Transcatheter septal myotomy devices to improve LVOT patency and methods of use

Abstract

A transcatheter septal myotomy device includes a shaft (120) including a first lumen and a channel formed in a sidewall thereof, and an electrosurgical wire (150) slidably disposed through the first lumen of the shaft. A distal end (154) of the electrosurgical wire is coupled to a distal end (126) of the shaft. The electrosurgical wire is configured to transform from a straightened configuration wherein the electrosurgical wire is within the first lumen and the channel to a deployed configuration wherein the electrosurgical wire is axially translated such that a distal portion of the electrosurgical wire extends out of the channel. The electrosurgical wire is configured to be energized to splay tissue of a heart.

Description

TRANSCATHETER SEPTAL MYOTOMY DEVICES TO IMPROVE LVOT PATENCY AND METHODS OF USECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 625,585, filed January 26, 2024, and U.S. Provisional Patent Application Serial No. 63 / 675,281, filed July 25, 2024, the entire contents of which are incorporated herein by reference.FIELD

[0002] The present technology is related to transcatheter septal myotomy devices, and more specifically to transcatheter septal myotomy devices and methods for improving left ventricular outflow tract (LVOT) patency.BACKGROUND

[0003] The human heart is a four chambered, muscular organ that provides blood circulation through the body during a cardiac cycle. The four main chambers include the right atrium and right ventricle which supplies the pulmonary circulation, and the left atrium and left ventricle which supplies oxygenated blood received from the lungs to the remaining body. To ensure that blood flows in one direction through the heart, atrioventricular valves (tricuspid and mitral valves) are present between the junctions of the atria and the ventricles, and semi-lunar valves (pulmonary valve and aortic valve) govern the exits of the ventricles leading to the lungs and the rest of the body. These valves contain leaflets or cusps that open and shut in response to blood pressure changes caused by the contraction and relaxation of the heart chambers. The leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream manner.

[0004] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, whichcan be congenital, age-related, drug -induced, due to atrial or ventricular remodeling, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots, which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0005] Heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based systems. Heart valve prostheses can be delivered while in a low profile or compressed / collapsed arrangement so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0006] With some transcatheter heart valve prosthesis devices, particularly with mitral heart valve prostheses, the replacement heart valve prosthesis may lead to left ventricular outflow tract obstruction (LVOTO). Due to the potential for LVOTO, a significant number of patients may not be eligible for transcatheter mitral valve replacement (TMVR), with patient eligibility failure rates exceeding 50% for some current devices.

[0007] Another disease associated with the heart and affecting left ventricular outflow tract (LVOT) patency is hypertrophic cardiomyopathy, a disease in which the heart muscle becomes thickened. Hypertrophic cardiomyopathy affects the interventricular septum, which is the muscular wall between the two bottom chambers (ventricles) of the heart, which can obstruct LVOT blood flow during ventricular systole.

[0008] Accordingly, there remains a need for improved devices and methods to improve left ventricular outflow tract (LVOT) patency and reduce left ventricular outflow tract obstruction (LVOTO).BRIEF SUMMARY

[0009] In an example of the present application, a transcatheter septal myotomy device comprises: a shaft including a first lumen and a channel formed in a sidewall thereof; and a wire slidably disposed through the first lumen of the shaft, a distal end of the wire coupled to a distal end of the shaft. The wire is configured to transform from a straightened configuration wherein the wire is within the first lumen and the channel to a deployed configuration whereinthe wire is axially translated such that a distal portion of the wire extends out of the channel. The wire is configured to splay tissue of a heart.

[0010] In another example hereof, in the transcatheter septal myotomy device of any of the preceding or following examples, the distal portion of wire is pre-shaped to the deployed configuration.

[0011] In another example hereof, in the transcatheter septal myotomy device of any of the preceding or following examples, distal portion is substantially U-shaped in the deployed configuration.

[0012] In another example hereof, the transcatheter septal myotomy device of any of the preceding or following examples further comprises an anchor coupled to the distal end of the shaft.

[0013] In another example hereof, in the transcatheter septal myotomy device of any of the preceding or following examples, the anchor is a helical anchor.

[0014] In another example hereof, the transcatheter septal myotomy device of any of the preceding or following examples further comprises an electrode coupled to an outer surface of the shaft, wherein the electrode is configured to monitor electrical parameters of tissue of the interventricular septum to determine depth the shaft into the tissue.

[0015] In another example hereof, in the transcatheter septal myotomy device of any of the preceding or following examples, the electrode comprises a plurality of electrodes coupled to the outer surface of the shaft spaced longitudinally apart from each other.

[0016] In another example hereof, the transcatheter septal myotomy device of any of the preceding or following examples further comprises a second lumen extending through the shaft and a wire coupled to the electrode and extending through the second lumen.

[0017] In another example hereof, in the transcatheter septal myotomy device of any of the preceding or following examples, the electrode is radiopaque.

[0018] In another example hereof, in the transcatheter septal myotomy device of any of the preceding or following examples, the wire is an electrosurgical wire configured to be energized to splay tissue of the heart.

[0019] In another example hereof, in the transcatheter septal myotomy device of any of the preceding or following examples, the electrosurgical wire includes a coated portion and an uncoated portion, wherein the uncoated portion is configured to contact tissue with the electrosurgical wire in the deployed configuration.

[0020] In another example hereof, in the transcatheter septal myotomy device of any of the preceding or following examples, the wire comprises a plurality of wires.

[0021] In another example hereof, in the transcatheter septal myotomy device of any of the preceding or following examples, the plurality of wires comprise exactly two wires, wherein the two wires are spaced about 180 degrees apart around a circumference of the shaft.

[0022] In another example of the present application a method for performing a septal myotomy comprises: transluminally delivering septal myotomy device to a left ventricle of a heart until a distal end of a shaft of the septal myotomy device is adjacent an interventricular septum at a desired location; anchoring the septal myotomy device within the tissue of the interventricular septum at a desired location; deploying a wire of the septal myotomy device such that a portion of the wire abuts against and / or is embedded within the tissue of the interventricular septum to splay the tissue of the interventricular septum.

[0023] In another example hereof, in the method of any of the preceding or following examples, anchoring the septal myotomy device comprises deploying an anchor into the tissue.

[0024] In another example hereof, in the method of any of the preceding or following examples, deploying the anchor comprises rotating the shaft to rotate a helical anchor at the distal end of the shaft.

[0025] In another example hereof, in the method of any of the preceding or following examples, deploying the wire comprises distally pushing the wire relative to the shaft such that a distal portion of the wire exits a channel of the shaft.

[0026] In another example hereof, in the method of any of the preceding or following examples, deploying the wire further comprises the wire deploying to a pre-set shape due to the distal portion of the wire being formed from a shape set material.

[0027] In another example hereof, in the method of any of the preceding or following examples, the pre-set shape is substantially U-shaped.

[0028] In another example hereof, the method of any of the preceding or following examples further comprises monitoring an electrical parameter of tissue of the interventricular septum to monitor depth of the shaft into the tissue.

[0029] In another example hereof, in the method of any of the preceding or following examples, transluminally delivering septal myotomy device to a left ventricle of a heart comprises delivering the septal myotomy device prior to implanting a mitral valve prosthesis to reduce the risk of left ventricular outflow tract obstruction.

[0030] In another example hereof, in the method of any of the preceding or following examples, the wire is an electrosurgical wire, and the method further comprises energizing the deployed electrosurgical wire to splay the tissue of the interventricular septum.

[0031] In another example of the present application, a method of treating hypertrophic cardiomyopathy comprising splaying tissue of an interventricular septum using any of the methods of preceding examples. In another example hereof, in the method of any of the preceding or following examples, deploying the wire comprises deploying a plurality of wires.

[0032] In another example hereof, in the method of any of the preceding or following examples, deploying the plurality of wires comprises deploying exactly two wires spaced about 180 degrees apart around a circumference of the shaft.

[0033] In another example of the present application, a transcatheter pericardial transection device comprises: a shaft including a first lumen and a channel formed in a sidewall; an anchor configured to stabilize the pericardial transection device within a pericardial cavity of a heart; a wire slidably disposed through the first lumen of the shaft, a distal end of the wire coupled to a distal end of the shaft. The wire is configured to transform from a straightened configuration when the wire is within the first lumen and the channel to a deployed configuration when the wire is axially translated such that a distal portion of the wire extends out of the channel and is configured to splay tissue of a heart.

[0034] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, the distal portion of the wire is pre-shaped to the deployed configuration.

[0035] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, the distal portion is substantially U-shaped in the deployed configuration.

[0036] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, the anchor is coupled to a distal end of the shaft.

[0037] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, the anchor comprises a helical anchor.

[0038] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, the anchor comprises an expandable frame.

[0039] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, the anchor comprises an expandable balloon.

[0040] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, the anchor comprises a helix or wrap.

[0041] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, the anchor comprises a plurality of splines configured to radially expand from the shaft.

[0042] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, further comprises a radiopaque marker coupled to the shaft.

[0043] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, the wire is an electrosurgical wire configured to be energized to splay tissue of the heart.

[0044] In another example hereof, in the transcatheter septal pericardial transection device of any of the preceding or following examples, the electrosurgical wire includes a coated portion and an uncoated portion, wherein the uncoated portion is configured to contact tissue with the electrosurgical wire in the deployed configuration.

[0045] In another example of the present application a method for performing a pericardial transection comprises: transluminally delivering pericardial transection device to a pericardial cavity of a heart until a distal portion of a shaft of the pericardial transection device is adjacent a pericardium at a desired location; stabilizing the pericardial transection device within the pericardial cavity at a desired location; and deploying a wire of the pericardial transection device such that a portion of the wire abuts against and / or is embedded within a tissue of the pericardium to splay the tissue of the pericardium.

[0046] In another example hereof, in the method of any of the preceding or following examples, stabilizing the pericardial transection device comprises deploying an anchor to engage tissue surrounding the pericardial cavity.

[0047] In another example hereof, in the method of any of the preceding or following examples, deploying the anchor comprises radially expanding an expandable member such that the expandable member engages tissue surrounding the pericardial cavity.

[0048] In another example hereof, in the method of any of the preceding or following examples, the expandable member is a balloon and radially expanding the expandable member comprises delivering inflation fluid to an interior of the balloon.

[0049] In another example hereof, in the method of any of the preceding or following examples, the expandable member comprises a self-expanding material and radially expanding the expandable member comprises releasing the expandable member from a constraining element to enable the expandable member to self-expand to a radially expanded configuration.

[0050] In another example hereof, in the method of any of the preceding or following examples, deploying the wire comprises distally pushing the wire relative to the shaft such that a distal portion of the wire exits a channel of the shaft.

[0051] In another example hereof, in the method of any of the preceding or following examples, deploying the wire further comprises the wire deploying to a pre-set shape due to the distal portion of the wire being formed from a shape set material.

[0052] In another example hereof, in the method of any of the preceding or following examples, the pre-set shape is substantially U-shaped.

[0053] In another example hereof, in the method of any of the preceding or following examples, the wire is an electrosurgical wire, and the method further comprises energizing the deployed electrosurgical wire to splay the tissue of the pericardium.

[0054] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0055] The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the present disclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure. The drawings are not to scale.

[0056] FIG. 1 depicts a side view of a transcatheter septal myotomy device according to embodiments hereof.

[0057] FIG. 2A depicts a cross-sectional view taken along line A-A of FIG. 1.

[0058] FIG. 2B depicts a cross-sectional view taken along line B-B of FIG. 1

[0059] FIG. 3 depicts an exploded view of the transcatheter septal myotomy device of FIG. 1.

[0060] FIG. 4 depicts a side view of a distal portion of an inner shaft of the transcatheter septal myotomy device of FIG. 1.

[0061] FIG. 5 depicts an illustration of a bioelectric impedance system for use with an internal electrode of the transcatheter septal myotomy device of claim 1, according to embodiments hereof.

[0062] FIG. 6 depicts a side view of a distal portion of an inner shaft of a septal myotomy device according to embodiments hereof.

[0063] FIG. 7 is a flow chart depicting a method for performing a septal myotomy with the transcatheter septal myotomy device 100, according to embodiments hereof.

[0064] FIG. 8 depicts a distal end of a guide catheter disposed within a left ventricle of a heart.

[0065] FIG. 9 depicts the transcatheter septal myotomy device of FIG. 1 extending through the guide catheter and an anchor of the transcatheter septal myotomy device disposed at a desired location adjacent an interventricular septum of the heart.

[0066] FIG. 10 depicts the transcatheter septal myotomy device of FIG. 1 with a distal portion thereof fixed anchored to the interventricular septum of the heart.

[0067] FIG. 11 depicts the transcatheter septal myotomy device of FIG. 1 with an electrosurgical wire rotationally oriented with an apex of a left ventricle of a heart.

[0068] FIG. 12 depicts the transcatheter septal myotomy device with an electrosurgical wire in a deployed configuration.

[0069] FIG. 13 depicts a cross-section of a left ventricle illustrating opened or spayed tissue of the interventricular septum following a septal myotomy procedure of the transcatheter septal myotomy device of claim 1.

[0070]

[0071] FIGS. 14 depicts a distal end of a guide catheter disposed within a left ventricle of a heart.

[0072] FIG. 15 depicts the transcatheter septal myotomy device of FIG. 1 extending through the guide catheter and an anchor of the transcatheter septal myotomy device disposed at a desired location adjacent an interventricular septum of the heart.

[0073] FIG. 16 depicts the transcatheter septal myotomy device of FIG. 1 with a distal portion thereof fixed anchored to the interventricular septum of the heart.

[0074] FIG. 17 depicts the transcatheter septal myotomy device of FIG. 1 with an electrosurgical wire rotationally oriented with an apex of a left ventricle of a heart.

[0075] FIG. 18 depicts the transcatheter septal myotomy device of FIG. 1 with an electrosurgical wire in a deployed configuration.

[0076] FIG. 19 depicts the transcatheter septal myotomy device of FIG. 1 with the anchor removed from the interventricular septum of the heart.

[0077] FIG. 20 depicts a side view of a transcatheter septal myotomy device according to embodiments hereof.

[0078] FIG. 21A depicts a cross-sectional view taken along line A-A of FIG. 20.

[0079] FIG. 2 IB depicts a cross-sectional view taken along line B-B of FIG. 20.

[0080] FIG. 22 depicts an exploded view of the transcatheter septal myotomy device of FIG. 20.

[0081] FIG. 23 depicts a side view of a distal portion of an inner shaft of the transcatheter septal myotomy device of FIG. 20.

[0082] FIGS. 24-29 depict steps in the method of FIG. 7 for performing a septal myotomy with the transcatheter septal myotomy device of FIG. 20 according to embodiments hereof.

[0083] FIG. 30 depicts a side view of a transcatheter pericardial transection device according to embodiments hereof.

[0084] FIG. 31A depicts a cross-sectional view taken along line A-A of FIG. 30.

[0085] FIG. 3 IB depicts a cross-sectional view taken along line B-B of FIG. 30.

[0086] FIG. 32 depicts an exploded view of the transcatheter pericardial transection device of FIG. 30.

[0087] FIG. 33 depicts a side view of a distal portion of an inner shaft of the transcatheter pericardial transection device of FIG. 30.

[0088] FIGS. 34A-34D depict anchors of the transcatheter pericardial transection device of FIG. 30 according to embodiments hereof.

[0089] FIG. 35 is a flow chart depicting a method for performing a pericardial transection with the transcatheter pericardial transection device of FIG. 30 according to embodiments hereof.

[0090] FIGS. 36-40 depict steps in the method of FIG. 35 for performing a pericardial transection with the transcatheter pericardial transection device of FIG. 30 according to embodiments hereof.DETAILED DESCRIPTION OF THE INVENTION

[0091] Specific embodiments of the present disclosure are now described with reference to the figures wherein like reference numbers indicate identical or functionally similar elements. The following detailed description describes examples of embodiments of the invention and is not intended to limit the present technology or the application and uses of the present technology. Although the description of embodiments hereof is in the context of a mitral heart valve prosthesis, the present technology may also be used in other valve prostheses. For example, embodiments of bridge skirts described herein may be utilized with a heart valve prosthesis configured for placement within a pulmonary, aortic, mitral, or tricuspid valve, or may be utilized with a valve prosthesis configured for placement within a venous valve or within other body passageways where it is deemed useful. Furthermore, there is no intentionto be bound by any expressed or implied theory presented in the preceding Field, Background, Brief Summary, or the following Detailed Description.

[0092] The terms “distal” and “proximal,” when used in the following description to refer to a native vessel, native valve, or a device to be implanted into a native vessel or native valve, such as a heart valve prosthesis, are with reference to the direction of blood flow. Thus, “distal” and “distally” refer to positions in a downstream direction with respect to the direction of blood flow, and the terms “proximal” and “proximally” refer to positions in an upstream direction with respect to the direction of blood flow. The terms “distal” and “proximal,” when used in the following description to refer to a catheter or similar device, such as a transcatheter septal myotomy device, are with reference to a position or direction relative to the treating clinician or handle of the catheter. Thus, “distal” and “distally” refer to positions distant from or in a direction away from the clinician or handle and “proximal” and “proximally” refer to positions near or in a direction toward the clinician or handle.

[0093] In addition, the term “pre-shaped” or “self-expanding” is used in the following description with reference to electrosurgical wires is intended to convey that a distal portion of the electrosurgical wires are shaped or formed from a material that can be provided with a mechanical memory to return a desired shape when released from a constricted configuration.

[0094] Embodiments disclosed herein are directed to transcatheter septal myotomy devices configured to cut or splay tissue of the interventricular septum. Cutting or splaying tissue of the interventricular septum may improve left ventricular outflow tract (LVOT) and neo-LVOT patency from a baseline. The transcatheter septal myotomy devices describe herein may be utilized to improve left ventricular outflow tract (LVOT) patency and reduce left ventricular outflow tract obstruction (LVOTO) in patients with, for example, and not by way of limitation, hypertrophic cardiomyopathy, or a transcatheter mitral valve replacement (TMVR). The transcatheter septal myotomy devices described herein include an outer sheath, an inner shaft including an anchor, a wire, and an electrode. An uncoated segment of a distal portion of the wire is configured to abut against and / or embed within tissue of the interventricular septum of a heart when the wire is in the deployed configuration to cut the tissue. In some embodiments, the wire is an electrosurgical wire configured to deliver radiofrequency energy (RF) to cut the tissue. The electrode is configured to provide interventricular septum depth information. The depth, shape, and length of the uncoated segment of the electrosurgical wire provide flexibility to accommodate different anatomies.

[0095] FIGS. 1-5 illustrate a transcatheter septal myotomy device 100 according to embodiments hereof. One skilled in the art will realize that FIGS. 1-5 illustrate one exampleof a transcatheter septal myotomy device and that existing components illustrated in FIGS. 1- 5 may be removed and / or additional components may be added to the transcatheter septal myotomy device 100. The transcatheter septal myotomy device 100 includes a shaft 120, an anchor 142, a wire 150, and an electrode 170. Although described herein as being an electrosurgical wire 150 energized to cut tissue, in other embodiments, the wire 150 need not be energized, and the distal end of the wire 150 being embedded in the tissue when the wire 150 is deployed causes the wire 150 to cut the tissue, without being energized. The transcatheter septal myotomy device 100 is configured to cut or splay tissue at an interventricular septum of a heart to reduce left ventricular outflow tract obstruction (LVOTO). FIG. 1 is a side view of the transcatheter septal myotomy device 100. FIG. 2A is a cross-sectional view taken along line A-A of FIG. 1, and FIG. 2B is a cross-sectional view taken along line B-B of FIG. 1. FIG. 3 is an exploded view of the shaft 120 and the wire 150. FIG. 4 is a side view of a distal portion of the shaft 120 of the transcatheter septal myotomy device 100 with the wire 150 in a deployed configuration. FIG. 5 is an illustration of a bioelectric impedance system BIS configured for use with the electrode 170.

[0096] The shaft 120 distally extends from a proximal end 122 coupled to a handle or luer 124 to a distal end 126, as best shown in FIG. 1. The shaft 120 is configured to be slidably disposed and tracked within a guide catheter or outer sheath, as described below. As used herein, the term “slidably” denotes back-and-forth movement in a longitudinal direction, along or generally parallel to a central longitudinal axis LA of the transcatheter septal myotomy device 100. The handle 124 may have any shape or size appropriate for convenient handling and manipulation by a user. A tapered nose cone or distal tip 128 may be coupled to the distal end 126 of the inner shaft 120 as shown in FIG. 3. In the embodiment shown, the shaft 120 is a solid shaft with lumens as described below. However, this is not meant to be limiting, and the shaft 120 may include other lumens. For example, and not by way of limitation, the shaft 120 may include a central lumen (not shown). Such a central lumen may be used for any purpose, for example, and not by way of limitation, as a guidewire lumen, or a coaxial coil to aid in torque transmission.

[0097] The shaft 120 further includes a proximal portion 130 and a distal portion 132. The proximal portion 130 is disposed proximal of the distal portion 132 and distally extends from the proximal end 122 to a distal end 140 of the proximal portion 130. A first lumen 134 extends through the proximal portion 130 of the shaft 120, as shown in FIG. 2A. A first channel 138 extends through the distal portion 132 of the shaft 120, as shown in FIG. 2B, and is in fluid communication with the first lumen 134. A second lumen 136 extends through the proximalportion 130 and the distal portion 132 of the shaft 120, as shown in FIGS. 2A and 2B. In embodiments, the second lumen 136 is disposed through the shaft 120 opposite the first lumen 134 and the first channel 138. In embodiments, the shaft 120 may be a flexible, elongated tubular body that may include, for example, a flexible metal matrix or braided catheter disposed within a polymer jacket.

[0098] The first lumen 134 extends from the proximal end 122 of the shaft 120 to the distal end 140 of the proximal portion 130 of the inner shaft 120, as shown in FIG. 1. The first lumen 134 is configured to slidably receive a proximal portion of the wire 150. The first channel 138 extends from a proximal end 141 of the distal portion 132 to the distal end 126 of the shaft 120 in a sidewall of the shaft 120. The first channel 138 is open to an outer surface of the shaft 120 and is configured to releasably receive a distal portion of the wire 150. In embodiments herein, the first lumen 134 and the first channel 138 are each configured such that the wire 150 may be disposed within the first lumen 134 and the first channel 138 from the proximal end 122 of the shaft 120 to the distal end 126 of the shaft 120.

[0099] The second lumen 136 extends from the proximal end 122 of the shaft 120 to the electrode 170. The second lumen 136 is configured to retain a wire, cable, or conductive medium 172 therein, such that the electrode 170 may be in electrical communication with a power supply external to the transcatheter septal myotomy device 100 as described below. While FIGS. 1-4 include the second lumen 136, this is not meant to limit the design and other configurations may be utilized. For example, and not by way of limitation, the wire 172 may be integrated into the wall of the shaft 120.

[0100] Although the first lumen 134 and the second lumen 136 are each depicted in FIGS. 2A-2B as circular in cross-section, this is not meant to be limiting, and other configurations may be utilized, including, but not limited to elliptical, crescent shaped, or other configurations suitable for the purposes described herein.

[0101] The shaft 120 may include the distal tip 128 and the anchor 142, as best shown in FIG. 4. In an embodiment, the distal tip 128 is a tapered, frusto-conical cylinder, disposed at and sealing the distal end 126 of the shaft 120. The anchor 142 distally extends from the distal tip 128 and is configured to burrow into septal myocardial tissue to releasably fix, or secure, or couple the transcatheter septal myotomy device 100 to the interventricular septum. In the embodiment of FIGS. 1-4, the anchor 142 is a helix or corkscrew including a proximal end 144 and a distal end 146. In the embodiment of FIG. 4, the anchor 142 includes a right-handed pitch. However, this is not meant to be limiting, and the anchor 142 may have a left-handed pitch, and may include a constant or uniform pitch, or a non-uniform pitch. The anchor 142may be formed, for example, and not by way of limitation, by machining, laser, cutting, or any other methods suitable for the purposes described herein. The anchor 142 may be coupled to the distal tip 128by various methods, including, but not limited to adhesives, welding, or any other suitable method. While described herein as a helix or corkscrew, this is not meant to be limiting, and the anchor 142 may utilize other configurations suitable for purposes described herein. Further, although the anchor 142 has been described as attached to the distal end of the shaft 120, in other embodiments, the anchor 142 may include a wire or coil (not shown) extending through the shaft 120 in another lumen (not shown) to an actuator (not shown) on the handle 124 such that the anchor 142 may be rotated relative to the shaft 120 to releasably fix, or secure, or couple the transcatheter septal myotomy device 100 to the interventricular septum, as described below. While described herein with the anchor 142 extending from the distal tip 128, this is not meant be limiting, and in an embodiment the distal tip 128 may be configured to act as an anchor (such as but not limited to coming to a point or being shaped as a helical or corkscrew pattern) such that the distal tip 128 itself burrows into septal myocardial tissue, thereby alleviating the need for an anchor.

[0102] The wire 150 includes a proximal end 152 and a distal end 154 as shown in FIG. 3. The proximal end 152 may be coupled to an actuator 180 that is disposed at the handle 124 such that actuating the actuator 180 may translate the proximal end 152 of the wire 150 within the first lumen 134, as described below. The distal end 154 of the wire 150 is fixed or coupled to the distal end 126 of the shaft 120. The distal end 154 of the wire 150 may be coupled to the distal end 126 of the shaft 120 by methods such as, but not limited to adhesives, mechanical coupling, welding, or any other method suitable for the purposes described herein. The wire 150 includes a proximal portion 156 and a distal portion, which may be a pre-shaped distal portion 158. The proximal portion 156 of the wire 150 is slidably disposed within the first lumen 134. The proximal portion 156 and a portion of the pre-shaped distal portion 158 includes a coating 160 to focus radiofrequency energy to the distal uncoated segment 162, as well as help prevent damage to adjacent tissue, the first lumen 134, and the first channel 138 from heat generated by application of radiofrequency (RF) energy to the wire 150. The coating 160 may be any coating to protect against such electrification, such as, but not limited to, a polymer jacket. The pre-shaped distal portion 158 includes an uncoated or operative segment 162, which is configured to enable the uncoated segment 162 to cut or splay tissue which it contacts, such as the tissue of interventricular septum, upon application of radiofrequency (RF) energy to the wire 150.

[0103] The pre-shaped distal portion 158 may be formed of a shape memory material with a preset shape that is configured to assume a straightened configuration when acted on by an outside force and a deployed configuration when released from such an outside force. For example, and not by way of limitation, the pre-shaped distal portion 158 may assume the straightened configuration when disposed within a lumen or channel, such as the first lumen 134 or the first channel 138, or when acted upon by a tensile force. In the present embodiment, for example, a tensile force may be applied to the wire 150 by moving the actuator 180 proximally. With the distal end 154 of the wire 150 fixed to the distal end 126 of the shaft 120, pulling the proximal end 152 of the wire 150 proximally via the actuator 180 applies a tensile force and straightens the pre-shaped distal portion 158 of the wire 150. Such straightening is further assisted by the wire 150, and in particular the pre-shaped distal portion 158 thereof, being disposed in the first lumen 134 and / or the first channel 138. When the tensile force is released and / or an axial compressive force is applied, such as by moving the actuator 180 distally, the pre-shaped distal portion 158 is released from the first channel 138 and assumes the deployed configuration.

[0104] In the deployed configuration, the pre-shaped distal portion 158 may have a variety of shapes based on pre-op planning. For example, and not by way of limitation, the size and shape of the pre-shaped distal portion 158 may be varied depending on the desired size of the myotomy desired. In embodiments of FIG. 3, the pre-shaped distal portion 158 is substantially U-shaped with a curve or bend formed between a coated segment 160 and a non-coated segment 162 when in the deployed, as best shown in FIG. 4.

[0105] Although described as pre-shaped, in other embodiments, the distal portion 158 need not be pre-shaped. In such an embodiment, pushing the wire 150 out of the first channel 138 with the distal end 154 fixed to the shaft 120 causes the distal portion to assume the deployed configuration.

[0106] The wire 150 may be formed of various materials, such as, but not limited to nickeltitanium alloys (e.g., Nitinol), nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N), stainless steel, high spring temper steel, or any other conductive and / or sufficiently stiff material suitable for the purposes describe herein.

[0107] In embodiments herein, the wire 150 utilizes radiofrequency (RF) energy to cut or splay abutting tissue of the interventricular septum when the electrosurgical wire 150 is energized with radiofrequency (RF) energy is activated. As will be understood by those skilled in the art, radiofrequency (RF) energy may be applied to the wire 150 to vaporize or cause sufficient heating to cut tissue of the interventricular septum abutting or in contact with thenon-coated segment 162 of the distal portion 158. In embodiments herein, the wire 150 may include a diameter in the range of 0.024” to 0.050”. However, this is not meant to be limiting, and the wire 150 may include various diameters suitable for the purposes described herein. The wire 150 is energized by the application of radiofrequency (RF) energy from a generator GE, as shown in FIG. 1.

[0108] In embodiments shown in FIG. 1, the wire 150 extends proximally from the distal end 126 of the inner shaft 120 through the first channel 138 and the first lumen 134 to the actuator 180. The proximal end 152 ofthe wire 150 may be electrically coupled to the generator GE, such as by another wire . In other embodiments, the wire 150 may be coupled to the actuator 180, but also continued through the handle 124 such that the proximal end 152 of the wire 150 is coupled to the generator GE. It is understood that additional components (e.g., cables, connectors, etc.) not illustrated in FIG. 1 may be included to facilitate electrical communication between the proximal end 152 of the wire 150 and the generator GE. As will be understood by those skilled in the art, the generator GE must be of suitable output power, frequency range, and duty cycle for the purposes described herein. The generator GE may include additional equipment such as, but not limited to dispersive electrodes, timers, and various configurations of activation or on / off switches. The septal myotomy device 100 may include an on / off switch that controls power delivery via the generator GE.

[0109] In embodiments herein, the electrode 170 is a conductor, through which electricity enters or leaves. In an embodiment, the electrode 170 is disposed on an outer surface of the shaft 120 opposite the first channel 138. The electrode 170 is part of a bioelectric impedance system BIS, shown in FIG. 5 and described below. The electrode 170 may be an electrically conductive electrode fabricated from a variety of conductive materials, non-limiting examples of which include titanium, platinum, platinum-iridium, cobalt, iron, chromium, molybdenum, nickel, manganese, carbon, stainless steel, copper, silver, gold and alloys, and combinations thereof. In an embodiment, the electrode 170 may be formed of radiopaque materials, such as, but not limited to gold, platinum, or tantalum and configured to provide visual cues regarding rotational orientation of the distal end 126 of the shaft 120 to a treating clinician.

[0110] As illustrated in FIG. 1, a distal end 174 of the wire 172 is coupled to the electrode 170. The wire 172 extends proximally from the electrode 170 through the second lumen 136, through the handle 124 exiting through a proximal port 176 to a power source PS of the bioelectric impedance system BIS. The wire 172 is configured such that the electrode 170 may be in electrical communication with the power source PS external to the transcatheter septal myotomy device 100. The bioelectric impedance system BIS is configured to monitorimpedance of tissue of the interventricular septum. In an embodiment, the bioelectric impedance system BIS may include the electrode 170, an external electrode EE, and an impedance monitor IM. The external electrode EE may be placed externally on the patient’s skin as shown in FIG. 5. The power source PS generates an electric current through the patient’s tissue between the electrode 170 and the external electrode EE. While current is flowing through the electrode 170 and the external electrode EE, a corresponding resistance or voltage drop is measured between the electrode 170 and the external electrode EE and the voltage drop is arithmetically converted to an impedance measurement at the impedance monitor IM. The impedance monitor IM may be configured to analyze, store, and display bioelectric information derived from the electrode 170 and the external electrode EE. Blood is a good conductor with relatively low impedance compared to tissue. Thus, when the electrode 170 penetrates tissue of the interventricular septum, the impedance detected between the electrode 170 and the external electrode EE, and displayed at the impedance monitor IM will increase, denoting crossing from the bloodstream into tissue of the interventricular septum. In embodiments herein, the electrode 170 is disposed a first distance DI from the distal end 126 of the shaft 120, as shown in FIG. 4. In a nonlimiting example, the first distance DI may be in the range of 6mm - 12mm. Accordingly, the bioelectric impedance system BIS may be utilized to monitor depth of the distal end 126 of the shaft 120 within tissue of the interventricular septum. In other embodiments, instead of the external electrode EE, a second electrode (not shown) may be disposed on the shaft 120 and spaced proximally from the electrode 170. In such an embodiment, the impedance difference from the electrode 170 penetrating into tissue of the interventricular septum while the second electrode remains in the blood stream in the left ventricle, or proximal of the interventricular septum, is detected by the bioelectric impedance system BIS. While described herein with the bioelectric impedance system BIS detecting an change in impedance to denote crossing from the bloodstream into tissue of the interventricular septum, this is not meant to be limiting, and in an embodiment septal engagement of the transcatheter septal myotomy device 100 may be determined by other methods including, but not limited to, use of myocardium pacing to cause ventricular polarization or capture at septal engagement, or the power supply PS could receive and the impedance monitor IM could display the local electrogram from the electrode 170, and the morphology of the signal could be analyzed to determine engagement with the septum.

[0111] While the bioelectric impedance system BIS of FIG. 5 is described herein with the electrode 170, the external electrode EE, the power source PS, and the impedance monitor IA, this is not meant to be limiting, and the bioelectric impedance system BIS may includeadditional components, including, but not limited to external monitors, shut off, switches, alarms, or other components suitable for the purposes described herein. For example, and not by way of limitation, the bioelectric impedance system BIS may be similar to pacing system analyzers used in the cardiac rhythm field to assess pacemaker leads. It is understood that additional components (e.g., cables, connectors, etc.) not illustrated in FIG. 1 may be included to facilitate electrical communication between a proximal end of the wire 172 and the impedance monitor IM.

[0112] Although described herein with one (1) electrode 170, this is not meant to be limiting, and the shaft 120 may include a plurality of internal electrodes. In an embodiment shown in FIG. 6, a shaft 220 is similar to the shaft 120 in all aspects, except the inner shaft 220 includes three (3) electrodes 270A, 270B, 270C. The first electrode 270A is disposed a first distance DI from a distal end 226 of the shaft 220. The second electrode 270B is disposed a second distance D2 from the distal end 226 of the shaft 220, and the third electrode 270C is spaced a third distance D3 from the distal end 226 of the shaft 220. The shaft 220 offers increased patient flexibility with three depth indicators associated with the electrodes 270A, 270B, and 270C. Accordingly, the shaft 220 may be utilized on a wider range of patients with different desired penetration depths.

[0113] With an understanding of the components of the transcatheter septal myotomy device 100 above, the interactions of the various components and methods for using the transcatheter septal myotomy device 100 to cut or splay tissue of the interventricular septum to thereby improve blood flow through the left ventricle outflow tract (LVOT) are described with respect to FIGS. 7-19. FIG. 7 is a flow chart showing a method 700 for performing a transcatheter septal myotomy with the transcatheter septal myotomy device 100. FIGS. 8-13 shows steps of the method 700 using the septal myotomy device 100 after implantation of a transcatheter mitral heart valve prosthesis TMV to enlarge the neo-LVOT. FIGS. 14-19 shows steps of the method 700 using the septal myotomy device 100 for treatment of hypertrophic cardiomyopathy or other conditions that cause a septal bulge impeding the LVOT. The embodiment of FIGS. 14-19 may also be used to enlarge the LVOT before a transcatheter mitral valve prosthesis is implanted. In each situation, the transcatheter septal myotomy device 100 is configured to reduce left ventricle outflow tract obstruction (LVOTO). One skilled in the art will realize that FIGS. 7-19 illustrate one example of a method of using transcatheter septal myotomy device and that certain steps of the method may be removed or combined, and that additional steps of the method may be performed in keeping with scope of the present disclosure.

[0114] In a step 702 of the method 700, a guide catheter 300 or other sheath is tracked through the vasculature of a patient with a distal end thereof disposed within a left ventricle LV of a heart HE, as shown in FIGS . 7 and 14. In the embodiment of FIG. 7, the guide catheter 300 is tracked through the transcatheter heart valve prosthesis TMV. In the embodiment of FIG. 14, the guide catheter 300 is tracked through a native mitral heart valve. However, it will be understood that the guide catheter 300 may instead be tracked through a native aortic heart valve to reach the left ventricle.

[0115] In a step 704 of the method 700, the transcatheter myotomy device 100 is tracked through the guide catheter 300 such that the distal end thereof is disposed adjacent to and abutting a desired portion of the interventricular septum IVS of the left ventricle LV, as shown in FIGS. 9 and 15.

[0116] In a step 706 the method 700, the shaft 120 of the transcatheter myotomy device 100 is rotated in the first rotational direction RD 1 such that the anchor 142 burrows into myocardial tissue of the interventricular septum IVS, as illustrated in FIGS. 10 and 16. The shaft 120 is rotated in the first rotational direction RD1 until the distal end 126 of the shaft 120 is disposed within tissue of the interventricular septum IVS to a desired depth DI. More specifically, the shaft 120 is rotated in the first rotational direction RD1 to engage the anchor 142 with tissue of the interventricular septum IVS, and rotation of the shaft 120 in the first rotational direction RD1 is continued to burrow the anchor 142 and a distal segment 127 of the shaft 120 into the interventricular septum IVS to the desired depth (distance) DI. The desired depth DI is the distance between the distal end 126 of the shaft 120 and a distal end of the electrode 170. The desired distance DI is calculated in pre-op planning prior to the procedure such that the shaft 120 with the desired distance DI may be selected. The electrode 170 provides depth information to the treating clinician via the bioelectric impedance system BIS. When the bioelectric impedance system BIS indicates the shaft 120 has engaged the interventricular septum IVS to the desired depth DI, the treating clinician ceases rotation of the shaft 120.

[0117] In a step 706 of the method 700, the shaft 120 is rotationally oriented by rotating the shaft 120 in the first direction RD1 or a second direction RD2 opposite the first direction RD1 such that the distal end 154 of the wire 150 is oriented in a desired direction, as shown in FIGS. 11 and 16. For example, in an embodiment the desired direction is generally towards an apex AX of the left ventricle LV. However, in other embodiments, such as if the anchor 142 is deployed below the desired cut, the desired direction may be generally towards the aortic valve AV. Further, as used herein, the term “generally towards” does not mean directly towards, just that overall it is towards the noted direction rather than the opposite direction. In someembodiments, the radiopacity of the electrode 170 provides visual cues to the treating clinician regarding the rotational orientation of the shaft 120.

[0118] In a step 708 of the method 700, with the shaft properly position and fixed to the interventricular septum IVS at the desired depth, the wire 150 is distally advanced through the first lumen 136 such that the distal portion 158 of the wire 150 deploys from the first channel 138 and in a direction generally towards the apex AX of the left ventricle LV, as shown in FIGS. 12 and 17. As the distal portion 158 deploys out of the first channel 138, the distal portion 158 assumes the pre-shaped (deployed) configuration, as explained above. In a step 710, the generator GE is activated to energize the wire 150 such that the uncoated segment 162 of the distal portion 158 of the wire 150 cuts tissue of the interventricular septum IVS to the desired depth and length, and direction, as shown in FIGS. 12 and 17. While the uncoated segment 162 is described in the step 710 as cutting tissue of the interventricular septum IVS to the desired depth, length and direction, it should be understood that the uncoated segment 162 of the distal portion 158 of the wire 150 may cut through the entire desired depth and length of the interventricular septum IVS, or the uncoated segment 162 of the distal portion 158 of the wire 150 may cut through a portion of the interventricular septum IVS to initiate cutting and the coated segment 160 of the distal portion 158 of the wire 150 may finish the cut through the remaining interventricular septum IVS to achieve the desired depth and length. In embodiments, the steps 708 and 710 may be performed simultaneously or either one before or after the other one.

[0119] The desired depth and the desired laceration or incision length of may be determined in pre-op planning and the transcatheter septal myotomy device 100 may be correspondingly configured. In a non-limiting example, the first length LI of the incision may be in the range of 16mm - 35mm. The tissue of the interventricular septum is not excised or removed, rather the laceration, cut, or incision opens or splays tissue as illustrated by 190 in FIG. 13. Thus, the depth and length of the incision may be controlled by the shape memory of the pre-shaped distal portion 158 of wire 150 and the depth to which the distal end 126 of the shaft 120 is inserted into the tissue of the interventricular septum. The splaying of tissue 190 of the interventricular septum IVS increases available volume within the left ventricle outflow tract (LVOT), and accordingly improves left ventricular outflow tract (LVOT) patency and blood flow to an aortic valve AV.

[0120] In a step 712 of the method 700, the wire 150 is deenergized by deactivating the generator GE. This terminates cutting of the tissue.

[0121] In a step 714 of the method 700, the wire 150 is proximally retracted such that the pre-shaped distal portion 158 transitions from the deployed configuration to the straightened configuration within the first channel 138 and the first lumen of the shaft 120. In a step 716 of the method 700, the shaft 120 is rotated in the second rotational direction RD2 to disengage the shaft 120 from tissue of the interventricular septum IVS of the heart HE. FIG. 19 shows the transcatheter myotomy device 100 after steps 714 and 716.

[0122] In a step 718, the transcatheter myotomy device 100 is proximally and removed from the patient.

[0123] Although the transcatheter myotomy device 100 is described herein with a single wire 150, this is not meant to be limiting. In other embodiments, the transcatheter myotomy device 100 may include more than one wire 150. For example, in an embodiment, the transcatheter myotomy device 100 may include two wires 150 disposed in lumens and channels opposite each other around the shaft 120 (e.g. 180 degrees apart), with the lumen for the wire of the electrode 170 circumferentially offset from each of the two lumens. Using such a transcatheter myotomy device 100 with two wires 150, the cut of the tissue by the two wires 150 would extend in opposite directions from the anchor 142. Thus, the length of the cut with each wire may be shorter. Also, the depth of the anchoring location may be more versatile as the cut may be made upward or downward from the anchoring location.

[0124] FIGS. 20-29 illustrate a transcatheter septal myotomy device 400 according to another embodiment hereof. The transcatheter septal myotomy device 400 is similar to the transcatheter septal myotomy device 100 shown in FIG. 1-5 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 20- 29 and the same reference numerals are used. Thus, generally, as described above, the transcatheter septal myotomy device 400 includes the shaft 120, the anchor 142, the wire 150, and the electrode 170. However, the transcatheter septal myotomy device 400 of FIGS. 20-29 differs from the transcatheter septal myotomy device 100 in that the transcatheter septal myotomy device 400 includes a plurality of wires 150, which could include an electrosurgical wire or a plurality of electrosurgical wires. For the following descriptions of FIGS. 20-29, the wire 150 is described as an electrosurgical wire that is energized to cut tissue . However, it shall be understood that the wire 150 need not be energized to cut tissue and the wire 150 may be coated and / or uncoated.

[0125] The transcatheter septal myotomy device 400 is configured to cut or splay tissue at an interventricular septum of a heart to reduce left ventricular outflow tract obstruction (LVOTO). FIG. 20 is a side view of the transcatheter septal myotomy device 400. FIG. 21A isa cross-sectional view taken along line A-A of FIG. 20, and FIG. 2 IB is a cross-sectional view taken along line B-B of FIG. 20. FIG. 22 is an exploded view of the shaft 120 and the plurality of wires 150. FIG. 23 is a side view of a distal portion of the shaft 120 of the transcatheter septal myotomy device 400 with the plurality of wires 150 in a deployed configuration.

[0126] In a non-limiting embodiment, the shaft 120 further includes the proximal portion 130 and the distal portion 132. The proximal portion 130 is disposed proximal of the distal portion 132 and distally extends from the proximal end 122 to the distal end 140 ofthe proximal portion 130. First and second lumens 134A, 134B extend through the proximal portion 130 of the shaft 120, as shown in FIG. 21A. First and second channels 138A, 138B extend through the distal portion 132 of the shaft 120, as shown in FIG. 2 IB. The first channel 138A is in fluid communication with the first lumen 134A and the second channel 138B is in fluid communication with the second lumen 134B. Athird lumen 136 extends through the proximal portion 130 and the distal portion 132 of the shaft 120. In embodiments, the third lumen 136 is disposed through the shaft 120 circumferentially between the first lumen 134A / first channel 138A, and the second lumen 134B / second channel 138B, as shown in FIGS. 21A-21B.

[0127] Each of the first and second lumens 134A, 134B extends from the proximal end 122 of the shaft 120 to the distal end 140 of the proximal portion 130 of the shaft 120, as shown in FIG. 20. Each of the first and second lumens 134A, 134B is configured to slidably receive a proximal portion of the corresponding first and second wire 150A, 150B, respectively. Each of the first and second channels 138A, 138B extends from a proximal end 141 of the distal portion 132 to the distal end 126 of the shaft 120 in a sidewall of the shaft 120. Each of the first and second channels 138A, 138B is open to an outer surface of the shaft 120 and is configured to releasably receive a distal portion of the corresponding wire 150A, 150B, respectively. In embodiments, the second lumen 134B / second channel 138B are disposed through the shaft 120 opposite the first lumen 134A / first channel 138A, i.e., about 180 degrees around the circumference of the shaft 120. In embodiments herein, the first and second lumens 134A, 134B and the first and second channels 138A, 138B are configured such that the corresponding wire 150A, 150B may be disposed therein from the proximal end 122 of the shaft 120 to the distal end 126 of the shaft 120.

[0128] The third lumen 136 extends from the proximal end 122 of the shaft 120 to the electrode 170. The third lumen 136 is configured to retain a wire, cable, or conductive medium 172 therein, such that the electrode 170 may be in electrical communication with a power supply external to the transcatheter septal myotomy device 400, as previously described with respect to the transcatheter septal myotomy device 100 in FIGS. 1-5.

[0129] Each wire 150A, 150B includes a proximal end 152A, 152B and a distal end 154A, 154B as shown in FIG. 22. Each proximal end 152A, 152B may be coupled to the actuator 180 that is disposed at the handle 124 such that actuating the actuator 180 may translate the proximal end 152A, 152B of each wire 150A, 150B within the corresponding first or second lumen 134A, 134B. The distal end 154A, 154B of each wire 150A, 150B is fixed or coupled to the distal end 126 of the shaft 120 as described previously. Each wire 150A, 150B includes a proximal portion 156A, 156B, respectively, and a distal portion 158A, 158B, respectively, which may include a pre-set shape. The proximal portion 156A of the first wire 150A is slidably disposed within the first lumen 134A, and the proximal portion 156B of the second wire 150B is slidably disposed within the second lumen 134B. The proximal portions 156A, 156B and a portion of the pre-shaped distal portions 158A, 158B may include the coating 160 to focus radiofrequency energy to the distal uncoated segments 162A, 162B and to prevent damage to adjacent tissue, the first and second lumens 134A, 134B, and the first and second channels 138A, 138B, as described previously. The pre-shaped distal portions 158A, 158B includes the uncoated or operative segments 162A, 162B, respectively, which are configured to enable each uncoated segment 162A, 162B to cut or splay tissue which it contacts, such as the tissue of interventricular septum, upon application of radiofrequency (RF) energy to the corresponding wire 150A, 150B. For the sake of clarity, it is understood that in the case the wire 150 is not an electrosurgical wire 150, the first wire 150A and second wire 150B may be completely uncoated, partially uncoated, and / or fully coated.

[0130] In a deployed configuration, the pre-shaped distal portion 158A, 158B of each wire 150A, 150B may have a variety of shapes based on pre-op planning. Thus, the shape of the distal portions 158A, 158B may each be varied and customized depending on the desired size of the myotomy desired and the native anatomy. Stated another way, the distal portion 158A of the first wire 150A may have length, depth and shape that is different than the distal portion 158B of the second wire 150B.

[0131] As shown in FIG. 20, each wire 150A, 150B extends distally from the actuator 180 through the corresponding first or second lumen 134A, 134B and the corresponding first or second channel 138A, 138B to the distal end 126 of the shaft 120. The proximal ends 152A, 152B of the first and second wires 150A, 150B are electrically coupled to a generator GE, as described previously with respect to the transcatheter septal myotomy device 100.

[0132] In embodiments herein, the electrode 170 may be part of a bioelectric impedance system BIS, as shown in FIG. 5 and described previously.

[0133] Methods for using the transcatheter septal myotomy device 400 to cut or splay tissue of the interventricular septum to thereby improve blood flow through the left ventricle outflow tract (LVOT) are described with respect to FIG. 7 and FIGS. 24-29. FIG. 7 is a flow chart showing the method 700 for performing a transcatheter septal myotomy with transcatheter septal myotomy devices such as the transcatheter septal myotomy device 400. FIGS. 24-29 shows steps of the method 700 using the septal myotomy device 400 at the site of a native mitral valve to enlarge the LVOT. Thus, using the transcatheter septal myotomy device 400 comprises the same steps as the transcatheter septal myotomy device 100, except the transcatheter septal myotomy device 400 deploys two wires 150A, 150B to cut or splay tissue of the interventricular septum. Therefore, the step 702 of advancing the septal myotomy device to the left ventricle as shown in FIG. 24, the step 704 of anchoring the septal myotomy device to the interventricular septum as shown in FIGS. 25 and 26, and the step 706 of orienting the septal myotomy device in a desired direction as shown in FIG. 27 are the same as above and the details described above are incorporated by reference herein.

[0134] In the step 708 of the method 700, with the shaft 120 properly positioned and fixed to the interventricular septum IVS at the desired depth, the plurality of wires 150A, 150B are distally advanced through the corresponding first or second lumen 134A, 134B such that the distal portion 158A, 158B of each wire 150A, 150B deploys from the corresponding first or second channel 138A, 138B, as shown in FIG. 28. More precisely, the plurality of wires 150A, 150B are distally advanced through the corresponding first or second lumen 134A, 134B, respectively. Each wire 150A, 150B is advanced such that the distal portion 158A of the first wire 150A deploys from the first channel 138A and the distal portion 158B of the second wire 150B deploys from the second channel 138B. In the non-limiting example shown in FIG. 28, the first wire 150A deploys in a direction generally towards the apex AX of the left ventricle LV and the second wire 150B deploys in a direction generally towards the aortic valve AV. As the distal portion 158A, 158B of each wire 150A, 150B deploys out of the corresponding first or second channel 138A, 138B, the distal portion 158A, 158B of each wire 150 assumes the pre-shaped (deployed) configuration.

[0135] In the step 710 of the method 700, the generator GE (shown in FIG. 20) is activated to energize the plurality of wires 150A, 150B such that the uncoated segments 162A, 162B of the distal portions 158A, 158B of the first and second wires 150A, 150B cut tissue of the interventricular septum IVS to allow for the desired depth and length of each incision in the desired direction, as shown in FIG. 28. It should be understood that the uncoated segments 162A, 162B of the distal portions 158A, 158B of the first and second wires 150A, 150B maycut through the entire desired depth and length of the interventricular septum IVS, or the uncoated segments 162A, 162B of the distal portions 158A, 158B of the first and second wires 150A, 15 OB may cut through a portion of the interventricular septum IVS to initiate cutting and the coated segments 160A, 160B of the distal portions 158A, 158B of the first and second wires 150A, 15 OB may cut through the remaining interventricular septum IVS to achieve the desired depth and length.

[0136] The desired depth and the desired laceration or incision length may be determined in pre-op planning and the transcatheter septal myotomy device 400 may be correspondingly configured. The splaying of tissue of the interventricular septum IVS increases available volume within the left ventricle outflow tract (LVOT), and accordingly improves left ventricular outflow tract (LVOT) patency and blood flow to an aortic valve AV.

[0137] In the step 712 of the method 700, the plurality of wires 150A, 150B are deenergized by deactivating the generator GE.

[0138] In the step 714 of the method 700, the plurality of wires 150A, 150B are proximally retracted such that the pre-shaped distal portions 158A, 158B of the wires 150A, 150B transition from the deployed configuration to the straightened configuration within the corresponding first or second channel 138A, 138B and the corresponding first and second lumen 134A, 134B of the shaft 120.

[0139] The transcatheter septal myotomy device 400 may be detached from the interventricular septum and removed as shown in FIG. 29, as previously described with respect to the steps 716 and 718.

[0140] While described herein with two wires 150A, 150B, this is not meant to be limiting, and more wires may be utilized. The rotational orientation, shape, and length of each wire 150 may be customized based on pre -op planning.

[0141] Embodiments disclosed herein are also directed to transcatheter pericardial transection devices configured to cut or splay tissue of the pericardium. Patients with heart failure and preserved ejection refraction (HFpEF) may experience increased left ventricular end-diastolic pressure, which may contribute to dyspnea. Studies demonstrate that pericardial transection, i.e., cutting or splaying of tissue of the pericardium through minimally invasive treatment approaches may reduce cardiac pressure in patients with heart failure and preserved ejection refraction (HFpEF). The transcatheter pericardial transection devices described herein may be utilized to cut the pericardium and reduce cardiac pressure in patients with heart failure and preserved ejection refraction (HFpEF). The transcatheter pericardial transection devices described herein may include an outer sheath, an inner shaft including a wire, and a distalanchor. A distal portion of the wire is configured to abut against and / or embed within tissue of the pericardium when the wire is in the deployed configuration to cut the tissue. In some embodiments, the wire is an electrosurgical wire configured to deliver radiofrequency energy (RF) to cut the tissue when energized. A radiopaque marker may be configured to rotationally orient the wire relative to the pericardium wall. The depth, shape, and length of an uncoated segment of the wire provides flexibility to accommodate different anatomies.

[0142] FIGS. 30-34D illustrate a transcatheter pericardial transection device 500 according to embodiments hereof. One skilled in the art will realize that FIGS. 30-34D illustrate one example of a transcatheter pericardial transection device and that existing components illustrated in FIGS. 30-34D may be removed and / or additional components may be added or combined to the transcatheter pericardial transection device 500. The transcatheter pericardial transection device 500 is similar to the transcatheter septal myotomy device 100 of FIGS. 1-5. Therefore, all of the details described above are incorporated into the description of FIGS. 30- 34D. The transcatheter pericardial transection device 500 includes a shaft 520, an anchor 542, and a wire 550. However, the transcatheter pericardial transection device 500 differs from the transcatheter septal myotomy device of FIGS. 1-5 in that the transcatheter pericardial transection device 500 may include a radiopaque marker 590 and, in the embodiment shown, does not include the electrode 170 and the BIS system. However, it should be understood that the transcatheter pericardial transection device 500 may include at least one electrode 170 to allow for pacing stimulation via the BIS system. Pacing stimulation may be desirable to evaluate positioning of the transcatheter pericardial transection device 500 relative to the phrenic nerve. If pacing stimulation causes the phrenic nerve to be stimulated, it could mean the cutting path of the transcatheter pericardial transection device 500 could injure the phrenic nerve and therefore the transcatheter pericardial transection device 500 should be moved to a different position and / or orientation. Therefore, the electrode(s) 170 may be placed along the entire cutting path on the shaft 520. The anchor 542 of the transcatheter pericardial transection device 500 is configured to anchor and / or stabilize the transcatheter pericardial transection device 500 within the pericardial cavity of a heart. The transcatheter pericardial transection device 500 is configured to cut or splay tissue of the pericardium of a heart to reduce cardiac pressure in patients with heart failure and preserved ejection refraction (HFpEF). FIG. 30 is a side view of the transcatheter pericardial transection device 500. FIG. 31A is a cross-sectional view taken along line A-A of FIG. 30, and FIG. 3 IB is a cross-sectional view taken along line B-B of FIG. 30. FIG. 32 is an exploded view of the shaft 520, the wire 550, and an anchor 542. FIG. 33 is a side view of a distal portion of the shaft 520 of the transcatheter pericardialtransection device 500 with the wire 550 in a deployed configuration. FIGS. 34A-34D illustrate various embodiments of anchors of the transcatheter pericardial transection device 500.

[0143] The shaft 520 distally extends from a proximal end 522 coupled to a handle or luer 524 to a distal end 526, as shown in FIG. 30. The shaft 520 is configured to be slidably disposed and tracked within a guide catheter or outer sheath. The shaft 520 further includes a proximal portion 530 and a distal portion 532. The proximal portion 530 is disposed proximal of the distal portion 532 and distally extends from the proximal end 522 to a distal end 540 of the proximal portion 530, as shown in FIG. 32. A first lumen 534 extends through the proximal portion 530 of the shaft 520, as shown in FIG. 31A. A first channel 538 extends through the distal portion 532 of the shaft 520, as shown in FIG. 3 IB, and is in fluid communication with the first lumen 534. The first lumen 534 and the first channel 538 are the same as or similar to the first lumen 134 and the first channel 138 described above. Therefore, details of the first lumen 534 and the first channel 538 will not repeated here and the above description is incorporated into the description of the transcatheter pericardial transection device 500. In embodiments, the shaft 520 includes a central lumen 539 configured to slidably receive a portion and / or the actuation mechanism of the anchor 542. The central lumen 539 extends from the proximal end 522 to the distal end through the proximal portion 530 and the distal portion 532 of the shaft 520. In embodiments, the shaft 520 may be a flexible, elongated tubular body that may include, for example, a flexible metal matrix or braided catheter disposed within a polymer jacket.

[0144] The shaft 520 may include the distal tip 528, as best shown in FIG. 33. In an embodiment, the distal tip 528 is a tapered, frusto-conical cylinder, disposed at the distal end 526 of the shaft 520. In embodiments, the distal tip 528 may include a distal portion of the central lumen 539.

[0145] In embodiments, the anchor 542 is configured to stabilize and anchor the transcatheter pericardial transection device 500 within the pericardial cavity of a heart during cutting of the pericardium, as described below. In embodiments of FIGS. 30-34D, the anchor 542 includes a proximal end 544 operatively coupled to an actuator 581 of the handle 524 and a distal end 546. The proximal end 544 of the anchor 542 may be coupled to the actuator 581 that is disposed at the handle 524 such that actuating the actuator 581 may translate the anchor 542 in a distal direction within the central lumen 539 of the shaft 520 and / or may rotate the anchor 542. In embodiments, the anchor 542 may include a shaft 582 and an expandable member 584. The shaft 582 extends from the proximal end 544 to a distal end 586, and the expandable member 584 extends distally from the distal end 586 of the shaft 582 to the distalend 546 of the anchor 542. As shown in FIG. 31A, the anchor 542 may define a lumen 588 configured to slidingly receive an auxiliary component, for example, a guidewire GW.

[0146] In embodiment, the anchor 542 may include a radially compressed state and an radially expanded state. The expandable member 584 may be a shape-set or self-expanding material that is pre-set shape to the radially expanded state. In the radially compressed state, the expandable member 584 of the anchor 542 has a first diameter D 1. The expandable member 584 may be retained in the radially compressed state by the shaft 520. Stated another way, when the expandable member 584 is disposed within the central lumen 539 of the shaft 520, the shaft 520 retains the expandable member 584 in the radially compressed state. Distally extending the expandable member 584 out of the central lumen 539 of the shaft 520 enables the expandable member 584 to self-expand to transition from the radially compressed state to the radially expanded state having a second diameter D2 larger than the first diameter D 1. Thus, the expandable member 584 is configured to self-expand from the compressed state to the expanded state to releasably fix, or secure, or couple the transcatheter pericardial transection device 500 to tissue defining the pericardial cavity, engaging tissue of the epicardium and / or the pericardium of a heart. The anchor 542 may be formed of various materials, such as, but not limited to nickel-titanium alloys (e.g., Nitinol), nickel-cobalt- chromium-molybdenum alloys (e.g., MP35N), stainless steel, high spring temper steel, expandable polymer, or any other conductive and / or sufficiently stiff material suitable for the purposes describe herein.

[0147] While an embodiment of the anchor 542 is described herein as a self-expanding expandable member 584 extending distally from the distal tip 528, this is not meant be limiting, and in embodiments herein the anchor 542 may utilize other configurations. For example, and not by way of limitation, the anchor 542 may be configured as an expandable balloon 584A coupled to the distal end 586 of the shaft 582, as shown in FIG. 34A. In such an embodiment, the shaft 582 includes an inflation lumen (not shown) in fluid communication with an interior of the expandable balloon 584A. In another non-limiting example, the anchor may be a helix or corkscrew 584B coupled to the distal tip 528 of the shaft 520, as shown in FIG. 34B. The corkscrew 584B may be configured to extend transverse to the shaft 520 when the corkscrew 584B exits the central lumen 539 of the shaft 520. In another non-limiting example, the anchor 542 may include a spiral or wrap 584C coupled to the distal end 586 of the shaft 582. In such an embodiment, the spiral or wrap 584C may be pre-set to a spiral or wrapped radially expanded state. When disposed within the central lumen 539, the spiral 584C may be in a radially compressed or straightened state. When the spiral 584C exits the central lumen 539, itmay return to its pre-set spiral or radially expanded state. In another non-limiting example, one or more expandable members 584D extending radially outward from an outer surface of the shaft 520 serve to stabilize the transcatheter pericardial transection device 500. For example, and not by way of limitation, the expandable members 584D may be splines that are selfexpanding or may be actuated to expand from a radially compressed configuration in which they are generally parallel to the central longitudinal axis of the shaft 520 to the radially expanded configuration shown in FIG. 34D. As noted, each of the anchors 542 described herein are examples only, and other anchors disposed at any location along the transcatheter pericardial transection device 500 configured to engage tissue of the epicardium and / or the pericardium of a heart from within the pericardial cavity to stabilize the transcatheter pericardial transection device 500 therein may be utilized.

[0148] The wire 550 is similar to the wire 150 described previously with FIGS. 1-5. Therefore, a detailed description of the wire 550 is not described here with respect to FIGS. 30-34D. In embodiments herein, the wire 550 includes a proximal end 552, a distal end 554, a proximal portion 556, a distal portion 558, a coating 560, and a distal uncoated segment 562, as shown in FIG. 32. In embodiments herein, the distal portion 558 of the wire 550 may be longer than the wire 150 of FIGS. 1-5 such that a larger cut or splay may be made in the pericardium.

[0149] In embodiments, the transcatheter pericardial transection device 500 may include the radiopaque marker 590 coupled to the shaft 520. The radiopaque marker 590 is configured to provide visual cues under fluoroscopic imaging to improve anatomical alignment or orientation of the transcatheter pericardial transection device 500 within the pericardial cavity of a heart. In particular, the radiopaque marker 590 is configured to enable a clinician to determine whether or not the transcatheter pericardial transection device 500 is in the proper rotational orientation such that the wire 550 will engage the pericardium of the heart when radially expanded. In embodiments herein, the radiopaque marker 590 may be disposed on or within the shaft 520 of the transcatheter pericardial transection device 500. In an embodiment, the radiopaque marker 590 is located longitudinally adjacent to the distal portion 558 of the wire 550 and circumferentially spaced from the wire 550, as shown in FIG. 33. The radiopaque marker 590 is positioned at a known longitudinal distance from the distal end 526 of the shaft 520 and a known rotational orientation from the first channel 538 such that the clinician may position the distal portion 558 of the wire 550 at the desired location within the pericardial cavity, abutting the inner wall of the pericardium. In an embodiment, the radiopaque marker 590 may be circumferentially spaced 180° from the wire 550 such that when the radiopaquemarker 590 is pointing toward the epicardium of the heart, the wire 550 is disposed adjacent the pericardium. However, this is not meant to be limiting, and in other embodiments, the radiopaque marker 590 may include various shapes and may be circumferentially spaced at other distances from the wire 550, or the radiopaque marker 590 may outline the lumen 534 at the distal end 540 of the proximal portion 530 of the shaft 520. The radiopaque marker 590 may be formed of a variety of radiopaque materials, non-limiting examples of which include gold, platinum, iridium, tungsten, tantalum, or any combination thereof.

[0150] The interactions of the various components and methods for using the transcatheter pericardial transection device 500 to cut or splay tissue of the pericardium to reduce cardiac pressure in patients with heart failure and preserved ejection refraction (HFpEF) are described with respect to FIGS. 35-40. FIG. 35 is a flow chart showing a method 800 for performing a transcatheter pericardial transection with the transcatheter pericardial transection device 500. FIGS. 36-40 shows steps of the method 800 using the transcatheter pericardial transection device 500 to splay or cut tissue of the pericardium to reduce cardiac pressure in the heart. One skilled in the art will realize that FIGS. 35-40 illustrate one example of a method of using transcatheter pericardial transection device and that certain steps of the method may be removed or combined, that additional steps of the method may be performed, and / or some of steps may be performed in a different order / sequence in keeping with scope of the present disclosure.

[0151] In a step 802 of the method 800, a guide catheter GC or other sheath is tracked into a pericardial cavity PC of a heart HE, as shown in FIGS. 36-37. Access to the pericardial cavity PC may be via a sub-xyphoid approach with a needle NE inserted through the skin and under the sternum of a patient. The needle NE is advanced through the pericardium PE and into the pericardial cavity PC, as shown in FIG. 36. A guidewire GW may be inserted though the needle NE and into the pericardial cavity PC. The guide catheter GC may be advanced over the guidewire GW and into the pericardial cavity, as shown in FIG. 37.

[0152] In a step 804, the transcatheter pericardial transection device 500 is tracked through the guide catheter GC such that the distal end of the transcatheter pericardial transection device 500 is disposed within the pericardial cavity PC, as shown in FIG. 38. A distal portion of the shaft 520 is disposed adjacent to a desired portion of the pericardium PE of the heart HE.

[0153] As shown in FIG. 38, in a step 806 of the method 800, the shaft 520 of the transcatheter pericardial transection device 500 may be rotated in a first rotational direction RD 1 or a second rotational direction RD2 opposite the first rotational direction RD 1 to align the wire 550 with an inner wall of the pericardium PE. Rotational alignment of the wire 550with the pericardium PE may be accomplished utilizing the radiopaque marker 590 and fluoroscopic imaging.

[0154] In a step 808 of the method 800, the anchor 542 is deployed within the pericardial cavity PE, as shown in FIG. 39. More specifically, the actuator 581 of the handle 524 may be actuated to distally advance the anchor 542 from the distal tip 528 of the shaft 520. As the anchor 542 exits the distal tip 528, the expandable member 584 radially expands and transitions from the radially compressed state to the radially expanded state. An outer surface of the expandable member 584 engages tissue of epicardium EP and the pericardium PE to stabilize the transcatheter pericardial transection device 500 within the pericardial cavity PC of the heart HE. Although the step 808 and FIG. 39 are shown with the expandable member 584, that is not meant to be limiting, and the balloon 584A, the corkscrew 584B, the helix or wrap 584C, the splines 584D of FIGS. 34A-34D, or other anchors may be utilized.

[0155] In a step 810 of the method 800, with the shaft 520 properly positioned and fixed within the pericardial cavity PC, the wire 550 is distally advanced through the first lumen 534 such that the distal portion 558 of the wire 550 deploys from the first channel 538 and in a direction generally towards the pericardium PE, as shown in FIG. 40. As the distal portion 558 deploys out of the first channel 538, the distal portion 558 assumes the pre-set shape of the deployed configuration, as explained above.

[0156] In a step 812 of the method 800, a generator is activated to energize the wire 550 such that the uncoated segment 562 of the distal portion 558 of the electrosurgical wire 550 cuts tissue of the pericardium PE to the desired length and direction, as shown in FIG. 40. It should be understood that the uncoated segment 562 of the distal portion 558 of the wire 550 may cut the entire desired length of the pericardium PE, or the uncoated segment 562 of the distal portion 558 of the wire 550 may only cut through a portion of the pericardium PE to initiate cutting and the coated segment 560 of the distal portion 558 of the wire 550 may cut through the remaining pericardium PE to achieve the desired length. Pre-op planning may determine the desired length of the incision, and the shape memory of the pre-shaped distal portion 558 of wire 550 of the transcatheter pericardial transection device 500 may be correspondingly configured. In a non-limiting example, the first length LI of the incision may be in the range of about 10 mm to about 150 mm based upon the desired length of the cut. For example, the first length LI may be a short length of the pericardium or may be a cut from the base to the apex of the heart. It shall be understood that that multiple short cuts may be performed in different areas of pericardium. The tissue of the pericardium PE is not excised or removed, rather the laceration, cut, or incision opens or splays tissue of the pericardium PE.The splaying of tissue of the pericardium PE increases the ability of the heart HE to expand, and accordingly reduces cardiac pressure within the left ventricle LV of the heart HE.

[0157] In a step 814 of the method 800, the electrosurgical wire 850 is deenergized by deactivating the generator GE to terminate cutting of the tissue.

[0158] In a step 816, the wire 550 is proximally retracted such that the pre-shaped distal portion 558 transitions from the deployed configuration to the straightened configuration within the first channel 538 and the first lumen 534 of the shaft 520.

[0159] In a step 818 of the method 800, the anchor 542 is proximally retracted to release the transcatheter pericardial transection device 500 from the adjacent walls of the epicardium EP and the pericardium PE. The expandable member 584 of the anchor 542 transitions from the expanded state to the compressed state as the expandable member 584 is received within the central lumen 539 of the shaft 520.

[0160] In a step 820, the transcatheter pericardial transection device 500 is proximally and removed from the patient.

[0161] While various embodiments have been described above, it should be understood that they have been presented only as illustrations and examples of the present technology, and not by way of limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail may be made therein without departing from the spirit and scope of the present technology. Thus, the breadth and scope of the present technology should not be limited by any of the above-described embodiments but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, may be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.

[0162] The following examples are illustrative of the techniques described herein.

[0163] Example 1. A transcatheter septal myotomy device comprising: a shaft including a first lumen and a channel formed in a sidewall thereof; and a wire slidably disposed through the first lumen of the shaft, a distal end of the wire coupled to a distal end of the shaft, wherein the wire is configured to transform from a straightened configuration wherein the wire is within the first lumen and the channel to a deployed configuration when the wire is axially translated such that a distal portion of the wire extends out of the channel, wherein the wire is configured to splay tissue of a heart.

[0164] Example 2. The transcatheter septal myotomy device of Example 1, wherein the distal portion of the wire is pre-shaped to the deployed configuration.

[0165] Example 3. The transcatheter septal myotomy device of Example 2, wherein ihe distal portion is substantially U-shaped in the deployed configuration.

[0166] Example 4. The transcatheter septal myotomy device of any one of Examples 1 to 3, further comprising an anchor coupled to the distal end of the shaft.

[0167] Example 5. The transcatheter septal myotomy device of Example 4, wherein the anchor is a helical anchor.

[0168] Example 6. The transcatheter septal myotomy device of any one of Examples 1 to 5, further comprising an electrode coupled to an outer surface of the shaft, wherein the electrode is configured to monitor electrical parameters of tissue of the interventricular septum to determine depth the shaft into the tissue.

[0169] Example 7. The transcatheter septal myotomy device of Example 6, wherein the electrode comprises a plurality of electrodes coupled to the outer surface of the shaft spaced longitudinally apart from each other.

[0170] Example 8. The transcatheter septal myotomy device of Example 6 or Example 7, further comprising a second lumen extending through the shaft and a wire coupled to the electrode and extending through the second lumen.

[0171] Example 9. The transcatheter septal myotomy device of any one of Examples 6 to8, wherein the electrode is radiopaque.

[0172] Example 10. The transcatheter septal myotomy device of any one of Examples 1 to9, wherein the wire is an electrosurgical wire configured to be energized to splay tissue of the heart.

[0173] Example 11. The transcatheter septal myotomy device of Example 10, wherein the electrosurgical wire includes a coated portion and an uncoated portion, wherein the uncoated portion is configured to contact tissue with the electrosurgical wire in the deployed configuration.

[0174] Example 12. The transcatheter septal myotomy device of any one of Examples 1 to 11, wherein the wire comprises a plurality of wires.

[0175] Example 13. The transcatheter septal myotomy device of Example 12, wherein the plurality of wires comprises exactly two wires, wherein the two wires are spaced about 180 degrees apart around a circumference of the shaft.

[0176] Example 14. A method for performing a septal myotomy comprising : transluminally delivering septal myotomy device to a left ventricle of a heart until a distal end of a shaft of the septal myotomy device is adjacent an interventricular septum at a desired location; anchoring the septal myotomy device within the tissue of the interventricular septum at adesired location; and deploying a wire of the septal myotomy device such that a portion of the wire abuts against and / or is embedded within the tissue of the interventricular septum to splay the tissue of the interventricular septum.

[0177] Example 15. The method of Example 14, wherein anchoring the septal myotomy device comprises deploying an anchor into the tissue.

[0178] Example 16. The method of Example 15, wherein deploying the anchor comprises rotating the shaft to rotate a helical anchor at the distal end of the shaft.

[0179] Example 17. The method of any one of Examples 14 to 16, wherein deploying the wire comprises distally pushing the wire relative to the shaft such that a distal portion of the wire exits a channel of the shaft.

[0180] Example 18. The method of Example 17, wherein deploying the wire further comprises the wire deploying to a pre-set shape due to the distal portion of the wire being formed from a shape set material.

[0181] Example 19. The method of Example 18, wherein the pre-set shape is substantially U-shaped.

[0182] Example 20. The method of any one of Examples 14 to 19, further comprising monitoring an electrical parameter of tissue of the interventricular septum to monitor depth of the shaft into the tissue.

[0183] Example 21. The method of any one of Examples 14 to 20, wherein transluminally delivering septal myotomy device to a left ventricle of a heart comprises delivering the septal myotomy device prior to implanting a mitral valve prosthesis to reduce the risk of left ventricular outflow tract obstruction.

[0184] Example 22. The method of any one of Examples 14 to 21, wherein the wire is an electrosurgical wire, further comprising energizing the deployed electrosurgical wire to splay the tissue of the interventricular septum.

[0185] Example 23. A method of treating hypertrophic cardiomyopathy comprising splaying tissue of an interventricular septum using any of the methods of Examples 14 to 22.

[0186] Example 24. The method of any one of Examples 14 to 23, wherein deploying the wire comprises deploying a plurality of wires.

[0187] Example 25. The method of Example 24, wherein deploying the plurality of wires comprises deploying exactly two wires spaced about 180 degrees apart around a circumference of the shaft.

[0188] Example 26. A transcatheter pericardial transection device comprising: a shaft including a first lumen and a channel formed in a sidewall thereof; an anchor configured tostabilize the pericardial transection device within a pericardial cavity of a heart; a wire slidably disposed through the first lumen of the shaft, a distal end of the wire coupled to a distal end of the shaft, wherein the wire is configured to transform from a straightened configuration wherein the wire is within the first lumen and the channel to a deployed configuration wherein the wire is axially translated such that a distal portion of the wire extends out of the channel, wherein the wire is configured to splay tissue of a heart.

[0189] Example 27. The transcatheter pericardial transection device of Example 26, wherein the distal portion of the wire is pre-shaped to the deployed configuration.

[0190] Example 28. The transcatheter pericardial transection device of Example 26, wherein the distal portion is substantially U-shaped in the deployed configuration.

[0191] Example 29. The transcatheter pericardial transection device of any one of Examples 26 to 28, wherein the anchor is coupled to a distal end of the shaft.

[0192] Example 30. The transcatheter pericardial transection device of any of Examples 26 to 29, wherein the anchor comprises a helical anchor.

[0193] Example 31. The transcatheter pericardial transection device of any of Examples 26 to 29, wherein the anchor comprises an expandable frame.

[0194] Example 32. The transcatheter pericardial transection device of any of Examples 26 to 29, wherein the anchor comprises an expandable balloon.

[0195] Example 33. The transcatheter pericardial transection device of any of Examples 26 to 29, wherein the anchor comprises a helix or wrap.

[0196] Example 34. The transcatheter pericardial transection device of any of Examples 26 to 29, wherein the anchor comprises a plurality of splines configured to radially expand from the shaft.

[0197] Example 35. The transcatheter pericardial transection device of any one of Examples 26 to 34, further comprising a radiopaque marker coupled to the shaft.

[0198] Example 36. The transcatheter pericardial transection device of any one of Examples 26 to 35, wherein the wire is an electrosurgical wire configured to be energized to splay tissue of the heart.

[0199] Example 37. The transcatheter pericardial transection device of Example 36, wherein the electrosurgical wire includes a coated portion and an uncoated portion, wherein the uncoated portion is configured to contact tissue with the electrosurgical wire in the deployed configuration.

[0200] Example 38. A method for performing a pericardial transection comprising: transluminally delivering pericardial transection device to a pericardial cavity of a heart untila distal portion of a shaft of the pericardial transection device is adjacent a pericardium at a desired location; stabilizing the pericardial transection device within the pericardial cavity at a desired location; and deploying a wire of the pericardial transection device such that a portion of the wire abuts against and / or is embedded within a tissue of the pericardium to splay the tissue of the pericardium.

[0201] Example 39. The method of Example 38, wherein stabilizing the pericardial transection device comprises deploying an anchor to engage tissue surrounding the pericardial cavity.

[0202] Example 40. The method of Example 39, wherein deploying the anchor comprises radially expanding an expandable member such that the expandable member engages tissue surrounding the pericardial cavity.

[0203] Example 41. The method of Example 40, wherein the expandable member is a balloon and radially expanding the expandable member comprises delivering inflation fluid to an interior of the balloon.

[0204] Example 42. The method of Example 40, wherein the expandable member comprises a self-expanding material and radially expanding the expandable member comprises releasing the expandable member from a constraining element to enable the expandable member to self-expand to a radially expanded configuration.

[0205] Example 43. The method of any one of Examples 38 to 42, wherein deploying the wire comprises distally pushing the wire relative to the shaft such that a distal portion of the wire exits a channel of the shaft.

[0206] Example 44. The method of Example 43, wherein deploying the wire further comprises the wire deploying to a pre-set shape due to the distal portion of the wire being formed from a shape set material.

[0207] Example 45. The method of Example 44, wherein the pre-set shape is substantially U-shaped.

[0208] Example 46. The method of any one of Examples 38 to 45, wherein the wire is an electrosurgical wire, further comprising energizing the deployed electrosurgical wire to splay the tissue of the pericardium.

Claims

CLAIMSWhat is claimed is:

1. A catheter (100, 400, 500) comprising: a shaft (120, 520) including a first lumen (134, 534) and a channel (138, 538) formed in a sidewall thereof; and a wire (150, 550) slidably disposed through the first lumen of the shaft, a distal end (154, 554) of the wire coupled to a distal end of the shaft, wherein the wire is configured to transform from a straightened configuration wherein the wire is within the first lumen and the channel to a deployed configuration when the wire is axially translated such that a distal portion (158, 558) of the wire extends out of the channel, wherein the wire is configured to splay tissue of a heart.

2. The catheter (100, 400, 500) of claim 1, wherein the distal portion (158, 558) of the wire is pre-shaped to the deployed configuration.

3. The catheter (100, 400, 500) of claim 2, wherein the distal portion (158, 558) is substantially U-shaped in the deployed configuration.

4. The catheter (100, 400, 500) of any one of claims 1 to 3, further comprising an anchor (142, 542) coupled to the distal end of the shaft.

5. The catheter (100, 400, 500) of claim 4, wherein the anchor (142, 542) is a helical anchor.

6. The catheter (100, 400, 500) of any one of claims 1 to 5, further comprising an electrode (170) coupled to an outer surface of the shaft, wherein the electrode is configured to monitor electrical parameters of tissue of the interventricular septum to determine depth the shaft into the tissue.

7. The catheter (100, 400, 500) of claim 6, wherein the electrode (170) comprises a plurality of electrodes coupled to the outer surface of the shaft spaced longitudinally apart from each other.

8. The catheter (100, 400, 500) of claim 6 or claim 7, further comprising a second lumen (136) extending through the shaft and a wire (172) coupled to the electrode (170) and extending through the second lumen.

9. The catheter (100, 400, 500) of any one of claims 6 to 8, wherein the electrode (170) is radiopaque.

10. The catheter (100, 400, 500) of any one of claims 1 to 9, wherein the wire (150, 550) is an electrosurgical wire configured to be energized to splay tissue of the heart.

11. The catheter (100, 400, 500) of claim 10, wherein the electrosurgical wire includes a coated portion (160, 560) and an uncoated portion (162, 562), wherein the uncoated portion (162, 562) is configured to contact tissue with the electrosurgical wire in the deployed configuration.

12. The catheter (400) any one of claims 1 to 11, wherein the wire (150) comprises a plurality of wires (150), or wherein the wire (150) comprises exactly two wires (150A, 150B), wherein the two wires are spaced about 180 degrees apart around a circumference of the shaft.

13. The catheter (100, 400) of any one of claims 1 to 12, wherein the catheter is a septal myotomy device configured to splay tissue of an interventricular septum of the heart.

14. The catheter (500) of any one of claims 1 to 12, wherein the catheter is a pericardial transection device configured to be delivered within a pericardial cavity of the heart and to splay tissue of a pericardium of the heart.

15. The catheter (500) of claim 14, further comprising an anchor (542) configured to stabilize the pericardial transection device within a pericardial cavity of a heart, wherein the anchor comprises at least one of a helical anchor (584B), an expandable frame (584), an expandable balloon (584A), a helix or wrap (584C), and a plurality of splines (584D) configured to radially expand from the shaft.

Images