Tissue resection, cutting, and removal system and method

Abstract

The present disclosure provides various embodiments of catheters having articulatable ends that can be used for various procedures, as well as method embodiments that can be performed using catheters according to the present disclosure.

Description

Technical Field

[0001] Cross - reference to related applications This application claims the benefit of priority under the following: 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), U.S. Patent Application No. 63 / 077,579 (filed September 12, 2020). This patent application is also related to the following: namely, U.S. Patent Application No. 16 / 563,925 (filed September 8, 2019. This, in turn, claims the benefit of U.S. Patent Application No. 62 / 728,413 (filed September 7, 2018).) and International Patent Application No. PCT / US 20 18 / 48177 (filed August 27, 2018. This, in turn, claims the benefit of priority under the following: namely, U.S. Provisional Application No. 62 / 550,347 (filed August 25, 2017), U.S. Provisional 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 Application No. 62 / 688,378 (filed June 21, 2018), and U.S. Provisional Patent Application No. 62 / 712,194 (filed July 30, 2018).). The foregoing patent applications are each incorporated by reference herein in their entirety for all purposes.

[0002] Background The present disclosure generally relates to therapeutic devices and techniques. And, in some aspects, to methods and devices for the diagnosis and treatment of heart valves. The present disclosure provides improvements beyond the state of the art in this field.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Summary of the disclosure The present disclosure provides various systems and methods. These remove structures such as clips, cysts, etc. from the valve tip. The present disclosure further provides a system for modifying or removing a luminal valve tip. The present disclosure also provides other innovations, as follows.

Brief Description of the Drawings

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Mode for Carrying Out the Invention

[0005] Detailed description The present disclosure provides various methods and systems. In some implementations, the present disclosure provides the following systems and The method That is , among the anatomical structures, the no-longer-desirable Structure structure is removed To form . For example, when using the Alfieri stitch (or clip) to attach a part of two Heart cusps to each other, the disclosed embodiments may be used to cut through one or both of the said cusps. Thereby, they are released from each other. And also, if desired, prepare a site for the replacement valve. This can be done, for example, by forming one or more additional cuts in each native cusp, or removing a part, or substantially the whole, or the whole, or one or more of the native said cusps. If desired, all of the said cusps may be removed. And any structure attached thereto (such as chordae tendineae) may also be cut or removed. In some implementations, sutures or clips (e.g., mitral clips) may be removed from a patient's mitral valve. Thereafter, further treatment steps may be performed. This may include repairing the valve leaflets, shaping the valve leaflets, removing all or a portion of one or all of the valve leaflets, or detaching the valve leaflets and any chordae tendineae mid-way, and creating room for a replacement valve, as desired.

[0006] Similar procedures for excising or cutting tissue anywhere in the body may be used by utilizing the devices and methods according to the present disclosure. Such procedures may be used to cut valve leaflets. For example, any of the heart valves, or any valve in a vein (e.g., IVC, etc.). Alternatively, any other anatomical structure in the body may be cut.

[0007] When using the energized tissue cutting technique, Any suitable power level and usage conditions may be used according to the disclosed embodiments. For example, continuous use (cutting) radio frequency (「RF」) energy may be used at a power level between, for example, about 50 to 100 watts (or any in between at about one watt increments). The cutting may be performed as follows. That is, power is applied for between about one-half second to about five seconds per second (or any in between at about one-tenth second increments).

[0008] Figure 1 presents an alternative embodiment of the grasping catheter 500. This may be used instead of a pair of catheters to simply grasp the edge of the valve leaflet 475. The catheter 500 includes a tubular outer body 510. This has a proximal end, a distal end, and a longitudinal passage therethrough. The slidable inner grasping mechanism is slidably disposed within the lumen of the outer body 510. This includes the proximal actuator or handle 502. This is connected to the elongated inner body 518. This separates at the bifurcation 516 into a first arm 512 and a second arm 514. These in turn terminate in grasping ends 524, 526 that taper inwardly. Arms 512, 514 are biased away from each other. And the arms and associated tips can be biased together by retracting them toward the distal end of the tubular member 510. Thus, by controlling the relative placement of the inner mechanism and the outer tube, the jaws formed by arms 512, 514 and grasping ends 524, 526 can be opened and 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. This has a proximal end and a distal end. This includes an elongated tubular arm. This has a proximal end and a distal end. And defines an elongated at least one passage therethrough. The elongated tubular arm defines a longitudinal axis along its length. The manipulator further includes a first elongated inner body. This has a proximal end and a distal end. This is slidably disposed within the elongated at least one passage of the elongated tubular arm. The distal end of the first elongated inner body is biased (such as by being configured (e.g., pre - formed or control wire, etc.)) such that when the first elongated inner body advances distally relative to the arm, it curls away from the longitudinal axis and toward the proximal direction. The manipulator further includes a second elongated inner body, which has a proximal end and a distal end, and is slidably disposed within at least one of the elongated passages of the elongated tubular arm. It may be slidably disposed relative to the first inner body. The distal end of the second elongated inner body may be biased as follows: when the second elongated inner body advances distally relative to the arm, it curls away from the longitudinal axis and faces the proximal-facing distal end where the first elongated inner body is disposed.

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

[0011] At least one of the first elongated inner body and the second elongated inner body may have an end effector attached thereto, which is configured to perform at least one of cutting, grasping, irrigation, aspiration, observation, or suction functions. Optionally, 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, which utilize the catheter or robotic manipulator 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 include accessing the patient's sinus passageways using one or more of the disclosed devices. The device may be used to, for example, remove one or more polyps. And it may even be used to break through thin bone layers within the sinus, thereby accessing the cranial cavity and performing a procedure inside the cranial cavity.

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

[0015] In further accordance with the present disclosure, FIG 2 illustrates a cross-sectional view of an extruded main body portion 600 of a further embodiment of the catheter. The body includes an extrusion that defines two offset channels 610, 620. The first channel 610 is illustrated as having a generally circular cross-section. And the second channel 620 parallel thereto is illustrated as having a circular cross-section. This is accompanied by a scalloped portion that has been 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 polymeric extrusion that has one or more reinforcing materials (such as braided layers) formed thereon or therein. The main body may be coated with any suitable coating or material to enhance its lubricity, if desired.

[0016] FIG 3 A is FIG 2Present a side view of an exemplary said catheter. This includes the main shaft 600 described above. At least one braided layer is provided thereon. The catheter further includes a distal tubular segment. This extends distally from the main shaft 600. It defines a lumen 610 therein. It is radially positioned together with the first said channel of the main body. For example, the distal tubular segment may be an extruded tube. This extends along the inside of the main body to the proximal end of the catheter for its entire length. The distal tubular segment may be similarly braided if desired. It may be pre-curved or deflectable as described elsewhere herein. This is, for example, by providing a pull wire within the lumen of the distal segment or within a co-extruded lumen of the distal segment (not specifically illustrated). The distal end of the said pull wire (not shown) may be attached to a collar embedded within or on the distal tubular segment as desired. Figure 3 As illustrated in Figure B, the distal tubular segment and the associated channel surrounding it may be used to act as a guide wire lumen. Thereby, the catheter can be used as an over-the-wire catheter. Alternatively, a smaller-profile catheter (e.g., a snare catheter, etc.) can be delivered through it. This is as shown in more detail below.

[0017] Figure 3Embodiment C is illustrated. The larger (e.g., non-circular) lumen defined within the main body may act as a delivery lumen for a catheter. This may be operable (e.g., by a steering wire). Alternatively, a curvature may be pre-formed therein (e.g., by heating and bending the catheter if it is polymeric in composition). This may be taken after the catheter has advanced distally and exited from the distal end of the large lumen of the main body. Figure 3 As presented in FIG. D, the distal tubular segment may be provided with a further tubular member disposed thereon. Alternatively, it may be integrated during co-extrusion. This may act as a guide wire lumen. This facilitates a rapid exchange (“RX”) procedure using the guide wire rather than passing the entire length of the catheter across the guide wire as in an over-the-wire (“OTW”) procedure.

[0018] Figure 4 is presented in FIGS. 3 A - 3 D. However, it includes a snare catheter 800. This is disposed passing through the small lumen. This performs, for example, capture of a guide wire in a mitral valve annuloplasty procedure as shown in U.S. Patent Application No. 15 / 796,344, filed Oct. 27, 2017. Further aspects of the snare catheter can be seen in that application as well as in U.S. Provisional Patent Application No. 62 / 615,309, filed Jan. 9, 2018. The applications described above are each incorporated by reference herein for all purposes as near as possible. This catheter may be used, for example, in such a mitral valve annuloplasty procedure. For example, the guide wire may be captured using the snare catheter. On the other hand, the large passage accommodates a septal catheter as described above. This grasps structures such as the cardiac valve leaflets.

[0019] Additional embodiments are shown in FIGS. 5 A to 5 B. This illustrates an articulated catheter. It has two bends pre-formed therein. This returns to its bent shape when advancing distally from the main catheter. FIG. 6 illustrates a further possible cross-section of the main catheter. Larger and smaller lumens 1010, 1020 are shown. However, two additional steering wire lumens 1030 are shown. If desired, additional steering wire lumens may be presented. These may be used to house pull wires. These are attached at their distal ends to a portion (not shown) of the catheter. For example, to a ring collar formed on or within the body of the catheter.

[0020] FIG. 7 A to 7 C shows a further embodiment of a catheter according to the present disclosure (or an aspect thereof). This includes a scope on one of the articulated arms, as shown. With the aid of the scope (or funnel), the other articulated arm may be guided into contact. If desired, permanent magnets may be added to the ends (not shown) of the respective articulated arms. Alternatively, windings may be created around both ends of the catheter to form solenoids at the ends of the respective arms (not shown). When current flows through each solenoid in the same helical direction, the magnetic fields created add to each other and attract each other. This causes the arms to move closer together into contact. The force is directly proportional to the current passing through the windings. Also illustrated is a push-pull actuator. This engages relative to each of the rims deployable within the catheter. The disclosed catheter uses a toothed wheel (or gear). This rotates around an axis and engages with a rack. This is within a sliding track. This is in turn attached to one of the engagement arms.

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

[0022] FIG. 8A - 8E illustrates a further embodiment 1400 of the catheter. The distal end 1404 of catheter 1400 is depicted emphasizing its functionality. Catheter 1400 also includes a proximal end and an elongate body (not shown). This has one or more actuators for operating the various sub-components of catheter 1400 described in detail below. Catheter 1400 is defined by an outer tubular member having a proximal end and a distal end 1404, and defines an elongate passage therethrough along its length. The elongate passage slidably houses therein an intermediate tubular member 1450, which has a proximal end (not shown) and a distal end 1452, and in turn defines a passage along its length, which slidably receives therein a sub-assembly, which includes at least one further catheter, tool or manipulator. FIG. 8 A- 8 As illustrated in FIGS. A-E, the sub-assembly is provided to be slidably received within the intermediate tubular member 1450 and includes a central tubular member 1410, which has a proximal end and a distal end 1414, and defines a passage along its length, which receives, for example, a guide wire for guiding catheter 1400 to a target location. As illustrated, the central tubular member 1410 is a straight member, but may be curved if desired. The sub-assembly further includes a second tubular member 1420. It has a proximal end (not shown), a distal end 1424, and an elongated body. It defines a central lumen along its length. The second tubular member 1420 is curved as illustrated. Also provided are collapsible loops 1430, 1440. These may be made of any suitable material. The particular loops illustrated are formed from nitinol. Each loop is defined by a filament. This may have stress distribution loops (1432, 1442) formed therein. This crosses more than 360 degrees. By providing stress distribution loops, the loops 1430, 1440 are made more prone to collapse. This is by distributing bending stress over a longer effective length of the wire. The material forming the loops 1430, 1440 may extend to the proximal end of the catheter 1400. Alternatively, it may be fixed within the distal end of an additional tubular member (not shown). This is slidably disposed within an intermediate tubular member 1450. The loops may be made of, for example, a shape memory material. For example, various nickel-titanium alloys and the like.

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

[0024] Figure 9 A~ 9 As illustrated in FIGS. A~C, the embodiment 1400 is illustrated in a state of being used with respect to the tricuspid valve structure. In use, after advancing the distal end 1402 of the catheter 1400, for example, to the tricuspid valve, the sub-assembly housed within the intermediate tubular member 1450 is advanced distally and exits out of the distal end 1402 of the catheter 1400. Then, the distal end 1414 of the central tubular member 1410 may be directed to pass through the center of the tricuspid valve between the valve leaflets. Next, the two loops 1430, 1440 are deployed and advanced under the valve leaflets to abut the center of each valve leaflet near the valve annulus. Thereby, the tubular member 1420 can be positioned at the center of the third valve leaflet near the valve annulus. At this time, any desired instrument (e.g., a cutting wire or a piercing instrument, etc.) may be advanced, at its edge, through the valve leaflets and near the valve annulus. Thereby, for example, an electrosurgical cutting wire is advanced to penetrate through the valve leaflets. Thereby, the cutting wire can be pulled radially inward through the valve leaflets. Thereby, the valve leaflets are cut in half. According to a further example, a suture may be secured by the sub-assembly component 1420. The suture may then be used as a guide rail to deliver a prosthesis to be implanted over the valve leaflets without first cutting them in half. The following will be recognized. That is, the catheter 1400 may be used in many different types of procedures. And these examples are merely illustrative.

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

[0026] Figure 10 A~ 10F will be specifically referred to illustrate a removal system for valve clips, cysts, etc. The system includes a catheter. This includes a deployable cutting snare and an associated capture system. In particular, the catheter includes an inner tubular member. This has a proximal end and a distal end. This has a deployable cutting snare 1520 slidably disposed therein. The cutting snare may be deployed by advancing it distally. The cutting snare is configured to form a loop that can surround a structure. After surrounding a structure (such as a mitral valve clip), the snare may be retracted. This allows it to penetrate through the structure such as tissue. And the removed structure may be captured and retracted by a capture or retention snare 1510. The cutting snare 1520 may be energized. And it may be electrically exposed or bare around its inner periphery. This helps to burn through the tissue. And if desired, it may be electrically insulated around its outer periphery. Figure 10 As illustrated in Figure C, the cutting snare forms a loop. This is characterized by two parallel sections. This bends outwardly to form a ring shape. The distal end portion is further bent to form a distal tip. The distal tip is 10 depicted at the top of the loop in Figure C. What characterizes this is a sharp bend. This transitions to sweep arcs on both sides, thereby defining the loop. The segment of the snare is then bent at a right angle to travel inside the lumen of the inner tubular member. This exits above the proximal end of the catheter. This is attached to an actuator or handle. This can pull the snare proximally relative to the inner tubular member. The proximal end of the snare catheter may be exposed as desired and connected to a power source capable of monopolar or bipolar operation. The distal portion of the snare catheter may be formed from a heat-treated shape memory material (e.g., nickel-titanium alloy). Thereby, it expands and becomes a hoop configuration as illustrated. Alternatively, it may be formed from a regular conductor. This is configured to bend outwardly 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. This facilitates visualization of the catheter under visualization.

[0027] Figure 10 A~ 10 As further illustrated in FIGS. A~F, the capture or retention snare 1510 may be placed on the outside of the inner tubular member and move therewith. Alternatively, it may be placed on an intermediate tubular member (which has a corresponding proximal end, a distal end, and an elongated tubular body). This slides over the inner tubular member. This facilitates the axial relative arrangement of the cutting snare and the capture snare. The capture or retention snare includes a collapsible basket. This is formed, for example, from a laser-cut hypo tube. This is formed in a pattern like a stent defined by a zigzag row such as struts. The gripping tether is woven around the open distal end of the basket. This has at least one end (two ends in this embodiment). This sews up an annular lumen. This is defined between the outer surface of the intermediate tubular member (if not provided, the outer surface of the inner tubular member) and the outer tubular member of the catheter (the outer tubular member has a corresponding proximal end, a distal end, and an elongated tubular body). The distal end portion of the outer tubular member may be slightly enlarged if necessary. Thereby, as illustrated, the capture basket is accommodated. The basket may be made of a heat-treated shape memory material (e.g., NiTi alloy, woven or non-woven composite metal, polymer, or formed polymer). Thereby, it self-expands into a basket shape when unconstrained. The distal mouth or opening of the basket includes a woven tether. This is routed around the distal opening end of the basket, enters into the fenestrations of the basket, and exits therefrom. 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. For example, a mitral clip to be removed, tissue containing Alfieri stitches, cysts, polyps, etc., unwanted anatomical formations, etc., as desired. As illustrated, the basket may be attached to the intermediate tubular member. This uses a radiopaque marker. This surrounds the proximal ends of the basket and the intermediate tubular member, and a radiopaque distal marker band. This surrounds the radially inner portion of the basket adjacent to the intermediate tubular member and the intermediate tubular member itself. As illustrated, the intermediate tubular member includes a radiopaque distal marker. Thereby, under fluoroscopic visualization, the visibility of the instrument is enhanced.

[0028] If desired, the tubular member outside the catheter may include an enlarged distal segment as illustrated in FIG. 10 F. FIG. 10 D and 10 E illustrate where the outer tubular member is deployed and exits out from the distal end of the guiding catheter. FIG. 10 D and 10 E illustrate before and after the laser cut portion expands, respectively. And FIG. 10F illustrates a relatively large-diameter distal portion over the delivery sheath or outer tubular member. Marker bands may be provided at the distal ends of the respective tubular members of the catheter. And the snares and baskets of the catheter may include a radiopaque material. If desired, the basket may be provided with an outer tubular layer of polymer coating or film. With this aid, excised clips or tissue segments can be accommodated as desired. The outer tubular member may have a deflectable distal tip. In another embodiment, the laser-cut hypo tube basket may be replaced with a polymer tubular section. This can expand without buckling around structures such as mitral valve clips.

[0029] For further illustrative purposes, FIGS. 11 A- 11 D present exemplary method steps. By performing this, previously implanted valve clips may be removed. This is, in this illustration, a mitral valve clip. This is attached to two valves that are adhered. This procedure is very advantageous. Because it can be performed percutaneously or from the apical side as desired, avoiding the need for open heart surgery or stopping the patient's heart while the patient's heart is beating. First, the distal end of the catheter is introduced apically through the bottom wall of the ventricle under 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. This forms a preformed hoop shape. This is oriented at right angles or approximately right angles with respect to the longitudinal axis of the catheter. The cutting snare is then positioned as follows. That is, the cutting snare surrounds the tissue or the mitral valve clip (such as the material to be removed as desired) adjacent to the tissue near the valve tip. Next, deploy the intermediate tubular member carrying the capture basket distally from the distal end of the outer tubular member. Then, manipulate the open end of the capture basket to cover over the mitral valve clip (or other material to be removed). Thereby, as illustrated in FIG. 11 B, the capture basket surrounds most of the mitral valve clip. Next, grip and tighten the top of the capture basket around the upper end of the mitral valve clip. Thereby, mechanically capture it. This is as illustrated in FIG. 11 C. Next, retract the cutting snare into the inner tubular member and penetrate the valve tip tissue attached to the mitral valve clip. As mentioned above, the cutting snare may be energized. The basket and the inner tubular member may then be retracted proximally and placed into the outer tubular member or delivery sheath. And it may be retracted. The following will be recognized. That is, the intermediate tubular member may be omitted. And the basket may instead be attached to the inner tubular member. However, by providing the intermediate tubular member, additional mechanical degrees of freedom can be provided when performing the procedure.

[0030] In a further implementation, FIGS. 12 A - 12 E present a further removal device. This may be used to remove clips, cysts, sutures, etc. in accordance with the present disclosure. FIG. 12 A illustrates that the device includes an outer tubular member or an outer delivery catheter housing. This has a proximal end and a distal end. This surrounds and slidably receives an intermediate tubular member (which has a proximal end and a distal end). This has a clip or cyst housing. There is a cutter tip in its distal end region. Within the middle tubular member, an inner catheter is slidably received. This includes a deployable gripper. This captures structures such as clips to be removed from a patient's anatomical structure. As illustrated, the gripper includes three gripping arms. It is configured as follows. That is, it biases radially outward when unconstrained. Each gripping arm may be formed from a planar strip of material that terminates at a converging distal tip. As illustrated, each gripping arm has a proximal end. This is attached to the distal end of a tubular or solid member inside the inner catheter. Each arm, as illustrated, then has a pre-formed bend. This bends the arm radially outward. And then, as the arm approaches the tapered distal tip, it bends radially inward. Optionally, two or four or more gripping arms may be used. The gripping arms may be formed from a polymer or metal material, optionally. And they may be formed from a shape memory material, or a material formed to spring outward when unconstrained radially. The abdominal pain arm may be configured as follows. That is, when retracted proximally within a tubular member (such as the cutter tip of the illustrated catheter), it collapses radially inward. The gripper may be retracted proximally and placed within a clip or cyst receptacle of the middle tubular member. And the middle tubular member may be retracted proximally and placed within the distal end region of the outer delivery catheter receptacle. Figure 12 B shows an enlarged view of a gripper extending distally. Figure 12 E illustrates different implementations of a cutting tip. This may be used at the cutter tip of the middle tubular member. For example, the cutting tip may include a rounded core-removing edge. This feature is on the pointed annular surface. Alternatively, it may include a distal end terminating in one or two cutting edges. This is the tapered extension of the tubular wall. This is sharp along one or both edges. Thereby, when the intermediate tubular member rotates with respect to an anatomical structure against which the cutting tip or tips are pressed, tissue is cut. Figure 12 As illustrated in Figure C, the cutter receiving portion of the intermediate tubular member is retracted into the outer delivery catheter until it is delivered. And then it advances distally and, as illustrated in Figure 12 D, for example, reaches a position where it cuts the valve leaflet tissue when rotated.

[0031] Figure 13 A~ 13 I, as illustrated in Figure 12 the apparatus of may be used to grasp and excise an object (e.g., a mitral valve clip, etc.). Figure 13 A illustrates the catheter being positioned in a simulated relative position below an existing mitral valve clip. Figure 13 B illustrates the gripper extending distally. This extends out from the distal end of the outer tubular member or delivery catheter and is above and over the clip or cyst. Thereby, the gripper surrounds the cyst. The cutter receiving portion is then advanced distally relative to the gripper. Thereby, the arm biased radially outward of the gripper is pushed inward under the force of the cutter receiving portion extending distally. Thereby, a structure such as the clip is grasped. Figure 13 D, as illustrated in Figure the outer sheath may then be advanced distally and directed toward the valve leaflet. 13 The cutter receiving portion may then be advanced distally. Thereby, as illustrated in Figure E, it contacts and pierces the tissue. Figure13 F illustrates rotating the cutter housing relative to the tissue. This causes the cutter to form a circular cut, thereby removing an object from the anatomical structure, such as a mitral valve clip. When cutting a material such as the tissue, materials such as the clip and cyst can be retracted and placed into the outer sheath and removed from the patient. Figure 13 H and 13 I illustrate that after the removed material such as the clip is removed from the patient, it may be ejected from the catheter.

[0032] Figure 14 A - 18 G illustrates the implementation of a torsion catheter. Using this, a structure such as a planar tissue structure may be twisted, such as a native or replacement valve leaflet, and retracted into the catheter to capture the tissue, which may then be detached from the surrounding anatomical structure.

[0033] Specifically, Figure 14 A illustrates the distal end region of the torsion catheter, which includes an expandable basket or a tubular end similar to the above - described embodiments and includes a torsion catheter inside it, which may have two lumens to accommodate an energized guide wire. 12 Alternatively, as illustrated in Figures B and 14 C, the inner elongated member may be provided with a gripping tool similar to the above - described embodiments and is slidably disposed within the intermediate tubular member. 14 Figure 13 D illustrates the guide wire of Figure Figure 14 D illustrates the guide wire of Figure 14 A, which has an energized distal tip 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. This is discussed in more detail below. The basket of the torsion catheter may be made of braided or unbraided composite metal, nitinol, polymer, formed polymer, etc. Figure 14 The energized snare of Figure E is fully insulated. However, this excludes the distal loop and the proximal 0.5 inches connected to the RF generator. The energized snare may itself be a separate catheter. Alternatively, it may be delivered through a long sheath. This houses both the torsion catheter and the energized snare.

[0034] Figure 15 A~ 15 Figure 14 D illustrates excising valve tissue using the system of Figure. The valve tip excision device may be used to remove valve tissue, for example, from the aortic valve, mitral valve, tricuspid valve, and pulmonary valve. It may be used for removal of tissue within the valve or for congenital tissue. The energized wire may be coated, for example, with PTFE or parailene and then covered with PTFE or PET. The energized wire may be a single layer. Alternatively, it may have a double layer PTFE coating or PET or a combination of both. The guide wire may have a pre-twisted or bent section in the center. This may be accomplished by slightly polishing to reduce the diameter or actually pre-twisting the wire. The twisted or polished section may be marked using visible marker bands on both sides of the section. This facilitates visualization under fluoroscopy. Figure 15 A illustrates positioning the guide catheter and the energized guide wire over the valve tip. Figure15 B illustrates where the snare catheter advances. And it also illustrates where the exposed distal tip of the guide wire is energized. Thereby, the guide wire is advanced to penetrate through the tissue at the valve tip.

[0035] Figure 15 C illustrates where the energized guide wire is grasped by the snare catheter. Figure 15 D illustrates where the snare is used to retract the guide wire proximally and out of the patient until the two ends of the wire are externalized from the introducer sheath. Figure 16 A illustrates where the torsion catheter advances. This may include a double-lumen elongated core member. One leg of the guide wire passes proximally along each lumen and covers over both ends of the energized guide wire. Figure 16 B illustrates where the tissue is twisted by applying torque to the elongated body of the torsion catheter. This has the effect of applying a rotational torque around the longitudinal axis of the catheter to the loop formed by the guide wire. Figure 16 C illustrates where the tissue is continuously twisted by applying torque to the torsion catheter until the valve tips are fully gathered. Figure 16 D illustrates where the outer tubular member advances distally to cover over the inner torsion catheter that covers over the twisted tissue at the valve tip. The tissue is contained simply by sliding the tube outside the catheter to cover over the elongated inner body and loop. When a basket is provided at the end of the outer catheter, the snare may be tightened to crush the distal end of the basket around the tissue at the valve tip. Figure 16 E~ 16F illustrates fixing the tissue by containing it within the distal tip of the catheter. 16 E illustrates the use of a basket. 16 F illustrates the use of an outer polymer 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 twisted catheter may be partially covered with PET or PTFE, reducing the exposed surface area and concentrating energy on the tissue. Figure 17 A shows the energized snare advancing over the proximal end of the combination of the twisted catheters. Figure 17 B illustrates squeezing the snare over the tissue to be excised and then energizing it to cut the tissue. The snare is then retracted while energized, completing the cutting of the tissue (Figure 17 C).

[0036] Figure 17 D illustrates the configuration of a partially covered and energized snare. Figure 17 E illustrates how a small section of the inner surface of the snare is exposed, allowing the applied power to flow out. This exposed section contacts the tissue, concentrating RF energy only on that part of the tissue and preventing inadvertent energy delivery to surrounding tissue. Figure 18 A - 18 G illustrates an in - vitro test using a porcine aorta, demonstrating complete excision of the aortic valve leaflet. Figure 18 A illustrates tissue twisted into the catheter. Figure 18 B illustrates an energized snare positioned over the tissue, thereby excising the tissue. Figure 18C illustrates the location where the tissue contained in the catheter is cut. Figure 18 D illustrates the cutting of the tissue. Figure 18 E shows the surrounding tissue with the valve tip removed. Figure 18 F illustrates the remaining tissue. And Figure 18 G shows the removed tissue.

[0037] Figure 19 A~ 22 C illustrates a further implementation of the tissue resection, cutting, and removal system. The valve tip cross wire described above functions as a rail or guide. This positions the cutting device over the valve tip to be cut. Using the inner guide wire lumen, the cutting head loop of the wire may be advanced distally, covering over the guide wire rail and reaching the edge of the valve tip. The cutting head loop of the wire may be shaped as follows. That is, a specific portion of the desired valve tip is removed. This creates an opening range for flowing near any coronary artery. One cutting head (wire) may be energized with RF energy. Alternatively, both cutting heads (wires) may be energized for cutting. If desired, one cutting head loop wire may be electrically exposed and energized while the other is insulated. A bending point may be set in the cutting wire. This causes positive contact and adhesion to the cutting wire. This ensures that when the outer delivery catheter advances covering over them while in position, it will actively burn through. By passing the guide wire through and leaving it in the valve tip, after cutting, the cut portion can be removed. Using a cover that covers over the opening of the cutting wire, in the case where the wire is lost and the cut portion cannot be held, it may be ensured that the cut portion of the valve tip can be captured.

[0038] Figure 19 A~ 19 D illustrate aspects of preparation for using such a system. Figure 19 A issues positioning a guide catheter and an energized guide wire over the valve tip. Figure 19 B illustrates the snare advancing from a position where the guide wire has passed through the valve tip to a position where it exits therefrom. Figure 19 C illustrates grasping the guide wire using the share. And, Figure 19 D illustrates externalizing and twisting the guide wire.

[0039] Figure 20 A - D illustrate further embodiments of a rail - based valve tip resection and cutting system. This involves a modular RF head cutting loop. This is without electrical insulation and is accompanied by... The delivery catheter for delivering the components may be provided with an expandable tip. For example, a protective basket for better capturing of the valve tip cutting loop and the like. As illustrated, the system includes an outer delivery catheter. This is in the form of a tubular member. This has a proximal end and a distal end. Using an inner tubular member, as illustrated in Figure 19 the guide wire may be introduced through the valve tip and then sutured through the guide wire. Thereby, the guide wire passing through the valve tip can be used as a "rail" to drive the delivery catheter as follows. That is, the inner tubular member is slid over both ends of the guide wire. The lumen of the inner tubular member may be provided with a diameter sufficient for the following. That is, six guide wires can pass through when three valve tips are captured (for example, in the case of a tricuspid valve, etc.). The following will be recognized. That is, FIG. 19 The treatment of A may be reproduced for each of one, two, or three valve tips on the same valve. Both ends of the guide wire may be externalized. If desired, a loop may be formed at one or more of the proximal ends of the guide wire. And the distal end of the guide wire may be sewn through the loop. And the resulting knot may be pushed down to the valve tip. As a result, the tubular member inside the catheter of FIG. 20 only needs to accommodate three guide wires instead of six. The intermediate tubular member may be slidably received covering over the inner tubular member which is inside the outer tubular member. This includes one, two, or three loops. This is placed at the distal end of the intermediate tubular member. One or more of these loops may be coupled to a power source (RF) at the proximal end of the intermediate tubular member via one or more conductors across the length of the intermediate tubular member.

[0040] As shown, each loop is coupled at the proximal end to the distal end of the intermediate tubular member. This is by any one of a number of suitable techniques. The wire of each corresponding loop then proceeds in the distal direction. And completes its path in a loop shape. For example, the loop may be formed from strands of insulated or non-insulated wire. This has two proximal ends. This may complete an electrical circuit by passing electricity along its length. The proximal portion of the loop extending distally may also be provided with a bend extending radially outward. Thereby, the wire of the loop first extends radially outward, bends, and then extends radially inward. Thereby, when the wire is bent outward, the outer tubular member of the delivery system can ride thereon. Thereby, a force directed radially inward is applied to the loop or loops. Thereby, the loop is bent radially inward to grasp and bias the valve tip. Figure 20 D illustrates a side view. The inner tubular member is retracting proximally.

[0041] Figure 21 A~ 21 E illustrates the aforementioned system. This uses a guide wire as described as a rail therein to cut tissue. In one embodiment, a single valve tip system may be advanced to cover both ends of the energized guide wire. This is directed through the valve tip as described above in the figure 19 and is about one-third from the edge of the valve tip. Figure 21 B illustrates how the guide wire lumen (or inner tubular member) can advance downward to reach the edge of the valve tip and be temporarily fixed. Figure 21 C illustrates how the cutting head can advance with the valve tip between the cutting elements while fixing the guide wire lumen to the valve tip. Figure 21 Referring to D, when the loop-shaped cutting element comes into place, the outer tubular member is then advanced distally to cover the bend point directed radially outward of the loop. Thereby, the loops are pressed against each other on the other side of the valve tip. Thereby, a firm pressure against the valve tip is created. At this point, the cutting element may be energized. Thereby, the valve tip is cut, the cut portion is retracted, placed in the delivery catheter, and removed.

[0042] Figure 22 A, 22 B and 22 C illustrate examples of cutting wires of different shapes. This may be placed on the distal end of the tubular member in the middle of FIG. 20 One of each pair of loops is covered with electrical insulation. Figure 24 A illustrates a round loop. This has a larger removal range. Figure 24 B shows a diamond-shaped loop. This can facilitate the retraction of the loop into the delivery catheter. And, FIG. 24 C depicts an oval-shaped loop with a smaller transverse range than the loops of FIGS. 24 A and 24 B.

[0043] Figure 23 A~ 23 C depict a catheter similar to that of FIG. 20 However, it has two electrically exposed cutting loops. This is used in combination with two transverse guide wires. These are each delivered to separate valve tips using the technique of FIG. 19 And, FIGS. 22 A~ 24 C depict an embodiment with three cutting loops. Thereby, three valve tips are cut. Each of them is similarly captured by a guide wire. However, the loop is configured to expand radially outward. Thereby, its distal end region can extend radially outward, thereby reaching the valve annulus. Similar to the previous embodiments, the tubular member inside the catheter is sutured along the guide wire passing through the valve tip. The cutting loop advances distally toward the valve tip and is configured to expand radially outwardly so as to contact the valve tip near the wall of the vasculature. The distal region of the loop is exposed so that when RF energy is energized, it penetrates through the valve tip near the valve annulus (preferably in a non-calcified region). The catheter and the energized loop are then rotated about the central axis of the catheter to effect the cutting. After cutting, the cut portion of the valve tip can be removed by routing the guide wire through the respective valve tip. The insulated portion of the cutting loop protects any undesired portion of the valve tip and prevents it from being cut.

[0044] Figure 25 A~ 26 D illustrate implementations with a rotating blade that cuts one or more valve tips with a protective basket that captures the cut portion of the valve tip and prevents embolization. These embodiments are preferably used by capturing the respective valve tips using guide wires as described above. In this embodiment, the inner tubular member and the outer tubular member are essentially the same as in previous embodiments, except that the intermediate tubular member includes a laterally offset blade attached to its distal end, which allows an annular cutting path to be drawn when the intermediate tubular member rotates around the inner member within the valve annulus range. The inner tubular member is reused to advance the cutting device to the edge of the valve tip and cover over the guide wire rail. A guide wire lumen stopper may be provided at the distal end of the inner tubular member, which would limit the cutting blade from advancing too far and passing through the valve. The rotary cutting blade attached to the intermediate tubular member may be sharpened on one or both sides to make it bidirectional. The rotary cutting blade may be energized with RF energy. By placing the guide wire and then removing the guide wire, the removed section of the valve tip is surely removed. This is routed through that part of the valve tip. Therefore, FIG. 26D includes a valve tip transverse guide wire. This is used as a rail for the valve tip removal device. FIG. 26 B illustrates the guide wire lumen. This is placed on the valve tip edge to be taken together. FIG. 26 C illustrates where the cutting blade advances and covers the inner tubular member. This defines the guide wire lumen through between or through the valve tips to the end stopper. The blade may be rotated to cut through two valve tips. FIG. 26 D depicts a view from below of the advanced cutting blade. This may rotate to cut through two valve tips. 。

[0045] FIG. 27 ~ 72 illustrates examples of further embodiments. By this, the procedures described elsewhere in this application are also performed.

[0046] FIG. 27 depicts the first step of the procedure. Here, a thick-walled animal guide catheter is introduced together with a flexible catheter and a JL4 catheter to a target location near the tricuspid valve. This is a standard left coronary ostium access catheter. JL is an abbreviation for Judkins left. Due to its curvature, it can be easily placed in the left coronary ostium. A 16Fr resection catheter (FIG. 28 ) may then be used to cross each of the three valve tips in the valve. The tethers from the transverse cuts may be fixed to each of the valve tips. For this, knots and cotton suture may be used, as desired (Fig. 29 ~ 30 ). Fig 31 Referring to Fig. 31 , remove the previously installed sentinel plug protection catheter.

[0047] Fig 32 ~ 33 Figs. 32 to 33 depict the system. This includes a guiding catheter. This includes a plurality of tubular members. Each of these includes a 0.014-inch guide wire. This has an exposed distal tip. This may be energized to thereby cross the corresponding valve tip. The catheter system may further include a central stylet. This includes a nose cone configured to receive a 0.035-inch wire passing therethrough. Each of the tubular members may be bent inside the stent frame of the associated TAVR valve (Fig. 34 ). This is installed after excising the valve tip halfway.

[0048] Fig 35 Fig. 35 depicts the introduction path of the guiding catheter. This is introduced via the IVC and enters the heart. And it is a second catheter. This is introduced via femoral access and reaches the aorta. Using these access paths, the catheter system may be deployed. This excises the valve tip and tissue for the aortic valve illustrated in Figs. 36 to 57 . This is by introducing guide wires along the passageways of both catheters and completing the passageways. 36 ~ 57 Then introduce the elongated distal portion of the tubular member inside the system along the entire passage covering the guide wire.

[0049] ​After introducing the distal portion of the inner tubular member, the remaining portion of the system is deployed. This is done by advancing the catheter outside the system past the aortic valve and retracting the outer tubular member proximally. First, the most distal capture basket is deployed. This occupies the space downstream of the aortic valve. This inner basket is attached to the remaining portion of the system. This is by means of three conductors coupled to the open peripheral edge of the basket. The basket self-expands. And is made of, for example, a shape memory material. Thereby occupying the width of the aorta downstream of the aortic valve. As the outer catheter is retracted proximally, the self-expanding inner basket expands. This is attached to the inner tubular member. This inner basket may be used as one pole of a bipolar electrosurgical system. Or alternatively as an expansion mechanism. The inner basket expands and thereby occupies the aortic valve. The electrosurgical cutting edge is defined on the peripheral peaks facing proximal to the capture basket. The capture basket is excited as follows. That is, the three leads are excited. These are coupled to the annular periphery of the capture basket. And the capture basket is drawn into the cusps of the aortic valve as follows. That is, the leads are pulled in the proximal direction. When using bipolar current, the circuit is completed as follows. That is, it crosses the gap passing through the aortic valve cusp and reaches the inner basket. The basket is finally pulled proximally enough to surround the inner basket. The inner basket and the outer basket cooperate with the inner tubular member of the system to define an annular cavity. Thereby collecting the anatomical structure and fragments of the detached aortic valve and capturing the detached material. Figure 37As depicted, the distal end of the inner basket terminates in a Coanda tip shape. This extends into the capture basket. This enters the center of the basket and enhances the flow passing through the system. Generally, this enables perfusion. The capture basket may be configured as follows. That is, after capturing the valve tip, it is removed from the venous access device. Alternatively, it may retract into the introducer catheter.

[0050] Figure 39 ~ 42 is depicting a variant of the system of Figure 36 ~ 38 This replaces the distal capture basket with one having a dual concentric electrode assembly. The outer electrode (Figure 40 ) includes three tips facing proximally. This is received within the valve leaflets of the aortic valve. This is positioned radially outward from the valve leaflets of the aortic valve. The inner electrode (Figure 42 ) may be concentrically arranged within the outer electrode and attached to the distal assembly. Alternatively, it may be placed on the distal end of the inner basket within the aortic valve and inside the valve leaflets as shown in Figure 36 ~ 38 . A circuit is completed through the tissue of the valve leaflet between the inner and outer electrodes. The inner and outer electrodes advance proximally as they penetrate through the tissue. The outer electrode may have a zigzag leading edge. This may be rotationally aligned or displaced from the zigzag electrode of the inner electrode. The arc is completed by the shortest path of travel between the inner and outer electrodes in a bipolar array (Figure 55 ). The monopolar array may be implemented as follows (Figure 56 ). That is, the inner and outer electrodes are aligned. And a circuit passing through the patient is completed. Thereby, the valve leaflet material is cut. The outer electrode may be powered by three electrical leads. As depicted, this extends from the proximal end of the device and passes through the IVC passage. If desired, as depicted in FIG. 57 the outer electrode may include a mechanical cutting edge. This aids in cutting through the tissue as the outer electrode advances in the proximal direction.

[0051] FIG. 58 ~ 72 depicts a further valve tip cutting catheter. This may be arranged in a "T" shape, which facilitates cutting across the valve tip. To illustrate this procedure, referring to FIG. 58 in a first step, the catheter is positioned at the desired location of the valve tip with the guide wire tip. The guide wire is energized to burn through the valve tip. Referring to FIG. 59 the opening is further traversed by a microcatheter, which enlarges the hole in the valve tip. Alternatively, it is also possible to have an expandable tip on the catheter. Referring to FIG. 60 the "T" is advanced out of the distal tubular end of the catheter. This is attached to the inner catheter and has inner and outer members. The dissector is in the collapsed elongated position past the valve tip. Next, the dissector is deployed as follows: the inner portion of the dissector connected to the tip is retracted relative to the outer tubular member of the dissector. The dissector is then positioned at the bottom of the valve tip in the desired orientation. The dissector is then energized and retracted, cutting through the valve tip. Referring to FIG. 61 the wire of the T dissector may be doubled at the joint, which makes it easier to collapse. The wire of the T dissector is insulated, except for the exposed or bare portion of the wire. This is energized and used to cut through tissue. Figure 62 Referring to, when the first cut is made at the base of the valve tip, the T dissector may be collapsed again, advanced again over the guide wire, and repositioned again under the valve tip. The T dissector may then be opened again and positioned to be orthogonal to the first cut. Figure 63 Referring to, energize the T dissector and create a second longitudinal cut in the valve tip. A T-shaped tear may be achieved in the aortic valve tip, thereby preventing the coronary ostia from being blocked for subsequent TAVR.

[0052] Figure 64 depicts the T dissector. It is in the collapsed position and shows the outer shaft. Figure 65 depicts the dilator tip. It has a guide wire lumen and shows a good transition in rigidity between the guide wire and the T dissector. Figure 66 depicts the inner shaft and the guide wire lumen. It is connected to the distal tip of the T dissector and is an intermediate tubular member. It is coupled at its distal end to the proximal end of the cut portion. By pulling the tip proximally relative to the intermediate member, the T dissector is deployed. Figure 67 depicts the T dissector. It is in the open or deployed position. Figure 68 illustrates the exposed and bare wire. It is on the surface disposed facing proximally to the T dissector. Figure 69Draws the inner shaft. This is retracted relative to the outer shaft. This causes the cutting wire to be further crushed. This makes them stiffer. Figure 70 Draws the crushed position of the catheter. This shows the following: namely, the dilator tip with the guide wire lumen; the wire of the inner shaft; and the outer shaft. Figure 71 Draws the device in a partially deployed position. This illustrates the exposed wire and the central guide wire lumen. On the other hand, Figure 72 Draws the device in a fully deployed configuration. The following will be recognized. Namely, a single circuit is depicted passing through the entire T-cutter. On the other hand, it is possible to have multiple wires. These form cutters that are electrically isolated from each other 。

[0053] By partially exposing the coated guide wire at the twisting part, preparing the guide wire to cut the valve tip during an electrosurgical procedure Twist block Of Implement the mounting in Figure 95 ~ 104 as depicted. The twist block includes a main horizontal body portion. This is coupled at both ends by pins to upright pivot arms. Each pivot arm terminates in a pivot knuckle. This in turn includes a blade. Place the wire in the groove by Figure 96 and lodge it in a clamp. This is parallel to the horizontal body portion. Figure 97 By Figure, the blade rotates towards the wire loaded in the groove and the clamp. The blade contacts the wire at the outer edge of the exposed area (Figure 98 ). As pressure is continuously applied to the outer top section, the blade begins to move towards the center (Figure 99 ). The blades then meet at the center. And the pressure is then directed downward. As a result, torsion begins to form in the wire (FIG. 100 ). FIG 101 ~ 103 illustrates the twisting process. And FIG 104 illustrates the twisted and exposed wire. This is, after the operation is completed, in the twister 。

[0054] FIG 73 A~ 94 illustrates various techniques for repairing or adjusting the performance of a valvular prosthesis. For example (without limitation), procedures for transcatheter tricuspid valve repair, etc. The following will be recognized. That is, the disclosed devices and techniques may be used on any valve structure having leaflets. The following exemplary description is not intended to be limiting. Rather, this description is intended to present a particular non-limiting implementation. Accordingly, what is disclosed in this embodiment is a method for repairing or adjusting the performance of a valve structure as described, and an apparatus for repairing or adjusting the performance of a valve structure as described.

[0055] Disclosed is a small-profile transvenous access system (e.g., compatible with an introducer sheath of 18F or greater). This is in the form of a transfemoral venous system. The system may use a multi-axis deflectable guide sheath. This has two or more coaxial shafts that are deflectable. And has an outer shaft. This traverses through the inferior vena cava and reaches the right atrium. And then passes through the tricuspid valve. This has, for example, an outer diameter of 10F and an effective length of 100 cm. The system may further include an inner shaft. This traverses to the apical side surface of the leaflet. This has, for example, an outer diameter of 8F and an effective length of about 110 cm. The system further includes a valve leaflet transection tool, which transects through the valve leaflet from the apical side to the atrial side. The transection tool may include, for example, a guide wire with an outer diameter of 0.014 inches. And the length of the transection tool may be energized using the transmission of high-frequency (RF) energy. And it may have an electrically insulated polymer coating along the effective length, except for the distal tip. Thereby, energy is delivered to the valve leaflet tissue, and with this assistance, the tissue is transected. At the proximal end, the guide wire is connected to an RF generator. The guide wire preferably has an effective length of, for example, 300 cm and has an electrosurgical connector, which facilitates the connection between the valve leaflet transection tool and the RF generator. The connector may be electrically shielded, thereby delivering 5 - 60 watts of RF energy through, for example, the effective length of the transection tool. And it may have a spring-loaded mechanism to firmly hold the energized transection tool in place and may be compatible with conventional electrosurgical generators (such as Medtronic Valleylab FX).

[0056] The system preferably further includes a retrieval tool, which delivers the following device. That is, when transecting through the valve leaflet to externalize the transection tool, it catches it. The retrieval tool may have an outer diameter of 6F, for example, and may have a snare, which catches the transection tool. This may be, for example, a self-expanding three-dimensional basket, which facilitates capture, or a gooseneck-type snare, which is easily positioned on the atrial side of the valve leaflet. The system preferably includes a guide wire, which stitches the "connector", thereby delivering a means to connect the transection tool to the radiopaque tension element for replacement. This connector should be easily and quickly engageable by a physician and should withstand high tensions (e.g., up to about 20 N according to ISO 10555). It may deliver a radiopaque tensioning element. For example, a suture loaded with a radiopaque material. This replaces the crosswire. This thereby tensions the prolapsed valve leaflets together. The radiopaque tensioning element may be provided in three independent elements. And it may be non-absorbable. And it may have mechanical and biological properties (tensile strength, strength retention, tissue reaction / blood flow) similar to commercially available sutures. And it may have different colors. This helps to identify the individual valve leaflets while adjusting the tension. And the minimum length may be 300 cm. The system should also include a radiopaque force distribution element. For example, cotton wadding loaded with a radiopaque material. This prevents the tensioning element from pulling out the valve leaflets. The tensioning element should have a foldable design mechanism. This allows it to be easily delivered through the guide sheath. And it should be about 4×3 mm in size. A radiopaque and echogenic landmark may also be provided. This is for real-time image guidance. This thereby delivers the system. For example, a radiopaque marker band or an echogenic coil. These may be located, for example, as follows. That is, at the distal tip of the device and at specific intervals along the length of the tensioning element. This helps to estimate the distance.

[0057] The system should also preferably be biocompatible in accordance with ISO 10993. And it should have at least three points juxtaposed with the three valve leaflets. This delivers the following system. That is, at least one tensioning element is provided per valve leaflet. The system also preferably provides adjustable trans-catheter suture fixation and includes the following mechanisms, i.e., ensuring and maintaining the tension delivered by the tension element to all three valve leaflets. Trans-catheter suture fixation can securely and permanently fix the cotton-spread suture tension element. Tension adjustment, tension reversal, and complete recovery after application are possible, it is corrosion-resistant, and engagement is relatively easy.

[0058] The system should also include a trans-catheter 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, this device can easily penetrate through the three sutures and is corrosion-resistant.

[0059] In accordance with the present disclosure, the method may include implanting a radiopaque suture through each valve leaflet, which is at least 0.5 cm to 1 cm away from the edge of the valve leaflet and the radiopaque cotton-spread thread is on the apical side. The sutures may be tensioned together towards the center of the valve, thereby effectively attaching the valve leaflets to each other and reducing tricuspid regurgitation. Thereafter, the tension is then maintained using a fixture, such as the lock shown in U.S. Patent No. 10,433,962, which uses a related lock delivery catheter.

[0060] Figure 73 A~ 73 C depicts the steps performed for trans-catheter tricuspid valve leaflet tricuspid valve suture repair, which is demonstrated in a tricuspid valve bench-top anatomical model. Figure 73 A shows a tricuspid regurgitation model. Figure 73 B and 73C each indicates a decrease in TR. This uses three sutures that are fluffed. These are tensioned and locked together. FIG. 82C illustrates the apical side of the valve tip. This shows the fluffed suture that distributes the applied tension force.

[0061] In further accordance with the present disclosure, the outer shape (and the interaction of multiple devices) of the disclosed device in this system may be compatible with a trans-femoral introduction sheath that passes through the right femoral vein. A multi-axial deflectable guide sheath may be provided. For example, a guide sheath may be used to ensure that a physician can navigate to a required target site. This guide sheath may have at least two coaxial shafts. Each of these is deflectable. This provides 360° access at various radii within and around the tricuspid valve. The outer shaft may, for example, have an outer shape of 10F and an effective length of 100 cm. The disclosed inner shaft may, for example, have an outer shape of 8F and an effective length of 110 cm.

[0062] FIG 74 A~ 74 B shows an example of a distal end device 。 Specifically, a valve tip crossing tool may be used to navigate to the target site required for this tricuspid valve repair procedure. By having a crossing tool (such as an energized guide wire, etc.), it becomes possible to puncture or cross the valve tip. This facilitates the juxtaposition points necessary to reduce TR. High-frequency energy transmission may be used to use a 0.014-inch guide wire coated with a polymer (having a high dielectric constant for insulation properties and a low coefficient of friction for lubricity. For example, PTFE.) along an effective length of, for example, 300 cm. However, excluding the distal tip (1 - 2 mm) and the proximal end (for connection to the RF generator). By using this energized wire, transfemoral navigation from the IVC to the tricuspid valve may be enabled. Thereafter, it may be energized and punctured across the valve tip. The wire may be captured (using the retrieval tool discussed below) and returned below the IVC and externalized, thereby exiting the transfemoral access sheath. To facilitate navigation, this crossing wire may have mechanical properties similar to the Asahi Start XS20 or XS40 guide wire.

[0063] Figure 75 illustrates an energized valve tip crossing tool that advances through the guide sheath. An electrosurgical connector may be used to transmit RF energy from an RF generator to the crossing wire. This connector may be plugged into the generator with an RF-compatible plug (e.g., Medtronic Bariatric Valve FX, etc.) and may then have a spring-loaded female connection portion to ensure reliable connection between the exposed proximal end of the crossing wire. The connector may be electrically shielded to deliver 5 - 60 watts of RF energy through the length of the crossing wire to the exposed distal tip. 。

[0064] Figure 76 A~ 76 Referring to C, a retrieval tool in the form of a capture basket is provided. The retrieval tool completes the crossing path and externalizes the crossing wire, thereby facilitating exchange with the tension element. The snare catheter may be, for example, 6F. Figure 76 A~ 76 As illustrated in C, a retrieval tool is provided that displays its distal end region and has a three-dimensional capture basket. The basket may have multiple configurations. For example, those depicted in U.S. Patent No. 10,433,962 and the like.

[0065] To facilitate the replacement of the transverse wire with the radiopaque tension element, a secure connection should be formed between the two. Figure 77 depicts an example of a crimping prototype. This attaches a guide wire to a radiopaque suture. For example, those depicted in U.S. Patent No. 10,433,962 and the like.

[0066] With the aid of incorporating a radiopaque tension element, the point where the device is juxtaposed with the valve tip may be maintained. Also, the tension applied to the valve tip to reduce TR may be maintained. It is possible to use a non - absorbable suture design having mechanical properties similar to commercially available sutures such as Gore - Tex CV - 4. The tension element may have a radiopaque core. This includes, for example, one or more of platinum, tungsten, tantalum, BaSO4 - loaded Pebax, etc. This enhances visibility under fluoroscopy and echocardiography when laminated under various outer layers (such as PET sutures). Thereby, surely, the tension element can withstand high tension. Depending on performance requirements (often determined during acute animal testing), the tension element can take one of several different laminated constructs. Additional radiopaque suture materials are disclosed in U.S. Patent No. 10,433,962. Each suture (anterior, posterior, septum) may have a mark such as a different color (for example, a radiopaque pattern). With this aid, when a physician adjusts the tension applied to each valve tip, the physician can quickly determine which suture to select. The suture has a minimum length of 300 cm. Thereby, it can easily pass through the valve tip and be exchanged and externalized. Figure 78depicts a) 80% tungsten-loaded 53D Teflex (0.014 inches), b) 99.99% pure platinum wire (0.004 inches), c) 99.95% pure platinum wire (0.006 inches), d) 99.95% pure platinum wire (0.008 inches), e) 99.95% pure platinum wire (0.010 inches), f) 90% / 10% platinum iridium wire (0.013 inches).

[0067] A force distribution element may be provided. It distributes the tension applied to the valve tip. This avoids and resists the tension element from being pulled out. For example, it can be a radiopaque pledget or the like. The cotton pledget may be constructed as follows. That is, a radiopaque material as described above is encapsulated between two small pieces of medical fabric (such as PET). The cotton pledget may be around a size of approximately L 4 mm × W 3 mm. And it may have a folding design mechanism. Thereby, it can be reliably delivered through the multi-axially deflectable guide catheter. Figure 79 depicts an exemplary radiopaque and pull-resistant cotton pledget.

[0068] An adjustable transcatheter suture fixation may be provided. For example, those depicted in U.S. Patent No. 10,433,962. By fixing the tension element, it becomes easy to deliver a secure and permanent fixation of the cotton-placed suture under tension. A transcatheter suture fixation system that enables adjustability (e.g., fixing and releasing multiple times without damaging the suture and withstanding a range of tensions) may be used in this disclosed procedure. Thereby, the physician can titrate the amount of tension applied to the valve tip. Thereby, if necessary, it can be inverted or completely retrieved after application. This is an important safety mechanism. The fixation system may include, for example, in particular, a locking mechanism or a knot. The lock may be made of a biocompatible and MRI-safe material (such as titanium, etc.). This can also provide visibility under fluoroscopy and echocardiography. The lock preferably passes easily through and fits into a small-profile introducer sheath. Figure 80 depicts an exemplary suture lock. This secures two sutures. The lock may similarly be configured to accommodate three sutures. Figure 81 depicts an exemplary "knot pusher". This may advance different half-hitch knots for a linear distance up to 30 cm.

[0069] When the cotton-spread suture (tension and force distribution element) passes through the valve tip and is deployed under appropriate tension and locked in place, the excess length of the suture externalized from the introducer sheath needs to be cut and removed. For this, for example, a suture cutter is used. Such as those depicted in U.S. Patent No. 10,433,962, for example. Preferably, the cutter is visible under fluoroscopy and echocardiography. The blade of the suture cutter may be corrosion-resistant. And the hardness may be at a level that can easily cut all three sutures simultaneously. The effective length is, for example, in the range of 120 cm to 140 cm and can fit through the longest commercially available guide catheter. This is for passing through and fitting into the longest commercially available guide catheter. Figure 82 depicts an exemplary example of such a suture cutter. This may be modified as follows. That is, make it flexible and longer for transfemoral use. And it may be updated as follows. That is, cut three sutures.

[0070] Radiopaque and echogenic markers may be provided for real-time image guidance. By incorporating radiopaque and echogenic markers, it is ensured that during this procedure, the physician can visualize the repair system. For fluoroscopy, markers (such as platinum-iridium marker bands, etc.) may be present in the following locations. That is, within a range such as the distal tip of the delivery system. And at specific increments along the tension element. This allows the physician to estimate the distance. And at the distal tips of the cutting tool and the retrieval tool. Biocompatibility is important for these markers. Because the host or patient has a tendency to be exposed to these materials, either temporarily or permanently. The shaft inside the guide sheath may have a distinct echogenic mechanism at the tip for visibility under cardiac echo. This may provide visualization during the cutting and puncturing of the valve leaflets. With an echogenic mechanism (such as segmented coils, etc.), the physician can bring the inner shaft into contact with the apical surface of the valve leaflet. This facilitates crossing the valve leaflet.

[0071] By providing at least three points juxtaposed with the three valve leaflets, the following is ensured. That is, the design for the transcatheter tricuspid valve suture repair system can maintain at least one point juxtaposed with each valve leaflet. This can easily reduce TR. The disclosed system and method meet this as follows. That is, deploy a radiopaque suture material scattered within each valve leaflet of the tricuspid valve. This is made possible by a custom guide catheter. This provides 360° access when navigating the valve. It will be recognized that fewer juxtaposed points (e.g., two) may be used. And three points are preferred. Similarly, these techniques may be used for other valve structures. For example, the mitral valve, the pulmonary valve, etc.

[0072] In order to provide insights into how the design detailed above can be used for the treatment of TR, the procedure may have the following aspects. The procedure is preferably performed under anesthesia and mechanical ventilation. Fluoroscopy may be the main imaging method for guidance or navigation during the procedure. On the other hand, echocardiography will be used to determine the transverse site above the tricuspid valve leaflets. And it will be used to evaluate TR before and after deployment.

[0073] Transvenous access may be established in the right femoral vein using a small-profile introducer sheath. Access to the right atrium may be achieved by passing through the inferior vena cava using the applicant's guiding catheter. The outer shaft of the guiding catheter may be articulated and passed through and across the tricuspid valve; the inner shaft may be articulated and further directed upward and back towards the valve leaflets. Figure 83 A - B depicts the guiding catheter. It progresses upward through the IVC, reaches the right atrium, and passes through the tricuspid valve. The inner shaft may be articulated towards the apical surface of the valve leaflets. The wire capture snare may be introduced through the sheath. And it navigates through the IVC and reaches the right atrium. The wire capture basket may be deployed directly above the atrial surface of the valve leaflets.

[0074] The energized transverse wire may then be introduced. And it is advanced through both shafts of the guiding catheter until it is juxtaposed to the apical side of one of the valve leaflets. The transection may be performed from the apical side to the atrial side of the valve leaflets. This utilizes the naturally concave shape of the valve leaflets. Transecting the valve leaflets in this way is easier than from the atrial side downward. This may cause slippage of the transverse wire.

[0075] Using echocardiography to confirm the crossing site (e.g., a calcium-free area between 0.5 cm and 1 cm from the central edge of the valve tip), pass through the guide wire and deliver power to the site. With this assistance, the valve tip tissue is transected. The deployed wire capture basket may capture the transection wire and externalize it from the introducer sheath down the IVC. Figure 84 A - C depict the deployed wire capture basket. The transection wire passes through and transects the basket (left). The transection wire is captured within the wire capture device (center). And the transection wire passes through and transects the valve tip, with both ends externalized from the introducer (right).

[0076] The suture loaded with cotton floss may be exchanged with the transection guide wire. Thereby, it is deployed through the three valve tips until the non-cotton-flossed end of the suture is externalized. Figure 85 illustrates delivering the cotton-flossed suture from the guide sheath. This entire process is repeated until each valve tip is tethered with the cotton-flossed suture. The sutures may be tensioned together and may be secured using a locking mechanism. Echocardiography may be used to evaluate the tension of the three leaflets of the tricuspid valve. Once the lock is placed, the suture may be cut. For this, a transcatheter suture cutter is used. Thereby, the implantation of the transcatheter tricuspid valve repair system is completed. Figure 86 (and 94 ) depict the three leaflets of the tricuspid valve. This is tensioned with the cotton-flossed suture (left) and locked in place (right), reducing TR.

[0077] Previous related techniques include Alfieri's "clover method" and PASTA (cotton-floss-assisted suture tricuspid annuloplasty). The "clover procedure" is a surgical repair as follows. That is, generally, it is performed on the regurgitant tricuspid valve. This involves suturing together the midpoints of the free edges of the valve leaflets, thereby creating a "clover" shape. Figure 87 depicts the "clover procedure" (suturing together the midpoints of the free edges of the tricuspid valve leaflets) for the treatment of TR. Figure 88 depicts the MitraClip (Abbott Vascular, Santa Clara, California). This is a percutaneous mitral valve repair that uses direct leaflet access from front to back from edge to edge. Figure 89 depicts an overview of E.PASTA as seen from the ventricle: (A) an enlarged tricuspid annulus. (B) a double-orifice valve. This is created by PASTA-sprinkled suture material between the posterior septum and the mid-anterior annulus. MRI images before (C) and after (D) PASTA. This demonstrates a reduction in the annular dimension from 10.4 cm2 to 2.9 cm2. (E) autopsy 30 days after PASTA as seen from the atrium. S5 septum; A5 anterior annulus; P5 posterior leaflet.

[0078] The device was designed and constructed as follows. That is, it enables transcatheter mitral valve repair via a plication annuloplasty procedure. The innovations brought by the applicant from this business include, for example, the following. That is, a guidewire capture snare. This uses a three-dimensional capture basket to easily capture guidewires of various sizes and externalize them (Figure 90 ). And a radiopaque implant tether. This is externally tensioned and fixed with a novel locking mechanism around the mitral valve (Figure 91 ). And a lock. And a delivery system. This may fix a plurality of sutures under high tension. And it is adjustable and removable (Figure 92 ). And a percutaneous suture cutter. This may cut the implanted radiopaque sutures to various lengths (Figure 82 ). The device may be used as shown herein to effect edge-to-edge repair of tricuspid regurgitation (TR). (Figure 93 ;A is TR before clip implantation. B is grasping of the anterior and posterior leaflets of the tricuspid valve. C is an end-systolic transgastric view showing the three clips implanted and the bicuspidized tricuspid valve. D is a three-dimensional (3D) frontal view after clip implantation. E is residual TR. F is a sketch of the procedural strategy. A indicates the anterior leaflet of the tricuspid valve; 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 as-is for other procedures. Alternatively, they may be modified to suit a particular procedure, if desired. Considering the many possible embodiments to which the principles of this disclosure may be applied, the following should be recognized. That is, the illustrated embodiments are merely preferred examples of this disclosure and should not be regarded as limiting the scope of this disclosure. Each and every patent and patent application referenced herein is hereby expressly incorporated by reference in its entirety for all purposes.

Claims

**Claim 1** In a catheter including a distal end, the catheter comprises: an inner tubular member having a proximal end and a distal end, the inner tubular member including a deployable cutting snare slidably disposed therein; a retention snare including a collapsible basket; wherein a user can use the basket to at least partially surround a tissue mass or an object attached to the tissue mass, collapse the retention snare and the basket around the tissue mass or the object, and then sever the tissue mass by cutting through the tissue mass with the cutting snare; the retention snare includes a gripping tether woven around an open distal end of the collapsible basket; when the cutting snare is deployed distally relative to the inner tubular member, the cutting snare assumes a pre-formed hoop shape that is oriented at a right angle or substantially at a right angle with respect to the longitudinal axis of the catheter and is disposed opposite the open distal end of the collapsible basket; a catheter. **Claim 2** The catheter of claim 1, wherein severing the tissue mass is at least partially accomplished by retracting the cutting snare into the catheter. **Claim 3** The catheter of claim 1, wherein the retention snare is disposed outside the inner tubular member and is configured to move with the inner tubular member. **Claim 4** The catheter of claim 1, wherein the retention snare is disposed on an intermediate tubular member having a corresponding proximal end, a distal end, and an elongate tubular body, the intermediate tubular member configured to slide over the inner tubular member to facilitate axial positioning of the cutting snare relative to the retention snare. **Claim 5** The catheter of claim 1, wherein the deployable cutting snare can be deployed by advancing distally, the cutting snare configured to form a loop capable of surrounding a structure. **Claim 6** The catheter of claim 5, wherein the cutting snare is configured to surround a structure and then retract to cut through tissue or other structures, and the removed structure can be captured by the holding snare and retracted.

7. The catheter of claim 1, further comprising an outer tubular member having a proximal end, a distal end, and an annular tubular body.

8. The catheter of claim 7, wherein the gripping tether stitches an annular lumen defined between the outer surface of the inner tubular member and the outer tubular member.

9. The catheter of claim 8, wherein by applying tension to the proximal end of the gripping tether, the basket is closed, and hoop stress and capture force are applied to the object or tissue mass introduced into the basket.

10. The catheter of claim 1, wherein the cutting snare is charged.

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