Catheter and actuator systems and methods

Abstract

A medical device comprising an elongate tether having a proximal end and a distal end, a first tubular catheter surrounding the elongate tether and slidably displaceable relative to the elongate tether, the first tubular catheter having a proximal end and a distal end, a second tubular catheter surrounding the first tubular catheter and slidably displaceable relative to the first tubular catheter along the first tubular catheter, the second tubular catheter having a proximal end and a distal end, and a third tubular catheter surrounding the second tubular catheter and slidably displaceable relative to the second tubular catheter along the second tubular catheter, the third tubular catheter having a proximal end and a distal end.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 477,317 (filed December 27, 2022), U.S. Provisional Patent Application No. 63 / 496,566 (filed April 17, 2023), U.S. Provisional Patent Application No. 63 / 533,271 (filed August 17, 2023), and U.S. Provisional Patent Application No. 63 / 605,856 (filed December 4, 2023). Each of the aforementioned patent applications is incorporated herein by reference in its entirety for all purposes. [Background technology]

[0002] background SUMMARY OF THE DISCLOSURE This disclosure relates generally to medical treatment devices and techniques, and in some aspects to methods and devices for the diagnosis and treatment of myocardial tissue. The present disclosure provides improvements over the state of the art. Summary of the Invention

[0003] Disclosure Summary BASILICA and LAMPOON are aortic and mitral valve leaflet disruption procedures that use transcatheter electrosurgery. A guidewire is passed across the potentially obstructing cardiac valve leaflet tissue, and then electricity is applied while pulling on the inner curve of the twisted guidewire across the leaflets, splitting the leaflets longitudinally.

[0004] Left ventricular outflow tract (LVOT) obstruction complicates hypertrophic cardiomyopathy and transcatheter mitral valve replacement. Septal reduction therapies, including surgical myectomy and alcohol septal ablation, are limited by surgical morbidity or high rates of coronary anatomy and pacemaker use, respectively. Applicant has developed a novel transcatheter procedure that mimics a surgical myotomy. It is called SASAME (Septal Scoring Along the Medial Intima). The SESAME procedure uses an insulated modified guidewire to transcribe the myocardium (heart muscle) rather than the heart valve tissue. It uses a different system design than the BASILICA and LAMPOON procedures. In some embodiments, the SESAME electrosurgical procedure may include an asymmetric insulating gap that spans a kink (or bend) in the guidewire. The twisting or bending concentrates the charge and helps position the charge delivery device at the treatment target, thereby avoiding nearby damage. The insulating gap (discussed below) is intended to overcome the tendency of charge to concentrate on the outer aspects of the twist.

[0005] In accordance with the present disclosure, an implementation of a device for cutting tissue is provided. Some such implementations include an elongate body having a proximal end and a distal end, and an elongate tether operably coupled to the elongate body, the elongate tether and the elongate body being configured to be longitudinally displaceable relative to one another. The device may further include a cutting element disposed on at least one of the elongate body and the elongate tether, such that relative longitudinal movement of the elongate tether and the elongate body causes the cutting element to cut through anatomical tissue adjacent to the device.

[0006] In some implementations, the elongate tether may be configured to be at least partially received within a lumen defined within the elongate body. The cutting element may include at least one blade, which is configured to cut through tissue. The cutting element may include a conductive element configured to be coupled to a power source for energizing the conductive element.

[0007] The cutting element may be disposed on an outer surface of the elongate body. Adjacent anatomical tissue may be cut by the cutting element as the elongate body is advanced or retracted along the elongate tether. In some implementations, The cutting element may include at least one blade, which is configured to cut through tissue. The cutting element may include a conductive element configured to be coupled to a power source for energizing the conductive element. The conductive element may include at least one applied electrode, which is configured to physically contact the tissue to be cut. The supply electrode may be configured to be operably coupled to a power supply that supplies current to the supply electrode.

[0008] In some implementations, the device may further include a return electrode configured to direct current from a region proximate the supply electrode back to the power supply source. The return electrode is operably coupled to the tether. In some implementations, the device may further include a tissue anchor, which is disposed at the distal end of the elongate tether. If desired, the return electrode is operably coupled to the anchor. The tether may include a return conductor along its length, which is operably coupled to the return electrode. The return electrode may include the anchor. At least one of the supply electrodes may be disposed on a circumferential surface of the elongate body. At least one of the supply electrodes may be disposed on a distal tip of the elongate body. At least one of the supply electrodes may at least partially surround the tether.

[0009] In some implementations, the tether may thread through and exit the distal end of the elongate body. In some implementations, the tether may exit through a lateral side port defined through a side wall of the elongate body proximate a region of the distal end of the elongate body. The device may further include a plurality of markers disposed along the tether, the markers being separated by predetermined intervals. In some implementations, the device may further include a guidewire passageway disposed along at least a portion of the length of the elongate body. The guidewire passage may extend to the distal tip of the elongate body. The tether may exit the elongate body through a lateral side port defined in the elongate body. The tissue anchor and elongate tether may be coupled to a proximal anchor. The elongate tether may be movably disposed within a lumen of the elongate body along a majority of the length of the elongate body. The elongate body may be slidably disposed within a lumen of at least one outer deflectable catheter.

[0010] In some implementations, the device may further include an actuator assembly operably coupled to a proximal portion of the elongate body and a proximal region of the elongate tether. The actuator assembly may be configured to allow a user to selectively move the elongate body relative to the elongate tether. In some implementations, the actuator assembly may include (1) a first actuator operably coupled to a proximal end of the elongate body and (2) a proximal anchor secured to a proximal region of the elongate tether. The first actuator may be configured to displace the elongate member longitudinally relative to the proximal anchor to selectively move the elongate body proximally and distally relative to the proximal anchor. The elongate body may be configured to move along the elongate tether.

[0011] In some implementations, the actuator assembly may further include a second actuator operably coupled to a proximal end of a first outer catheter, the first outer catheter defining a lumen along its length that may surround the elongate member and the tether. The second actuator may be operable to longitudinally displace the first outer catheter relative to the elongate tether and the elongate body. The actuator assembly may further include a third actuator operably coupled to the proximal end of the second outer catheter. The second outer catheter may define a lumen along its length, which surrounds the first outer catheter and the elongate member and the tether. The third actuator may be operable to longitudinally displace the second outer catheter relative to the elongate tether, the elongate body, and the first outer catheter.

[0012] In some implementations, the first outer catheter and the second outer catheter may include an active steering mechanism that allows a user to actively steer the distal end region of each of the catheters. The elongate member may include an inner catheter that includes a steering mechanism that allows a user to actively steer the distal end region of the inner catheter. In some implementations, the elongate tether may be configured to be coupled to a distal anchor, which is configured to be deployed into tissue proximate the distal end of the device. The proximal anchor may include a tensioner that selectively applies tension to the tether when the distal anchor is deployed in the tissue. The inner catheter may be configured to slide proximally and distally over the tether after the tether is tensioned. A first outer catheter may be configured to slide proximally and distally over the inner catheter. The second outer catheter may be configured to slide proximally and distally over the first outer catheter. The proximal anchor, first actuator, second actuator and third actuator may each be operably coupled to a corresponding delivery device. Each corresponding carriage may be configured to slide on a common guide rail.

[0013] In some implementations, the proximal end of the inner catheter may be configured to lift outwardly from the first actuator. The proximal end of the first outer catheter may be configured to be lifted outwardly from the second actuator. The proximal end of the second outer catheter may be configured to be lifted outwardly from the third actuator. The tensioner may include a first body that is coupled to the common guide rail. And, it may include a second body, which is movable relative to the first body. The second body is fixedly coupled to the tether. The second body is coupled to the first body by a resilient member, such as a tension spring or a coil spring, or such as a leaf spring. The second body may be movable from a first position in which the tether is not tensioned to a second position in which the tether is tensioned. The second said body may move along a linear path from the first said position to the second said position. The second said body may move along a curved path from the first said position to the second said position.

[0014] In some implementations, the first outer catheter may include a distally deployable anchor wire, which facilitates anchoring the distal end of the first outer catheter at a desired location. The tether may include a tubular member that defines a passageway therethrough. The tissue anchor may be operably coupled to the distal end of the tether via a flexible joint. The flexure joint allows the tissue anchor to pivot relative to the distal end of the tether. The at least one source electrode may include at least one electrode configured to source current, at least one electrode that returns current to the power source to complete a circuit, and at least one sensing electrode, which may comprise the same physical electrode or different physical electrodes.

[0015] In some implementations, Radiopaque markers may be provided adjacent the lateral side ports to allow a user to determine the longitudinal and rotational orientation of the lateral side ports. The elongate tether may include an elongate tubular member, and the tissue anchor may be configured to be deployed out a distal port of the elongate tubular member. The tissue anchor may be pivotally coupled about a pivot point to a distal end of an elongate inner member disposed within the elongate tubular member. The device may further include a tensioning member coupled proximate to the distal end of the tissue anchor. The tensioning members may be directed proximally through the elongate tubular member externalized from the patient. By applying tension to the tensioning member, The tissue anchor may articulate about the pivot point until at least one prong of the anchor points along a proximal direction. The device may further include at least one visualization marker proximate a distal end or exit port of at least one of the elongate body, the first outer catheter, the second outer catheter, the elongate tether, and the anchor. One or more of the visualization markers may comprise a radiopaque material. One or more of the visualization markers may be configured to be visible under a magnetic resonance imaging modality. In some implementations, one or more of the first actuator, second actuator, and third actuator may be operably coupled to an automated surgical device.

[0016] In some implementations, the present disclosure provides a medical device implementation that includes an elongate body having a proximal end and a distal end, and an elongate tether operably coupled to the elongate body. The elongate tether and elongate body are configured to be longitudinally displaceable relative to one another. The device may further include electrodes disposed on at least one of the elongate body and the elongate tether, and may include electrical circuitry operably coupled to the electrodes. The electrical circuitry may be configured to determine a condition of at least one of the medical device and an anatomical structure. The electrical circuitry may be configured to detect signals coming from anatomy to confirm that the electrodes are in physical contact with the anatomy. The signals coming from the anatomical tissue may include electrocardiogram signals from cardiac tissue. If desired, the electrical circuitry may be configured to detect a voltage or current drop across the electrodes after power is applied to the electrodes. In some implementations, relative longitudinal movement between the elongate tether and the elongate body may cause the electrode to cut through the anatomical tissue adjacent to the device when the electrode is energized. The electrical circuitry may be configured such that the voltage or current drop correlates with a condition selected from the group consisting of: (1) the condition of the tissue to be cut by the electrode; and (2) the condition of the electrode fouling. The device may further include a pressure sensor, which is located in proximity to the electrode. The pressure sensor may be operably coupled to a processing unit. The processing unit may be programmed to determine at least one biological parameter based on receiving a signal from the pressure sensor. At least one biological parameter.

[0017] The elongate body may be configured to be held stationary adjacent anatomy. At least one of the cutting elements may be disposed on the elongate tether. The elongate tether and cutting element may be configured to slide in a reciprocating manner alongside or within the elongate body while the elongate body is held in a stationary position adjacent the anatomical tissue. The elongate tether may be configured to be at least partially received within a lumen defined in the elongate body. The elongate tether may be configured to exit the elongate body at a proximal exit port formed in the elongate body, and further configured to re-enter the elongate body at a distal entrance port. The elongate body may be configured to bend into a deployed configuration along a region including the proximal exit port and the distal entrance port. The elongate body may bend into the deployed configuration, and the elongate tether may be directed away from the elongate body when the elongate tether is under tension.

[0018] In some implementations, a distal end of the elongate tether is coupled to a distal portion of the elongate body by a resilient element that is longitudinally extensible, and further configured to retract the elongate tether distally when tension at the proximal end of the tether is reduced. The resilient element may include a tension spring. The elongate body may be configured to at least partially deform around an anatomical structure to be cut by the device. The elongate tether may include a cutting electrode mounted thereon, which is configured to be coupled to an electrosurgical power source. In some implementations, the device may further include a depth sensing electrode, which senses the depth of the tissue through which the elongate tether is threaded. In some implementations, the elongate body may include a flexible distal section disposed distal to the distal inlet port that conforms to the anatomy of the patient's ventricle. If desired, the elongate tether may be threaded around a support surface located on or within the elongate body distal to the distal entry port, and the elongate tether may be threaded through the elongate body, allowing both ends of the elongate tether to be externalized from the patient while performing the cutting operation within the patient's heart. The elongate body may define a first elongate body, and a proximal end of the elongate tether may be coupled to a second elongate body configured to move alongside or at least partially within the first elongate body. The elongate tether may comprise at least one of a radiopaque wire, a radiopaque suture material, a woven fabric, a radio frequency (RF) electrode, and a razor wire. In some implementations, the elongate tether may be operably coupled to an outer tubular member, which is configured to advance proximally and distally over the elongate body. The elongate tether may be configured to cause the outer tubular member to form into an arcuate shape when tension is applied to the elongate tether. The elongate tether may be configured to be biased laterally away from the outer tubular member when the outer tubular member is formed into an arcuate shape, thereby allowing at least one cutting element disposed on the elongate tether to cut through tissue as the outer tubular member is advanced proximally and distally over the elongate body. In some implementations, the elongate body may define a tissue anchor that deploys proximally from a first location, the tissue anchor being positioned at least partially within the elongate body at a second location, and the tissue anchor advancing proximally outward from the elongate body into a tissue mass.

[0019] Further in accordance with the present disclosure, a medical device implementation is provided. The medical device may include an elongate tether having a proximal end and a distal end. The medical device may include a first tubular catheter that surrounds and is slidably displaceable along and relative to the elongate tether. The first tubular catheter may have a proximal end and a distal end. The medical device may include a second tubular catheter that surrounds the first tubular catheter and is slidably displaceable along and relative to the first tubular catheter. The second tubular catheter may have a proximal end and a distal end. The medical device may include a third tubular catheter that surrounds the second tubular catheter and is slidably displaceable along and relative to the second tubular catheter. a third tubular catheter having a proximal end and a distal end;

[0020] Further in accordance with the present disclosure, the medical device may further include an actuator assembly, if provided, coupled to a corresponding proximal end of one or more of the elongate tether, the first tubular catheter, the second tubular catheter, and the third tubular catheter. In some implementations, the medical device may further include a tissue anchor, which is operably coupled to the distal end of the elongate tether. The actuator assembly may include a proximal anchor operably coupled to the proximal end of the elongate tether. The proximal anchor may be configured to apply tension to the elongate tether when the tissue anchor is anchored in tissue.

[0021] Further in accordance with the present disclosure, the actuator assembly may further include a first actuator operably coupled to a proximal end of the first tubular catheter, the first actuator configured to advance and retract the first tubular catheter proximally and distally over the elongate tether. The actuator assembly may further include a second actuator operably coupled to the proximal end of the second tubular catheter. The second actuator may be configured to advance and retract the second tubular catheter proximally and distally over the first tubular catheter. The distal end of the second tubular catheter may be retractable proximally past the distal end of the first tubular catheter. The actuator assembly may further include a third actuator operably coupled to the proximal end of the third tubular catheter. The third actuator may be configured to advance and retract the third tubular catheter proximally and distally over the second tubular catheter. The distal end of the third tubular catheter may be retractable proximally past the distal end of the first tubular catheter and the distal end of the second tubular catheter.

[0022] In some implementations, at least one of the first tubular catheter, the second tubular catheter, and the third tubular catheter may include an active or passive steering mechanism that allows a user to actively steer the distal end region of each of the catheters. Each of the proximal anchor, first actuator, second actuator, and third actuator may be operatively coupled to a corresponding carriage in the actuator assembly, and each corresponding carriage may be configured to slide on a common guide rail. The relative longitudinal positions of each of the proximal anchor, first actuator, second actuator and third actuator may be adjusted longitudinally along the common guide rail relative to other components mounted on the common guide rail. The device may further include at least one cutting element disposed on at least one of the elongate tether, the first tubular catheter, the second tubular catheter, and the third tubular catheter. Longitudinal movement of at least the cutting element relative to another component of the device may cause the cutting element to cut through anatomical tissue adjacent to which the cutting element is placed.

[0023] In some implementations, the device may further include at least one electrode disposed on at least one of the elongate tether, the first tubular catheter, the second tubular catheter, and the third tubular catheter, wherein longitudinal movement of the at least one electrode relative to another component of the device causes the at least one electrode to cut through the anatomical tissue adjacent to which the at least one electrode is positioned. The device may further include at least one visualization marker disposed on at least one of the elongate tether, the first tubular catheter, the second tubular catheter, and the third tubular catheter. At least one of the visualization markers may be used to visualize the distal region of the device while inside a patient, allowing a user of the device to determine the axial and rotational locations of different component systems relative to each other and the surrounding anatomy.

[0024] The present disclosure further provides implementations of methods for performing medical procedures. The method may include providing a device as described herein, directing the device over a target location within a patient, placing the distal end of the third tubular catheter at a first location, placing the distal end of the second tubular catheter at a second location distal to the first location, placing the distal end of the first tubular catheter at a third location distal to the second location, and performing a therapeutic or diagnostic procedure using at least one of the first tubular catheter, the second tubular catheter, and the third tubular catheter.

[0025] In some implementations, a distal region of the third tubular catheter may be positioned within the patient's aortic arch, a distal region of the second tubular catheter may be positioned through the patient's heart valve, and the first tubular catheter may be manipulated to perform a therapeutic or diagnostic procedure. The therapeutic procedure may involve cutting into the left ventricular outflow tract obstruction to increase the effective cross-sectional area of ​​the left ventricular outflow tract. In some implementations, the first tubular catheter may include a microcatheter, and the method may include directing the first tubular catheter into the patient's right ventricle, through the patient's septum, and into the patient's left ventricle to incise a left ventricular outflow tract obstruction and increase an effective cross-sectional area of ​​the left ventricular outflow tract. In some implementations, the first tubular catheter comprises a delivery catheter, which may deliver a beneficial agent or medical device to an anatomical location. The first tubular catheter includes a cutting element, which may cut through the anatomical tissue. The procedure, diagnostic or therapeutic, may be selected from the group consisting of a MIRTH procedure, a LAMPOON procedure, an ANTEPASTA procedure, an ELASTIC procedure, a robotic surgical procedure, a suture procedure or delivery of a medical device. The medical device may be selected from the group consisting of a stent and a prosthetic valve, such as a prosthetic heart valve, including, but not limited to, a prosthetic mitral, aortic, tricuspid, or pulmonary valve. The device is introduced into the patient through the wall of the heart via, for example, a femoral access point, a jugular access point, a carotid access point, or an apical access point.

[0026] In some implementations, at least one of the source electrodes may include a finned electrode located on a dorsal surface adjacent the distal end of the elongate body. If desired, the device may further include a rinse port configured to flow a rinse fluid over at least one of the source electrodes when the electrode is energized. The device may further include a steering wire configured to laterally deflect a distal region of the device.

[0027] The above-mentioned features, advantages and other aspects of the disclosed technology will become more apparent from the following detailed description of several embodiments, which proceeds with reference to the accompanying drawings.

[0028] A brief description of the figure [Brief explanation of the drawings]

[0029] [Figure 1] Figure 1 is a representative illustration of a three-dimensional cardiac computed tomography image in which a prosthetic SAPIEN™ valve is virtually implanted in the mitral valve position to provide guidance in predicting LVOT failure. [Figure 2] 2A-2B are typical echocardiograms illustrating the presence of a flow obstruction in the left ventricular outflow tract, which contributes to blocking blood flow into the patient's aorta. [Figure 3] Figure 3 is a typical computed tomography (CT) scan illustrating a cross section of a patient's heart, indicating the location of left ventricular outflow tract obstruction (LVOTO). [Figure 4] Figure 4 is a typical computed tomography (CT) scan illustrating a cross section of a patient's heart, showing a typical path of a catheter for accessing the patient's left ventricle. [Figure 5] 5 is an exemplary implementation of a catheter-based system for performing a percutaneous procedure to cut tissue, according to the present disclosure, which uses a reciprocating cutting tool. [Figure 6] 6 illustrates an embodiment of the catheter-based system of FIG. 5, according to some embodiments of the present disclosure. [Figure 7] 7A-7C illustrate yet further system embodiments based on the catheter of FIG. 5, according to some embodiments of the present disclosure. [Figure 8A] 8A-8F illustrate features of the catheter-based system of FIG. 5 that confirm device orientation while performing a procedure, in accordance with the present disclosure. [Figure 8G] 8G-8P depict further embodiments of implementations of distal tips for the catheter-based systems, according to the present disclosure or aspects thereof. [Figure 9] 9A-12C illustrate exemplary procedural embodiments for treating LVOTO, according to some embodiments of the present disclosure. [Figure 13] 13A-13C illustrate the results of an exemplary LVOTO therapeutic treatment in a porcine model, according to some embodiments of the present disclosure. [Figure 14] 14 is an exemplary anchor implementation according to the present disclosure. [Figure 15] 15 is an illustration of a further system, according to the present disclosure, that uses a reciprocating cutting tool to cut tissue. [Figure 16] 16 is a schematic diagram of cardiac anatomy illustrating a targeted ablation site to treat LVOTO in accordance with the present disclosure. [Figure 17] 17A-17B are schematic diagrams illustrating an embodiment of a system being introduced into a patient's heart to treat LVOTO, according to the present disclosure. [Figure 18] 18A-18B are schematic diagrams illustrating further aspects of a technique for treating LVOTO, according to the present disclosure, which includes delivering anchors to hold the treatment system in place within the patient's heart. [Figure 19] 19A-19C are schematic diagrams illustrating further aspects of a technique for treating LVOTO, according to the present disclosure, which involves performing a cutting action on LVOTO using a reciprocating cutting tool. [Figure 20] 20A-20B are schematic diagrams illustrating a further embodiment of a technique for treating LVOTO, according to the present disclosure, which includes resheathing the cutting tool and retrieving the anchors of the system. [Figure 21] 21A-21B are schematic diagrams illustrating further aspects of techniques for treating LVOTO, according to the present disclosure, including withdrawing the catheter-based system from the patient to illustrate treated LVOTO. [Figure 22] 22A-22C illustrate embodiments of further techniques for treating LVOTO, according to the present disclosure, that involve deploying an anchor proximate to a distal location of the LVOTO structure. [Figure 23] 23A-23C illustrate yet further embodiments of methods and systems for cutting tissue, according to the present disclosure, that utilize a deflectable cutting catheter. [Figure 24] 24A-25C illustrate embodiments of yet further techniques for treating LVOTO, according to the present disclosure, which include deploying additional implementations of anchors. [Figure 26] 26-30B illustrate additional method and system embodiments for cutting tissue according to the present disclosure. [Figure 31] 31 is a side plan view of a further implementation of an actuator assembly for a catheter system according to the present disclosure. [Figure 32] 32 is an enlarged upper isometric view of a portion of the actuator assembly of FIG. 31. FIG. [Figure 33] 33 is a further enlarged upper isometric view of a portion of the actuator assembly of FIG. 31. FIG. [Figure 34] Figure 34 is a side view of the handle portion of the actuator assembly of Figure 31, with a side half of the outer housing removed. [Figure 35] FIG. 35 is a diagram of the internal components of an exemplary handle assembly according to the present disclosure. [Figure 36] 36 is an isometric view of a linear tensioner according to the present disclosure, with half of the housing removed; [Figure 37] FIG. 37 is an isometric view of the housing components omitted from FIG. [Figure 38] 38 is an isometric view of a variation of an actuator assembly according to the present disclosure. [Figure 39A]39A-39B are different isometric views of the actuator assembly of FIG. 38, mounted on a stool. [Figure 39C] 39C is an isometric view of an actuator assembly according to the present disclosure, which includes two actuators. [Figure 40] 40A-40D are different isometric views of a further actuator assembly according to the present disclosure. [Figure 41] 41 is a different side view of a distal portion of a further catheter according to the present disclosure, configured to deploy tissue anchors through and out of lateral side ports of the catheter. [Figure 42] Figures 42A-42D are images of the catheter of Figure 41 illustrating the sequential steps of deploying tissue anchors through and out of the lateral side ports of the catheter. [Figure 43] 43-44 are views of the tissue anchor removed from the catheter of FIG. [Figure 45] 45A-45B illustrate an embodiment utilizing a catheter-based system to perform a LAMPOON procedure in accordance with the present disclosure. [Figure 46] 46A-46B illustrate an embodiment utilizing a catheter-based system to perform a BASILICA procedure according to the present disclosure. [Figure 47] 47A-47B illustrate an embodiment utilizing a catheter-based system to perform an ELASTIC procedure in accordance with the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0030] Detailed Description This application presents advantages and improvements over the system described in International Patent Application No. PCT / US2023 / 060223 (filed January 6, 2023). The above-referenced patent applications are incorporated herein by reference in their entirety for all purposes.

[0031] Implementations according to the present disclosure provide improved systems and methods for cutting tissue, including but not limited to myocardial tissue. Implementations according to the present disclosure can create longitudinal cuts through tissue by utilizing a reciprocating cutting tool that cuts from the outer surface of an obstruction (e.g., LVOTO) downward into the tissue. This can be contrasted with the technique described in PCT / US2023 / 060223, which teaches forming a passageway through tissue near the bottom region of the tissue to be cut, and then cutting the tissue above the passageway to complete the cut. Those skilled in the art will recognize that the disclosed implementations are fundamentally different from those described in PCT / US2023 / 060223 in various ways.

[0032] 1-4 depict aspects of left ventricular outflow tract obstruction (herein "LVOTO"). While ablation of LVOTO is specifically illustrated, it will be appreciated that the disclosed embodiments can be used for other purposes, including ablating myocardial tissue to debulk other cardiac structures, or to perform different percutaneous procedures within the cardiovascular system, within a patient's sinus passageways, or within a patient's neurovascular, urinary, abdominal, or digestive structures. Additionally, implementations according to the present disclosure may be utilized in laparoscopic, thoracic, etc. procedures.

[0033] Figure 1 is a typical illustration of a three-dimensional cardiac computed tomography image in which a prosthetic SAPIEN valve is virtually implanted in the mitral valve position to provide guidance in predicting LVOT failure. In some implementations of procedures according to the present disclosure, pre-treatment planning may include generating dedicated cardiac computed tomography (CT) images to measure one or more various variables and aid in the execution of the tissue cutting procedure. For example, CT images may be used to determine or closely estimate valve size. This may also facilitate transesophageal echocardiogram ("TEE"). It is also possible to measure the actual internal dimensions of the valve under visualization, which may then be correlated with the true internal dimensions of the failed tissue valve. Comparing the measured values ​​to known values ​​of the device provides an accurate basis for scaling the image to more closely measure the actual dimensions of internal cardiac structures. With continued reference to Figure 1, it is further possible to measure the aortic-mitral angle, where the preferred angle is greater than 105 degrees. Additionally, the dimensions of the neo-left ventricular outflow tract (LVOT) area after "virtual" implantation of the SAPIEN valve are measured, or at least estimated, as depicted in FIG. Preferably, the LVOT area is greater than 200 mm2, thereby preventing LVOT failure. If the patient has a thick septum, alcohol septal ablation may be performed beforehand to reduce some of the septum bulking and reduce the risk of LVOT failure if the predicted new LVOT area is less than 200 mm2. It is also possible to perform balloon-assisted repositioning of the anterior mitral valve leaflet, thereby preventing LVOT obstruction, which is significantly related to transcatheter mitral valve replacement ("TMVR"). The success rate of TMVR procedures is approximately 94-97%, with a 30-day survival rate of 91-95% and a 1-year survival rate of 86%.

[0034] 2A-2B are typical echocardiograms illustrating the presence of flow obstruction in the left ventricular outflow tract, which contributes to impeding blood flow to the patient's aorta. In FIG. 2A, LVOT obstruction prevents blood flow through the LVOT to the aorta (area within the dashed line in FIG. 2B).

[0035] Figure 3 is a typical computed tomography (CT) scan illustrating a cross section of a patient's heart, indicating the location of left ventricular outflow tract obstruction ("LVOTO"). The procedure described in PCT / US2023 / 060223 may be performed, where an energized guidewire is navigated through the lesion by tunneling through the mass starting at the proximal end of the mass (facing away from the ventricular apex) and along a direction toward the ventricular apex, where the guidewire exits the mass and re-enters the ventricular volume, effectively forming a tunnel through the base of the tissue mass. The distal end of the guidewire may be caught as it emerges from the tissue mass. The initial trajectory for the guidewire is perpendicular to the surface of the septum, thereby penetrating the sometimes tough base of the septum. As can be seen in Figure 3, the guidewire path is not straight, but curves away from the initial vector to avoid crossing into the right ventricle and causing a ventricular septal defect ("VSD"). In FIG. 3, for clarity, "LA" denotes the left atrium and "LV" denotes the left ventricle.

[0036] 4 is a further exemplary "three-dimensional" computed tomography (CT) scan illustrating a cross section of a patient's heart, indicating a typical path of a catheter accessing the patient's left ventricle. In FIG. 4, the intended proximal path of the ablation generally begins just to the right of the left and right commissures of the aortic valve. In light of the foregoing and the teachings of PCT / US2023 / 060223, it will be appreciated that further approaches for performing similar procedures that allow for additional control of the device during the procedure may be desirable.

[0037] Thus, further in accordance with the present disclosure, a first exemplary implementation of a system 100 for cutting tissue is depicted in FIG. Further embodiments of the system 100 are depicted in Figures 6-12C.

[0038] 5 is an exemplary implementation of a catheter-based system 100 for performing a percutaneous procedure to cut tissue, according to the present disclosure. While system 100 utilizes a reciprocating cutting tool (described below), system 100 may be configured with different end effectors to perform different procedures. System 100, as depicted, includes three concentrically arranged deflectable catheters, including a radially outermost catheter 110 within which a second, middle deflectable catheter 120 is slidably received, and a third, innermost deflectable catheter 130 slidably disposed within deflectable catheter 120. A tether 140 (or other means, eg, a guidewire, snare, etc.) is slidably received within catheter 130 . Each deflectable catheter 110, 120, 130 may include one or more steering wires (not shown) to which tension may be applied, thereby selectively bending the distal end (114, 124, 134) of each corresponding catheter 110, 120, 130 in a preferential direction. Each catheter 110, 120, 130 comprises a tubular body having a proximal end coupled to an actuator and a free distal end. Each catheter 110 , 120 , 130 is capable of axial and rotational movement relative to the other components of the system 100 . Each catheter 110, 120, 130 is held in relative position by a corresponding carriage 210, 220, 230, which is slidably received on rails 201 of a platform 200 of the system 100. Each carriage 210 , 220 , 230 is capable of axially moving between the proximal end 202 and the distal end 204 of the rail 201 . In some implementations, one or more of the carriages 210, 220, 230 can be locked in place relative to the rails 201. As depicted, each catheter 110, 120, 130 is slidably received in an upright orientation within a forked joint (eg, 214) within the upwardly extending portion of a corresponding carriage. For example, a channel 115 is formed in the catheter 100 that is slidably received within the fork 214, thereby preventing axial movement of the catheter 210 relative to the carriage 210. Each carriage (e.g., 210) is defined by a main body portion (e.g., 212) that defines a channel (e.g., 218) therethrough that at least partially surrounds the rails 201 of the platform 200.

[0039] Each of the catheters 110, 120, 130 may be rotationally displaced relative to the tether 140 and each other about a central axis of the system 100 (eg, about the tether 140). It will be appreciated that any of catheters 110, 120, 130 may be utilized with platform 200 alone or in conjunction with other system components. Thus, a triple catheter assembly may be used as depicted in FIG. 5, or if all three catheters are not required, a single or dual catheter assembly may be used. The catheters 110, 120, 130 may be of any desired length. According to some implementations, the catheter 110 may be between about 80 cm and about 120 cm in length, or any approximately one centimeter increment therebetween. According to a further embodiment, the catheter 120 may be between about 90 cm and about 140 cm in length, or any approximately one centimeter increment therebetween. According to yet a further embodiment, catheter 130 may be between about 100 cm and about 160 cm in length, or any approximately one centimeter increment therebetween. Tether 140 may be of any desired length, for example, between about 120 and 300 cm in length, or any approximately one centimeter increment therebetween.

[0040] With continued reference to Figure 5, the outermost catheter 110 comprises an elongated tubular body 113. It has a proximal end 112 operably coupled to an actuator 116 and a free distal end 114. It may be steered by tensioning steering wires, for example, activated by one or more buttons or levers within the actuator 116. The outermost catheter 110 further defines a lumen 118 (not shown) along at least a portion of its length, which slidably receives the tubular shaft 123 of the catheter 120. Catheter 110 can slide along rail 201 and, if desired, can be locked in place on rail 201 . In use, the outer surface of the tubular portion 113 of the catheter 110 is received in a fluid-sealed manner through an inlet port (not shown), which is fluidly coupled to the patient's anatomy. As a result, in use, the sliding movement of carriage 210 relative to track or rail 201 causes proximal-distal movement of catheter 110 within the patient's vascular system, independent of movement of catheters 120 , 130 or tether 140 .

[0041] The intermediate catheter 120, in turn, comprises an elongated tubular body 123. It has a proximal end 122 operably coupled to an actuator 126 and a free distal end 124. It may be steered by tensioning steering wires, for example, which may be actuated by one or more buttons or levers within the actuator 126. Intermediate catheter 120 further defines a lumen 128 (not shown) along at least a portion of its length, which slidably receives tubular shaft 133 of catheter 130 therein. The intermediate catheter 120 can slide along the rail 201 and, if desired, can be locked in place on the rail 201, similar to the catheter 110. In use, the outer surface of the tubular portion 123 of the catheter 120 is fluidly sealed and received through an inlet port (not shown) located proximal to or within the actuator / handle 116 of the catheter 110. This prevents unwanted leakage of fluid across any annular gap formed between the inner surface of the lumen 118 and the outer surface of the tubular member 123. Similar to catheter 110, in use, the sliding movement of carriage 220 relative to track or rail 201 causes catheter 120 to move proximally-distally within the patient's vascular system, independent of the movement of catheters 110, 130 or tether 140. Additionally, catheter 120 may be rotationally displaced relative to tether 140, catheter 110, and catheter 130 about the central axis of system 100 (eg, about tether 140).

[0042] With continued reference to Figure 5, the innermost catheter 130 comprises an elongate tubular body 133. It has a proximal end 132 operably coupled to an actuator 136 and a free distal end 134. It may be steered by tensioning steering wires. For example, it may be actuated by one or more buttons or levers within the actuator 136. Intermediate catheter 130 further defines a lumen 138 (not shown) along at least a portion of its length, which slidably receives tether 140 therethrough. The innermost catheter 130 can slide along the rail 201 and, if desired, can be locked into place on the rail 201, similar to catheters 110 and 120. In use, the outer surface of the tubular portion 133 of the catheter 130 is fluidly sealed and received through an inlet port (not shown) located proximal to or within the actuator / handle 126 of the catheter 120. This prevents unwanted leakage of fluid across any annular gap formed between the inner surface of the lumen 128 and the outer surface of the tubular member 133. As with catheters 110, 120, in use, the carriage 230 slides relative to the track or rail 201, causing the catheter 130 to move proximally-distally within the patient's vascular system, independent of the movement of catheters 110, 120 or tether 140. Additionally, catheter 130 may be rotationally displaced relative to tether 140 , catheter 110 , and catheter 120 about the central axis of system 100 (eg, about tether 140 ).

[0043] Each of the catheters specified herein (e.g., 110, 120, 130) may be made from a variety of materials, including multilayer polymeric extrusions, such as those described in U.S. Pat. No. 6,464,683 (Samuelson) or U.S. Pat. No. 5,538,510 (Fontilosch), the disclosures of each of which are incorporated herein by reference in their entirety for all purposes. Other constructions are possible, including single or multi-layered tubes reinforced with braid, such as metallic braided materials. Any of the catheters or guidewires or portions thereof disclosed herein may be provided with regions of varying or tapering stiffness with length using any of the techniques set forth in U.S. Patent No. 7,785,318, which is incorporated herein by reference in its entirety for all purposes. The catheters therein (eg, 110, 120, 130) may be provided with structures such as these that enhance pushability and torqueability. The catheters disclosed herein (e.g., 110, 120, 130) may vary in stiffness along their length, particularly in their distal regions, by adjusting the cross-sectional dimensions of the material, which affects stiffness and flexibility while maintaining pushability, as well as the durometer of the material. Hardness / stiffness is described herein with reference to Shore durometer ("D") values. Shore hardness is measured using an instrument known as a durometer, and is therefore also known as "durometer hardness." Hardness values ​​are determined by penetrating the foot of a durometer indenter into the sample. The ASTM test method number is ASTM D2240 00. For example, in some implementations, the more proximal region of the catheter may have a durometer of about 72D, the middle portion of the catheter (the most proximal 20-30 cm of the last 35 cm, e.g., this generally crosses the aortic arch) may have a durometer of about 55D, and the distal 5-10 cm of the catheter may have a durometer of about 35D.

[0044] Any of the surfaces of the various components or portions thereof (e.g., 110, 120, 130, 140, 150) of the systems described herein may be provided with one or more suitable lubricious coatings, which facilitates the procedure by reducing frictional forces. Such coatings may include, for example, hydrophobic materials such as polytetrafluoroethylene ("PTFE") or silicone oil, hydrophilic coatings such as polyvinylpyrrolidone ("PVP"), etc. Other coatings are also possible, including, for example, echogenic materials, radiopaque materials, hydrogels, etc.

[0045] With continued reference to Figure 5, tether 140 has a proximal end 142, which is operably coupled to a hub 146 (or proximal anchor), which can be used to apply tension to tether 140. Tether 140 also has a distal end 144, which extends distally from passageway 138 and from the distal end of innermost catheter 130. As depicted, hub 146 is removably coupled to carriage 240. Sliding movement of carriage 240 relative to track or rail 201 causes proximal-distal movement of tether 140. Preferably, the hub 146 and carriage 240 may be used to maintain tension on the tether or rail 140, thereby making the system 100 easier to use. For example, in some implementations, the hub 146 may include a tension spring or elastic member that can be stretched to maintain tension in the tether 140. Similarly, if desired, any one of the carriages 210, 220, 230, 240 may include an upper component that is slidably coupled to the main body portion (e.g., 210) of the corresponding carriage. If so equipped, the carriages may also include tension springs to return the catheter carried by the corresponding carriage to a desired axial location along the direction of rail 201. This can be useful, for example, in the case of catheter 130, to spring-load it from a first deformed position back to a contracted position between a first axial location and a second axial location, thereby facilitating a reciprocating cutting action.

[0046] Figure 6 illustrates a further embodiment of the catheter-based system 100 of Figure 5, according to some aspects of the present disclosure. For purposes of illustration, and not limitation, Figure 6 illustrates a distal region of system 100, according to some implementations of the present disclosure. Illustrated are the distal end 114 of the outermost catheter 110, the distal end 124 of the intermediate catheter 120 extending distally from the lumen 118 of the outer catheter, and the distal end 134 of the innermost catheter 130 extending distally from the lumen 128 of the intermediate catheter 120. A distal region of tether 140 extends distally from lumen 138 of innermost catheter 130 . The distal region of tether 140 may include a plurality of markers 141, which are visible under imaging modalities such as fluoroscopy (e.g., MRI, etc.), mounted a predetermined, known distance apart from one another. The distal end 144 of the tether 140 is operably coupled to a tissue anchor 150 . Tissue anchor 150 is anchored into tissue within the patient (discussed in more detail below), thereby applying tension to tether 140. Once the appropriate amount of tension is applied to the tether 140, the tether 140 acts as a guide rail, guiding, for example, the movement of the distal end region of the innermost catheter 130, thereby facilitating the tissue cutting action. Anchor 150 may include a proximally located pivot joint 152 that allows tether 140 to pivot relative to anchor 150. Anchor 150 may be made from a radiopaque material, or may be provided with markers, such as one or more radiopaque markers (not shown), if desired. The markers (e.g., 141) can facilitate in situ measurement of LVOTO while helping to identify the distance that catheter 130 travels back and forth to perform the ablation procedure, including helping to define the limits of proximal and distal movement of catheter 130 when the cutting element (e.g., electrode) of catheter 130 is energized. This may be used to control the length cut through the tissue. In some implementations, if desired, tether 140 and anchor 150 may be eliminated, and instead a microcatheter or needle (not shown) may be slidably received within lumen 138 of catheter 130. Additionally, the innermost catheter 130 may be provided with retractable or fixed electrodes, or may be provided with one or more sensors that detect the presence of myocardium or detect electrical signals within the myocardium. According to a further implementation, the marker 141 or anchor may be an electrode, which provides a return path for the current supplied by a supply electrode, which is defined in the distal region or at or near the distal end of the catheter 130. When so equipped, tether 140 may include a conductive core, such as when tether 140 comprises a conductively insulated tether. Anchor 150 or marker 141 may be in electrical communication with the conductive core of tether 140. This provides a return path for the electrical current. In any of these implementations, a separate catheter (e.g., a pigtail catheter, etc.) may be provided and introduced alongside the system (e.g., 100) to provide a return electrode, which provides a return path for the current and controls the direction of current flow in the region of interest where the patient's tissue is being treated. The cutting electrode and the return electrode preferably move together in tandem. The return electrode preferably has an extended surface area, which reduces the current density at the surface electrode and reduces ohmic heating of the surrounding tissue, thereby reducing or preventing undesirable cauterization and thermal effects.

[0047] In further accordance with the disclosure, the electrodes (e.g., source, return, sense, etc.) used in the various embodiments disclosed herein may have any desired length or shape and may have variable exposed lengths if desired, such as by extending the exposed portions of the electrodes outwardly through ports defined in an electrically insulating tubular member. The electrodes may have shapes and surface features configured to concentrate the desired charge and current density. The catheter may be configured to direct irrigation fluid over or adjacent to the electrode to help cool the electrode, help avoid blood clotting, and enhance cutting, if desired. Any of the embodiments disclosed herein may be operated in monopolar or bipolar mode, as desired. A return electrode may be built into the catheter or may be an adjacent (e.g., pigtail) catheter, thereby providing a return path for electrical flow.

[0048] 7A-7C illustrate yet further embodiments of the catheter-based system of FIG. 5, according to some embodiments of the present disclosure. 7A illustrates a close-up view of the distal region of catheter 130, which protrudes from the distal end of intermediate catheter 120. Figure 7B depicts a close-up view of tissue anchor 150, and Figure 7C illustrates the placement of one or more electrodes 137 within the distal end region of catheter 130 for various purposes. The electrodes 137 are electrically coupled to one or more elongated conductors (not shown) that extend through the body 133 of the catheter 130, thereby allowing the conductors to be externalized from the patient to be coupled to diagnostic equipment or an electrosurgical supply.

[0049] 7A depicts the distal end region of system 100. It illustrates the distal end of catheter 120, from which extends the distal region of catheter 130. As depicted, catheter 130 may be a steerable catheter with active steering. The distal end 134 of the catheter 130 may include a tapered region. One or more electrodes 137 may be present near the distal end of the catheter 130 . Electrodes therein (eg, 137, 137') may function as one or more of a source electrode, a return electrode, and a sense electrode. The rail 140 may define a plurality of markers 141 along the length of the rail 140 in areas where tissue should be measured and cut. Markers 141 may be used under in situ visualization to measure the distance of tissue to be cut. The start point for cutting and the end point for cutting may be recorded by the user. In some implementations, the marker 141 may be configured as an electrode that can function as one or more of a source electrode, a return electrode, and a sense electrode. If desired, a stop (not shown) may be placed adjacent the actuator / handle 136 to limit the proximal-distal extent of the distal end region of the catheter 130. This may be done by defining the travel length of the electrode 137 as it cuts through tissue. A distal marker 134 may be provided at the distal end 134 of the catheter 130 to optimize positioning of the distal end 134 of the catheter 130 .

[0050] 7B and 14, anchor 150 may include a pivot joint 152, which is pivotally coupled to distal end 144 of tether 140. As depicted, tether or rail 140 terminates at its distal end in loop 149, which may interlock with loop 152. This provides a swivel joint, allowing tether 140 a large degree of rotational advancement, particularly once anchor 150 is anchored in tissue. The anchor may include one or more prongs, which can be anchored into tissue. Anchor 150, as depicted, includes three prongs 154. Anchor 150 is preferably formed from a shape-memory material, such as a nickel-titanium alloy, that has shape memory formed therein, such that prongs 154 of anchor 150 curl proximally, such that when tension is applied to tether 140 inside a patient's heart, one or more of prongs 154 are pulled into myocardial tissue, securing the anchor in place. In some implementations, anchor 150 may be made from NiTi alloy and drawn filled tube (DFT), as indicated, including, for example, NiTi alloy combined with a radiopaque material for visibility, such as platinum. Delivery of anchor 150 may be accomplished by pushing anchor 150 into the target location confined within the distal end region of catheter 120 . Catheter 130 may surround tether 140. Distal end 134 of catheter 130 may then push anchor 150 out the distal end of catheter 120 to deploy anchor 150. Alternatively, anchor 150 may be deployed by pulling it into lumen 138 at the distal end of catheter 130. This may be done, for example, by advancing a small profile push rod down lumen 138 to push anchor 150 out of catheter 130. Once unconstrained by lumen 128 of catheter 120, the shape memory configuration of anchor 150 allows anchor 150 to be deployed. A swivel or articulation joint attaching the tether to the anchor may control the orientation of the prongs 154 . One or more markers 153 may be provided on the anchor near the pivot loop 152 and on the prongs 154 to help inform the user when the anchor prongs have been anchored into the tissue under visualization modalities. Catheter 130 may be articulated and pushed into the myocardium, thereby pushing the anchor out of the catheter so that anchor 150 penetrates the myocardium and becomes anchored in the tissue. According to further implementations, any of the anchors (eg, 150, 350) may be formed in a flattened configuration. For example, rather than the three-dimensional barb implementation of Figure 14, the prongs may be formed from a flat piece of material with one or more unidirectional barbs (of varying lengths and curvatures) positioned adjacent to each other widthwise along the flat piece of material, ensuring that all barbs are embedded in the tissue.

[0051] In some aspects, the present disclosure provides sensing catheters and sensing catheters that can perform additional actions, such as cutting. For example, the present disclosure provides an implementation of a medical device having an elongate body, having a proximal end and a distal end, and an elongate tether, operably coupled to the elongate body. The elongate tether and the elongate body are configured to be longitudinally displaceable relative to one another. The device further includes an electrode disposed on at least one of the elongate body and the elongate tether, and electrical circuitry operably coupled to the electrode, the electrical circuitry configured to determine a condition of at least one of the medical device and the anatomical tissue.

[0052] According to further aspects, electrical circuitry may include one or more analog or digital circuit components, such as a programmable processing device, that is programmed with machine-readable code, that may be embodied in a non-transitory medium such as a memory, that may be configured or programmed to carry out the functionality of the circuitry. The term circuitry is intended to encompass analog and digital circuitry. In some implementations, the circuitry may detect incoming signals from the anatomy to verify that the electrodes (e.g., 137, 141) are in physical contact with the anatomy. The signals coming from the anatomical tissue may include electrocardiogram signals from cardiac tissue. In a further implementation, the electrical circuitry may be configured to detect a voltage or current drop across the electrodes after power is applied to the electrodes.

[0053] In some implementations, the electrode may be configured to cut tissue when energized, and relative longitudinal movement of the elongate tether and elongate body may cause the electrode to cut through anatomical tissue adjacent to which the device is placed when energized. In such applications, the electrical network may be configured so that the voltage or current drop correlates with physical conditions, such as (1) the condition of the tissue being cut by the electrode, the fouling of the electrode, etc. If desired, such a system may further include one or more pressure sensors, which are located in proximity to the electrodes. The pressure sensor may, for example, be operably coupled to the circuitry. For example, the processing unit may be programmed to determine at least one physiological parameter, such as blood pressure, based on receiving a signal from the pressure sensor. The pressure sensor may include any suitable pressure sensor, such as a fiber optic pressure sensor, having a distal crystal configured to direct light out of the distal crystal. The properties of the reflected light (eg, wavelength, frequency, etc.) may allow the local fluid pressure to be calculated or estimated. Such a fiber optic sensor may be slidably received in a system (such as 100) and deployed at a target location to measure local pressure. Such blood pressure probes may have one or more visualization markers to facilitate visualization of the blood pressure sensor under imaging modalities such as fluoroscopy or MRI. In another implementation, a pressure plug (or opening) may be located at a desired location (e.g., a side port or distal opening of the catheter) that communicates with a passageway that runs through the device (e.g., 100) to an external pressure sensor. The static pressure at a predetermined location (e.g., a side port or distal opening of the catheter) can be measured. A pressure sensor may be deployed to help the user understand when the catheter is located distally beyond the aortic valve and within the patient's left ventricle. Such a sensor may also help the user know whether the electrode is proximal to a node (e.g., SA or AV node), thereby avoiding inadvertently delivering current to the node.

[0054] See Figure 7C. The electrodes may be retractable into a further lumen defined in tubular member 133 (not shown), or may be fixed in place. Such electrodes 137 may be distributed around some or all of the circumference of the distal end region of the catheter 130 . Additionally, instead of a cutting electrode, a blade may be provided, which may be fixed to the surface of the catheter 130 and which may be retracted into the distal end of the catheter 120. If a blade is provided, it may also be retractable into the catheter 130 . Cutting tools may therefore include, for example, cutting electrodes, blades, cutting wires such as diamond wires, wires having cutting implements coupled thereto, narrow gauge metal wires, etc. The electrodes may be raised above the surface of the catheter 130 (e.g., protruding slightly when unconstrained), but may curve down to surface level to reduce their profile when delivered through the lumen 128 of the catheter 120. One or more electrodes 137A-137N may be provided along the length of tubular member 133 or around its circumference. Some of the electrodes (eg, 137A-137N) may function as one or more of a supply electrode, a return electrode, and a sensing electrode. When used as cutting electrodes, electrodes 137A-137N may fire at different times, or simultaneously, if desired. For example, a first row of electrodes may function as source electrodes and a second row of electrodes may function as return electrodes. Tissue placed between the supply and return electrodes in FIG. 7C may function as a conductive medium to complete the circuit, as in all other bipolar arrangements disclosed herein. Some electrodes may be dedicated to cutting, and some of the electrodes may be dedicated to other purposes, such as sensing electrical properties of tissue (e.g., myocardial tissue). For example, some electrodes may be EKG sensing electrodes. Additionally, one or more of the electrodes may have more than one state of operation. For example, one or more of the electrodes 137 may be configured to sense electrical signals or properties of adjacent tissue when no power is applied to the electrode to cut the tissue. Additionally, one or more of the electrodes 137 may be a source electrode that supplies current, and one or more of the electrodes 137 may be an electrode that returns current to the electrosurgical generator. In a further implementation, the anchor 150 or marker may function as a return electrode as mentioned above. The system may operate in a monopolar operating state when utilizing one or more electrosurgical cutting electrodes, where the electrode is the source electrode and the return path for current to the electrosurgical generator is through the patient and by conductive pads attached to the patient. Alternatively, the system may operate in a bipolar mode of operation, where one or more electrodes may be source electrodes and one or more electrodes may be return electrodes, such that electricity only needs to pass from the source electrode to the return electrode, thereby completing the circuit. Suitable electrical supply and return conductors may be provided and extend through additional lumens in catheter 130 or along a core conductor (not shown) of tether 140, which may be externalized and operably coupled to, for example, an electrosurgical generator or diagnostic equipment.

[0055] Figures 8A-8F illustrate features of the catheter-based system of Figure 5 that confirm axial and rotational orientation of the device while performing a procedure according to the present disclosure. Figure 8A depicts a specially configured marker 139 which, when integrated into the catheter, allows the user to determine the rotational orientation of the catheter 130. Additionally, means such as an exit port for a movable electrode or electrode 137 may be positioned diametrically opposite the marker 139 . 8B depicts an implementation of catheter 130 in which a cutting tool (which includes a cutting electrode, or blade) or an ultrasonic transducer or element (which is coupled to cutting element 137) is provided at the distal end region of catheter 130. In use, the cutting electrode may be coupled to an RF power supply, which operates in a conventional or microwave regime, which is less likely to interfere with the beating of the heart or the operation of the cardiac nodes. Ultrasonic cutting tools have advantages such as reduced tissue heating and not interfering with the electrical operation of the heart or the ablation procedure. An ultrasonic transducer may be operatively coupled to the cutting blade, which performs the cutting according to any implementation of the present disclosure.

[0056] Figure 8C depicts the implementation of Figure 8B, but with the addition of marker 139. Marker 139 may also function as a return electrode for bipolar operation when attached to a current return line (not shown). The shape of the marker 139 includes an elongated spine section that is joined at the midpoint of a "C" shape at each end of the spine, such that the "C" shaped portion wraps around a portion of the periphery of the catheter 130, either above or below the surface of the body 133. If the user knows that the marker 139 is oriented opposite the electrode 137, the user can rotate the catheter 130 until the electrode contacts the surface to be cut. If the electrode 137 is configured to sense electrical activity in tissue, the user can be notified that the electrode 137 has made electrical contact with the myocardium when the electrode 137 conducts an electrical signal from the myocardium to a signal detector or processing device (which is configured to detect, for example, electrical signals). 8D depicts deployable electrode 137, which retracts into a lumen defined in body 133 of catheter 130. When the electrodes are deployed as depicted in Figure 8E, the location of the marker 139 indicates where the electrodes exit. 8F is a diagram of marker 139, illustrating under fluoroscopy that electrode 137 has been advanced out through the side opening of catheter 130.

[0057] 8G-8P illustrate further implementations of the distal region of inner catheter 2130, according to the present disclosure, which may be used in place of catheter 130 described above. FIG. 8G is a side view of the distal end region of catheter 2130. Figure 8I shows a cross-section of the distal end region of catheter 2130 taken along its vertical longitudinal centerline, and Figure 8H shows a wireframe view of the distal end region of catheter 2130. Figure 8J shows an isometric view of the distal end region of catheter 2130, while Figure 8K shows the same view, with distal tubular covering 2130C removed to illustrate the relative locations of the internal components.

[0058] The catheter 2130 may be coupled at its proximal end to a suitable actuator, including but not limited to those described elsewhere in this disclosure with reference to Figures 31-40D. The inner catheter 2130 is built around an inner tubular member 2130E, which defines a lumen 2130A along at least a portion of its length (all or part of its length). An electrode 2131 is concentrically positioned around and coupled to the distal end region of the inner tubular member 2130E. The electrode 2131 is electrically coupled at its proximal end to an electrical conductor, such as an elongated metallic member, which may or may not be electrically insulated, that extends proximally from the proximal end of the catheter 2130 and is operably coupled to an electrosurgical power source (not shown). The inner tubular member 2130E may be partially or completely polymeric, or may include a braided layer of polymeric or metallic braid co-extruded with another material, a polymeric or metallic coil, or a laser cut hypotube, which may enhance flexibility.

[0059] Lumen 2130A may have an anchor 2150 and an extension rod 2140 slidably disposed therein, similar to other implementations herein. As illustrated, proximal movement of anchor 150 may be limited by stop 2139, which may be in the form of a boss, nub, protrusion, or, as illustrated, a tubular member, which is attached to the inside surface of tubular member 2130E, through which rod 2140 is slidably disposed. Alternatively, it may be attached to the exterior of tubular member 2130E as a tubular member, which applies a radially inward force to compress or restrict the inner diameter of tubular member 2130E. Catheter 2130 may further include irrigation lumen 2135, which may be defined by a tubular member, for example, disposed alongside and parallel to tubular member 2130E, or concentrically, if desired. As depicted, irrigation lumen 2135 is diametrically displaced from or diametrically disposed relative to conductor 2133 around tubular member 2130E.

[0060] As further depicted, a puller wire 2161 is attached at its distal end to the distal tip region of catheter 2130 . As illustrated in Figure 8L, the puller wire 2161 is attached, for example, via welding, gluing, crimping, etc., to a distal retainer, anchor band or crimp 2165, which has a "C" shaped or circular cross section. Distal retainer 2165 is attached directly or indirectly to the distal region of tubular member 2130E. For example, sleeve 2169 may be provided with a longitudinal slit, where the slit accommodates lumen 2135 and steering wire 2161 but contacts the inner cylindrical surface of anchor 2165 and the outer surface of tubular member 2130E. The outer shaft 2130C may be formed from a suitable material that facilitates structural deflection, such as braid.

[0061] The pull or steering wire 2161 extends proximally and into the distal end of the tubular member 2167, which in turn is operably coupled to the proximal region of the catheter (at a location in the distal end region of the catheter proximal to the distal retainer 2165). As illustrated, a distal location of tubular member 2167 is attached to a retainer or anchor 2163, which in turn may (but need not) be directly or indirectly coupled to tubular member 2130E. Thus, when tension is applied to the pull wire 2161, the catheter tip deflects in the direction of the tension, thereby aiding in steering the distal end of the catheter 2130 through tortuous anatomy. The distal tubular covering 2130C may be a continuation of the braided shaft 2130D. It has an outer jacket and liner of a radiopaque polymer (e.g., PEBAX). It surrounds the components 2130E, 2133, 2135, and 2161. It transitions to the proximal tubular covering 2130D, which preferably has an appropriate durometer to complement the surrounding anatomy and facilitate deflection of the distal region of the catheter under the tension of the steering wire 2161.

[0062] 8P and 8L, electrode 2131 is formed from tubular section 2131B, which surrounds the distal tip region of tubular member 2130E. One or more windows 2131D may be defined through the tubular section 2131. This provides an additional contact boundary for adhesion to facilitate bonding of the electrode 2131 to the tubular member 2130E. The window 2131D, in conjunction with the dorsal fin 2131A and connecting structure, may function as a three-dimensional marker when formed from a material that is visible on an imaging modality (e.g., MRI), such as a radiopaque material, to aid the user in determining longitudinal, rotational, and angular displacement and movement. In particular, the windows 2131D may act as alignment holes, allowing the user to conclude that the orientation of the device tips is relatively certain when aligned with one another under visualization. Additionally, the overall shape of the structure may be "P" shaped, which further aids in alignment.

[0063] Electrode 2131 further includes a proximally extending section 2131C that provides contact with conductor 2133 to facilitate electrical and structural attachment between the two components. Section 2131C may be a partial peripheral continuation of tubular section 2131B. Electrode 2131 further includes a dorsal fin 2131A that extends radially upward from tubular section 2131B and is oriented to be axially aligned with exit port 2135D of the irrigation lumen. The electrode 2131 is preferably coated in a dielectric coating 2131F, which surrounds both planar sides of the tubular section 2131B and the dorsal fin 2131A, but which leaves some or all of the edges of the dorsal fin 2131A electrically exposed. In this way, when electrode 2131 is energized, charge is concentrated on this edge surface, providing a more efficient distribution of power and also helping to ensure that the electrically energized surface is in the flow of fluid outlet port 2135D. For example, a solution such as a glucose solution may be spurted through the irrigation lumen 2135 and cover the fins 2131A of the electrode 2131. This keeps blood cells away from the electrified surface when the electrodes are energized, and in the case of non-conductive fluids such as glucose, focuses the current to flow in tissues other than those surrounding the fluid, thereby reducing the likelihood of clot formation and associated blood clotting.

[0064] 8M-8O more fully illustrate anchor 2150 and pusher or tube 2140, which is slidably disposed within the distal end region of lumen 2130A. Anchor 2150 is in many respects similar to anchor 150 described elsewhere herein. Figures 8N and 8P illustrate anchor tines 2154 in a constrained state when pulled proximally into lumen 2130A, and Figure 8M illustrates tines 2154 after being deployed. The relative location of stop 2139 is indicated in Figure 80. It can be seen that stop 2139 is coupled to the inner surface of tubular member 2130E within lumen 2130A.

[0065] The electrode 2131 may be a monopolar electrode, and the system may include a return electrode as a separate catheter (or a standard return pad electrode located elsewhere), which is placed near the ablation site to provide a return path for the current. Alternatively, catheter 2130 may be provided with one or more return electrodes (not shown), located near electrode fin 2131A. For example, the return electrode may be located on the dorsal surface of catheter 2130, in a suitable location such as proximal to exit port 2135D of irrigation lumen 2135.

[0066] 9A-12C illustrate exemplary procedural embodiments for treating LVOTO, according to some embodiments of the present disclosure. For purposes of illustration, and not limitation, FIGS. 9A-9C depict the distal region of system 100 from different angles. As depicted, the outermost catheter 120 is deflected over the aortic arch and into the ascending aorta. Catheter 120 facilitates deflection of the left ventricular outflow tract obstruction ("LVOTO") proximally just below the valve. 10A-10B, catheter 130 holds the electrode and the distal portion of catheter 130 supporting anchor 150, and is deflected in a controlled manner beyond LVOTO, thereby delivering anchor 150 to a location proximal to the distal end of LVOTO toward the apex of the left ventricle. As depicted in Figure 10C, tension is then applied to tether 140 and catheter 130, causing catheter 130 to conform to the shape of the lesion.

[0067] 11A-11C illustrate aspects of a cutting operation, according to the present disclosure, that utilizes a reciprocating cutter. For purposes of illustration, and not limitation, the innermost catheter 130 is retracted proximally and advanced distally in a reciprocating manner while the electrodes 137 are energized, contacting the myocardium forming the lesion. 11A depicts the innermost catheter as its distal end carries the cutting electrode (not shown) during its reciprocating motion along tether rail 140. 11B, certain markers 141 may be provided along the length of the tether or rail 140 to allow the user to measure the cut length, and therefore the linear progress that the innermost catheter actuator / handle 136 must traverse along the proximal region of the tether 140. The linear range of movement of actuator 136 or carriage 230 may then be fixed, for example, by placing clamps on either side of carriage 230 to prevent carriage 230 from moving too far proximally or too far distally. The distal end of catheter 130 functions as a cutting tool as electrode 137 is energized and moves back and forth. With each movement, the electrode 137 burns further into the tissue of the lesion along a line defined by the path of the tether between the anchor 150 and the distal end 124 of the intermediate catheter 120 until the cutting tool bottoms out. The maximum depth of the cut is therefore controlled by the position of the distal end 124 of the intermediate catheter 120 and the rotation 152 of the anchor 150 . 12A depicts innermost catheter 130 being advanced distally over tether / rail 140, causing it to flex outward into the left ventricle until it contacts anchor 150. Tether 140 is then retracted proximally into distal end 134 of catheter 130, as depicted in Figure 12B. Catheters 110, 120, and 130 may then be withdrawn proximally as indicated in FIG. 12C, leaving behind a cut-away, dissected, and dilated LVOT. If necessary, a second cut may be made through the LVOT, substantially parallel to the first cut, before removing the system 100, by realigning and redeploying the anchors, or by shifting the distal end 124 of the intermediate catheter 120. 13A-13C illustrate the results of an exemplary LVOTO therapeutic treatment in a porcine model, according to some embodiments of the present disclosure. FIG. 13A illustrates a slit made in a lesion by system 100. Also illustrated is the relative location of the LV apex and aortic valve, which are not damaged by the procedure. As depicted in Figure 13B, the cut is over 5 mm deep. And, as depicted in Figure 13C, the cut is approximately 40 mm long.

[0068] 15-21B illustrate additional implementations of tissue cutting systems in accordance with the present disclosure.

[0069] For purposes of illustration, and not limitation, Figure 15 illustrates a multi-catheter system 100', where like reference numerals designate system components similar to system 100 described above. System 100' is illustrated as having the same basic catheter arrangement as system 100: an outermost catheter 110', a middle catheter 120', and an innermost catheter 130, which, like implementation 100, may be actively steerable. While the system 100 shown above describes the use of an inner tether or rail 140, the system 100' instead includes an inner pusher tube 140' that extends along a defined passageway through the catheter 130'. It includes an anchor 150' that is disposed at its distal end. System 100' may be made from similar materials and dimensions as system 100. The anchor 150' pivots at the distal end 144' of the pusher tube 140', allowing the pusher tube 140' to lie against and follow the myocardial tissue (e.g., the septum, etc.) as a guide rail, in a similar manner to the rail / tether 140 discussed for the implementation 100.

[0070] The innermost catheter 130' may include a ring-shaped electrode 137', which is configured to cut adjacent tissue when energized. One or more supplemental electrodes 137A' may be provided to sense electrical parameters of the myocardial tissue and to serve as a return path for current to facilitate bipolar operation of the system 100'. Similarly, push tube 140' or a conductor (not shown) disposed therein may serve as a conductive return path to facilitate bipolar operation. The electrode 137' at the distal tip of the catheter 130' may be of fixed depth to cut a predetermined amount, or may be adjustable to adjust the cutting depth. The electrode 137 may further be operatively coupled to a hollow needle, which is disposed within the catheter 130 and allows access for a wire such as a movable electrode.

[0071] System 100' may also be configured to read blood pressure from within lumen 128' of intermediate catheter 120' to confirm that the distal end of catheter 120 is positioned below the patient's aortic valve. Additionally, with respect to all of the catheter systems shown in this disclosure, fluid channels may be provided to deliver beneficial agents, such as a surge (e.g., a glucose surge) to the area to be treated. Such fluid may be delivered through the annular space defined between the inner wall of catheter 130' and the outer surface of tube 140', if desired, or by another route or separate catheter.

[0072] With continued reference to Figure 15, intermediate catheter 120' may further include a deployable anchor wire 127', which facilitates anchoring the distal end of catheter 120' at a desired location, such as the base of an LVOTO. In some implementations, the anchor wire 127 ′ may be deployed distally from a lumen defined in the distal end of the catheter 120 . In other implementations, the anchor wire may be deployed from the innermost catheter 130 location. The anchor wire 127' may comprise a tubular member, such as a hypotube, which may accommodate a wire (e.g., an electrode), such as a guidewire. In other implementations, the anchor wire 127' may include a wire pigtail loop that seats within the leaflets of the aortic valve.

[0073] 16 is a schematic diagram of cardiac anatomy illustrating targeted ablation sites for treating LVOTO in accordance with the present disclosure. In particular, this schematic diagram illustrates a cross section of the heart, illustrating the relative locations of the left ventricle, right ventricle, left atrium, aortic valve, and LVOTO, indicating the boundaries of LVOTO relative to what is believed to be the normal septal wall. 17A-17B are schematic diagrams illustrating an embodiment of a system for treating LVOTO within a patient's heart, according to the present disclosure. In particular, a guidewire 160' is introduced into the left ventricle (eg, a 0.035 inch wire, etc.), and a dilator catheter 170' is introduced over the guidewire 160'. Catheters 110' and 120' are then introduced over dilatation catheter 170', thereby delivering the distal end of catheter 110' proximal to the aortic valve, and catheter 120' adjacent to the tissue mass to be ablated by system 100'.

[0074] 18A-18B are schematic diagrams illustrating further aspects of the deployment of system 100'. Figure 18A depicts anchor 150', which has been deployed into the myocardium using push tube 140', which is surrounded by the distal regions of catheters 130' and 120'. If necessary, catheter 120' may be advanced to the site of anchor 150' to assist in the deployment of anchor 150'. Figure 18B illustrates the system after proximal retraction of intermediate catheter 120 beyond the lesion, proximal to the lesion and near its base, indicating deployment of anchor 127' into the tissue of the mass. Also illustrated is the alternative placement of anchor 127 within the aortic valve leaflet, where anchor 127' acts as a brake, pressing against and partially trapping within the aortic valve leaflet.

[0075] 19A-19C are schematic diagrams illustrating a further embodiment of the use of system 100' for treating LVOTO, according to the present disclosure. 19A depicts the deployment of a dynamic electrode 137', which may be advanced distally and radially outward relative to the distal end of the catheter 130. The catheter may alternatively be a fixed or static electrode 137', as indicated in Figure 19B. As a dynamic electrode 137', the depth of the cut may be adjusted by advancing the electrode 137' slightly from the catheter 130'. To complete passage through the severed tissue, catheter 130' is then retracted proximally over pusher tube 140', which acts as a guide rail. One or more passes may be performed to cut the tissue multiple times along the same line of cut to obtain a cut deep enough to open the LVOT to an appropriate degree.

[0076] 20A-20B are schematic diagrams illustrating further embodiments and uses of a system 100' for treating LVOTO, according to the present disclosure, including resheathing the cutting tool and retrieving the anchors of the system. Figure 20A depicts innermost catheter 130' advanced distally over push tube 140' to the location of anchor 150'. As illustrated in FIG. 20B, the pusher tube 140' is retracted into the distal end of the catheter 130'. 21A-21B depict withdrawal of the catheter-based system from the patient and illustrate treated LVOTO. Figure 21A depicts the distal portion of the catheter system 100' as it is withdrawn from the patient's heart. Figure 22 depicts the bottom of a cut made through the LVOT, which helps open a channel and increase the cross-sectional area of ​​the LVOT. If it is desired to make a deeper cut or to make a second cut in the tissue generally parallel to the first cut, system 100' may be redeployed into the left ventricle, anchor 150' may be re-anchored at a location displaced laterally from the first site at which anchor 150' was deployed, and the second cut may be performed in a manner similar to the first cut.

[0077] 22A-23C illustrate embodiments of further techniques for treating LVOTO, according to the present disclosure, which utilize further variations of catheter-based system 100. System 100" includes an inner rod or tubular member 140", which forms the main body of the system, around which the other system components are concentrically arranged. An intermediate anchoring catheter 120" is slidably disposed around member 140" such that catheter 120" can slide proximally and distally over member 140". A second distal catheter 180" is disposed distal to catheter 120" and is also slidably disposed about member 140". In embodiment 100″, the catheter system 100″ is anchored in place at the distal base of the lesion (e.g., LVOTO), which holds the system in place and performs the ablation along the lesion at a location proximal to the anchor. As illustrated, the system 100" is deployed in the left ventricle, where the distal catheter 180 is advanced distally past the lesion toward the apex of the left ventricle. The distal end region of catheter 120" is advanced to the base of the lesion, and the anchor wire exit port is "aimed" at the distal base of the lesion. Anchor wire 127" is similar to anchor wire 127'; it is advanced proximally into the distal base portion of the lesion and may be pulled proximally into the tissue mass. In the implementation of Figures 22A-22C, this is accomplished by pulling outer catheter 180" proximally, which is attached to anchor wire 127". This pushes the anchor wire 127" proximally into the tissue mass. At this point in the procedure, catheters 120" and 180" are maintained in position by anchor wire 127". This applies tension to the system, forcing the catheter system against the tissue mass.

[0078] Referring to Figures 23A-23C, an outer catheter 110" is slidably disposed around an intermediate catheter 120". An elongated cutting electrode 137" extends alongside the outer catheter 110". The energized wire 137" is forced against the tissue by articulating or steering the catheter 110" or by applying tension to the cutting wire while the catheter 110" is bent over the tissue mass. When energized, the electrode 137" completes a circuit passing through the tissue mass in either a monopolar or bipolar manner. A bipolar circuit may be completed by passing through the anchor wire 127". The outer catheter 110'' may be reciprocated in a proximal-distal direction over the middle catheter 120'', thereby completing the ablation procedure. System 100' may then be removed by pushing catheter 180'' distally over core member 140'', which causes anchor wire 127'' to retract into catheter 120''. The system may then be removed, leaving behind the obstruction that has now been cut along its length and opened the LVOT channel. Although not specifically illustrated, the system components may be surrounded by an outer deflectable catheter in a location proximal to the aortic valve region, thereby protecting the aortic valve from the electrodes 137.

[0079] 24A-25C illustrate embodiments of yet further techniques for treating LVOTO, according to the present disclosure, which include deploying additional implementations of anchors. As illustrated, rather than using anchors similar to anchors 150 or 127″ shown above, additional implementations of anchors (350, 450) are described that may be deployed out the distal end of the innermost catheter (e.g., 130, 130′, etc.) and anchor a rail (e.g., 140, 140′) in place to facilitate a reciprocating cutting action through a tissue mass (e.g., LVOTO), as discussed elsewhere herein.

[0080] 24A-24C illustrate an anchor 350 that is pivotally coupled to the distal end of an elongate inner member 340, such as a tubular member, about a pivot point 345. Preferably, inner elongate member 340 includes sufficient pushability to push anchor 350 distally out of a hypotube (eg, 140' in FIG. 15), polymeric or composite tubular member, or the like. The inner member 340 may be deployed distally from the distal end 334 of the sheath or innermost catheter, for example. A tensioning member 344 (e.g., a tether, etc.) may be coupled to anchor 350 at its distal end and directed proximally into the lumen of inner member 340 through exit port 342, externalizing it from the patient. 24A depicts anchor 350 being deployed from a sheath or inner catheter. The free distal tissue-piercing end of anchor 350 may be shaped as a flat wire or the like, which contacts tissue along the direction indicated by the arrow. Tension is applied to tether 344, causing it to shorten and anchor 350 to articulate about pivot point 345. This causes the prongs of anchor 350 to begin pointing along the proximal direction, as indicated by the arrows in Figures 24B and 24C. In some implementations, tether 344 may include a pushable wire that can be pulled proximally or pushed distally, causing the anchor to pivot about pivot point 345 to aid in deploying and retrieving anchor 350. When anchor 350 is oriented sufficiently proximally, inner member 340 may be pulled proximally, thereby anchoring the prongs of anchor 350 into tissue, such as the distal base of a lesion (e.g., LVOTO). 2A-25C depict an alternative version of anchor 450, which is also configured to be pulled by a proximally tensioned tether (not shown), causing anchor 450 to articulate about pivot 445. Tension may then be applied to the inner member of the system, drawing the prongs of anchor 450 proximally into the tissue mass.

[0081] 26-30B further illustrate embodiments of an exemplary system 500 and associated method of cutting tissue, according to the present disclosure.

[0082] Figure 26 depicts a catheter-based system that is encased within a sheath 500 (or an outer steerable catheter), which may surround the system as it is delivered to the patient's left ventricle. The outer sheath 510 has a distal end that abuts the soft distal tip 524 of the system. The distal end of any of these systems may be rounded or tapered, if desired. An inner lumen of the system 500 may accommodate a guidewire 560 . A guidewire 560 may be first advanced into the left ventricle, and the system 500 may then be advanced over the guidewire. The system 500 is flexible enough to conform to the inner surface of the left ventricle, as depicted in FIG. 26. The outer catheter 510 may be deflectable or may have a preset curvature to facilitate control of delivery and subsequent cutting system operation, as discussed in more detail below. The outer catheter 510 may be retracted proximally to a desired extent, thereby exposing the cutting wire 537, which is discussed in more detail below. As depicted in Figure 26, system 500 is positioned within the left ventricle such that the main curve is formed within the system within the apex of the left ventricle, and the distal portion of the system is positioned between the papillary muscles on the far wall of the ventricle. The system also conforms to and flexes around obstructions in the LVOT.

[0083] Figure 27 illustrates a further step in the procedure using system 500, which creates a cut in the LVOT. In this position, the outer sheath 510 is retracted such that the distal end 514 of the outer sheath is proximal to the tissue lesion but distal to the aortic valve, thereby providing protection to the aortic valve during the ablation procedure. The inner catheter 520 is coupled to the soft distal tip 524 of the system. Additionally, inner catheter 520 defines cutting accessory exit port 537A and cutting accessory entrance port 537B, which receives reciprocating cutting element 537 therethrough. Cutting element 537 extends distally into the body of catheter 520, passes through distal port 537B, and may be anchored in a fixed location by a rigid structure, or may be a resilient structure (e.g., a tension spring or elastic strip). Cutting element 537 may also extend proximally into the body of catheter 520 and through proximal port 537A to an actuator (not shown) external to the patient. When tension is applied proximally to cutting element 537, the cutting element is pulled proximally against the force of, for example, a tension spring (not shown), which is disposed within the body of catheter 520. It is located distal to distal port 537B. When the proximal tension is released, the cutting element 537 is pulled distally. Thus, repeatedly applying and releasing proximally directed tension to cutting element 537 creates a sawing action, which cuts through tissue when cutting element 537 is energized and sharpened. Additionally, the cutting element 537 may include one or more discrete electrodes thereon, which, when energized, cut through tissue when drawn along with the cutting element. If desired, a distal anchoring wire 527 and associated exit port 527 may be provided, where the anchoring wire 527 may be advanced proximally into the distal portion of the tissue mass, thereby helping to stabilize the system 500 in place. If desired, one or more radiopaque markers (not shown) may be provided at various locations on the system 500, such as at the distal end 514 of the sheath, at the exit port 537A, at the entry port 537B, at the distal tip 524 of the system, etc.

[0084] Various embodiments may be used to anchor or stabilize the system 500 in place. For example, inner catheter 520 may be placed in the apex of the left ventricle with the distal segment against the free wall of the ventricle between the papillary muscles. This stability may be enhanced by presetting the curvature to accommodate hypertrophic cardiomyopathy (HC) or lesions above the septum. An exit port may allow an element to anchor / stabilize and exit the shaft distally or proximally to the cutting target, such as element 527 mentioned above. The element may, for example, comprise a wire that traverses the myocardium and enters the right ventricle, or it may comprise a curved element that is implanted into the myocardium, or it may comprise a pre-formed element (e.g., from a NiTi alloy) that exists as a stabilizing leg. A pre-formed curve may be formed in the body 520 at a location that traverses beyond the ablation target (LVOTO), thereby pre-positioning the curve and retracting the distal point of the curve closer to the base of the ablation target. This may be augmented by shortening the cutting element from the proximal handle, thereby applying tension to the region of the device 520 distal to the entry port 537B. The sheath 510 may be a deflectable catheter, which has a curvature directed toward the proximal portion of the ablation target. This keeps the proximal portion of the arcuate close to the myocardium. The proximal sheath 510 may also help control the location of the proximal anchoring element relative to the cutting target and mechanism.

[0085] Referring to Figure 28, system 500 is depicted in cross section from the same side as Figures 26-27. Here, exposed cutting accessory 537 penetrates tissue through a variety of potential cutting mechanisms (e.g., a reciprocating element), which moves back and forth along the tissue. A variety of reciprocating mechanisms may be used to effect cutting with cutting element 537. For example, as mentioned above, after the cutting tool is pulled proximally, the cutting element may be returned distally using a distally located spring, for example, located within body 520. Alternatively, both ends of the cutting element 537 may be connected to proximal tensioning elements, where the cutting element or the tether attached thereto reverses direction around a transition point, such as the distal entry port 537B or a rounded boss located inside the inner catheter 520 distal to the distal entry port 537B. Thus, both ends of a tensioning element coupled to cutting tool 537 may be externalized, and each end may be alternately pulled to produce a reciprocating cutting motion. In another implementation, the proximal end of cutting tool 537 may be connected to a tube or rod (not shown) that is located within inner catheter 520. This is located proximal to exit port 537A, which is advanced and retracted through inner catheter 520. The distal end of cutting tool 537 is connected to a resilient element, such as a spring, which is disposed within inner catheter 520. The cutting element 537 within the area where cutting is performed may include a smooth radiopaque wire or tether, a woven radiopaque wire or tether, a diamond coated wire, a radio frequency ("RF") wire or electrode operating in the microwave regime, a length of razor wire, a cutting blade coupled to a reciprocating tether, an ultrasonic transducer, or an element coupled to an ultrasonic transducer, etc.

[0086] FIG. 29 depicts an isometric view of the implementation depicted in FIGS. As depicted, once the cut is complete, the LVOTO tissue is a widened opening, as defined by boundary line 590 illustrated in FIG. This widened opening in the tissue increases the cross-sectional area of ​​the LVOT, thereby reducing the risks associated with implanting a prosthetic valve, as mentioned above. System 500 may then be removed, for example, by advancing sheath 510 distally over inner catheter 520 and cutting tool 537 to protect the surrounding tissue from cutting tool 537 during withdrawal. The system 500 may then be withdrawn using the guidewire 560 .

[0087] 30A-30B depict a variation of system 500, in which a reciprocating cutting tool 537 includes a first electrode 537C for RF cutting disposed thereon and a second electrode 537S for EDEN (Electrocardiographic Radial Depth Navigation) sensing mounted thereon. EDEN detection detects tissue depth based on detection of EKG signals. Each electrode 537C, 537S is electrically coupled to a conductor that may pass through the interior of cutting tool 537, extend proximally through system 500, and exit the patient. When cutting with electrode 537C, electrode 537S picks up an EKG signal that may be used to help estimate the current depth of the cut into the myocardial tissue.

[0088] 31-40 depict further implementations or aspects of a catheter system according to the present disclosure, which have different actuator assemblies than the system of FIG. For reference purposes, the proximal and distal directions of the assembly are indicated in the various views.

[0089] 31 is a side view of a catheter-based system 1100 for performing a percutaneous tissue cutting procedure in accordance with the present disclosure. While system 1100 can utilize a reciprocating cutting tool as described elsewhere herein, system 1100 may be configured to perform different procedures using different end effectors, and any desired number of redundant catheters may be provided. For example, while the illustrated implementation 1100 includes a pair of concentric catheters 1120, 1130 that surround a central tether 1140, a third, fourth, or fifth concentric catheter may be added that surrounds catheter 1120. As a further example, the central tether 1140 may be omitted in the assembly, and the system may be used as a two-catheter system. Alternatively, a smaller catheter (e.g., a microcatheter) may be inserted within the lumen of catheter 1130. Additional actuators similar or identical to actuators 1126, 1136 may then be used proximal to and within catheter 1130.

[0090] As indicated above, system 1100 includes two concentrically arranged deflectable catheters, including a radially outermost catheter 1120 within which a second, middle deflectable catheter 1130 is slidably received. The tether 1140 may be in the form of a flexible suture, a wire with column strength and pushability, or a pushable tubular member or other device (e.g., a guidewire), a snare, or the like, which is slidably received within the catheter 1130. Each deflectable catheter 1120, 1130 may include one or more steering wires (FIG. 34, 1121) that can be tensioned to selectively bend the distal end of each corresponding catheter 1120, 1130 in a preferred direction. References herein to the steerability or deflectability of the catheter may include active steering (e.g., using tension wires, etc.) or steering using a flexible or deflectable catheter with a low relative durometer. The distal region of one or more catheters may be configured to bend in a preferred direction. Rotating each corresponding catheter 1120, 1130 about its central axis causes the curved distal end of each corresponding catheter to point in a desired direction within the patient. The catheters 1120, 1130 may then be advanced distally into the desired anatomy.

[0091] 31, each 1120, 1130 comprises a tubular body that is coupled at its proximal end to an actuator 1126, 1136 and free at its distal end (not shown), in a manner similar (or identical) to catheters 120, 130. Each catheter 1120 , 1130 is capable of axial and rotational movement relative to the other components of the system 1100 . Each catheter 1120, 1130 is held in relative position by a corresponding carriage 1220, 1230, which is slidably received on rails 1201 of platform 1200 (see Figures 37 and 38). Tether 1140 is in turn coupled to tensionable anchor 1146, which in turn is operably coupled to carriage 1240. Each carriage 1220 , 1230 , 1240 is capable of axial translation between the proximal end 1202 and the distal end 1204 of the rail 1201 . In the illustrated implementation, one or more of the carriages 1220, 1230, 1240 can be locked in place relative to the rail 1201 by rotating the locking handles 1225, 1235, 1245 to engage the rail locks. For example, the locking handles 1225, 1235, 1245 may activate a clamping mechanism that clamps the actuator 1126 in place against the rail 1201, for example, by advancing a threaded fastener against the rail 1201, by tightening a clamp that surrounds the rail 1201, or by rotationally advancing a cammed fastener against the rail 1201.

[0092] 31-32, the actuator 1126 is formed from a first component, which includes a main body portion 1222, which partially or completely surrounds the rail 1201 and may slide proximally and distally over the rail when the locking handle 1225 is disengaged. The actuator 1126 extends upwardly from the base portion 1222 and into an upwardly extending portion or mount 1224, which is illustrated in FIG. 31 as a hollow outer housing portion. It extends upwardly and into the upwardly extending housing portion, which defines a cradle, which receives the proximal end of the catheter 1120 therein. The clamp or door 1224A closes over the catheter and holds it in place, for example via a suitable releasable connection such as an interference fit.

[0093] See Figure 32. Similar to the implementation of Figure 5, each catheter 1120, 1130 is received in a mount 1224, 1234 that extends vertically upwardly of the corresponding carriage 1220, 1230. More specifically, the handle portion 1226A, 1236A of each actuator 1126, 1136 can be lifted out of its respective mount 1224, 1234 when the removable cover 1224A, 1234A is removed, thereby allowing the corresponding catheter and handle to be lifted out of the mount. In the implementation of FIG. 5, the catheter is received in a fork-shaped coupling. In the implementation of FIG. 32, the proximal end of each catheter 1120, 1130 is surrounded by a hub 1272, which is comprised of a gear 1252 and collars 1272A-1272E, which defines a peripheral channel 1272E around at least a portion of its circumference that straddles a ridge or boss 1229 (FIG. 33) in the mount 1224 and is rotatably received relative to the ridge or boss 1229. This rotates the knob 1254 and worm gear radius 1256, which may rotate the handle 1126A within the mount 1224 when the gear 1252 is rotated. When mounted around ridge 1229, the catheter, including handle portion 1226A, is held in place longitudinally within mount 1224 when door 1224A is closed, but the handle and hub 1272 can rotate in place within mount 1224 when knob 1254 is rotated. Placement in mount 1224 prevents axial movement of catheters 1120, 1130 relative to carriages 1220, 1230. Each carriage (e.g., 1240) is defined by a main body portion (e.g., 1242) that defines a channel (e.g., 1248) therethrough that at least partially surrounds the rails 2201 of the platform 2200.

[0094] 32-33. When installed in mounts 1224, 1234, each catheter, a proximal gear 1252 operably coupled to each catheter, meshes with a corresponding worm gear 1256, which is rotatably positioned in its respective mount and operably coupled to a corresponding handle 1254. In this manner, when the handle 1254 is rotated, the worm gear 1256 rotates about the central axis of rotation. The helix of the worm gear intermeshes with the teeth of gear 1252, causing gear 1252 to rotate about the central axis of catheters 1120, 1130. A gear 1252 is coupled directly or indirectly to the proximal end of each catheter 1120, 1130 so that the catheters 1120, 1130 also rotate when their corresponding handles or knobs 1254 are rotated. This provides fine control to aid in steering the catheter through each tortuous anatomical structure.

[0095] Thus, each of the catheters 1120, 1130 can be rotationally displaced relative to one another about the central axis of the system (eg, about the tether 1140). It will be appreciated that any of catheters 1120, 1130 (or additional catheters in combination with catheters 1120, 1130) may be utilized with platform 1200 alone (or in combination with other system components). Thus, a dual catheter assembly may be used as depicted in Figure 31, or if all three catheters are not required, a single or dual catheter assembly may be used. The catheters 1120, 1130 may be of any desired length. According to some implementations, the catheter 1120 may be between about 90 cm and about 140 cm in length, or any approximately centimeter increment therebetween. According to yet a further embodiment, catheter 1130 may be between about 100 cm and about 160 cm in length, or any approximately one centimeter increment therebetween. Tether 1140 may be of any desired length, for example, between about 120 and 300 cm in length, or any approximately one centimeter increment therebetween. Other than the actuator portion, catheters 1120, 1130 may be identical or substantially identical to catheters 120, 130, for example.

[0096] As further depicted in Figures 31-32, actuators 1126, 1136 can be selectively translated proximally or distally relative to rail 1201 by unclamping the locking handle 1225, which holds each actuator in place. When the corresponding locking handle 1225 is loosened, each actuator 1136, 1136 can slide along the rail 1201. When the desired location within the patient's vascular system is reached, the actuators 1126, 1136 can be locked in place by tightening their corresponding locking handles 1225. This provides a "coarse" adjustment of the position of each catheter 1120, 1130. If desired, finer adjustment may be provided between the carriages 1220, 1230, 1240 and the rails, for example, by providing a rack gear in or on top of the rail 1201. This allows the rotational actuators (not shown) of each carriage to engage with the gear teeth, which in turn engage the racks, allowing the position of the carriages 1220, 1230, 1240 to be adjusted by rotating the knobs on the rotational actuators. The exemplary carriage is depicted with only the coarse adjustments described above.

[0097] 33-34, each actuator 1126, 1136 may include a steering mechanism that utilizes one or more tensioned pull wires that are actuated from within the handle (e.g., 1226A) of the actuator 1126. Figure 34 depicts catheter 1120 and handle 1226A after it has been lifted out of main body 1224 and after one half of the outer housing has been removed to reveal the internal components. The handle 1226A is constructed from an outer housing, which includes a distal housing section 1273, which is connected to a proximal housing section 1278 by one or more longitudinal bridges, which pass radially outwardly past a rotatable pull wire actuator handle 1275, which defines threads along its interior surface. Hub 1272 includes gear 1252 and collars 1272A-1272E, which may be formed from a single molding. It is received within distal housing component 1273. As illustrated, the collar portion of the hub 1272 includes two distally located disc-shaped portions 1272B, 1272C separated by a channel 1272. This is defined by an outwardly facing annular surface that contacts the ridge or collar 1229 of the actuator 1126. Hub 1272 further includes a proximal enlarged portion 1272A shaped to be slidably received within channels defined in each half of the housing of handle 1226A, which prevents rotation of hub 1272 relative to housings 1273, 1278 of handle 1226A. On its proximal face, hub 1272 defines a pair of sockets that slidably receive the distal ends of one or more rails 1274. The proximal ends of the one or more rails 1274 are received by a proximal collar 1277 . The proximal collar 1277 is fixedly coupled to the proximal end 1122 of the tubular portion of the catheter 1120 . Carrier 1276 defines a plurality of threads thereon that are threadably received by the internally threaded surface of handle 1275 and are slidably received over rail 1274. The carriage 1276 is attached to the proximal end 1121P of the puller wire 1121, which is operably coupled to the distal end of the catheter 1120. Proximal or distal movement of the carriage over rails 1274 is accomplished by rotation of handle 1275 relative to the housing of handle 1226A. The internal threaded surface of the handle 1275 pushes the carriage 1276 along the rails. Movement of carriage 1276 applies tension proximally to pull wire 1121, which deflects the distal tip of catheter 1120 away from the longitudinal axis of the catheter. Rotation of the handle 1226A within and relative to the carrier 1220 allows rotation of the deflected end of the catheter, thereby allowing the distal end of the catheter to be advanced through tortuous anatomy.

[0098] 34 further illustrates that the proximal collar 1277 is held in a fixed rotational and axial position within the housing of the handle 1226A, thereby also holding the proximal end 1122 of the catheter in a fixed axial and rotational position relative to the housing of the handle 1226A. The proximal portion of the handle 1226A is defined and surrounded by a proximal housing portion 1278. This receives the irrigation line 1262 and the inflation line 1264 (discussed below). It also receives the proximal cap 1279 and the additional locking collar 1269, which contains an additional peripheral fluid seal. This prevents fluids that accumulate in the handle 1226A from leaking out.

[0099] As further illustrated in Figures 31, 34, and 35, the actuator 1126 includes a valved irrigation line 1262, which is in fluid communication with the inner lumen of the catheter 1120 and a second lumen 1264. It receives pressurized fluid to inflate a toroidal-shaped expandable member (or balloon) 1265 (Figure 35), which seals against the outer surface of the catheter 1120, thereby preventing fluid from leaking from the patient past the proximal end of the catheter 1120. 35 depicts a slight variation 1226A' of handle 1226A (also illustrated in FIGS. 36 and 38-40), showing the internal components of handle 1226. Although not visible in Figure 34, Figure 35 illustrates additional internal components to which cleaning line 1262 and expansion line 1264 are attached. In particular, the internal fluid manifold is depicted, which includes an irrigation housing 1261, an inflation housing 1263, an expandable member 1265, and a proximal locking collar 1269. The fluid manifold may be formed from integral or separate components. Irrigation line 1262 is in fluid communication with the interior volume (not shown) of irrigation housing 1261, which in turn is in fluid communication with the interior lumen of catheter 1120. In this manner, irrigation fluid (or other beneficial agent) may be introduced to the tissue area to be treated by directing the fluid through line 1262, into a chamber in irrigation housing 1261, along the lumen of catheter 1120, and to the distal end of catheter 1120, where the fluid may be ejected in proximity to the tissue to be cut, for example, during an electrosurgical procedure. The beneficial agent or wash may include, for example, a glucose wash to the area to be treated.

[0100] With continued reference to Figure 35, adjacent and more proximal to the irrigation housing 1261 is an inflation housing 1263, which has an internal cavity (not shown), which is in fluid communication with an inflation line 1264. The chamber within the expansion housing 1263 is in turn in fluid communication with a toroidal or toroidal shaped expandable member 1265, which is defined by inner and outer flexible surfaces that deflect when the expandable member 1265 is expanded by directing pressurized fluid through the expansion line 1264. The annular expandable member expands radially inward to seal around the outer surface of the catheter 1130 and expands radially outward to occupy a volume within the housing of the handle 1226A, for example, to prevent irrigation fluid from leaking out of the handle 1226A or bodily fluids from leaking away from the patient. The fluid manifold terminates at its proximal end with a locking collar 1269, which may comprise an internally threaded outer member that can rotate relative to an externally threaded inner member and a compressible seal between the two components, such that when the locking collar 1269 is tightened, it presses the compressible seal against the outer surface of the catheter 1130.

[0101] A detailed illustration of the tensionable anchor 1146 is depicted in FIG. The anchor 1146 includes a housing having a slidable handle 1145 that slides along a slot 1148 (FIGS. 31, 37) in the outer surface of the anchor's 1146 housing. Handle 1145 is operably coupled to the proximal region (or proximal end) of tether 1140 in any of a variety of ways. In the illustrated implementation, the handle 1145 may be coupled to a shaft (not shown), which passes through the shuttle 1141, which in turn is connected to a coil spring 1143, which is coupled to an interior portion of the housing of the anchor 1146. The tension of the coil spring 1143 can be adjusted by rotating the handle 1145 . This then applies a proximally directed force to the proximal end or end region of tether 1140, applying tension to tether 1140 when the distal anchor coupled to the tether is anchored in tissue. FIG. 36 depicts half of the housing of anchor 1146 as removed, and is present in FIG. Shuttle 1141 includes one or more bosses that ride within channel 1242A, which is formed into the housing of anchor 1146. Anchor block 1141A (FIG. 37) is operably coupled to the proximal end of tether 1140. The anchor block 1141 may be slidably received (eg, vertically) within the shuttle 1141 .

[0102] Figure 35 depicts a slight variation of actuator assembly 1100. It shows three actuators 1116', 1126', and 1136', which have similar components and functionality as actuators 1126 and 1136. It is configured to couple to three concentric catheters, such as catheters 110, 120, and 130. A further anchor 1146' is depicted which applies tension to the central tether. Here, the anchor includes arms which are attached to the tether, where the arms pivot about a pivot point and are spring loaded to apply tension to the tether. The actuator is slidably mounted on rail 1201, which in turn is coupled to base frame 1200. This is clamped to an object, such as a seat, by clamp 1200A. Figures 39A and 39B illustrate examples of how the actuator assembly can be coupled to an object such as a seat. In particular, rail 1201 is coupled to base portion 1200. This rests on a surface (e.g., a table or stool). It may be clamped in place using clamp 1200A. It wraps around the edge of the surface, on which the base portion rests. In the illustrated implementation, the clamp operates by moving up and down. If desired, rail 1201 may include measurement markings along its surface, and, if desired, may be provided with an additional stop (not shown) that can be received over rail 1201, slid into a desired position, and tightened in place against rail 1201. Stops may be placed on either side of one or more of the actuators to limit the degree of travel along rail 1201 of the corresponding actuator.

[0103] Further in accordance with the present disclosure, various methods are provided for performing medical procedures using the actuator assemblies and catheter arrays described herein. For example, a system of nested catheters (eg, 110, 120, 130) may be directed or advanced to a target location within a patient. The distal end of the outermost tubular catheter (eg, 110) may be placed in a first location. The distal end of a further tubular catheter (e.g., 120) may be located at a second location, which is distal to the first location. The distal end of the inner tubular catheter (e.g., 130) may be located at a third location, which is distal to the second location. The method may then proceed to perform any one or more of a variety of therapeutic or diagnostic procedures using at least one of the catheters (e.g., 110, 120, 130).

[0104] In some implementations, a distal region of an outermost catheter (e.g., 110) may be positioned within the patient's aortic arch, a distal region of an additional tubular catheter (e.g., 120) may be positioned through the patient's heart valve, and an innermost tubular catheter (e.g., 130) may be manipulated to perform a therapeutic or diagnostic procedure, such as the SESAME procedure described herein. Thus, therapeutic treatment may, in some implementations, involve cutting into the left ventricular outflow tract obstruction to increase the effective cross-sectional area of ​​the left ventricular outflow tract.

[0105] In some implementations, the innermost tubular catheter may include a microcatheter, and the method may include procedures such as directing the microcatheter into the patient's right ventricle, penetrating the patient's septum, and into the patient's left ventricle, and incising into the left ventricular outflow tract obstruction to increase the effective cross-sectional area of ​​the left ventricular outflow tract. In some implementations, the first tubular catheter may include a delivery catheter, which delivers a beneficial agent or medical device (e.g., a stent, shunt, etc.) to an anatomical location. One or more of the catheters may include one or more visualization markers (e.g., visible under fluoroscopy or MRI), one or more electrodes, or one or more cutting elements that cut through the anatomical tissue. The diagnostic or therapeutic procedure may be selected from the group consisting of a MIRTH procedure, a LAMPOON procedure, a PASTA (puff-assisted tricuspid annuloplasty) procedure, an ELASTIC procedure, a BASILICA procedure, a robotic surgical procedure, a suture procedure, or delivery of a medical device. In one example of FIG. 39C, the disclosed system is configured to perform a MIRTH procedure.

[0106] The MIRTH (Myocardial Intramural Remodeling with Transvenous Tether) procedure is a transcatheter ventricular remodeling procedure in which a transvenous tensioning element is placed within the beating left ventricle and shortens, narrowing the chamber size. Further details of the MIRTH procedure can be found in U.S. Patent Application No. 18 / 151,601, which is incorporated by reference in its entirety for all purposes. The MIRTH method may be used to reduce the size of a portion of a patient's heart. The method may include advancing a guidewire into the patient's circulatory system and into the patient's heart, advancing the guidewire through the myocardium (e.g., between layers of cardiac tissue around a chamber of the heart) to define a passage around at least a portion of the heart between an outer surface of the heart and an inner surface of the heart, replacing the guidewire with an implant including a tensioning element such that the tensioning element traverses the passage, advancing a locking device over the tensioning element, applying tension to the tensioning element to change the dimension of the portion of the heart, and locking the locking device to maintain tension on the tensioning element. Such techniques may be implemented using system 100 (or components thereof). A variety of support catheters are useful for performing MIRTH procedures. In the context of the present disclosure, a two-catheter system may be used, as illustrated in Figure 39C, where, for example, catheters 110 and 120 are used to navigate the myocardium and perform a MIRTH procedure. Further exemplary procedures appear in International Application No. PCT / US2020 / 045674, which is incorporated herein by reference, and may be performed using the catheter system 100 disclosed herein.

[0107] 40A-40D depict a further implementation of a catheter system according to the present disclosure (or aspects thereof), which has a different actuator assembly than the systems of FIGS. For reference purposes, the proximal and distal directions of the assembly are indicated in the various views. This illustrated implementation of the actuator includes a variation on that of Figures 31-39C. Here, closing cover 2234A pushes pin 2280 downward, which rotates gear 2288, which pushes inner support or journal 2290 upward, which rotatably receives worm gear 2256. Journal 2290 is slidably disposed within the actuator assembly housing and is biased into place downward by tension spring 2292. When cover 2234A is opened, spring 2292 pulls journal or support 2290 downward, as illustrated in FIG. 40C . This causes worm gear 2256 to lower and disengage from gear 2252. This allows gear 2252 (and thereby the catheter seated in the actuator) to rotate about its axis without mechanical interference from worm gear 2256. With the cover 2234A open, once the desired rotational orientation of the catheter is achieved, the cover may be closed, causing a boss 2234B formed on the underside of the cover to press downwardly against the top surface 2282 of the pin 2280 (FIG. 40B). 40C, downward movement of pin 2280 causes a gear rack 2284 formed into the lower surface of pin 2280 to rotate a sprocket or gear 2288 about an axle 2286. The teeth of gear 2288 further engage a complementary toothed rack on journal 2290. This urges journal 2290 upward against the force of tension spring 2292, thereby creating a mechanical engagement between worm gear 2256 and gear 2252, which surrounds and is operatively coupled to a corresponding catheter (e.g., 130).

[0108] See Figure 40A. The actuator assembly may be similar in design and operation to that illustrated in Figures 31-39C, but with the addition of the features described above, which, when open, allows for coarse rotational adjustment of the catheter about its longitudinal axis. Accordingly, reference numbers for components such as rail 2201 are meant to be parallel and reflective of the embodiment of Figures 31-39C.

[0109] 40B, a top view of the assembly, illustrates cover 2234A in the open position, showing the relative location of boss 2234B, which contacts and depresses upper surface 2282 of pin 2280. A similar dial adjustment 2275 may be operably coupled to the pull wire, similar to the embodiment of Figures 31-39C, and the same flushing and sealing ports may be provided.

[0110] As mentioned above, with reference to FIG. 40C, when the top cover 2234A is opened, the tension spring 2292 returns to its contracted rest position, pulling the worm gear 2256 and journal or mount 2290 downward, causing the worm gear 2256 to disengage from the gear 2252. The catheter is then free to rotate within the carriage housing.

[0111] As illustrated in Figure 40D, when the carriage top cover 2234A is closed, a boss 2234B on the interior of the top cover 2234A depresses the pin 2280. The pin rotates gear 2288, which expands spring 2292 and causes worm gear 2256 to rise and engage gear 2252, thereby locking the catheter rotational position. In this state, spring 2292 is actually under tension, although this is not directly illustrated in FIG. 40D.

[0112] 41 illustrates a side view of a distal portion of an additional catheter 1330, in accordance with the present disclosure, that is configured to deploy tissue anchors through and out of lateral side ports of the catheter. As illustrated in Figure 41, catheter 1330 is formed from outer tubular member 1335, which contains a deployable anchor that can be deployed through side port 1340, which is defined through tubular member 1335. The catheter further includes an electrode 1337, which includes an electrically exposed portion (not shown) that can complete an electrical circuit through the tissue to be cut during an electrosurgical procedure. The electrically exposed portion may be along the outer edge of the bow facing outward, with insulating material remaining around the remainder of the electrode 1337. Electrodes 1337 extend through corresponding side ports 1337A, as depicted, which are defined through wall 1335 of catheter 1330. However, it will be appreciated that the electrodes may simply be formed in or protrude from the sidewall without the side port 1337A, similar to the electrodes 137 illustrated in other embodiments herein. The electrode 1337 may be configured to be deployed outward from the side port 1337A, for example, by pushing the electrode and applying a columnar force or axial compression to the electrode, causing the electrode 1337 to protrude from the port 1337A. Similarly, the electrode may be spring loaded or otherwise biased to extend outward through the port 1337A, where the electrode may be pushed back laterally into the port by, for example, retracting the catheter 1330 proximally into a guide catheter or sheath. As illustrated, catheter 1330 further includes distal marker band 1360, which may comprise a band of radiopaque material, or may be configured to be visible under additional or alternative visualization modalities depicted herein.

[0113] Figures 42A-42D are images of the catheter of Figure 41 illustrating successive steps in deploying a tissue anchor 1350 through and out of a lateral side port 1340 of a catheter 1330. Figure 42A illustrates the catheter 1330 prior to deployment of the anchor 1350. The relative locations of the anchor exit port 1340, distal marker band 1360, electrode 1337, and side electrode port 1337A are shown. 42B illustrates the initial step in the deployment of anchor 1350. A pair of prongs 1354 begins to emerge from port 1340, which is distal to electrode 1337. In other implementations, the lateral anchor port 1340 may be located proximal to the electrode 1337 . Figure 42C illustrates the tines 1354 of the anchor when it is about half deployed, and Figure 42D illustrates the tines 1354 of the anchor 1350 when it is fully deployed. 43-44, anchor 1350 comprises an elongated wire 1356, which is slidably disposed along a lumen defined within tubular body 1335 and along the interior of catheter 1330. It is in fluid communication with exit port 1340. Anchor 1350 is deployed by pushing wire 1356 distally relative to outer tubular body 1335. Prongs 1354 of anchor 1350 are oriented proximally, which allows prongs 1354 of anchor 1350 to easily anchor into tissue. The prongs 1354 may be coupled to the wire 1356 at a joint 1352, where the joint can prevent rotation or bending between the wire and the prongs 1354. Alternatively, the joint can be a swivel joint, if desired. As will be appreciated, the bifurcated design of the anchor 1350 facilitates lateral deployment. The trifurcated design of the implementation 150 (FIG. 14) is well suited for deployment out of a distal passageway of a catheter (e.g., 130).

[0114] 45A-45B illustrate an embodiment utilizing a catheter-based system (e.g., 100) according to the present disclosure to perform the LAMPOON procedure, a transcatheter electrosurgical technique that splits the anterior mitral valve leaflet immediately prior to transcatheter mitral valve replacement (TMVR). As illustrated, to facilitate this procedure, catheter 110 is deflected across the aortic arch and into the ascending aorta, where the distal end of catheter 110 is external to the aortic valve. Catheter 120 is deployed distal to catheter 110 until the distal end of catheter 120 is just below the aortic valve. Catheter 130 includes cutting element 137, which is deployed and maneuvered to the wall of the left ventricle, where anchor 150 is deployed out the distal end of catheter 130 and into the wall of the left ventricle. Catheter 130 may then be retracted proximally, exposing a tether in the form of hypotube 140, which has sufficient column strength to aid in inserting anchor 150 into tissue. The catheter 130 may then be aligned so that the cutting element 137 (whether an electrosurgical, sharp surface, or ultrasonic cutter) is placed adjacent to the anterior mitral valve leaflet and cuts through the anterior mitral valve leaflet by starting the cut at its bottom edge, and then oscillating back and forth to cut through the leaflet. Catheter 130 may be selectively withdrawn, thereby maintaining the cutting element in place and continuing to cut the leaflets until cutting tool 137 is near the anterior leaflet of the mitral valve annulus and the anterior leaflet is split. After disrupting the leaflets, a replacement valve may be placed. The stiffness of element 140' (whether provided as a solid element or as a tubular element) in combination with the stiffness of catheter 130 helps position the cutting tool in the correct location to continue cutting the tissue.

[0115] 46A-46B illustrate an embodiment utilizing a catheter-based system according to the present disclosure to perform a BASILICA procedure to cut the leaflets of the aortic valve. In this implementation, the catheter 120 is deflected across the aortic arch and down into the ascending aorta. Catheter 130 supports a crossing wire 370 within the leaflets of the aortic valve. A transverse wire 370 is advanced through the aortic valve leaflets near the radially outer edges of the leaflets, for example, by energizing the wire 370, where the wire 370 includes an electrically exposed distal end and an electrically insulated jacket proximal to the wire 370 distal end. Snare catheter 310 is introduced alongside catheters 120, 130. It comprises a tubular member with snare 312, which terminates in a loop that surrounds and captures the distal end of wire 370 after wire 370 has pierced the aortic valve leaflets and formed a hole. The wire 370 is pulled into the distal end of the catheter 310. At this point in the procedure, the wire 370 may be pulled into the catheter 310 to hold it in place and then provide a rail or guide. This may allow any suitable form of cutting tool 137 to enlarge the hole created by the wire 370. Wire 370 may be pulled further into catheter 310, applying tension to wire 370, which provides a lateral force component to catheter 130 and cutting tool 137, causing the cutting tool to cut through the aortic valve leaflets. This procedure may be repeated for the other two aortic valve cusps.

[0116] 47A-47B illustrate an embodiment utilizing a catheter-based system according to the present disclosure to perform an ELASTIC (Alfieri stitch electrosurgical rupture) procedure, which removes the mitral valve clip or Alfieri stitch to facilitate placement of the TMVR. In this procedure, catheter 120 is deployed across the atrial septum from right to left toward the mitral valve and left ventricular apex. Catheter 130 is deployed distally to the apex of the left ventricle, and anchor 150 is deployed into tissue at that location. Catheter 130 is retracted proximally until cutting tool 137 is in the region of the Alifieri suture (or mitral valve clip that attaches the anterior and posterior mitral valve leaflets to one another). The cutting tool 137 is aligned with the tissue adjacent to the stitches and makes a cut through the tissue, separating the two leaflets, thereby deploying the TMVR. Tether 140' may comprise a rod or tube that provides sufficient stiffness to help guide the cut in conjunction with the movement of catheter 130 supporting cutting tool 137.

[0117] As a further example, rather than being configured for manual operation, the actuator assembly may be configured to be received by an actuator hub of a robotic surgical system. The system (e.g., 100) may be introduced into the patient via a femoral access point, a carotid artery access point, or a jugular access point, depending on the procedure being performed. The system may be sized and configured for introduction into a patient's vascular system to perform a procedure within the patient's neurovascular region. It will be appreciated that the system (e.g., 100) may be used in a variety of percutaneous cardiovascular, thoracic, or laparoscopic procedures, as well as to access a patient's brain via the patent circulatory system or sinus passageways. The systems of the present disclosure may also be used to access a patient's digestive system, as well as a patient's urinary or reproductive system.

[0118] The present disclosure also provides an electrosurgical system that includes a radio frequency power supply (such as that described in U.S. Pat. No. 6,296,636, which is incorporated by reference herein in its entirety for all purposes) operably coupled to an electrode (e.g., 137, 137') and, optionally, an anchor (e.g., 150). A radio frequency power supply is operably (and selectively) coupled to the electrodes via a conductor, such as a cable. Any suitable power level and duty cycle may be used, consistent with the disclosed embodiments. For example, continuous duty cycle (cutting) radio frequency ("RF") energy may be used, for example, at a power level between about 10 and about 50 watts, or any increment therebetween, for example, in about 1 watt increments. Cutting may be achieved by applying power for between about one-half second and about five seconds, or any increment of about one-tenth of a second therebetween. The electrosurgical generator may be a Medtronic Force FX-C generator, which achieves, for example, 5W to 300 Watts of monopolar radio frequency (RF) energy.

[0119] Guidewire packaging for use in the disclosed embodiments preferably comprises a sterile, single-use device intended for cutting soft tissue. References herein to specification information such as dimensions are intended to be exemplary and not limiting. In one implementation, the disclosed guidewire has an outer diameter of 0.035" and an effective length of 260-300 cm. The proximal end of the disclosed guidewire does not contact the patient, it may be uninsulated, and it can be connected to an electrosurgical generator if desired.

[0120] The devices and methods disclosed herein may be used as is for other procedures, or may be modified as needed for a particular procedure. This procedure for cutting myocardium may be used as an adjunct to a variety of procedures. It will also be recognized that while a monopolar cutting system is disclosed, in certain implementations the system may be configured to operate in a bipolar configuration. During the myocardial ablation procedure, the system may be configured to deliver energy to the myocardium with electrosurgical pads, which are coupled to the patient to complete the circuit. When a structure such as myocardium is severed with a bent, bare cutting wire, most of the energy is dissipated into the patient.

[0121] 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 do not limit the scope of the present disclosure. Each and every patent and patent application referenced herein is incorporated by reference in its entirety for all purposes.

Claims

1. 1. A medical device comprising: an elongate tether having a proximal end and a distal end; a first tubular catheter surrounding the elongate tether and slidably displaceable along and relative to the elongate tether, the first tubular catheter having a proximal end and a distal end; a second tubular catheter surrounding the first tubular catheter and slidably displaceable along and relative to the first tubular catheter, the second tubular catheter having a proximal end and a distal end; and a third tubular catheter surrounding the second tubular catheter and slidably displaceable along and relative to the second tubular catheter, the third tubular catheter having a proximal end and a distal end; Medical equipment.

2. 10. The medical device of claim 1, further comprising an actuator assembly coupled to corresponding proximal ends of the elongate tether, the first tubular catheter, the second tubular catheter, and the third tubular catheter; Medical equipment.

3. 3. The medical device of claim 2, a tissue anchor operably coupled to the distal end of the elongate tether; and The actuator assembly includes a proximal anchor operably coupled to the proximal end of the elongate tether, and further includes: the proximal anchor is configured to apply tension to the elongate tether when the tissue anchor is anchored in tissue. Medical equipment.

4. 4. The medical device of claim 3, The actuator assembly further includes a first actuator operably coupled to a proximal end of the first tubular catheter; the first actuator is configured to advance and retract the first tubular catheter proximally and distally over the elongate tether; Medical equipment.

5. 5. The medical device of claim 4, The actuator assembly further includes a second actuator operably coupled to a proximal end of the second tubular catheter; the second actuator is configured to advance and retract the second tubular catheter proximally and distally over the first tubular catheter, and further The distal end of the second tubular catheter can be retracted proximally past the distal end of the first tubular catheter. Medical equipment.

6. 6. The medical device of claim 5, The actuator assembly further includes a third actuator operably coupled to a proximal end of the third tubular catheter; a third actuator configured to advance and retract the third tubular catheter proximally and distally over the second tubular catheter, and further the distal end of the third tubular catheter can be retracted proximally past the distal end of the first tubular catheter and the distal end of the second tubular catheter; Medical equipment.

7. 7. The apparatus of claim 6, At least one of the first tubular catheter, the second tubular catheter, and the third tubular catheter includes an active steering mechanism that allows a user to actively steer a distal end region of each of the catheters. Device.

8. 8. The apparatus of claim 7, each of the first tubular catheter, the second tubular catheter, and the third tubular catheter includes an active steering mechanism that allows a user to actively steer a distal end region of each of the catheters; Device.

9. 7. The apparatus of claim 6, each of the proximal anchor, the first actuator, the second actuator, and the third actuator is operably coupled to a corresponding delivery device; and further comprising: Each corresponding carriage is configured to slide on a common guide rail; a relative longitudinal position of each of the proximal anchor, the first actuator, the second actuator, and the third actuator is longitudinally adjustable along the common guide rail relative to other components mounted on the common guide rail; Device.

10. 10. The apparatus of claim 9, further comprising at least one cutting element disposed on at least one of the elongate tether, the first tubular catheter, the second tubular catheter, and the third tubular catheter; longitudinal movement of at least the cutting element relative to other components of the device causes the cutting element to cut through anatomical tissue adjacent to which the cutting element is placed; Device.

11. 10. The apparatus of claim 9, further comprising at least one electrode disposed on at least one of the elongate tether, the first tubular catheter, the second tubular catheter, and the third tubular catheter; longitudinal movement of the at least one electrode relative to another component of the device causes the at least one electrode to cut through the anatomical tissue adjacent to which the at least one electrode is positioned; Device.

12. 10. The apparatus of claim 9, further comprising at least one visualization marker disposed on at least one of the elongate tether, the first tubular catheter, the second tubular catheter, and the third tubular catheter; At least one of the visualization markers can be used to visualize the distal region of the device while inside the patient, thereby allowing a user of the device to determine the axial and rotational locations of different component systems relative to each other and the surrounding anatomical structures. Device.

13. 1. A method of performing a medical procedure, comprising: Provided is an apparatus according to claim 9, directing the device of claim 9 to a target location within a patient; placing the distal end of the third tubular catheter at a first location; placing the distal end of the second tubular catheter at a second location distal to the first location; placing the distal end of the first tubular catheter at a third location distal to the second location; and performing a therapeutic or diagnostic procedure using at least one of the first tubular catheter, the second tubular catheter, and the third tubular catheter; method.

14. 14. The method of claim 13, positioning a distal region of the third tubular catheter within the aortic arch of the patient; positioning a distal region of the second tubular catheter through the patient's heart valve; and manipulating the first tubular catheter to perform a therapeutic or diagnostic procedure; method.

15. 15. The method of claim 14, The therapeutic procedure involves cutting into the left ventricular outflow tract obstruction to increase the effective cross-sectional area of ​​the left ventricular outflow tract. method.

16. 14. The method of claim 13, The first tubular catheter comprises a microcatheter, and further comprises: In the method, directing the first tubular catheter into the patient's right ventricle, through the patient's septum, and into the patient's left ventricle; and cutting into the left ventricular outflow tract obstruction to increase the effective cross-sectional area of ​​the left ventricular outflow tract; method.

17. 14. The method of claim 13, The first tubular catheter comprises a delivery catheter, which delivers a beneficial agent or medical device to an anatomical location; method.

18. 14. The method of claim 13, the first tubular catheter includes a cutting element that cuts through the anatomical tissue; method.

19. 14. The method of claim 13, The diagnostic or therapeutic procedure is selected from the group consisting of a MIRTH procedure, a LAMPOON procedure, an ANTEPASTA procedure, an ELASTIC procedure, a robotic surgical procedure, a suture procedure or the delivery of a medical device; method.

20. 20. The method of claim 17 or 19, The medical device is selected from the group consisting of a stent and a prosthetic valve. method.

21. 14. The method of claim 13, The device is introduced into the patient via a femoral access point. method.

22. 14. The method of claim 13, The device is introduced into the patient via a jugular vein access point. method.

23. 14. The method of claim 13, The device is introduced into the patient through the wall of the heart via an apical access point. method.

24. 11. The apparatus of claim 10, At least one of the first actuator, the second actuator, and the third actuator a first gear that surrounds and is operatively coupled to a portion of a corresponding catheter; and a second toothed element selectively engageable with the first gear, wherein displacement of the second toothed element rotationally displaces the corresponding catheter; Device.

25. 25. The apparatus of claim 24, at least one of the first actuator, the second actuator, and the third actuator includes a displaceable cover that, when opened, disengages the first gear from the second toothed element to allow the corresponding catheter to rotate freely within the corresponding actuator; Device.

26. 25. The apparatus of claim 24, At least one of the first actuator, the second actuator, and the third actuator includes at least one irrigation port that directs fluid along the lumen of the corresponding catheter. Device.

27. 25. The apparatus of claim 24, at least one of the first actuator, the second actuator, and the third actuator includes at least one sealing bladder that seals against an outer surface of the corresponding catheter; Device.

28. In medical devices, an elongate body having a proximal end and a distal end; an elongated tether operably coupled to the elongated body, the elongated tether and the elongated body configured to be longitudinally displaceable relative to one another; an electrode disposed on at least one of the elongate body and the elongate tether; and and electrical circuitry operably coupled to the electrodes, the electrical circuitry configured to determine a condition of at least one of the medical device and an anatomical tissue. Medical equipment.

29. 30. The medical device of claim 28, The electrical circuitry is configured to detect an incoming signal from an anatomical tissue to confirm that the electrode is in physical contact with the anatomical tissue. Medical equipment.

30. 30. The medical device of claim 29, the signals coming from anatomical tissue include electrocardiogram signals from cardiac tissue; Medical equipment.

31. 30. The medical device of claim 28, the electrical circuitry is configured to detect a voltage or current drop across the electrodes after power is applied to the electrodes; Medical equipment.

32. 32. The medical device of claim 31, Relative longitudinal movement between the elongate tether and the elongate body causes the electrodes to cut through anatomical tissue adjacent to the device when the electrodes are energized; and The electrical circuitry is configured to correlate the voltage or current drop with a condition selected from the group consisting of: (1) the condition of the tissue to be cut by the electrode; and (2) the condition of the electrode fouling. Medical equipment.

33. 30. The medical device of claim 28, a pressure sensor located proximate to the electrode; The pressure sensor is operably coupled to a processing unit, and further comprising: the processing unit is programmed to determine at least one biological parameter based on receiving a signal from the pressure sensor. Medical equipment.

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