Catheter apparatus for treating septal hypertrophy

Abstract

A catheter apparatus includes a first catheter, a housing configured to contain a laceration device in the retracted configuration, and a distal attachment device. In aspects, the first catheter can be within the outer catheter, and the housing can be movably attached to the outer catheter and surround a portion of the first catheter. In aspects, the housing can be within the first catheter, and the laceration device can extend beyond the first catheter in a deployed configuration. Methods of ameliorating septal hypertrophy of a heart include positioning a distal end of a first catheter at a first location proximate an aortic valve and extending the first catheter towards an apex of a left ventricle. Methods include anchoring the distal end to a second location proximate the apex. Methods include activating a laceration device to lacerate a portion of the septal wall between the apex and the aortic valve.

Description

CATHETER APPARATUS FOR TREATING SEPTAL HYPERTROPHYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Nos. 63 / 652,984, filed May 29, 2024; 63 / 667,745, filed July 4, 2024; 63 / 667,746, filed July 4, 2024; 63 / 683,923, filed August 16, 2024; 63 / 683,975, filed August 16, 2024; 63 / 684,027, filed August 16, 2024; 63 / 697,122, filed September 20, 2024; 63 / 697,137, filed September 20, 2024; 63 / 697,156, filed September 20, 2024; 63 / 718,974, filed November 11, 2024; 63 / 718,990, filed November 11, 2024; 63 / 718,996, filed November 11, 2024; 63 / 719,007, filed November 11, 2024; and 63 / 733,696, filed December 13, 2024; and Greek National Application No. 20240100875, filed December 12, 2024; the entire contents of each application which are incorporated herein by reference.FIELD

[0002] The present disclosure relates generally to catheter apparatus and methods of using the same, and, more particularly, to a catheter apparatus having a laceration device and methods of using the same in a heart.BACKGROUND

[0003] It is known to provide a prosthetic heart valve assembly for implanting a heart valve prosthesis within a target site of the vasculature of a patient. However, certain physiological conditions can contraindicate implantation of a heart valve prosthesis. Consequently, there is a desire to provide apparatus and methods for ameliorating such contraindications.

[0004] Also, it is known that left ventricle outflow tract (LVOT) obstruction (LVOTO) limits the flow of blood out of the left ventricle of the heart. Consequently, LVOTO is a risk factor for heart failure, hypotension, and syncope. It is known to surgically lacerate or remove tissue in a septal myotomy or septal myectomy, respectively. However, complication rates and mortality rates associated with the surgical procedure are high. Consequently, there is a need to provide a method of treating LVOTO with improved (e.g., decreased) complication rates and / or mortality rates.SUMMARY

[0005] The following presents a simplified summary of the disclosure to provide a basic understanding of some aspects described in the detailed description. The catheter apparatus (including the laceration device and methods of using the same) can ameliorate septal hypertrophy by lacerating a portion of the septal wall (e.g., a septal myotomy). By lacerating a portion of the septal wall (e.g., corresponding to a portion of the septal wall in or proximate the LVOT), the LVOT can be enlarged (e.g., by a lacerated portion of the septal wall retracting). Enlarging theLVOT (e.g., ameliorating septal hypertrophy) can improve patient outcomes and / or create sufficient volume of the LVOT to enable implanting of a prosthetic heart valve to replace a preexisting heart valve (e.g., a native heart valve, or defective prosthetic heart valve) without impairing or otherwise impeding a function of the heart. Further, providing a catheter apparatus that can lacerate a portion of the septal wall (e.g., perform a septal myotomy) in a minimally invasive manner that can facilitate improved patient outcomes (e.g., relative to surgical interventions or forgoing any intervention).

[0006] The catheter apparatus can include the laceration device and optionally a distal attachment device and / or a proximal attachment device. Providing a distal attachment device can facilitate precise and / or accurate positioning of the laceration device and / or laceration of a portion of the septal wall. Since the catheter apparatus can be used in the heart while the heart is still beating, the distal attachment device can aid in maintaining a relative positioning of the catheter apparatus (e.g., laceration device) in the heart (e.g., left ventricle, position along the septal wall). Further, providing a distal attachment device can facilitate control of the laceration device such that laceration of non-target locations and / or structures (e.g., chordae, aortic valve, mitral valve) is minimized if not avoided entirely. Providing a proximal attachment device or otherwise contacting physiology with a proximal portion of the catheter apparatus in or near the heart can facilitate precise and / or accurate positioning of the laceration device and / or laceration of a portion of the septal wall (either on its own or in combination with a distal attachment device). Additionally, providing both a proximal attachment device (or wedging a corresponding portion of the catheter apparatus in a corresponding physiology) and a distal attachment device can provide a well-defined pathway that the laceration device can be positioned along and / or translate along (e.g., while lacerating a portion of the septal wall). In aspects, catheter apparatus comprise a first catheter or an inner catheter and a laceration device. In further aspects, the catheter an outer catheter, an inner catheter positioned within the outer catheter, and a housing movably attached to the outer catheter and surrounding a portion of the inner catheter. In aspects, the catheter apparatus can be configured to extend into a left ventricle of a heart, and the laceration device can be configured to lacerate tissue of a septal wall. The housing can contain a laceration device in a retracted configuration.

[0007] In aspects, a distal end of the inner catheter has a distal attachment device. In further aspects, the distal attachment device can be configured to attach using cryo-adhesion. In further aspects, the distal attachment device can be in thermal communication with a cryo-thermal source. In further aspects, the distal attachment device can comprise a helical shape or an aperture that a vacuum can be pulled through. In further aspects, the distal attachment device can comprise one or more tines. In further aspects, the distal attachment device is configured to be activatedhydraulically. In further aspects, the distal attachment device comprises a hook. In even further aspects, the catheter apparatus further comprises a first pull wire attached to the hook configured to deploy the hook, and a second pull wire configured to retract the hook. In even further aspects, the catheter apparatus further comprises an attachment spring configured to bias the hook into an extended configuration. In further aspects, the distal attachment device comprises a cleat. In further aspects, the catheter apparatus can further comprise a proximal attachment device attached to the outer catheter at a proximal location. In even further aspects, the proximal attachment device can comprise at least one expandable balloon with a first aperture that the outer catheter extends through a second aperture separate from the first aperture. In further aspects, the proximal attachment device comprises a cleat.

[0008] A laceration device can be configured to extend beyond the first catheter when the laceration device is in a deployed configuration. In further aspects, the laceration device can be configured to be coiled in the retracted configuration, and the laceration device can be configured to be activated to a deployed configuration by rotating the laceration device relative to the housing to extend the laceration device through an aperture of the housing. A length of the laceration device extending beyond the housing in the deployed configuration can be adjustable by adjustably rotating the laceration device, which can comprise a blade. The housing can be configured to translate independently from the inner catheter and the outer catheter. In further aspects, a maximum cross-sectional dimension of the outer catheter is from 15 French to 22 French and a maximum cross-sectional dimension of the inner catheter is from 5 French to 15 French, where a maximum cross-sectional dimension of the housing is less than or equal to the maximum cross- sectional dimension of the outer catheter.

[0009] In further aspects, the catheter apparatus can comprise a housing movably attached to the outer catheter and surrounding a portion of the inner catheter. The housing can be configured to contain a laceration device in a retracted configuration. The laceration can be configured to extend beyond the housing when the laceration device is in a deployed configuration. In further aspects, the laceration device can comprise a blade. In further aspects, the housing can be configured to rotate relative to the laceration device, and the housing can comprise a housing aperture, where the laceration device can be configured to extend through the housing aperture when the housing aperture is aligned with the laceration device in the deployed configuration. The housing can be configured to translate independently from the inner catheter.

[0010] In further aspects, the distal end of the first catheter can be configured to translate along guide rails relative to a proximal portion of the first catheter. In even further aspects, the catheter apparatus further comprises a housing configured to contain the laceration device, and thehousing can be restrained from rotating along the guide rails. In further aspects, the laceration device can comprise a blade. In further aspects, the laceration device is configured to extend beyond the inner catheter when the laceration device is in the deployed configuration by extending from an inner location within the inner catheter through an aperture of the inner catheter, and the laceration device is configured to pivot from an internal configuration with an entirety of the laceration device within the inner catheter to the deployed configuration. In further aspects, the laceration device comprises at least a section of bare wire configured to lacerate tissue when the section of bare wire is energized. In even further aspects, a distal end of the wire is attached to another location on the wire by an attachment device, and there is a bend in the wire between the distal end of the wire and the another location on the wire. In even further aspects, the laceration device is configured to translate along the inner catheter while the laceration device is in the deployed configuration. In even further aspects, the inner catheter comprises an aperture, the laceration device is configured to extend through the aperture, and the aperture is configured to maintain an orientation of the laceration device. In still further aspects, the wire of laceration device is configured to bend at a predetermined location when the laceration device transforms from a retracted configuration to a deployed configuration. In yet further aspects, the laceration device transforms from the retracted configuration to the deployed configuration by linearly extending a proximal end of the wire.

[0011] In further aspects, the catheter apparatus can further comprise a control handle. The control handle can comprise one or more of: a first actuator configured to adjust at least one of a position or an orientation of the outer catheter, a second actuator configured to adjust an orientation of the distal attachment device, a third actuator configured to adjust a position of the inner catheter relative to the outer catheter, a fourth actuator configured to extend the laceration device to the deployed configuration, and / or a fifth actuator configured position of the housing. In further aspects, a maximum cross-sectional dimension of the outer catheter is from 18 French to 22 French, and a maximum cross-sectional dimension of the inner catheter is from 10 French to 20 French, wherein the maximum cross-sectional dimension of the inner catheter is less than the maximum cross-sectional dimension of the outer catheter. In further aspects, a length that the laceration device extends beyond the first catheter is adjustable based on an angle that the laceration device pivots relative to the retracted configuration.

[0012] In further aspects, the laceration device comprises a guiding rod configured to extend from the distal end of the first catheter and a wire configured to extend between the guiding rod and the distal attachment device. In even further aspects, the distal attachment device is configured translate in a first direction, and the guiding rod is configured to translate parallel to thefirst direction. In still further aspects, the wire is configured to extend between the guiding rod and the distal attachment device in a second direction perpendicular to the first direction. In even further aspects, the wire is movably attached to the distal attachment device; and the wire is attached to a distal end of the guiding rod. In further aspects, the distal attachment device comprises a needle. In further aspects, the laceration device is configured to expand into a deployed configuration. In even further aspects, the catheter apparatus comprises a cauterizing device configured to cauterize tissue when energized.

[0013] In aspects, a catheter apparatus comprises a first catheter comprising a magnet and a laceration device at a distal end of the first catheter and a second catheter comprising a magnetic monitoring device. In further aspects, the magnetic monitoring device of the second catheter is configured to monitor a location of the distal end of the first catheter. In further aspects, the magnetic monitoring device of the second catheter is configured to guide the distal end of the first catheter. In further aspects, the laceration device comprises a fluid jet device.

[0014] In even further aspects, the laceration device is configured to transition between a retracted configuration and a deployed configuration, and the laceration device is configured to change shape to a curved configuration in the deployed configuration. In still further aspects, the laceration device is configured to transition between the retracted configuration and the deployed configuration by decreasing a distance between opposing ends of the laceration device. In still yet further aspects, the distance between the opposing ends of the laceration device in the curved configuration is from about 15 millimeters (mm) to about 25 mm. In still yet further aspects, a distal end of the laceration device is configured to translate relative to the distal end of the first catheter. In even yet further aspects, the laceration device comprises a pull wire attached to the distal end of the laceration device, where the pull wire is configured to translate the distal end of the laceration device relative to the distal end of the first catheter, and the pull wire is configured to provide electrical communication between the laceration device and an energy source. In still yet further aspects, a width of the laceration device tapers from the opposing ends towards a midpoint of the laceration device. In still further aspects, the laceration device comprises a housing that is translatable along the first catheter, and the laceration device is configured be positioned entirely within the housing and the first catheter in the retracted configuration. In still further aspects, the curved configuration of the laceration device can extend for a lateral distance of from 5 mm to 15 mm relative to the retracted configuration of the laceration device. In still further aspects, a length of the laceration device in the retracted configuration is from 25 mm to 50 mm.

[0015] In further aspects, the catheter apparatus comprises: a second catheter comprising a second distal attachment device at the distal end of the second catheter, wherein the lacerationdevice is attached to the first distal attachment device and the second distal attachment device. In even further aspects, the first distal attachment device and the second distal attachment device are configured to anchor the catheter apparatus through a septal wall of a heart. In even further aspects, the laceration device comprises at least a section of wire extending between the first distal attachment device and the second distal attachment device. In still further aspects, the laceration device further comprises a location on the at least the section of wire configured to lacerate tissue when the location on the at least the section of wire is energized. The at least the section of wire is configured to translate between the distal attachment devices. In further aspects, the laceration device comprises a guidewire, where the distal attachment device is at a distal end of the guidewire, and the first catheter is configured to translate along the guidewire.

[0016] In further aspects, the catheter apparatus comprises one or more wires (e.g., two wires) extending through a wire aperture in a distal end of a second catheter to a distal end of the first catheter. Translating the two wires relative to the second catheter is configured to bias the catheter apparatus. In still further aspects, a position of the catheter apparatus can be adjusted by adjusting one of the two wires independent of the other wire of the two wires. In still further aspects, an angle between the two wires is from 45 degrees to 135 degrees. A section of the one or more wires between the wire aperture of the distal end of the second catheter and the distal end of the first catheter is configured to bulge away from the first catheter as the one or more wires is extended through the wire aperture.

[0017] In further aspects, the distal attachment device comprises an aperture, and the distal attachment device is configured to draw a vacuum through the aperture. In even further aspects, the aperture comprises a plurality of apertures arranged in two rows, the laceration device is configured to be positioned between a first row and a second row of the two rows of the plurality of apertures. In still further aspects, the laceration device is configured to translate along a length of a row of the two rows of the plurality of apertures while positioned between the first row and the second row. In even further aspects, the catheter apparatus further comprises a proximal attachment device comprising a proximal aperture configured to draw vacuum therethrough.

[0018] In further aspects, the laceration device comprises a laceration wire configured to lacerate tissue when the laceration wire is energized. In even further aspects, the laceration device further comprises a pair of laceration attachment devices, and the laceration wire comprises two sections, where each section of the two sections is configured to extend around a corresponding attachment device of the pair of laceration attachment devices. In even further aspects, the distal attachment device is configured to be laterally positioned between the pair of laceration attachment devices when the laceration device is in the deployed configuration. In even further aspects, at leastone laceration attachment device of the pair of laceration attachment devices comprises a hook. In even further aspects, a first laceration attachment device of the pair of laceration attachment devices can translate independently of another laceration attachment device of the pair of laceration attachment devices. In even further aspects, the laceration device further comprises an attachment wire extending between the pair of laceration attachment devices. In still yet further aspects, the pair of laceration attachment devices are configured to translate along a path of the attachment wire. In even further aspects, the laceration device is configured to translate independently from the inner catheter and the outer catheter.

[0019] In further aspects, the distal end of the first catheter is configured to axially translate relative to a proximal portion of the first catheter. In further aspects, the laceration device is configured to lacerate tissue when the laceration device is energized. In further aspects, the laceration device comprises a blade configured to extend beyond the first catheter in the deployed configuration, and a wire extending between the blade and the first catheter, wherein the wire is configured to lacerate tissue when the wire is energized. In even further aspects, the laceration device further comprises an actuator configured to extend the blade. In still further aspects, the laceration device is configured to axially translate away from the distal end when the laceration device is in the deployed configuration. In still further aspects, the laceration device is further configured to cauterize tissue when the laceration device is energized. In still further aspects, the blade comprises a tapered end extending away from the distal end. In still further aspects, the laceration device further comprises a guide rail extending within the first catheter, the laceration device is configured to axially translate along the guide rail, and the laceration device is restrained from rotating relative to the first catheter. In even further aspects, the laceration device comprises: a blade configured to extend beyond the first catheter in the deployed configuration, and a laser source configured to emit a laser beam towards a protective sheath of the blade. In even further aspects, the distal attachment device comprises a helical shape or a spiral shape. In even further aspects, the distal attachment device comprises an aperture, and the distal attachment device is configured to apply a vacuum using the aperture. In even further aspects, the distal attachment device tapers towards the distal end thereof. In even further aspects, the catheter apparatus further comprises a second catheter with the first catheter positioned within the second catheter, and a proximal attachment device attached to the outer catheter at a proximal location. In still further aspects, the proximal attachment device comprises an expandable mesh. In still further aspects, the first catheter is configured to translate relative to the second catheter. In still further aspects, the catheter apparatus further comprises a pull wire configured to adjust an orientation of the second catheter. The laceration device can be configured to rotate relative to the second catheter.

[0020] In further aspects, the catheter apparatus further comprises a second distal attachment device at the distal end of the first catheter, where the laceration device is attached to the first distal attachment device and the second distal attachment device. In even further aspects, the laceration device comprises a wire extending between the first distal attachment device and the second distal attachment device. In still further aspects, the laceration device further comprises a location on the wire configured to lacerate tissue when the location on the wire is energized, and the wire is configured to translate between the first distal attachment device and the second distal attachment device. In still further aspects, a cross-section of the wire can be polygonal (e.g., triangular). In even further aspects, the laceration device comprises a braided cable comprising an electrically conductive core and the electrically conductive core is exposed at a location on the braided cable between the first distal attachment device and the second distal attachment device. In even further aspects, wherein the laceration device comprises a cable saw configured to translate between the first distal attachment device and the second distal attachment device. In even further aspects, the first catheter comprises two lumens, the first distal attachment device is attached to the first lumen of the two lumens, and the second distal attachment device is attached to the second lumen of the two lumens.

[0021] Method of ameliorating septal hypertrophy of a heart can comprise positioning a first catheter or an inner catheter at a first location proximate an aortic valve of the heart, extending a distal end of the first catheter towards an apex of a left ventricle of the heart, anchoring the distal end of the first catheter to a second location proximate the apex by deploying a distal attachment device, activating a laceration device to lacerate a portion of a septal wall of the heart between the apex and the aortic valve, releasing the distal attachment device, and retracting the first catheter from the left ventricle. In aspects, the catheter apparatus can comprise the inner catheter surrounded by an outer catheter, where methods can comprise positioning a distal end of an outer catheter at a first location proximate an aortic valve, extending the inner catheter towards an apex of a left ventricle independent of the outer catheter, anchoring a distal end of the inner catheter to a second location proximate the apex, activating a laceration device to lacerate a portion of the septal wall between the apex and the aortic valve, and retracting the inner catheter from the left ventricle. In aspects, the extending the distal end of the inner catheter can position the inner catheter in the left ventricle extending through the aortic valve. In aspects, the activating the laceration device can comprise translating the laceration device relative to the distal end of the inner catheter while the laceration device is in the deployed configuration. In further aspects, the activating the laceration device can further comprise translating the laceration device towards the distal end of the outer catheter. In further aspects, the portion of the septal wall lacerated by the laceration device ispositioned between the aortic valve and the second location. In further aspects, the activating the laceration device comprises translating the laceration device towards a distal end of the distal attachment device. In further aspects, the activating the laceration device further comprises translating the laceration device away from the distal attachment device while the laceration device is in the deployed configuration to lacerate the portion of the septal wall.

[0022] In aspects, the anchoring can comprise cryo-adhesion of the distal end of the inner catheter to the second location. In aspects, the deploying the distal attachment device comprises hydraulically activating the distal attachment device. In aspects, the deploying the distal attachment device comprises torquing the distal attachment device. In aspects, the anchoring can comprise rotating a distal attachment device having a helical shape at the distal end of the inner catheter. In aspects, the anchoring comprises pulling a vacuum through an aperture in the distal attachment device at the distal end of the inner catheter. In further aspects, the anchoring the distal attachment device comprises pulling a vacuum through an aperture of the distal attachment device, and the pulling the vacuum brings the aperture in contact with the second location of the heart. In aspects, the deploying the distal attachment device comprises rotating a hook to attach the distal end of the first catheter to the septal wall at the second location. In aspects, the deploying the distal attachment device can comprise inserting one or more tines at the second location. In further aspects, the distal attachment device comprises a cleat. In further aspects, the anchoring the distal attachment device comprises puncturing the septal wall at the second location by translating the distal attachment device. In even further aspects, the method further comprises activating at least a section of a laceration wire at a distal end of the distal attachment device to facilitate translating the distal attachment device and the anchoring the distal attachment device to the second location on the septal wall. In even further aspects, the distal attachment device tapers towards a distal end thereof. In aspects, methods can further comprise forming a proximal anchor by wedging a distal end of the outer catheter into one or more of the ascending aorta, the aortic valve, or a location proximate thereof. In aspects, methods can further comprise deploying a proximal attachment device before the activating the laceration device, where the proximal attachment device is attached to the outer catheter at a proximal location. In further aspects, the method further comprises anchoring a proximal attachment device to a third location of the septal wall in the left ventricle of the heart, wherein the activating the laceration device comprises lacerating the portion of the septal wall between the second location and the third location. In further aspects, the proximal attachment device comprises a cleat. In further aspects, the deploying the proximal attachment device can comprise expanding at least one balloon, the at least one balloon comprises a first aperture that the outer catheter extends through a second aperture separate from the first aperture. In even furtheraspects, the positioning the outer catheter further comprising expanding a balloon of the at least one balloon to achieve a predetermined position, predetermined orientation, or both In further aspects, the anchoring the proximal attachment device comprises pulling a vacuum through a proximal aperture of the proximal attachment device, and the pulling the vacuum through the proximal aperture of the proximal attachment device brings the proximal attachment device in contact with the septal wall at the third location. In further aspects, the proximal attachment device can be deployed at a location in an ascending aorta.

[0023] In aspects, the activating the laceration device comprises lacerating the portion of the septal wall with a blade. In aspects, the laceration device comprises a wire, and the activating the laceration device comprises energizing the wire to lacerate the portion of the septal wall. In further aspects, the wire comprises at least a section of bare wire. In further aspects, the activating the laceration device comprises positioning a housing at a third location along the inner catheter and extending the laceration device beyond the housing towards the septal wall, where the third location is proximate the septal wall. The extending the laceration device can comprise rotating the laceration device relative to the housing. In further aspects, the extending the laceration device can transform the laceration device from a retracted configuration positioned entirely within the housing to a deployed configuration with at least a portion of the laceration device extending through an aperture of the housing. In further aspects, the method further comprises adjusting an angle that the laceration device extends through the aperture relative to the retracted configuration to control a distance that the laceration device extends beyond the first catheter. In further aspects, during the activating the laceration device, the laceration device resists deflection from tissue of the septal wall at least due to a crimp in the wire or a guide system in the inner catheter, and the guide system is configured to maintain an orientation of the laceration device.

[0024] In further aspects, the activating the laceration device can comprise rotating a housing relative to the laceration device to align a housing aperture of the housing with the laceration device so that the laceration device can extend through the housing aperture in a deployed configuration from a retracted configuration where the laceration device is entirely contained within the housing, and the housing can be attached to the outer catheter. In even further aspects, method can further comprise translating the housing independently from the inner catheter. In further aspects, methods can further comprise tensioning the inner catheter during the activating the laceration device so that the laceration device contacts the septal wall. In further aspects, methods can further comprise translating the housing and the laceration device in the deployed configuration relative to the distal end of the inner catheter.

[0025] In further aspects, the extending the laceration device can comprise pivoting thelaceration device. In further aspects, the extending the laceration device can comprise activating a spring. In further aspects, the extending the distal end of the first catheter can translate the distal end along guide rails relative to a proximate location of the first catheter, wherein the housing translates along the guide rails, and the housing is prevented from rotating along the guide rails.

[0026] In further aspects, the activating the laceration device further comprises transforming the laceration device from a retracted configuration to a deployed configuration by extending a peripheral location of the wire towards the septal wall. In yet further aspects, the transforming comprises linearly extending a proximal end of the wire towards the distal attachment device, and the linearly extending the proximal end of the wire causes a peripheral location of the wire to bend and extend towards the septal wall. In even further aspects, the activating the laceration device further comprises tensioning the inner catheter. In even further aspects, the activating the laceration device further comprises adjusting a distance that the wire extends beyond the first catheter by translating a first end of the laceration device relative to a second end of the laceration device opposite the first end to adopt a curved configuration.

[0027] In further aspects, the activating the laceration device comprises expanding the laceration device to an expanded configuration while within the septal wall. In even further aspects, the laceration device expands on one side of the first catheter but not an opposite side of the first catheter. In even further aspects, the method further comprises energizing a wire to cauterize tissue proximate the portion of the septal wall lacerated. In further aspects, the activating the laceration device comprises energizing a wire to lacerate the portion of the septal wall. In further aspects, the translating the laceration device comprises extending a guiding rod in a second direction parallel to a first direction that the distal attachment device was extended, and the wire is attached to a distal end of the guiding rod.

[0028] In further aspects, the anchoring the distal end of the first catheter comprises anchoring the first catheter through an entire thickness of the septal wall. In further aspects, methods further comprise anchoring a distal end of a second catheter at a third location on the septal wall of the heart. In even further aspects, the anchoring the distal end of the second catheter comprises anchoring the second catheter through an entire thickness of the septal wall. In further aspects, the method further comprises anchoring the laceration device to a third location on the septal wall of the heart, wherein the laceration device extends between the second location and the third location. In even further aspects, the activating the laceration device comprises translating a location of the laceration device between the second location and the third location. In even further aspects, the activating the laceration device comprises applying tension to the laceration device.

[0029] In further aspects, methods further comprise extending one or more wires througha wire aperture in a distal end of a second catheter positioned around the first catheter, the one or more wires extending through the wire aperture in the distal end of the second catheter to the distal end of the first catheter. The extending the one or more wires biases the laceration device into the septal wall. The extending the one or more wires extends the one or more wires towards an inner surface of the left ventricle opposite the septal wall. In further aspects, the one or more wires comprises two wires extending through a corresponding aperture of the wire aperture, and extending the one or more wires comprises extending the two wires at an angle from 45° to 135°.

[0030] In further aspects, the distal attachment device comprises a plurality of apertures arranged in two rows configured to pull a vacuum, and pulling the vacuum brings the plurality of apertures in contact with the septal wall, and the activating the laceration device comprises lacerating the portion of the septal wall proximate the second location between a first row and a second row of the two rows of the plurality of apertures. In further aspects, the activating the laceration device comprises translating the laceration device along a length of a row of the two rows of the plurality of apertures while positioned between the first row and the second row. In further aspects, the activating the laceration device comprises translating the laceration device to lacerate the portion of the septal wall along at least a portion of a path between the second location and the third location. In further aspects, the activating the laceration device lacerates tissue within the aperture of the distal attachment device to lacerate the portion of the septal wall. In further aspects, the activating the laceration device extends the laceration device through the aperture of the distal attachment device to lacerate the portion of the septal wall.

[0031] In further aspects, the activating the laceration device comprises extending a pair of laceration attachment devices towards the septal wall to contact the septal wall at corresponding initial locations, the distal end of the inner catheter positioned between a first laceration attachment device of the pair of laceration attachment devices and a second laceration attachment device of the pair of laceration attachment devices, and activating two sections of wire to laceration tissue corresponding to locations of the pair of laceration attachment devices, each section of the two sections is configured to extend around a corresponding attachment device of the pair of laceration attachment devices. In still further aspects, the method further comprises adjusting a position of the first laceration attachment device of the pair of laceration attachment devices independent from the second laceration attachment device of the pair of laceration attachment devices. In further aspects, the activating the laceration device further comprises translating the pair of laceration attachment devices to bring the pair of laceration attachment devices together while activating the two sections of wire to lacerate tissue along a path between corresponding initial locations. In still further aspects, the activating the laceration device further comprises translating the pair oflaceration attachment devices to increase a distance between the pair of laceration attachment devices to a pair of final locations along the septal wall while activating the two sections of wire to lacerate tissue along a path between the pair of final locations. In even further aspects, bringing the pair of laceration attachment devices together comprises guiding the pair of laceration attachment devices along an attachment wire extending between the pair of laceration attachment devices. In still further aspects, the method further comprises extending the attachment wire towards the septal wall before extending the pair of laceration attachment devices towards the septal wall, wherein the extending the pair of laceration attachment devices comprises guiding the pair of laceration attachment devices along the attachment wire. In still further aspects, the method further comprises, after lacerating the tissue of the septal wall, further extending the attachment wire towards the septal wall, guiding the pair of laceration attachment devices along the attachment wire to contact the septal wall again, and activating the two sections of wire to further laceration tissue of the septal wall.

[0032] In further aspects, the activating the laceration device comprises extending the laceration device beyond the first catheter in a direction towards the septal wall so that the laceration device contacts the septal wall and energizing a wire to lacerate the portion of the septal wall. In even further aspects, the laceration device comprises a blade and the wire extending between the blade and a proximal portion of the first catheter, and the blade contacts the septal wall when the laceration device contacts the septal wall. In further aspects, the activating the laceration device comprises extending the laceration device beyond the first catheter in a direction towards the septal wall so that the laceration device contacts the septal wall, and emitting a laser beam from a laser source towards a protective sheath of a blade of the laceration device, wherein the emitting the laser beam lacerates the portion of the septal wall proximate the protective sheath. In even further aspects, the activating the laceration device further comprises activating an actuator to further extend a blade of the laceration device into the septal wall. In even further aspects, the method further comprises adjusting a depth that the laceration device extends beyond the first catheter by adjusting an actuator attached to the laceration device. In further aspects, the activating the laceration device further comprises translating the laceration device relative to the first catheter in a direction away from the distal end of the first catheter. In further aspects, the laceration device is translated along the septal wall during at least a part of the activating the laceration device. In further aspects, the anchoring the distal end comprises rotating a helical or spiral distal attachment device at the second location, applying a vacuum through an aperture of the distal attachment device, or both. In further aspects, the method further comprising deploying a proximal attachment device before the activating the laceration device. In even further aspects, the deploying theproximal attachment device comprises expanding a mesh proximate at the first location. In further aspects, the anchoring the distal end of the inner catheter comprises puncturing the septal wall at the second location by translating the inner catheter.

[0033] In further aspects, the method further comprises orienting the first catheter so that the laceration device can extend towards the septal wall while activating the laceration device. In further aspects, the activating the laceration device comprises decreasing a distance between opposing ends of the laceration device so that the laceration device adopts a deployed configuration, and the laceration device has a curved configuration extending towards the septal wall in the deployed configuration. In even further aspects, the decreasing the distance comprises translating a distal end of the opposing ends of the laceration device away from the distal end of the first catheter. In still further aspects, the method further comprises energizing the laceration device through a pull wire attached to the distal end of the laceration device, wherein translating the pull wire translates the distal end of the laceration device, and energizing the laceration device lacerates the portion of the septal wall.

[0034] In further aspects, the activating the laceration device comprises emitting a fluid jet from the laceration device to lacerate the portion of the septal wall. In still further aspects, the method further comprises positioning a distal end of a second catheter in a right ventricle of the heart and modulating an intensity of the fluid jet based on a distance between a magnetic monitoring device of the second catheter and a magnet at the distal end of the first catheter. In further aspects, the method further comprises positioning a distal end of a second catheter in a right ventricle of the heart and guiding a magnet at the distal end of the first catheter using a magnetic monitoring device at the distal end of the second catheter. In even further aspects, the activating the laceration device comprises emitting a fluid jet from the laceration device to lacerate the portion of the septal wall. In still further aspects, the method comprises modulating an intensity of the fluid jet based on a distance between the magnetic monitoring device of the second catheter and the magnet of the first catheter. In even further aspects, the activating the laceration device further comprises translating the distal end of the first catheter in a direction towards an aortic valve of the heart by translating the magnetic monitoring device. In still further aspects, translating the distal end of the first catheter comprises rotating a magnetic wheel comprising the magnet along the septal wall.

[0035] In further aspects, methods further comprises anchoring the laceration device to a third location on the septal wall of the heart, wherein a laceration device extends between the second location and the third location. In even further aspects, the activating the laceration device comprises applying tension to the laceration device, for example, using a ratcheting mechanism.In even further aspects, the laceration device can comprise a wire having a polygonal (e.g., triangular) cross-section that lacerates the portion of the septal wall. In even further aspects, the activating comprise energizing an electrically conductive core of a braided cale that is exposed at a location on the between the first distal attachment device and the second distal attachment device that is otherwise to lacerate tissue at the location. In even further aspects, the activating the laceration device lacerates the portion of the septal wall by abrading the portion of the septal wall with a cable saw.

[0036] Additional features and advantages of the aspects disclosed herein will be set forth in the detailed description that follows, and in part will be clear to those skilled in the art from that description or recognized by practicing the aspects described herein, including the detailed description which follows, the claims, as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description present aspects intended to provide an overview or framework for understanding the nature and character of the aspects disclosed herein. The accompanying drawings are included to provide further understanding and are incorporated into and constitute a part of this specification. The drawings illustrate various aspects of the disclosure, and together with the description explain the principles and operations thereof.BRIEF DESCRIPTION OF THE DRAWINGS

[0037] These and other features, aspects and advantages are better understood when the following detailed description is read with reference to the accompanying drawings, in which:

[0038] FIG. 1 schematically illustrates insertion of a catheter apparatus through a femoral artery towards a heart in accordance with aspects of the disclosure;

[0039] FIG. 2 schematically illustrates insertion of a catheter apparatus through a carotid artery and into a left ventricle of a heart in accordance with aspects of the disclosure;

[0040] FIG. 3 illustrates a schematic side view of the catheter apparatus in accordance with aspects of the disclosure;

[0041] FIG. 4 illustrates a schematic side view of a control handle of the catheter apparatus in a cradle in accordance with aspects of the disclosure;

[0042] FIG. 5 is a flowchart of a method of ameliorating septal hypertrophy using the catheter apparatus in accordance with aspects of the disclosure;

[0043] FIG. 6 illustrates a distal end of a catheter apparatus proximate an aortic valve of a heart in accordance with aspects of the disclosure;

[0044] FIG. 7 illustrates a catheter apparatus in a left ventricle of a heart where the distal end of the catheter apparatus has been extended towards a septal wall and / or an apex of the heartin accordance with aspects of the disclosure;

[0045] FIG. 8 schematically illustrates a generic catheter apparatus positioned in a left ventricle of the heart to lacerate a portion of a septal wall of the heart in accordance with aspects of the disclosure;

[0046] FIG. 9 illustrates a catheter apparatus having a proximal attachment device, a distal attachment device (e.g., having a helical shape), and a laceration device configured to lacerate a portion of a septal wall of a heart in accordance with aspects of the disclosure;

[0047] FIGS. 10A-10C schematically illustrates a proximal attachment device comprising a mesh (FIG. 10A) that can transition between a retracted configuration (FIG. 10B) and a deployed configuration (FIG. 10C) in accordance with aspects of the disclosure;

[0048] FIG. 11 illustrates an exploded view of a catheter apparatus having a proximal attachment device with more than one aperture in accordance with aspects of the disclosure;

[0049] FIG. 12 illustrates a proximal attachment device of a catheter apparatus positioned in a left ventricle of a heart when a prosthetic heart valve assembly is present at a location of an aortic valve in accordance with aspects of the disclosure;

[0050] FIGS. 13A-13C illustrate aspects of an attachment device (e.g., distal attachment device) comprising one or more tines in accordance with aspects of the disclosure, where FIG. 13A shows aspects where the one or more tines are mechanically controlled while FIGS. 13B-13C show aspects where the one or more tines are hydraulically controlled with views showing the retracted configuration (FIG. 13B) and the deployed configuration (FIG. 13C);

[0051] FIGS. 14A-14C illustrate aspects of an attachment device (e.g., distal attachment device) having a helical shape in accordance with aspects of the disclosure, where FIG. 14A shows aspects where the distal attachment device is mechanically rotated while FIGS. 14B-14C show aspects where the distal attachment device is hydraulically controlled with views showing the retracted configuration (FIG. 14B) and the deployed configuration (FIG. 14C);

[0052] FIG. 15 illustrates a schematic cross-section of an attachment device (e.g., proximal attachment device, distal attachment device) in a deployed configuration having a cleat in accordance with aspects of the disclosure;

[0053] FIGS. 16A-16B illustrates an attachment device (e.g., distal attachment device) that can transition between a retracted configuration (FIG. 16A) and a deployed configuration (FIG. 16B) using one or more pull wires in accordance with aspects of the disclosure;

[0054] FIG. 17 schematically illustrates a catheter apparatus with a distal end of the catheter apparatus attached to a location in a left ventricle of the heart using cryo-adhesion and a laceration device configured to lacerate a portion of a septal wall of the heart in accordance withaspects of the disclosure;

[0055] FIG. 18 schematically illustrates a catheter apparatus with a distal attachment device comprising one or more tines attached to a left ventricle of a heart and a laceration device configured to lacerate a portion of a septal wall of the heart in accordance with aspects of the present disclosure;

[0056] FIG. 19 schematically illustrates a catheter apparatus having a laceration device lacerating a portion of a septal wall of a heart in accordance with aspects of the disclosure;

[0057] FIG. 20 illustrates a portion of a catheter apparatus having a distal attachment device, a laceration device comprising a blade in a deployed configuration, and a housing configured to contain the laceration device in a retracted configuration in accordance with aspects of the disclosure;

[0058] FIG. 21 schematically illustrates a laceration device comprising a blade and having a helical configuration as part of a catheter apparatus in accordance with aspects of the disclosure;

[0059] FIG. 22 schematically illustrates a laceration device having a blade extending through an aperture of a housing in a deployed configuration in accordance with aspects of the disclosure;

[0060] FIG. 23 illustrates a catheter apparatus having a distal attachment device attached to a left ventricle of a heart by cryo-adhesion and a laceration device lacerating a portion of a septal wall of a heart in accordance with aspects of the disclosure;

[0061] FIG. 24 illustrates a portion of a catheter apparatus having a distal attachment device, a laceration device comprising a blade in a retracted configuration, and a housing configured to contain the laceration device in the retracted configuration in accordance with aspects of the disclosure;

[0062] FIG. 25 illustrates the catheter apparatus shown in FIG. 24, where the blade of the laceration device is in the deployed configuration when the blade is aligned with a housing aperture of the housing in accordance with aspects of the disclosure;

[0063] FIG. 26 illustrates a catheter apparatus having a helical distal attachment device attached to a left ventricle of a heart and a laceration device lacerating a portion of a septal wall of a heart with a blade in accordance with aspects of the disclosure;

[0064] FIG. 27A illustrates a portion of a catheter apparatus having a laceration device comprising a blade in a retracted configuration, where the blade is entirely positioned within a first catheter in accordance with aspects of the disclosure;

[0065] FIG. 27B illustrates a cross-sectional view taken along line 27B-27B of FIG. 27A;

[0066] FIGS. 28 illustrates a portion of the catheter apparatus shown in FIG. 27, wherethe blade of the laceration device is being deployed and extends beyond the first catheter and extends through a housing aperture of a housing within the first catheter;

[0067] FIG. 29 illustrates a portion of the catheter apparatus shown in FIG. 27, where a spring can be used to bias the laceration device towards the deployed configuration in accordance with aspects of the disclosure being;

[0068] FIG. 30 illustrates a portion of a catheter apparatus having a laceration device, where a length that the laceration device extends beyond a housing is controlled by a set screw in accordance with aspects of the disclosure;

[0069] FIG. 31 illustrates a portion of a catheter apparatus having a laceration device, where a length that the laceration device extends beyond a housing is controlled by a cam attached to a pull wire in accordance with aspects of the disclosure;

[0070] FIG. 32 illustrates a portion of a catheter apparatus having a laceration device, where a length that the laceration device extends beyond a housing is controlled by a translatable wedge in accordance with aspects of the disclosure;

[0071] FIG. 33 illustrates a portion of a catheter apparatus with guide rails connecting a distal portion of a catheter to a proximal portion of a catheter in accordance with aspects of the disclosure;

[0072] FIG. 34 illustrates a catheter apparatus having a distal attachment device with one or more tines attached to a left ventricle of a heart and a laceration device lacerating a portion of a septal wall of a heart in accordance with aspects of the disclosure;

[0073] FIG. 35 illustrates a portion of a catheter apparatus having a laceration device comprising a blade in a deployed configuration in accordance with aspects of the disclosure;

[0074] FIG. 36 illustrates a portion of a catheter apparatus having a laceration device comprising a blade in a retracted configuration, where the blade is entirely positioned within a first catheter in accordance with aspects of the disclosure;

[0075] FIG. 37 illustrates a portion of a catheter apparatus of FIG. 36 where the laceration device is in a deployed configuration in accordance with aspects of the disclosure;

[0076] FIG. 38 schematically illustrates a cross-sectional end view of the catheter apparatus shown in FIGS. 36-37 in accordance with aspects of the present disclosure;

[0077] FIG. 39 schematically illustrates a catheter apparatus having a distal attachment with one or more cleats attached to a left ventricle of a heart and a laceration device lacerating a portion of a septal wall of a heart in accordance with aspects of the disclosure;

[0078] FIG. 40 illustrates a cross-sectional view of a catheter apparatus having a laceration device comprising a blade in a retracted configuration in accordance with aspects of the disclosure;

[0079] FIG. 41 illustrates a cross-sectional view of the catheter apparatus in FIG. 40 with the laceration device in a deployed configuration in accordance with aspects of the disclosure;

[0080] FIG. 42 illustrates a cross-sectional view of a catheter apparatus having a laceration device comprising a wire configured to laceration tissue when energized in a retracted configuration in accordance with aspects of the disclosure;

[0081] FIG. 43 illustrates a cross-sectional view of the catheter apparatus in FIG. 42 with the laceration device in a deployed configuration in accordance with aspects of the disclosure;

[0082] FIG. 44 illustrates a portion of catheter apparatus having a laceration device comprising a wire configured to laceration tissue when energized in a retracted configuration in accordance with aspects of the disclosure;

[0083] FIG. 45 illustrates a cross-sectional view of the catheter apparatus in FIG. 44 with the laceration device in a deployed configuration in accordance with aspects of the disclosure;

[0084] FIG. 46 illustrates a laceration device comprising a wire configured to laceration tissue when energized in accordance with aspects of the disclosure;

[0085] FIG. 47 illustrates a portion of a catheter apparatus having a slot that the laceration device can translate along in accordance with aspects of the disclosure;

[0086] FIG. 48 schematically illustrates a catheter apparatus having a distal attachment device with one or more tines attached to a left ventricle of a heart and a laceration device having a wire lacerating a portion of a septal wall of a heart in accordance with aspects of the disclosure;

[0087] FIG. 49 schematically illustrates a catheter apparatus having a laceration device configured to bend into a deployed configuration when an end of the laceration device is linearly translated relative to the other end of the laceration device, where the laceration device is shown in the retracted configuration in FIG. 49;

[0088] FIG. 50 schematically illustrates the catheter apparatus shown in FIG. 49 where the laceration device is in the deployed configuration;

[0089] FIG. 51 schematically illustrates a catheter comprising a laceration device extending between a distal attachment device and a guiding rod;

[0090] FIG. 52 schematically illustrates a catheter apparatus having a distal attachment device that punctures a septum of a heart and has a guiding rod attached to a laceration device movably attached to the distal attachment device for lacerating a portion of a septal wall of the heart in accordance with aspects of the disclosure;

[0091] FIG. 53 schematically illustrates a catheter apparatus having a distal attachment device that punctures the septum and has a laceration device configured to be positioned within a septum of the heart to lacerate a portion of a septal wall of a heart in accordance with aspects ofthe disclosure;

[0092] FIG. 54 schematically illustrates the catheter apparatus of FIG. 53, the laceration device expands within septal wall to lacerate a portion of a septal wall of a heart in accordance with aspects of the disclosure;

[0093] FIG. 55 schematically illustrates a catheter apparatus comprising a first catheter having a magnet and laceration device configured to lacerate a portion of a septal wall of a heart in accordance with aspects of the disclosure in conjunction with a second catheter having a magnetic monitoring device positioned in the right ventricle of the heart in accordance with aspects of the disclosure;

[0094] FIG. 56 schematically illustrates a catheter apparatus having a laceration device extending between a first distal attachment device and a second distal attachment device that extend through an entire thickness of a septum of a heart for lacerating a portion of a septal wall of a heart in accordance with aspects of the disclosure;

[0095] FIG. 57 schematically illustrates a catheter apparatus having one or more wires configured to extend through a wire aperture of first catheter to a distal end of second catheter in accordance with aspects of the disclosure;

[0096] FIG. 58 schematically illustrates a catheter apparatus having one or more wires configured contact an inner surface of a left ventricle of the heart to bias a laceration device towards a septal wall of the heart to lacerate a portion of a septal wall of a heart in accordance with aspects of the disclosure;

[0097] FIG. 59 schematically illustrates a catheter apparatus comprising a laceration device configured in a deployed configuration extending through an aperture in accordance with aspects of the disclosure;

[0098] FIG. 60 schematically illustrates a catheter apparatus comprising a distal attachment device having one or more apertures that a vacuum is configured to be drawn through in accordance with aspects of the disclosure;

[0099] FIG. 61 is a side view of the catheter apparatus shown in FIG. 60;

[0100] FIG. 62 schematically illustrates a catheter apparatus having a laceration aperture that a laceration device is configured to extend through that is positioned between a pair of rows of apertures a vacuum is configured to be drawn through in accordance with aspects of the disclosure;

[0101] FIG. 63 is a side view of catheter apparatus shown in FIG. 62 with a laceration device extending through the laceration aperture;

[0102] FIG. 64 schematically illustrates a laceration device having a laceration devicepositioned between a distal attachment device and a proximal attachment device, where the distal attachment device and the proximal attachment device are configured to pull a vacuum through an aperture therein;

[0103] FIG. 65 is a cross-sectional view of a catheter apparatus configured to change orientation when an electrical potential is applied in accordance with aspects of the present disclosure;

[0104] FIG. 66 is a cross-sectional view of a catheter apparatus configured to change orientation when an inner member is mechanically translated and / or rotated relative to a body of the catheter apparatus in accordance with aspects of the present disclosure;

[0105] FIG. 67 schematically illustrates a catheter apparatus having a laceration device extending through a septal wall as part of lacerating a portion of the septal wall in accordance with aspects of the disclosure;

[0106] FIG. 68 schematically illustrates a catheter apparatus having a laceration device comprising a wire configured to lacerate a portion of the septal wall in accordance with aspects of the disclosure;

[0107] FIG. 69 schematically illustrates a catheter apparatus in an expanded configuration in accordance with aspects of the disclosure;

[0108] FIG. 70 is an enlarged view 69 of the catheter apparatus shown in FIG. 69;

[0109] FIG. 71 schematically illustrates the catheter apparatus of FIG. 69 in a left ventricle of a heart and configured to lacerate a portion of the septal wall in accordance with aspects of the disclosure;

[0110] FIG. 72 schematically illustrates a catheter apparatus in a curved configuration positioned in left ventricle of a heart and configured to lacerate a portion of the septal wall in accordance with aspects of the disclosure

[0111] FIG. 73 illustrates a front view of a laceration device that tapers towards its midpoint in accordance with aspects of the present disclosure;

[0112] FIG. 74 schematically illustrates a catheter apparatus having a laceration device comprising a skiver blade lacerating a septal wall of a heart in accordance with aspects of the present disclosure;

[0113] FIG. 75 schematically illustrates an alternative catheter apparatus having a laceration device for lacerating a septal wall of a heart in accordance with aspects of the present disclosure;

[0114] FIG. 76 schematically illustrates a catheter apparatus having a laceration device configured to lacerate a septal wall of a heart using electromagnetic radiation in accordance withaspects of the present disclosure;

[0115] FIG. 77 is an enlarged view 77 of the catheter apparatus shown in FIG. 76;

[0116] FIG. 78 schematically illustrates a catheter apparatus having a bladed laceration device configured to lacerate a septal wall of a heart in accordance with aspects of the present disclosure; and

[0117] FIG. 79 schematically illustrates the catheter apparatus shown in FIG. 79 positioned in a left ventricle of the heart lacerating the septal wall of the heart in accordance with aspects of the present disclosure;

[0118] FIG. 80 schematically illustrates a cross-sectional view of a catheter apparatus having a laceration device extending between a pair of distal attachment devices in accordance with aspects of the present disclosure, where the distal attachment devices have a helical shape; and

[0119] FIG. 81 schematically illustrates the catheter apparatus shown in FIG. 80 positioned in a left ventricle of the heart lacerating the septal wall of the heart in accordance with aspects of the present disclosure;

[0120] FIG. 82 schematically illustrates a laceration device comprising an exposed section of wire in accordance with aspects of the present disclosure;

[0121] FIG. 83 schematically illustrates a cross-sectional perspective view of a laceration device comprising an electrically conductive core circumferentially surrounded by a braided cable in accordance with aspects of the present disclosure;

[0122] FIG. 84 schematically illustrates a cross-sectional view of the catheter apparatus shown in FIG. 80, where the catheter apparatus comprises two lumens corresponding to the two distal attachment devices in accordance with aspects of the present disclosure;

[0123] FIG. 85 schematically illustrates a cross-sectional view of the catheter apparatus shown in FIG. 86;

[0124] FIG. 86 schematically illustrates a cross-sectional view of a catheter apparatus having a laceration device extending between a pair of distal attachment devices in accordance with aspects of the present disclosure, where the distal attachment devices are clips; and

[0125] FIG. 87 schematically illustrates the catheter apparatus shown in FIG. 86 positioned in a left ventricle of the heart lacerating the septal wall of the heart in accordance with aspects of the present disclosure.DETAILED DESCRIPTION

[0126] Aspects will now be described more fully hereinafter with reference to the accompanying drawings in which example aspects are shown. Whenever possible, the samereference numerals are used throughout the drawings to refer to the same or like parts. However, this disclosure may be embodied in many different forms and should not be construed as limited to the aspects set forth herein.

[0127] As used herein, the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not, and need not be, exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art. Ranges can be expressed herein as from “about” one value, and / or to “about” another value. When such a range is expressed, aspects include from the one value to the other value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. The terms “substantial,” “substantially,” and variations thereof as used herein are intended to represent that a described feature is equal or approximately equal to a value or description. For example, a “substantially planar” surface is intended to denote a surface that is planar or approximately planar. Moreover, “substantially” is intended to denote that two values are equal or approximately equal. The term “substantially” may denote values within about 10% of each other, for example, within about 5% of each other, or within about 2% of each other.

[0128] Unless otherwise expressly stated, it is in no way intended that any methods set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus, specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred in any respect. This holds for any possible non-express basis for interpretation, including matters of logic relative to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of aspects described in the specification.

[0129] As used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise. As used herein, the terms “comprising,” “including,” and variations thereof shall be construed as synonymous and open-ended, unless otherwise indicated. A list of elements followingthe transitional phrases comprising or including is a non-exclusive list, such that elements in addition to those specifically recited in the list may also be present. The word “exemplary,” “example,” or various forms thereof are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “exemplary” or as an “example” should not be construed as preferred or advantageous over other aspects or designs. Furthermore, examples are provided solely for purposes of clarity and understanding and are not meant to limit or restrict the disclosed subject matter or relevant portions of this disclosure in any manner. It can be appreciated that myriad additional or alternate examples of varying scope could have been presented but have been omitted for purposes of brevity.

[0130] Modifications may be made to the instant disclosure without departing from the scope or spirit of the claimed subject matter. Unless specified otherwise, “first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc. For example, a first end and a second end generally correspond to end A and end B or two different ends.

[0131] Directional terms as used herein - for example up, down, right, left, front, back, top, bottom, upper, lower, etc. - are made only with reference to the figures as drawn and are not intended to imply absolute orientation. Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” may be used in the following description with reference to one or more structures of the catheter apparatus (e.g., proximal attachment device, distal attachment device, laceration device) and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudoelastic metal such as a nickel -titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof include polymers such as polynorbornene, trans-polyisoprene, styrenebutadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprolactone copolymer, and poly cyclo-octene can be used separately or in conjunction with other shape memory polymers.

[0132] With reference to FIG. 6, an enlarged septum 770 (e.g., septal hypertrophy) can cause the septal wall 170 to bulge out into the left ventricle 130 of the heart 120. Further, as shown, a left ventricle outflow tract 720 (LVOT) can be obstructed (causing LVOT obstruction (LVOTO) or otherwise restricted (e.g., note the narrow passage between the mitral valve and the septal wall of the enlarged septum). By lacerating a portion of the septal wall (e.g., corresponding to a portion of the septal wall in or proximate the LVOT), the LVOT can be enlarged (e.g., by a lacerated portion of the septal wall retracting). Enlarging the LVOT (e.g., ameliorating septal hypertrophy) can improve patient outcomes and / or create sufficient volume of the LVOT to enable implanting of a prosthetic heart valve to replace a preexisting heart valve (e.g., a native aortic heart valve, or preexisting prosthetic aortic heart valve) without impairing or otherwise impeding a function of the heart. Further, providing a catheter apparatus that can lacerate a portion of the septal wall (e.g., perform a septal myotomy) in a minimally invasive manner can facilitate improved patient outcomes (e.g., relative to surgical interventions or forgoing any intervention).

[0133] FIGS. 3-4 schematically illustrates exemplary catheter apparatus 30 and 601 including a handle 33 and 611 at a proximal end thereof. As shown in FIG. 3, the catheter apparatus includes a proximal end 32, a distal end 31, and the handle 33. The handle 33 enables a physician to manipulate a distal portion (e.g., distal end 31) of the catheter apparatus 30 and includes actuators for moving parts of the catheter apparatus 30 relative to other parts. For example, as shown in FIG. 3, an outer catheter 34 of the catheter apparatus 30 is coupled to an actuator 39 of the handle 33, which can move the outer catheter 34 relative to another portion of the catheter apparatus (e.g., an inner catheter - not shown). In further aspects, the catheter apparatus can include an inner catheter and / or control wires (not shown) that may be coupled to the handle 33 and movement of the handle 33 corresponds to movement of the inner catheter or other components at the distal end 37 of the catheter apparatus 30 (e.g., distal end of the inner catheter and / or outer catheter). In such aspects, the inner catheter and associated distal end 37 may also be translated relative to the outer catheter 34 and the handle 33. The various configurations and / or components of the distal end of the catheter apparatus will be discussed in further detail below. Consequently, it is to be understood that the distal end of the catheter apparatus shown in FIG. 3 may apply to some aspects and does not necessarily apply to other aspects of the present disclosure. The distal end of the catheter apparatus includes a laceration device, which can be contained by a housing and / or a catheter (e.g., outer catheter). In aspects, as shown in FIG. 3, a housing containing a laceration device of the laceration device can appear as the capsule 35, where the capsule 35 is configured to be retracted when inserted in the heart to reveal the laceration device.

[0134] As shown in FIG. 4, the handle 611 of the catheter apparatus 601 can compriseone or more actuators (e.g., see actuator 39 in the handle 33 in FIG. 3). In aspects, as shown, the one or more actuators can include toggles or sliders (e.g., actuators 633 and / or 643 as part of a larger section (e.g., section 631 and / or 641) of the handle 611) and / or a rotatable or other translatable actuator (e.g., actuators 625 and / or 635). In aspects, as shown, the handle can comprise two or more sections 621, 631, and / or 641 (e.g., three or more sections, three sections). For example, a first section 641 and / or a first actuator 643 can be configured to adjust (e.g., control) a position and / or an orientation of an outer catheter or sheath (not shown - see distal end 813 of outer catheter 811 in FIGS. 7, 9 11-12, and 17-19) or even control a proximal attachment device (not shown - see FIGS. 9, 10A-10B and 11-12). A second section 631 of the handle 611 of the catheter apparatus 601 can comprise one or more actuators 633 and / or 635 configured to manipulate a laceration device and / or housing or capsule containing a laceration device (not shown - see laceration device 850 in FIGS. 8-9, 11-12, and 17-18). In further aspects, the second section 631 can comprise a second actuator 635 configured to adjust (e.g., control) an orientation of the laceration device and / or housing (e.g., rotationally). For example, when the catheter apparatus has a housing containing and / or covering the laceration device, the second actuator 635 (or another actuator in the second section 631) can adjust a position (e.g., retracting a housing corresponding to the capsule 35 shown in FIG. 3) of a housing (e.g., relative to the laceration device) and / or an orientation of the housing (e.g., relative to the laceration device - an alignment of an aperture of the housing and the laceration device). In further aspects, the second section 631 can comprise a third actuator 633 configured to adjust (e.g., control) a configuration (e.g., deployed configuration versus retracted configuration) of the laceration device, for example by translating the third actuator 633. Additionally, as shown, the second section 631 can translate independently from the first section 641 and / or the third section 621, which can control a position of the laceration device relative to an outer catheter (e.g., distal end of the outer catheter) and / or an inner catheter (e.g., first catheter and / or distal end thereof), for example allowing the laceration device to translate along a path corresponding to a length of a portion of the septal wall to be lacerated. Athird section 621 can comprise a fourth actuator 625 and / or a fifth actuator 623. In further aspects, the fourth actuator 625 and / or a relative position of the third section 621 relative to the first section 641 can be configured to adjust (e.g., control) a position of an inner catheter (e.g., first catheter - a distal end of the inner catheter or first catheter) relative to the outer catheter. In further aspects, the fifth actuator 623 can be configured to adjust (e.g., control) an orientation and / or configuration (e.g., deployed configuration versus retracted configuration) of a distal attachment device (not shown - see distal attachment device 860, 940, and / or 1701 in FIGS. 8-9 and 17-18). It is to be understood that the handle of the catheter apparatus within the scope of the present disclosure can include twosections (see FIG. 3), three sections (see FIG. 4) or any number of sections. It is to be understood that the handle of catheter apparatus within the scope of the present disclosure can include some, all, or more than the actuators discussed with reference to FIG. 4 in this paragraph.

[0135] In aspects, the catheter apparatus 30 shown in FIG. 3 (e.g., including the handle 33) can be physically supported and / or manipulated by a physician (e.g., without the cradle shown in FIG. 4) while inserted in the patient and / or performing methods in accordance with the present disclosure (e.g., performing a septal myotomy). Alternatively, in aspects, as shown in FIG. 4, the catheter apparatus 601 can be supported by and / or secured in the cradle 500. In further aspects, as shown in FIG. 4, the cradle 500 comprises a base 510 and an inclined track that two or more supports 520, 530, and / or 540 (e.g., three supports) can translate along. In even further aspects, the cradle 500 can comprise a first support 540 configured to support or otherwise secure a position of the first section 641 of the handle 611 of the catheter apparatus 601. In still further aspects, a position of the first support 540 in the cradle can be fixed (with the other supports translatable relative to the first section), although the first support can be configured to translate relative to the base 510 in other aspects. In even further aspects, the cradle 500 can comprise a second support 530 configured to support or otherwise secure a position of the second section 631 of the handle 611 of the catheter apparatus 601. In still further aspects, a position of the second support 530 along the track of the cradle 500 can be adjusted using a first controller 513 (e.g., first knob). Adjusting a position of the second support 530 relative to the first support 540 (i.e., first distance 501 defined as a distance between the second support 530 relative to the first support 540) can, in turn, adjust a relative positioning of the laceration device relative to the outer catheter or sheath at the distal end of the catheter apparatus. For example, as shown, the second support 530 can translate along the track of the cradle 500 by translating a first pin 543 (attached to the second support 530) along a first slot 531 in the cradle 500. In even further aspects, the cradle 500 can comprise a third support520 configured to support or otherwise secure a position of the third section 621 of the handle 611 of the catheter apparatus 601. In still further aspects, a position of the third support 520 along the track of the cradle 500 can be adjusted using a second controller 511 (e.g., second knob). Adjusting a position of the third support 520 relative to the first support 540 and / or the second support 530 (i.e., second distance 503 defined as a distance between the third support 520 relative to the second support 530) can, in turn, adjust a relative positioning of the distal end of an inner catheter (e.g., first catheter) relative to the laceration device of the catheter apparatus.

[0136] For example, as shown, the third support 520 can translate along the track of the cradle 500 by translating a second pin 533 (attached to the third support 520) along a second slot521 in the cradle 500. In yet further aspects, as shown, adjusting a position of the second support530 relative to the first support 540 (i.e., first distance 501) can also adjust a position of the third support 520 relative to the first support 540 while maintaining a distance between the third support 520 and the second support 530 (i.e., second distance 503), for example, by the second pin 533 and the third support 520 being movably attached to the first pin 543 and the second support 530. Alternatively, the cradle may have only two supports in other aspects, for example, either (1) supporting a first section controlling a position of a laceration device and a second section controlling a distal end of a first catheter (e.g., distal attachment device) or (2) supporting a first section controlling a position of an outer catheter or sheath (e.g., proximal attachment device) and a second section controlling a laceration device. Also, it is to be understood that the cradle may have additional supports that serve to reinforce the supports shown in FIG. 4 and translate with the corresponding support. Additionally, it is to be understood that the cradle may have additional supports that can move relative to the other supports, for example, with the number of supports corresponding to a number of sections in the handle of the catheter apparatus.

[0137] The catheter apparatus of the present can be inserted in a patient (e.g., in the patient’s vasculature) as part of a minimally invasive percutaneous interventional procedure, including ameliorating septal hypertrophy (e.g., septal myotomy). Minimally invasive percutaneous interventional procedures, including cardiac procedures, require access to the venous or arterial system. In general, it is desirable to make the smallest incision point with the shortest tissue contact time when entering the body. Small incisions and short tissue contact time generally lead to improved patient outcomes, less complications, and less trauma to the vessels or organs being accessed, as well as less trauma to the skin and tissue through which the access point is created. In medical procedures including ameliorating septal hypertrophy (e.g., septal myotomy), access site trauma can occur, often resulting in vessel damage, excessive bleeding, increased case time, increased risk of infection, and increased hospitalization time if care is not taken. To reduce access trauma, physicians try to use the smallest devices possible and place the smallest sheath size. As discussed herein, a maximum cross-sectional dimension of the catheter apparatus can be less than or equal to 22 French (e.g., 23 mm circumference and / or 7.3 mm outer diameter), less than or equal to 20 French (e.g., 21 mm circumference and / or 6.7 mm outer diameter), less than or equal to 18 French (e.g., 19 mm circumference and / or 6.3 mm outer diameter), less than or equal to 16 French (e.g., 17 mm circumference and / or 5.3 mm outer diameter), or less than or equal to 15 French (e.g., 16 mm circumference and / or 5.0 mm outer diameter) that can facilitate minimal trauma. Also, the catheter apparatus can be inserted with a sheath, for example an expandable sheath that can facilitate navigation of vasculature and / or orientation of the catheter apparatus. Expandable sheaths can be expanded within the body and thus do not require removal to upsize.Expandable sheath designs may be regionally or locally expansive to selectively and temporarily expand when necessary (e.g., a larger portion of the catheter apparatus) is passing through a region of the sheath and to retract or recover when the device is not passing or has already passed through the sheath. Aspects disclosed herein may be employed with an expandable introducer sheath that may solve these and other issues that contribute to vascular trauma. Various aspects disclosed herein may include an introducer sheath that has a selectively expandable diameter to allow for the passage of a relatively larger device therethrough and further is configured to return to its original diameter upon passage of the device. The various aspects may reduce damage to surrounding tissues by reducing contact with those tissues and by eliminating the need to exchange sheaths of different sizes. As a result, in comparison to known sheaths, these aspects can reduce procedure time, vascular trauma, bleeding, and the resulting risk of infection and other complications. However, it should be understood that the present disclosure is not limited for use with an expandable introducer sheath. Rather, one or more features of the present disclosure can be employed either alone or in combination without an introducer sheath, with a non-expandable introducer sheath, or with an expandable introducer sheath. Likewise, if employed, the introducer sheath may be an integrated introducer sheath or a non-integrated introducer sheath.

[0138] FIGS. 1-2 schematically illustrate insertion of a catheter apparatus and navigation towards a heart 120 in accordance with aspects of the disclosure. In aspects, the catheter apparatus (and / or introducer sheath) can be inserted into and / or navigated through one or more arteries (e.g., leading to or itself being the aorta 80 - see FIG. 1) to reach the heart 120 (e.g., proximate an aortic valve 210 of the heart and / or through the aortic valve 210 - see FIG. 2). For example, as shown in FIGS. 1-2, the catheter apparatus (and / or introducer sheath) can pass through the ascending aorta 100 towards the heart 120. In further aspects, as shown in FIG. 1, the catheter apparatus can be inserted percutaneously into a femoral artery 110 (e.g., at insertion location 160). Alternatively, as shown in FIG. 2, the catheter apparatus can be inserted percutaneously into a carotid artery 230 (e.g., at insertion location 260). The insertion location 160 and / or 260 can correspond to an initial incision in the skin of the patient to allow an introducer sheath 75 (e.g., expandable introducer sheath) and / or catheter apparatus to be inserted in the vasculature. Although not shown, the introducer sheath can have a tubular shaft and a proximal hub with a hemostatic seal and a luer lock. As discussed above, the catheter apparatus can be advanced within the introducer sheath and the introducer sheath can expand and / or deform a location where the distal end of the catheter apparatus passes through, where the introducer sheath can retract or recover its original diameter after the distal end of the catheter has passed therethrough (or removed from the corresponding portion of the introducer sheath). As one non-limiting example, the introducer sheath 75 isdescribed as being an expandable introducer sheath 75 for introduction of a laceration device including the catheter apparatus. In further aspects, as shown in FIGS. 2 and 6, the introducer sheath 75 and / or the catheter apparatus (e.g., distal end 813 of an outer catheter 811 (second catheter)) can extend to the heart 120, for example, past the aortic arch 220 to a location proximate the aortic valve 210. In even further aspects, as shown in FIGS. 2 and 7, the introducer sheath 75 and / or the catheter apparatus 730 (e.g., distal end 813 of an outer catheter 811 (or second catheter)) into a left ventricle 130 of the heart 120, for example, towards an apex 140 of the heart 120.

[0139] Aspects and embodiments of the distal end of the catheter apparatus in accordance with aspects of the present disclosure will now be discussed with reference to FIG. 8 with further embodiments discussed below with reference to additional figures. In aspects, as shown in FIG. 8, the catheter apparatus 730 can comprise a laceration device 850 and optionally one or more of a distal attachment device 860 and / or a proximal attachment device 840. As used herein, the distal attachment device 860 is distal from the handle (see FIGS. 3-4) relative to the laceration device 850, and the proximal attachment device 840 is proximal to the handle relative to the laceration device 850. In further aspects, as shown, the distal attachment device 860 can be attached to a portion of the left ventricle 130 at a location proximate an apex 140 of the heart. It is to be understood that the distal attachment device 860 can attach to a portion of a septal wall 170 while still being proximate the apex 140 (e.g., relative to the laceration device 850). In further aspects, the distal attachment device 860 can be at the distal end of the catheter apparatus 730, for example, at a distal end 933 of an inner catheter 931 (e.g., inner catheter). In further aspects, the distal attachment device 860 can be configured to attach to a portion of the left ventricle 130 by mechanical means (e.g., extending one or more tines, deploying one or more cleats, extending a needle, rotating a helical wire, pulling a control wire, pushing a rod) through cryo-thermal adhesion, or by pulling a vacuum, although other features are possible in other aspects. Further aspects of the distal attachment device are discussed below with reference to FIGS. 9, 13A-19, 51- 53, and 60-64. Alternatively, as discussed below with reference to FIGS. 57-58, the distal attachment device can contact (e.g., push against) an inner surface of a left ventricle of a heart in order to bias the laceration device towards (e.g., into) the septal wall of the heart. Providing a distal attachment device can facilitate precise and / or accurate positioning of the laceration device and / or laceration of a portion of the septal wall. Since the catheter apparatus can be used in the heart while the heart is still beating, the distal attachment device can aid in maintaining a relative positioning of the catheter apparatus (e.g., laceration device) in the heart (e.g., left ventricle, position along the septal wall). Further, providing a distal attachment device can facilitate control of the laceration device such that laceration of non-target locations and / or structures (e.g., chordae, aortic valve,mitral valve) is minimized if not avoided entirely.

[0140] In further aspects, as shown in FIG. 8, the catheter apparatus 730 can comprise a proximal attachment device 840 that is configured to be positioned proximate the aortic valve 210. In even further aspects, as shown, the proximal attachment device 840 can be attached to an outer catheter 811 (e.g., distal end of a second catheter, where the second catheter can surround at least a portion of the first catheter). In even further aspects, the proximal attachment device can be an expandable device (e.g., mesh or balloon) that contacts the walls of the corresponding physiological structure (e.g., ascending aorta) while allowing the flow of blood therethrough. Alternatively, as shown in FIG. 12, when a prosthetic heart valve 1201 is placed in the aortic valve 210 (e.g., prosthetic aortic valve replacement, transcatheter prosthetic heart valve), the proximal attachment device 901 (e.g., mesh 902 - expandable mesh shown in FIGS. 9 and 10A-10C, one or more balloons 1101 (e.g., balloon 1105) shown in FIG. 11, or one or more cleats 1503 shown in FIG. 15) can be positioned within the left ventricle (rather than in the ascending aorta) while still being proximate the aortic valve 210. Alternatively, the catheter apparatus can provide stability for the laceration device 850 by positioning (e.g., wedging) a portion of the catheter apparatus (e.g., at the location indicated by the proximal attachment device) against a corresponding physiology (e.g., wall of the ascending aorta, aortic valve). In aspects, providing a proximal attachment device and / or pushing a portion of the catheter apparatus (e.g., at the location indicated by the proximal attachment device) against a corresponding physiology can position the catheter apparatus towards one end of the aortic valve or the other (e.g., left or right side of the cross-sectional views shown in FIGS. 9 and 11), which can facilitate operation of the laceration device. For example, the proximal attachment device can position the catheter apparatus towards a side of the aortic valve 210 (and / or ascending aorta) opposite the septal wall 170 (e.g., the catheter apparatus positioned closer to and / or in contact with the physiology on the right side than the left side in FIG. 11). Alternatively, the proximal attachment device can position the catheter apparatus towards a side of the aortic valve 210 (and / or ascending aorta) in line with the septal wall 170 (e.g., the catheter apparatus positioned closer to and / or in contact with the physiology on the left side than the right side in FIG. 9).

[0141] Further aspects of the proximal attachment device are discussed below with reference to FIGS. 9-12 and 15. Providing a proximal attachment device or otherwise contacting physiology with a proximal portion of the catheter apparatus in or near the heart can facilitate precise and / or accurate positioning of the laceration device and / or laceration of a portion of the septal wall (either on its own or in combination with a distal attachment device). Additionally, providing both a proximal attachment device (or wedging a corresponding portion of the catheterapparatus in a corresponding physiology) and a distal attachment device can provide a well-defined pathway that the laceration device can be positioned along and / or translate along (e.g., while lacerating a portion of the septal wall). Alternatively, as shown in FIG. 64, the proximal attachment device 840 (e.g., positioned at a distal end 6413 of an outer catheter 6411) can comprise a nozzle 6451 comprising an aperture (not shown), where a vacuum (see arrow 6452) is configured to be pulled through the aperture of the nozzle 6451. Alternatively, as shown in FIG. 19, the catheter apparatus can comprise a laceration device 1940 without a proximal attachment device and / or a distal attachment device.

[0142] In aspects, as shown in FIG. 8, the catheter apparatus 730 comprises a laceration device 850 that is configured to contact the septal wall 170 and laceration a portion of the septal wall. In further aspects, the laceration device 850 comprises a blade or a wire that can lacerate tissue when energized (e.g., radio-frequency (RF) laceration). For example, shown in FIGS. 42- 46, 49-54, 56, 58, 63-64, 67-70, 72, 75, 80-81, and 86 the laceration device 850, 4221, 4421, 4621, 4921, 5123, 5321, 5621, 6321, 6421, 6721, 6821, 6921, 7221, 7523, 8021, or 8621 comprises a wire 4223, 4423, 4623, 4923, 5123, 5323, 5623, 6323, 6423, 6723, 6823, 6923, 7223, 7523, 8023, or 8223 that can lacerate tissue when energized (e.g., radio-frequency (RF) laceration). As shown in FIGS. 46 and 82, the wire 4623 or 8223 can comprise (e.g., an insulated portion 4601 having) insulation 4603, 8213, and / or 8215 around the wire 4623 or 8023 to isolate the energy to the laceration device 4621 other than an exposed portion (between ends 8225 and 8227 - exposed length 8229) to isolate the energy of the laceration device 4621 or 8221 and / or concentrate the energy at the exposed portion to facilitate laceration of tissue there. In aspects, a size, material, shape, and / or arrangement (e.g., twisted or otherwise braided) can be selected to provide stiffness to the laceration device (e.g., wire) such that the laceration device can lacerate tissue (e.g., of the septal wall) when energized at a predetermined location (or along a predetermined path), for example, without significant deflection. In further aspects, as shown in FIGS. 42-46, the wire 4223, 4423, or 4623 of the laceration device 4221, 4421, or 4621 can be bent, for example, to provide a hairpin 4225, 4425, or 4625. Providing the hairpin can increase a stiffness of the wire, concentrate the energy to improve an efficacy of laceration when energized, and / or provide a predetermined width of the laceration device to contact the tissue of the septal wall to be lacerated. In even further aspects, as shown in FIGS. 44-45, an end of the wire 4423 can be crimped (see crimp 4427) to another section of the wire 4423, which can further provide stability to the laceration device by maintaining a predetermined configuration of the wire 4423 even when subjected to loads expected during use. Alternatively, as shown in FIG. 72, the wire 7223 can adopt a curved configuration that can provide additional stability to the laceration device 7221.Alternatively, as shown in FIG. 46, the wire 4623 can be bent (e.g., hairpin 4625) without being crimped (see gap 4607). Similarly, as shown in FIGS. 42-43, a predetermined configuration of the wire 4423 can be maintained by attaching the wire to a common structure (e.g., pivot point 4429) at locations 4224 and 4226 on either side of the portion (e.g., hairpin 4225 - with sections of wire 4223 and 4227 therebetween) configured to lacerate tissue of the septal wall when energized. Alternatively, as shown in FIGS. 51-52, a predetermined section of wire 5123 can extend between a distal attachment device (e.g., rod 5131, needle) and a guiding rod 5141; in aspects, the wire 5123 can be attached to a distal end 5143 of the guiding rod 5141 such that translating the guiding rod 5141 can progress the wire along the rod 5131, and / or a distance and / or orientation between the distal attachment device (e.g., rod 5131, needle) and the guiding rod 5141 can maintain tension on the wire 5123. Likewise, as shown in FIG. 68, the wire 6823 can extend between two attachments (e.g., distal attachment device 6831 and proximal anchor 6835) such that tension can be applied to the wire 6823 by translating the wire through one of these attachments (see arrow 6804). Alternatively, as shown in FIGS. 63-64, a distance 6359 (see FIG. 63) that the wire 6423 extends beyond the inner catheter 6431 (e.g., wall 6433) can be controlled by extending the wire 6423 (see arrow 6402), although an end of the wire can be translated (e.g., brought together with and / or relative to an opposite end of the wire) to adjust this distance. Alternatively, as shown in FIG. 58, the wire 5723 can be wrapped around a portion (e.g., body 5715) of the outer catheter 5711 of the catheter apparatus 5701. Alternatively, as shown in FIGS. 70 and 75, the wire 6923 and 7523 can be connected to and / or extend around another structure (e.g., hook 6961, foot 7525) that facilitates maintenance of a predetermined configuration of the wire 6923 and 7523 during the laceration. Alternatively or additionally, as shown in FIG. 83, the laceration device 8321 can comprise a braided cable 8311 (e.g., cables 8313a-8313f that may be electrically insulating or otherwise physically separated from the electrically conductive core 8323) that can circumferentially surround an electrically conductive core 8323 extending therethrough, although the electrically conductive core can be exposed at a location (e.g., see exposed length 8229 of the wire 8223 in FIG. 82). Additionally or alternatively, although not shown, the laceration device (e.g., wire 8723 in FIG. 87 or braided cable as the laceration device 8321 in FIG. 83) can comprise a polygonal cross-sectional shape (e.g., triangular, although other polygonal shapes including quadrilateral, pentagonal, hexagonal, heptagonal, octagonal can be provided in other aspects), which can enable a portion of the laceration device corresponding to an edge of the cross-sectional polygonal shape to lacerate tissue - in addition to any laceration occurring due to energizing the laceration device. Additionally or alternatively, a cross-sectional shape of the laceration device (e.g., braided cable as the laceration device 8321 in FIG. 83 and / or cable saw) can lacerate tissue by abrading tissueas the laceration device is translated along the septal wall, as discussed below.

[0143] Alternatively, as shown in FIGS. 19-30, 33-37, 39-41, 59, 74, and 78, the laceration device 1940, 2021, 2421, 2721, 3521, 4021, 5721, 7421, or 7821 comprises a blade 1935, 2023, 2423, 2723, 3523, 4023, 5923, 7423, or 7825. The laceration device 850 can be configured to transition between a retracted configuration and a deployed configuration. In the deployed configuration, the laceration device can contact the septal wall 170, for example by extending beyond a catheter (e.g., first catheter, outer catheter) and / or a housing. In the retracted configuration, the laceration device can be contained within one or more structures in the catheter apparatus (e.g., first catheter, outer catheter, and / or a housing). In aspects, the laceration device 850 can be contained in a housing with an aperture that the laceration device can extend through, although the laceration device can be contained in the catheter apparatus (e.g., first catheter, outer catheter) without a housing in other aspects. In aspects, as shown in FIGS. 20, 23-26, and 57 a housing 2011, 2411, and 5731 can surround at least a portion of the inner catheter 1711 and 2441. Alternatively, in aspects, as shown in FIGS. 27A-27B, 28-30, and 34, the housing 2735 can be contained within (e.g., a cross-sectional footprint, in a retracted configuration) a first catheter 2707 (e.g., inner catheter, wall 2715). Alternatively, as shown in FIG. 76, the laceration device can rely on electromagnetic radiation in the form of a light beam (e.g., laser beam 7633).

[0144] Further aspects of the laceration device are discussed below with reference to FIGS. 19-79. The laceration device (and the catheter apparatus more generally) can ameliorate septal hypertrophy by lacerating a portion of the septal wall (e.g., a septal myotomy). With reference to FIG. 6, an enlarged septum 770 (e.g., septal hypertrophy) can cause the septal wall 170 to bulge out into the left ventricle 130 of the heart 120. Further, as shown, a left ventricle outflow tract 720 (LVOT) can be obstructed (causing LVOT obstruction (LVOTO 710) or otherwise restricted (e.g., note the narrow passage between the mitral valve and the septal wall of the enlarged septum). By lacerating a portion of the septal wall (e.g., corresponding to a portion of the septal wall in or proximate the LVOT), the LVOT can be enlarged (e.g., by the lacerated portion of the septal wall retracting). Enlarging the LVOT (e.g., ameliorating septal hypertrophy) can improve patient outcomes and / or create sufficient volume of the LVOT to enable a prosthetic heart valve to be placed in the heart (e.g., transcatheter prosthetic heart valve, prosthetic replacement aortic valve - see FIG. 12) without impairing or otherwise impeding a function of the heart. Further, providing a catheter apparatus that can lacerate a portion of the septal wall (e.g., perform a septal myotomy) in a minimally invasive manner can facilitate improved patient outcomes (e.g., relative to surgical interventions or forgoing any intervention).

[0145] Now, aspects of the proximal attachment device 840 (see FIG. 8) will bediscussed with reference to FIGS. 9-12, 15, 36, 39, and 46. In aspects, as shown in FIGS. 15, 36, and 39, the proximal attachment device can comprise one or more cleats 1503, which is discussed in further detail below with reference to its use as a distal attachment device. In aspects, as shown in FIGS. 9, 10A-10C, and 12, the proximal attachment device 901 can be a mesh 902 (e.g., expandable mesh). As shown in FIGS. 10A-10C, the mesh 902 can comprise a plurality of cells 905 that allow the flow of fluids (e.g., blood) therethrough. In further aspects, as shown in FIG. 9, the proximal attachment device 901 (e.g., mesh 902) can extend from the distal end 813 of the outer catheter 811 (e.g., second catheter). In further aspects, as shown in FIG. 10A, the mesh 902 can comprise a first aperture 903, where the outer catheter 811 (e.g., second catheter) can extend therethrough as shown in FIGS. 10B-10C. In even further aspects, as shown in FIG. 10A, the first aperture 903 can be off-center (e.g., spaced away from a centroid of the mesh 902), which can enable the catheter apparatus to be supported and / or secured at the location of the proximal attachment device without impairing or otherwise impeding navigation of the catheter apparatus through the vasculature and heart physiology. In further aspects, as shown in FIGS. 10B-10C, the proximal attachment device 901 (e.g., mesh 902) can be configured to transform from a retracted configuration (FIG. 10B) to a deployed configuration (FIG. 10C) and vice versa. For example, as shown in FIG. 10B, the length of the mesh 902 along the outer catheter 811 (e.g., second catheter) can decrease (see arrow 1002) and the width of the mesh 902 (perpendicular to the length) can increase (see arrow 1004). In even further aspects, the mesh 902 can be made of a shape memory material (e.g., nitinol) or other self-expanding materials discussed above that can transition to the deployed configuration (from FIG. 10B to FIG. 10C) when released or even naturally at physiological temperatures (e.g., about 36°C). Although not shown, it is to be understood that a pull wire (or stiff rod) can be attached to one or more locations on the mesh 902 to facilitate the transition from the retracted configuration to the deployed configuration, from the deployed configuration to the retracted configuration, or both. After a portion of the septal wall is lacerated by the laceration device, the proximal attachment device 901 (e.g., mesh 902) can transition from the deployed configuration to the retracted configuration to facilitate removal of the catheter apparatus. Alternatively, as shown in FIG. 64, the proximal attachment device 840 can comprise a nozzle 6451 comprising an aperture (not shown), where a vacuum (see arrow 6452) is configured to be pulled through the aperture of the nozzle 6451. While a small amount of blood may initially be pulled through the aperture of the nozzle 6451, it is expected that the vacuum being pulled will bring the nozzle in contact with tissue (e.g., of the septal wall or aorta) that prevents the loss of further blood; also, any blood can be collected from a liquid trap (e.g., catch basin) in-line with the vacuum to be readministered to the patient.

[0146] Alternatively, as shown in the exploded view of FIG. 11, the proximal attachment device 901 can comprise more than one aperture (e.g., first aperture 1107 and second aperture 1103). For example, two apertures 1103 and 1107 are shown, where the outer catheter 811 (e.g., second catheter) and / or the inner catheter (e.g., first catheter - attached to the laceration device 850) can extend through the first aperture 1107 while the second aperture 1103 can allow blood to flow therethrough (see arrow 1102), although additional apertures can be present in other aspects. Since the one or more balloons 1101 may not permit blood to flow therethrough in the absence of the apertures (in contrast to the mesh discussed above with reference to FIGS. 9 and 10A-10C), at least a second aperture is provided. In aspects, as shown in FIG. 11, the proximal attachment device 901 can be one or more balloons 1101 configured to expand (e.g., pneumatically) to contact corresponding physiology (e.g., walls of the ascending aorta) proximate the aortic valve 210. For example, a single balloon 1105 is shown in exploded view of FIG. 11 having the two apertures 1103 and 1107, although the apertures (e.g., two or more apertures) can be formed collectively by multiple balloons (e.g., two balloons opposite each other with the rest of the catheter apparatus extending therebetween to achieve the asymmetric position discussed above with reference to FIGS. 10A and 10C, and / or additional balloons positioned around the rest of the catheter apparatus). In aspects, as shown in the exploded view FIG. 11, the proximal attachment device 901 (e.g., one or more balloons 1101) can be attached to the outer catheter 811 (e.g., second catheter - distal portion thereof). In methods, the one or more balloons 1101 can be expanded (e.g., inflated, pneumatically filled, although the one or more balloons can be self-expanding in some aspects). Additionally, the one or more balloons 1101 can be retracted (e.g., deflated) after a portion of the septal wall is lacerated by the laceration device to facilitate removal of the catheter apparatus.

[0147] Now, aspects of the distal attachment device 860 (see FIG. 8) will be discussed with reference generally to FIGS. 13-17, 53, 64, 80, and 86 as well as FIGS. 9, 18-19, and 51-52. In aspects, as shown in FIGS. 9 and 80 (with further aspects shown in FIGS. 14A-14C), the distal attachment device 940 can have a helical shape (e.g., distal attachment devices 8019 or 8039). In further aspects, as shown in FIG. 9, the distal attachment device can be attached to (e.g., be positioned at) the distal end 933, 8013, or 8033 of the inner catheter 931, 8011, or 8031 (e.g., first catheter). In further aspects, the helical shape of the distal attachment device 940 can allow the helical distal attachment device to advance into tissue defining the left ventricle 130 (e.g., proximate the apex 140) as the helical distal attachment device is rotated. For example, as shown in FIG. 14A, the distal attachment device 1401 has a helical shape 1403 and can be positioned in channels 1406 of a structure (e.g., at the distal end of the inner catheter or first catheter) such that rotation of the distal attachment device 1401 (indicated by arrow 1402) results in the helical shapeadvancing relative to an end 1407 of the rest of the distal attachment device (indicated as downward movement in the arrangement shown in FIG. 14A). In further aspects, as indicated in FIG. 14A, the distal attachment device 1401 can be controlled by rotating a portion of the inner catheter (e.g., first catheter). Alternatively, as shown in FIGS. 14B-14C, the distal attachment device 1411 (e.g., shown in the deployed configuration 1425 and in the retracted configuration 1413) can be controlled hydraulically. In even further aspects, the helical shape of the distal attachment device can be attached to a piston 1429 that can translate in direction 1422. Due to the shape of an exit channel 1415 at the end 1407 of the rest of the distal attachment device, the piston 1429 (and the helical shaped distal attachment device) can be configured to rotate as the piston 1429 translates (e.g., linearly in direction 1422). As shown, the piston 1429 can translate within a hydraulic cylinder 1417 defining a lower chamber 1421 closer to the end 1407 and an upper chamber 1423 further from the end 1407. FIG. 14B shows the distal attachment device in a retracted configuration 1413, where the piston 1429 is far from the end 1407 due to fluid 1431 in the lower chamber 1421. The piston 1429 can advance towards the end 1407 (in direction 1422) as fluid 1431 is removed from the lower chamber 1421 (e.g., through an inner channel 1427) (as shown in FIG. 14B) and / or fluid 1431 is added (e.g., pumped) into the upper chamber 1423 (as shown in FIG. 14C). In further aspects, as shown in FIGS. 14A-14C, the helical shape 1403 (e.g., shown in the deployed configuration 1425 and in the retracted configuration 1413) of the distal attachment device 1401 and / or 1411 can be terminated with a tapered tip 1404, which can facilitate insertion of the distal attachment device 1401 and / or 1411 into tissue of the heart. It is to be understood that, (1) a position of the piston 1429 can be controlled using just the upper chamber 1423, where the upper chamber 1423 can be filled with fluid 1431 to transform the distal attachment device to the deployed configuration, and the fluid 1431 can be withdrawn from that chamber to transform the distal attachment device to the retracted configuration; (2) a position of the piston 1429 can be controlled using just the lower chamber 1421, where the upper chamber 1423 can be filled with fluid 1431 to transform the distal attachment device to the retracted configuration, and the fluid 1431 can be withdrawn from that chamber to transform the distal attachment device to the retracted configuration; or (3) both the upper chamber 1423 and the lower chamber 1421 can be selectively filled and / or emptied of fluid to control the position of the piston 1429 to transform the distal attachment device between the retracted configuration and the deployed configuration (and vice versa). When distal attachment device is initially in the retracted configuration, a position of the piston 1429 can be maintained by a saline solution in the lower chamber 1421 that can be ejected (e.g., into the left ventricle of the heart) when upper chamber 1423 is filled with the fluid 1431 to transform the distal attachment device to the deployed configuration.

[0148] In aspects, as shown in FIG. 18 (with further aspects shown in FIGS. 13A-13C), the distal attachment device 940, 1301, and / or 1311 can comprise one or more tines 1303. In further aspects, as shown, the distal attachment device 940, 1301, and / or 1311 can be attached to (e.g., be positioned at) the distal end 1833 of the inner catheter 1831 (e.g., first catheter). In further aspects, as shown, the one or more tines 1303 of the distal attachment device 940, 1301, and / or 1311 can be inserted into the tissue defining the left ventricle 130 (e.g., proximate the apex 140). Additionally, as shown, the one or more tines can curve at the corresponding distal end, which can further secure the distal attachment device in the tissue. For example, the one or more tines can curve due to a shape memory of the one or more tines or strain imposed on the one or more tines that induces a bending moment. As shown in FIGS. 13A and 18, the distal attachment device 1301 has four tines 1304a-1304d wherein three of the tines 1304a, 1304b, and 1304d are shown in FIGS. 13B-13C (with the understanding that tine 1304c is visible in the not illustrated in the cross section of FIGS. 13B-13C). Although four tines are shown, a single tine or any number of tines may be provided in further aspects. In further aspects, as shown in FIG. 13A, the one or more tines 1303 (e.g., tines 1304a-1304d) can extend (e.g., be deployed) relative to a distal end 1307 (e.g., end cap 1308) of the rest of the distal attachment device by linearly translating (see arrow 1306) a portion of the one or more tines 1303. In even further aspects, a proximal end of a corresponding tine can comprise an attachment device 1305b-1305c that can be attached to a pull wire (or stiff rod) that can convey actions made by a physician at the handle directly into linear motion of the one or more tines. Alternatively, in further aspects, as shown in FIGS. 13B-13C, the distal attachment device 1311 (e.g., shown in the deployed configuration in FIG. 13C and in the retracted configuration in FIG. 13B) can be controlled hydraulically. In even further aspects, as shown in FIGS. 13B-13C, the distal attachment device can be attached to a piston 1329 that can translate in direction 1322. The end cap 1308 can comprise one or more exit channels 1315 that the one or more tines 1303 can extend therethrough in the deployed configuration (see FIG. 13C), for example as the piston 1329 shown in FIG. 13B translates in direction 1322. As shown, the piston 1329 can translate within a hydraulic cylinder 1317 defining a lower chamber 1321 closer to the distal end 1307 and an upper chamber 1323 further from the distal end 1307. FIG. 13B shows the distal attachment device in a retracted configuration, where the piston 1329 is far from the distal end 1307 due to fluid 1331 in the lower chamber 1321 and the one or more tines are retracted tines 1313. The piston 1329 can advance towards the distal end 1307 (in direction 1322) as fluid 1331 is removed from the lower chamber 1321 (e.g., through an inner channel 1327) (as shown in FIG. 13B) and / or fluid 1331 is added (e.g., pumped) into the upper chamber 1323 (as shown in FIG. 13C). It is to be understood that, in some aspects, (1) a position of the piston 1329 can be controlledusing just the upper chamber 1323, where the upper chamber 1323 can be filled with fluid 1331 to transform the distal attachment device to the deployed configuration, and the fluid 1331 can be withdrawn from that chamber to transform the distal attachment device to the retracted configuration; (2) a position of the piston 1329 can be controlled using just the lower chamber 1321, where the upper chamber 1323 can be filled with fluid 1331 to transform the distal attachment device to the retracted configuration, and the fluid 1331 can be withdrawn from that chamber to transform the distal attachment device to the retracted configuration; or (3) both the upper chamber 1323 and the lower chamber 1321 can be selectively filled and / or emptied of fluid to control the position of the piston 1329 to transform the distal attachment device between the retracted configuration and the deployed configuration (and vice versa). When distal attachment device is initially in the retracted configuration, in further aspects, a position of the piston 1329 can be maintained by a saline solution in the lower chamber 1321 that can be ejected (e.g., into the left ventricle of the heart) when upper chamber 1323 is filled with the fluid 1331 to transform the distal attachment device to the deployed configuration. Alternatively, although not shown, the distal attachment device can comprise an orifice (i.e., one or more orifices) that a vacuum is configured to be pulled therethrough to bring the aperture in contact with a portion of the left ventricle (e.g., septal wall) and / or maintain contact with the portion of the left ventricle.

[0149] In aspects, as shown in FIG. 86, the distal attachment device 8651 or 8671 can comprise a clip. As shown, the distal attachment device 8651 or 8671 comprise a pair of arms 8653, 8655 or 8673, 8675 that can rotate relative to one another (e.g., at pivot point 8657 or 8677). Consequently, the clip can be opened by rotating (e.g., at pivot point 8657 or 8677) the pair of arms 8653, 8655 or 8673, 8675 away from each other to allow tissue (e.g., a portion of the septal wall) to be positioned therebetween (e.g., by translating the distal attachment device 8651 or 8671); and then the pair of arms 8653, 8655 or 8673, 8675 can be brought together (as shown in a clamped configuration) such that the catheter apparatus 8601 is anchored thereto by the distal attachment device 8651 or 8671. Additionally, as shown, the laceration device can be configured to extend through the clip (e.g., pivot point), although the laceration device can be slidably attached to the clip through the laceration attachments discussed herein with reference to FIGS. 80 and 84. In further aspects, although not shown, a pull wire (e.g., control rod) can be activated to open and / or close the clip. For example, a pull ring (not shown) within the corresponding catheter can be used in conjunction with the pull wire (e.g., control) to maintain the clip in the close configuration when the clips are to be retracted, which can function similar to a pair of salad tongs. An exemplary aspect of a clip is a hemostatic clip. Exemplary materials for the clips include stainless steel and ni tinol.

[0150] In aspects, as shown in FIG. 53 (with further aspects shown in FIGS. 51-52), the distal attachment device 940 can comprise a rod 5131 (e.g., inner catheter 5311, needle) with a tapered end 5317 (e.g., pointed end 5133 in FIG. 51, distal end 5313). In further aspects, as shown in FIG. 53, the inner catheter 5311 (e.g., having a tapered end 5317, needle) can puncture the septal wall 170. In further aspects, as shown, the rod 5131 (e.g., inner catheter 5311, needle) can be configured to extend in a direction towards the apex 140 of a heart 120 as it punctures the septal wall 170. For example, as shown, the rod 5131 (e.g., inner catheter 5311, needle) can obliquely pierce the septal wall (e.g., in contrast to the anchors shown in FIG. 56). Alternatively, as shown in FIG. 56, the catheter apparatus 5601 can comprise an anchor 5632 or 5642 at a corresponding distal end 5625 or 5627 configured to extend through an entire thickness of the septal wall 170. For examples, as shown, the anchor 5632 or 5642 can be configured to extend from the left ventricle 130 through the septal wall 170 to the right ventricle, where an end cap 5635 is located (e.g., to prevent the anchor from sliding while the septal wall is being lacerated). In further aspects, as shown in dashed lines, the anchor 5632 or 5642 can further comprise a washer 5637 or 5647 (or other structure that is wider than the rest of the anchor - other than the end cap 5635 or 5645) that can be used to compress the septal wall 170 and / or further secure an orientation of the laceration device relative to the septal wall 170.

[0151] Alternatively, as shown in FIG. 64, the proximal attachment device 840 can comprise a nozzle 6451 comprising an aperture (not shown), where a vacuum (see arrow 6452) is configured to be pulled through the aperture of the nozzle 6451. While a small amount of blood may initially be pulled through the aperture of the nozzle 6451, it is expected that the vacuum being pulled will bring the nozzle in contact with tissue (e.g., of the septal wall or aorta) that prevents the loss of further blood; also, any blood can be collected from a liquid trap (e.g., catch basin) inline with the vacuum to be readministered to the patient.

[0152] Additionally or alternatively, as shown in FIGS. 57-58, the distal attachment device can contact (e.g., push against) an inner surface of a left ventricle of a heart in order to bias the laceration device towards (e.g., into) the septal wall of the heart. In aspects, as shown, the one or more wires 5751 (e.g., wires 5753 and 5755) extending to a distal end 5743 of an inner catheter 5741. In further aspects, as shown, the distal end 5743 can comprise a sharp end 5745 configured to secure a location of the distal end 5743, and / or the distal end 5743 can comprise a structure having an increased cross-sectional area relative to the cross-sectional area of rest of the inner catheter 5741, which can provide additional stability to the inner catheter 5741 (e.g., when subjected to rotational - torquing - forces from the one or more wires 5751 that can bias the laceration device). In further aspects, as shown, the one or more wires 5751 (e.g., wires 5753 and5755) can extend from corresponding wire apertures 5714 and 5716 in an outer catheter 5711 (e.g., flared structure 5717 and / or distal end 5713), where the outer catheter 5711 is positioned around (e.g., circumscribes at least a portion of) the inner catheter 5741. In even further aspects, extending the one or more wires 5751 (e.g., wires 5753 and 5755) through the corresponding wire aperture 5714 and / or 5716 (see arrow 5802 in FIG. 58) can cause the one or more wires 5751 to bulge away from the inner catheter 5741 (see arrow 5804 in FIG. 58) (e.g., since the location of the distal end 5743 is fixed by the relatively rigid inner catheter 5741). Consequently, the one or more wires 5751 effectively expands a volume occupied by the catheter apparatus, where the one or more wires 5751 can conform to a shape of an inner surface of a left ventricle 130 of a heart 120 without obstructing blood flow. As shown in FIG. 58, the extended one or more wires 5751 can extend towards (e.g., contact and / or push against - see arrow 5804) an inner surface of the left ventricle 130 of the heart 120 opposite the septal wall 170 that can, in turn, bias the laceration device 5721 into the septal wall 170 (see arrow 5806), which can facilitate laceration of the septal wall 170. In further aspects, as shown in FIG. 57, the one or more wires 5751 can comprise two wires 5753 and 5755, although additional wires can be provided in further aspects. In even further aspects, an angle between the two wires 5753 and 5755 (e.g., extending through the corresponding wire apertures 5714 and 5718) can be from 45° to 135° (e.g., from 60° to 120°, from 75° to 105°, or any range or subrange therebetween), which can facilitate biasing the laceration device 5721. In further aspects, a wire 5753 of the one or more wires 5751 can be adjusted independently of another wire 5755 of the one or more wires 5751, which can allow all of the one or more wires 5751 to contact the inner surface of the left ventricle 130 of the heart 120.

[0153] In aspects, as shown in FIG. 15, the distal attachment device 1501 can comprise one or more cleats 1503 (e.g., cleats 1504a, 1504b). In further aspects, as shown, the distal attachment device 1501 can extend (e.g., laterally, from a side of) from a catheter 1507, which can be a distal end of the inner catheter (e.g., first catheter as a distal attachment device) or the outer catheter (e.g., second catheter as a proximal attachment device), although the catheter is shown extending beyond the location that the cleat extend from. Although not shown, it is to be understood that the one or more cleats can be inserted into the tissue defining the left ventricle 130 (or proximate an aortic valve when used as a proximate attachment device) which can further secure the corresponding attachment device in the corresponding tissue. In further aspects, as shown, the one or more cleats 1503 (e.g., cleat 1504a, 1504b) can comprise a tapered end 1505, which can facilitate insertion into tissue defining the left ventricle or proximate the aortic valve. Additionally, as shown, the one or more cleats 1503 (e.g., cleats 1504a, 1504b) can curve as it extends from the catheter 1507. For example, the one or more cleats can curve due to a shape memory of the one ormore cleats or strain imposed on the one or more cleats that induces a bending moment. As shown in FIG. 15, the one or more cleats 1503 of the distal attachment device 1501 has two cleats 1504a, 1504b, although only a single cleat or additional cleats can be provided in other aspects. In further aspects, as shown, the one or more cleats 1503 (e.g., cleats 1504a, 1504b) can extend (e.g., be deployed) laterally relative to the catheter 1507 by linearly translating (see arrow 1502) a control rod and / or a proximal portion of the one or more cleats 1504a, 1504b within the catheter 1507 which can translate into a bending (see arrow 1508) of the one or more cleats 1503 (e.g., cleat 1504a, 1504b) as the cleats extend beyond the catheter 1507.

[0154] In aspects, as shown in FIGS. 16A-16B, the distal attachment device 1601 can comprise a hook 1605 (e.g., one or more hooks). In further aspects, as shown, the hook 1605 of the distal attachment device 1601 can taper and / or have a curved shape. In further aspects, the hook 1605 of the distal attachment device 1601 can transition between a retracted configuration 1613 (see FIG. 16A) and a deployed configuration 1615 (see FIG. 16B), for example by rotating (in direction 1602) about an axis 1603. In even further aspects, as shown, the distal attachment device 1601 can comprise one or more holes 1604 and / or 1606, where one or more pull wires 1609 and / or 1611 can be attached to the hook 1605, for example, on opposite sides of the hook 1605 relative to the axis 1603. For example, as shown in FIG. 16A, the distal attachment device 1601 can transition from the retracted configuration 1613 to the deployed configuration 1615 (see FIG. 16B) when a physician modifies an actuator that activates (e.g., pulls in direction 1608) the first pull wire 1609 that is attached to the first hole 1604 in the hook 1605 to cause the hook 1605 to rotate in direction 1602. Likewise, when in the deployed configuration 1615 (see FIG. 16B), a physician can modify an actuator that activates (e.g., pulls in direction 1612) the second pull wire 1611 that is attached to the second hole 1606 in the hook 1605 to cause the hook to rotate opposite direction 1602 to transition to the retracted configuration 1613 (see FIG. 16A). In further aspects, as shown in FIGS. 16A-16B, the distal attachment device 1601 (e.g., hook 1605, axis 1603) can be positioned at and / or proximate to a distal end 1607 of the corresponding catheter (e.g., first catheter, inner catheter - or second catheter, outer catheter if used as a proximate attachment device).

[0155] In aspects, as shown in FIG. 17, the distal attachment device 1701 can be configured to attach to the distal end 1713 of the inner catheter 1711 (e.g., first catheter) to tissue defining the left ventricle 130 (e.g., septal wall 170 and / or proximate the apex 140) by cryoadhesion at an attachment location 1717. In further aspects, as shown, the distal attachment device 1701 can comprise a source 1703 of cryogenic fluid (e.g., nitrous oxide, liquid nitrogen, liquid oxygen, or a refrigerant) that can be in fluid communication and / or thermal communication (e.g., by one or more umbilicals 1704a-1704b and / or connection 1705 to the rest of the catheterapparatus) with a chamber 1715 at the distal end 1713 of the inner catheter 1711. Further, the fluid (e.g., from the source 1703) can travel within the inner catheter 1711 to the chamber 1715, where the fluid can expand endothermically, cooling the distal end 1713, including the attachment location 1717 and / or effected tissue 1721 proximate thereof. This cooling in the chamber 1715 can reversibly change the effected tissue 1721 and attach the distal end 1713 of the inner catheter 1711 to the effected tissue 1721 at the attachment location 1717. When the portion of the septal wall 170 has been lacerated by the laceration device 850, the source 1703 can be disconnected from the chamber 1715 and / or the flow of fluid can be reversed to release the distal end 1713 from the effected tissue 1721 (e.g., attachment location 1717). In further aspects, the inner catheter 1711 (e.g., first catheter) can comprise a marker 1719 that can be proximate the distal end 1713 thereof to facilitate placement of the inner catheter 1711 and / or the distal attachment device 1701 by the physician. In even further aspects, the marker 1719 can be echogenic (e.g., can be visualized by ultrasound) and / or radio-opaque (e.g., can be visualized by fluoroscopy and / or x-ray).

[0156] Now, aspects of the laceration device 850 (see FIGS. 8-9, 11-12, and 17-18) will be discussed with reference to FIGS. 19-87. As discussed above, the laceration device 850 can comprise a blade, a wire that can lacerate tissue when energized (e.g., radio-frequency (RF) laceration), abrading tissue, and / or using electromagnetic radiation (e.g., light beam, laser beam). Also, as discussed above, the laceration device 850 can transition from a retracted configuration to a deployed configuration, where the laceration device 850 can contact the septal wall 170 (e.g., penetrate and / or lacerate a portion of the septal wall 170), for example, by extending beyond a catheter (e.g., first catheter, outer catheter) and / or a housing. In aspects, as shown in FIGS. 19, 26, 34, 39, 48-50, 59, 63, 69, 72, 74-76, or 80-87, the laceration device 1940, 2021, 2421, 2721, 3521, 4421, 4901, 5721, 6221, 6921, 7221, 7421, 7521, 7621, 8021, 8221, 8321, 8621, or 8721 (e g , blade 1935, 2023, 2423, 2723, 3523, 4023, 5923, or 7423; wire 4223, 4423, 4923, 6323, 6923, 7223, 7523, 8023, 8623, or 8723; braided cable; cable saw; or laser beam 7633) is shown in a deployed configuration extending from the inner catheter 1711, 1831, 1931, 2441, 3541, 6941, or 7211 (e.g., first catheter 2707, 4011, or 5931) into the septal wall 170. In further aspects, as shown in FIGS. 19, 26, 39, 48, and 59, the laceration device 1940, 2021, 2421, 3521, 4421, or 5721 (e.g., blade 1935, 2423, 3523, or 5923 or wire 4423) can be deployed at an initial location proximate the distal end 1833, 1933, 2443, or 3543 of the inner catheter 1831, 1931, 2441, or 3543 (e.g., first catheter 5931). The laceration device 1940, 2021, 2421, 3521, 4421, or 5721 (e.g., blade 1935, 2423, 3523, or 5923 or wire 4423) can then be translated in the direction indicated by arrow 1942, 2442, 3502, 4502, 4512, or 5904 away from the distal end 1833, 1933, 2443, or 3543 of the inner catheter 1831, 1931, 2441, or 3541 (e.g., first catheter 5931) and / or towards the distal end 813 ofthe outer catheter 811 (second catheter) (and / or the towards the aortic valve 210) to arrive at a final location, although those laceration devices can be configured to go in the opposite direction in other aspects. For example, as shown in FIG. 87, the laceration device 8721 can be translated in both directions (as indicated by arrows 8722 and 8724 - e.g., towards and away from the distal attachment device 8731; towards and away from a distal end 813 of the outer catheter 811). Likewise, as shown in FIGS. 55, 58, or 62, the laceration device 5521, 5721, or 6021 (e.g., nozzle 5523 configured to emit a fluid j et 5525 or wire 5723) can be configured to translate in the direction 5404, 5812, or 6623 towards the distal end 813 or 6013 of the outer catheter 811 or 6011 (and / or the towards the aortic valve 210) while lacerating the septal wall 170. Alternatively, as shown in FIGS. 34, the laceration device can be deployed at an initial location - further from the distal end 2703 (e.g., of a distal portion 2705) of the first catheter 2707 (e.g., inner catheter) relative to a final configuration (shown in dashed lines) - and then translated in a direction (indicated by arrow 2732) towards the distal end 2703 (e.g., of a distal portion 2705) of the first catheter 2707 (e.g., inner catheter) and / or away from the aortic valve 210 (and / or away from a proximate portion 2711 of the first catheter 2707 (e.g., inner catheter)) to arrive at a final location with, although the laceration device can be configured to go in the opposite direction in other aspects. Translating the laceration device towards the distal end of the first catheter (e.g., inner catheter) - when the laceration device is configured appropriately - can be facilitated by a mechanical advantage for the physician. In either situation, the lacerated tissue is along a path between the initial location and the final location of the laceration device. Consequently, the lacerated tissue is part of the septal wall positioned between the apex and the aortic valve. FIGS. 20-36, 38-41, 59, and 74, the laceration device 2021, 2421, 2721, 3521, 4021, 5721, or 7421 can comprise a blade 2023, 2423, 2723, 3523, 4023, 5923, or 7423. In further aspects, as shown in FIGS. 20-34, 40-41, and 59, the laceration device 2021, 2421, 2721, 4021, or 5721 can comprise a blade 2023, 2423, 2723, 4023, or 5923 (discussed in further detail below) configured to extend beyond a housing 2011, 2411, 2735, 5731, or 5931 in the deployed configuration (and into the septal wall 170). In further aspects, as shown in FIGS. 20, 23-26, and 57, a housing 2011, 2411, or 5731 can surround at least a portion of the inner catheter 1711, 2441, or 5741. Alternatively, in further aspects, as shown in FIGS. 27A-27B, 28-30, and 34, the housing 2735 can be contained within (e.g., within a cross-sectional footprint and / or in a retracted configuration) a first catheter 2707 (e.g., inner catheter). Alternatively, as shown in FIGS. 42-46, 48-54, 56, 58, 63-64, 69, 72, 75, or 80-87, the laceration device 4221, 4421, 4621, 4921, 5121, 5321, 5621, 5821, 6221, 6421, 6921, 7221, 7521, 8021, 8221, 8321, 8621, or 8721 comprises a wire 4223, 4423, 4623, 4923, 5123, 5323, 5623, 5823, 6323, 6423, 6923, 7223, 7523, 8023, 8623, or 8723 that can lacerate tissue when energized (e.g., radio-frequency (RF) laceration). In furtheraspects, as shown in FIGS. 51-52, the wire 5123 can extend between a distal attachment device (e.g., rod 5131, needle) and a guiding rod 5141. In further aspects, as shown in FIG. 56, the wire 5623 can be pulled (arrow 5602) to lacerate a portion of the septal wall 170. Alternatively, as shown in FIGS. 80-81 and 86-87, the laceration device 8021, 8621, or 8721 can extend between a pair of distal attachment devices 8019, 8039, 8651, 8671, 8731, and / or 8735. Alternatively, as shown in FIG. 55, the laceration device 5521 can comprise nozzle 5523 configured to emit a fluid jet 5525 (e.g., water jet). In aspects, the laceration device 1940 translates along the inner catheter 1831, 1931, 2441, or 3541 (e.g., first catheter 2707) (or within the inner catheter) while the inner catheter 1831, 1931, 2441, or 3541 (e.g., first catheter 2707) can be in stationary position relative to the septal wall (e.g., through the use of a proximal attachment device 840 and / or a distal attachment device 860) to allow controlled and / or precision laceration of the septal wall 170, which may occur while the heart is still beating.

[0157] In aspects, as shown in FIGS. 21-22, catheter apparatus 2001 can comprise the laceration device 2021 having the blade 2023. In further aspects, as shown in FIG. 21, the laceration device 2021 comprises a helical shape 2025 that is coiled 2041. In even further aspects, as shown, the laceration device 2021 (including the portion that is coiled 2041) can be rotated (see arrow 2042), which can extend the blade 2023 of the laceration device (see arrow 2044) through the aperture 2017 in the wall 2013 of the housing 2011. As shown in FIGS. 20 and 22, a distance 2039 that the blade 2023 extends beyond the wall 2013 after extending through the aperture 2017 of the housing 2011 can be controlled to limit the laceration depth into the septal wall by the blade 2023. In further aspects, as shown in FIGS. 20 and 22, the catheter apparatus 2001 comprises the housing 2011 having an aperture 2017 that the laceration device 2021 is configured to extend therethrough in a deployed configuration. In even further aspects, the laceration device 2021 is configured to be entirely contained within the housing 2011 (e.g., circumscribed by the wall 2013) when the laceration device is in a retracted configuration (e.g., if the laceration device 2021 including the blade 2023 is translated opposite the direction (indicated by arrow 2044) by rotating the helical shape 2025 opposite the direction (indicated by arrow 2042 - see FIG. 21) to be substantially coiled 2041 within the housing 2011). In further aspects, as shown in FIG. 20, the housing 2011 and the laceration device 2021 can surround at least a portion of the inner catheter 1711 (e.g., first catheter). Also, as shown, the housing can be configured to translate relative to (e.g., independently from) the inner catheter 1711 (e.g., first catheter), for example, translating along the inner catheter 1711 in direction 2012 or opposite the direction 2012, which can allow the laceration device to lacerate a predetermined length of a portion of the septal wall without needing to reposition the distal attachment device. Also, as shown, in FIG. 20, the housing 2011 cantranslate independently from the distal end 813 of the outer catheter, for example, with an extendable shaft 2003 extending therebetween. In even further aspects, a steerable wire 2015 (e.g., control rod) can extend into the housing 2011, which can be configured to rotate the laceration device 2021 and / or control a position or location of the housing 2011. The laceration device 2021 (e.g., at least partially contained in the housing 2011) can comprise one or more (e.g., all) of the aspects discussed above with reference to FIGS. 20-22.

[0158] In aspects, as shown in FIGS. 24-26, catheter apparatus 2401 can comprise the laceration device 2021 or 2421 having the blade 2423. In further aspects, as shown in FIG. 24, the blade 2423 can be within (e.g., within an outer periphery and / or a footprint of) a housing 2411 in a retracted configuration. In further aspects, as shown in FIGS. 24-25, the housing comprises an aperture 2417. In even further aspects, as shown, the laceration device 2021 or 2421 can transform from a retracted configuration (see FIG. 24 where the blade 2423 is within a housing 2411 (e.g., wall 2413) to a deployed configuration (see FIG. 25 where the blade 2423 extends beyond housing 2411 (e.g., wall 2413) through the aperture 2417) by rotating (see arrow 2422 in FIG. 24) the housing 2411 relative to the blade 2423 (and / or from the deployed configuration to the retracted configuration by rotating - see arrow 2424). In even further aspects, as shown in FIG. 24, the blade 2423 can occupy a pocket 2431 in a sleeve 2403 in the retracted configuration. As shown in FIG. 25, when the blade 2423 is aligned with the aperture 2417, the blade can move from being within the pocket 2431 to extending through the aperture 2417 and beyond the housing 2411. In still further aspects, the blade 2423 can be biased to adopt the deployed configuration when not restrained by the housing 2411. For example, the blade 2423 can comprise a shape-memory or other self-expanding material (discussed above) that will revert to the deployed configuration (e.g., at physiological conditions or always) and / or the blade can be biased by a spring within or adjacent to the pocket 2431. Consequently, the blade 2423 may “pop out” of the pocket 2431 and selfexpand through the aperture 2417 into the deployed configuration when not restrained by the housing 2411 (i.e., when the aperture 2417 is aligned with the blade 2423). Also, the blade 2423 can be transformed (e.g., folded, pivoted) from the deployed configuration to the retracted configuration by recapturing the blade 2423 within the housing 2411 to restrain the blade 2423 within the pocket 2431, as indicated, by rotating the housing 2411 in the direction of arrow 2424.

[0159] In further aspects, as shown in FIGS. 24-25, the housing 2411 (e.g., wall 2413) and / or the laceration device 2421 (e.g., blade 2423) can surround at least a portion of the inner catheter 2441 (e.g., first catheter). In even further aspects, as shown, the housing 2411 can be configured to rotate relative to (e.g., independently from) the inner catheter 2441 (e.g., first catheter), for example, arrow 2422 and / or 2424. Also, as shown in FIG. 25, the housing 2411 canbe configured to translate relative to (e.g., independently from) the inner catheter 2441 (e.g., first catheter), for example, translating along the inner catheter 2441 in direction 2442 (e.g., away from a distal end 2443 of the inner catheter 2441) or opposite the direction 2442 (e.g., towards the distal end 2443 of the inner catheter 2441), which can allow the laceration device 2421 to lacerate a predetermined length of a portion of the septal wall without needing to reposition the distal attachment device 940 and / or 1401. In even further aspects, as shown, in FIG. 26, the housing 2411 can translate independently from (e.g., be movably attached to) the distal end 813 of the outer catheter 811, for example, with an extendable shaft and / or steerable shaft 2451 extending therebetween. Alternatively, in even further aspects, the outer catheter can comprise the housing. In even further aspects, although not shown, a steerable wire or shaft can extend into the housing, which can be configured to rotate the laceration device and / or control a relative position or location of the housing. The laceration device 2421 (e.g., at least partially contained in the housing 2411) can comprise one or more (e.g., all) of the aspects discussed above with reference to FIGS. 24-26.

[0160] In aspects, as shown in FIGS. 27A-27B, 28-33, 40-41, 59, 74, and 78, catheter apparatus 2701, 4001, 7401, and 7801 can comprise the laceration device 2021, 2721, 5721, 7421, or 7821 having the blade 2723, 5923, 7423, or 7825. In further aspects, as shown in FIG. 27, the laceration device 2021 or 2721 (e.g., blade) can be within (e.g., within an outer periphery and / or a footprint of) a housing 2735, 5731, or 5931 (and / or a first catheter 2707) in a retracted configuration. In further aspects, as shown in FIGS. 27A-27B, 28-30, 40-41, and 59, the housing 2735 or 5931 (or first catheter 4015) comprises an aperture 2733, 4033, or 5933. In even further aspects, as shown, the laceration device 2021 or 2721 can transform from a retracted configuration (see FIG. 27 where the blade 2723 is within the housing 2735 (and / or the first catheter 2707) to a deployed configuration (see FIGS. 29-30 where the blade 2723 extends beyond housing 2735 (and / or the first catheter 2707) through the aperture 2733). In even further aspects, as shown in FIG. 28, the blade 2723 can transform from the retracted configuration to the deployed configuration by pivoting (see arrow 2722). In still further aspects, as shown in FIG. 27, the blade 2723 can be prevented from pivoting in the retracted configuration by a portion (e.g., proximate portion 2711) of the first catheter 2707 that can cover the aperture 2733. In yet further aspects, as shown in FIG. 27, the first catheter 2707 can be configured to separate into a proximate portion 2711 and a distal portion 2705 by translating relative to one another (see arrow 2702 as well as arrow 2712 in FIG. 28). For example, going from FIG. 27 to FIG. 29, the proximate portion 2711 (e.g., distal end 2713 of the proximate portion 2711) translates relative to the housing 2735 to reveal the aperture 2733 so that blade 2723 can extend through the aperture 2733 and beyond the first catheter 2707. In still further aspects, as shown in FIG. 29, the blade 2723 can be biasedtowards the deployed configuration (see arrow 2752) by a spring 2743 (e.g., within the housing 2735). For example, shown between FIGS. 28-29, the spring 2743 can be configured to transition between a resting configuration 2741 and an activated configuration 2751, where the spring can bias the blade 2723 towards the deployed configuration when the spring is in the activated configuration 2751, for example, with an end 2745 of the spring contacting a portion of the blade 2723 when the spring is in the activated configuration 2751. Additionally or alternatively, although not shown, a pivot point for the blade can be selected so that blade tends towards the retracted configuration.

[0161] In further aspects, as shown in FIGS. 27A-27B, 28-30, 74, and 78, the blade 2723, 7423, or 7825 can comprise a cutting edge 2725, 7823, or 7827 that at least partially extends beyond the first catheter 2707, 7411, or 7811 (and / or the housing 2735). The laceration device 2721, 7421, or 7821 can be configured such that the cutting edge 2725, 7823, or 7827 faces the direction indicated by arrow 2732, 7402, or 7802 (shown in FIGS. 29, 74, or 78) that the laceration device 2721 is to be translated to lacerate the portion of the septal wall. In further aspects, as shown, the blade 2723 can comprise a side edge 2729. As shown in FIG. 27, the side edge 2729 can extend substantially parallel to and / or contact a portion of an inner wall of the housing 2735 in the retracted configuration. In further aspects, as shown in FIGS. 29-31, the blade 2723 can comprise a back edge 2727 that can restrain a deployment of the blade 2723 in the deployed configuration. As shown in FIG. 29, the blade 2723 can extend beyond the housing 2735 for a distance 2959, which can be adjusted as discussed below with reference to FIGS. 29-32. In still further aspects, as shown in FIG. 29, a maximum distance (e.g., distance 2959) can be enforced by the back edge 2727 contacting an inner wall of the housing 2735. In still further aspects, as shown in FIG. 30, the distance 2959 can be adjusted by rotating (see arrow 3002) a set screw 3001 to increase a depth that an end 3003 of the set screw 3001 extends into the housing 2735 (see arrow 3004) such that the back edge 2727 of the blade 2723 contacts the end 3003 of the set screw 3001 before contacting an inner wall of the housing 2735. For example, the set screw 3001 can be rotated (see arrow 3002) by a physician based on imaging (e.g., scans) of the septal wall before inserting the catheter apparatus; alternatively, the set screw can be attached to a pull wire or other control device that can activated by a physician while the catheter apparatus is in the patient (e.g., heart). Also, it is to be understood that the set screw can be flush with an outer surface of the housing 2735 (e.g., having an internal hex head set screw with the head flush with the housing and the rest of the set screw extend inwards) rather than the end of the set screw extending beyond the housing 2735, which is shown for clarity. Alternatively, in still further aspects, as shown in FIG. 31, a cam 3105 can be used to adjust the distance 2959, where the anisotropic shape of the cam 3105 allows the back edge2727 of the blade 2723 to contact the cam 3105 in different arrangements (e.g., orientation of the cam 3105 by rotating the cam 3105 about an axis 3107 see arrow 3104 so that the oblong end 3103 moves away from a wall of the housing 2735 towards the back edge 2727 of the blade 2723) that thereby adjusts the distance 2959. In yet further aspects, as shown, the cam 3105 can be adjusted (e.g., rotated, see arrow 3104) by a physician activating a control rod 3101 (or one or more pull wires) (e.g., translating the control rod 3101, see arrow 3102). Alternatively, in still further aspects, as shown in FIG. 31, the housing 2735 can have a non-uniform thickness, where at least a portion of the housing 2735 can be rotated (see arrow 3114) so that a thicker portion 3135 (or thinner portion) of the wall is configured to contact the back edge 2727 of the blade 2723). As described for the cam 3105, the portion of the housing 2735 can be rotated by activating a control rod 3101 (e.g., translating the control rod 3101, see arrow 3102). It is to be understood that the portion of the housing with the non-uniform thickness may be able to rotate independently from the aperture (see aperture 2733 in FIGS. 27A-27B and 28-30) and / or a width of the aperture may be enlarged so that the blade 2723 can extend therethrough for different rotational alignments between the blade 2723 and the housing 2735. Alternatively, in still further aspects, as shown in FIG. 32, a wedge 3203 can be configured to translate (see arrow 3202) (e.g., by translating a control rod 3201 or one or more pull wires that can be activated by a physician while the catheter apparatus in in the heart of the patient). In yet further aspects, a plurality of grooves 3207 can be formed on an inner surface of the housing 2735 such that the wedge 3203 can be secured in a configuration set by the physician and / or a physician can reliably control a position of the wedge 3203 in the housing 2735. As shown, translating the wedge 3203 (in direction indicated by arrow 3202), a distance between a wedge surface 3205 and the inner surface of the housing 2735 can be increased (or decreased) such that a position where the back edge 2727 contacts the wedge surface 3205 is adjusted, which in turn, adjusts a distance that the blade extends beyond the housing in the extended configuration. Alternatively or additionally, a set screw (see set screw 3001 in FIG. 30) could be aligned with a longitudinal direction of the housing 2735 (and / or the catheter apparatus 2701), where a physician can adjust the position of the set screw by torquing the set screw through an actuator in the control handle. In further aspects, the set screw can contact the blade 2723 to control the distance the blade extends in the deployed configuration. It is to be understood that the set screw can be used in conjunction with the cam (see cam 3105 in FIG. 31), the wedge (see wedge 3203 in FIG. 32), and / or other aspects, for example, with the set screw being used to adjust a position of the other elements (e.g., cam, wedge) that, in turn, can contact the blade to control the distance the blade extends in the deployed configuration.

[0162] In further aspects, as shown in FIGS. 35, 37, 41, 43, 49-50, 59, and 72, catheterapparatus 3501, 4001, 4201, 4901, or 7201 has the laceration device 3521, 4021, 4221, 4921, or 7221 (e.g., blade 3523 or 4023, or wire 4223, 4923, or 7223) can at least partially extend beyond the first catheter 4011 or 7211 (e.g., inner catheter 3541) by distance 3569, 4159, 4359, 5039, or 7237 in a deployed configuration. For example, in the deployed configuration, the laceration device 3521, 4021, 4221, or 4921 can extend beyond the inner catheter 3541 (e.g., first catheter 4011 - see wall 3535 or 4015) by extending from an inner location of the first catheter 4011 (e.g., inner catheter 3541) the through an aperture 3533 or 4033 in the first catheter 4011 (e.g., inner catheter 3541). In even further aspects, as shown in FIGS. 35-37 or 40-43, or 59 the laceration device 3521, 4021 or 4221 (e.g., blade 3523, 4023, or 5923, or wire 4223) can be configured to rotate (e.g., pivot) about a pivot point 3529, 4029, 4229, or 5959 (e.g., the laceration device 3521, 4021, 4221, or 5721 can be rotatably attached to a body 3641 of an inner support 3631 or shaft 4035 or 5951 (e.g., distal end 5953), and / or 4235 by a pin at the pivot point 3529, 4029, 4229, or 5959). In still further aspects, as shown in FIGS. 36-37 or 40-41, one or more pull wires 3651, 3653, 4051, and 4053 can be attached to a corresponding portion (e.g., attachment points 3526, 3528, 4026, and 4028) of the laceration device 3521 or 4021 (e.g., blade 3523 or 4023) to allow a physician to transform the laceration device 3521 or 4021 (e.g., blade 3523 or 4023) between the retracted configuration (see FIGS. 36 or 40) and the deployed configuration (see FIGS. 35, 37, and 41) and / or vice versa. For example, as shown in FIGS. 36 and 40, the laceration device 3521 or 4021 (e.g., blade 3523 or 4023) can be transformed from the retracted configuration to the deployed configuration by a physician activating (e.g., pulling) the first pull wire 3651 or 4051 (see arrow 3652 or 4052) attached to the laceration device 3521 or 4021 at the first attachment point 3528 or 4026 to rotate (e.g., pivot) the laceration device 3521 or 4021 about the pivot point 3529 or 4029 (see arrow 3654, 4022, or 4222). Also, as shown in FIGS. 38 or 41, the laceration device 3521 or 4021 (e.g., blade 3523 or 4023) can be transformed from the deployed configuration to the retracted configuration by a physician activating (e.g., pulling) the second pull wire 3653 or 4053 (see arrow 3756 or 4256) attached to the laceration device 3521 or 4021 at the second attachment point 3526 or 4028 to rotate (e.g., pivot) the laceration device 3521 or 4021 about the pivot point 3529 or 4029 (see arrow 3758 or 4158). Although not shown in FIGS. 42-43 and 59, it is to be understood that the laceration device 4221 or 5721 (e.g., wire 4223 or blade 5923) can be rotated (e.g., pivoted - see arrow 4222 or 5902) about the pivot point 4229 or 5959 by a similar or the same mechanism as discussed above in this paragraph, although any of the laceration devices discussed in this paragraph can be rotated (e.g., pivoted) by another mechanism, for example, a single control rod rotating the laceration device about the pivot point in other aspects. Alternatively, as shown in FIGS. 49-50, the laceration device 4921 (e.g., wire 4923) can be configured to bend at apredetermined location 4925 when the laceration device transforms from a retracted configuration (FIG. 49) to a deployed configuration (FIG. 50), for example, when a compressive stress is applied through the ends of the laceration device 4921 that causes the laceration device 4921 to preferentially bend at the predetermined location having plurality of recesses 4928 on an inner side 4926 of the laceration device 4921. In even further aspects, as shown in FIGS. 36, 40, 42, and 49, the laceration device 3521, 4021, 4221, or 4921 can be entirely within the inner catheter 3541 (e.g., first catheter 4011) in the retracted configuration. In even further aspects, as shown in FIGS. 35, 37, 41, and 59, the laceration device 3521, 4021, 4221, or 5923 can translate (in direction indicated by arrow 3502, 4102, 4302, or 5904) relative to the outer catheter 3511 (e.g., wall 3513) and / or the inner catheter 3541 (e.g., first catheter 4011 or 5931) (while the laceration device is still extending through the aperture 3533, 4033, or 4233). For example, the laceration device 3521, 4021, or 4221 can translate relative to the inner catheter 3541 (e.g., first catheter 4011) by translating an inner support 3631 or shaft 4035, or 4235.

[0163] FIGS. 44-45 show a laceration device 4421 (e.g., wire 4423 - see laceration device 4621 shown in FIG. 46 and discussed above) and a support structure 4411 that can be within a first catheter (e.g., an inner catheter). In aspects, the view shown can correspond to a cross-section of the first catheter (e.g., inner catheter) with the laceration device extending through a distal end thereof, although the view shown can be inside of first catheter (e.g., inner catheter) similar to the arrangement shown in FIGS. 40-41 with the laceration device configured to extend through an aperture in the first catheter in other aspects. In aspects, as shown in FIGS. 44-45, the laceration device 4421 can be attached to a wheel 4431 (e.g., pivot point 4429) by a support 4433 (e.g., attached to the crimp 4427). In further aspects, as shown, the wire 4423 of the laceration device 4421 can be attached to (e.g., part of) an insulated wire 4451 that can both convey energy to the laceration device 4421 and can be used to transform the laceration device 4421 between a retracted configuration and a deployed configuration (or vice versa). For example, as shown in FIG. 44, a physician can pull (see arrow 4452) the insulated wire 4451, which can cause the wheel 4431 and the laceration device 4421 to rotate (see arrow 4422) into the deployed configuration. In aspects, the pivot point 4429 and / or the wheel 4431 can be in a fixed relationship with the support structure 4411and / or the inner catheter, although the position of the pivot point 4429 and / or the wheel 4431 can be controlled by a guide shaft similar to or identical to the body 3641 or the shaft 4035 or 4235 shown in FIGS. 36-37 or 40-43 (such that the wheel and the laceration device can be translated in the direction 4502) in other aspects. As shown in FIG. 44, the laceration device 4421 can extend parallel to (or substantially parallel to) a direction that the support structure 4411 and / or the inner catheter extends. Although not shown in FIGS. 44-45, there can be a spring configured to bias thelaceration device 4421 into the deployed configuration, which can have the opposite function of spring 2743 in FIGS. 27A-27B and 28-33. As shown in FIG. 45, the laceration device 4421 can adopted an angled configuration relative to a direction that the support structure 4411 and / or the inner catheter extends when the laceration device 4421 is in the deployed configuration. A maximum distance that the laceration device extends beyond (e.g., beyond a projection of the first catheter or wall 4415, as discussed above) can be controlled by a physical arrangement of the laceration device 4421 (e.g., crimp 4427) and the support structure 4411 or, although not shown, a stop attached to the wheel 4431. Also, the angled configuration (of the deployed configuration) can be adjusted based on the tension applied by the physician on the insulated wire 4451. In aspects, as shown in FIG. 45, the laceration device 4421 can be used when the laceration device is fully deployed such that the physician can maintain tension (see arrow 4554) on the laceration device 4421 through the insulated wire 4451 to resist deflection of the laceration device 4421 while contacting and / or translating (e.g., in direction 4502 or 4512) relative to the septal wall. Other aspects of laceration devices including a wire in catheter apparatus are discussed below with reference to FIGS. 51-54 and 56-58.

[0164] As shown in FIGS. 20 and / or 22, the catheter apparatus 2001 can comprise one or more markers 1719, 2051, 2053, 2055, and / or 2057. Also, FIGS. 24-25 show that the catheter apparatus 2401 can comprise one or more markers 2455, 2457, and / or 2459. Also, markers 2761, 2762, 2763, 2765, 2767, and / or 2769 are shown in one or more of FIGS. 27A-27B, 28-29, and 32. Similarly, markers 3561, 3563, 3565, 4061, 4063, and 4065 are shown between FIGS. 35, 40, and 49-50; markers 5361, 5363, 5365, and 5367 are shown between FIGS. 53-54; marker 6267 shown in FIGS. 62-63; and markers 6461, 6463, 6465, and 6467 are shown in FIG. 64. As shown in FIG. 82, the catheter apparatus and / or laceration device 8221 can comprise one or more markers 8261 and / or 8263. The one or more markers can independently be radio-opaque, echogenic, or both. In further aspects, a marker 2051, 2457, 2761, 3563, or 4061 can be provided on a distal end of the blade 2023, 2423, 2723, 3523, or 4023 which can communicate the position and / or laceration depth of the blade 2023 to the physician. Similarly, as shown in FIGS. 49-50 and 82, a marker 4961, 8261, and / or 8263 can be provided on a wire 4923 or 8223 of the laceration device 4921 or 8221. Additionally or alternatively, a material of the laceration device (e.g., blade, wire) can be radioopaque, echogenic, or both. Likewise, the magnetic wheels 5527 and 5577 shown in FIG. 55 can be radio-opaque, echogenic, or both. In further aspects, the catheter apparatus 2001, 2401, or 2701 can comprise one or more (e.g., a pair) of markers (e.g., markers 2053 and 2055; marker 2455; or markers 2762, 2763, and / or 2765) on the housing 2011, 2411, or 2735 (e.g., wall 2013 or 2413). Similarly, the catheter apparatus 3501, 4001, 4901, 5301, or 6401 can comprise one or more (e.g.,a pair) of markers (e.g., marker 3561; markers 4063 and 4065; markers 5361, 5363, 5365, and / or 5367; or markers 6463 and 6465) on the first catheter 4011 or 5311 (e.g., inner catheter 3541 or 6431). One or more markers (e.g., markers 2051, 2053, and / or 2055 - pairs of these markers including as markers 2051 and 2053 or markers 2053 and 2055; markers 2455 and 2457; markers 2762, 2763, and / or 2765 - pairs of these markers including markers 2762 and 2763 or markers 2762 and 2765; markers 4063 and 4065 and / or 4961; markers 5361, 5363, 5365, and / or 5367 - pairs of these markers including markers 5361 and 5363, markers 5361 and 5365, or markers 5365 and 5367; markers 6463 and 6465; or pairs of markers 8261 and 8263) can be used to determine an orientation of the laceration device 2021, 2421, 2721, 4021, 4221, 4921, 5321, 6421, or 8221, the first catheter 4011 or 5311 (e.g., inner catheter 6431), and / or the housing 2011, 2411, or 2735 based on an apparent size (e.g., projection) of the marker(s), which can be used to orient the aperture 2017, 2417, or 2733 to face the septal wall. For example, as shown, the one or more markers on the housing 2011, 2411, or 2733 can include a marker 2053, 2455, or 2763 positioned at an end of the aperture 2017, 2417, or 2733 (e.g., proximal end of the aperture) to allow a physician to locate the exact position of the aperture and thereby properly position the aperture 2017, 2417, or 2733 prior to the laceration. Similarly, the one or more markers (markers 3561 or markers 4063 and 4065) on the first catheter 4011 (e.g., inner catheter 3541) can be positioned at an end of the aperture 3533 or 4033 to allow a physician to locate the exact position of the aperture and thereby properly position the aperture 3533 or 4033 prior to the laceration. Likewise, as shown in FIG. 82, the one or more markers 8261 and / or 8263 can be positioned at location (e.g., corresponding to exposed length 8229) where the laceration device 8221 is configured to lacerate tissue to allow a physician to locate the exact location being lacerated. Additionally or alternatively, as discussed above with reference to FIGS. 17, 24-25, 27, 35, and 40 (although also shown in FIGS. 20 and 23), a marker 1719, 2459, 2769, 3561, 4065, 5161 or 5163, 5365 or 5367, or 6461 can be positioned at and / or proximate to a distal end 1713, 2443, 2703, 3543, or 4013 of the inner catheter 1711, 2441, 3541, or 6441 (e.g., first catheter 2707 - distal portion 2705, or first catheter 4011, 5111, or 5311), for example, to indicate to the physician a location of a distal attachment device. In further aspects, as shown in FIGS. 20 and 40, a marker 2057 or 3565 can be positioned at a distal end 813 or 3515 of the outer catheter 811 or 3511, for example, to allow a physician to monitor (and adjust) a position of the distal end 813 or 3515 of the outer catheter 811 or 3511 for determining the stability of the proximal attachment device and / or whether the distal end 813 or 3515 is wedged in corresponding physiology (e.g., aortic arch, aortic valve 210, or otherwise proximate the aortic valve).

[0165] A specific embodiment of catheter apparatus 2001 shown in FIG. 20 will bediscussed with additional reference to the laceration device 2021 depicted in FIGS. 20-21 and its usage in a heart with reference to FIGS. 17 and 23. In aspects, the catheter apparatus 2001 comprises an outer catheter 811 having a distal end 813. In further aspects, as shown in FIG. 23 by arrow 2302, a portion of the outer catheter 811 (e.g., distal end 813) can be pushed (e.g., wedged) in a portion of the corresponding physiology (e.g., aortic valve 210, although other physiology including an ascending aorta can be used), for example as shown in FIG. 20, if the distal end 813 of the outer catheter 811 is attached to or includes a steerable shaft 2005. In further aspects, as shown in FIG. 20, an extendable shaft 2003 can extend between the outer catheter 811 and / or steerable shaft 2005 (e.g., distal end 2007) and the housing 2011, and / or the extendable shaft 2003 can be attached to the housing 2011 using a lock washer 2027. In even further aspects, as shown in FIG. 17, the distal end 1713 of the inner catheter 1711 can be attached (e.g., anchored) to the tissue defining the left ventricle 130 (e.g., proximate the apex 140) by cryo-adhesion.

[0166] A specific embodiment of the catheter apparatus 2401 shown in FIG. 24 will be discussed with additional reference to the laceration device 2421 depicted in FIGS. 24-25 and its usage in a heart with reference to FIGS. 9, 11, and 26. In aspects, the catheter apparatus 2401 comprises an outer catheter 811 having a distal end 813. In further aspects, as shown in FIGS. 9 and 11, a proximal attachment device 901 can be deployed proximate the aortic valve 210, for example, to secure a position of the outer catheter 811 (e.g., distal end 813). In even further aspects, as shown in FIG. 11, the proximal attachment device 901 can comprise one or more balloons 1101 having a plurality of apertures (e.g., apertures 1103 and 1107). In further aspects, as shown in FIG. 26, an extendable shaft and / or steerable shaft 2451 can extend between the outer catheter 811 and the housing 2411. In even further aspects, as shown in FIGS. 9 and 26, the distal attachment device 940 or 1401 can comprise a helical shape. As shown in FIG. 26, the housing 2011 can rotate (arrow 2422) to allow the blade 2423 to extend from the sleeve 2403 beyond the housing 2411 (e.g., wall 2413) in the deployed configuration, where it can lacerate a portion of the septal wall 170.

[0167] A specific embodiment of the catheter apparatus 2701 shown in FIG. 34 will be discussed with additional reference to the laceration device 2721 depicted in FIGS. 27A-27B and 28-33 and its usage in a heart with reference to FIGS. 18 and 34. In aspects, as shown in FIG. 34, the catheter apparatus 2701 can optionally comprises an outer catheter 811 having a distal end 813 that the first catheter 2707 (e.g., inner catheter) can extend from, although the first catheter 2707 can be provided without an outer catheter in other aspects. In even further aspects, as shown in FIGS. 18 and 32, the distal attachment device 940, 1301, or 1311 can comprise a one or more tines and / or the distal attachment device 940, 1301, or 1311 can be positioned at a distal end 2703 of the first catheter 2707 (e.g., distal portion 2705). In aspects, as shown in FIGS. 33-34, the first cathetercan separate into a proximate portion 2711 and a distal portion 2705 by translating relative to one another (see arrow 2702 or arrow 2712 in FIG. 28). In further aspects, as shown, the separated portions (e.g., distal portion 2705 and proximate portion 2711) of the catheter apparatus 2701 can reveal the housing 2735 containing the laceration device 2721. In further aspects, as shown in FIG. 33, the catheter apparatus 2701 can comprise a plurality of guide rails 3361 and 3363 that can allow the distal portion 2705 to translate relative to the proximate portion 2711. In even further aspects, although not shown for clarity, the plurality of guide rails 3361 and 3363 can extend through the housing 2735 on either side of the blade 2723 so that the motion of the blade 2723 and any mechanism of controlling the extension of the blade 2723 (e.g., the spring 2743 in FIGS. 27B and 28-33, set screw 3001 in FIG. 30, the cam 3105 in FIG. 31, the wedge 3203 in FIG. 32) is not impeded. In even further aspects, the plurality of guide rails 3361 and 3363 can restrain rotation of the distal portion 2705 relative to the proximate portion 2711. In even further aspects, the plurality of guide rails 3361 and 3363 can restrain rotation of the housing 2735 and / or the blade 2723 relative to the first catheter 2707 (e.g., distal portion 2705 and / or proximate portion 2711). In further aspects, as discussed above, the distance 2959 (see FIGS. 29-30) that the blade 2723 extends beyond the housing 2735 can be adjusted, for example, by a physician adjusting (e.g., activating an actuator) part of a control handle that controls a movement of a control rod 3101 or 3201 or pull wires that controls a position and / or an orientation of one or more of the set screw 3001 in FIG. 30, the cam 3105 in FIG. 31, the wedge 3203 in FIG. 32, and / or a portion the housing 2735 (e.g., thicker portion 3135 in FIG. 31). In further aspects, as discussed above, the blade 2723 can be allowed to extend beyond the housing 2735 when the first catheter 2707 separates (e.g., into the distal portion 2705 and the proximate portion 2711). In still further aspects, as discussed above with reference to FIG. 29, a spring 2743 can be in an activated configuration 2751 (e.g., transform from a resting configuration 2741 by electrically activating the spring 2743 and / or by activating a pull wire) that biases the blade towards the deployed configuration. In further aspects, as shown in FIG. 33, the housing 2735 and the blade 2723 can be configured to translate in direction (indicated by arrow 2732) along the plurality of guide rails 3361 and 3363 between the distal portion 2705 and the proximate portion 2711 of the first catheter 2707 to lacerate at least a portion of the septal wall 170 (see FIG. 34) while the blade 2723 is in the deployed configuration. In further aspects, as shown in FIG. 29, the laceration device 2721 (e.g., blade 2723) can transform from the deployed configuration to the retracted configuration by translating the first catheter 2707 (e.g., proximate portion 2711 - wall 2715) relative to the housing 2735 (see arrow 2742) such that the first catheter 2707 (e.g., proximate portion 2711 - wall 2715) relative to the housing 2735 (see arrow 2742) pushes the laceration device 2721 (e.g., blade 2723) back into the housing 2735.

[0168] A specific embodiment of the catheter apparatus 3501 shown in FIG. 39 (with similar features generally applicable to catheter apparatus 4001 and / or 4201) will be discussed with additional reference to the laceration device 3521 in FIGS. 35-37 and its usage in a heart with reference to FIGS. 15, 18, and 39. In aspects, as shown in FIGS. 35 and 39, the catheter apparatus 3501 can comprise one or more cleats 1503 or 3517 (see cleats 3818a-3818b in FIG. 38) attached to the outer catheter 811 (e.g., distal end 813) and one or more cleats 1503 or 3537 (see cleats 3838a-3838b in FIG. 38) attached to the inner catheter 3541 (e.g., distal end 3525 or 3543) with the laceration device 3521 (e.g., blade 3523) positioned therebetween. For example, the one or more cleats 1503 or 3517 attached to the outer catheter 811 (e.g., distal end 813) can be attached to a location of the heart proximate the aortic valve 210 before the one or more cleats 1503 or 3537 attached to the inner catheter 3541 (e.g., distal end 3525 or 3543) is attached to a location (e.g., on the septal wall 170) proximate the apex 140 (e.g., relative to the outer catheter 811), and then, the laceration device 3521 can be transformed from the retracted configuration to the deployed configuration. As discussed above with reference to FIG. 36, the laceration device 3521 (e.g., blade 3523) can transform from the retracted configuration to the deployed configuration by rotating (e.g., pivoting about the pivot point 3529, which can be activated by pulling a pull wire 3651 see arrow 3652) to extend through the aperture 3533, as shown indicated by arrow 3654. In further aspects, as shown in FIGS. 37 and 39, the laceration device 3521 (e.g., the blade 3523) can be configured to translate (e.g., in the direction indicated by arrow 3502, relative to the inner catheter 3541, the one or more cleats 1503, 3517, or 3537, and / or the outer catheter 811) to lacerate at least a portion of the septal wall 170 (see FIG. 39) while the laceration device 3521 (e.g., blade 3523) is in the deployed configuration (e.g., by translating the body 3641 of the inner support 3631 that the pivot point 3529 is attached to). In further aspects, as shown in FIG. 37, the laceration device 3521 (e.g., blade 3523) can transform from the deployed configuration to the retracted configuration by rotating (e.g., pivoting about the pivot point 3529, which can be activated by pulling a pull wire 3653 see arrow 3756), back into the inner catheter 3541 (see arrow 3758). Also, it to be understood that the laceration device 4021 and / or 4221 of catheter apparatus 4001 and / or 4201 shown in FIGS. 40 and / or 42 can function similarly to and / or identical to the laceration device 3521, for example, with the laceration device 4021 and / or 4221 rotating (e.g., pivoting) between the retracted configuration and the deployed configuration (or vice versa). Instead of the one or more tines in FIGS. 35-37 and 39, the catheter apparatus 4001 shown in FIGS. 40-41 can be anchored by the hook 1605, which is discussed above with reference to FIGS. 16A-16B. Also, the catheter apparatus 4201 shown in FIGS. 42-43 can have a laceration device 4221 (e.g., wire 4223) that can lacerate tissue when the laceration device 4221 is energized, which can be similarto and / or identical with the function of the laceration device 4421 discussed below with reference to FIG. 48

[0169] Specific embodiments of the catheter apparatus 5501 or 5601 shown in FIGS. 55- 56 will be discussed along with its usage in a heart. In aspects, the catheter apparatus 5501 or 5601 comprise two independently controllable catheters, namely first catheter 5541 or 5631 and second catheter 5571 or 5641. Also, both catheter apparatus 5501 or 5601 have a laceration device 5521 or 5621 that attached to at least a distal end 5543 or 5633 of the first catheter 5541 or 5631. In aspects, as shown in FIG. 55, the first catheter 5541 comprises a magnet (e.g., magnetic wheel 5527) at the distal end 5543. In further aspects, the magnetic wheel 5527 can be radio-opaque or echogenic. In further aspects, as shown, the laceration device 5521 can be a fluid jet device (e.g., nozzle 5523) configured to emit a fluid jet 5525 (e.g., waterjet) to lacerate a portion of the septal wall 170. In aspects, as shown, the second catheter 5571 has a magnetic monitoring device 5575 at a distal end 5573 thereof configured to monitor a location of the distal end 5543 (e.g., magnetic wheel 5527) of the first catheter 5541. In further aspects, the magnetic monitoring device 5575 can include magnetic wheel 5577. Providing magnetic wheels for the first catheter and / or the second catheter can facilitate translation of the corresponding catheter along the septal wall (e.g., going between the dashed structures in direction 5502 or 5404), for example, by rotating and / or translating along the septal wall. The magnetic monitoring device 5575 can be radio-opaque or echogenic. In further aspects, the magnetic monitoring device 5575 can be configured to guide the distal end 5543 of the first catheter 5541 (e.g., through the septal wall 170 with a position of the first catheter 5541 positioned in the left ventricle 130 having the laceration device 5521 being monitored and guided by magnetic monitoring device 5575 of the second catheter 5571). For example, the magnetic wheel 5577 of the second catheter 5571 as part of the magnetic monitoring device 5575 can guide (e.g., drag, rotate) the magnetic wheel 5527 of the first catheter 5541 due to the magnetic attraction therebetween. In aspects, the catheter apparatus 5501 can lacerate the portion 5565 of the septal wall 170 starting from an initial position (see the dashed structures towards the bottom of FIG. 55) and translating in direction 5502 and / or 5404 (e.g., towards the aortic valve relative to the initial position) while the laceration device 5521 is activated (e.g., emitting the fluid jet 5525 from the nozzle 5523). In further aspects, in addition to monitoring and guiding the first catheter 5541, the magnetic monitoring device 5575 can further be used (e.g., by a physician or controlling software) to modulate an intensity of the fluid jet 5525, for example, based on a distance between the magnetic wheel 5527 and the magnetic monitoring device 5575 (e.g., magnetic wheel 5577) to lacerate the portion of the septal wall to achieve a predetermined profile 5561 (with region 5563 already lacerated when the laceration device 5521 is in the shownconfiguration). In aspects, the first catheter 5541 and the second catheter 5571 can translate within (e.g., be guided by) an outer catheter 811 or 5551 and extend through the distal end 813 or 5553 thereof. Alternatively, in aspects, as shown in FIG. 56, the catheter apparatus 5601 comprises an anchor 5632 or 5642 configured to extend through an entire thickness of the septal wall 170. As shown, the anchor 5632 or 5642 (e.g., distal attachment device) can extend from the left ventricle 130 through the septal wall 170 with an end cap 5635 or 5645 in the right ventricle, although the opposite arrangement can be provided in other aspects. In further aspects, the anchor 5632 or 5642 can comprise a washer 5637 or 5647 (or other structure that is wider than the rest of the anchor - other than the end cap 5635 or 5645) opposite the end cap 5635 or 5645 that can be used to compress the septal wall 170 and / or further secure an orientation of the laceration device relative to the septal wall 170. In further aspects, the distal end 5633 or 5643 of each catheter 5631 or 5641 (e.g., end cap 5635 or 5645) can be radio-opaque and / or echogenic. In further aspects, as shown, a laceration device 5621 can comprise a section of wire 5623 extending between at least the first anchor 5632 (e.g., first end cap 5635) to the second anchor 5642 (e.g., second end cap 5645). In even further aspects, at least a location on the section of wire 5623 can be exposed (e.g., uninsulated) that is configured to lacerate tissue when energized, and the section of wire can slide through end caps 5635 and 5645 to adjust a position of the location (e.g., translating between the distal attachment devices - the anchors 5632 and 5642). In still further aspects, the location on the section of wire 5623 can be echogenic and / or radio-opaque, which can be monitored by a physician to determine the status of the laceration, adjust a position of the location, and / or a tension on the wire. As shown, the laceration device 5621 can extend along the septal wall 170 between the anchors 5632 and 5642. In aspects, methods can comprise activating the laceration device 5621 by energizing the section of wire 5623 to lacerate the portion of the septal wall, after the anchors 5632 and 5642 are positioned. Further, activating the laceration device 5621 can further comprise translating the section of wire 5623 (e.g., location) to lacerate the portion of the septal wall. Additionally or alternatively, tension can be applied to the section of wire 5623 that bring the section of wire 5623 deeper into the septal wall 170 (see arrow 5602) towards a final configuration (indicated by dashed line) between the end caps 5635 and 5645.

[0170] A specific embodiment of the catheter apparatus 4401 shown in FIG. 48 will be discussed with additional reference to the laceration device 4421 in FIGS. 44-46 and 48 and its usage in a heart with reference to FIGS. 13A-13B, 18, and 48. In aspects, as shown in FIG. 48, the catheter apparatus 4401 can comprise a distal attachment device 940, 1301, or 1311 having one or more tines attached to the distal end 1833 of the first catheter and / or inner catheter 1831. The laceration device 4421 can be transformed from the retracted configuration to the deployedconfiguration, for example, by activating (e.g., pulling, see arrow 4452) an insulated wire 4451 attached to the laceration device 4421 (e.g., wire 4423) that can cause the laceration device 4421 to rotate (e.g., pivot about pivot point 4429). As discussed above with reference to FIG. 45, the insulated wire 4451 can tension (see arrow 4554) the laceration device 4421 (e.g., wire 4423) to resist (e.g., prevent) deflection of the laceration device 4421 (e.g., wire 4423) while the laceration device 4421 is translated (in direction 4512). Also, the bend (e.g., hairpin 4425) and / or crimp 4427 can further provide stiffness to the laceration device 4421 (e.g., wire 4423). As shown in FIG. 48, the laceration device 4421 (e.g., wire 4423) can be activated to lacerate tissue of the septal wall 170 by energizing the wire 4423 - at least part of which can be simultaneous with tensioning the laceration device 4421 (see arrow 4554 in FIG. 45) and / or translating the laceration device 4421 (see direction 4512). As shown in FIG. 47, the support structure 4411 (of the catheter apparatus 4401 shown in FIGS. 44-46) can comprise a support bar 4711 having a channel 4721 that the laceration device (e.g., laceration device 4421 through wheel 4431 and pivot point 4429 shown in FIG. 45) can translate along in direction 4702 (see also direction 4502 in FIG. 45). At a distal end 4713 of the support bar 4711, there can be distal attachment slots 4731 that can be used to overmold (or otherwise attach) the distal attachment device (see distal attachment device 940, 1301, or 1311 in FIG. 48) can be attached to. Also, there can be a transverse slot 4741 opposite the distal end 4713, where the support bar 4711 (and / or the inner catheter) can interface with the rest of the catheter apparatus (e.g., outer catheter).

[0171] FIGS. 49-50 show a laceration device 4921 (e.g., wire 4923) that can be configured to bend at a predetermined location 4925 when the laceration device transforms from a retracted configuration (FIG. 49) to a deployed configuration (FIG. 50). In aspects, the predetermined location 4925 can comprise a plurality of recesses 4928 on an inner side 4926 of the laceration device 4921 such that the laceration device 4921 preferentially bends at the predetermined location 4925 (see arrow 4904) when compressive stress is applied through the ends of the laceration device 4921. In aspects, as shown, the laceration device 4921 can be transformed from the retracted configuration to the deployed configuration by adjusting a distance between ends 4927 and 4929 of the laceration device 4921. Also, as shown, the ends 4927 and 4929 are configured to rotate (e.g., pivot) relative to the rest of the laceration device 4921. In further aspects, as shown, the proximal end 4929 can be extended (see arrow 4902) towards the distal end 4927, for example, by extending a control rod 4935 pivotally attached to the proximal end 4929 at location 4922, although a location of the distal end can be translated closer to the proximal end in other aspects. For example, the proximal end 4929 can slide (e.g., translate) within a slot 4924 of the laceration device 4921. Decreasing the distance between the ends 4927 and 4929 can inducethe laceration device 4921 to bend at the predetermined location 4925 so that the laceration device 4921 extends beyond by the first catheter 4011 by a deployed distance 5039 (see FIG. 50). Also, as shown in FIG. 50, the deployed distance 5039 can be controlled by adjusting an extension distance 5037 that the proximal end 4929 is extended relative to the retracted configuration. In even further aspects, an orientation of the laceration device 4921 and / or the aperture 4033 can be adjusted (e.g., to face the septal wall 170) by rotating the first catheter 4015 (see arrow 5002).

[0172] FIGS. 72-73 show a laceration device 7221 (e.g., wire 7223) that can be configured to transform from a straight configuration (e.g., retracted configuration indicated by dashed line 7231 in FIG. 72) to a curved configuration (e.g., deployed configuration indicated in solid lines as wire 7223 in FIG. 72). In aspects, the laceration device 7221 can transform from the straight configuration (e.g., retracted configuration) to the curved configuration (e.g., deployed configuration) in response to heat (e.g., as a shape memory material such as nitinol) or in response to an applied mechanical force. In further aspects, the laceration device 7221 can be naturally heated by being in the patient; alternatively or additionally, the laceration device 7221 can be resistively heated by passing an electrical current through the laceration device 7221 (e.g., wire 7223) that can enable the physician to control the heating and / or configuration of the laceration device more directly. In further aspects, with reference to FIG. 72, a force can be applied to the laceration device 7221 by translating a distal end 7213 of the inner catheter 7211 (see arrow 7202), where a distal end the laceration device 7221 is attached to the distal end 7213 of the inner catheter 7211 and a proximal end of the laceration device is attached to a proximal end of the laceration device. For example, a pull wire can be attached to the distal end 7213 of the inner catheter 7211 (e.g., extending along dashed line 7231) that can enable a physician to apply a force (see arrow 7202) that induces the laceration device 7221 to transform to the curved configuration. In even further aspects, the pull wire can further provide electrical communication between an energy source (e.g., RF energy, RF generator) and the laceration device such that the laceration device (e.g., wire) can be energized to lacerate tissue, although other arrangements of providing electrical communication are possible in other aspects. In further aspects, although not shown, a second pull wire can be attached to a proximal end of the laceration device and / or a proximal location on the inner catheter to bias the laceration device toward and / or into the septal wall to facilitate laceration thereof. Alternatively or additionally, although not shown, tension can be applied to a proximal end of the laceration device to decrease the distance between opposing ends thereof to induce transforming of the laceration device to the curved configuration, where the device (e.g., control rod) applying tension can also provide electrical communication between an energy source and the laceration device. In further aspects, as shown in FIG. 72, the laceration device 7221 and the innercatheter 7211 can translate independently of the outer catheter 811, which can enable the laceration device 7221 and the inner catheter 7211 to be deployed for the septal myotomy and later retracted while allowing the laceration device 7221 to be contained within the outer catheter 811 while the catheter apparatus 7201 is being navigated through the patient’s vasculature going to and / or from the heart. Alternatively, although not shown, a housing can be provided that can entirely contain the laceration device (e.g., in the retracted configuration) and the laceration device can be removed from (e.g., translated independently from) to allow the laceration device to transform to the curved configuration and lacerate tissue (e.g., region 7251 of the septal wall 170). In aspects, as shown in FIG. 73, the laceration device 7221 (e.g., wire 7223) can have a width that tapers towards a midpoint thereof (e.g., midpoint width 7333 is less than peripheral widths 7331 and 7335), which can facilitate the laceration device transforming (e.g., bending) to the curved configuration due to the reduced stiffness near the midpoint. In further aspects, as shown, the width of the laceration device can continuously and smoothly decrease towards the midpoint thereof, which can facilitate transformation of the laceration device into an arcuate (e.g., elliptical) curved configuration. In aspects, as shown in FIG. 73, the laceration device 7221 can comprise an aperture 7313 at the distal end 7317 thereof that can be attached to the distal end 7213 of the inner catheter 7211 (see FIG. 72) and / or one or more apertures 7311 at a proximal end 7315 thereof that can be attached to a proximal location of the inner catheter 7211 (e.g., body 7215 - see FIG. 72). In further aspects, a length of the laceration device in the straight configuration (e.g., retracted configuration) can be from 25 mm to 50 mm, from 30 mm to 45 mm, from 35 mm to 40 mm, or any range or subrange therebetween. In further aspects, as shown in FIG. 72, transforming the laceration device 7221 from the straight configuration to the curved configuration can comprise decreasing a distance between opposing ends of the laceration device (e.g., axial distance 7339, arrow 7202) that causes the laceration device 7221 (e.g., midpoint) to laterally extend (e.g., lateral distance 7237, arrow 7204) towards the septal wall 170. In even further aspects, the axial distance 7339 of the decrease between opposing ends of the laceration device 7221 can be from 5 mm to 15 mm, from 7 mm to 12 mm, from 8 mm to 10 mm, or any range or subrange therebetween. Consequently, a distance between the opposed ends of the laceration device 7221 in the curved configuration can be from 15 mm to 25 mm, from 17 mm to 23 mm, from 20 mm to 22 mm, or any range or subrange therebetween. In even further aspects, the lateral distance 7237 that the laceration device 7221 (e.g., midpoint) extends relative to the straight configuration (e.g., dashed line 7231 and / or body 7215 of the inner catheter 7211) can be from 5 mm to 15 mm, from 7 mm to 12 mm, from 8 mm to 10 mm, or any range or subrange therebetween. In even further aspects, a ratio of the lateral distance 7237 to the axial distance 7339 can be about 1, for example, from 0.5 to 2.0, from 0.7 to1.5, from 0.8 to 1.2, from 0.9 to 1.0, or any range or subrange therebetween. In further aspects, as shown in FIG. 73, a pair of markers 7361 and 7363 can be positioned at opposing ends of the laceration device 7221 (e.g., proximal end 7315 and distal end 7317, respectively), which can enable a physician to monitor a configuration of the laceration device 7221 based on the distance therebetween, as discussed above. Additionally or alternatively, with reference to FIG. 53, a pair of markers 5361 and 5363 can be used to determine (and / or monitor) an orientation of the laceration device (and / or inner catheter) based on the projection of the markers as viewed by the physician (e.g., the projections can be configured to overlap when in a predetermined orientation). In even further aspects, this pair of markers can be echogenic or radio-opaque. Additionally or alternatively, a material of the laceration device 7221 itself (e.g., nitinol, tungsten, stainless steel) can be echogenic or radio-opaque, which can allow the physician to more directly monitor a configuration of the laceration device 7221.

[0173] Specific embodiments of the catheter apparatus 5101, 5301, and 6701 shown in FIGS. 51-54 and 67 will be discussed along with its usage in a heart. In aspects, as shown, the catheter apparatus 5101 and 5301 can have a distal attachment device comprising a rod 5131 (e.g., inner catheter 5311, needle) with a tapered end 5317 (e.g., pointed end 5133 in FIG. 51, distal end 5313). Alternatively, as shown in FIG. 67, the catheter apparatus 6701 can comprise an anchoring device 6731 (e.g., wires 6733 and 6735 or other expandable device) at a distal end 6713 of the inner catheter 6711 that can be expanded (e.g., curling a pair of wires 6733 and 6735 to a butterfly configuration) that can anchor the distal end 6713 of the inner catheter 6711 in the septal wall 170. As shown in FIGS. 51-53 and 67, the inner catheter 5311 or 6711 (e.g., rod 5131, needle) can be extended in the left ventricle 130 in a direction towards the apex 140 (see arrow 5102 in FIG. 51 or arrow 5302; arrow 6702) to puncture the septal wall 170 (e.g., obliquely pierce). In any such embodiment (e.g., FIGS. 52-53 and 67), the portion of the septal wall between the inner catheter 5311 or 6711 (e.g., rod 5131, needle) and the left ventricle 130 can be lacerated by the catheter apparatus (e.g., region 6751 shown in FIG. 67). In combination with one or more markers (e.g., markers 5361, 5365, or 5367 shown in FIGS. 53-54), a physician can verify the depth and extent of the septal wall to be lacerated by the laceration device prior to activating the laceration device. In aspects, as shown in FIGS. 51-52, the catheter apparatus 5101 can comprise one or more bumpers 5151 (e.g., bumper 5152 and / or 5154 with the wire 5123 extending therebetween, proximate the guiding rod 5141) that can be configured to position the laceration device 5121 relative to the septal wall 170 in a configuration advantageous for laceration. In aspects, as shown in FIGS. 51-52, the laceration device 5121 of the catheter apparatus 5101 comprises a section of wire 5123 extending between a distal attachment device (e.g., rod 5131, needle) and a guiding rod5141. The section of wire 5123 can be translated by translating the guiding rod 5141 (e.g., when the wire 5123 is be attached to a distal end 5143 of the guiding rod 5141 at a first end 5127) with the wire slidably attached to the distal attachment device (e.g., ring) at the other end 5129 of the wire 5123. Consequently, a physician can advance the wire 5123 by translating the guiding rod 5141. Additionally, a distance and / or orientation between the distal attachment device (e.g., rod 5131, needle) and the guiding rod 5141 can maintain tension on the wire 5123. For example, a body 5115 of the first catheter 5111 can be bifurcated (see split 5117) to allow a first end 5116 of a first part 5112 of the first catheter 5111 to flex (e.g., bend) relative to the distal end 5113 in the second part 5114 of the first catheter 5111. In further aspects, a length 5128 of the wire 5123 (e.g., between the ends 5127 and 5129) can be from 2 mm to 6 mm, from 3 mm to 5 mm, from 3 mm to 4 mm, or any range subrange therebetween. In further aspects, the laceration device 5121 can lacerate the portion of the septal wall by energizing the wire 5123 as the guiding rod 5141 is translated towards the apex (see arrow 5142, which can be parallel to the direction that the distal attachment device was extended in to puncture the septal wall 170). Alternatively, as shown in FIG. 67, the laceration device 6721 can comprise a wire 6723 (e.g., exposed section of wire) positioned proximate (e.g., at) the distal end 6713 of the inner catheter 6711. In further aspects, as shown, the inner catheter 6711 can puncture and obliquely extend through the septal wall 170 (e.g., still in the left ventricle 130) with the anchoring device 6731 positioned in (e.g., extending into) the left ventricle 130 that maintains a distal end 6713 at a surface of the septal wall 170. Consequently, activating the laceration device 6721 (e.g., energizing the wire 6723) can lacerate tissue (e.g., of the septal wall 170) and / or cauterize tissue at the distal end 6713. Then, the inner catheter 6711 can be translated towards the outer catheter 811 (e.g., distal end 813, see arrow 6704), which repositions the laceration device 6721 at a new surface of the septal wall 170 (based on the combination of the translation - arrow 6704 - and the anchoring device 6731). This can be repeated (e.g., performed as a continuous process) until the laceration device 6721 has lacerated the septal wall 170 (e.g., region 6751) along the entire path that the inner catheter 6711 originally within the septal wall 170. In aspects, the wire can comprise tungsten, stainless steel, or a combination thereof, which can be radio-opaque. Additionally, the wire 5123 can cauterize as well as lacerate the portion of the septal wall 170. Also, as shown in FIG. 53, the catheter apparatus 5301 (like catheter apparatus 5101) can comprise a distal attachment device configured to pierce the septal wall 170. Additionally or alternatively, the catheter apparatus 5301 can comprise a laceration device 5321 on one side of the inner catheter 5311 (but not the opposite side of the inner catheter). In further aspects, the laceration device 5321 can be configured to expand (see arrow 5304 in FIG. 53 resulting in expanded state 5431 in FIG. 54) when the laceration device 5321 is activated. In evenfurther aspects, the laceration device 5321 can comprise a polymer-based material (e.g., a balloon) configured to expand. In still further aspects, the expansion can lacerate the portion of the septal wall 170. Additionally or alternatively, as shown, the laceration device 5321 can include a wire 5323 configured to lacerate the portion of the septal wall 170 (e.g., from within the septal wall 170). Additionally, the wire 5323 can cauterize as well as lacerate the portion of the septal wall 170

[0174] Additionally or alternatively, as shown in FIGS. 65-66, a portion of the catheter apparatus 6501 or 6601 (e.g., corresponding to an outer catheter with an open-ended endcap 6551 at the distal end 6513 or an inner catheter - or first catheter in other aspects) can be oriented (e.g., steered, directed, turned, rotated) using methods other than a pull wire (discussed throughout). In aspects, as shown in FIGS. 65-66, the first catheter 6511 comprises a body 6515 having a bending portion 6541 or 6641, for example, having a plurality of recess 6543 or 6643 (or grooves) that enable the bending portion 6541 or 6641 to preferentially bend (relative to other portions of the body 6515). The catheter apparatus 6501 or 6601 comprises an inner member 6531 (e.g., inner catheter, control rod) that can be attached to the distal end 6513 of the first catheter 6511. Consequently, translating the inner member 6531 (e.g., extension, see arrow 6542, or retraction, see arrows 6642 and / or 6662) induces compression or tension on the body 6515 of the first catheter 6511 that, in turn, results in bending of the corresponding 6541 or 6641 to change an orientation of the distal end 6513 (see arrow 6544 or 6644). In further aspects, as shown in FIG. 65, the inner member 6531 can be extended (see arrow 6542) by expanding (see arrows 6562 and 6564) a device 6563 through the application of a potential difference (e.g., from an energy source 6567 - battery - connected to the device by wires 6569 and 6565). For example, the device 6563 can be a piezoelectric device that changes dimensions (e.g., expands) in response to an applied potential difference (and / or electrical current); alternatively or additionally, the device 6563 can have a coefficient of thermal expansion such that the potential difference causes resistive heating that expands the device 6563). Alternatively, in further aspects, as shown in FIG. 66, the inner member 6531 can be retracted (see arrows 6662 and / or 6664; or expanded), for example, by rotating (see arrows 6664) a threaded portion 6663 of the inner member 6531 relative to another portion 6661 of the catheter apparatus 6601 (e.g., mating portion 6665 attached to the first catheter 6511).

[0175] Embodiments of the catheter apparatus 6001, 6201, or 6401 shown in FIGS. 60- 64 having at least one aperture configured to draw a vacuum therethrough will be discussed with reference to its usage in a heart. In aspects, as shown in FIGS. 60-63, the catheter apparatus 6001 or 6201 can comprise a plurality of apertures 6031 or 6231 (e.g., vacuum port 6037 or 6237), for example, arranged in two rows 6033 and 6035 or 6233 and 6235. In further aspects, as shown, thelaceration device 6021 or 6221 (e.g., blade 6023 or wire 6323 - see FIG. 63) can be positioned between the first row 6033 and the second row 6035. Additionally, as shown, the laceration device 6021 can be configured to translate along a length (see arrow 6002, 6223, or 6304) of the rows 6033 and 6035 or 6233 and 6235 (while positioned therebetween). Consequently, the portion of septal wall to be lacerated (e.g., corresponding to a location of the laceration device 6021) can be stabilized by drawing a vacuum through the plurality of apertures 6031 (e.g., rows 6033 and 6035) positioned on either side thereof. Also, as shown in FIG. 60, the translation of the laceration device 6021 relative to the plurality of apertures 6031 can be enabled by the laceration device 6021 being attached to a control rod 6025 that can translate independently of (e.g., within) of the body 6015 of the first catheter 6011. Similarly, as shown in FIG. 63, the laceration device 6221 (e.g., wire 6323) can be extended (e.g., arrow 6302) and / or translated (e.g., arrow 6304) of the first catheter 6011 by translating freely therein and through structure 6351 (that can facilitate orientation and extension of the wire to the distance 6359). In even further aspects, as shown in FIG. 60, the rows 6033 and 6035 can be separate structures (in contrast to FIGS. 62-63) distal from the first catheter 6011 (e.g., distal end 6013) that can flex or otherwise adapt to the local physiology. Alternatively, as shown in FIG. 62, the rows 6233 and 6235 can be attached to one another (distal from the distal end 6013 of the first catheter 6011) by stabilizing ribs 6245 and 6247 with the laceration device extending through an aperture 6243 in a central portion 6241 positioned therebetween, which can provide additional rigidity to the catheter apparatus. Alternatively or additionally, with reference to FIGS. 62-63, a vacuum can be pulled through the same aperture 6243 that is used to lacerate the portion of septal wall (e.g., laceration device 6221 can extend therethrough to lacerate tissue, or tissue can be sucked into and / or through the aperture 6243 where it may be lacerated by the laceration device 6221); in such aspects, it is to be understood that the rows 6233 and 6235 may be omitted to reduce a size of the catheter apparatus. Alternatively, as shown in FIG. 64, the catheter apparatus 64 can comprise nozzles 6451 and / or 6453 as the proximal attachment device 840 and / or the distal attachment device 860 with the laceration device 6421 positioned therebetween. As discussed above, the nozzles comprise nozzles 6451 and / or 6453 can comprise an aperture through which a vacuum can be drawn, which can bring the nozzle in contact with tissue (e.g., of the septal wall or aorta, see arrow 6452 or 6454). In aspects, as shown in FIGS. 63- 64, a distance 6359 (see FIG. 63, and arrow 6404) that the wire 6423 extends beyond the inner catheter 6431 (e.g., wall 6433) can be controlled by extending the wire 6423 (see arrow 6402), although an end of the wire can be translated (e.g., brought together with and / or relative to an opposite end of the wire) to adjust this distance. In further aspects, as shown in FIG. 64, the distal nozzle 6453 can be positioned at the distal end 6443 of inner catheter 6441 (e.g., body 6445extending from the distal end 6435 of the inner catheter 6431) that can be translated (e.g., extended, see arrow 6410) independent of the outer catheter 6411 (e.g., body 6415) and / or the inner catheter 6431 having the laceration device 6421.

[0176] Embodiments of the catheter apparatus 6801, 8001, 8601, or 8701 shown in FIGS. 68, 80, or 86-87 having a wire 6823, 8023, 8623, or 8723 as a laceration device 6821, 8021, 8621 , or 8721 configured to lacerate a portion of the septal wall 170 when the wire 6823, 8023, 8623, or 8723 is energized will now be discussed. In aspects, at least a section of the wire 6823, 8023, 8623, or 8723 can be echogenic or radio-opaque to allow a physician to monitor the location of the wire. In aspects, as shown, the catheter apparatus 6801 further comprises a guidewire 6811 (e.g., inner catheter) having a distal attachment device 940 or 6831 at a distal end 6813 thereof, where the distal attachment can comprise any of the aspects discussed herein. For example, the distal attachment device 940 or 6831 can anchor the guidewire 6811 to a location proximate the apex 140. In further aspects, as shown, the wire 6823 (e.g., laceration device 6821) can be attached to the distal end of the guidewire 6811 and / or the distal attachment device 940 or 6831. Alternatively or additionally, the wire 6823 (e.g., laceration device 6821) can be wrapped (e.g., twisted) around the guidewire one or more times (e.g., at the location shown for the proximal anchor 6835 and / or the distal attachment device 6831) so that the wire 6823 can translate along the guidewire 6811 while being guided by guidewire 6811, which may be anchored by the distal attachment device 940 or 6831. For example, an end of the wire can be configured to concentrate RF energy and extend towards the septal wall (e.g., arrow 6802, relative to the guidewire), and the wire can be translated along the guidewire to lacerate a portion of the septal wall (e.g., region 6851) extending towards the aortic valve 210 relative to the distal end 6813 of the guidewire 6811 (e.g., distal attachment device 940). Additionally or alternatively, the guidewire 6811 can be anchored to the septal wall 170 at a proximal location by the proximal anchor 6835. Alternatively or additionally, as shown in FIGS. 80, 86, and 87, the laceration device 8021 or 8721 can extend between the pair of distal attachment devices 8019, 8039; 8651, 8671; or 8731, 8735 (e.g., between proximal anchor 6835 and the distal attachment device 940 or 6831). In further aspects, the wire 8023, 8623, or 8723 of the laceration device 8021, 8621 or 8721 can be the only thing extending between the pair of distal attachment devices 8019, 8039; 8651, 8671; or 8731, 8735. Additionally or alternatively, proximal portions 8713 and 8715 can extend beyond the distal end 813 of the outer catheter 811 to the corresponding distal attachment device 8731 or 8735, and / or the proximal portions can comprise and / or consist of the wire 8723 (including any insulation thereon) and / or laceration device 8721 (or laceration device 8221 shown in FIG. 82). Additionally or alternatively, as shown in FIG. 68, the catheter apparatus 6801 can comprise a proximal attachment device 901(e.g., mesh) attached to distal end 813 of an outer catheter, where the wire 6823 and the guidewire 6811 can be at least partially positioned therein and translate independently. In further aspects, as shown, the proximal attachment device 901 can bias and / or position the wire 6823 and / or the guidewire 6811 closer to the side of aortic valve 210 proximate the septal wall 170 than the other side, although the other arrangement can be provided in other aspects. In further aspects, as shown in FIGS. 68, 80, and 86-87, the laceration device 6821, 8021, 8621, and 8721 (e.g., wire 6823, 8023, 8623, or 8723) can be attached to (e.g., translate through distal attachment devices 6825, 6827; 8651, 8671; or 8725, 8727 - see laceration attachments 8025 and 8027 in FIGS. 80) the proximal anchor 6835 or the pair of distal attachment devices 8019, 8039; 8651, 8671; or 8731, 8735. In even further aspects, a portion of the wire 6823, 8023, 8623, or 8723 (e.g., location shown for wire 8723 in FIG. 87 that can correspond to exposed length 8229 between ends 8225 and 8227 of the insulation 8213 and 8215 in FIG. 82) configured to lacerate tissue (e.g., of the septal wall 170) can be positioned between the proximal anchor 6835 and the distal attachment device 940 or 6831 (e.g., pair of distal attachment devices 8019, 8039; 8651, 8671; or 8731, 8735) and / or configured to translate therebetween (e.g., to lacerate a region 6851 or 8751 of the septal wall). In even further aspects, tension can be applied to the laceration device 6821, 8021, or 8721 (e.g., by pulling a proximal portion 6829 or 8713 thereof, see arrow 6804, 8704, and / or 8706), which can bring the wire 6823, 8023, or 8723 in contact with the septal wall 170 (see arrow 6802 or 8702) including newly exposed portions of the septal wall 170 during the laceration, which can extend to until the wire 6823, 8023, or 8723 has lacerated the region 6851 or 8751 such that the wire 6823, 8023, or 8723 is a straight segment (e.g., extending from the proximal anchor 6835 and the distal attachment device 940 or 6831, between the pair of distal attachment devices 8019, 8039 or 8731, 8735), although the laceration can be stopped before reaching this point in other aspects. In even further aspects, the distal attachment device 8019, 8039; 8651, 8671; or 8731, 8735 (e.g., laceration attachments 8025 and / or 8027) can include a ratcheting mechanism that can enable the tension to be increased and maintained (e.g., until released by the physician activating a pull wire). Alternatively or additionally, the laceration device can comprise a stopper that limits an extent that the laceration device can translate (e.g., keeping a predetermined section of the wire between the proximal anchor and the distal anchor). Alternatively or additionally, the laceration device can be fixed to the distal attachment device while being allowed to translate through the attachment in the proximal anchor such that tension can be applied by pulling on the proximal end of the laceration device. In aspects, one or both of the pair of distal attachment devices 8019, 8039 or 8731, 8735 can be echogenic or radio-opaque. Additionally or alternatively, although not shown, the laceration device (e.g., wire 8723 in FIG. 87 or braided cable as the laceration device 8321 in FIG. 83) cancomprise a polygonal cross-sectional shape (e.g., triangular, although other polygonal shapes including quadrilateral, pentagonal, hexagonal, heptagonal, octagonal can be provided in other aspects), which can enable a portion of the laceration device corresponding to an edge of the cross- sectional polygonal shape to lacerate tissue - in addition to any laceration occurring due to energizing the laceration device. Additionally or alternatively, a cross-sectional shape of the laceration device (e.g., braided cable as the laceration device 8321 in FIG. 83 and / or cable saw) can lacerate tissue by abrading tissue as the laceration device is translated along the septal wall. In aspects, as shown in FIG. 86, a distal end of the catheter apparatus 8601 can comprise a catheter tip 8641 positioned between the pair of distal attachment devices 8651, 8671 (e.g., the body 8613 or 8633 of the inner catheters 8611 and 8631; lumens 8515 and 8535 shown in FIG. 85). For example, as shown by the dashed line in FIG. 86, the distal attachment devices 8651, 8671 can fit into a smooth longitudinal cross-sectional profile with the catheter tip 8641 to facilitate navigation of the catheter apparatus through the patient’s vasculature. In even further aspects, as shown, the distal end 8643 of the catheter tip 8641 can be blunted (e.g., truncated) to reduce incidental damage and / or laceration from the catheter apparatus (e.g., other than the predetermined portion of the septal wall).

[0177] Embodiments of the catheter apparatus 8001 shown in FIGS. 80-81 along with the laceration device 8321 (e.g., braided cable) shown in FIG. 83 will now be used to discuss aspects and / or embodiments where the laceration device is configured to lacerate tissue by abrading tissue, for example, where the laceration device 8021 or 8321 is a cable saw. In aspects, as shown in FIGS. 80-81, the laceration device 8021 can extend between a pair of distal attachment devices 8019 or 8039, where the laceration device 8021 can translate relative to (e.g., through laceration attachments 8025 and 8027 shown in FIG. 80) the distal attachment devices 8019 and / or 8039. In further aspects, the laceration device can have polygonal cross-sectional shape (e.g., triangular cross-sectional shape) which can enable a portion of the laceration device corresponding to an edge of the cross-sectional polygonal shape to lacerate tissue. Additionally or alternatively, as shown in FIG. 83, the laceration device 8321 can comprise a braided cable, where a cross- sectional shape changes (e.g., is rotated relative to adjacent cross-sectional shapes due to the braided nature of the braided cable) or is otherwise irregular, which can enable differences in the cross-sectional shape along the length of the laceration device to abrade tissue as the laceration device is translated (e.g., along the septal wall). For example, as shown in FIG. 80, the laceration device 8021 can be translated back and forth (e.g., see arrows 8122 and 8124; towards and away from the distal end 813 of the outer catheter 811) to lacerate the portion of the septal wall 170 by abrading tissue along that portion of the septal wall. Additionally, in aspects, as discussed abovewith reference to FIGS. 68 or 86-87, tension can be applied to the laceration device 8021 or 8321 (e.g., by pulling a proximal portion - shown as inner catheters 8011 or 8031 - as indicated by arrows 8104 or 8106), which can bring the wire 8023 in contact with the septal wall 170 (see arrow 8102), including newly exposed portions of the septal wall 170 during the laceration, which can extend to until the laceration device 8021 has lacerated the region 8151 such that the laceration device 8021 is a straight segment between the pair of distal attachment devices 8019, 8039, although the laceration can be stopped before reaching this point in other aspects.

[0178] Embodiments of the catheter apparatus 6901 and portions thereof shown in FIGS. 69-71 having a laceration device 6921 comprising at least two sections (e.g., two sections) that is configured to lacerate a portion of the septal wall 170 when the laceration device 6921 is energized will now be discussed. In aspects, as shown in FIGS. 69 and 71, the laceration device 6921 comprises at least two laceration attachment devices 6933 and 6935 corresponding an equal number of sections of the laceration device 6921. In further aspects, as shown in FIG. 70, the laceration attachment device can comprise a hook 6961 and the laceration device 6921 (e.g., wire 6923) extends around the hook 6961 including a distal end 6963 thereof. For example, as shown in FIG. 71, the laceration attachment device 6933 or 6935 (e.g., hook) can enable the laceration device 6921 to contact and / or extend into the septal wall 170. In further aspects, the laceration device can comprise two or more laceration catheters 6953 and 6955 having corresponding laceration attachment devices 6933 and 6935 at the distal end thereof, where each laceration catheter 6953 and 6955 can be independently translated to position the corresponding laceration attachment device 6933 or 6935 at a predetermined location (e.g., on the septal wall). In further aspects, as shown in FIG. 69, the catheter apparatus 6901 can comprise an attachment wire 6931 attached to (extending through) the laceration attachment devices 6933 and 6935. In even further aspects, as shown in FIG. 70, the laceration attachment device 6935 comprises an aperture 6929 that the attachment wire 6931 can extend through and / or translate through; likewise, as shown in FIG. 69, the laceration attachment device 6933 comprises an aperture 6927 that the attachment wire 6931 can extend through and / or translate through. As shown, the attachment wire 6931 can further extend along the laceration catheters 6953 and 6955. Consequently, as shown in FIG. 69, the laceration attachment devices 6933 and 6935 can be brought together (see arrow 6904 and 6906) by pulling the attachment wire 6931. For example, the laceration devices 6921 (e.g., laceration attachment devices 6933 or 6935) can translate along a path of the attachment wire 6931 therebetween. In further aspects, the catheter apparatus 6901 can comprise an inner catheter 6911 having a distal attachment device 940 or 1401 at the distal end 6913 thereof. In even further aspects, the distal attachment device 940 or 1401 can be laterally positioned between the lacerationattachment devices 6933 and 6935 (e.g., pair of two laceration attachment devices shown). Also, as shown in FIG. 69, the laceration attachment device 6935 can comprise a marker 6965 that can be echogenic or radio-opaque to allow a physician to monitor a location of the corresponding laceration attachment device. In further aspects, the laceration catheters 6953 and 6955 and the inner catheter 6911 can be positioned in an outer catheter 6941. In aspects, with reference to FIGS. 69 and 71, methods of using the catheter apparatus 6901 can comprise: bringing a distal end 6943 of the outer catheter 6941 towards the septal wall 170 (e.g., in the position indicated by dashed lines 6945), deploying the distal attachment device 940 or 1401 (e.g., including extending the inner catheter 6911 towards the septal wall 170 and rotating the distal attachment device 940 or 1401, see arrow 6908), retracting the distal end 6943 of the outer catheter 6941 (see arrow 6902) to provide room for the laceration catheters 6953 and 6955 to be independently maneuvered (e.g., beyond sheath 6951), positioning the laceration attachment devices 6933 and 6935 (e.g., in contact with the septal wall 170), activating the laceration devices 6921 to lacerate tissue of the septal wall 170 and pulling the attachment wire 6931 to bring the laceration devices 6921 (e.g., laceration attachment devices 6933 and 6935) together (see arrow 6904 and 6906) to lacerate a larger portion of the septal wall (see dashed line in FIG. 71). As necessary, the laceration catheters 6953 and 6955 (e.g., the laceration attachment devices 6933 and 6935) can be repositioned and the rest of the method repeated to achieve a deeper laceration of the septal wall. Likewise, the entire catheter apparatus can be repositioned at another location on the septal wall and the method repeated to lacerate additional portions of the septal wall (e.g., forming a longer portion of the septal wall that is lacerated).

[0179] Embodiments of catheter apparatus 7401, 7501, 7601, and 7801 shown in FIGS. 74-79 that have a hydrofoil-inspired design that is configured to lacerate a portion of the septal wall 170 when the laceration device 7421, 7521, 7621, or 7821 is activated will now be discussed. For example, with reference to FIG. 74, the laceration device 7421 of the catheter apparatus 7401 has a lower skid 7431 that pushes against and / or penetrates a lower part of the septal wall 170 (see arrow 7433) applying a force at least partially in a direction indicated by arrow 7404 that generates a reaction force (see arrow 7406) that pushes the laceration device 7421 in the opposite direction so that the laceration device remains near the surface of the septal wall 170 as the laceration device is translated (see arrow 7402) to lacerate the septal wall. Also, in further aspects, the catheter apparatus 7401 further comprises an upper skid 7435 that can be configured to travel along (or slightly above) the septal wall 170 (e.g., with upper skid surface 7437 facing and / or contacting the septal wall 170), which can also help the laceration device remains near the surface of the septal wall 170 as the laceration device is translated (see arrow 7402 - away from the distal end 7413 ofthe first catheter 7411). In even further aspects, a blade 7423 of the laceration device 7421 can be positioned between the lower skid 7431 and the upper skid 7435. In still further aspects, a swept angle 7425 between the lower skid 7431 and the upper skid 7435 can be adjustable, for example by pivoting the lower skid 7431 at pivot point 7439 to control a depth that the laceration device 7421 lacerates the septal wall 170 (see lacerated region 7451). Although now shown for clarity, it is to be understood that a control wire or other actuator can be attached to the lower skid 7431 and / or pivot point 7439 to allow a physician to adjust the swept angle 7425 while the catheter apparatus 7401 is in the left ventricle of the heart. In further aspects, as shown, the laceration device 7421 can be attached to a distal end 7413 of a first catheter 7411 (e.g., inner catheter). In even further aspects, although not shown, the first catheter 7411 can comprise a proximal attachment to facilitate orientation and / or positioning of the laceration device 7421, although the laceration device 7421 can be used without additional attachment devices due to the inherent stabilization provided by the hydrofoil-inspired design (as discussed above) in other aspects. In aspects, as shown in FIG. 75, the laceration device 7521 of catheter apparatus 7501 can comprise a wire 7523 configured to lacerate tissue when energized extending to a foot 7525 that functions similar to the lower skid 7431 in FIG. 74 with reference to the reaction force principle. In further aspects, the foot 7525 can be a blade that also lacerates tissue in combination with the wire 7523, although the foot 7525 need not be sharp and can resemble the design of the laceration device 7621 shown in FIG. 77 in other aspects. In further aspects, the foot 7525 can taper towards its distal end. As shown, the laceration device 7521 can be translated (see arow 7532) to lacerate tissue (e.g., while the wire is energized) of the septal wall 170 (see lacerated region 7551). Additionally, in further aspects, the wire can further cauterize the septal wall as (or after) it is being lacerated. In further aspects, a support wire 7537 can extend from the foot 7525 to distal end 7513 of a first catheter 7511 of the laceration device 7521. In even further aspects, the support wire 7537 can be an insulated portion of the same wire as wire 7523, where the insulation prevents the support wire 7537 from lacerating tissue. In even further aspects, a depth that the laceration device 7521 lacerates the septal wall 170 can be adjusted by translating an actuator (e.g., retaining washer 7533) to adjust how much of the support wire 7537 can extend from first catheter 7511 versus how much is retained in the first catheter (see retained portion 7531). In still further aspects, the first catheter can separate into a proximal portion (left) and a distal end 7513 to reveal the laceration device 7521, which can be similar to or identical to the function of the catheter apparatus 2701 discussed above with reference to FIGS. 27A-27B and 28-34. For example, as shown in FIG. 75, the distal end 7513 can be connected to the rest of the first catheter 7511 by a guide rail 7535 (e.g., pair of guide rails) extending within a cross-sectional footprint (perpendicular to the view shown) of thefirst catheter 7511. The guide rail 7535 can provide additional stability to the laceration device 7521, for example, by allowing the laceration device to be axially translated therealong while restraining rotation relative to the rest of the catheter apparatus 7501. Additionally, although not shown, the distal end 7513 can have a distal attachment device, including one or more apertures configured to pull a vacuum, although other distal attachment devices discussed herein (or no distal attachment device) can be provided in other aspects. In aspects, as shown in FIG. 76, the catheter apparatus 7601 include a light beam (e.g., laser beam 7633) as part of the laceration device. For example, the light beam (e.g., laser beam 7633) can travel within an interior of the first catheter 7611 towards the distal end 7613 thereof before being redirected by a reflector 7631 travel through an aperture 7639 of the first catheter 7611 (as reflected laser beam 7635) to impinge a portion of the septal wall 170. In even further aspects, the light beam can be emitted within the catheter apparatus (e.g., from a light-emitting diode or a laser diode) or can be optically coupled from an internal light source. In even further aspects, as shown, a foot 7625 can be provided having a reflective upper surface 7637 to reflect the light beam (e.g., laser beam 7633), which can ensure a lower limit on the depth that the septal wall is lacerated. As discussed above, the foot 7625 can be a blade, taper towards its distal end, and / or be blunt. An enlarged view of the foot 7625 is provided in FIG. 77 showing it tapering towards the distal ends thereof but with a truncated front end to provide a blunt end when the foot 7625 itself is not a blade. Also, an under surface of the foot can be smooth to facilitate the foot maintaining the configuration schematically shown in FIG. 77. In still further aspects, as shown in FIG. 76-77, there can be marker 7661 on the foot 7625 that can be echogenic or radiopaque (or the foot itself can be echogenic or radiopaque) to allow a physician to monitor the depth of the laceration. In even further aspects, the foot 7625 can be attached to a distal end of a support arm 7641 configured to extend from the first catheter 7611. In still further aspects, as shown, the support arm 7641 can be pivotally attached to the first catheter 7611 at pivot point 7649. Additionally, a position of the support arm 7641 (and, in turn, the foot 7625) can be controlled (and / or supported) by a crossbar 7643 that can be attached to both the support arm 7641 at a first location (that can be a first pivot point 7647) and a body of the first catheter 7611 at an attachment pin 7645. Although not shown, the attachment pin 7645 can be configured to translate axially along a portion of the first catheter 7611 (e.g., in or against the direction indicated by arrow 7602) to extend or retract the support arm 7641 (and, in turn, the foot 7625), for example, by translating along a channel similar to or identical to the channel shown in FIG. 47. Consequently, methods of using catheter apparatus 7601 can comprise: positioning the first catheter 7611 proximate the septal wall 170, deploying the foot 7625 using the support arm 7641, emitting a light beam (e.g., laser beam 7633) that impinges and lacerates a portion of the septal wall 170 andeventually reflects off the reflective upper surface 7637 of the foot 7625, and translating the laceration device (e.g., reflector 7631 and foot 7625) and / or at least a portion of the first catheter 7611 in the direction indicated by arrow 7602 and continuing to lacerate portions of the septal wall 170 (e.g., region 7651). In aspects, as shown in FIGS. 78-79, catheter apparatus 7801 can comprise a laceration device 7821 having a blade 7825 with a cutting edge 7823 at a distal end 7813 of a first catheter 7811 (e.g., inner catheter). In further aspects, a marker 7861 can be located at the distal end 7813 of the first catheter 7811. In further aspects, as shown in FIG. 79, the laceration device 7821 can be configured so that the cutting edge 7823 of the blade 7825 faces away from the septal wall such that the opposing surface (opposite the cutting edge 7823) generates a reaction force similar the principle discussed above with reference to FIG. 74 to maintain a position of the laceration device 7821 relative to septal wall 170 as the laceration device 7821 is translated in the direction indicated by arrow 7802. In further aspects, as shown in FIGS. 78-79, the laceration device can comprise a secondary cutting surface 7827 facing the cutting edge 7823. Alternatively, although not shown, the surface opposite the cutting edge 7823 may not be a cutting surface in other aspects. As shown in FIG. 78, a swept angle 7829 can be formed between the cutting edge 7823 and the secondary cutting surface 7827 that is acute. Although not shown, similar to or identical to the aspects discussed above with reference to FIG. 74, the swept angle 7829 can be adjustable. As the laceration device 7821 is translated (see arrow 7802), a tapered end (e.g., sharp end, leading end) of the blade 7825 can be configured to initially penetrate (e.g., obliquely penetrate) a surface of the septum 770 (e.g., septal wall 170) and then a portion of the septal wall is lacerated by the cutting edge 7823 (and additional cutting support can be provided by the secondary cutting surface 7827). In further aspects, as shown in FIGS. 78-79, the portion of the laceration device 7821 having the secondary cutting surface 7827 can have a blunt outer edge 7831 (e.g., rounded outer edge) to reduce an incidence of unintended laceration of additional tissue.

[0180] As used herein, maximum cross-section dimension refers to a “width” of a catheter, which corresponds to a diameter when the cross-section is circular; widths are specified in French, which corresponds to a specific outer diameter, although the circumference is specified below with the understanding that the conversion therebetween can be used to specify the outer diameter. In aspects, as shown in FIG. 20, a maximum cross-sectional dimension 2009 (e.g., width) of the outer catheter 811 can be less than or equal to 22 French (e.g., 23 mm circumference), less than or equal to 20 French (e.g., 21 mm circumference), less than or equal to 18 French (e.g., 19 mm circumference), less than or equal to 16 French (e.g., 17 mm circumference), greater than or equal to 15 French (e.g., 16 mm circumference), greater than or equal to 16 French (e.g., 17 mm circumference), greater than or equal to 17 French (e.g., 18 mm circumference), greater than orequal to 18 mm), greater than or equal to 18 French (e.g., 19 mm circumference), or greater than or equal to 20 French (e.g., 21 mm circumference). In aspects, a maximum cross-sectional dimension 2009 (e.g., width) of the outer catheter 811 can be from greater than or equal to 15 French to less than or equal to 22 French, from greater than or equal to 16 French to less than or equal to 20 French, from greater than or equal to 17 French to less than or equal to 18 French, or any range or subrange therebetween. In aspects, as shown in FIG. 20, a maximum cross-sectional dimension 2019 (e.g., width) of the inner catheter 1711 can be less than or equal to 15 French (e.g., 16 mm circumference), less than or equal to 13 French (e.g., 14 mm circumference), less than or equal to 11 French (e.g., 12 mm circumference), less than or equal to 10 French (e.g., 11 mm circumference), less than or equal to 8 French (e.g., 8 mm circumference), less than or equal to 7 French (e.g., 7 mm circumference), greater than or equal to 5 French (e.g., 5 mm diameter), greater than or equal to 6 French (e.g., 6 mm diameter), greater than or equal to 7 French (e.g., 7 mm circumference), greater than or equal to 8 French (e.g., 8 mm circumference), greater than or equal to 10 French (e.g., 12 mm circumference), or greater than or equal to 12 French (e.g., 13 mm circumference). In aspects, as shown in FIG. 20, a maximum cross-sectional dimension 2019 (e.g., width) of the inner catheter 1711 can be from greater than or equal to 5 French to less than or equal to 15 French, from greater than or equal to 6 French to less than or equal to 13 French, from greater than or equal to 7 French to less than or equal to 11 French, from greater than or equal to 8 French to less than or equal to 10 French, or any range or subrange therebetween. In aspects, the maximum cross-sectional dimension 2019 of the inner catheter 1711 can be less than the maximum cross- sectional dimension 2009 of the outer catheter 811 by 1 mm or more, 1.5 mm or more, 2 mm or more, 2.5 mm or more, 3 mm or more, 4 mm or more, or 5 mm or more. In aspects, as shown in FIG. 20, a maximum cross-sectional dimension 2029 (e.g., width) of the housing 2011 (e.g., wall 2013) can be less than or equal to the maximum cross-sectional dimension 2009 of the outer catheter 811 and greater than the maximum cross-sectional dimension 2019 of the inner catheter 1711. In aspects, the maximum cross-sectional dimension 2029 (e.g., width) of the housing 2011 can be from greater than or equal to 7 French (Fr) to less than or equal to 20 Fr, from greater than or equal to 8 Fr to less than or equal to 18 Fr, from greater than or equal to 9 Fr to less than or equal to 16 Fr, from greater than or equal to 10 Fr to less than or equal to 14 Fr, from greater than or equal to 11 Fr to less than or equal to 12 Fr, or any range or subrange therebetween.

[0181] In aspects, as shown in FIG. 38, a maximum cross-sectional dimension 3509 (e.g., width) of the outer catheter 3511 can be within one or more of the ranges discussed above with reference to the maximum cross-sectional dimension 2009, for example, from greater than or equal to 18 French (Fr) to less than or equal to 22 Fr, from greater than or equal to 19 Fr to less than orequal to 21 Fr, from greater than or equal to 19 Fr to less than or equal to 20 Fr, or any range or subrange therebetween. In aspects, as shown in FIG. 38, a maximum cross-sectional dimension 3659 of the inner support 3631 can be within one or more of the ranges discussed above for the maximum cross-sectional dimension 2029, for example, from greater than or equal to 10 Fr to less than or equal to 20 Fr, from greater than or equal to 11 Fr to less than or equal to 18 Fr, from greater than or equal to 12 Fr to less than or equal to 16 Fr, from greater than or equal to 13 Fr to less than or equal to 14 Fr, or any range or subrange therebetween. In aspects, as shown in FIG. 38, a maximum cross-sectional dimension 3549 of the inner catheter 3541 is greater than the maximum cross-sectional dimension 3659 of the inner support 3631 and less than the maximum cross- sectional dimension 3509 of the outer catheter 3511 to allow relative translation of the components, to accommodate the proximal attachment device (e.g., cleats 3818a-3818b of the cleats 1503 or 3517), and / or to accommodate the distal attachment device (e.g., cleats 3838a-3838b of the one or more cleats 1503 or 3537). For example, a maximum cross-sectional dimension 3819 of the cleats 3818a-3818b of the one or more cleats 1503 or 3517 can be from greater than or equal to 1 Fr to less than or equal to 5 Fr, from greater than or equal to 2 Fr to less than or equal to 4 Fr, from greater than or equal to 2 Fr to less than or equal to 3 Fr, or any range or subrange therebetween.

[0182] In aspects, as shown in FIGS. 84-85, the catheter apparatus 8001 or 8601 can have an outer catheter 811 that is a dual lumen catheter (e.g., lumens 8415, 8435 or 8513, 8533). In further aspects, as shown in FIG. 84, inner catheters 8011 and 8031 (e.g., body 8015 or 8035) can be positioned within and / or through the corresponding lumens 8415 and 8435. In even further aspects, as shown, the laceration attachments 8025 and 8027 (that the laceration device including portions 8017 and 8037 extend therethrough) can be positioned adjacent one another on the inside portion of the lumens, which can help prevent the laceration device (e.g., wire) from getting tangled with itself and / or other portions of the laceration device 8021. Additionally, as shown in FIG. 84, the catheter apparatus 8001 can optionally include another lumen 8041, for example, configured to allow a guidewire to be advanced therethrough. In further aspects, a maximum cross-sectional dimension 8619 of a lumen 8515 or 8535 and / or the body 8613 or 8633 of the inner catheter 8611 or 8631 can be within one or more of the ranges discussed above for the maximum cross-sectional dimension of the inner catheter in the previous paragraph. In further aspects, a maximum cross- sectional dimension 8659 of the outer catheter 811 can be within one or more of the ranges discussed above for maximum cross-sectional dimension 2009 discussed above (e.g., from 15 Fr to 22 Fr, from 16 Fr to 20 Fr, from 17 Fr to 18 Fr). In further aspects, as shown in FIG. 85, the catheter apparatus 8601 can comprise inner catheters 8611 and 8631 (e.g., body 8613 or 8633) that can be positioned within and / or through the corresponding lumens 8515 and 8535. In even furtheraspects, as shown, the catheter tip 8641 can be positioned between the lumens 8515 and 8535 (e.g., inner catheters 8611 and 8631). A maximum cross-sectional dimension 8649 of a tip of the catheter tip 8641 can be greater than or equal to 1 Fr, greater than or equal to 3 Fr, greater than or equal to 5 Fr, greater than or equal to 7 Fr, less than or equal to 12 Fr, less than or equal to 10 Fr, or less than or equal to 7 Fr, for example, from greater than or equal to 1 Fr to less than or equal to 12 Fr, from greater than or equal to 3 Fr to less than or equal to 10 Fr, from greater than or equal to 5 Fr to less than or equal to 7 Fr, or any range or subrange therebetween. Alternatively, with reference to FIG. 85, a laceration device 8221 (see FIG. 82) can extend through the lumens 8515 and 8535 with distal attachment devices positioned at the ends of the corresponding lumens 8515 and 8535, which can be deployed at corresponding locations along the septal wall (e.g., locations of distal attachment devices 8731 and 8735 along septal wall 170 in FIG. 87) as the outer catheter 811 (e.g., distal end 813) is navigated within the left ventricle 130 of the heart 120 (e.g., towards the apex 140 to deploy the distal attachment device 8731 first and then retracted to deploy the distal attachment device 8735 or vice versa).

[0183] Methods of ameliorating septal hypertrophy (e.g., performing a septal myotomy) will now be discussed with reference to the flow chart in FIG. 5 and the example method steps shown in FIGS. 6-8, 23, 80, and 87. In aspects, methods can start at step 401 comprising positioning a distal end of an outer catheter (e.g., first catheter and / or second catheter) at a first location proximate the aortic valve. As discussed above with reference to FIGS. 1-2, the catheter apparatus can be inserted in and navigated through the vasculature (e.g., femoral artery, carotid artery, aorta) towards the heart. As shown in FIG. 6, the outer catheter 811 is navigated through the vasculature so that the distal end 813 of the outer catheter 811 is positioned proximate the aortic valve 210. Although not shown, a guidewire can be navigated before feeding the outer catheter (e.g., first catheter and / or second catheter) to the location shown in FIG. 6 (with the understanding that a guide wire can further extend into the left ventricle 130, for example, with a distal end 803 of the guide wire ending towards the apex 140, as shown in FIG. 7).

[0184] In aspects, after step 401, methods can proceed to step 403 comprising extending a catheter (e.g., inner catheter, outer catheter) towards an apex of a left ventricle. In aspects, as shown in FIG. 8 (relative to FIG. 6), a distal end 933 of the inner catheter 931 has been extended towards the apex 140 of the left ventricle 130. In further aspects, the inner catheter 931 can be extended independent of the outer catheter 811. In further aspects, although not shown, a pull wire can be attached to the outer catheter or the inner catheter(s) configured to allow the physician to control an orientation of (e.g., orient) the corresponding catheter, for example based on feedback from observing a location of a marker on the catheter apparatus that is radio-opaque and / orechogenic.

[0185] In aspects, after step 403 or 405, methods can optionally proceed to step 407 comprising securing a proximal portion of the catheter apparatus and / or a distal portion of the catheter apparatus. For example, as shown in FIG. 23, step 407 can comprise positioning (e.g., wedging, see arrow 2302) a distal end 813 of the outer catheter 811 into a corresponding physiology (e.g., aortic arch, aortic valve 210). Alternatively, as shown in FIGS. 9 and 11, a proximal attachment device 901 (e.g., mesh 902, one or more balloons 1101) can be deployed that contacts the walls of the corresponding physiological structure (e.g., ascending aorta) while allowing the flow of blood therethrough. Also, as discussed above, anchoring a proximal portion of the catheter apparatus (e.g., distal end of the outer catheter) can comprise deploying the one or more cleats 1503 shown in FIG. 15, a helical distal attachment device 8019 or 8039 shown in FIG. 81, a clip (distal attachment device 8651 or 8671 shown in FIGS. 86-87), inserting one or more tines (see FIGS. 13A-13C), and / or drawing a vacuum through an aperture (e.g., nozzle) discussed above with reference to FIG. 64. In further aspects, as shown between FIGS. 81 and 86-87, the catheter apparatus 8001, 8601, and 8701 can comprise a pair of distal attachment devices 8019, 8039 or 8651, 8671 that can be extended independently (see arrows 8606 and 8664 in FIG. 86) to reach predetermined locations (e.g., along the septal wall on either side of the portion to be lacerated). Also, stabilizing a distal portion of the catheter apparatus can comprise extending one or more wires that can contact an inner surface of the left ventricle (e.g., opposite the septal wall) as discussed above with reference to FIGS. 57-59. Alternatively, stabilizing a distal portion of the catheter device can comprise piercing the septal wall, for example, with an extent of the tissue to be lacerated demarcated (in at least one direction) by the structure that pierced the septal wall, as discussed above with reference to FIGS. 55-56 and / or FIGS. 51-54. Alternatively, in aspects, step 407 can be omitted (e.g., following arrow 402 to step 409 or going from step 403 to step 405 and then to step 409). It is to be understood that a distal attachment device can be deployed without also using a proximal attachment device. Also, it is to be understood that the distal attachment device can be deployed before the proximal attachment device or vice versa. Additionally, in aspects, the proximal attachment device, proximal anchor (see FIG. 68), and / or distal attachment device can be placed prior to extending the inner catheter or the first catheter into the left ventricle of the heart, although it is generally simpler to use the inner catheter or the first catheter to place the corresponding attachment device while the corresponding catheter is in the left ventricle of the heart.

[0186] In aspects after step 403, 405, or 407, methods can proceed to step 409 comprising activating the laceration device to lacerate at least a portion of the septal wall. In further aspects,as shown in FIGS. 19, 23, 26, 34, 39, 48, 52, 53-54, 55-56, 58, 67-68, 71-72, 79, 81, or 87, the laceration device 1940, 2021, 2421, 2721, 3521, 4421, 5121, 5321, 5521, 5621, 5721, 6721, 6821, 6921, 7221, 7821, 8021, or 8621 can lacerate at least a portion of the septal wall 170 that is positioned between the apex 140 and the aortic valve 210. In even further aspects, as shown in FIGS. 23, 26, and 34, the housing 2011, 2411, or 2735 (e.g. containing the laceration device 2021, 2421 , or 2721) can be positioned at a third location along the inner catheter 1711 or 2441 between the second location (e.g., distal end 1713, 2443, or 2703 of the inner catheter 1711 or 2441, proximate the apex 140) and the first location (e.g., distal end 813 of the outer catheter 811, proximate the aortic valve 210, or proximate portion 2711 (e.g., wall 2715) of the first catheter 2707 in FIG. 34). In further aspects, as shown between FIGS. 27A-27B and 34, when the housing 2735 and / or laceration device 2721 is within the first catheter 2707 (e.g., inner catheter), the activating the laceration device can comprise separating the first catheter 2707 into a proximate portion 2711 and a distal portion 2705 by translating relative to one another (see arrow 2702 as well as arrow 2712 in FIG. 28) to reveal the housing 2735 so that the laceration device 2721 (e.g., blade 2723) can extend beyond the housing 2735. In further aspects, methods can further comprise tensioning the inner catheter during the activating the laceration device so that the laceration device contacts the septal wall (see arrows 8104, 8106, 8704, and / or 8706 in FIGS. 81 and 87).

[0187] In further aspects, a position and / or orientation of the housing can be monitored (and thus adjusted) by the physician using the one or more markers, for example, the markers 2051, 2053, and / or 2055 shown in FIG. 22, the markers 2455, 2457, and 2459 shown in FIGS. 24-25; the markers 2761, 2762, 2763, 2765, 2767 and / or 2769 (see FIG. 27) shown between FIGS. 27 and 29; the markers 3561, 3563, and / or 3565 shown in FIG. 35; the markers 4061, 4063, and / or 4065 show in FIGS. 40 and / or 49-50; the markers 5161 and / or 5163 shown in FIG. 51; the markers 5361, 5363, 5365, and / or 5367 shown in FIGS. 53-54; and / or the markers 8261 and / or 8263 shown in FIG. 82. In further aspects, as shown in FIGS. 19 and 23, activating the laceration device can comprise extending (e.g., see arrow 2044 in FIGS. 21-22) the laceration device 1940 or 2021 beyond another portion of the catheter apparatus (e.g., the rest of the laceration device, the inner catheter 1931 shown in FIG. 19, and / or the housing 2011 shown in FIG. 23). In even further aspects, as shown in FIG. 21, extending the laceration device 2021 (see arrow 2044) when the laceration device 2021 comprises a helical shape 2025 (e.g., blade) can comprise rotating the laceration device (see arrow 2042), for example, relative to the housing 2011 (see FIGS. 22-23). The rotating the laceration device 2021 can transform the laceration device from a retracted configuration (e.g., contained entirely within the housing) to a deployed configuration (see FIGS. 22-23), where a portion (e.g., blade 2023) extends beyond the housing 2011 (e.g., extendingthrough an aperture 2017 in the housing 2011), see arrow 2044. Also, the distance 2039 that laceration device 2021 (e.g., blade 2023) extends beyond the housing 2011 can be adjusted by rotating the laceration device 2021, and / or the distance 2039 can be monitored (and thus adjusted) by the physician using at least the marker 2051 shown in FIG. 22. In further aspects, as shown in FIGS. 24-25, activating the laceration device can comprise rotating (see arrow 2422) the housing 2411 relative to the laceration device 2421 (e.g., blade 2423, sleeve 2403), for example, to align the aperture 2417 with the blade 2423 so that the blade can extend beyond the housing 2411 (e.g., wall 2413) in the deployed configuration. The alignment of the aperture 2417 relative to the blade 2423 can be monitored (and thus adjusted) by the physician using at least the markers 2455 and 2457 shown in FIGS. 24-25. Also, an orientation and / or placement of the laceration device 2421 (e.g., blade 2423) can be monitored (and thus adjusted) by the physician using at least the marker 2457. In further aspects, as shown in FIGS. 28, 36, 40, 42, 44, or 59, activating the laceration device 2721, 3521, 4021, 4221, 4421, or 5721 can comprise pivoting the laceration device 2721, 3521, 4021, 4221, 4423, or 5923 (see arrow 2722, 3654, 4022, 4222, 4422, or 5902) (e.g., from the retracted configuration entirely within the housing 2735 or the inner catheter 3541 or 4411 - first catheter 4011 - to the deployed configuration extending beyond the housing 2735 or the inner catheter 3541 or 4411 - first catheter 4011). In further aspects, as shown between FIGS. 28-29, activating the laceration device 2721 can comprise biasing the blade 2723 (of the laceration device 2721) into the deployed configuration (see arrow 2722, for example, with spring 2743 in the activated configuration 2751 and indicated by arrow 2752). Alternatively, in further aspects, as shown in FIGS. 36 and 40, the laceration device 3521 or 4021 can be rotated (e.g., pivoted) by activating a pull wire 3651 or 4051 (see arrow 3652 or 4052), although other means can be used in other aspects. Alternatively, in further aspects, as shown in FIG. 44, the laceration device 4421 can be rotated (e.g., angled, pivoted) by activating an insulated wire 4451 that is in electrical communication with the wire 4423 of the laceration device 4421. In still further aspects, a position of the blade 2723, 3523, or 4061 can be monitored by the physician using at least the marker 2761, 3563, or 4061 on the blade 2723, 3523, or 4061 (e.g., relative to one or more of markers 2762, 2765, 2769, 3561, 3565, 4063, or 4065). Further, in aspects, the physician can adjust the position based on this information using one or more of the set screw 3001 in FIG. 30, the cam 3105 in FIG. 31, the wedge 3203 in FIG. 32, and / or a portion the housing 2735 (e.g., thicker portion 3135 in FIG. 31). In further aspects, as shown in FIGS. 29 or 40, a location and / or orientation of the aperture 2733 or 4033 can be monitored using one or more of marker 2763 or 4063 (e.g., on the housing 2735 at a proximate end of the aperture 2733, or on the first catheter 4011 at a proximate end of the aperture 4033), marker 2765 or 4065 (e.g., on the housing 2735 at a distal end of theaperture 2733, or on the first catheter 4011 at a distal end of the aperture 4033), and / or marker 2762 that is non-colinear with the aperture 2733. In further aspects, as shown in FIGS. 29 or 35, a position of the first catheter 2707 (e.g., distal portion 2705, or distal end 3543 of the inner catheter 3541) can be monitored (and thus adjusted) by the physician using marker 2769 or 3561 at a distal end 2713 or 3543 thereof (e.g., the proximate portion 2711 - wall 2715 - of the first catheter 2707, or the distal end 3543 of the inner catheter 3541), for example, relative to one or more of markers 2761, 2762, 2763, 2765, or 3565; consequently, with reference to FIG. 29, the physician can monitor separation of the first catheter 2707 into a proximate portion 2711 and a distal portion 2705 by translating relative to one another (see arrow 2702 and arrow 2712 in FIG. 28) to reveal the housing 2735 so that the laceration device 2721 (e.g., blade 2723) can extend beyond the housing 2735. In further aspects, as shown in FIGS. 19, 23, 26, 34, 39, 40, 74, or 78-79 the laceration device 1940, 2021, 2421, 2721, 3521, 4021, 5921, 7421, or 7821 can comprise a blade 1935, 2023, 2423, 2723, 3523, 4023, 5923, 7423, or 7825. Alternatively, in further aspects, as shown in FIGS. 42, 44, 46, 48-50, 51-54, 56, 58, 63-64, 69, 72, 75, 80-81, or 86 the laceration device 4221, 4421, 4621, 4921, 5121, 5321, 5621, 5721, 6221, 6421, 6921, 7221, 7521, 8021, or 8621 can comprise a wire 4223, 4423, 4623, 4923, 5123, 5323, 5623, 5723, 6323, 6423, 6923, 7223, 7523, 8023, or 8623 configured to lacerate tissue when energized. Alternatively, in further aspects, as shown in FIG. 76, the laceration device 7621 can use a light beam (e.g., laser beam 7633) configured to lacerate tissue. In even further aspects, as discussed with reference to FIG. 62, tissue to be lacerated can be sucked towards or into an aperture where it can be lacerated. In even further aspects, as discussed with reference to FIGS. 63-64, the laceration device can expand (e.g., in addition to energizing the wire) to lacerate tissue of the septal wall from within the septal wall. Alternatively or additionally, the laceration device can comprise a braided cable and / or a cable saw that can (further) lacerate tissue through abrasion.

[0188] In aspects, after step 409, methods can proceed to step 411 comprising translating the laceration device to extend a length of a portion of the septal wall lacerated. In further aspects, as shown in FIGS. 19, 23, or 26, the laceration device 1940, 2021, or 2421 (e.g., blade 1935, 2023, or 2423) can be translated in the direction 1942, 2012, or 2442 (e.g., towards the distal end 813 of the outer catheter 811, or away from the distal end 1713, 1933, or 2443 of the inner catheter 1711, 1931 , or 2441) from an initial location (shown) to a final location (shown in dashed lines in FIGS. 23 and 26). Alternatively, in further aspects, as shown in FIGS. 34, 39, 48, 52, or 79, the laceration device 2721, 3521, 4421, 5121, or 7821 (e.g., blade 2723, 3523, or 7825, wire 4423 or 5123) can be translated in the direction (indicated by arrow 2732, 3502, 4502, 4512, 5142 or 7802) (e.g., away from the distal end 813 of the outer catheter 811, away from the distal end 1833 or 3543 ofthe inner catheter 1831 or 3541, away from the proximate portion 2711 of the first catheter 2707, and / or towards a distal end 2703 (of a distal portion 2705) of the first catheter 2707) from an initial location (shown) to a final location (shown in dashed lines in FIGS. 23 and 26). In even further aspects, as shown in FIG. 23, the housing 2735 and / or the laceration device 2721 can be retrained from rotating relative to the first catheter 2707 (e.g., proximate portion 2711, distal portion 2705) by translating along the plurality of guide rails 3361 and 3363. Alternatively or additionally, as shown in FIG. 87, the laceration device 8721 can be translated in both directions (as indicated by arrows 8602, 8608 or 8722, 8724 - e.g., towards and away from the distal attachment device 8731; towards and away from a distal end 813 of the outer catheter 811) to lacerate tissue of the septal wall (e.g., by abrading tissue and / or energizing a wire).

[0189] In aspects, after step 409 or 411, methods can proceed to step 413 comprising retracting the catheter apparatus (e.g., inner catheter) from the left ventricle. In further aspects, step 413 can comprise retracting the laceration device. In further aspects, step 413 can comprise releasing and / or retracting the distal attachment device (e.g., cryo-adhesion, one or more tines, one or more cleats, clips, helical distal attachment device). In further aspects, step 413 can comprise retracting the proximal attachment device (e.g., mesh, one or more balloons). Alternatively, the distal attachment device may be biodegradable such that the distal attachment device can be safely left in the patient and will disappear after a predetermined period of time. The inner catheter and / or the entire catheter apparatus can be retracted from the left ventricle and / or the patient.

[0190] At the end of step 413, methods can be complete. In aspects, as discussed above with reference to the flow chart in FIG. 5, methods can start at step 401 and then proceed sequentially through steps 401, 403, 405, 409, 411, and 413. In aspects, methods can follow arrow 402 from step 403 to step 409, for example, if the catheter apparatus is to be used without deploying a distal attachment device or a proximal attachment device. In aspects, methods can follow arrow 404 from step 403 to step 407, for example, if a proximal attachment device is to be deployed (or otherwise secure a position of a proximal portion of the laceration device) before deploying a distal attachment device or a distal attachment device is not to be used. In aspects, methods can follow arrow 406 from step 407 to step 405, for example, if a distal attachment device is to be deployed after deploying a proximal attachment device (or otherwise secure a position of a proximal portion of the laceration device). In aspects, methods can follow arrow 408 from step 405 to step 405, for example, a proximal attachment device (or otherwise secure a position of a proximal portion of the laceration device) is to be deployed after deploying the distal attachment device. In aspects, methods can follow arrow 410 from step 407 to step 409, for example, if methods are to proceed to lacerating the portion of the septal wall after deploying the proximal attachment device (orotherwise secure a position of a proximal portion of the laceration device). In aspects, methods can follow arrow 412 from step 409 to step 413, for example, if the catheter apparatus is to be withdrawn from the left ventricle (and / or the patient) after activating the laceration device in step 409 without further translating the laceration device (step 411). Any of the above options may be combined to make a laminate in accordance with aspects of the disclosure.

[0191] In accordance with the disclosure, non-limiting aspects of the disclosure will now be described. Various combinations of the aspects can be provided in accordance therewith.

[0192] Example Al . A catheter apparatus comprising: a first catheter; a distal attachment device at a distal end of the first catheter; and a laceration device configured to translate relative to the first catheter.

[0193] Example A2. The catheter apparatus of example Al , wherein the distal attachment device is configured to attach using cryo-adhesion.

[0194] Example A3. The catheter apparatus of any one of examples A1-A2, wherein the distal attachment device is in thermal communication with a cryo-thermal source.

[0195] Example A4. The catheter apparatus of any one of examples A1-A3, wherein the distal attachment device comprises one or more tines.

[0196] Example A5. The catheter apparatus of any one of examples A1-A4, wherein the distal attachment device comprises a helical shape.

[0197] Example A6. The catheter apparatus of any one of examples A1-A5, wherein the distal attachment device comprises a cleat.

[0198] Example A7. The catheter apparatus of any one of examples A1-A6, wherein the distal attachment device comprises a clip.

[0199] Example A8. The catheter apparatus of any one of examples A1-A7, wherein the distal attachment device is configured to be activated hydraulically.

[0200] Example A9. The catheter apparatus of any one of examples A1-A7, wherein the distal attachment device is configured to be activated by torquing a control wire attached to the distal attachment device.

[0201] Example A10. The catheter apparatus of any one of examples A1-A7, wherein the distal attachment device comprises a hook.

[0202] Example Al l. The catheter apparatus of example A10, further comprising a first pull wire attached to the hook configured to deploy the hook, and a second pull wire configured to retract the hook.

[0203] Example A12. The catheter apparatus of any one of examples A10-A11, further comprising an attachment spring configured to bias the hook into an extended configuration.

[0204] Example A13. The catheter apparatus of any one of examples A1-A12, wherein the distal attachment device comprises an aperture, and the distal attachment device is configured to draw a vacuum through the aperture.

[0205] Example A14. The catheter apparatus of example A13, wherein the aperture comprises a plurality of apertures arranged in two rows, the laceration device is configured to be positioned between a first row and a second row of the two rows of the plurality of apertures.

[0206] Example A15. The catheter apparatus of example A14, wherein the laceration device is configured to translate along a length of a row of the two rows of the plurality of apertures while positioned between the first row and the second row.

[0207] Example A16. The catheter apparatus of example A13, further comprising: a proximal attachment device, wherein the laceration device is positioned between the proximal attachment device and the distal attachment device.

[0208] Example A17. The catheter apparatus of example A13, wherein the laceration device is further configured to extend through the aperture of the distal attachment device.

[0209] Example A18. The catheter apparatus of any one of examples A1-A17, further comprising: a second catheter positioned around the first catheter and configured to translate along the first catheter, the laceration device attached to the second catheter; and one or more wires extending through a wire aperture in a distal end of the second catheter to a distal end of the first catheter.

[0210] Example Al 9. The catheter apparatus of example Al 8, wherein the one or more wires comprises two wires extending through corresponding apertures of the wire aperture, and translating the two wires relative to the second catheter is configured to bias the catheter apparatus.

[0211] Example A20. The catheter apparatus of example Al 9, wherein a position of the catheter apparatus can be adjusted by adjusting one of the two wires independent of the other wire of the two wires.

[0212] Example A21. The catheter apparatus of any one of examples A19-A20, wherein an angle between the two wires is from 45 degrees to 135 degrees.

[0213] Example A22. The catheter apparatus of any one of examples A19-A21, wherein a section of the one or more wires between the wire aperture of the distal end of the second catheter and the distal end of the first catheter is configured to bulge away from the first catheter as the one or more wires is extended through the wire aperture.

[0214] Example A23. The catheter apparatus of any one of examples A19-A22, wherein the one or more wires is echogenic or radio-opaque.

[0215] Example A24. The catheter apparatus of any one of examples A1-A23, furthercomprising a proximal attachment device attached to the catheter apparatus at a proximal location.

[0216] Example A25. The catheter apparatus of example A23, wherein the proximal attached device is configured to be expanded in an ascending aorta of a heart.

[0217] Example A26. The catheter apparatus of any one of examples A24-A25, wherein the proximal attachment device comprises at least one expandable balloon with a first aperture that the first catheter extends through a second aperture separate from the first aperture.

[0218] Example A27. The catheter apparatus of any one of examples A24-A26, wherein the proximal attachment device comprises a cleat.

[0219] Example A28. The catheter apparatus of any one of examples A24-A27, wherein the proximal attachment device comprises a proximal aperture, and the proximal attachment device is configured to draw a vacuum through the proximal aperture.

[0220] Example A29. The catheter apparatus of any one of examples A24-A28, wherein the laceration device is configured to translate between the distal attachment device and the proximal attachment device for at least a portion of a distance between the distal attachment device and the proximal attachment device.

[0221] Example A30. The catheter apparatus of any one of examples A24-A29, wherein: the proximal attachment device configured to anchor the first catheter at a first location of the first catheter; the laceration device positioned at a second location between the first location of the first catheter and the distal end of the first catheter; the distal attachment device is configured to attach to a third location proximate an apex of a left ventricle of a heart; the proximal attachment device is configured to attach to a fourth location on a septal wall of the heart in the left ventricle proximate an aortic valve of the heart, the fourth location positioned between the third location and the aortic valve; and the laceration device is configured to lacerate tissue of the septal wall between the third location and the fourth location.

[0222] Example A31. The catheter apparatus of any one of examples A24-A30, wherein at least a portion of the proximal attachment device is echogenic or radio-opaque.

[0223] Example A32. The catheter apparatus of any one of examples A1-A31, wherein the laceration device comprises a blade.

[0224] Example A33. The catheter apparatus of any one of examples A1-A31, wherein the laceration device comprises: a blade configured to extend beyond the first catheter in the deployed configuration; and a laser source configured to emit a laser beam towards a protective sheath of the blade.

[0225] Example A34. The catheter apparatus of any one of examples A1-A10, wherein the laceration device comprises at least a section of wire configured to lacerate tissue when thesection of wire is energized.

[0226] Example A35. The catheter apparatus of example A34, wherein a distal end of the wire is attached to another location on the wire by an attachment device, and there is a bend in the wire between the distal end of the wire and the another location on the wire.

[0227] Example A36. The catheter apparatus of example A35, wherein at least one of the wire or the attachment device is echogenic or radio-opaque.

[0228] Example A37. The catheter apparatus of any one of examples A35 -A36, wherein the wire of laceration device is configured to bend at a predetermined location when the laceration device transforms from a retracted configuration to a deployed configuration.

[0229] Example A38. The catheter apparatus of example A37, wherein the laceration device transforms from the retracted configuration to the deployed configuration by linearly extending a proximal end of the wire.

[0230] Example A39. The catheter apparatus of example A34, wherein the laceration device is configured to transition between a retracted configuration and a deployed configuration, and the laceration device is configured to change shape to a curved configuration in the deployed configuration.

[0231] Example A40. The catheter apparatus of example A39, wherein the laceration device is configured to transition between the retracted configuration and the deployed configuration by decreasing a distance between opposing ends of the laceration device.

[0232] Example A41. The catheter apparatus of example A40, wherein the distance between the opposing ends of the laceration device in the curved configuration is from about 15 millimeters to about 25 millimeters.

[0233] Example A42. The catheter apparatus of any one of examples A39-A41, wherein the curved configuration of the laceration device can extend for a lateral distance of from 5 millimeters to 15 millimeters relative to the retracted configuration of the laceration device.

[0234] Example A43. The catheter apparatus of any one of examples A39-A42, wherein a length of the laceration device in the retracted configuration is from 25 millimeters to 50 millimeters.

[0235] Example A44. The catheter apparatus of any one of examples A34-A43, wherein a distal end of the laceration device is configured to translate relative to the distal end of the first catheter.

[0236] Example A45. The catheter apparatus of example A44, further comprising a pull wire attached to the distal end of the laceration device, wherein the pull wire is configured to translate the distal end of the laceration device relative to the distal end of the first catheter, andthe pull wire is configured to provide electrical communication between the laceration device and an energy source.

[0237] Example A46. The catheter apparatus of any one of examples A33-A45, where a width of the laceration device tapers from the opposing ends towards a midpoint of the laceration device.

[0238] Example A47. The catheter apparatus of any one of examples A34-A46, wherein the laceration device comprises a wire extending between the first distal attachment device and the second distal attachment device.

[0239] Example A48. The catheter apparatus of example A47, wherein the laceration device further comprises a location on the section of wire configured to lacerate tissue when the location on the wire is energized.

[0240] Example A49. The catheter apparatus of any one of examples A47-A48, wherein the section of wire is configured to translate between the first distal attachment device and a second distal attachment device.

[0241] Example A50. The catheter apparatus of any one of examples A47-A49, wherein a cross-section of the wire is polygonal.

[0242] Example A51. The catheter apparatus of example A50, wherein the cross-section of the wire is triangular.

[0243] Example A52. The catheter apparatus of any one of examples A30-A51, further comprising a housing that is translatable along the first catheter, the laceration device is configured be positioned entirely within the housing and the first catheter in the retracted configuration.

[0244] Example A53. The catheter apparatus of any one of examples A34-A52, further comprising a blade configured to extend beyond the first catheter in the deployed configuration, wherein the wire extends between the blade and the first catheter, and the wire is configured to lacerate tissue when the wire is energized.

[0245] Example A54. The catheter apparatus of example A53, further comprising an actuator configured to extend the blade.

[0246] Example A55. The catheter apparatus of any one of examples A53-A54, wherein the laceration device is configured to axially translate away from the distal end of the first catheter when the laceration device is in the deployed configuration.

[0247] Example A56. The catheter apparatus of any one of examples A34-A55, further comprising a guide rail extending within the first catheter, the laceration device is configured to axially translate along the guide rail, and the laceration device is restrained from rotating relative to the first catheter.

[0248] Example A57. The catheter apparatus of example A34, wherein the laceration device further comprises a pair of laceration attachment devices, and the laceration wire comprises two sections, each section of the two sections is configured to extend around a corresponding attachment device of the pair of laceration attachment devices.

[0249] Example A58. The catheter apparatus of example A57, wherein the distal attachment device is configured to be laterally positioned between the pair of laceration attachment devices when the laceration device is in the deployed configuration.

[0250] Example A59. The catheter apparatus of any one of examples A57-A58, wherein at least one laceration attachment device of the pair of laceration attachment devices comprises a hook.

[0251] Example A60. The catheter apparatus of any one of examples A57-A59, wherein the pair of laceration attachment devices are echogenic or radio-opaque.

[0252] Example A61. The catheter apparatus of any one of examples A57-A60, wherein a first laceration attachment device of the pair of laceration attachment devices can translate independently of another laceration attachment device of the pair of laceration attachment devices.

[0253] Example A62. The catheter apparatus of any one of examples A57-A61, further comprising an attachment wire extending between the pair of laceration attachment devices.

[0254] Example A63. The catheter apparatus of example A62, wherein the pair of laceration attachment devices are configured to translate along a path of the attachment wire.

[0255] Example A64. The catheter apparatus of any one of examples A1-A63, further comprising a guidewire, wherein the distal attachment device is at a distal end of the guidewire, and the first catheter is configured to translate along the guidewire.

[0256] Example A65. The catheter apparatus of any one of examples A1-A64, further comprising a second distal attachment device at the distal end of the first catheter, wherein the laceration device is attached to the first distal attachment device and the second distal attachment device.

[0257] Example A66. The catheter apparatus of any one of examples A1-A64, further comprising a second catheter comprising a second distal attachment device at a distal end of the second catheter, wherein the laceration device is attached to the distal end of the second catheter and extends between the distal end of the first catheter and the distal end of the second catheter.

[0258] Example A67. The catheter apparatus of any one of examples A65-A66, wherein the second distal attachment device comprises a helical shape, one or more tines, a clip, or combinations thereof.

[0259] Example A68. The catheter apparatus of any one of examples A65-A67, whereinat least a portion of the laceration device between the distal end of the first catheter and the distal end of the second catheter is echogenic or radio-opaque.

[0260] Example A69. The catheter apparatus of any one of examples A65-A68, wherein the distal end of the first catheter, the distal end of the second catheter, or both are echogenic or radio-opaque.

[0261] Example A70. The catheter apparatus of any one of examples A65-A69, wherein the laceration device comprises a braided cable comprising an electrically conductive core, a portion of the braided cable extends between the first distal attachment device and the second distal attachment device, and the electrically conductive core is exposed at a location on the braided cable between the first distal attachment device and the second distal attachment device.

[0262] Example A71. The catheter apparatus of any one of examples A65-A70, wherein the laceration device comprises a cable saw extending between the distal end of the first catheter and the distal end of the second catheter.

[0263] Example A72. The catheter apparatus of example A71, wherein the cable saw is configured to translate between the first distal attachment device and the second distal attachment device.

[0264] Example A73. The catheter apparatus of any one of examples A65-A72, wherein the attachment between the laceration device and the first catheter comprises a ratcheting mechanism configured to maintain a tension on the laceration device.

[0265] Example A74. The catheter apparatus of any one of examples A65-A73, wherein the first catheter comprises two lumens, the first distal attachment device is attached to the first lumen of the two lumens, and the second distal attachment device is attached to the second lumen of the two lumens.

[0266] Example A75. The catheter apparatus of any one of examples A65-A74, wherein one or more of the first catheter and the second catheter comprise a pull wire configured to orient the corresponding catheter.

[0267] Example A76. The catheter apparatus of any one of examples A1-A75, wherein the distal attachment device is configured to attach to a location proximate an apex of a left ventricle of the heart, and the laceration device is configured to lacerate tissue of a septal wall of the heart.

[0268] Example A77. The catheter apparatus of any one of examples A1-A76, further comprising: a housing movably surrounding a portion of the first catheter, the housing configured to contain a laceration device in a retracted configuration, wherein the laceration device is configured to extend beyond the housing when the laceration device is in a deployed configuration.

[0269] Example A78. The catheter apparatus of example A77, wherein a length of the laceration device extending beyond the housing in the deployed configuration is adjustable.

[0270] Example A79. The catheter apparatus of example A78, further comprising a set screw configured to adjust the length of the laceration device.

[0271] Example A80. The catheter apparatus of example A79, further comprising a wedge configured to adjust the length of the laceration device.

[0272] Example A81. The catheter apparatus of example A78, wherein a length of the laceration device extending beyond the housing in the deployed configuration is adjustable by adjustably rotating the laceration device.

[0273] Example A82. The catheter apparatus of any one of examples A77-A81, wherein the laceration device is configured to be coiled in the retracted configuration, and the laceration device is configured to be activated to a deployed configuration by rotating the laceration device relative to the housing.

[0274] Example A83. The catheter apparatus of examples A77-A82, wherein the distal end of the first catheter is configured to translate along guide rails relative to a proximal portion of the first catheter, and the housing is restrained from rotating along the guide rails.

[0275] Example A84. The catheter apparatus of any one of examples A77-A83, wherein the housing is configured to rotate relative to the laceration device.

[0276] Example A85. The catheter apparatus of any one of examples A77-A84, wherein the laceration device is configured to pivot from the retracted configuration with an entirety of the laceration device within the first catheter to the deployed configuration.

[0277] Example A86. The catheter apparatus of example A85, further comprising a spring configured to bias the laceration device to pivot from the retracted configuration to the deployed configuration.

[0278] Example A87. The catheter apparatus of any one of examples A85-A86, wherein the housing comprises an aperture, the laceration device is configured to extend through the aperture in the deployed configuration.

[0279] Example A88. The catheter apparatus of example A87, wherein the aperture is configured to maintain an orientation of the laceration device.

[0280] Example A89. The catheter apparatus of any one of examples A77-A88, wherein the housing is configured to translate independently from the first catheter.

[0281] Example A90. The catheter apparatus of any one of examples A77-A89, wherein the housing movably surrounds a portion of the first catheter.

[0282] Example A91. The catheter apparatus of any one of examples A77-A90, whereina maximum cross-sectional dimension of the first catheter is from 5 French to 15 French, a maximum cross-sectional dimension of the housing is from 15 French to 22 French.

[0283] Example A92. The catheter apparatus of any one of examples A77-A91, wherein a maximum cross-sectional dimension of the first catheter is from 10 French to 20 French.

[0284] Example A93. The catheter apparatus of any one of examples A77-A92, wherein the housing is positioned within the first catheter.

[0285] Example A94. The catheter apparatus of example A93, wherein the laceration device is configured to retract from the deployed configuration to the retracted configuration by translating the housing relative to a portion of the first catheter.

[0286] Example A95. The catheter apparatus of any one of examples A64-A94, wherein a length that the laceration device extends beyond the first catheter is adjustable based on an angle that the laceration device pivots relative to the retracted configuration.

[0287] Example A96. The catheter apparatus of any one of examples A64-A95, wherein the laceration device is configured to translate along the first catheter while the laceration device is in the deployed configuration.

[0288] Example A97. The catheter apparatus of any one of examples A64-A95, wherein the laceration device is configured to translate away from the distal attachment device while the laceration device is in the deployed configuration.

[0289] Example A98. The catheter apparatus of any one of examples A64-A95, wherein the laceration device is configured to translate towards the distal attachment device while the laceration device is in the deployed configuration.

[0290] Example A99. The catheter apparatus of any one of examples A1-A98, wherein the laceration device comprises: a guiding rod configured to extend from the distal end of the first catheter; and a wire configured to extend between the guiding rod and the distal attachment device.

[0291] Example A100. The catheter apparatus of example A99, wherein: the distal attachment device is configured translate in a first direction; and the guiding rod is configured to translate parallel to the first direction.

[0292] Example A101. The catheter apparatus of example Al 00, wherein the wire is configured to extend between the guiding rod and the distal attachment device in a second direction perpendicular to the first direction.

[0293] Example Al 02. The catheter apparatus of any one of examples A99-A101 further comprising a bumper at the distal end of the first catheter proximate the guiding rod.

[0294] Example Al 03. The catheter apparatus of any one of examples A99-A102, wherein: the wire is movably attached to the distal attachment device; and the wire is attached to adistal end of the guiding rod.

[0295] Example A104. The catheter apparatus of any one of examples A99-A103, wherein the laceration device comprises the wire configured to lacerate tissue when the wire is energized.

[0296] Example Al 05. The catheter apparatus or any one of examples A99-A104, wherein a length of the wire between the distal attachment device and the guiding rod is from 2 mm to 6 mm.

[0297] Example Al 06. The catheter apparatus of any one of examples A99-A105, wherein an orientation of the guiding rod relative to the distal attachment device is adjustable.

[0298] Example Al 07. The catheter apparatus of any one of examples A99-A106, wherein the distal attachment device comprises a needle.

[0299] Example A108. The catheter apparatus of any one of examples A99-A107, wherein the laceration device is configured to expand into a deployed configuration.

[0300] Example Al 09. The catheter apparatus of example Al 08, wherein the laceration device comprises an inflatable balloon.

[0301] Example Al 10. The catheter apparatus of any one of examples A108-A109, wherein the laceration device is positioned on one side of first catheter but not the opposite side of the first catheter in the deployed configuration.

[0302] Example Al l i. The catheter apparatus of any one of examples A108-A110, wherein the laceration device comprises a polymer-based material.

[0303] Example Al 12. The catheter apparatus of any one of examples A108-A111, further comprising a cauterizing device configured to cauterize tissue when energized.

[0304] Example Al 13. The catheter apparatus of example Al 12, wherein the cauterizing device is positioned along at least a portion of an outer periphery of the laceration device when the laceration device is in the deployed configuration.

[0305] Example Al 14. The catheter apparatus of any one of examples A87-A113, wherein the cauterizing device comprises at least a portion of a wire comprising stainless steel, tungsten, or a combination thereof.

[0306] Example Al 15. The catheter apparatus of any one of examples A37-A114, further comprising a control handle comprising an actuator configured to adjust the length of the laceration device.

[0307] Example Al 16. The catheter apparatus of any one of examples Al-Al 14, further comprising a control handle comprising: a first actuator configured to adjust at least one of a position or an orientation of an outer catheter; a second actuator configured to adjust at least oneof an orientation or a deployment of the distal attachment device; a third actuator configured to adjust a position of the first catheter relative to the outer catheter; a fourth actuator configured to extend the laceration device to the deployed configuration; and a fifth actuator configured to adjust a position of a housing.

[0308] Example Al 17. The catheter apparatus of any one of examples Al-Al 14, further comprising a control handle comprising: a first actuator configured to adjust a position of the proximal attachment device; a second actuator configured to adjust a position of the distal attachment device; a third actuator configured to control a position of the first catheter relative to an outer catheter; and a fourth actuator configured to extend the laceration device to the deployed configuration.

[0309] Example Al 18. The catheter apparatus of any one of examples Al-Al 17, further comprising a cradle configured to support the control handle, wherein the cradle comprises at least three supports that are translatable relative to one another.

[0310] Example Al 19. The catheter apparatus of any one of examples Al-Al 18, wherein the distal attachment device comprises at least a portion of a laceration wire configured lacerate tissue when the at least the portion of the laceration wire is energized.

[0311] Example A120. The catheter apparatus of any one of examples Al-Al 19, further comprising a pair of markers on the housing, the pair of markers are one or more of radio-opaque or echogenic.

[0312] Example A121. The catheter apparatus of any one of examples A1-A120, comprising a first marker is positioned at an aperture of the housing, and the laceration device comprises a second marker, wherein the first marker and the second marker are one or more of radio-opaque or echogenic.

[0313] Example A122. The catheter apparatus of examples A1-A121, further comprising a marker positioned at a proximal end of an aperture of the housing, wherein the marker is echogenic or radio-opaque.

[0314] Example A123. The catheter apparatus of any one of examples A1-A122, comprising a fourth marker on a tip of the laceration device, the fourth marker is one or more of radio-opaque or echogenic.

[0315] Example A124. The catheter apparatus of any one of examples A1-A123, wherein at least a portion of the laceration device is echogenic or radio-opaque.

[0316] Example A125. The catheter apparatus of any one of examples A1-A124, further comprising a third marker positioned at the distal end of the first catheter, the third marker is one or more of radio-opaque or echogenic.

[0317] Example A126. The catheter apparatus of any one of examples A1-A125, wherein the distal attachment device further comprises a marker that is echogenic or radio-opaque, and an echogenic or radio-opaque projection of the distal attachment device differs based on the orientation of the distal attachment device.

[0318] Example A127. The catheter apparatus of any one of examples A1-A126, further comprising a pair of markers at either end of the laceration device on the first catheter, wherein each of the pair of markers is independently echogenic or radio-opaque.

[0319] Example A128. The catheter apparatus of any one of examples A1-A127, further comprising a first radio-opaque marker positioned at an intermediate location on the first catheter that is proximate an end of a proximate portion of the first catheter.

[0320] Example A129. The catheter apparatus of any one of examples A1-A128, wherein the catheter apparatus is configured to extend into a left ventricle of a heart, and the laceration device is configured to lacerate tissue of a septal wall.

[0321] Example A130. A method of ameliorating septal hypertrophy of a heart comprising: positioning a distal end of a first catheter at a first location proximate an aortic valve; extending the first catheter towards an apex of a left ventricle; anchoring a distal end of the first catheter to a second location proximate the apex; activating a laceration device to lacerate a portion of the septal wall between the apex and the aortic valve; and retracting the first catheter from the left ventricle.

[0322] Example A131. The method of example A130, wherein the anchoring comprises cryo-adhesion of the distal end of the first catheter to the second location.

[0323] Example A132. The method of any one of examples A130-A131, wherein the anchoring the distal end of the first catheter comprises deploying a distal attachment device.

[0324] Example A133. The method of example A132, wherein the distal attachment device comprises a cleat.

[0325] Example A134. The method of any one of examples A130-A133, wherein the deploying the distal attachment device comprises hydraulically activating the distal attachment device.

[0326] Example A135. The method of any one of examples A130-A134, wherein the deploying the distal attachment device comprises torquing the distal attachment device.

[0327] Example A136. The method of any one of examples A130-A135, wherein the deploying the distal attachment device comprises rotating a hook to attach the distal end of the first catheter to the septal wall at the second location.

[0328] Example A137. The method of any one of examples A130-A136, wherein theanchoring comprises inserting one or more tines at the second location.

[0329] Example A138. The method of any one of examples A130-A137, wherein the anchoring comprises rotating a distal attachment device having a helical shape at the distal end of the first catheter.

[0330] Example A139. The method of any one of examples A130-A138, wherein the anchoring comprises clamping a clip on the septal wall at the second location.

[0331] Example A140. The method of any one of examples A130-A139, wherein the anchoring comprises pulling a vacuum through an aperture in the distal attachment device at the distal end of the first catheter.

[0332] Example A141. The method of example A140, wherein the anchoring the distal attachment device comprises pulling a vacuum through an aperture of the distal attachment device, and the pulling the vacuum brings the aperture in contact with the second location of the heart.

[0333] Example A142. The method of example A141, wherein the second location of the heart is part of the septal wall in the left ventricle of the heart.

[0334] Example A143. The method of any one of examples A141-A142, wherein the distal attachment device comprises a plurality of apertures arranged in two rows, the pulling the vacuum brings the plurality of apertures in contact with the septal wall, and the activating the laceration device comprises lacerating the portion of the septal wall proximate the second location between a first row and a second row of the two rows of the plurality of apertures.

[0335] Example A144. The method of example A143, wherein the activating the laceration device comprises translating the laceration device along a length of a row of the two rows of the plurality of apertures while positioned between the first row and the second row.

[0336] Example A145. The method of any one of examples A143-A144, wherein the activating the laceration device lacerates tissue within the aperture of the distal attachment device to lacerate the portion of the septal wall.

[0337] Example A146. The method of any one of examples A143-A144, wherein the activating the laceration device extends the laceration device through the aperture of the distal attachment device to lacerate the portion of the septal wall.

[0338] Example A147. The method any one of examples A130-A146, wherein the anchoring the distal attachment device comprises puncturing the septal wall at the second location by translating the distal attachment device.

[0339] Example A148. The method of any one of examples A146-A147, further comprising activating at least a section of a laceration wire at a distal end of the distal attachment device to facilitate translating the distal attachment device and the anchoring the distal attachmentdevice to the second location on the septal wall.

[0340] Example A149. The method of example A148, wherein the distal attachment device tapers towards a distal end thereof.

[0341] Example A150. The method of any one of examples A130-A149, further comprising extending one or more wires through a wire aperture in a distal end of a second catheter, the second catheter positioned around the first catheter, the one or more wires extending through the wire aperture in the distal end of the second catheter to the distal end of the first catheter.

[0342] Example A151. The method of example Al 50, wherein the extending the one or more wires biases the laceration device into the septal wall.

[0343] Example Al 52. The method of any one of examples Al 50-Al 51, wherein the extending the one or more wires extends the one or more wires towards an inner surface of the left ventricle opposite the septal wall.

[0344] Example Al 53. The method of any one of examples Al 50-Al 52, wherein the one or more wires comprises two wires extending through a corresponding aperture of the wire aperture in the distal end of the second catheter, and extending the one or more wires comprises extending the two wires at an angle from 45 degrees to 135 degrees.

[0345] Example A154. The method of any one of examples A130-A153, further comprising deploying a proximal attachment device before the activating the laceration device.

[0346] Example A155. The method of example A154, wherein the deploying the proximal attachment device comprises expanding at least one balloon, the at least one balloon comprises a first aperture that the first catheter extends through a second aperture separate from the first aperture.

[0347] Example Al 56. The method of example Al 55, where the positioning the first catheter further comprising expanding a balloon of the at least one balloon to achieve a predetermined position, predetermined orientation, or both.

[0348] Example Al 57. The method of any one of examples Al 54-Al 56, wherein the proximal attachment device is deployed at a location in an ascending aorta.

[0349] Example Al 58. The method of any one of examples Al 54-Al 56, wherein deploying the proximal attached device comprises expanding the proximal attachment device in an ascending aorta of the heart.

[0350] Example Al 59. The method of any one of examples Al 54-Al 58, wherein the deploying the proximal attachment device comprises inserting a cleat at the first location.

[0351] Example A160. The method of any one of examples A154-A158, wherein the deploying the proximal attachment device comprises inserting one or more tines at the firstlocation.

[0352] Example A161. The method of any one of examples A154-A158, further comprising: anchoring a proximal attachment device to a third location of the septal wall in the left ventricle of the heart, wherein the activating the laceration device comprises lacerating the portion of the septal wall between the second location and the third location.

[0353] Example Al 62. The method of example Al 60, wherein the anchoring the proximal attachment device comprises pulling a vacuum through a proximal aperture of the proximal attachment device, and the pulling the vacuum through the proximal aperture of the proximal attachment device brings the proximal attachment device in contact with the septal wall at the third location.

[0354] Example Al 63. The method of any one of examples A160-A161, wherein the activating the laceration device comprises translating the laceration device to lacerate the portion of the septal wall along at least a portion of a path between the second location and the third location.

[0355] Example A164. The method of any one of examples A130-A162, wherein the laceration device extends from a third location proximate to the distal end of the first catheter to a fourth location distal from the distal end of the first catheter, the laceration device comprises a wire, and the activating the laceration device comprises energizing the wire to lacerate a portion of the septal wall.

[0356] Example A165. The method of example A163, wherein the activating the laceration device further comprises tensioning the wire to maintain contact between the portion of the septal wall and the laceration device, and the laceration device can translate independently of the first location anchored by the proximal attachment device.

[0357] Example A166. The method of any one of examples A130-A160, further comprising: anchoring the laceration device to a third location on the septal wall of the heart, wherein the laceration device extends between the second location and the third location.

[0358] Example A167. The method of any one of examples A130-A160, further comprising: anchoring a distal end of a second catheter to a third location on the septal wall of the heart, wherein the laceration device extends between the distal end of the first catheter and the distal end of the second catheter.

[0359] Example A168. The method of example A167, wherein the activating the laceration device comprises translating a location of the laceration device between the second location and the third location.

[0360] Example Al 69. The method of example Al 68, wherein the translating thelaceration device further comprises tensioning the laceration device using a ratcheting mechanism between the first distal attachment device and the laceration device.

[0361] Example Al 70. The method of any one of examples Al 66-Al 68, wherein the activating the laceration device comprises applying tension to the laceration device.

[0362] Example A171. The method of any one of examples A130-A169, wherein the activating the laceration device comprises energizing a wire of the laceration device to lacerate the portion of the septal wall.

[0363] Example Al 72. The method of example A171, wherein the laceration device comprises a wire comprising a polygonal cross-section configured to lacerate the portion of the septal wall.

[0364] Example Al 73. The method of any one of examples Al 71 -Al 72, wherein the laceration device comprises a wire comprising a triangular cross-section configured to lacerate the portion of the septal wall.

[0365] Example A174. The method of any one of examples A166-A173, wherein the laceration device comprises a braided cable comprising an electrically conductive core, a portion of the braided cable extends between the first distal attachment device and the second distal attachment device, the electrically conductive core is exposed at a location ...

Claims

What is claimed:

1. A catheter apparatus comprising: a first catheter; a distal attachment device at a distal end of the first catheter; and a laceration device configured to translate relative to the first catheter.

2. The catheter apparatus of claim 1, wherein the distal attachment device is in thermal communication with a cryo-thermal source.

3. The catheter apparatus of any one of 1-2, wherein the distal attachment device comprises one or more tines.The catheter apparatus of any one of claims 1-3 wherein the distal attachment device comprises a helical shape.

5. The catheter apparatus of any one of claims 1-4, wherein the distal attachment device comprises a cleat.

6. The catheter apparatus of any one of claims 1-5, wherein the distal attachment device comprises a clip.

7. The catheter apparatus of any one of claims 1-6, wherein the distal attachment device is configured to be activated hydraulically.

8. The catheter apparatus of any one of claims 1-6, wherein the distal attachment device is configured to be activated by torquing a control wire attached to the distal attachment device.

9. The catheter apparatus of any one of 1-6, wherein the distal attachment device comprises a hook, a first pull wire attached to the hook configured to deploy the hook, and a second pull wire configured to retract the hook.

10. The catheter apparatus of any one of claim 9, further comprising an attachment spring configured to bias the hook into an extended configuration.

11. The catheter apparatus of any one of claims 1-10, wherein the distal attachment device comprises an aperture, and the distal attachment device is configured to draw a vacuum through the aperture.

12. The catheter apparatus of claim 11, wherein the aperture comprises a plurality of apertures arranged in two rows, the laceration device is configured to be positioned between a first row and a second row of the two rows of the plurality of apertures.

13. The catheter apparatus of claim 12, wherein the laceration device is configured to translate along a length of a row of the two rows of the plurality of apertures while positioned between the first row and the second row.

14. The catheter apparatus of claim 11, further comprising: a proximal attachment device, wherein the laceration device is positioned between the proximal attachment device and the distal attachment device.

15. The catheter apparatus of claim 11, wherein the laceration device is further configured to extend through the aperture of the distal attachment device.

16. The catheter apparatus of any one of claims 1-15, further comprising: a second catheter positioned around the first catheter and configured to translate along the first catheter, the laceration device attached to the second catheter; and one or more wires extending through a wire aperture in a distal end of the second catheter to a distal end of the first catheter.

17. The catheter apparatus of claim 16, wherein the one or more wires comprises two wires extending through corresponding apertures of the wire aperture, and translating the two wires relative to the second catheter is configured to bias the catheter apparatus.

18. The catheter apparatus of claim 17, wherein a position of the catheter apparatus can be adjusted by adjusting one of the two wires independent of the other wire of the two wires.

19. The catheter apparatus of any one of claims 17-18, wherein an angle between the two wires is from 45 degrees to 135 degrees.

20. The catheter apparatus of any one of claims 16-19, wherein a section of the one or more wires between the wire aperture of the distal end of the second catheter and the distal end of the first catheter is configured to bulge away from the first catheter as the one or more wires is extended through the wire aperture.

21. The catheter apparatus of any one of claims 1-13, further comprising a proximal attachment device attached to the catheter apparatus at a proximal location.

22. The catheter apparatus of any one of claim 21, wherein the proximal attachment device comprises at least one expandable balloon with a first aperture that the first catheter extends through a second aperture separate from the first aperture.

23. The catheter apparatus of any one of claims 21 -22, wherein the proximal attachment device comprises a cleat.

24. The catheter apparatus of any one of claims 21-23, wherein the proximal attachment device comprises a proximal aperture, and the proximal attachment device is configured to draw a vacuum through the proximal aperture.

25. The catheter apparatus of any one of claims 21-24, wherein the laceration device is configured to translate between the distal attachment device and the proximal attachment device for at least a portion of a distance between the distal attachment device and the proximal attachment device.

26. The catheter apparatus of claims 1-25, wherein the laceration device comprises a blade.

27. The catheter apparatus of any one of claims 1-25, wherein the laceration device comprises: a blade configured to extend beyond the first catheter in the deployed configuration; and a laser source configured to emit a laser beam towards a protective sheath of the blade.

28. The catheter apparatus of any one of claims 1-25, wherein the laceration device comprises at least a section of wire configured to lacerate tissue when the section of wire is energized.

29. The catheter apparatus of claim 28, wherein a distal end of the wire is attached to another location on the wire by an attachment device, and there is a bend in the wire between the distal end of the wire and the another location on the wire.

30. The catheter apparatus of any one of claims 28-29, wherein the wire of laceration device is configured to bend at a predetermined location when the laceration device transforms from a retracted configuration to a deployed configuration.

31. The catheter apparatus of claim 30, wherein the laceration device transforms from the retracted configuration to the deployed configuration by linearly extending a proximal end of the wire.

32. The catheter apparatus of claim 28, wherein the laceration device is configured to transition between a retracted configuration and a deployed configuration, and the laceration device is configured to change shape to a curved configuration in the deployed configuration.

33. The catheter apparatus of claim 32, wherein the laceration device is configured to transition between the retracted configuration and the deployed configuration by decreasing a distance between opposing ends of the laceration device.

34. The catheter apparatus of claim 33, wherein the distance between the opposing ends of the laceration device in the curved configuration is from about 15 millimeters to about 25 millimeters.

35. The catheter apparatus of any one of claims 32-34, wherein the curved configuration of the laceration device can extend for a lateral distance of from 5 millimeters to 15 millimeters relative to the retracted configuration of the laceration device.

36. The catheter apparatus of any one of claims 32-35, wherein a length of the laceration device in the retracted configuration is from 25 millimeters to 50 millimeters.

37. The catheter apparatus of any one of claims 28-36, wherein a distal end of the laceration device is configured to translate relative to the distal end of the first catheter.

38. The catheter apparatus of claim 37, further comprising a pull wire attached to the distal endof the laceration device, wherein the pull wire is configured to translate the distal end of the laceration device relative to the distal end of the first catheter, and the pull wire is configured to provide electrical communication between the laceration device and an energy source.

39. The catheter apparatus of any one of claims 28-38, where a width of the laceration device tapers from the opposing ends towards a midpoint of the laceration device.

40. The catheter apparatus of any one of 28-40, wherein the laceration device comprises a wire extending between the first distal attachment device and the second distal attachment device.

41. The catheter apparatus of claim 40, wherein the laceration device further comprises a location on the section of wire configured to lacerate tissue when the location on the wire is energized, and the section of wire is configured to translate between the first distal attachment device and a second distal attachment device.

42. The catheter apparatus of any one of claims 40-41, wherein a cross-section of the wire is polygonal.

43. The catheter apparatus of claim 42, wherein the cross-section of the wire is triangular.

44. The catheter apparatus of any one of claims 26-43, further comprising a housing that is translatable along the first catheter, the laceration device is configured be positioned entirely within the housing and the first catheter in the retracted configuration.

45. The catheter apparatus of any one of claims 28-44, further comprising a blade configured to extend beyond the first catheter in the deployed configuration, wherein the wire extends between the blade and the first catheter, and the wire is configured to lacerate tissue when the wire is energized.

46. The catheter apparatus of claim 46, further comprising an actuator configured to extend the blade.

47. The catheter apparatus of any one of claims 45-46, wherein the laceration device is configured to axially translate away from the distal end of the first catheter when the lacerationdevice is in the deployed configuration.

48. The catheter apparatus of any one of claims 28-47, further comprising a guide rail extending within the first catheter, the laceration device is configured to axially translate along the guide rail, and the laceration device is restrained from rotating relative to the first catheter.

49. The catheter apparatus of claim 28, wherein the laceration device further comprises a pair of laceration attachment devices, and the laceration wire comprises two sections, each section of the two sections is configured to extend around a corresponding attachment device of the pair of laceration attachment devices.

50. The catheter apparatus of claim 49, wherein the distal attachment device is configured to be laterally positioned between the pair of laceration attachment devices when the laceration device is in the deployed configuration.

51. The catheter apparatus of any one of claims 49-50, wherein at least one laceration attachment device of the pair of laceration attachment devices comprises a hook.

52. The catheter apparatus of any one of claims 49-51, wherein a first laceration attachment device of the pair of laceration attachment devices can translate independently of another laceration attachment device of the pair of laceration attachment devices.

53. The catheter apparatus of any one of claims 49-52, further comprising an attachment wire extending between the pair of laceration attachment devices, wherein the pair of laceration attachment devices are configured to translate along a path of the attachment wire.

54. The catheter apparatus of any one of claims 1-53, further comprising a guidewire, wherein the distal attachment device is at a distal end of the guidewire, and the first catheter is configured to translate along the guidewire.

55. The catheter apparatus of any one of claims 1-54, further comprising a second distal attachment device at the distal end of the first catheter, wherein the laceration device is attached to the first distal attachment device and the second distal attachment device.

56. The catheter apparatus of any one of claims 1-54, further comprising a second catheter comprising a second distal attachment device at a distal end of the second catheter, wherein the laceration device is attached to the distal end of the second catheter and extends between the distal end of the first catheter and the distal end of the second catheter.

57. The catheter apparatus of any one of claims 55-56, wherein the second distal attachment device comprises a helical shape, one or more tines, a clip, or combinations thereof.

58. The catheter apparatus of any one of claims 55-57, wherein the laceration device comprises a braided cable comprising an electrically conductive core, a portion of the braided cable extends between the first distal attachment device and the second distal attachment device, and the electrically conductive core is exposed at a location on the braided cable between the first distal attachment device and the second distal attachment device.

59. The catheter apparatus of any one of claims 55-58, wherein the laceration device comprises a cable saw extending between the distal end of the first catheter and the distal end of the second catheter, and the cable saw is configured to translate between the first distal attachment device and the second distal attachment device.

60. The catheter apparatus of any one of claims 55-59, wherein the attachment between the laceration device and the first catheter comprises a ratcheting mechanism configured to maintain a tension on the laceration device.

61. The catheter apparatus of any one of claims 55-60, wherein the first catheter comprises two lumens, the first distal attachment device is attached to the first lumen of the two lumens, and the second distal attachment device is attached to the second lumen of the two lumens.

62. The catheter apparatus of any one of claims 55-61, wherein one or more of the first catheter and the second catheter comprise a pull wire configured to orient the corresponding catheter.

63. The catheter apparatus of any one of claims 1-62, further comprising: a housing movably surrounding a portion of the first catheter, the housing configured to contain a laceration device in a retracted configuration, wherein the laceration device is configured to extend beyond the housing when thelaceration device is in a deployed configuration.

64. The catheter apparatus of claim 63, wherein a length of the laceration device extending beyond the housing in the deployed configuration is adjustable.

65. The catheter apparatus of claim 64, further comprising a set screw configured to adjust the length of the laceration device.

66. The catheter apparatus of claim 64, further comprising a wedge configured to adjust the length of the laceration device.

67. The catheter apparatus of claim 64, wherein a length of the laceration device extending beyond the housing in the deployed configuration is adjustable by adjustably rotating the laceration device.

68. The catheter apparatus of any one of claims 64-67, wherein the laceration device is configured to be coiled in the retracted configuration, and the laceration device is configured to be activated to a deployed configuration by rotating the laceration device relative to the housing.

69. The catheter apparatus of claims 64-68, wherein the distal end of the first catheter is configured to translate along guide rails relative to a proximal portion of the first catheter, and the housing is restrained from rotating along the guide rails.

70. The catheter apparatus of any one of claims 64-69, wherein the housing is configured to rotate relative to the laceration device.

71. The catheter apparatus of any one of claims 64-70, wherein the laceration device is configured to pivot from the retracted configuration with an entirety of the laceration device within the first catheter to the deployed configuration.

72. The catheter apparatus of claim 71, further comprising a spring configured to bias the laceration device to pivot from the retracted configuration to the deployed configuration.

73. The catheter apparatus of any one of claims 71-72, wherein the housing comprises anaperture, the laceration device is configured to extend through the aperture in the deployed configuration.

74. The catheter apparatus of claim 73, wherein the aperture is configured to maintain an orientation of the laceration device.

75. The catheter apparatus of any one of claims 64-74, wherein the housing is configured to translate independently from the first catheter.

76. The catheter apparatus of any one of claims 64-75, wherein the housing movably surrounds a portion of the first catheter.

77. The catheter apparatus of any one of claims 64-76, wherein the housing is positioned within the first catheter, and the laceration device is configured to retract from the deployed configuration to the retracted configuration by translating the housing relative to a portion of the first catheter.

78. The catheter apparatus of any one of claims 54-77, wherein a length that the laceration device extends beyond the first catheter is adjustable based on an angle that the laceration device pivots relative to the retracted configuration.

79. The catheter apparatus of any one of claims 54-78, wherein the laceration device is configured to translate along the first catheter while the laceration device is in the deployed configuration.

80. The catheter apparatus of any one of claims 54-78, wherein the laceration device is configured to translate away from the distal attachment device while the laceration device is in the deployed configuration.

81. The catheter apparatus of any one of 54-78, wherein the laceration device is configured to translate towards the distal attachment device while the laceration device is in the deployed configuration.

82. The catheter apparatus of any one of claims 1-81, wherein the laceration device comprises: a guiding rod configured to extend from the distal end of the first catheter; and a wire configuredto extend between the guiding rod and the distal attachment device.

83. The catheter apparatus of claim 82, wherein: the distal attachment device is configured translate in a first direction; and the guiding rod is configured to translate parallel to the first direction.

84. The catheter apparatus of claim 83, wherein the wire is configured to extend between the guiding rod and the distal attachment device in a second direction perpendicular to the first direction.

85. The catheter apparatus of any one of claims 83-84, further comprising a bumper at the distal end of the first catheter proximate the guiding rod.

86. The catheter apparatus of any one of claims 83-85, wherein: the wire is movably attached to the distal attachment device; and the wire is attached to a distal end of the guiding rod.

87. The catheter apparatus of any one of claims 83-86, wherein the laceration device comprises the wire configured to lacerate tissue when the wire is energized.

88. The catheter apparatus of any one of claims 83-87, wherein an orientation of the guiding rod relative to the distal attachment device is adjustable.

89. The catheter apparatus of any one of claims 83-88, wherein the distal attachment device comprises a needle.

90. The catheter apparatus of any one of claims 83-89, wherein the laceration device is configured to expand into a deployed configuration.

91. The catheter apparatus of claim 90, wherein the laceration device comprises an inflatable balloon.

92. The catheter apparatus of any one of claims 90-91, wherein the laceration device is positioned on one side of first catheter but not the opposite side of the first catheter in the deployed configuration.

93. The catheter apparatus of any one of claims 90-92, further comprising a cauterizing device configured to cauterize tissue when energized.

94. The catheter apparatus of claim 93, wherein the cauterizing device is positioned along at least a portion of an outer periphery of the laceration device when the laceration device is in the deployed configuration.

95. The catheter apparatus of any one of claims 73-94, wherein the cauterizing device comprises at least a portion of a wire comprising stainless steel, tungsten, or a combination thereof.

96. The catheter apparatus of any one of claims 1-95, further comprising a control handle comprising an actuator configured to adjust the length of the laceration device.

97. The catheter apparatus of any one of claims 1-95, further comprising a control handle comprising: a first actuator configured to adjust at least one of a position or an orientation of an outer catheter; a second actuator configured to adjust at least one of an orientation or a deployment of the distal attachment device; a third actuator configured to adjust a position of the first catheter relative to the outer catheter; a fourth actuator configured to extend the laceration device to the deployed configuration; and a fifth actuator configured to adjust a position of a housing.

98. The catheter apparatus of any one of claims 1-97, further comprising a cradle configured to support the control handle, wherein the cradle comprises at least three supports that are translatable relative to one another.

99. The catheter apparatus of any one of claims 1-98, wherein the distal attachment device comprises at least a portion of a laceration wire configured lacerate tissue when the at least the portion of the laceration wire is energized.

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