Tissue excision, cutting and removal systems and methods

Abstract

To provide methods and devices for diagnosis and treatment of cardiac valves.SOLUTION: A catheter includes a distal end. The distal end includes: a collapsible basket mounted thereon; and a deployable snare. A user can use the basket to at least partially surround an object attached to a tissue mass, collapse the basket around the object, and then sever the tissue mass by cutting through the tissue mass with the snare.SELECTED DRAWING: Figure 10A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority from: Namely, U.S. Patent Application No. 62 / 913,150 (filed October 9, 2019), U.S. Patent Application No. 62 / 913,158 (filed October 9, 2019), U.S. Patent Application No. 62 / 924,358 (filed October 22, 2019), U.S. Patent Application No. 62 / 939,907 (filed November 25, 2019), U.S. Patent Application No. 62 / 939,877 (filed November 25, 2019), U.S. Patent Application No. 63 / 047,995 (filed July 3, 2020), U.S. Patent Application No. 63 / 052,450 (filed July 15, 2020), and U.S. Patent Application No. 63 / 077,579 (filed September 12, 2020). This patent application is also related to U.S. Patent Application No. 16 / 563,925 (filed September 8, 2019), which in turn claims the benefit of U.S. Patent Application No. 62 / 728,413 (filed September 7, 2018), and International Patent Application No. PCT / US2018 / 48177 (filed August 27, 2018), which in turn claims the benefit of priority from U.S. Provisional Application No. 62 / No. 550,347 (filed August 25, 2017), U.S. Provisional Patent Application No. 62 / 567,203 (filed October 2, 2017), U.S. Provisional Patent Application No. 62 / 663,518 (filed April 27, 2018), U.S. Provisional Patent Application No. 62 / 688,378 (filed June 21, 2018), and U.S. Provisional Patent Application No. 62 / 712,194 (filed July 30, 2018). Each of the foregoing patent applications is incorporated herein by reference in its entirety for all purposes.

[0002] background The present disclosure relates generally to treatment devices and techniques, and in some aspects to methods and devices for the diagnosis and treatment of heart valves. The present disclosure offers improvements over the state of the art. Summary of the Invention [Problem to be solved by the invention]

[0003] Summary of the Disclosure The present disclosure provides various systems and methods for removing structures such as clips, cysts, etc. from valve leaflets. The present disclosure further provides a system for modifying or removing a luminal valve leaflet. The present disclosure also provides other innovations, which are as follows: [Brief explanation of the drawings]

[0004] [Figure 1] FIG. 1 illustrates a further embodiment of a grasping catheter according to the present disclosure. [Figure 2] FIG. 2 illustrates a cross-sectional view of an extruded main body portion of an exemplary catheter according to the present disclosure. [Figure 3] 3A-3D present various embodiments of dual lumen catheters according to the present disclosure. [Figure 4] Figure 4 shows the embodiment of Figure 3A, which includes a snare catheter that is positioned through the small lumen, for example, to capture a guidewire in a medical procedure. [Figure 5] 5A-5B illustrate an articulating catheter that has two preformed bends that revert to their bent shape when advanced distally from the main catheter. [Figure 6] FIG. 6 illustrates an exemplary cross section of a catheter according to the present disclosure. [Figure 7] 7A-7C present various views of a further embodiment of a catheter according to the present disclosure. [Figure 8] 8A-8E provide views of yet further catheters according to the present disclosure. [Figure 9]Figures 9A-9C present a procedural perspective that uses the embodiment of Figures 8A-8E with the tricuspid valve anatomy. [Figure 10] 10A-18G illustrate an embodiment of a first clip or cyst removal system according to the present disclosure. [Figure 19] 19A-26D illustrate embodiments of leaflet removal systems according to the present disclosure. [Figure 27] 27-57 illustrate embodiments of methods and systems for removing aortic valve cusps according to the present disclosure. [Figure 58] 58A-94 illustrate embodiments of methods and systems for coupling valve leaflets according to the present disclosure. [Figure 95] 95-104 illustrate yet further embodiments of guidewire denudation systems according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0005] Detailed Description The present disclosure provides various methods and systems. In some implementations, the present disclosure provides systems and methods for: Removing structures within an anatomical structure that are no longer desired. For example, if Alfieri sutures (or clips) are used to attach portions of two heart valve leaflets to one another, the disclosed embodiments may be used to cut through one or both of the leaflets, thereby freeing them from one another and, if desired, preparing the site for a replacement valve, for example, by making one or more additional cuts in each native leaflet or by removing a portion, substantially all, all, or one or more of the native leaflets. If desired, all of the leaflets may be removed, and any structures attached thereto (e.g., chordae tendineae) may also be severed or removed. In some implementations, the sutures or clips (e.g., Mitral clips) may be removed from the patient's mitral valve, after which further treatment steps may be performed, including repairing the leaflets, reshaping the leaflets, removing all or part of one or all leaflets, or severing the leaflets and any chordae tendineae to make room for a replacement valve, if desired.

[0006] Similar procedures for ablating or cutting tissue anywhere in the body may be used by utilizing devices and methods according to the present disclosure. Such a procedure may be used to cut a valve leaflet, for example, any of the heart valves, any valve in a vein (such as the IVC), or any other anatomical structure in the body.

[0007] When using energized tissue cutting techniques, any suitable power levels and conditions of use may be used in accordance with the disclosed embodiments. For example, continuous duty (cutting) radio frequency ("RF") energy may be used at a power level of, for example, between about 50 and 100 watts (or any about 1 watt increment therebetween). The cutting may be accomplished by applying power for about one-half to about five seconds (or any tenth of a second increment therebetween).

[0008] 1 presents an alternative embodiment of grasping catheter 500, which may be used in place of a pair of catheters to simply grasp the edges of valve leaflets 475. The catheter 500 includes a tubular outer body 510 having a proximal end, a distal end, and a longitudinal passageway therethrough. A slidable inner gripping mechanism is slidably disposed within the lumen of outer body 510. It includes a proximal actuator or handle 502. This is connected to an elongated inner body 518, which separates at bifurcation 516 into first arm 512 and second arm 514, which in turn terminate in inwardly pointed gripping ends 524, 526. Arms 512, 514 are biased away from one another and can be biased together by retracting the arms and associated tips toward the distal end of the tubular member 510. Thus, by controlling the relative positioning of the inner mechanism and the outer tube, the jaws formed by the arms 512, 514 and gripping ends 524, 526 can be opened or closed. Catheter 500 may be used as a secondary catheter in any of the embodiments herein.

[0009] The present disclosure also provides a robotic manipulator having a proximal end and a distal end, including an elongated tubular arm having a proximal end and a distal end and defining at least one elongated passageway therethrough, the elongated tubular arm defining a longitudinal axis along its length. The manipulator further includes a first elongated inner body having a proximal end and a distal end, slidably disposed within the at least one elongated passageway of the elongated tubular arm. The distal end of the first inner elongated body is biased (or otherwise configured (e.g., preformed, steering wire, etc.)) to curl and point proximally away from the longitudinal axis when the first inner elongated body is advanced distally relative to the arm. The manipulator further includes a second elongated inner body having a proximal end and a distal end, which is slidably disposed within the at least one elongated passageway of the elongated tubular arm, and which may be slidably disposed relative to the first inner body. The distal end of the second inner elongate body may be biased to curl away from the longitudinal axis and toward the deployed proximally-facing distal end of the first inner elongate body when the second inner elongate body is advanced distally relative to the arm.

[0010] At least one of the elongate tubular arm, first elongate inner body or second elongate inner body may be connected to an axial actuator configured to advance the connected component along a direction parallel to the longitudinal axis. Additionally, at least one of the first elongate inner body or the second elongate inner body of the elongate tubular arm may be connected to a rotational actuator configured to rotate one or more of the elongate tubular arm, the first elongate inner body, and the second elongate inner body.

[0011] At least one of the first elongate inner body and the second elongate inner body may have an end effector attached thereto that is configured to perform at least one of the following functions: cutting, grasping, irrigating, evacuating, observing, or aspirating. If desired, the end effector may include one or more of an electrosurgical device, a blade, and an ultrasonic transducer.

[0012] The present disclosure also provides for the implementation of laparoscopic, urological, gynecological, neurological, or orthopedic surgical procedures utilizing the catheters or robotic manipulators disclosed herein. The disclosed catheter / manipulator may also be used in any suitable minimally invasive or percutaneous procedure.

[0013] For example, the percutaneous procedure may involve accessing a patient's sinus passageways using one or more of the disclosed devices. The device may be used, for example, to remove one or more polyps, and may even be used to breach the thin bone layer within the sinus, thereby gaining access to the cranial cavity and thereby performing a procedure inside the cranial cavity.

[0014] In other embodiments, the percutaneous procedures disclosed herein may include ablation procedures (eg, at locations such as within a patient's heart) and cryoablation procedures.

[0015] Further in accordance with the present disclosure, FIG. 2 illustrates a cross-sectional view of an extruded main body portion 600 of a further embodiment of a catheter. The body includes an extrusion that defines two offset channels 610, 620. A first channel 610 is illustrated as having a generally circular cross-section, and a second parallel channel 620 is illustrated as having a circular cross-section with a scalloped portion that is removed to accommodate the channel having the circular cross-section. The main body 600 may be made from any suitable polymeric material, such as those shown herein. The main body may be formed from a multi-layer polymer extrusion having one or more reinforcements (e.g., layers of braid) formed thereon or therein. The main body may be coated with any suitable coating or material to enhance its lubricity, if desired.

[0016] Figure 3A provides a side view of the exemplary catheter of Figure 2. It includes the main shaft 600 described above, which is provided with at least one braided layer. The catheter further includes a distal tubular segment that extends distally from the main shaft 600 and defines a lumen 610 therein that is radially aligned with the first channel of the main body. For example, the distal tubular segment may be an extruded tube that runs the entire length along the inside of the main body to the proximal end of the catheter. The distal tubular segment may similarly be braided, if desired, and may be pre-curved or deflectable as described elsewhere herein, for example, by providing a pull wire within the lumen of the distal segment or within a co-extruded lumen (not specifically illustrated) of the distal segment. The distal end of the pull wire (not shown) may be attached to a collar embedded in or on the distal tubular segment, if desired. As illustrated in Figure 3B, the distal tubular segment and associated surrounding channel may be used to act as a guidewire lumen, allowing the catheter to be used as an over-the-wire catheter or to deliver a smaller profile catheter (e.g., a snare catheter) therethrough, as will be described in more detail below.

[0017] 3C illustrates one embodiment. A larger (e.g., non-circular) lumen defined within the main body may act as a delivery lumen for the catheter. This may be steerable (e.g., by a steering wire) or may have a pre-formed curve in it (e.g., by heating the catheter to bend it if it is polymeric in composition), which can be assumed after the catheter is advanced distally and out the distal end of the large lumen of the main body. As shown in Figure 3D, the distal tubular segment may have an additional tubular member disposed thereon, or integrated therewith in a coextrusion, which may act as a guidewire lumen, facilitating a rapid exchange ("RX") procedure using the guidewire rather than having the guidewire traverse the entire length of the catheter as in an over-the-wire ("OTW") procedure.

[0018] Figure 4 shows the embodiment of Figures 3A-3D, but includes a snare catheter 800 that is positioned through the small lumen to capture a guidewire in a mitral valve plication procedure, such as that shown in U.S. Patent Application No. 15 / 796,344 (filed October 27, 2017). Further aspects of the snare catheter can be found in that application as well as U.S. Provisional Patent Application No. 62 / 615,309 (filed January 9, 2018). Each of the above-referenced applications is hereby incorporated by reference for any and all purposes. The catheter may be used, for example, in such a mitral valve plication procedure. For example, the snare catheter may be used to capture a guidewire, while the large passageway accommodates an articulation catheter, as described above, which grasps structures such as heart valve leaflets.

[0019] A further embodiment is presented in Figures 5A-5B, which illustrates an articulating catheter with two preformed bends that revert to their bent shape when advanced distally from the main catheter. 6 illustrates a further possible cross section of the main catheter, showing large and small lumens 1010, 1020. However, two additional steering wire lumens 1030 are also shown. If desired, an additional steering wire lumen is provided, which may be used to house a puller wire, which is attached at its distal end to a portion of the catheter (not shown), such as a ring collar formed on or within the body of the catheter.

[0020] 7A-7C show further embodiments of catheters according to the present disclosure (or aspects thereof), which, as shown, include a scope on one of the articulating arms. With the aid of the scope (or funnel), the other articulating arm may be guided into contact. If desired, a permanent magnet may be added to the end of each articulating arm (not shown), or a coil may be made around each end of the catheter to form a solenoid at the end of each arm (not shown). When current flows through each solenoid in the same helical direction, the magnetic fields created add up and attract each other, causing the arms to move closer together and touch. The force is directly proportional to the current passing through the winding. Also illustrated is a push-pull actuator that articulates within the catheter relative to each of the deployable limbs. The catheter disclosed uses a toothed wheel (or gear) that rotates about an axis and engages a gear rack, which resides in a sliding track, which in turn is attached to one of the articulating arms.

[0021] For purposes of illustration, and not limitation, FIGS. 8A-9C depict yet another embodiment of a catheter according to the present disclosure.

[0022] 8A-8E illustrate a further embodiment 1400 of the catheter. The distal end 1404 of catheter 1400 is depicted to emphasize its functionality. Catheter 1400 also includes a proximal end and an elongate body (not shown) that has one or more actuators for operating various subcomponents of catheter 1400, which are described in detail below. Catheter 1400 is defined by an outer tubular member having a proximal end, a distal end 1404, and defines an elongated passageway therethrough along its length. The elongate passage slidably receives therein an intermediate tubular member 1450, which has a proximal end (not shown), a distal end 1452, and which in turn also defines a passage along its length, which slidably receives therein a subassembly, including at least one additional catheter, tool, or manipulator. As illustrated in Figures 8A-8E, the subassembly is slidably received within an intermediate tubular member 1450, which includes a central tubular member 1410 having a proximal end, a distal end 1414, and defines a passageway along its length, which may receive, for example, a guidewire, to guide the catheter 1400 to a target location. As illustrated, the central tubular member 1410 is a straight member, however, it may be curved if desired. The subassembly further includes a second tubular member 1420 having a proximal end (not shown), a distal end 1424, and an elongate body that defines a central lumen along its length. The second tubular member 1420 is curved as illustrated. Also provided are collapsible loops 1430, 1440, which may be made from any suitable material. The particular loop illustrated is formed from nitinol. Each loop is defined by a filament, which may have stress distribution loops (1432, 1442) formed therein, that traverses 360 degrees or more. The provision of stress distribution loops facilitates collapse of the loops 1430, 1440 by distributing the bending stress over a longer effective length of the wire. The material forming loops 1430, 1440 may extend to the proximal end of the catheter 1400, or may be secured within the distal end of an additional tubular member (not shown), which is slidably disposed within intermediate tubular member 1450. The loop may be made, for example, from a shape memory material, such as various nickel titanium alloys.

[0023] As illustrated, the subassemblies within tubular member 1450 may be slidably and rotatably movable relative to said tubular member on the exterior of catheter 1400 . If desired, the sub-components 1410, 1420, 1430, and 1440 may be slidably and rotatably movable relative to each other and relative to the main body and intermediate tubular member 1450 of the catheter 1400, respectively.

[0024] As illustrated in Figures 9A-9C, the embodiment 1400 is illustrated in use with a tricuspid valve configuration. In use, the distal end 1402 of catheter 1400 is advanced, for example, to the tricuspid valve, and the subassembly housed within intermediate tubular member 1450 is advanced distally out of the distal end 1402 of catheter 1400. The distal end 1414 of central tubular member 1410 may then be directed to pass through the center of the tricuspid valve between the leaflets. The two loops 1430, 1440 are then deployed and advanced under the leaflets until they rest against the center of each leaflet, near the annulus. This allows the tubular member 1420 to be positioned near the annulus and centered on the third leaflet. Any desired instrument (e.g., a cutting wire or piercing instrument) may then be advanced by its edge through the leaflets and adjacent to the annulus, such as by advancing an electrosurgical cutting wire through the leaflets, dragging the cutting wire radially inward through the leaflets, thereby cutting the leaflets in half. According to a further example, the suture may be anchored by subassembly component 1420. The suture may then be used as a guide rail to deliver the prosthesis to be implanted over without first cutting the leaflets in half. It will be appreciated that catheter 1400 may be used in many different types of procedures, and these illustrations are by way of example only.

[0025] U.S. Patent Application No. 62 / 913,150 (filed October 9, 2019) and U.S. Patent Application No. 62 / 913,158 (filed October 9, 2019) show further implementations of leaflet tissue resection systems in accordance with the present disclosure. For purposes of illustration and not limitation, exemplary implementations of the system that can be used to remove structures such as valve clips, Alfieri stitches, cysts, tumors, etc., as desired, are shown in FIGS. 10A-18G.

[0026] With particular reference to Figures 10A-10F, removal systems for valve clips, cysts, and the like are illustrated. The system includes a catheter, which contains a deployable cutting snare and an associated capture system. In particular, the catheter includes an inner tubular member having a proximal end and a distal end, within which a deployable cutting snare 1520 is slidably disposed. The cutting snare may be deployed by advancing it distally, the cutting snare being configured to form a loop that can encircle a structure. After encircling a structure (such as a mitral valve clip), the snare may be retracted, allowing it to cut through the tissue or other structure, and the removed structure may then be captured and retracted by the capturing or holding snare 1510. The cutting snare 1520 may be electrically conductive and may be electrically exposed or denuded around its inner periphery to aid in burning through tissue, and may, if desired, be electrically insulated around its outer periphery. As shown in Figure 10C, the cutting snare forms a loop, characterized by two parallel sections that bend outward to form a ring shape. The distal end portion is further bent to form the distal tip. The distal tip is depicted at the apex of the loop in Figure 10C. It is characterized by a sharp bend that transitions into sweeping arcs on either side, thereby defining the loop. The snare segment is then bent at a right angle so that it travels inside the lumen of the inner tubular member. It exits the proximal end of the catheter. It is attached to an actuator or handle, which can pull the snare proximally relative to the inner tubular member. The proximal end of the snare catheter may be bare and connected to a power supply capable of monopolar or bipolar operation, as desired. The distal portion of the snare catheter may be formed from a heat-treated shape-memory material (e.g., a nickel-titanium alloy) that expands into the illustrated hoop configuration, or may be formed from a regular conductor that is configured to flex outward when unconstrained, as desired. The snare may include a radiopaque material, and the distal end of the inner tubular member may optionally include a radiopaque marker to facilitate visualization of the catheter under visualization.

[0027] 10A-10F, the capture or retention snare 1510 may be mounted on the outside of the inner tubular member and move therewith, or may be mounted on an intermediate tubular member (having corresponding proximal and distal ends and an elongated tubular body) that slides over the inner tubular member, facilitating axial positioning of the cutting snare and the capture snare relative to one another. The capture or retention snare includes a collapsible basket, formed, for example, from laser cut hypotube, which is formed into a stent-like pattern defined by zigzag rows of struts or the like. A gripping tether is woven around the open distal end of the basket, has at least one end (in this embodiment, two ends), and sews down an annular lumen defined between the outer surface of the intermediate tubular member (or, if not provided, the outer surface of the inner tubular member) and the outer tubular member of the catheter (the outer tubular member having corresponding proximal and distal ends and an elongated tubular body). The distal end portion of the outer tubular member may be slightly oversized if necessary to accommodate the catch basket, as illustrated. The basket may be made from a heat-treated shape-memory material (e.g., NiTi alloy, braided or non-braided composite metal, polymer, or formed polymer) that self-expands to a basket shape when unconstrained. The distal port or opening of the basket includes an interwoven tether that is routed around the distal open end of the basket and into and out of the basket fenestrations. By applying tension to the proximal end of the tether routed to the proximal end of the catheter, the looped tether at the end of the basket tightens, closing the basket. Hoop stress and capture force are applied to any object introduced into the basket, such as a mitral valve clip to be removed, tissue containing Alfieri stitches, a cyst, a polyp, or other undesirable anatomical formation, as desired. As illustrated, the basket may be attached to the intermediate tubular member using a radiopaque marker that surrounds the proximal ends of the basket and intermediate tubular member, and a radiopaque distal marker band that surrounds the radially inner portion of the basket adjacent the intermediate tubular member and the intermediate tubular member itself. As illustrated, the intermediate tubular member includes a radiopaque distal marker to enhance visibility of the device under fluoroscopic visualization.

[0028] If desired, the outer tubular member of the catheter may include an enlarged distal segment, as illustrated in FIG. 10F. 10D and 10E illustrate the deployment of the outer tubular member out the distal end of the guiding catheter. Figures 10D and 10E illustrate the laser cut portion before and after expansion, respectively, and Figure 10F illustrates the larger diameter distal portion overlying the delivery sheath or outer tubular member. A marker band may be provided at the distal end of each tubular member of the catheter, and the snare and basket of the catheter may comprise a radiopaque material. If desired, the basket may be provided with an outer tubular layer of polymer coating or film to aid in the storage of excised clips or tissue segments, as desired. The outer tubular member may have a deflectable distal tip. In another embodiment, the laser-cut hypotube basket may be replaced with a polymeric tubular section that can expand around a structure such as a mitral valve clip without buckling.

[0029] For further illustrative purposes, Figures 11A-11D present exemplary method steps that may be performed to remove a previously placed valve clip, in this example a mitral valve clip, which is attached to two coapted valves. This procedure is highly advantageous because it can be performed percutaneously or apically, as desired, while the patient's heart is beating, avoiding open heart surgery or the need to stop the patient's heart. First, the distal end of the catheter is introduced apically through the floor wall of the ventricle below the mitral valve. The inner tubular member is advanced distally relative to the outer tubular member or delivery sheath, and the snare is deployed distally relative to the inner tubular member, thereby assuming a preformed hoop shape that is oriented perpendicular or nearly perpendicular relative to the longitudinal axis of the catheter. The cutting snare is then positioned so that it surrounds the tissue or adjacent to the tissue near the valve leaflets, surrounding the mitral valve clip (or other material to be removed, if desired). The intermediate tubular member carrying the capture basket is then deployed distally from the distal end of the outer tubular member, and the open end of the capture basket is manipulated to fit over the mitral valve clip (or other material to be removed), so that the capture basket surrounds most of the mitral valve clip, as illustrated in FIG. The top of the capture basket is then clamped around the upper end of the mitral valve clip, thereby mechanically capturing it, as illustrated in Figure 11C. The cutting snare is then retracted into the inner tubular member and cuts through the leaflet tissue attached to the mitral valve clip. As mentioned above, the cutting snare may be energized. The basket and inner tubular member may then be retracted proximally into the outer tubular member or delivery sheath and then retracted. It will be appreciated that the intermediate tubular member may be omitted and the basket may instead be attached to the inner tubular member, but the inclusion of the intermediate tubular member may provide additional mechanical freedom when performing the procedure.

[0030] In a further implementation, Figures 12A-12E present additional removal devices that may be used to remove clips, cysts, sutures, etc., in accordance with the present disclosure. 12A illustrates that the device includes an outer tubular member or outer delivery catheter housing, which has a proximal end and a distal end, that surrounds and slidably receives an intermediate tubular member (which also has a proximal end and a distal end), which has a clip or cyst housing, and a cutter tip at its distal end region. An inner catheter is slidably received within the intermediate tubular member, which includes a deployable grasper for capturing a structure, such as a clip, to be removed from the patient's anatomy. As illustrated, the gripper includes three gripping arms configured to bias radially outward when unconstrained. Each gripping arm may be formed from a planar strip of material terminating in a converging distal tip. As illustrated, each gripping arm has a proximal end that is attached to the distal end of the inner tubular or solid member of the inner catheter. Each arm then has a preformed bend, as shown, which causes the arm to bend radially outward, and then bend radially inward as the arm approaches its tapered distal tip. Two or more than three gripping arms may be used as desired. The gripping arms may be formed from a polymeric or metallic material as desired, and may be formed from a shape memory material or a material configured to recoil outwardly when radially unconstrained otherwise. The abdominal arms may be configured to collapse radially inward when retracted proximally into a tubular member (such as the cutting tip of the illustrated catheter). The grasping tool may be retracted proximally into the clip or sac recess of the intermediate tubular member, and the intermediate tubular member may be retracted proximally into the distal end region of the outer delivery catheter recess. FIG. 12B shows a close-up of the distally extending gripper. Figure 12E illustrates a different implementation of a cutting tip that may be used for the cutter tip of the intermediate tubular member. For example, the cutting tip may include a rounded coring edge, which may be a sharp annular surface. Alternatively, the cutting tip may include a distal end that terminates in one or two cutting edges, which are tapered extensions of the tubular wall, which are sharp along one or both edges, thereby cutting tissue when the intermediate tubular member is rotated relative to the anatomical structure against which the cutting tip or tips are pressed. The cutter recess of the intermediate tubular member retracts into the outer delivery catheter until delivery, as illustrated in Figure 12C, and then advances distally into position to cut leaflet tissue, e.g., when rotated, as illustrated in Figure 12D.

[0031] As illustrated in Figures 13A-13I, the device of Figure 12 may be used to grasp and remove an object (eg, a mitral valve clip, etc.). FIG. 13A illustrates the catheter being placed relative to a simulated lower portion of an existing mitral valve clip. 13B illustrates the grasping tool extending distally out the distal end of the outer tubular member or delivery catheter and over and above the clip or cyst, such that the grasping tool surrounds the cyst. The cutter receptacle is then advanced distally relative to the grasper, causing the arms, which are biased radially outward of the grasper, to be pushed inward under the force of the distally extending cutter receptacle, thereby grasping the clip or other structure. The outer sheath may then be advanced distally toward the valve leaflets, as illustrated in FIG. 13D. The cutter recess may then be advanced distally, contacting and piercing the tissue, as illustrated in Figure 13E. Figure 13F illustrates rotating the cutter recess relative to the tissue, causing the cutter to make a circular cut, thereby removing an object from the anatomy, such as a mitral valve clip. Once the tissue or other material has been severed, the clip, cyst or other material may be retracted into the outer sheath and removed from the patient. As illustrated in Figures 13H and 13I, the removed material, such as the clip, may then be expelled from the catheter after removal from the patient.

[0032] 14A-18G illustrate implementation of a twisting catheter, which may be used to twist a planar tissue structure, such as a native or replacement valve leaflet, and then retract the catheter, thereby capturing the tissue, which may then be separated from the surrounding anatomical structure.

[0033] Specifically, Figure 14A illustrates the distal end region of a torsion catheter, which includes an expandable basket or tubular end similar to the embodiment of Figure 12 above, which contains the torsion catheter therein, which may have two lumens to accommodate an energized guidewire therein. Alternatively, as illustrated in Figures 14B and 14C, the inner elongate member may be provided with a gripping device similar to the embodiment of Figure 13, which is slidably disposed within the intermediate tubular member. Figure 14D illustrates the guidewire of Figure 14A, with the distal tip energized prior to being formed into a loop. Figure 14C illustrates the relative placement of the energized snare catheter with respect to the torsion catheter and capture catheter, which is discussed in more detail below. The basket of the torsional catheter may be made of braided or non-braided composite metal, NITI, polymer, formed polymer, or the like. The energized snare in Figure 14E is completely insulated except for the distal loop and the proximal 0.5 inches which are connected to an RF generator. The energized snare may itself be a separate catheter, or may be delivered through a long sheath that houses both the torsion catheter and the energized snare.

[0034] 15A-15D illustrate the use of the system of FIG. 14 to ablate valve tissue. The leaflet resection device may be used to remove valve tissue from, for example, the aortic, mitral, tricuspid, and pulmonary valves. It may also be used for removal of valve-in-valve tissue or native tissue. The energized wire may be coated with, for example, PTFE or paralyene, and then coated with PTFE or PET. The energized wire may be single layer, or may have a double layer PTFE covering or PET or a combination of both. The guidewire may have a central pre-twisted or pre-bent section. This may be accomplished by slightly grinding to reduce the diameter, or by actually pre-twisting the wire. The twisted or polished section may be marked with visible marker bands on either side of the section, allowing for easy visualization under fluoroscopy. FIG. 15A illustrates the positioning of the guide catheter and the energized guidewire over the valve leaflets. Figure 15B illustrates the advancement of the snare catheter and also illustrates energizing the exposed distal tip of the guidewire, thereby advancing the guidewire and penetrating the tissue of the valve leaflet.

[0035] FIG. 15C illustrates the energized guidewire being grasped by a snare catheter. FIG. 15D illustrates the snare being used to retract the guidewire proximally and out of the patient until the two ends of the wire are externalized from the introducer sheath. 16A illustrates the advancement of the torsional catheter, which may include a dual-lumen elongate core member, with one leg of the guidewire passing proximally along each lumen and over both ends of the energized guidewire. 16B illustrates twisting the tissue by applying a torque to the elongate body of the torsion catheter, which has the effect of applying a rotational torque to the loop formed by the guidewire about the longitudinal axis of the catheter. FIG. 16C illustrates continuing to twist the tissue by applying torque to the twisting catheter until the leaflets are fully converged. FIG. 16D illustrates the outer tubular member being advanced distally over the inner twisting catheter, which overlies the torsional tissue of the valve leaflets. The tissue is contained by simply sliding the tube over the exterior of the catheter, over the elongated interior body and loops. If a basket is provided at the end of the outer catheter, a snare may be tensioned to collapse the distal end of the basket around the tissue of the valve leaflet. 16E-16F illustrate the containment and fixation of the tissue within the distal tip of the catheter. 16E illustrates the use of a basket. 16F illustrates the use of an outer polymeric tube. The energized snare is then introduced over the combined and twisted outer catheter until it surrounds the base of the twisted tissue. The snare of the torsional catheter may be partially covered with PET or PTFE, which reduces the exposed surface area and focuses energy on the tissue. Figure 17A shows the energized snare being advanced over the proximal end of the torsional catheter combination, and Figure 17B illustrates the snare being clamped over the tissue to be excised and then energized to cut the tissue. The snare is then withdrawn while energized, thereby completing the severing of the tissue (Figure 17C).

[0036] FIG. 17D illustrates an embodiment of a partially covered and energized snare. FIG. 17E illustrates how a small section of the snare's inner surface is exposed, thereby allowing the applied power to escape. This exposed section comes into contact with the tissue and focuses the RF energy only on that portion of the tissue, preventing inadvertent energy delivery to surrounding tissue. Figures 18A-18G illustrate an in vitro study using a porcine aorta, demonstrating complete resection of the aortic valve leaflets. Figure 18A illustrates tissue twisted into the catheter. Figure 18B illustrates an energized snare positioned over the tissue, thereby resecting it. Figure 18C illustrates cutting tissue contained within the catheter. Figure 18D illustrates tissue cutting. FIG. 18E shows the surrounding tissue with the leaflets removed. Figure 18F illustrates the tissue remaining, and Figure 18G shows the tissue removed.

[0037] 19A-22C illustrate further implementations of the tissue ablation, cutting and removal system. The trans-leaflet wire described above acts as a rail or guide to position the cutting device over the leaflet to be cut. An inner guidewire lumen may be used to advance a wire cutting head loop distally over the guidewire rail and to the edge of the valve leaflet. The cutting head loop of wire may be shaped to remove a specific portion of the desired valve leaflet, thereby creating an open area for flow to either coronary artery nearby. One cutting head (wire) may be energized with RF energy, or both cutting heads (wires) may be energized to perform the cutting. If desired, one cutting head loop wire may be electrically exposed and energized while the other is insulated. A bend point may be placed in the cutting wire to allow positive contact and adhesion to the cutting wire, ensuring positive burning when the outer delivery catheter is advanced over them during positioning. The guidewire may be placed through the leaflets to allow for cutting and subsequent removal of the severed portion. A cover may be used over the opening in the cutting wire to ensure that the severed portion of the leaflet is captured in the event that the wire is lost and is unable to hold the severed portion.

[0038] 19A-19D illustrate an embodiment of preparation for use of such a system. FIG. 19A shows the guide catheter and energized guidewire being positioned over the valve leaflets. FIG. 19B illustrates the advancement of the snare to a position where the guidewire passes through and exits the valve leaflet. Figure 19C illustrates the use of the shear to grasp the guidewire, and Figure 19D illustrates the externalization and twisting of the guidewire.

[0039] 20A-D illustrate further embodiments of a rail-based leaflet resection and cutting system with a modular RF head cutting loop, both with and without electrical isolation. The delivery catheter for delivering the components may be provided with an expandable tip, such as a protective basket to better capture the leaflet cutting loop. As illustrated, the system includes an outer delivery catheter, which is in the form of a tubular member having a proximal end and a distal end. An inner tubular member may be used to thread the guidewire through the leaflets and then sew the guidewire through, as illustrated in FIG. This allows the guidewire to be used as a "rail" as it passes through the valve leaflets, driving the delivery catheter by sliding the inner tubular member over both ends of the guidewire. The lumen of the inner tubular member may be of sufficient diameter to allow passage of as many as six guidewires when capturing three valve leaflets (e.g., in the case of a tricuspid valve). It will be appreciated that the procedure of Figure 19A may be repeated for each of one, two, or three leaflets on the same valve. Both ends of the guidewire may be externalized. If desired, a loop can be formed in the proximal end of one or more of the guidewires. The distal end of the guidewire can then be sewn through the loop. The resulting knot can then be pushed down onto the valve leaflet. This allows the inner tubular member of the catheter of FIG. 20 to accommodate only three guidewires instead of six. An intermediate tubular member may be slidably received over the inner tubular member inside the outer tubular member, and may include one, two, or three loops, which are mounted on the distal end of the intermediate tubular member. One or more of these loops may be coupled to a source of electrical power (RF) at the proximal end of the intermediate tubular member via one or more electrical conductors that traverse the length of the intermediate tubular member.

[0040] As shown, each loop is attached at its proximal end to the distal end of the intermediate tubular member by any one of a number of suitable techniques. The wire of each corresponding loop is then advanced distally, completing its path in a loop shape. For example, the loop may be formed from a strand of insulated or non-insulated wire with two proximal ends, which may complete an electrical circuit by passing electricity along its length. The proximal portion of the distally extending loop may also have a radially outward bend, such that the wire of the loop first extends radially outward, bends, and then extends radially inward, allowing the tubular member on the exterior of the delivery system to ride over the wire as it bends outward, thereby applying a radially inward force to the loop or loops, causing the loop or loops to bend radially inward and grip and bias the valve leaflets. 20D illustrates a side view of the inner tubular member retracted proximally.

[0041] 21A-21E illustrate the system described above, which utilizes a guidewire, described herein as a rail, to cut tissue. In one embodiment, a single leaflet system may be advanced over both ends of an energized guidewire, directed through the leaflet, approximately one-third of the way from the edge of the leaflet, as described above in FIG. FIG. 21B illustrates how the guidewire lumen (or inner tubular member) can be advanced down to the edge of the valve leaflet and temporarily secured. FIG. 21C illustrates how the cutting head can be advanced with the leaflets between the cutting elements while the guidewire lumen is anchored to the leaflets. 21D, once the loop-shaped cutting element is in place, the outer tubular member is then advanced distally over the radially outwardly oriented fold points of the loop, forcing the loops toward each other on the other side of the valve leaflet, thereby creating firm pressure against the leaflet. At this point, the cutting element may be energized, thereby cutting the leaflets and retracting the cutting portion back into the delivery catheter for removal.

[0042] Figures 22A, 22B, and 22C illustrate examples of differently shaped cutting wires that may be mounted on the distal end of the intermediate tubular member of Figure 20. One of the loops in each pair is covered with electrical insulation. Figure 24A illustrates a round loop, which has a larger removal range. Figure 24B shows a diamond-shaped loop, which may facilitate retraction of the loop into the delivery catheter, and Figure 24C depicts an oval-shaped loop that is smaller in transverse extent than the loops of Figures 24A and 24B.

[0043] Figures 23A-23C depict a catheter similar to that of Figure 20, but with two electrically exposed cutting loops, used in combination with two crossing guidewires, each delivered to a different leaflet using the technique of Figure 19. And Figures 22A-24C depict an embodiment with three cutting loops, which cut three leaflets, each of which is similarly captured by a guidewire. However, the loop is configured to flare outward radially, allowing its distal end region to extend radially outward and thereby reach the valve annulus. As with the previous embodiment, the tubular member inside the catheter is threaded over the guidewire which passes through the valve leaflets. The cutting loop is advanced distally toward the valve leaflet and is configured to expand radially outward to contact the leaflet near the vessel wall. The distal region of the loop is denuded, so that application of RF energy cuts through the leaflets near the annulus (preferably in a non-calcified region), and the catheter and energized loop are then rotated about the central axis of the catheter, thereby performing the cut. The guidewire can be routed through each corresponding leaflet to cut and then remove the cut portion of the leaflet. The insulated portion of the cutting loop protects any unwanted portions of the valve leaflet from being cut.

[0044] 25A-26D illustrate an implementation involving a rotating blade that severs one or more leaflets with a protective basket that captures the severed portions of the leaflets and prevents embolization. These embodiments are preferably used by capturing each corresponding leaflet using a guidewire as described above. In this embodiment, the inner and outer tubular members are essentially the same as in the previous embodiment, except that the middle tubular member includes a laterally offset blade attached to its distal end, which can delineate an annular cutting path when the middle tubular member is rotated around the inner member in the area of ​​the annulus. The inner tubular member is again used to advance the cutting device over the edge of the valve leaflet and over the guidewire rail. A guidewire lumen stop may be provided at the distal end of the inner tubular member, which may limit the cutting blade from advancing too far through the valve. The rotary cutting blade attached to the intermediate tubular member may be sharpened on one or both sides, making it bi-directional. The rotating cutting blade may be energized with RF energy. Placement of the guidewire ensures that the removed section of the valve leaflet is removed by subsequently removing the guidewire, routing it through that portion of the valve leaflet. Thus, Figure 26D includes a leaflet crossing guidewire, which is used as a rail for the leaflet removal device. Figure 26B illustrates the guidewire lumen, which is placed at the leaflet edges to be brought together. 26C illustrates the cutting blade being advanced over the inner tubular member, defining the guidewire lumen through and between the leaflets to the end stop. The blade may be rotated to cut through the two leaflets. Figure 26D depicts a bottom view of the cutting blade advanced, which may rotate to cut through both leaflets.

[0045] 27-72 illustrate further example embodiments, which perform the procedures described elsewhere in this application.

[0046] Figure 27 depicts the first step of the procedure, in which a pachyderm guide catheter is introduced to the target location just proximal to the tricuspid valve, along with a flexible catheter and a JL4 catheter. This is a standard left coronary ostium access catheter. JL stands for Judkins Left. Its curvature allows for easy placement within the ostium of the left coronary artery. A 16 Fr ablation catheter (FIG. 28) may then be used to traverse each of the three leaflets in the valve. The tethers from the transverse incisions may be secured to each of the valve leaflets using knots and pledgets, if desired (FIGS. 29-30). Referring to Figure 31, the previously placed Sentinel embolic protection catheter is removed.

[0047] 32-33 depict a system including a guiding catheter, which includes multiple tubular members, each containing a 0.014 inch guidewire, which has an exposed distal tip, which may be energized to cross the corresponding valve leaflet. The catheter system may further include a central stylet that includes a nosecone configured to accept a 0.035 inch wire threaded therethrough. Each of the tubular members may be folded inside the stent frame (FIG. 34) of an associated TAVR valve, which is then placed after the leaflets have been cut out.

[0048] Figure 35 illustrates the introduction path of a guiding catheter, introduced via the IVC and into the heart, and a second catheter, introduced via femoral access and into the aorta. These access routes may be used to deploy a catheter system to ablate the leaflets and tissue for the aortic valve, as illustrated in Figures 36-57, by introducing a guidewire along both catheter routes to complete the routes. The elongated distal portion of the inner tubular member of the system is then introduced along the entire tract over the guidewire.

[0049] After the distal portion of the inner tubular member is introduced, the remainder of the system is deployed by advancing the outer catheter of the system past the aortic valve and retracting the outer tubular member proximally. The most distal capture basket is deployed first, which occupies the space downstream of the aortic valve. This inner basket is attached to the rest of the system by three conductors bonded to the open periphery of the basket. The basket is self-expanding and may be made, for example, of a shape-memory material, so that it occupies the width of the aorta downstream of the aortic valve. As the outer catheter is retracted proximally, a self-expanding inner basket expands, which is attached to the inner tubular member. This inner basket may be used as one pole of a bipolar electrosurgical system, or it may be used as a magnification mechanism. The inner basket expands, thereby occupying the aortic valve. The electrosurgical cutting edge is defined on a proximally facing peripheral ridge of the capture basket. The capture basket is energized by energizing the three leads, which are coupled to the annular periphery of the capture basket, and the capture basket is then drawn into the aortic valve leaflets by pulling the leads proximally. When bipolar current is used, the circuit is completed as follows: across the gap through the aortic valve cusps to the inner basket. The basket is eventually pulled proximally enough to encircle the inner basket, which in turn cooperates with the inner tubular member of the system to define an annular cavity that collects separated aortic valve anatomy and debris and captures the separated material. As depicted in Figure 37, the distal end of the inner basket terminates in a Coanda tip shape that extends into the capture basket. This enhances flow into the center of the basket and through the system. Generally, this allows for perfusion. The capture basket may be configured to capture a valve leaflet and then be removed from the venous access device, or may be retracted into the introducer catheter.

[0050] Figures 39-42 depict a variation of the system of Figures 36-38, replacing the distal capture basket with one having a dual concentric electrode assembly. The outer electrode (Figure 40) includes three proximally facing tips that are received within the aortic valve leaflets and are positioned radially outward from the leaflets. An inner electrode (FIG. 42) may be concentrically positioned within the outer electrode and attached to the distal assembly, or may be positioned on the distal end of the inner basket of FIGS. 36-38 that is introduced into the aortic valve inside the valve leaflets. A circuit is completed between the inner and outer electrodes and through the tissue of the valve leaflets. The inner and outer electrodes advance proximally as they burn through tissue. The outer electrodes may have a zigzag leading edge, which may be rotationally aligned or offset from the zigzag of the inner electrodes. The arc is completed by the shortest path between the inner and outer electrodes in a bipolar arrangement (FIG. 55). A unipolar arrangement may be performed (FIG. 56) by aligning the inner and outer electrodes and completing a circuit through the patient, thereby cutting the leaflet material. The outer electrodes may be powered by three electrical leads, which extend from the proximal end of the device and thread through the IVC tract as depicted. If desired, the outer electrode may include a mechanical cutting edge, as depicted in Figure 57, to aid in cutting through the tissue as the outer electrode advances proximally.

[0051] 58-72 depict additional leaflet ablation catheters that may be deployed in a "T" configuration to facilitate cutting laterally through the leaflets. To illustrate this procedure, with reference to Figure 58, in a first step, a catheter is positioned with the guidewire tip at the desired location on the valve leaflet. Electricity is applied to the guidewire to burn through the valve leaflets. Referring to Figure 59, the opening is further traversed by a microcatheter, thereby enlarging the hole in the valve leaflet. Alternatively, a dilating tip can be provided on the catheter. Referring to Figure 60, the "T" is advanced out of the distal tubular end of the catheter. It is attached to an inner catheter. It has inner and outer members. The dissector is in a collapsed, elongated position past the valve leaflets. The lancet is then deployed by retracting the inner portion of the lancet connected to the tip relative to the outer tubular member of the lancet. The dissector is then positioned at the base of the valve leaflet in the desired orientation. The dissector is then energized and pulled back, thereby cutting through the valve leaflets. Referring to Figure 61, the wires of the T-splitter may be doubled with a joint, which makes them easier to collapse. The wire of the T-slash is insulated except for the exposed or stripped area of ​​wire, which is energized and used to cut through tissue. Referring to FIG. 62, once the initial cut is made at the base of the leaflet, the T-splitter may be re-collapsed, re-advanced over the guidewire, and re-positioned under the leaflet again. The T-slash may then be reopened and positioned perpendicular to the initial cut. Referring to Figure 63, the T-splitter is energized and a second longitudinal cut is made in the leaflet. A T-shaped incision may be achieved in the aortic valve cusp, which allows the coronary ostia to be unobstructed for subsequent TAVR.

[0052] Figure 64 depicts the T-splitter in the collapsed position, showing the shaft on the outside. Figure 65 depicts the dilator tip with the guidewire lumen, which provides a good transition in stiffness between the guidewire and the T-splitter. Figure 66 depicts an inner shaft and guidewire lumen connected to the distal tip of the T-splitter, and an intermediate tubular member attached at its distal end to the proximal end of the cutting section, such that pulling the tip proximally relative to the intermediate member deploys the T-splitter. Figure 67 depicts the T-splitter in the open or deployed position. Figure 68 illustrates an exposed, stripped wire on the proximally facing surface of the T-splitter. Figure 69 depicts the inner shaft being pulled back relative to the outer shaft, which further collapses the cutting wires, making them more rigid. Figure 70 depicts the collapsed position of the catheter, showing the dilator tip with a guidewire lumen, the wire inside the shaft, and the shaft outside. Figure 71 depicts the device in a partially deployed position, illustrating the exposed wire and central guidewire lumen, while Figure 72 depicts the device in a fully deployed configuration. It will be appreciated that while a single circuit is depicted running through the entire T-splitter, it is possible to have multiple wires, which form splitters that are electrically isolated from each other.

[0053] 95-104 depict implementations of a torsion block that twists and partially exposes a coated guidewire, preparing it to sever valve leaflets during an electrosurgical procedure. The torsion block includes a main horizontal body portion that is connected at each end by pins to upstanding pivot arms, each of which terminates in a pivot knuckle, which in turn contains a blade. The wire is placed in the groove according to Figure 96 and placed in the clamp, which is parallel to the horizontal body part. According to Figure 97, the blade is rotated towards the wire loaded into the groove and clamp, and the blade contacts the wire at the outer edge of the exposed area (Figure 98). As pressure continues to be applied to the outer apex section, the blade begins to move towards the center (Figure 99). The blades then meet in the center and pressure is then directed downward, which begins to form a twist in the wire (Figure 100). Figures 101-103 illustrate the twisting process, and Figure 104 illustrates the twisted and exposed wires in the twisting tool after the operation is completed.

[0054] 73A-94 illustrate various techniques for repairing or adjusting the performance of a luminal valve, such as (but not limited to) a procedure for transcatheter tricuspid valve repair. It will be appreciated that the disclosed devices and techniques may be used on any valve structure having leaflets. The following illustrative description is not intended to be limiting. Rather, this description is intended to present specific, non-limiting implementations. Thus, disclosed in this embodiment are methods for restoring or adjusting the performance of the valve structures as described, and devices for restoring or adjusting the performance of the valve structures as described.

[0055] Disclosed is a small profile transvenous access system (e.g., compatible with 18F or larger introducer sheaths) in the form of a transfemoral system. The system may use a multi-axial deflectable guide sheath, which has two or more deflectable coaxial shafts and an outer shaft that navigates through the inferior vena cava to the right atrium and then through the tricuspid valve, for example, with an outer diameter of 10F and a working length of 100 cm. The system may further include an inner shaft for navigating the apical surface of the valve leaflet, for example, having an outer diameter of 8F and an effective length of approximately 110 cm. The system further includes a leaflet crossing tool for passing through and crossing the leaflets from the apical side to the atrial side. The crossing tool may include, for example, a 0.014 inch outer diameter guidewire, and may be energized along its length using radio frequency (RF) energy transmission. The crossing tool may have an electrically insulating polymer coating along its active length, except for the distal tip, to deliver energy to the leaflet tissue and aid in crossing the tissue. At the proximal end, the guidewire connects to an RF generator. The guidewire preferably has an effective length of, for example, 300 cm and includes an electrosurgical connector to facilitate connection between the leaflet crossing tool and the RF generator. The connector may be electrically shielded to deliver, for example, 5-60 watts of RF energy through the working length of the transverse tool, and may have a spring-loaded mechanism to hold the energized transverse tool securely in place, and may be compatible with conventional electrosurgical generators (such as the Medtronic ValleyLab FX).

[0056] The system preferably further includes a retrieval tool to deliver the device to capture as it passes through and traverses the leaflets to externalize the crossing tool. The retrieval tool may have an outer diameter of, for example, 6F and may include a snare, which captures the crossing tool. This may be, for example, a self-expanding three-dimensional basket, which facilitates capture, or a gooseneck snare, which facilitates positioning on the atrial side of the valve leaflet. The system preferably includes a guidewire, which provides a suture "connector" to deliver a means of connecting the crossing tool with the radiopaque tensioning element for exchange. The connector should be easy and quick to engage by the physician and should be able to withstand high tensile forces (such as ∼20 N according to ISO 10555). A radiopaque tensioning element may be delivered, such as a suture loaded with a radiopaque material, to replace the crossing wire, thereby tensioning the regurgitated leaflets together. The radiopaque tensioning elements may be provided in a quantity of three individual elements, may be non-absorbable, may have mechanical and biological properties (tensile strength, strength retention, tissue response / blood flow) similar to commercially available sutures, may have different colors to aid in identifying individual leaflets during tension adjustment, and may have a minimum length of 300 cm. The system should also include a radiopaque force distribution element, such as a pledget loaded with a radiopaque material, to prevent the tensioning element from retracting the leaflets. The tensioning element should have a foldable design, allowing for easy delivery through the guide sheath, and should be approximately 4 x 3 mm in size. Radiopaque and echogenic markers may also be provided for real-time image guidance during delivery of the system, such as radiopaque marker bands and echogenic coils. These may be located, for example, at the distal tip of the device and at specific increments along the length of the tensioning element, with the aid of which distances are estimated.

[0057] The system is also preferably biocompatible according to ISO 10993 and has at least three points of apposition with the three leaflets, delivering a system that deploys at least one tensioning element per leaflet. The system also preferably provides adjustable transcatheter suture anchoring and includes a mechanism to secure and maintain tension delivered by the tensioning elements to all three leaflets. Transcatheter suture anchoring allows for secure and permanent anchoring of the sprinkled suture tensioning element. It allows for tension adjustment, tension reversal, and complete retraction after application, is corrosion resistant, and is relatively easy to engage.

[0058] The system should also include a transcatheter suture cutter, such as that provided in U.S. Patent No. 10,433,962, which is incorporated herein by reference in its entirety for all purposes. Preferably, the device easily cuts through three sutures and is corrosion resistant.

[0059] In accordance with the present disclosure, the method may include placing a radiopaque suture through each leaflet at least 0.5 cm to 1 cm from the edge of the leaflet, with a radiopaque pledget on the apical side. The sutures may be tensioned together toward the center of the valve, effectively drawing the leaflets together and thereby reducing tricuspid regurgitation. Tension is then maintained using a locking device, such as the lock shown in U.S. Patent No. 10,433,962, which uses an associated lock delivery catheter.

[0060] 73A-73C depict the steps performed to perform a transcatheter tricuspid suture repair, as demonstrated in a benchtop anatomical model of the tricuspid valve. Figure 73A shows a tricuspid regurgitation model. Figures 73B and 73C show a reduction in TR, respectively, using three sprinkled sutures that are tensioned and locked together. Figure 82C illustrates the apical side of the valve leaflet, thereby displaying the pledget distributing the applied tension force.

[0061] Further in accordance with the present disclosure, the disclosed device configuration (and device interaction) within this system may be compatible with a transfemoral introducer sheath threaded through the right femoral vein. A multi-axis deflectable guide sheath may be provided. For example, a guide sheath may be used to ensure that the physician can navigate to the desired target site. The guide sheath may have a minimum of two coaxial shafts, each of which is deflectable, to provide 360° access at various radii within and around the tricuspid valve. The outer shaft may, for example, have an outer diameter of 10F and an effective length of 100cm. The disclosed inner shaft may, for example, have an outer diameter of 8F and an effective length of 110 cm.

[0062] 74A-74B show examples of distal end devices. Specifically, a leaflet crossing tool may be used to navigate to the target site required for this tri-leaflet repair procedure. Having a crossing tool (such as an energized guidewire) allows for puncturing or crossing the leaflets, which facilitates the apposition points necessary to reduce the TR. Using radiofrequency energy transmission, a polymer-coated (high dielectric constant for insulating properties and low coefficient of friction for lubricity, e.g., PTFE) 0.014 inch guidewire may be used along an effective length of, for example, 300 cm, excluding the distal tip (1-2 mm) and proximal end (for connection to the RF generator). This energized wire may be used to allow transfemoral navigation from the IVC to the tricuspid valve, after which it may be energized and punctured across the valve leaflets. The wire may be captured (using the retrieval tool discussed below) and externalized back down the IVC, thereby exiting the transfemoral access sheath. To facilitate navigation, this crossing wire may have similar mechanical properties to the Asahi Start XS20 or XS40 guidewire.

[0063] Figure 75 illustrates an energized leaflet crossing tool that is advanced through the guide sheath. An electrosurgical connector may be used to transfer RF energy from the RF generator to the traversing wires. This connector may plug into the generator (e.g., Medtronic ValleyLab FX) with an RF compatible plug and then have a spring-loaded female connection, ensuring that the exposed proximal end of the traversing wire makes a secure connection between the two. The connector may be electrically shielded to deliver 5-60 watts of RF energy through the length of the traversing wire to the exposed distal tip.

[0064] Referring to Figures 76A-76C, a retrieval tool in the form of a capture basket is provided. The retrieval tool completes the crossing and externalizes the crossing wire, facilitating its replacement with a tensioning element. The snare catheter may be, for example, 6F. As illustrated in Figures 76A-76C, a retrieval tool is provided, showing its distal end region, which has a three-dimensional capture basket. The basket may have several configurations, such as those depicted in U.S. Patent No. 10,433,962.

[0065] To facilitate the exchange of the transverse wire with the radiopaque tensioning element, a secure connection should be formed between the two. Figure 77 depicts an example of a crimping prototype that attaches a guidewire to a radiopaque suture, such as that depicted in U.S. Patent No. 10,433,962.

[0066] The incorporation of a radiopaque tensioning element may aid in maintaining the device in apposition with the valve leaflets and in maintaining tension applied to the leaflets to reduce TR. It is possible to use a non-absorbable suture design that has similar mechanical properties to commercially available sutures, such as Gore-Tex CV-4. The tensioning element may have a radiopaque core, including, for example, one or more of platinum, tungsten, tantalum, BaSO4-loaded Pebax, etc., which enhances visibility under fluoroscopy and echocardiography when layered under various outer layers (e.g., PET sutures), thereby ensuring that the tensioning element can withstand high tension forces. Depending on performance requirements (often determined during acute animal testing), the tensioning elements can take on one of several different laminate constructions. Additional radiopaque suture materials are disclosed in US Pat. No. 10,433,962. Each suture (anterior, posterior, septal) may have a different color or other markings (e.g., radiopaque patterns, etc.) to help the physician quickly determine which suture to select when adjusting the tension on each leaflet. The suture has a minimum length of 300 cm, which allows for easy exchange and externalization through the leaflets. Figure 78 depicts a) 80% tungsten loaded 53D Tecoflex (0.014 inch), b) 99.99% pure platinum wire (0.004 inch), c) 99.95% pure platinum wire (0.006 inch), d) 99.95% pure platinum wire (0.008 inch), e) 99.95% pure platinum wire (0.010 inch), f) 90% / 10% platinum iridium wire (0.013 inch).

[0067] A force distribution element may be provided to distribute the tension applied to the leaflets, thereby avoiding and resisting pull-out of the tensioning element, such as a radiopaque pledge. The pledget may be constructed as follows: a radiopaque material, as described above, is encapsulated between two pieces of medical fabric (such as PET). The pledget may be approximately 4mm long by 3mm wide and may have a folding design to ensure it can be delivered through the multi-axis deflectable guide catheter. FIG. 79 depicts an exemplary radiopaque, pull-out resistant pledget.

[0068] An adjustable transcatheter suture anchor may be provided, such as that depicted in U.S. Patent No. 10,433,962. Fixing the tensioning element facilitates delivery of a secure and permanent fixation of the spread suture material under tension. A transcatheter suture anchoring system that allows for adjustability (e.g., the ability to secure and release the suture multiple times without damaging it and to withstand a range of tension) may be used in the disclosed procedure, allowing the physician to titrate the amount of tension being applied to the valve leaflets. This allows it to be reversed or fully withdrawn after application if necessary, an important safety feature. The fastening system may, for example, include a locking mechanism or a knot, among others. The lock may be made from a biocompatible and MRI-safe material, such as titanium, which may also provide visibility under fluoroscopy and echocardiography. The lock preferably fits easily through a small profile introducer sheath. Figure 80 depicts an exemplary suture lock, which secures two sutures together. The lock may also be configured to accommodate three sutures. Figure 81 depicts an exemplary "knot pusher," which may advance different half-hitch knots over linear distances up to a range of 30 cm.

[0069] Once the spread suture (tensioning and force distribution element) has been passed through the leaflets and deployed under the appropriate tension and locked in place, the excess length of suture externalized out of the introducer sheath must be cut and removed, for example, using a suture cutter, such as that depicted in U.S. Patent No. 10,433,962. Preferably, the cutter is visible under fluoroscopy and echocardiography. The blade of the suture cutter may be corrosion resistant and may be hard enough to easily cut all three sutures simultaneously. The effective length is, for example, in the range of 120 cm to 140 cm, so that it can be inserted through the longest commercially available guide catheter. Figure 82 depicts an illustrative example of such a suture cutter, which may be modified to be more flexible and longer for transfemoral use, and updated to cut three sutures.

[0070] Radiopaque and echogenic landmarks may be provided for real-time image guidance. The incorporation of radiopaque and echogenic landmarks ensures that the physician can visualize the repair system during the procedure. For fluoroscopy, landmarks (e.g., platinum-iridium marker bands) may be present within the area such as the distal tip of the delivery system, at specific increments along the tensioning elements to allow the physician to estimate distances, and at the distal tips of the crossing and retrieval tools. Biocompatibility is important for these markers because the host or patient is likely to be exposed to these materials on both a short-term and permanent basis. The shaft inside the guide sheath may have distinct echogenic features at the tip for visibility under echocardiography. This may provide visualization during the leaflet traversal and puncture procedure. An echogenic mechanism (such as a segmented coil) allows the physician to create contact between the inner shaft and the apical surface of the valve leaflet, facilitating traversal of the leaflet.

[0071] Providing at least three points of apposition with the three valve leaflets ensures that the design for the transcatheter tricuspid tricuspid valve suture repair system maintains at least one point in apposition with each leaflet, which facilitates a reduction in TR. The disclosed system and method accomplishes this by deploying radiopaque, spread suture material into each leaflet of the tricuspid valve. This is made possible by a custom-made guide catheter, which provides 360° reach when navigating the valve. It will be appreciated that fewer juxtaposition points (e.g., two) may be used, with three being preferred. Similarly, these techniques may be used in other valve structures, such as the mitral valve, the pulmonary valve, etc.

[0072] To provide insight into how the designs detailed above can be used to treat TR, the treatment may have the following aspects. The procedure is preferably performed under anesthesia and mechanical ventilation. Fluoroscopy may be the primary imaging modality for guidance or navigation during the procedure, while echocardiography will be used to determine the transverse site above the three leaflets of the tricuspid valve and used to assess TR before and after deployment.

[0073] Transvenous access may be established using a small profile introducer sheath in the right femoral vein. Access to the right atrium may be achieved through the inferior vena cava using applicant's guide catheter. The outer shaft of the guide catheter may be articulated and passed through and across the tricuspid valve; the inner shaft may be articulated and directed back up toward the valve leaflets. Figures 83A-B depict a guide catheter that is advanced up the IVC into the right atrium and through the tricuspid valve. The inner shaft may articulate toward the apical surface of the valve leaflet. The wire capture snare may be introduced through the sheath and navigated through the IVC to the right atrium. The wire capture basket may be deployed just above the atrial surface of the tricuspid.

[0074] An energized crossing wire may then be introduced and advanced through both shafts of the guide catheter until it is in apical apposition to one of the three valve leaflets. The traversal may be performed from the apical side of the leaflet to the atrial side, taking advantage of the leaflet's natural concave shape. It is easier to traverse the leaflet in this manner than from the atrial side downwards, which can cause slippage of the traversal wire.

[0075] Once the crossing site is identified using echocardiography (e.g., a calcium-free region between 0.5 cm and 1 cm from the central edge of the leaflet), power is delivered to the site by threading the guidewire, aiding in crossing the leaflet tissue. Once deployed, the wire capture basket may capture the crossing wire and externalize it down the IVC and out the introducer sheath. Figures 84A-C depict a deployed wire capture basket, with the crossing wire passing through the basket (left), the crossing wire captured in the wire capture device (center), and the crossing wire passing through the valve leaflets with both ends externalized from the introducer (right).

[0076] A pledget-loaded suture may be exchanged for the crossing guidewire, which is then deployed through the three valve leaflets until the unpledged end of the suture is externalized. FIG. 85 illustrates delivery of spread suture material from the guide sheath. This entire process is repeated until each leaflet is anchored with sprinkled suture material. The sutures may be tensioned together and secured using a locking mechanism. Echocardiography may be used to assess tricuspid valve tricuspid tone. Once the lock is in place, the suture may be cut using a transcatheter suture cutter, thereby completing the implantation of the transcatheter tricuspid suture repair system. Figures 86 (and 94) depict the three leaflets of the tricuspid valve, which are tensioned with sprinkled suture material (left) and locked in place (right) to reduce TR.

[0077] Previous related techniques include Alfieri's "Crowbar technique" and PASTA (Pledget-Assisted Suture Tricuspid Annuloplasty). The "crowbar" procedure is a surgical repair commonly performed on regurgitant tricuspid valves in which the midpoints of the free edges of the leaflets are sutured together, thereby creating a "crowbar" shape. FIG. 87 depicts the "crowbar technique" (suturing the midpoints of the free edges of the tricuspid valve leaflets together) for treatment of TR. Figure 88 depicts the MitraClip (Abbott Vascular, Santa Clara, Calif.), a percutaneous mitral valve repair using limbus-to-limbus direct anterior-posterior leaflet approach. Figure 89 depicts an overview of E. PASTA from the ventricle: (A) Dilated tricuspid annulus. (B) Double-opening valve, created by PASTA-swathed suture material between the posterior septum and mid-anterior annulus. MRI images before (C) and after (D) PASTA, demonstrating a reduction in annular dimension from 10.4 cm2 to 2.9 cm2. (E) Autopsy 30 days after PASTA from the atrium. S5 septum; A5 anterior annulus; P5 posterior leaflet.

[0078] A device was designed and constructed to allow transcatheter mitral valve repair via a suture annuloplasty procedure. Innovations brought by applicant from this work include, for example, a guidewire capture snare that uses a three-dimensional capture basket to easily capture and externalize guidewires of various sizes (Figure 90); a radiopaque implant tether that is externally tensioned and secured around the mitral valve with a novel locking mechanism (Figure 91); a lock; a delivery system that may secure multiple sutures under high tension and is adjustable and removable (Figure 92); and a percutaneous suture cutter that may cut implanted radiopaque sutures to various lengths (Figure 82). The device may be used as shown herein to achieve edge-to-edge repair of tricuspid regurgitation (TR). (Figure 93; A, TR before clip implantation; B, grasping of the anterior and posterior tricuspid leaflets; C, diastolic transgastric view showing three clips placed and a bicuspid tricuspid valve; D, three-dimensional (3D) frontal view after clip implantation; E, residual TR; F, sketch of procedural strategy. A, showing the anterior tricuspid leaflet; AV, aortic valve; CS, coronary sinus; P is the posterior leaflet; and S is the septal leaflet. *Clip device).

[0079] The devices and methods disclosed herein may be used in their original form for other procedures, or may be modified as needed to suit a particular procedure. In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the present disclosure and should not be considered as limiting the scope of the present disclosure. Each and every patent and patent application referenced herein is expressly incorporated herein by reference in its entirety for any and all purposes.

Claims

1. A catheter including a distal end, said distal end comprising: a collapsible basket disposed thereon; and Includes a deployable snare A user can use the basket to at least partially encircle an object attached to a tissue mass, collapse the basket around the object, and then separate the tissue mass by cutting through the tissue mass with the snare. catheter.

2. 10. A method of removing a mitral valve clip device from a native mitral valve leaflet using the catheter of claim 1.

3. 2. The catheter of claim 1, wherein the cutting step is accomplished at least in part by retracting the snare into the catheter.

4. In the catheter, an outer tubular member with at least one sharp distal protrusion; and an inner rod, which includes a tissue grasper; The tissue grasper can be advanced distally and out of the distal end of the tubular member to grasp tissue; Furthermore, at least one of the sharpened distal tips can be used to cut through tissue by rotating the outer tubular member about the central axis of the outer tubular member. catheter.

5. A method of removing tissue structures such as mitral valve clips and cysts using any of these devices.

6. The catheter of claim 1, The collapsible basket can be moved distally relative to the second portion of the catheter, thereby manipulating the collapsible basket around the object. catheter.

7. The catheter of claim 4, the outer tubular member comprises a laser cut hypotube; catheter.

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