Fig.46An embodiment of a removal catheter 100 with a current overflow hole 111 in the outer tubular sheath 110 is illustrated. This embodiment is most beneficial for embodiments having a single cinch and cutting ring and a polymer or minimally conductive basket 102. When the cutting element 104 and the fixed basket 102 are retracted into the outer tubular sheath 110 to begin cutting the leaflet tissue, the distal end of the outer tubular sheath 110 can be sealed from the blood pool. If this occurs after the tissue has been cut, the current delivered to the cutting element 104 is no longer transmitted to the tissue or blood, but instead transmits heat and / or electricity through the basket 102 and can damage it. The current overflow hole 111 in the outer tubular sheath 110 can ensure that the cutting element 104 is always in communication with the blood pool, even after the cutting has been completed. In this way, the current will choose to flow through the blood to the opposing RF electrode attached elsewhere on the patient instead of the basket.

[0329] Alternatively, wire 113 may be attached to internal control member 108 to ensure that the current path always involves the blood pool, even after the cut has been completed, such as Fig.47 10. The wire 113 is preferably designed to be long enough to always protrude from the distal end of the outer tubular sheath 110, even when the basket 102 is completely collapsed inside the outer tubular sheath 110. It will also preferably have a very small exposed metal area at the very distal tip, and the rest will be insulated. In this way, when the cut is completed, the current will choose to flow through the lower resistance wire and flow to the blood, rather than flowing through the higher resistance basket 102 (e.g., silicone).

[0330] Figure 48-Figure 53 A side view of a removal catheter 100 with its basket 102 deployed and tightened is shown. Fig.48 1 , the basket 102, cinch ring 106, and cutting ring 104 are all positioned within an outer tubular sheath 110. As can be seen in this figure, these components are radially compressed to a relatively small diameter to allow passage through a patient's blood vessel (keeping them compressed in the outer tubular sheath enables passage through smaller holes and also between multiple clips).

[0331] exist Fig.49 In the embodiment of the present invention, the inner control member 108 is advanced distally (e.g., via the sliding member 174), causing the basket 102 to begin to leave the outer tubular sheath 110 and expand radially. This distal movement continues until both the basket 102 and the cutting ring 104 have been deployed and fully expanded outside the sheath 110, as in Fig.50 Visible in.

[0332] Fig.51 and Fig.52The inner control wire 108 is shown retracted, causing both the tightening ring 106 and the cutting wire 104 to retract and close radially in diameter. Typically, the RF energy will be activated during this time so that when the cutting wire 104 closes, it cuts the tissue of the valve leaflet. When the cutting ring 104 is fully pulled into the outer tubular sheath 110, the RF current is deactivated. This can be achieved in a variety of different ways. For example, the sliding member 174 of the handle 170 previously described may include a position switch that turns the RF energy on / off at a predetermined longitudinal position. Alternatively, a manual on / off switch may be included on the handle 170 or the RF power source.

[0333] To assist in determining when to manually turn off the RF energy, a radiopaque marker can be placed at the distal end of the outer tubular sheath 110. When the physician performs a tissue bridge cut, they will place their eyes on a fluorescent screen. Since tissue is not usually visible on fluoroscopy, it can be useful to provide the operator with a visual indicator on the catheter 100 indicating that the tissue bridge has been cut. During the cutting process, the internal control member 108 and the cutting ring 104 are retracted into the sheath 110, and the radiopaque marker is positioned so that when the operator sees the entire cutting ring 104 on the proximal side of the radiopaque marker under fluoroscopy, the tissue bridge has been cut. This is not only a useful visual indicator for the operator, but it also makes the operation safer. Once the cutting ring 104 has passed through the radiopaque marker, the RF cutting energy can be terminated immediately by the operator to prevent any unintended heating caused by applying power longer than required.

[0334] Finally, the opening of the basket 102 is almost completely tightened closed, and the positioning of the inner control member 108 can be optionally locked in place (e.g., using a locking mechanism 173 on the handle 170). The basket 102 can be maintained outside the outer tubular sheath 110 and pulled into a larger guide catheter used during the procedure.

[0335] The present invention includes various methods or approaches for removing a heart valve treatment, such as valve clip 40. For example, Figure 56-Figure 61 A removal procedure is shown in which the atrial septum 18 is passed through to access the mitral valve 20. Although exemplary access methods and procedures are described, it should be understood that variations are possible based on known catheter access techniques. In addition, these access techniques may be used with any embodiment of the present specification.

[0336] In one embodiment, Figure 56-Figure 61 The mitral valve access procedure may include an inner control member 108, an outer tubular sheath 110, an inner steerable catheter 180, and an outer transseptal guide catheter 182, which may be Fig.54 Seen separately in Fig.551 and further discussed below. Three nested but independent curved and axially articulated catheters enable the removal device to be positioned anywhere in the heart, regardless of size or surgical location. However, other tools, sheaths, catheters, and similar devices may alternatively be used to guide the removal catheter 100, as described below.

[0337] First turn Fig.56 , the left atrium 12 can be accessed by advancing a transseptal wire or needle to the atrial septum 18 (e.g., via the inferior vena cava 17 or the superior vena cava 19), using the wire to pass through the atrial septum 18, and finally moving the wire into the left atrium. Next, a relatively large diameter external transseptal guide catheter 182 can be advanced over the wire and through the atrial septum 18 so that its distal end is located in the left atrium 12. Alternatively, the transseptal guide catheter 182 can be advanced through the atrial septum 18 without the use of any transseptal wire. The external transseptal guide catheter 182 can optionally have a predetermined bend or flexure, which can help to angle it from the inferior vena cava 17 toward the atrial septum 18.

[0338] The guidewire can be removed, and the inner steerable guide catheter 180 can then be advanced through the outer transseptal guide catheter 182 so that its distal end is located within the left atrium 12. The distal end of the inner steerable guide catheter 180 can be "steered" or deflected so that its distal opening is directed toward the desired position of the mitral valve 20. Because the guide catheter is independent of the outer transseptal guide catheter 182, the physician is able to guide the inner steerable guide catheter 180 to any position along the mitral valve 20 so that it can be rotated, advanced / retracted, or have a changed degree of deflection while keeping the outer transseptal guide catheter 182 in the same position.

[0339] In the example of a mitral valve 20 with a leaflet clip 40, the inner steerable guide catheter 180 is preferably directed toward either of the two valve openings on each side of the central clip 40 (see Figure 6 Once directed to the desired target location, removal catheter 100 is advanced through inner steerable guide catheter 180 and out its distal end, into left atrium 12, through a side opening of mitral valve 20, and into left ventricle 14, as shown. Fig.56 shown.

[0340] like Fig.57 and Fig.58As shown, the internal control member 108 is advanced distally through the outer tubular sheath 110 of the removal catheter 100, thereby causing the capture basket 102, the cinch ring 106, and the cutting ring 104 to be advanced out of the outer tubular sheath 110. Preferably, the capture basket 102, the cinch ring 106, and the cutting ring 104 are connected to the internal control member 108 so that they expand to an orientation in which the opening of the basket 102 and the opening of the cutting ring 104 are directed or pointed toward the leaflet clip 40. For example, the plane 103A of the opening of the basket 102 and the opening of the cutting ring 104 may be at an angle 103C (e.g., 90 degrees) between 45 degrees and 135 degrees relative to the axis 103B of the internal control member 108. The internal control member 108 may be rotated relative to the outer tubular sheath 110 (or alternatively, the entire removal catheter 100 may be rotated) so that the capture basket 102, the cinch ring 106, and the cutting ring 104 also rotate within the left ventricle 14. In this manner, the physician may align or orient the basket 102 to a desired position directly beneath the leaflet clip 40 .

[0341] Once the capture basket 102, cinch ring 106, and cutting ring 104 are deployed, the inner control member 108 (or alternatively, the outer tubular sheath 110) can be retracted proximally so that the leaflet clip 40 is positioned inside the basket 102, as shown in FIG. Fig.59 Preferably, both the cutting ring 104 and the tightening ring 106 are positioned above the leaflet clip 40, ie, between the leaflet clip 40 and the bottom of the surface adjacent to the leaflets 22 and 24.

[0342] Steering Fig.60 , the inner control member 108 is retracted proximally to partially retract the tightening ring 106 and the cutting ring 104. This causes the top opening of the basket 102 to close in diameter above the leaflet clip 40, and also causes the cutting ring 104 to reduce in diameter and engage between the atrial side portions of the leaflets 22, 24 and the leaflet clip 40.

[0343] like Fig.61 , RF energy is applied to the cutting ring 104 as the cutting ring 104 is proximally retracted and reduced in diameter. The non-insulated portion 104B presses against the portion of the 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. The RF energy to the cutting ring 104 is turned off. Preferably, the outer transseptal guide catheter 182 has a diameter large enough to allow the basket 102 to contain the leaflet clip 40 therein. However, if desired, the removal catheter 100, the inner steerable catheter 180, and the outer transseptal guide catheter 182 can all be retracted from the patient as a single unit.

[0344] It is further contemplated that after the leaflet clip 40 is removed, a prosthetic valve may be installed in the place of the mitral valve 20. If a guide wire is used during the removal procedure, it may also be used to advance and orient the valve delivery catheter to deliver and implant the prosthetic valve. An example of such a prosthetic valve replacement may be found in U.S. Pat. No. 8,579,964, entitled "Transcatheter Mitral Valve Prosthesis," the contents of which are incorporated herein by reference.

[0345] It is further contemplated that, following removal of the leaflet clip, a blood flow management device (such as a spacer, catheter, balloon, or other device) is in place of the valve and can be expanded in place of the valve to manage flow through the valve until such time as additional therapy (such as a replacement valve) can be delivered.

[0346] Figure 62-Figure 65 Another method of removing a leaflet positioning device (such as 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 a transapical sheath 184 is advanced through the incision, through the apex of the heart 10, and into the left ventricle 14, as shown. Fig.62 The removal catheter 100 is then advanced through the transapical sheath 184 so that the distal end of the outer tubular sheath 110 extends outwardly into the left ventricle 14 .

[0347] Steering Fig.63 , the inner control member 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 cinch ring 106 and cutting ring 104 preferably have a predetermined flexion (e.g., a heat set flexion / bend) that orients the top opening of the basket 102 and the opening of the cutting ring 104 toward the leaflet clip 40. For example, the plane of the top opening of the basket 102 and the opening of the cutting ring 104 can be in the range of 135 degrees to 225 degrees (e.g., about 180 degrees) relative to the axis of the inner control member 108. The inner control member 108 can be further rotated by the physician (or the entire removal catheter 100 can be rotated) to optimally align the cutting ring 104 and the basket 102 with the leaflet clip 40.

[0348] like Fig.64 As shown, the outer tubular sheath 110 is further advanced beyond the transapical sheath 184 so that the leaflet clip 40 is fully positioned within the basket 102. Fig.65As shown, the inner control member 108 is retracted proximally to cause the diameter of the tightening ring 106 and the cutting ring 104 to decrease. As the diameters of the rings 104 and 106 decrease, the top opening of the basket 102 decreases, thereby capturing the leaflet clip 40 therein. Alternatively, as the cutting ring 104 decreases, RF energy is activated and delivered to the ring 104, thereby allowing the non-insulated portion 104B to cut through the leaflet tissue immediately above the leaflet clip 40.

[0349] Preferably, capture basket 102, cinch ring 106, and cutting ring 104 are connected to internal control member 108 such that they extend to an orientation in which the opening of basket 102 and the opening of cutting ring 104 are directed or pointed toward leaflet clip 40. For example, plane 103A of the opening of basket 102 and the opening of cutting ring 104 may be at an angle 103C (e.g., 90 degrees) between 25 and 135 degrees relative to axis 103B of internal control member 108.

[0350] If the transapical sheath 184 has a large enough diameter, the outer tubular sheath 110 can be retracted proximally and the basket 102 containing the leaflet clip 40 can be withdrawn into the passage of the transapical sheath 184 for removal. If the basket 102 and leaflet clip 40 are too large for the transapical sheath 184, both the sheath 184 and the removal catheter 100 can be pulled out simultaneously.

[0351] Fig.66 and Fig.67 Another method of removing a heart valve treatment, such as a leaflet clip 40, via a transapical approach is illustrated. Fig.66 , the aortic guide catheter 186 is first positioned into the aorta 11 and advanced into the left ventricle 14. The aortic guide catheter 186 may have a fixed curve / shape, which helps the physician guide the distal end of the catheter 186 below the leaflet clip 40. Alternatively or additionally, the aortic guide catheter 186 may include a steerable mechanism to allow deflection in different directions.

[0352] Next, the removal catheter 100 is advanced through the aortic guide catheter 186 such that the distal end of the outer tubular sheath 110 extends from the distal end of the catheter 186 and into the left ventricle 14. The inner control member 108 is further advanced distally relative to the outer tubular sheath 110 such that the basket 102 and the cutting ring 104 are deployed, expanded, and positioned in the left ventricle 14. Both the opening of the basket 102 and the opening of the cutting ring 104 are oriented such that they face the leaflet clip 40. For example, the faces of the opening of the basket 102 and the opening of the cutting ring 104 may be within a range of about 300 degrees and 45 degrees (e.g., about 320 degrees) relative to the axis of the inner control member 108.

[0353] Reference Fig.67, the aortic guide catheter 186 is moved or deflected (in the case of a steerable catheter) such that the cutting ring 104 and the basket 102 are positioned above the leaflet clip 40. The inner control member 108 is retracted proximally within 110, causing the tightening ring 106 and the cutting ring 104 to decrease in diameter, thereby closing the top opening of the basket 102. As the diameter of the cutting ring 104 decreases, RF energy is delivered to the ring 104, allowing the non-insulated portion 104 to cut the area of ​​the leaflet tissue adjacent to the leaflet clip 40 and thereby release the leaflet clip 40 from the mitral valve 20. The basket 102 and the leaflet clip 40 can be retracted through the aortic guide catheter 186, or all of the catheters can be removed together as a single unit at the same time.

[0354] The present invention also contemplates the use of removal catheter 100 (or any of the variations described herein) on tricuspid valve 15, such as Fig.68 and Fig.69 First refer to Fig.68 , the external tricuspid valve guide catheter 188 is first delivered to the right atrium 16 by passing through the inferior vena cava 17 or the superior vena cava 19. The tricuspid valve guide catheter 188 can include a fixed curve at its distal end to help its distal end open toward the tricuspid valve 15, or can include a steering mechanism to enforce the opening of its distal end toward the tricuspid valve 15. Then, the internal intermediate catheter 189 can be advanced through the external tricuspid valve guide catheter 188 to provide a better angle toward the tricuspid valve 15. For example, the internal intermediate catheter 189 can have a fixed curve toward the tricuspid valve 15, or can include a steerable catheter mechanism to allow the physician to deflect the distal end of the catheter 189 toward the tricuspid valve 15.

[0355] Next, the removal catheter 100 can be advanced through the inner intermediate catheter 189 so that it exits the distal end of the inner intermediate catheter 189, enters the right atrium 16, passes through the tricuspid valve 15, and enters the right ventricle 13. Since the leaflet clip 40 is generally positioned in the middle of the valve 15 (e.g., similar to Figure 6 ), a side valve opening is formed, so the removal catheter 100 is preferably positioned on either side of the leaflet clip 40.

[0356] The inner control member 108 is further advanced distally relative to the outer tubular sheath 110, so that the basket 102 and the cutting ring 104 are deployed, expanded, and positioned in the right ventricle 13. Both the opening of the basket 102 and the opening of the cutting ring 104 are oriented so that they face the leaflet clip 40. For example, the plane 103A of the face of the opening of the basket 102 and the opening of the cutting ring 104 can be an angle 103C in the range of about 0 degrees and 90 degrees (e.g., about 45 degrees) relative to the axis 103B of the inner control member 108. The removal catheter 100 is retracted proximally relative to the inner intermediate catheter 189, so that the cutting ring 104 and the basket 102 are positioned above and outside the leaflet clip 40.

[0357] The inner control member 108 is retracted proximally, causing the cinch ring 106 and the cutting ring 104 to decrease in diameter, thereby closing the top opening of the basket 102. As the cutting ring 104 decreases in diameter, RF energy is delivered to the ring 104, allowing the non-insulated portion 104 to cut an area of ​​leaflet tissue adjacent to the leaflet clip 40 and thereby release the leaflet clip 40 from the tricuspid valve 15. The basket 102 and leaflet clip 40 may be retracted through the inner intermediate catheter 189, or all catheters may be removed together as a single unit at the same time.

[0358] It should be understood that any embodiment of the present specification can be used according to the access and delivery methods described in this application. In addition, other methods can be used with these access and delivery methods, such as delivering and implanting artificial valves (mitral or tricuspid valves).

[0359] While previously described embodiments of removal catheters have included a basket or similar device for capturing a heart valve treatment (eg, leaflet clip 40), different capture methods and devices are also contemplated.

[0360] Figure 70-Figure 72 A removal catheter 200 for removing a heart valve treatment leaflet clip 40 is illustrated. The removal catheter 200 includes an elongated piercing member 202 in a piercing device and an external cutting catheter 204 disposed on the piercing member 202. The elongated piercing member 202 may be a wire, catheter, or similar elongated device having a distal end with a sharp, spiral-shaped, expandable barb or rotating element so that the elongated piercing member 202 may be pressed into the top of the leaflet clip 40 (and optionally rotated or expanded) to initially engage or capture the leaflet clip 40, as shown in FIG. Fig.70 as shown in .

[0361] like Fig.71As shown, the external cutting catheter 204 is advanced distally on the elongated piercing member 202 until its distal end contacts the upper surface of the valve leaflet. The external cutting catheter 204 can be configured to cut the leaflet tissue with a variety of different mechanisms, such as mechanical (e.g., rotation or forward pressure) and / or electrosurgical cutting devices (e.g., electricity or cryogenics). Fig.72 As shown, once released from the leaflet tissue, the leaflet clip 40 can be removed by the slender piercing member 202.

[0362] Figure 73-Figure 75 A removal catheter 210 is shown that is similar to the previously described catheter 200, but the cutting catheter 212 also includes a grasping mechanism having two articulated jaw members ( Fig.76 After the elongated piercing member 202 is engaged with the leaflet clip 40 ( Fig.73 ), the outer cutting member 212 is advanced distally on the elongated piercing member 202 until it contacts the upper surface of the leaflet ( Fig.74 ). The articulated jaw member preferably includes a tissue cutting mechanism at its end, such as a blade or an electric / cryogenic electrosurgical cutting device mechanism, thereby allowing the leaflet tissue surrounding the leaflet clip 40 to be cut. Fig.75 In the embodiment of the present invention, the jaws of the cutting catheter 212 are brought toward each other to engage and grasp the tissue clip 40.

[0363] Figure 77-Figure 82 Another embodiment of a removal catheter 220 is illustrated, which is inserted into a previously placed leaflet clip 40, followed by the passage of an annular tool 224 that encapsulates, cuts, and removes the clip 40. Fig.77 In the embodiment, the annular removal catheter 220 includes an anchoring mechanism 226 connected to a central push rod 227 , a side push rod 223 , and a pushable element 225 .

[0364] Fig.78 The diagram shows an end view of an annular removal catheter 220, which may be circular, oval, multi-section, or a combination of these shapes and elements. The side push rods 223 push the pushable element 225, while the central push rod 227 applies force to the anchoring mechanism 226. Fig.79 In FIG. 2 , the entire annular removal catheter 220 is folded for placement within the delivery catheter sheath 221. Fig.80 In the embodiment, the anchoring mechanism 226 is pushed into the heart valve treatment hardware (i.e., the leaflet clip 40) using the central push rod 227 and the pushable element 125. Fig.78 and Fig.79 In the embodiment of the present invention, the pushable element 225 is then pushed using the side push rod 223 to wrap the annular removal catheter 220 completely or partially around the leaflet clip 40. The target tissue is then removed by cutting mechanically or electronically.

[0365] Figure 83-Figure 88 The illustration shows the insertion of a removal catheter 230 of a previously placed heart valve treatment (e.g., leaflet clip 40), followed by the passage of a tool to expand the leaflet clip 40, and then removal of the hardware. Fig.83 In the embodiment of the present invention, a steerable guide catheter 231 is used to position a removal catheter 232, which includes an expansion tool 234 for expanding the leaflet clip 40. The expansion tool 234 may have a barb, anchor, or embedding mechanism for removing or grasping native or foreign leaflets or tissue material from the tissue clip 40. Fig.84 In the embodiment of the present invention, anchor 235 is advanced and implanted. Fig.85 In the embodiment of the present invention, the expansion tool 234 is advanced into the interior of the leaflet clip 40. Fig.86 In the embodiment, the expansion tool 235 is mechanically expanded to expand the leaflet clip 40. The expansion can be performed by electrification, heating, hydraulic means, rotation, internal or external ultrasound or energy. Tissue is cut from the leaflet clip 40. In the embodiment, the expansion tool 235 is mechanically expanded to expand the leaflet clip 40. Fig.89 In the embodiment of the present invention, the expansion tool 235 is closed and then removed and released from the leaflet. Fig.88 A similar approach using a balloon expansion element 129 is shown.

[0366] Fig.89 and Fig.90 is a cross-sectional view of a mitral valve 20 that has been treated with a heart valve therapy that includes one or more chord structures 50. The chord structure 50 generally includes chords or strands 52 that are connected to the leaflets and to the left ventricle via anchors 54. The chords 52 may be anchored on the ventricular side of the leaflets 24 ( Fig.89 ) or the atrial side of leaflet 24 ( Fig.90 ) on. As further described in the embodiments below, a similar device can be used to remove the chord structure 50, just as the leaflet clip 40 is removed.

[0367] Figure 91-92 A removal tool 240 is illustrated for cutting and capturing a previously placed heart valve treatment including a cord or chord structure implanted into a valve leaflet. Fig.91 In the present invention, the procedure is performed using the previously described cutting catheter 212, which has the functions of opening, closing, energizing and removing hardware, similar to the above-mentioned Figure 73-Figure 76 Description of other heart valve treatments in

[0368] exist Figure 93-Figure 97 In the present invention, the procedure is performed by passing through a ring tool 250, which encapsulates, cuts and removes hardware, similar to Figure 77-Figure 82 of the above description.

[0369] exist Figure 98-Figure 100 In the present invention, the procedure is performed using a cutting catheter 260, similar to Figure 70-Figure 72Other heart valve treatments shown above are described in.

[0370] Additionally, during any of the procedures described herein, a flow restrictor may be used to help restrict flow. Fig.109 Picture shows Fig.60 4. An embodiment of a removal catheter 100 with an additional flow limiting device 341 is provided. The flow limiting device 341 can be positioned in the valve 20 region (e.g., through the valve 20) before, during, or after the removal of the clip 40, and maintained in the valve region to manage the patient's blood flow by restricting blood flow. The flow limiting device 341 can be any flow restrictor known to those familiar with the art, such as but not limited to a balloon, a stent with a covering, or a catheter. Any or all of these examples are configured or have expansion capabilities to occupy a clinically appropriate space to manage blood flow alone or in combination with a valve structure. As shown, the flow limiting device 341 can be introduced separately via delivery catheters 342 and 343. In addition, the flow limiting device 341 can also be integrated with a delivery mechanism (such as an internal steerable catheter 180). Alternatively, the flow limiting device 341 can be a delivery system for another treatment, such as but not limited to a heart valve.

[0371] When performing the cutting procedure of the present specification, it is helpful to maintain good mechanical contact or force between the leaflet tissue and the cutting element (e.g., cutting wire 104), especially when using radiofrequency energy as a mechanism to perform the cutting. Such contact or force is important to ensure that the electrodes of the cutting element / ring are not exposed to a large amount of blood.

[0372] When using a constant power generator, such as many commercially available RF energy generators, the impedance seen by the generator is typically low (e.g., 0-300 ohms) when the cutting element is mostly exposed to the patient's blood. This low impedance may result in insufficient voltage to cut through the tissue. In this situation, some RF energy generators will increase the current to maintain a constant power level.

[0373] In contrast, when the cutting element is firmly pressed against the patient's tissue and exposed to a small amount (if any) of the patient's blood, the impedance seen by the generator will be relatively higher (e.g., greater than 300 ohms) or a greater resistance to the current flow. The greater resistance may cause the generator to increase the voltage output to maintain constant power. Once the voltage reaches a certain level, the tissue cutting process will begin and will continue as long as the cutting element remains in contact with the target tissue.

[0374] Exploiting this phenomenon enables electrosurgery to be performed in the heart and the patient's blood pool.Thus, in the context of the present invention, it may be helpful to include a mechanism to create and / or help maintain pressure or force between the cutting element and the target tissue.

[0375] In general, when considering removal of an implanted valve clip 40, consideration of several factors may help ensure that there is sufficient mechanical force between the cutting element and the target leaflet tissue. Specifically, 1) the length of leaflet tissue inserted into the arms of the valve clip 40, 2) the chordae tendineae extending from and around the valve clip 40, and 3) the use of multiple valve clips 40 and their spacing and position angles.

[0376] Furthermore, at least four different valve clip removal scenarios may be encountered. Specifically, 1) the cutting ring may be tightened on the atrial side of the valve clip 40 without any further "reaction force" against the clip 40 (as described in earlier embodiments / methods of this specification), 2) reaction force on the valve clip 40 may help or be required to stretch the tissue so that the cutting ring can be tightened on the atrial side of the valve clip 40, 3) reaction force may be helpful or required and the cutting ring must first cut through some leaflet side tissue before it can be tightened on the atrial side of the valve clip 40, and 4) a cutting snare may be used to substantially release the engaged tissue from the valve clip 40 and then be used to facilitate engagement of the cutting ring and basket.

[0377] In the first case, the cutting ring and basket can be placed on the valve clip 40 and the cutting ring can be tightened on the tissue bridge so that the cutting ring is positioned on the atrial side of the valve clip 40 without using any other tools, as has been described previously in this specification. This technique has been described previously in this specification. Tightening the cutting ring in this manner ensures that the cutting element is firmly pressed against the tissue and moves through the entire tissue bridge when it is pulled inside the delivery catheter.

[0378] In the second scenario, some means of pushing or pulling the valve clip 40 is provided as the cutting ring is retracted or tightened. The counterforce helps to stretch the tissue into / toward the left ventricle 14 and away from the direction in which the cutting ring is being pulled, thereby allowing the cutting ring to be positioned and tightened on the atrial side of the valve clip 40. Applying such a counterforce may be helpful and sometimes even necessary if a relatively large length of leaflet tissue has been inserted into the arms of the clip 40, multiple clips 40 have been implanted (especially closely spaced clips 40), the leaflets are too soft, the leaflets are too rigid, or a relatively large tissue bridge has previously formed.

[0379] In the third case, the reaction force helps stabilize the valve clip 40 and the valve leaflets so that the cutting ring can be firmly pulled against the valve leaflet edge. Once the cutting ring is firmly pressed against the valve leaflet tissue, the first cut can be performed by pulling the cutting ring until the cutting ring is located on the atrial side of the valve clip 40, and then the cutting ring can be tightened and the final cut can be completed.

[0380] In a fourth situation, removal of engaged tissue may be necessary to facilitate snare engagement and allow the snare to provide a counterforce to stabilize the valve clip.

[0381] In these situations, several embodiments and methods may be used to generate a reaction force toward / into the left ventricle 14 and away from the left atrium 12 .

[0382] In one example, a steerable catheter 180 used to deliver a cutting and retrieval catheter can be used to press against the valve leaflets 22, 24 and the valve clip 40 to generate a reaction force toward the left ventricle 14. For example, a distal edge around its distal opening can be positioned against the valve leaflets and / or the valve clip 40.

[0383] In another example, the valve clip 40 can be pushed from the left atrium side of the valve clip 40 toward the left ventricle using the pushing catheter 470. Fig.142 As shown. A slender standard catheter or a steerable catheter can be used, or the catheter 470 can further include a specialized distal end portion 472 to assist in pressing or engaging the valve clip 40. For example, the distal end portion 472 can be selectively expandable (e.g., a balloon or expandable mesh structure), and the distal end portion 472 can be expanded to better contact the valve clip 40. The distal end portion 472 can alternatively or additionally have a blunted distal end. The distal end portion 472 can alternatively or additionally be configured to be mechanically secured to the valve clip 40, or even to leaflet tissue proximate to the valve clip 40. For example, Figure 70-Figure 100 The devices and mechanisms shown in can be used to secure to the valve clip 40 or adjacent tissue.

[0384] In either configuration, the catheter 470 can be pushed against the valve clip 40 from the left atrium 12 toward the left ventricle 14, and then the cutting ring is positioned between the atrial side of the valve clip 40 and the leaflets 22, 24. Finally, the cutting ring (e.g., the cutting ring of any embodiment of the present specification) is activated to complete the cutting through of the leaflet tissue.

[0385] In yet another example, the valve clip 40 can be pulled out of position within the left ventricle 14 and further into the left ventricle 14 to generate a reaction force, thereby allowing the cutting ring to be positioned and cut tissue as previously described.

[0386] Fig.110 and Fig.111One embodiment of a removal system 400 is illustrated, which can be used to pull the valve clip 40 into the left ventricle 14 to generate a reaction force, and includes a cutting-capturing catheter 403 and a separate snare catheter 401 (or alternatively, a separate cutting catheter and a separate capturing catheter). The snare catheter 401 can be used to first grasp the valve clip 40 and pull it further into the left ventricle 14, while the cutting-capturing catheter 403 can be used to cut the leaflets 22, 24 and capture the valve clip 40. Note that this technique can also be used for other valves, such as the tricuspid valve.

[0387] The cut-capture catheter 403 is generally similar to the previous embodiments and may include any of the variations previously discussed in this regard. For example, the cut-capture catheter 403 may include a basket 102 and a cut ring 404 connected to an elongated inner control member 108 that moves all components in and out of a tubular outer jacket or sheath 110.

[0388] like Fig.112 and Fig.113 As shown, the basket 102 may include a basket tip 414 at its distal end. The basket tip 414 may be used for one or more of the following purposes. First, the basket tip 414 may connect or contain the ends of the wires that make up the basket 102. In one example, the basket tip 414 includes a cylindrical wall portion with a plurality of apertures 414B through which the ends of the wires pass, thereby preventing the ends of the wires from becoming loose or injuring the patient. The ends of the wires may be tied, welded, or adhered within the basket tip 414. Alternatively, the ends of the wires may be welded or fused together with the basket tip 414 without the apertures 414B. The basket 102 may be woven with a single wire, in which case only two apertures 414B are required, or woven with multiple wires, in which case multiple apertures 414B may be required (e.g., two apertures per wire).

[0389] Second, the basket tip 414 includes an atraumatic distal end shape 414A that helps prevent the basket tip 414 from damaging tissue within the patient. For example, the atraumatic distal end shape 414A may be spherical, circular, elliptical, or conical. Likewise, the basket tip 414 may also be used in any other embodiment of the present specification.

[0390] Back to Fig.110 and Fig.111, the cutting-capture catheter 403 further includes a cutting element or ring 404, which is similar in structure and use to the previously described embodiments. However, the present cutting ring 404 has a saddle shape similar to the cutting ring 350. That is, the cutting ring 404 has a side portion that forms a depression or curve downward toward the distal end and then forms a valley shape upward toward the proximal end. This shape may be desirable because when the cutting ring 404 is retracted proximally inward into the outer sheath 110, the cutting ring 404 can maintain a desired cutting angle relative to the remaining elements of the catheter 403. For example, if the cutting ring 404 forms a vertical right angle relative to the internal control member 108, when the right-angle joint is retracted into the outer sheath 110, the angle of the ring 404 may be tilted downward. In contrast, the arc or saddle shape helps maintain the end of the ring 404 within the desired vertical range when it is retracted. This may be particularly useful if the electrode of the cutting ring 404 is located on the side opposite to the internal control member 108. Similarly, the cutting ring 404 can be used in any of the embodiments described in this specification.

[0391] The snare catheter 401 includes a snare ring 420 connected at or near the distal end of an inner control member 418 (similar to component 108) that moves longitudinally within the lumen of an outer tubular jacket or sheath 416. This allows the inner control member 418 to move the snare ring 420 into or out of the sheath 416. Similar to the sheath 110, the outer tubular sheath 416 can have an opening at the distal bottom (i.e., at the axis of the sheath) or can include a tip member 422 having an opening in its sidewall that extends into the inner lumen of the sheath 416 (e.g., a side opening that opens in a non-axial direction relative to the sheath). The outer sheath 416 can be elongated and thus can have sufficient length to enter a patient so that its distal end can reach the interior of the patient's heart (e.g., near the mitral valve). The lumen can be open at or near the proximal end of the outer tubular sheath 416. The inner control member 418 may be a wire, tube, or similar elongated member and may extend from a proximal end to a distal end of the outer tubular sheath 416 .

[0392] Optionally, the snare ring 420 may include a previously described cutting element (e.g., an RF electrode near its tip) that allows it to engage tissue surrounding the clip and at least partially cut that tissue to initially facilitate capture and removal of the valve clip 40. Additionally, a cutting and capture procedure may also be performed. Initial removal of at least a portion of the engaged tissue may be necessary to facilitate engagement of the snare ring 420 and allow the snare ring 420 to provide a reaction force to stabilize the valve clip 40. For example, a channel or valley may be cut into the tissue surrounding the valve clip 40, which may then allow the snare ring 420 to more securely engage the valve clip 40. In Fig.145 and Fig.146One exemplary configuration in this regard can be seen, which includes a radiofrequency electrode 421 at the distal end of the snare loop 4 .

[0393] The snare ring 420 can have a variety of different shapes configured to clamp the valve clip 40. For example, Fig.114 and Fig.115 A "saddle-shaped" or curved ring similar to the cutting ring 404 is shown (i.e., curves downward distally and then curves upward when connected to each other to form curved or concave sides). This curved shape prevents the distal end or tip of the snare ring 420 from moving distally downward beyond the distal end of the snare catheter 401. In other words, because the distal end of the snare ring 420 is tilted upward when fully extended out of the catheter 401, the ring 420 itself may tilt distally downward as it is pulled in, but because the distal end is curved proximally, the distal angle of the ring 420 is not sufficient to move the ring 420 away from the valve clip 40. In other words, the proximal curve of the ring 420 is sufficient to prevent the distal end of the ring from positioning itself distally beyond the distal end of the snare catheter 401.

[0394] exist Fig.116 In another example shown in FIG. 4 , the snare loop 424 can have a generally circular shape that can optionally include a notched or curved segment 424A that extends radially outward from the circular shape opposite the outer sheath 416. Although only one notch or notch 424A is shown, multiple segments 424A can also be positioned partially or completely around the snare loop 424.

[0395] The snare ring 424 has a given shape memory shape so that it is connected to the inner control member 418 at approximately 90 degrees. In some cases, this 90 degree flexion may cause the ring 424 to tilt or deflect downward when it is pulled into the snare catheter 401 and may cause the ring 424 to move away from the valve clip 40. In contrast, the saddle-shaped snare ring 420 has a distal / downward arc curve and therefore helps maintain the original orientation of the ring 420 when the ring 420 is pulled into the snare catheter 401, and thus better maintains the ring 420 on the valve clip 40.

[0396] The snare ring 420 may further include features that enhance its grip on the valve clip 40. For example, Fig.114 and Fig.115 As shown in the snare ring 420 in FIG. 1 , a friction coating or friction sleeve may be arranged on part or all of the snare ring. In another example, a plurality of relatively small protrusions 426A (round bumps, pointed teeth or similar shapes) may be located on part or all of the inner radial surface / side of the snare ring 426, such as Fig.117 In another example, the snare ring can be in a compressed configuration 428A ( Fig.118 ) or vertical expansion configuration 428B ( Fig.119 ) wire loops, which can produce different degrees of texture and thereby increase the grip of the ring on the valve clip 40. Likewise, these different ring shapes and friction engagement features can be mixed and matched with each other and with any of the embodiments in this specification.

[0397] Although the snare catheter 401 and snare ring 420 previously described are used to grasp the valve clip 40, they can also be used for other purposes. For example, it can be used to capture other tissues. It may be desirable to remove calcified nodules within the valve leaflets to facilitate placement of the valve. It can be used to capture and remove valve leaflet tissue to facilitate flow after the replacement valve is inserted. It can also be used to remove the heartstrings to facilitate movement of the valve. In this regard, the snare ring 420 can be used to grasp such tissue, while the cutting ring 404 is used to cut the tissue. However, it is also helpful to include a cutting element (e.g., an RF electrode) on the snare ring 420 to help cut such tissue first.

[0398] like Fig.120 and Fig.121 As best shown, the snare catheter 401 may further include a tip member 422 at the distal end of the outer tubular sheath 416. The tip member 420 may be configured to maintain the snare ring 420 at a desired angle or orientation relative to the outer tubular sheath 416 and the valve clip 40. Because the valve clip 40 is generally conical or "V" shaped, as described earlier in this specification, the tightening snare ring may have a tendency to squeeze out of the valve clip 40 when the valve clip 40 is tightened. If the snare ring 420 is positioned at a large angle relative to the vertical axis of the valve clip 40, this tendency to slip off may increase. If the snare ring 420 exits the outer tubular member 416 from the distal-facing opening (e.g., without the tip member 422), then when the snare ring 420 is pulled into the outer tubular sheath 416, its angle may increase relative to the axis, thereby potentially slipping off the valve clip 40.

[0399] Rather, the tip member 422 includes an opening 422A through its sidewall, and an angled or curved surface 422B configured to direct the snare loop 420 out of the opening 422A at a generally perpendicular angle relative to the axis of the outer tubular sheath 416 and the axis of the valve clip 40 .

[0400] In addition, the tip member 422 may include features that facilitate engagement with the valve clip 40 and / or create friction such that when the snare ring 420 tightens the valve clip 40 against the tip member 422, these features help prevent the valve clip 40 from slipping out of the snare ring 420. Fig.120 and Fig.121In the example of FIG. 4 , the shape of the opening 422A may include relatively sharp or abrupt corners around it, which helps to push the valve clip 40 in to maintain its position.

[0401] exist Fig.122 In the example of , the proximal channel 422C and the distal channel 422D can extend from the main opening 422A to provide additional areas having sharp or abrupt angles, the additional areas extending a greater longitudinal distance. Fig.123 In the example of the tip member 422, the tip member 422 may include a plurality of ridges or grooves 422E adjacent to the opening 422A and / or the channels 422C, 422D on the surface of the tip member 422. These ridges or grooves 422E may be relatively straight and circumferentially oriented relative to the opening 422A and / or the channels 422C, 422D, or may have different patterns, such as a wavy or zigzag pattern. Fig.124 In the example of FIG. 4 , a plurality of spikes, hooks, or similar sharp shapes may extend from the side surface around the main opening 422A or other locations nearby. Any combination of these engagement features may be used together to provide a surface that can better engage the valve clip 40 when in contact.

[0402] The snare catheter 401 may also include a handle 440 configured to retract the internal control member 418, and thus the snare ring 420, in a controlled manner. Specifically, the handle 440 allows a predetermined and limited force to be applied to the snare ring 420 while also being able to lock the position or force of the snare ring 420 at a desired level. This allows the valve clip 40 to be relatively firmly grasped without requiring sufficient force to break the catheter 401, and further allows such force to be maintained throughout the procedure without having to hold a portion of the handle 440 during a majority of the procedure.

[0403] The handle 440 may have different possible mechanisms for controlling and locking the position / force of the snare loop 420 . Fig.125 and Fig.126 An exemplary mechanism is illustrated having an outer housing 442 forming a generally cylindrical shape and a knob 448 at the proximal end of the outer housing 442, the knob 448 being configured to be pulled proximally (i.e., to the right in the figure) from the housing housing 442. Pulling the knob 448 proximally also pulls the inner control member 418 proximally, causing the snare loop 420 to retract proximally into the opening of the tip 422.

[0404] As the knob 448 is pulled out by the spring 450 located in the housing 442, the force applied to the knob 448 can be limited or the resistance can be increased. The spring 442 can be connected to the distal portion 440 of the inner control member 418 or the knob 448, or can be connected to the interior of the housing 442, so that when the knob 448 is pulled proximally, the spring 450 either compresses or expands to produce increased resistance. Depending on the configuration of the spring 450 (e.g., size, initial compression amount, spring constant, and the like), the force applied by the spring 450 can be optimized to apply a constant predetermined tension over the entire length that the knob 448 is pulled, or alternatively, to apply increasing tension as the knob 448 is pulled further proximally.

[0405] The handle 440 may also include a locking mechanism that can lock the position of the inner control member 418 relative to the housing 442 and the outer sheath 416. Fig.125 and Fig.126 In the present example of the embodiment of the present invention, the locking mechanism includes a longitudinal slot 444 extending along at least a portion of the length of the housing 442. A tracking pin 446 is fixed to the internal control member 418 and is at least partially positioned within or through the slot 444. When the knob 448 is pulled rearwardly and proximally, the tracking pin 446 moves along the length of the slot 444. When the internal control member 418 has reached the desired position, the knob 448 can be rotated so that the tracking pin 446 enters one of a plurality of slot branches laterally relative to the length of the slot 444. Preferably, these slot branches are shaped to retain the position of the tracking pin 446, thereby retaining the position of the internal control member 444, when the user releases the knob 448. For example, the slot branches can be distally inclined to a certain extent so that the distal force of the spring 450 maintains the tracking pin 446 within the slot branches, thereby releasably locking the internal control member 418 in place.

[0406] The handle 440 may also include a port 452 that communicates with the interior of the handle housing 442 and the outer sheath 416. The port 452 may be used to supply saline, contrast media, or similar fluids during a surgical procedure.

[0407] The handle 440 may also include electrical connections to the RF generator and the snare ring 420 (if the ring includes RF electrodes or similar cutting elements) for providing energy to the cutting snare 420 during the procedure. As previously mentioned, in some cases, it is helpful for the snare ring 420 to include cutting elements to cut at least some tissue surrounding the valve clip 40 or other heart valve treatment so that the snare ring 420 can better engage the valve clip 40.

[0408] Generally, it may be desirable to include and deliver the cutting-capture catheter 403 and the snare catheter 401 through the same delivery catheter (e.g., steerable catheter 180). However, depending on the specific procedure, the cutting-capture catheter 403 and the snare catheter 401 may also be delivered separately in separate delivery catheters, or without any covering catheter.

[0409] Figure 127-Figure 130 An exemplary technique is illustrated using a removal system 400, including a cut-and-capture catheter 403 and a snare catheter 401. Although a particular removal system 401 is illustrated and discussed, variations of the procedure are contemplated, including using different embodiments described herein.

[0410] First, a delivery catheter (e.g., steerable delivery catheter 180) containing a cutting-capture catheter 403 and a snare catheter 401 is advanced into the left atrium 12 of the patient's heart. It is generally desirable that the tip of catheter 180 be advanced first through the leaflets 22, 24 and into the left ventricle 14. This helps prevent the cutting-capture catheter 403 or snare catheter 401 from becoming entangled with any chordae extending from or near the leaflets 22, 24. The basket tip 414 of basket 102 may be positioned at or partially beyond the opening of the delivery catheter 180 to help create a generally smooth surface that will not "hook" or otherwise become stuck when passing through the leaflets 22, 24 or nearby chordae.

[0411] Next, the cutting-capture catheter 403 and the snare catheter 401 are pushed out of the catheter 180 and into the left ventricle 14. Initially, the opening 422A of the tip member 422 is oriented toward the valve clip 40. If the snare ring 420 has not yet expanded outward, the internal control member 418 is moved distally via the handle 440 to cause it to expand and expand. The snare ring 420 is aligned with the valve clip 40, and then the snare catheter 401 is moved proximally so that the snare ring 420 surrounds the valve clip 40, as shown in FIG. Fig.127 shown.

[0412] During this time, the basket 102 and cutting loop 404 may be positioned in a different or opposite rotational orientation from the snare loop 420 , and / or positioned distally beyond the snare loop 420 .

[0413] Reference Fig.128 , the snare ring 420 is tightened or tightened around the valve clip 40 until the valve clip 40 is pressed against the tip member 422. This can be achieved by retracting the inner control member 418 proximally via the handle 440 (e.g., by pulling back on the knob 448 and locking its position within the slot 444). The cutting ring 404 and the basket 102 are vertically aligned with both the valve clip 40 and the snare catheter 401, if not already aligned.

[0414] like Fig.129 As shown, the snare catheter 401 is pushed distally to generate a reaction force to pull the valve clip 40 toward or further into the left ventricle 14. The cutting-capturing catheter 403 is retracted proximally (while or before generating the reaction force) so that the cutting ring 404 is positioned on the atrial side of the valve clip 40, between the clip 40 and the leaflets 22, 24. The basket 102 is positioned partially or almost completely around the valve clip 40 and the distal portion of the snare catheter 401 (e.g., the snare ring 420 and the distal tip 422).

[0415] Reference Fig.130 , while maintaining the reaction force from the snare catheter 401, both the tightening ring 106 and the cutting ring 404 are tightened or reduced in size. As previously described, this reaction force allows the electrodes of the cutting ring 404 to make good contact with the leaflet tissue. Therefore, when the electrodes of the snare ring 404 are activated, a quick and clean cut can be made through the tissue, resulting in the valve clip 40 being completely removed and captured by the basket 102. Finally, the cutting-capture catheter 403 and the snare catheter 401 can be at least partially retracted into the delivery catheter 180 and removed from the patient. The distal end / opening of the delivery catheter 180 can remain in the left atrium 12, or can be pushed into the left ventricle 14 when the cutting-capture catheter 403 and the snare catheter 401 are retracted into the left ventricle 14.

[0416] In the event that the delivery catheter 180 is returned into the left ventricle 14 to then retract the cutting-capture catheter 403 and the snare catheter 401, there is a risk that the chordae with the valves will impede the return of the delivery catheter 180 into the left ventricle 14. For example, the distal end of the delivery catheter 180 may not be tapered enough and may "hang up" on the chordae.

[0417] One solution to this problem is to include a chord dilator that can be positioned partially outside the distal opening of the delivery catheter 180 as it transitions through the leaflets 22, 24 and chordae. Such a chord dilator can include a tapered and / or angled distal surface and can be sized to radially occupy most or all of the opening of the delivery catheter 180.

[0418] Figure 134-Figure 137One example of a chord dilator 432 is best shown. In this embodiment, the chord dilator 432 includes a body having a bottom surface 432D having an angle (i.e., an edge forming an angle, such as about 45 degrees, relative to the vertical axis of the dilator 432). In addition, the bottom surface 432D can be rounded or conical to help transition with the delivery catheter 180. Optionally, the chord dilator 432 can include a similarly shaped top surface 432C, which may help deflect the chordae in both directions of the mitral or tricuspid valve.

[0419] The chord dilator 432 includes two passages 432A and 432B; one passage 432A is used to accommodate the snare catheter 401, and the other passage 432B is used to accommodate the cutting-capture catheter 403. Alternatively, the chord dilator 432 may have only one passage that can accommodate only one of the snare catheter 401 or the cutting-capture catheter 403. In either case, the passage preferably allows the respective catheter to rotate therein during the procedure. In addition, one of the passages can be "C" shaped (i.e., not completely surrounding the catheter) so that one of the catheters is separated from the chord dilator 432. Optionally, one, two or more radiopaque markers 432E are also included in the chord dilator 432. For example, the radiopaque markers 432E can be located on opposite circumferential sides of the chord dilator 432 and extend at least partially between the proximal end and the distal end of the chord dilator 432.

[0420] When the user desires to move the delivery catheter 180 into the left ventricle to capture the snare catheter 401 and / or the cutting-capture catheter 403, the snare catheter 401 and / or the cutting-capture catheter 403 are moved relative to the delivery catheter 180 so that they position the chord dilator 432 portion into the distal opening of the delivery catheter 180, similar to Fig.135 Then, the delivery catheter 180 , the snare catheter 401 , and the cutting-capturing catheter 403 are all pushed distally until the distal end of the delivery catheter 180 is located in the left ventricle 14 .

[0421] Alternatively, the chord dilator 432 may be configured only to connect the snare catheter 401 and the cut-capture catheter 403 without any specific surface for chord dilation. In this regard, the chord dilator 432 may be used primarily to maintain the two catheters parallel to each other, and not necessarily for chord dilation, which may be useful in achieving desired alignment during surgery.

[0422] The chord expander 432 may alternatively include three passages. For example, one passage 432A is used to accommodate the snare catheter 401, another passage 432B is used to accommodate the cutting-capture catheter 403, and another passage is used to facilitate the threading of the wire. The chord expander 432 can also be used to facilitate the relative axial alignment of the snare, cutting ring and basket. The position of the other components relative to the chord expander 432 will change the length of the free component arm and thus control the distance and angle between the component axes.

[0423] Although the snare catheter 401 previously described is used to grasp the valve clip 40, it can also be used for other purposes. For example, during a procedure (e.g., during a transapical approach), it can be used to grasp or snare a guide wire or Fogarty balloon to help pull these components through the target valve and prevent them from becoming tangled or stuck.

[0424] The removal system 400 is previously described as being delivered through an external transapical guide catheter 182 or similar catheter. However, the removal system 400 may be further configured to have a guidewire path or passageway so that it may be delivered over a guidewire 430. When the removal system is present, the guidewire may have a more subtle force and stiffness transition to the tissue, thereby ensuring safe introduction into various anatomical structures. Figure 131-Figure 133 One exemplary removal system 400 having such a guidewire passage is illustrated. Specifically, the guidewire passage extends from the proximal opening of the snare catheter 401 into the outer sheath 416 , through the opening in the distal tip member 422 , through the basket 102 , and finally through the passage in the basket tip 414 .

[0425] The wire 430 may also take other paths. For example, Fig.138A Wire 430 is shown extending along the outside of basket 405 and into a passage in basket tip 415 that is open near its outer top and bottom to allow wire 430 to pass through. In this example, wire 430 never passes through the interior of basket 405. Alternatively, Fig.138B In the embodiment of the present invention, the guide wire 430 can pass through a cell of the basket 405, enter the interior opening of the passageway of the basket tip 415, and extend distally out of the basket tip 415.

[0426] like Fig.138A As shown, the guide wire 430 can extend proximally only through the steerable catheter 180, can extend through a passage in the snare catheter 401 or the cut-and-capture catheter 403. Alternatively, as shown in FIG. Fig.138B As shown, the guidewire 430 may be passed completely through the exterior of the steerable catheter 180, snare catheter 401, or cut-and-capture catheter 403 in the proximal direction (except through the basket tip 415).

[0427] Alternatively, if Fig.139 As shown, the basket tip 415 may include a wire-like pigtail or flex wire 431 attached and extending distally from the tip 417 to aid in passage through the valve and prevent damage to various heart structures.

[0428] The use of a guide wire 430 to deliver the removal system 400 can facilitate passage through valves with smaller holes, which is particularly common in valves implanted with multiple valve clips 40. Navigation over the guide wire 430 can also allow for easier removal of the two valve clips 40. For example, a catheter with a cutting ring 420 can be advanced over the guide wire 430 and used to cut the leaflet tissue between the two valve clips 40, allowing them to be separated and thus allowing for easier sequential capture via the sequential removal system 400.

[0429] With respect to sequential removal, the procedure may include placing a steerable catheter 180 within the left atrium, navigating a guide wire 430 through a target orifice of the valve, advancing a cutting-capture catheter 403 over the guide wire 430, removing the guide wire 430, cutting and removing the valve clip 40 with the cutting-capture catheter 403, removing the cutting-capture catheter 403, again advancing the guide wire 430 through the target orifice of the valve, and repeating the removal process. After removing the first valve clip 40, if the steerable catheter 180 is sized large enough to completely remove the valve clip 40, it may be left in place; otherwise, the steerable catheter 180 may be removed and a second steerable catheter 180 may be placed.

[0430] In certain embodiments and procedures, it is desirable that the cut-and-capture catheter 403 has a basket 460 that can be expanded or stretched from a longitudinally compressed configuration. This allows a single-sized basket 460 to be used to accommodate valve clips 40 of different sizes, without requiring several baskets of different sizes, and also allows the valve clip 40 to be "enclosed" by the snare catheter 401. For example, Fig.140 The basket 460 is shown in a longitudinally compressed configuration. Fig.141 Basket 460 is illustrated in a deployed configuration.

[0431] The longitudinally stretchable functionality of basket 460 can be achieved in several different ways. For example, basket 460 can be braided or woven from one or more wires of a shape memory material (e.g., nitinol) and then heat set to a compressed configuration ( Fig.140). As an alternative or in addition to heat setting, the weave pattern may also be configured to generally bias the basket 460 in its compressed configuration or at least encourage the basket 460 in its compressed configuration. Alternatively or in addition, the basket 460 may also include a longitudinal elastic tether or elastic cover that biases the basket 460 to its compressed configuration. Alternatively, the wires of the basket 460 may be constructed of an elastic material that allows stretching. In another alternative embodiment, one or more struts / wires of the basket 460 may be coiled to form a spring. In yet another alternative embodiment, a plurality of pull wires connected to the basket 460 and the proximal end of the device near the user may maintain the basket 460 in the compressed configuration and may be released proximally as needed to increase the diameter and / or length of the basket 460.

[0432] The baskets described in this specification (e.g., basket 102 or 460) have been shown as having a generally cylindrical, expanded shape. However, baskets of other shapes may also be used. For example, Fig.143A A basket 102' is illustrated having a generally conical shape. In one example, the expanded basket shape tapers from about 30 mm to about 6 mm. Fig.143B As shown, when the steerable catheter 180 is partially positioned, the tapered shape creates a smooth, atraumatic shape without any large edges. This helps prevent the steerable catheter 180 from snagging or getting stuck as it passes through the valve, leaflets, and chordae tendineae. This shape can also allow the basket to be more easily loaded into the steerable catheter 180 or other catheters.

[0433] Although it is desirable to include the basket 102 when capturing the valve clip 40 or other heart valve treatment, the basket 102 may be eliminated from the cut-and-capture catheter 403, such as Fig.144 In such a device, the snare ring 420 (as well as other possible clip engagement features described previously) can be used to grasp the valve clip 40 while the cutting ring 404 is moved proximally onto the clip 40 and the snare ring 420 and activated to cut the desired valve tissue. The snare ring 420 can maintain the retention of the valve clip 40 and retract the valve clip 40 proximally from the patient's body.

[0434] The present specification describes the use of one or more snare catheters that can be used in connection with the removal of various heart valve therapies (e.g., valve clips). When using a snare ring with a cutting ring (e.g., in any of the techniques described herein), there may be a risk that the snare ring or other components of the snare catheter may come into contact with or move proximal to an active electrode on the cutting ring. In general, any metal or conductive surface that is proximally close to an active RF electrode may result in direct coupling (e.g., arcing between the active electrode and a conductive object). Such unintended arcing may be undesirable because it may damage a portion of the snare catheter or snare ring, or cause damage to unintended areas of tissue. Because existing snares are typically used for purposes that are not proximally close to an RF cutting element, they typically include exposed metal or other conductive material.

[0435] Thus, it may be desirable to have a snare loop and other snare catheter components that are insulated and electrically isolated from other conductive portions of the loop. For example, an electrical insulator may be included on one or all of the wires of the snare loop itself, the internal control member, the inner and / or outer surface of the outer sheath, and the inner and / or outer surface of the distal tip of the outer sheath. For example, the electrical insulator may be comprised entirely of a non-conductive material or may include one or more non-conductive layers or coatings, such as silicone, polyimide, a dielectric coating, PTFE (e.g., heat shrink tubing), FEP, or similar biocompatible and non-conductive materials. In a more specific example, the snare loop may be comprised of one or more nitinol wires that are insulated via silicone tubing, a dielectric coating, a braided polymer tube (e.g., a polyimide), a coiled polymer tube (e.g., a polyimide or a polyolefin). This helps prevent any conductive material of the underlying loop wire (e.g., nitinol, 304 stainless steel, or a similar plastic material) from conducting electrical current (e.g., RF current) during surgery.

[0436] Figure 147-Figure 152 An exemplary embodiment of a snare catheter 500 is illustrated with an electrical insulator that helps electrically isolate the snare loop 502 when approaching or contacting the cutting loop. This can prevent damage to the snare loop 502 and other components, as well as tissue in non-target areas. The snare catheter 500 is generally similar in structure to the catheters described previously in this specification. For example, the snare loop 502 is located at the distal portion of the snare catheter 500 and can be connected to the internal control member 418 to allow the user to increase or decrease the size of the loop 502 outside the tubular outer jacket or sheath 416 and the distal tip member 508. The user can achieve size adjustment via the proximal handle 514, which has a movable interface element (e.g., a slidable pull tab) that can longitudinally move the internal control member 418 within the outer tubular sheath 416.

[0437] In the present embodiment, the snare loop 502 has a saddle shape as previously described, but may be any shape or configuration described elsewhere in this specification. The loop may include features that facilitate visualization for medical imaging. For example, part or all of the loop may include a radiopaque material. In one particular example, discrete radiopaque markers 504 may be included at the tip and / or other lateral locations of the loop (e.g., a radiopaque tube or sleeve placed over the nitinol wire forming the loop 502). In another particular example, the radiopaque wire may be braided, wrapped, coiled, or otherwise combined with the nitinol wire to form the loop 502.

[0438] As previously described, the snare loop can include a coating, layer, or tube positioned over a portion or all of the snare wire (e.g., shape memory material (such as Nitinol), stainless steel, and radiopaque materials described herein) positioned beneath the snare loop. Such coating / layer / tube can include silicone, polyimide, dielectric material (such as polyolefin), PTFE (such as heat shrink tubing), FEP, or similar biocompatible and non-conductive materials. More specifically, the coating of the wire beneath the snare loop 502 can be comprised of a silicone tube, a dielectric coating, a braided polymer tube (such as polyimide), a coiled polymer tube (such as polyimide). The internal control member 418 and its connection point to the snare loop 502 can also be partially or fully insulated with a similar material.

[0439] The snare catheter 500 may also include a distal tip member 508 including an open area that leads into one or more openings 510 (e.g., one or two openings) from which portions of the snare loop 502 exit. As shown, these openings 510 may be located at the sidewalls of the distal tip member 508, or a single opening may alternatively be located at the distal axial (did you mean distal?) end. An atraumatic distal end may also be included, such as the rounded or spherical tip of the distal tip member 508 shown in the figures.

[0440] The distal tip member 508 (ie, its structural material) can be composed of a non-conductive material, such as a polymer. Alternatively, the distal tip member 508 can be composed of a conductive metal at least partially coated or fully coated with a non-conductive material, such as those previously described.

[0441] The distal tip member 508 may also include a molded part or insert 512 ( Fig.149), the molding or insert 512 can be constructed of a non-conductive material, such as those previously described. In addition, the insert 512 can be positioned on the edge of each opening to help prevent any sharp edges around the opening 510 from scraping off any insulation on the snare ring 502 when moving in or out of the distal tip member 508. For example, the insert 512 can be formed into a rounded, curved, or blunted shape on and around the edge of the opening 510. Alternatively, if the distal tip member 508 otherwise has rounded or blunted edges around the opening 510 and is constructed entirely of a non-conductive material or has a non-conductive outer coating, then the insert 512 may not be required.

[0442] As previously discussed elsewhere in this specification, it may be helpful to move the snare ring 502 out of the snare catheter 500 (e.g., from the distal tip member 508) in a generally lateral trajectory relative to the axis of the snare catheter 500. The side exit point of the snare ring 502 and its generally concave-shaped proximal opening may help maintain the captured heart valve treatment device at a relatively constant proximal / distal position relative to the snare catheter 500 as the snare ring 502 is tightened and the heart valve treatment device is brought closer to the distal tip. Maintaining such a constant proximal / distal position may be important for grasping the heart valve treatment device from a more "atrial" position (i.e., closer to the valve leaflets). Generally speaking, the more "atrial" the position of the snare ring 502 on the heart valve treatment device, the more stable and secure the snare ring 502 will be in holding throughout the procedure.

[0443] and Fig.115 Unlike the distal tip member 422 previously described in the prior art, the distal tip member 508 includes a vertical or axially parallel rod 511 or structural feature that separates the two openings 510. The vertical rod 511 can help prevent the snare loop 502 from being fully pulled into the distal tip member 508 and thereby damaging the snare loop 502 (e.g., deforming the snare loop 502 and / or removing a portion of the insulating coating). The use of a relatively large diameter wire to form the snare loop 502 and the need to maintain a relatively small diameter / profile of the snare catheter as a whole may cause the snare loop wire to be deformed or damaged if fully retracted into the distal tip member 508, depending on the size of these components.

[0444] Fig.153 and Fig.154An alternative embodiment of a distal tip member 516 is illustrated having a single opening, a lower angled surface, and a cylindrical intermediate rod 518 that can be inserted into the distal tip member 516 during the manufacturing process. Likewise, the intermediate rod 518 can help prevent the snare loop 502 from being completely pulled into the distal tip member 516 and damaged. All of these components can be constructed entirely of non-conductive materials or can be coated with non-conductive materials.

[0445] During the procedure, several factors may exert forces on the snare ring, which may cause the snare ring to deflect, thereby increasing the difficulty of snare the heart valve treatment device. For example, the patient's heartbeat, blood flow, the presence of chordae tendineae, the movement of the valve leaflets, and the movement of the heart valve treatment device itself may cause the snare ring to unexpectedly deflect, rotate, twist, or similar movement. Therefore, it is desirable that the snare ring has a certain hardness, which reduces deflection when the snare ring is retracted into the snare catheter, while also limiting damage or deflection. More specifically, it is desirable that the snare ring has a certain hardness, which reduces or substantially prevents deflection, rotation, or twisting about the axis of the snare catheter (e.g., buckling of the proximal or distal end relative to the axis of the snare catheter), or twisting / torsion of the snare ring relative to the axis of the snare catheter. For example, the snare ring may be hard enough to prevent at least the deflection of blood flow through the heart. In another example, the snare ring can be stiff enough to deflect the chordae tendineae and or push the heart valve clip and valve tissue to optimize the ability to capture the heart valve clip.

[0446] Please note that the following examples describe the forces applied to the snare loop in units of mass (e.g., grams) under standard gravity conditions. Those skilled in the art will be able to convert these numbers into force values. The following examples assume that the diameter of the wire below the snare loop is in the range of about 0.001 inches to about 0.030 inches. The following examples assume that the working diameter (i.e., the unconstrained expanded diameter) of the shape of the snare loop is in the range of about 0.100 inches to 1.5 inches. In one example, when a force in the range of about 0 grams to 3 grams is applied to the snare loop (e.g., the distal tip), the snare loop is constructed in a manner that limits the deflection of the distal tip (proximal or distal end) of the snare loop to a range of about 0 mm to 10 mm. In a more specific example, when a force in the range of about 0 grams to 2 grams is applied to the snare loop (e.g., the distal tip), the snare loop is constructed in a manner that limits the deflection of the distal tip (proximal or distal end) of the snare loop to a range of about 0 mm to 5 mm. In another more specific example, when a force in the range of about 0 grams to 2 grams is applied to the snare loop (e.g., the distal tip), the snare loop is constructed in a manner that limits the deflection of the distal end (proximal or distal) of the snare loop to a range between about 0 millimeters and 2 millimeters. In a more specific example, when a force in the range of about 0 grams to 2 grams is applied to the snare loop (e.g., the distal tip), the snare loop is constructed in a manner that limits the deflection of the distal end (proximal or distal) of the snare loop to a range between about 0 millimeters and 2 millimeters. In yet another specific example, the snare ring is constructed in such a manner that: when a weight of about 0.75 grams is applied, its distal tip deflects about 1 mm; when a weight of about 1.125 grams is applied, its distal tip deflects about 1 mm; when a weight of about 1.5 grams is applied, its distal tip deflects about 2 mm; when a weight of about 1.875 grams is applied, its distal tip deflects about 2 mm ("about" means a range of + / - about 15%). Please note that the stiffness, underlying wire size, and working ring diameter of the snare ring examples described above also apply to the examples of cutting rings and tightening rings of capture baskets described elsewhere in this specification.

[0447] In general, there are several different ways to construct a snare loop that is relatively stiff and therefore deflects or twists less during surgery (e.g., deflection as noted in the example ranges above). In one example, the snare loop can be formed from a solid wire (such as Nitinol) rather than a braided / twisted / wrapped wire. In another example, the snare loop can be formed from a wire with an outer coating (such as a metal or polymer coating). Solid or braided / twisted / wrapped Nitinol wire can be coated with stainless steel, polymers, or even radiopaque materials such as gold, platinum, or tantalum. Therefore, drawn fill tubes (DFTs) can also be used for snare loops. In another example, multiple wires adjacent to each other can also be used. In another example, a braided reinforced tube or wire (i.e., a tube or wire with a braided wire layer on the outside) can also be used. In another example, a square or rectangular cross-sectional shape can also be used.

[0448] Fig.155 An example of a snare loop 502 connected to an internal control member 418 (e.g., a core wire) is illustrated, which can provide a desired level of anti-deflection capability or stiffness during surgery. The snare loop 502 can be composed of a solid shape memory wire (such as a nitinol wire) with a diameter in the range of about 0.001 inches to 0.03 inches. Such a nitinol wire can optionally include one or more radiopaque markers (e.g., a radiopaque coil or sleeve at the tip or side, or a radiopaque coating on the nitinol wire). An electrically insulating coating can also be located on the shape memory wire and the radiopaque markers.

[0449] The proximal end of the shape memory wire can be connected to the inner control member 418 via a distal crimp 505A (e.g., a metal sleeve crimped onto another component). The distal region of the inner control member 418 can include a polymer heat shrink tubing 507, which can add some rigidity but can also electrically insulate the inner control member 418 to avoid use near the cutting ring. The heat shrink tubing 507 can be further connected to the inner control member 418 via a distal crimp 505A and a proximal crimp 505B.

[0450] The snare loop may also include a sharpened distal end to aid in navigating through the chordae tendineae during surgery. Fig.148 The snare loop 502 includes a rounded point, but may also be a more aggressive angled point. For example, it is desirable to form a distal point in which two areas of the line of the snare loop are connected together at an angle (rounded or abrupt) in the range of about 80 degrees to about 130 degrees. Alternatively, the snare loop may have a protruding feature (e.g., spherical, cubic, triangular, pyramidal, or elongated) extending outward from the distal portion of the distal tip.

[0451] Cutting rings have been discussed in this specification as being used to cut tissue within a patient's vascular system, and in particular, for example, during a surgical procedure to remove a heart valve (note that the term "cutting ring" is broadly defined in this specification to include a full ring, a partial ring, or any elongated curved shape). In addition, the cutting rings of this specification may also be used to cut chordae tendineae and / or heart / valve tissue. The cutting ring may be used alone, as part of a separate cutting ring catheter, or in combination with other devices described in this specification, such as a capture basket (e.g., combined as a single tool or used as a separate tool). In addition, the cutting rings of this specification may have the same dimensions, and in particular, the same level of stiffness, as the snare rings previously described, such that deflection or twisting of the cutting ring is minimized or prevented, at least based on blood flow pressure within the heart.

[0452] In certain uses, it is desirable to deliver relatively high RF powers to the cutting ring to better cut the target tissue (e.g., powers in the range of about 5 watts to 1600 watts). However, such higher RF powers may damage portions of the cutting ring in certain circumstances (e.g., during partial or full exposure to blood and not fully embedded in tissue) because they generate higher temperatures. Since the cutting ring may be primarily composed of shape memory materials (e.g., nitinol), these higher temperatures may change any heat-set shape imparted to the material and cause other damage. Such damage may hinder or prevent further cutting and increase the difficulty of removing the cutting ring from the patient. Therefore, it is desirable to improve the delivery of higher RF powers by incorporating certain materials and / or shapes into the electrodes. These techniques may be used with any cutting ring or cutting device described in this specification.

[0453] Turning first to materials, it is desirable that the electrodes of the cutting ring be constructed of a material that can withstand higher temperatures before damage. In this case, a material that does not have shape memory properties, such as stainless steel or similar metals, may be used. For example, the cutting ring may be formed from one or more wire segments of shape memory wire (e.g., Nitinol) connected to adjacent wire segments of non-shape memory wire (e.g., stainless steel). Alternatively, a non-shape memory tube or sleeve may also be connected (e.g., crimped, welded, adhered, etc.) to a shape memory wire (e.g., Nitinol) to form an electrode. The shape memory wire segment may include an electrically insulating outer layer such that only the non-shape memory portion is exposed to form the electrode.

[0454] Fig.156 and Fig.157An exemplary embodiment of such a configuration is illustrated, wherein a cutting ring 520 has a main ring segment 524 formed of a partial shape memory wire and one or more electrodes 522 formed of a partial or full non-shape memory material (e.g., a stainless steel wire segment or sleeve). An electrically insulating layer 525 may be provided on at least the main ring segment 524 and may also be provided on a portion of the electrode 522 if desired. Again, while only one electrode 522 is shown, multiple electrodes and segments are possible.

[0455] Turning next to the geometry of the cutting ring electrode, the shape of the electrode also helps to reduce damage to the components of the cutting ring (such as shape memory wires and electrical insulators). The applicant has found that electrodes with points, edges, raised surfaces, or similar features may concentrate electrical dissipation areas. In this regard, electrodes with these features may require less RF power than electrodes without these features, and therefore may help to keep the temperature of the non-electrode portion of the ring at a more desirable level to avoid damage. Therefore, such electrodes may have a larger diameter relative to the adjacent main ring segments, including the shapes specified herein. Exemplary electrode shapes include cylindrical, spherical, cubic, arc-shaped, ridged, and similar variations and combinations (e.g., cylindrical with ridges). These electrode shapes can be used with any other electrode or cutting ring features described in this specification. In addition, if multiple electrodes are included, the shapes of all electrodes may be the same or different. In addition, the shape may extend uniformly or uniformly around the circumference of the electrode, or may extend only from a portion of the electrode (e.g., from the inside or outside of the ring).

[0456] Figure 158-Figure 160 An example of a cutting ring 526 is shown that is generally similar to the previously described cutting ring 520, but has an electrode 528 that has a generally cylindrical shape that is thicker or taller than the surrounding portion of the main ring segment 524 and the insulating layer 525. The electrode 528 can be formed from a discrete section of wire (e.g., stainless steel) connected to the main ring segment 524, or can be formed from a sleeve of shape memory wire that partially or completely surrounds the lower portion of the cutting ring 526, such as Fig.160 As shown in the cross-sectional view.

[0457] Fig.161 Another exemplary shape of electrode 530 is illustrated, where the electrode 530 is relatively spherical or rounded in shape and is elevated relative to adjacent areas of the cutting ring.

[0458] Fig.162The generally cylindrical electrodes 532 are shown connected to two adjacent ends of the main ring segment 524. To enhance the connection with the main ring segment 524, the electrodes 532 may form a cylindrical linear cavity on either end, sized so that the main ring segment 524 and optional insulating layer 525 may fit and be connected (e.g., adhered, welded, etc.) in the cavity.

[0459] Fig.163 The electrode 534 is similar to the cylindrical electrode 532, but its outer surface has a raised rounded middle relative to its two ends. In other words, the radial diameter of the electrode 534 gradually decreases from its middle toward the two ends.

[0460] Fig.164 The electrode 536 is illustrated as having a generally cylindrical shape with a central ridge extending partially or completely around the electrode 536. In this example, the electrode 536 is connected around the main ring segment 524, and the insulating layer is provided on a portion of one or more ends of the electrode 536. Alternatively, the insulating layer 525 may not be provided on the electrode, such as Fig.165 As described in electrode 538.

[0461] Fig.166 An electrode 540 is illustrated that is similar to electrodes 536 and 538, but has a relatively wider cylindrical middle ridge.

[0462] In another example, the electrode may be a wire that is spaced apart from the main ring segment 524 and the insulating layer 525 along most of its length. Fig.167 One such example of a cutting ring 542 is illustrated with a wire electrode 544 connected to the cutting ring 542 at each of its ends such that part or all of the wire electrode 544 is spaced apart from the cutting ring 542 to form a space or gap. In this example, both ends of the wire electrode 544 are connected at locations on either side of the middle end or point of the cutting ring 542, however, other locations (e.g., along only one side of the cutting ring 542) may also be possible.

[0463] As described earlier in this specification, the cutting ring may also include a plurality of electrodes. For example, Figure 168-Figure 170 A cutting ring catheter 541 is illustrated having a distal cutting ring 546 having a plurality of electrodes 548 (e.g., the electrodes 548 have any shape or configuration mentioned in this specification). In this example, a first electrode 548A is positioned at the middle and most distal position on the cutting ring 542, while a second electrode 548B and a third electrode 548C are positioned on either side of the first electrode 548A and within the distal half of the cutting ring 542. Fig.171A similar cutting ring 545 is illustrated without the middle electrode but with a first electrode 547A and a second electrode 547B on either side of the distal half of the cutting ring 545. Element numbers 549A and 549B indicate the location of additional optional electrodes or alternative locations of electrodes.

[0464] Monopolar RF can be used to power these cutting rings with multiple electrodes (as well as single electrode embodiments). In these examples, each of the multiple electrodes can be connected to the same circuit so that they are activated at the same time. For example, each electrode can be connected to a shape memory wire underneath the cutting ring, which is further electrically connected to an internal control member (or a separate wire) that is ultimately connected to an RF power source near the proximal end of the cutting ring catheter.

[0465] Alternatively, all or some of the electrodes may be located on separate circuits from one another so that they can be independently activated by the RF power source. Thus, additional wires may be added under the insulating layer 525 and connected to one or more electrodes. As described later in this specification, this may allow a user to activate some or all of the electrodes via the RF power source. In addition, the electrode impedance may be measured by the RF power source to help determine whether the electrode is in contact with tissue or blood.

[0466] Although the cutting ring described in this specification is mainly considered to be a closed ring shape, other shapes are also possible. For example, an open ring shape, a partial spiral disk shape and the like are also possible. Fig.172 An example of a cutting ring device 556 having a hook, "C" or open loop shape 558 is illustrated. The arcuate shape may lie substantially within a single plane or may be a non-planar spiral. The inner surface 558A may include one or more electrodes, the outer surface may include one or more electrodes, or the electrodes may wrap around the inner and outer surfaces. In addition to tissue release heart valve treatment devices, this shape may be particularly useful for cutting chordae tendineae.

[0467] Whether using a full ring shape, the previous hook shape, or other chord cutting devices described in this specification, several different ways to reach and cut the chordae of the mitral valve are possible. For example, a transaortic approach to the mitral valve may be possible. A transapical approach to the mitral valve may also be possible. A transatrial approach to the mitral valve may also be possible. After performing the desired cut, a snare and / or capture basket may optionally be used.

[0468] The cutting rings in this manual include Figure 156-Figure 168 The cutting ring, recently discussed in , can be included as a single catheter device with a capture basket, such as Figure 9-11 or Fig.105The capture basket shown in the figure may be a separate cutting loop catheter connected to an internal control member (such as a control wire) within the sheath, similar to the snare catheter described in this specification. The latter configuration may allow the user to use different cutting loop configurations during surgery and / or to use the cutting loop catheter separately from the capture basket catheter (i.e., the cutting loop catheter, the capture basket catheter, and / or the snare catheter may be used separately as needed).

[0469] In addition, it is conceivable that certain surgeries may only require the use of a cutting ring or a chord cutting tool, so in this case a "stand-alone" cutting ring catheter may be used. For example, the cutting ring of the cutting catheter can be used as both a cutting ring and a snare ring. The cutting ring can be pushed into the patient's heart and the desired tissue (cutting chords and / or leaflet tissue). The cutting ring is placed around a heart valve treatment device (such as a valve clip) and tightened, while the electrodes of the cutting ring are optionally activated again to cut the necessary remaining tissue, thereby completely releasing the heart valve treatment device. The cutting ring can then be used to retract the heart valve treatment device.

[0470] The cutting ring and similar electrical cutting mechanisms of the present specification may include one or more electrodes that form a circuit that can be connected to an RF power source. In a cardiac environment, such electrodes may be in contact with blood and tissue to varying degrees, which can complicate tissue cutting. Applicants have found that it is sometimes necessary for electrodes on a cutting ring or similar device to generate sparks or plasma within the heart in order to cut tissue as desired. Applicants have also found that by using RF power within a certain range, particularly RF power within a range of about 5 watts to 1600 watts, and by using electrodes with specific areas, plasma generation and subsequent tissue cutting can be enhanced. It should be noted that the use of additional electrodes on the same circuit may require proportionally increased power (or providing a separate power generator for each electrode), and that activating only specific electrodes of multiple electrodes that are all located on different circuits may limit the required power.

[0471] For example, the surface area of ​​a single electrode may be in the range of about 0.003 square inches to about 0.006 square inches. In another example, the surface area of ​​a single electrode may be in the range of about 0.003 square inches to about 0.030 square inches. In another example, the surface area of ​​a single electrode may be in the range of about 0.004 square inches to about 0.005 square inches. In a specific example, the surface area of ​​a single electrode is about 0.00437506 square inches. A cutting ring with multiple electrodes may have similar values ​​for each electrode that is part of the cutting ring (e.g., 0.00437506 times the number of electrodes). The electrode area may include all exposed surfaces, including horizontal and vertical surface areas.

[0472] This specification describes different capture baskets for capturing and removing a heart valve therapy device. As previously described, a patient's heartbeat may cause movement of valve leaflets, chordae tendineae, and heart valve therapy devices, among other things. Such movement may cause the capture basket (and other components) to move or beat within the patient's heart. Therefore, it may be helpful to limit the freedom of movement of the capture basket in its deployed or expanded state.

[0473] For example, it may be helpful to provide multiple points along the length of the basket for connection to the basket catheter (e.g., the tip of the basket catheter). In a more specific example, the catheter may be connected near a distal-most first location (e.g., a cinch ring) and at a more distal second location (e.g., a more distal portion of the wire attached to the basket). Alternatively, the outlet of the cinch ring of the basket may be located proximal to the catheter tip to allow the catheter tip to extend distally along the basket (e.g., 2-10 mm) and thereby act as a stop to prevent the basket from rotating around the catheter tip.

[0474] For example, Figure 173-Figure 175 Various aspects of a capture basket catheter 550 having multiple connection points to the capture basket 102 are illustrated. The capture basket catheter 500 is depicted as including only the capture basket 102 and can be used with other components described herein, such as a snare catheter and a cutting loop catheter. However, a cutting loop can also be incorporated into the catheter 550 as described in other embodiments of the present specification.

[0475] Capture basket catheter 550 may include an elongated catheter body having at least one inner lumen through which the wires of cinch ring 106 are positioned, allowing a user at the proximal end of catheter 550 to pull and cinch the top of basket 102 to close.

[0476] The distal portion of the catheter 550 may include a distal tip member 552 that facilitates connecting the basket to the catheter 550 at two axial or longitudinal locations. Specifically, the distal tip member 554 may include one or more (e.g., two) openings 552A at a first axial location (i.e., at a first length from the distal end of the distal tip member 552A). The wire of the cinch ring 106 may pass through the one or more openings 552A and into the lumen of the catheter body 554 (e.g., if there are two openings, a portion of the wire may enter one opening and a second portion of the wire may enter the second opening).

[0477] The distal tip member 554 may also include a second connection point located distal to the opening 552A. The second connection point may be one or more openings 552B (e.g., 2) through which the wires of the basket 102 may pass, or alternatively, a separate connection member (such as a wire or a strap) may pass through the opening 552B to connect, tie, weld, adhere, or otherwise connect to a portion of the basket 102 and the distal tip member 554. Alternatively, the distal tip member 554 may be directly welded or adhered to the wires of the basket 102, or a further distal portion of the distal tip member 554 may not be further connected, but rather act as a stop to prevent the basket from rotating beyond the axis of the basket catheter 550.

[0478] As previously mentioned, in some situations it may be desirable to use separate catheters for the cutting ring, capture ring, and capture basket, or to use a catheter with multiple components (e.g., a cutting ring and capture basket) on a single catheter. Figure 176-Figure 179 A delivery sheath 580 is illustrated that assists a user in delivering and / or switching between multiple catheter devices. In general, a delivery sheath can include an elongated tubular portion 581 having a sheath lumen connected to a hub 582. The hub 582 serves as an entry point for the elongated tubular portions 581 of multiple catheters during a procedure.

[0479] The hub 582 may include a plurality of ports that open into an inner lumen 590 formed by the housing of the hub 582. The hub 582 may include 2, 3, 4, 5, 6, or more ports. In this example, the hub 582 may include three ports 584, 588, and 586 that open at different angles relative to each other at the proximal end of the hub 582.

[0480] The width of the cavity 590 may taper or decrease in the distal direction toward the elongated tubular portion 581 to allow multiple catheters to converge and all enter the lumen of the elongated tubular portion 581. In one example, the cavity 590 may have a generally triangular shape. To further assist the converging of the catheters into the elongated tubular portion 581, a funnel member 591 may be provided at the distal end of the cavity 590. The funnel member 591 may have a passageway of decreasing width, but also have a generally elliptical cross-sectional shape, the width of which is generally consistent with the triangular width of the cavity 590. The funnel member 591 may be a separate member from the housing member forming the cavity 590, or may be an integral shape of the housing member forming the cavity 590.

[0481] You can also include an additional port 589 ( Fig.176) to access cavity 590 during surgery for the purpose of removing air and / or connecting a fluid dropper. Note that port 589 is positioned so that when the port is facing upward, any air within cavity 590 may rise toward port 589 to facilitate removal of the air. Any or all ports may include a valve, such as a hemostatic valve, for closing the port when not in use or around a passing catheter. Fig.179 The delivery sheath is shown for use with three separate catheters 550, 500 and 541, which have been described herein.

[0482] It is desirable to use a loading tool such as Fig.178 The loading tool 592 in the hub 582 is used to load a catheter or a guide wire into the hub 582, especially to facilitate the exchange of such tools in the patient during surgery. In one example, the loading tool 592 can have an elongated tubular portion that is optionally reduced at its distal end and can further include a valve, such as a hemostatic valve, at its proximal end. Some ports (such as ports 584 and 586) may be relatively larger than other ports to accommodate loading tools with larger diameters during surgery, while other ports (such as port 588) are relatively small and may not be intended to be used or exchanged with the loading tool during surgery (e.g., may have a locking TuohyBorst valve). The loading tool 592 may also include a releasable locking mechanism that engages the catheter therein and can therefore maintain the position of the catheter in the patient during surgery.

[0483] Capture basket catheters have been previously described primarily as being oriented so that they are open proximally relative to the user and the catheter. However, depending on the manner of access to the patient's heart, a distally open basket may be desired. For example, Fig.180 A capture basket catheter 556 is illustrated with a basket 102 having a distal opening. The proximal end of the basket 102 may be connected to an elongated catheter or sheath 557, and the snare catheter 500 and the cutting loop catheter 541 may be positioned along or through the central channel of the capture basket catheter 556. In either arrangement, features may be included to reduce the likelihood of scraping the snare catheter and / or cutting any electrical insulator on the catheter (e.g., the basket 102 may include a coating to reduce wear and / or rounding / reducing sharp edges). Optionally, the basket 102 may also include a cinch ring 106 for closing the basket 102, similar to the cinch rings discussed previously in this specification. Such a cinch ring 106 may pass through a second catheter 559 or a portion of a catheter 557 having a distal end that extends distally to the distal opening of the basket 102.

[0484] The chordae tendineae or chordae are generally considered to be inelastic cords of fibrous connective tissue that connect the papillary muscles to the tricuspid and mitral valves in the heart. Multiple chordae tendineae are attached to each leaflet or cusp of the valve of the valve. During the removal of heart valve treatment surgery or other surgical procedures, it may be necessary to move, restrict and / or cut one or more chordae tendineae. In this regard, during certain surgical procedures, a chord capture-cutting device may be helpful.

[0485] A general example of a chord capture-cutting device may include a capture member having an elongated catheter body having at least one lumen extending through and a distal opening of the lumen that can move into and out of the catheter body. The distal end of the capture member may include a feature or shape that can engage with one or more chords in the heart. For example, the capture member may be an elongated shape memory wire, the distal end of which has a memory shape of a spiral, annular, hook, conical / spiral ring, sail, square ring, elliptical ring, circular ring, triangular ring, rectangular ring, and similar shapes when unconstrained. Alternatively, the capture member may be a steerable catheter or guide wire that allows the user to actuate and create the shape described above when needed. Once engaged with one or more chords, the capture member may limit the position of the chord or may cut the chord. For example, the chord may be partially pulled into the opening and lumen of the catheter and a cutting element with a sharp edge is pushed against the chord, or the chord may be cut by activating a radiofrequency electrode on the capture member.

[0486] Fig.181 An example of a chord capture-cutting device is illustrated, comprising an elongated catheter body 562 having at least one lumen opening at a proximal end of the device and an opening 562A at a distal end of the device. Opening 562A is shown opening at a sidewall of the catheter body 562 (e.g., generally perpendicular to the axis of the catheter body 562), but may also be located at the most distal end of an axial or distal opening location.

[0487] The cutting element 564 can be positioned within the lumen of the catheter body 562. In this embodiment, the cutting element can have a generally tubular shape at its distal end and can extend to the proximal end of the catheter body so that a user can translate the cutting element 564 distally and proximally. The distal edge of the cutting element 564 has a sharp edge, here a rounded terminal edge of the tubular shape, which can be used to cut one or more chordae tendineae, as described below.

[0488] Capture member 560 can be an elongated wire, multiple wires, a tubular structure, or a similar elongated structure and can be positioned within the lumen of catheter body 562 and can be positioned adjacent to or within the lumen of cutting element 564, such as Fig.181In this embodiment, the distal end of the capture member 560 has an arcuate or spiral shape (eg, a spiral or helical / spiral shape within a single plane) when unconstrained (giving the shape memory material a memory shape).

[0489] The capture member may have a variety of different distal end shapes for capturing one or more chordae tendineae (e.g., forming a curved diameter in the range of about 0.15 inches to about 1.5 inches). Fig.182 A capture member 566 having a hook shape is illustrated. In another example, Fig.183 The capture member 568 is illustrated as forming a plurality of spiral shaped loops. In another example, Fig.184 The capture member 570 is shown as forming a plurality of loops and ending in a spiral shape. In another example, Fig.185 Capture member 572 is shown having a helical shape with a sudden curve or hook-like shape terminating therein. Fig.186 The capture member 574 is shown forming a relatively wide, gentle curve. The diameter of the wire, line or structure below the capture member can be between 0.001 inches and 0.030 inches.)

[0490] The cutting element 564 is shown as a tube with its distal edge generally perpendicular to the axis of the cutting element 564. However, other shapes and configurations may also be used. For example, Fig.187 An offset cutting edge 564A is illustrated, wherein the edge is positioned at a non-perpendicular angle (e.g., 45 degrees) relative to the axis of the cutting element 564. In another example, Fig.188 The distal edge 564B is shown forming a plurality of points (eg, two points of a fork). In another example, Fig.189 The distal edge forming a single point 164C is illustrated. In another example, Fig.190 The distal edge 564D is illustrated as being formed in a stepped shape with square or relatively vertical edges. Any of these distal edges can be created in the form of a tubular or solid device (eg, edge 564C can be a tapered shape).

[0491] Any cutting element example can be used with any capture member example disclosed in this specification.

[0492] Figure 191-194 An example of a method of using the chordae tendineae capture-cutting device is shown. First, the distal end of the catheter body 562 is advanced into the heart so that the opening 562A is positioned near the chordae tendineae 21 to be cut, such as Fig.191 In the present example, this may involve entering the left atrium and passing through the leaflets 22, 24 of the valve, although passing through the left atrium is also possible.

[0493] like Fig.192 As shown, the capture member 560 is pushed distally out of the opening 562A, which causes the distal portion of the capture member 560 to slowly form its unconstrained, memorized shape, in this example, a spiral or ring shape, as it is pushed. In this example, as the distal end of the capture member 560 is pushed distally, it will slowly form its memorized shape to partially or completely surround one or more chordae 19. In addition, the capture member 560 can also be rotated, especially when it has a spiral shape, to surround the chordae 21 one or more times.

[0494] like Fig.193 As shown, once capture member 560 has encircled one or more chordae with its distal end, capture member 560 can be retracted proximally, pulling at least a portion of the chordae into the lumen of catheter body 562. In this regard, it may be helpful for opening 562A to be large enough to allow the distal end of capture member 560 to return to the lumen of catheter body 562 after expansion without releasing chordae 19.

[0495] Steering Fig.194 , the cutting element 560 can be advanced distally by the user so that its distal cutting edge contacts and cuts the chordae tendineae 19. The positioning-cutting element described above can be performed multiple times during the surgical procedure until all target chordae tendineae 21 are cut.

[0496] Figure 195-198 A similar technique is shown, but the capture member 560 is initially advanced distally to surround the chordae tendineae 21 and the heart valve clip 40 ( Fig.196 ), tighten( Fig.197 ), and then the capture member 560 moves downwardly away from the heart valve clip 40 ( Fig.198 The tendon 21 may be cut using a cutting element as previously described, or may be cut using a separate cutting device such as a hook-shaped cutting loop.

[0497] Figure 199-Figure 200 A similar procedure as previously described is illustrated, however, capture member 560 may include electrodes 561 that may be energized (eg, using radiofrequency energy) to cut the chordae tendineae.

[0498] As discussed previously in this specification, any cutting ring disclosed in this specification may include multiple independently wired electrodes (ie, each electrode forms a different circuit that can be independently actuated). For example, Figure 168-Figure 170 The cutting ring 546 in the embodiment of the present invention. Such a multi-electrode cutting ring can be connected to a power source (e.g., an RF power source) that can independently sense and energize the electrodes, allowing a user to determine whether a particular electrode is in contact with tissue or blood and then specify which electrode should be electrically activated.

[0499] For example, Fig.201 and202 An RF power generator or power supply 600 is illustrated having a user interface 602 configured to display information within the housing of the RF power generator or as a separately connectable display. The generator 600 may also include a user input, such as a keyboard or via a touch screen interface. It should be understood that the generator 600 is a computerized device that may include a processor and a memory, with software stored in the memory executable by the processor to perform the described functions.

[0500] like Fig.201 As shown, the user interface 602 may include a first tissue contact display that displays information indicating which electrode is in contact with the tissue (e.g., electrode 1, 2, and / or 3). The tissue contact display may be in the form of Fig.201 The cutting rings shown may be graphically depicted, numerically indicated, or variations thereof. Tissue contact may be determined by continuously measuring an electrical value (such as impedance) at each electrode, and tissue contact may be determined when the electrical value exceeds a threshold.

[0501] like Fig.202 As shown, the user interface 602 may also include a second electrode activation display that allows the user to determine which electrodes will be electrically activated when power is delivered to the cutting ring. The electrode activation display may be in the form of Fig.202 The cutting ring graphical depiction, numerical indication, or variations thereof shown. The display may also include an indicator, symbol, text, or other display element indicating whether the electrode is activated or deactivated. In addition, the activation display and tissue contact display may be combined into the same screen so that data is displayed simultaneously.

[0502] Since some situations require the removal of the heart valve clip from the patient, it may be desirable to implant a heart valve clip that is easier to remove. For example, the heart valve clip may include a shape or area that is easier to snug, such as a groove or an enlarged distal end. In addition, the heart valve clip may be configured to apply radiofrequency energy at specific locations that contact the valve tissue, so that when contact is made with the electrodes of the cutting ring, the radiofrequency energy is directed to these tissue contact areas to release the heart valve clip more quickly and reliably. For example, the heart valve clip may be made of a conductive material (such as a fully conductive or electrical pathway), and the rest of the clip is insulated except for the area in the "arm" of the clip that engages the tissue. Alternatively, the outer surface of the heart valve may have an electrode area (e.g., a raised area, ridge, or similar feature) that forms an electrode, allowing the user to apply power to the valve clip and then turn, twist, pull, or otherwise move the valve clip to cut the valve clip and release it from the patient.

[0503] Figure 203-Figure 207An example of a heart valve clip 610 is illustrated having an elongated body with a leaflet attachment mechanism having two elongated arms 610A that form an adjustable "U" shape to clamp or engage leaflet tissue. The distal end of the valve clip 610 may include a snare engagement feature 612 that allows the snare ring to engage more easily. In this example, the feature 612 may include a channel or groove that extends partially or entirely around the diameter of the valve clip 610. Alternatively, the valve clip 610 may include an enlargement on its distal end. In both cases, the snare ring can be positioned on the feature 612 and tightened to form a secure connection. The distal end of the feature 612 is depicted as being circular or cylindrical, but may also be other shapes, such as Fig.208 The rectangular shape of feature 616.

[0504] The heart valve 610 may include areas where electrodes are formed, such as electrodes on the inner surface of the arm 610A. These areas may include raised edges or shapes similar to the cutting ring electrodes discussed previously. Depending on the configuration of the valve clip 610, an insulating coating may be applied to areas that are unlikely to contact tissue.

[0505] The cutting ring can contact another location on the valve clip 610 that is in electrical communication with the electrode surfaces, thereby allowing these electrode surfaces to conduct electrical current. For example, feature 612 can create an electrical path for the inner surface of arm 610A that contacts the leaflet tissue. In such an example, the cutting ring with electrodes can act as a snare to wrap around and engage feature 612 while also delivering power to various areas of the valve clip 610 that engage the leaflet tissue.

[0506] This specification and drawings include many different embodiments and features of the removal device and method of using the same. Although features or techniques may be associated with a particular embodiment, it is the applicant's intent that any feature shown in any embodiment may be incorporated into other embodiments. In other words, any features described herein may be mixed and matched with each other, and therefore, the claims should not be otherwise limited or confined to only the embodiments discussed and described herein.

[0507] As used herein, the term "substantially" or "generally" refers to the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, an object that is "substantially" or "generally" enclosed means that the object is completely enclosed or almost completely enclosed. In some cases, the exact degree of deviation from absolute completeness may depend on the specific context. However, in general, the degree of near completion should be roughly the same as the overall result of absolute and complete completion. When "substantially" or "generally" is used to refer to the complete or nearly complete absence of a certain action, characteristic, property, state, structure, item, or result, its negative connotation also applies. For example, an element, composition, embodiment, or composition that is "substantially free of" or "generally free of" a certain ingredient or element may actually still contain such an item as long as there is generally no measurable effect.

[0508] As used herein, "one embodiment" or "embodiment" means that a particular element, feature, structure or characteristic associated with an embodiment is included in at least one embodiment. The phrase "in one embodiment" appearing in different places in the specification does not necessarily refer to the same embodiment.

[0509] As used herein, the terms "comprises," "includes," "including," "has," "having," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or device that comprises a list of elements is not necessarily limited to those elements and may include other elements not expressly listed or elements native to those processes, methods, articles, or devices. In addition, unless expressly stated to the contrary, "or" refers to an inclusive or and not an exclusive or. For example, condition A or B satisfies any of the following conditions: A is true (or exists) and B is false (or does not exist); A is false (or does not exist) and B is true (or exists); both A and B are true (or exist).

[0510] In addition, "a" or "an" is also used herein to describe elements and components in the embodiments of the present invention. This is done only for convenience and to give a general sense of the description. This description should be understood to include one or at least one, and the singular also includes the plural, unless it is obvious that there is another meaning.

[0511] In addition, the preferred embodiments described in the figures are for illustration purposes only. Those skilled in the art will readily recognize from the discussion herein that alternative embodiments of the structures and methods described herein can be adopted without departing from the principles described herein.

[0512] Although the present invention has been described in specific embodiments and applications, those skilled in the art can, based on the teachings of the present invention, produce more embodiments and modifications without departing from the spirit of the present invention or exceeding the scope of the present invention. Therefore, it should be understood that the drawings and descriptions herein are provided by way of example to facilitate understanding of the present invention and should not be construed as limiting the scope of the present invention.

Claims

1. A snare catheter for use in patient medical treatment, comprising: an elongated sheath having a lumen and one or more openings into the lumen at a distal portion of the elongated sheath; an internal control member extending within the elongated sheath; a snare loop at a distal end of the inner control member and extending from the one or more openings; as well as An electrical insulator is configured to reduce the transmission of electrical current between the patient's heart and the electrical cutting device.

2. The snare catheter according to claim 1, wherein: The electrical insulator is disposed on part or all of the snare ring.

3. The snare catheter according to claim 1, wherein: The electrical insulator includes a coating or tube comprising silicone, polyolefin, polyimide, dielectric material, PTFE, FEP.

4. The snare catheter according to claim 1, wherein: The snare loop includes one or more wires composed of Nitinol or stainless steel.

5. The snare catheter according to claim 1, wherein: The elongated sheath further comprises a distal tip member located at a distal end of the elongated sheath and forming one or more openings; And wherein the electrical insulator further comprises a layer, coating or structural material.

6. The snare catheter according to claim 5, wherein: The distal tip member includes a rounded, curved, or blunted shape around the perimeter of the one or more openings to reduce or limit damage to the electrical insulator.

7. The snare catheter according to claim 6, wherein: The rounded, arcuate or blunted shape is formed by an insert connected to the distal tip member, or by the distal tip member.

8. The snare catheter according to claim 7, wherein: The one or more openings are located on a side of the distal tip member relative to an axis of the elongated sheath.

9. A snare catheter for use in patient medical treatment, comprising: an elongated sheath having a lumen; an internal control member extending within the elongated sheath; a snare ring located at a distal end of the inner control member; as well as a distal tip member connected at the distal end of the elongated sheath, the distal tip member having a first opening and a second opening leading into the lumen of the elongated sheath; wherein the snare loop is positioned through the first opening and the second opening such that a structural feature between the first opening and the second opening prevents the snare loop from being fully pulled into the lumen of the elongated sheath.

10. The snare catheter according to claim 9, wherein: The structural feature of the distal tip member is a rod or a pin.

11. A snare catheter for use in patient medical treatment, comprising: an elongated sheath having a lumen and one or more openings into the lumen at a distal portion of the elongated sheath; an internal control member extending within the elongated sheath; as well as a snare loop at a distal end of the inner control member and extending from the one or more openings; Wherein, the snare loop is configured to limit the deflection of the distal tip of the snare loop to a range of about 0 mm to about 10 mm when a force in a range of about 0 grams to about 3 grams is applied to the snare loop.

12. The snare catheter according to claim 11, wherein The snare loop is configured to limit deflection of a distal tip of the snare loop to a range of about 0 mm to about 5 mm when a force in a range of about 0 grams to about 2 grams is applied to the snare loop.

13. The snare catheter according to claim 11, wherein: The snare loop includes a solid shape memory wire having a diameter in a range of approximately 0.001 inches to 0.03 inches.

14. A tissue cutting catheter for use in patient medical treatment, comprising: an elongated catheter body; as well as A cutting ring extends from a distal portion of the elongated catheter body; wherein the cutting ring comprises one or more shape memory wire segments and one or more electrodes, the one or more electrodes comprising a non-shape memory material.

15. The tissue cutting catheter according to claim 14, wherein: The one or more electrodes include stainless steel.

16. The tissue cutting catheter according to claim 14, wherein: The one or more electrodes include a tube or sleeve connected to the one or more shape memory wire segments.

17. The tissue cutting catheter according to claim 14, wherein: The one or more electrodes each include a non-shape memory wire segment.

18. The tissue cutting catheter according to claim 14, wherein: The one or more electrodes are radially larger than the one or more shape memory wire segments.

19. The tissue cutting catheter according to claim 14, wherein: The cutting ring is an open ring or a closed ring.

20. A tissue cutting catheter for use in patient medical treatment, comprising: an elongated catheter body; as well as A cutting ring extends from a distal portion of the elongated catheter body; wherein the cutting ring includes a main ring segment and one or more electrodes; wherein a diameter of the one or more electrodes is greater than a diameter of the main ring segment.

21. The tissue cutting catheter according to claim 20, wherein: The one or more electrodes have a cylindrical, spherical, cubic, curved and / or ridged shape.

22. The tissue cutting catheter according to claim 20, wherein: The one or more electrodes are disposed on a portion of some of the main cutting ring segments; and wherein the one or more electrodes are positioned on top of, below, or adjacent to an insulating layer of the main cutting ring segments.

23. The tissue cutting catheter according to claim 20, wherein: The one or more electrodes extend completely around or partially around the circumference of one of the primary cutting ring segments.

24. The tissue cutting catheter according to claim 20, wherein: The one or more electrodes are wire segments connected to adjacent ones of the main cutting ring segments.

25. A tissue cutting catheter for use in patient medical treatment, comprising: an elongated catheter body; as well as A cutting ring extending from a distal portion of the elongated catheter body; wherein the cutting ring comprises one or more main ring segments and an electrode; wherein the electrode comprises a wire connected at a first location on the cutting ring and at a second location on the cutting ring so as to form a space or gap with a portion of the cutting ring.

26. A tissue cutting catheter for use in patient medical treatment, comprising: an elongated catheter body; as well as A cutting ring extends from a distal portion of the elongated catheter body; wherein the cutting ring includes a plurality of electrodes.

27. The tissue cutting catheter according to claim 26, wherein: The plurality of electrodes includes a first electrode located at a middle and distal-most position of the cutting ring.

28. The tissue cutting catheter according to claim 27, wherein: The plurality of electrodes include a second electrode and a third electrode located on either side of the first electrode and within a distal half of the cutting ring.

29. The tissue cutting catheter according to claim 26, wherein: The plurality of electrodes include a first electrode on a first side of the cutting ring and a second electrode on a second side of the cutting ring.

30. A capture basket catheter for use in patient medical treatment, comprising: an elongated catheter body; as well as A capture basket at a distal portion of the elongated catheter body; wherein the capture basket is connected at a first distance from the distal end of the elongated catheter body and is connected at a second distance from the distal end of the catheter body, wherein the second distance is less than the first distance.

31. The capture basket catheter of claim 30, wherein: The capture basket is connected at the first distance by a cinch ring.

32. The capture basket catheter of claim 31 , wherein: The capture basket is connected at a second distance between the wire of the capture basket and the opening of the elongated catheter body.

33. The capture basket catheter of claim 32, wherein: The opening is located within the distal tip of the elongated catheter body.

34. A catheter delivery device for use in patient medical treatment, comprising: an elongated sheath having a sheath lumen therethrough; as well as A sheath hub connected to the proximal end of the elongated sheath; wherein the sheath hub includes a plurality of ports opening into a cavity; and wherein the width of the cavity decreases distally; and wherein the cavity further includes a funnel component at the distal end of the cavity and opening into the sheath lumen of the elongated sheath.

35. A chord cutting device for use in the medical treatment of a patient, comprising: an elongated catheter body having a catheter lumen and an opening at a distal end portion of the elongated catheter body that opens into the catheter lumen; a cutting element positioned within the catheter lumen and movable longitudinally within the catheter lumen; as well as an elongated capture member having a distal end that forms an arcuate shape when unconstrained and is movable by a user to extend out of the opening; wherein the arcuate shape is configured to at least partially surround one or more chordae tendineae within the heart and retract the chordae tendineae into the opening; and wherein the cutting element is movable distally against the chordae tendineae to cut the chordae tendineae within the catheter lumen.

36. The tendon cutting device according to claim 35, wherein: The elongated capture member is positioned within the lumen of the cutting element.

37. The tendon cutting device according to claim 35, wherein: The elongated capture member is positioned within the catheter lumen and outside the cutting element.

38. The tendon cutting device according to claim 35, wherein: The opening is positioned through a sidewall of the catheter body.

39. The tendon cutting device according to claim 35, wherein: The arc shape is a ring shape, a spiral shape, a helix shape, a hook shape, or a plurality of ring shapes with hook ends.

40. The tendon cutting device according to claim 35, wherein: The capture member includes one or more wires having a diameter in the range of 0.001 to 0.030 inches.

41. The tendon cutting device according to claim 35, wherein: The arcuate shape has a working diameter in the range of about 0.15 inches to about 1.5 inches.

42. The chord cutting device of claim 35, wherein: The cutting element has a distal end forming a beveled edge, multiple points, a single point, or a stepped shape.

43. The tendon cutting device according to claim 35, wherein: The cutting element is tubular or solid in shape.

44. The tendon cutting device according to claim 35, wherein: The cutting element is an electrode located on the capture member and configured to deliver electrical current to cut tissue.

45. A method for treating tendon chordae tendineae, comprising: advancing the elongated catheter body into the heart; pushing a distal end portion of the elongated capture member out of the opening of the elongated catheter body; allowing a distal portion of the elongated capture member to bend about one or more chordae; moving a distal portion of the elongated capture member and a portion of the one or more chordae proximally into the lumen of the elongated catheter body; as well as A cutting element within the lumen of the elongated capture member is actuated to cut the one or more chordae tendineae.

46. ​​The method of claim 45, wherein: Actuating the cutting element further includes moving a cutting edge of the cutting element distally against the one or more chordae.

47. The method of claim 45, wherein: Actuating the cutting element includes supplying radio frequency power to electrodes on the elongated capture member.

48. The method of claim 45, wherein: Allowing the distal portion of the elongated capture member to bend around the one or more chordae also includes allowing the distal portion of the elongated capture member to bend around a heart valve clip.

49. A method for treating tendinous chordae, comprising: advancing the elongated catheter body into the heart; pushing a distal end portion of the elongated capture member out of the opening of the elongated catheter body; allowing a distal portion of the elongated capture member to bend about one or more chordae tendineae and a heart valve clip; moving a distal portion of the elongated capture member and a portion of the one or more chordae proximally into the lumen of the elongated catheter body; as well as A separate cutting element is advanced into the heart and cuts the captured one or more chordae tendineae.

50. A method for treating chordae tendineae, comprising: advancing the elongated catheter body into the heart; pushing a distal end portion of the elongated capture member out of the opening of the elongated catheter body; allowing a distal portion of the elongated capture member to bend about one or more chordae; as well as Electrodes on the elongated capture member are actuated to cut the one or more chordae tendineae.

51. A radio frequency power generator for patient medical treatment, comprising: A radio frequency power generator housing, the radio frequency power generator housing comprising a processor, a memory, and software code executable by the processor; as well as a user interface capable of being controlled by the processor and the software code; Therein, the software code is configured to measure electrical signals of a plurality of electrodes on the cutting ring and then display whether each of the plurality of electrodes is in contact with tissue.

52. A radio frequency power generator for patient medical treatment, comprising: A radio frequency power generator housing, the radio frequency power generator housing comprising a processor, a memory, and software code executable by the processor; as well as a user interface capable of being controlled by the processor and the software code; Wherein the software code is configured to individually activate or deactivate each of the plurality of electrodes on the cutting ring.

53. A heart valve clip for treating a heart valve, comprising: Clip body; a leaflet attachment mechanism configured to attach to leaflet tissue; as well as A snare loop engagement feature includes a channel, groove or enlargement at the bottom of the clip body.

54. A heart valve clip for treating a heart valve, comprising: Clip body; a leaflet attachment mechanism configured to attach to leaflet tissue; as well as An electrode is configured to deliver current when current is supplied to the clip body.

55. A tissue cutting catheter for use in patient medical treatment, comprising: an elongated catheter body; as well as a cutting ring extending from a distal portion of the elongated catheter body and comprising one or more electrodes; Wherein the surface area of ​​each of the one or more electrodes is in the range of about 0.003 square inches to about 0.006 square inches.

56. The tissue cutting catheter of claim 55, wherein: The one or more electrodes each have a surface area of ​​approximately 0.00437506 square inches.

57. The tissue cutting catheter of claim 55, wherein: The one or more electrodes are connected to a power source configured to supply radio frequency power in a range of approximately 5 Watts to 1600 Watts.

58. The tissue cutting catheter of claim 55, wherein: The one or more electrodes each have a surface area in a range of 0.003 square inches to 0.030 square inches.

Images