Pericardotomy device with shape-setting electrodes - Patent application

Abstract

The medical device includes a flexible catheter including a distal end, at least one lumen, and a longitudinal axis, a cutting device coupled to the distal end of the catheter, and a distal tip coupled to and projecting from the cutting assembly. The cutting device includes one or more electrodes for creating an incision through the pericardium. A method of improving cardiac function in a heart of a subject having cardiac dysfunction includes creating at least one incision length through the pericardium and reducing pressure applied to the heart by the pericardium.

Description

[Technical field]

[0001] The present disclosure is directed to devices and methods for dissecting the pericardium that are generally applicable to the treatment of heart failure, e.g., heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced infusion fraction (HFrEF), by introducing one or more incision lengths into the pericardium, e.g., the parietal layer. [Background technology]

[0002] Pericardial constraint is a normal physiological process that is exaggerated in some patients with, for example, heart failure with preserved ejection fraction (HFpEF), causing the right heart to run out of space during filling, thereby compressing and overpressuring the left heart during physical activity in these patients. The increased left heart pressure is returned to the lungs, and these patients experience significant dyspnea when attempting minimal activity (dyspnea on exertion). Dyspnea on exertion is the most common symptom in patients with HFpEF and the most common cause of hospitalization in patients with HF in general. Currently, there are no treatment options for HFpEF patients that specifically target pericardial constraint. Summary of the Invention

[0003] In one aspect, the present invention encompasses a medical device for creating an incision in a body tissue, such as the pericardium, including but not limited to an incision of a parietal layer. In some exemplary embodiments, alone or in combination with any previous embodiment, the medical device comprises a transcatheter including at least one lumen, a longitudinal axis, a proximal end, a distal end, a distal tip adjacent the distal end of the transcatheter, the distal tip including a body having an exterior surface and a distal opening, a cutting device operably coupled to the distal end of the transcatheter, and a biasing member operably coupled to a second end of a wire. The cutting device includes a wire including a first end secured to an exterior surface of the body of the distal tip, a second end extending through the distal opening of the body of the distal tip, and an electrode. The wire has a first configuration, in which a portion of the wire extending from the first end to the distal opening of the body of the distal tip contacts or abuts an exterior surface of the body, and a second configuration, in which (i) a portion of the wire extending from the first end to the distal opening of the body of the distal tip forms a shape including a protrusion that extends at an angle to the longitudinal axis of the transcatheter (and in some cases extends substantially perpendicular to the longitudinal axis), and (ii) an electrode is positioned proximal to the protrusion. In some exemplary embodiments, alone or in combination with any previous embodiment, the biasing member is configured to advance at least a portion of the wire through the distal opening of the body of the distal tip to move the wire from the first configuration to the second configuration.

[0004] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the wires are shaped to form a second configuration.

[0005] In some exemplary embodiments, alone or in combination with any previous embodiment, the biasing member is configured to retract at least a portion of the wire through a distal opening of the body of the distal tip to move the wire from the second configuration to the first configuration.

[0006] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the electrodes are configured to receive electrical current and / or radio frequency energy to ablate, burn, vaporize, and / or separate tissue.

[0007] In some exemplary embodiments, alone or in combination with any previous embodiment, after an incision is made in the pericardium, when the wire is in the second configuration and when the incision device is positioned under the pericardium, the protrusion extends through the incision.

[0008] In some exemplary embodiments, alone or in combination with any previous embodiment, when the wire is in the second configuration, the electrodes are positioned on the wire adjacent the base of the protrusion.

[0009] In some exemplary embodiments, alone or in combination with any previous embodiment, the wire comprises a drawn filled tube (DFT).

[0010] In some exemplary embodiments, alone or in combination with any previous embodiments, the wire includes a core within a shell, the shell being less conductive than the core.

[0011] In some exemplary embodiments, alone or in combination with any previous embodiments, the wire comprises a core within a shell, the shell being Nitinol and the core being silver.

[0012] In some exemplary embodiments, alone or in combination with any previous embodiments, the wire includes a core within a shell, and the electrodes are formed by removing a portion of the shell.

[0013] In some exemplary embodiments, alone or in combination with any previous embodiment, the wires include a frame, and the electrodes and wires are attached to the frame.

[0014] In some exemplary embodiments, alone or in combination with any previous embodiment, the wire comprises a frame having a rectangular cross-section.

[0015] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the wire comprises a Nitinol frame.

[0016] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the transcatheter is steerable.

[0017] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least a portion of the transcatheter is radiopaque.

[0018] In some exemplary embodiments, alone or in combination with any previous embodiment, the at least one lumen includes a guidewire lumen extending through the dissection device.

[0019] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least a portion of the incision device is radiopaque.

[0020] In some exemplary embodiments, alone or in combination with any previous embodiment, a lancing device includes a rigid housing and a lancing surface received by the rigid housing.

[0021] In some exemplary embodiments, alone or in combination with any previous embodiment, the rigid housing is metal.

[0022] In some exemplary embodiments, alone or in combination with any of the previous embodiments, a biasing member is positioned within the lancing device.

[0023] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the biasing member applies a rotational force, or torque, to the cutting surface.

[0024] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the medical device includes an actuator coupled to a biasing member.

[0025] In some exemplary embodiments, alone or in combination with any previous embodiment, the medical device includes a guidewire slidably positioned within the guidewire lumen.

[0026] In some exemplary embodiments, alone or in combination with any previous embodiment, the distal tip includes a lumen operably coupled to the guidewire lumen.

[0027] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the distal tip lumen slidably receives a guidewire.

[0028] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least a portion of the distal tip is radiopaque.

[0029] In some exemplary embodiments, alone or in combination with any previous embodiment, the medical device includes a sheath having a distal end slidably positionable over the transcatheter.

[0030] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least a portion of the distal end of the sheath is radiopaque.

[0031] In some exemplary embodiments, alone or in combination with any previous embodiment, the sheath includes at least one opening adjacent a distal end of the sheath.

[0032] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the distal end of the sheath is traversable along the trans-catheter and aligns with at least one opening in the trans-catheter.

[0033] In some exemplary embodiments, alone or in combination with any previous embodiment, at least one opening in the sheath is traversable along the trans-catheter to cover or expose at least one opening in the trans-catheter.

[0034] In some exemplary embodiments, alone or in combination with any previous embodiment, at least a portion of the distal end of the sheath and at least a portion of the at least one opening of the trans-catheter are radiopaque in order to align the distal end of the sheath and the at least one opening of the trans-catheter.

[0035] In some exemplary embodiments, alone or in combination with any previous embodiment, at least a portion of the periphery of at least one opening in the sheath and at least a portion of the periphery of at least one opening in the trans-catheter are radiopaque in order to align their respective openings.

[0036] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one opening in the sheath is traversable to align with at least one opening in the trans-catheter, allowing the cutting surface to protrude laterally through both the sheath and the trans-catheter.

[0037] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one opening in the sheath is traversable to align with at least one opening in the trans-catheter, allowing the actuator to cause the cutting surface to protrude laterally through both the sheath and the trans-catheter.

[0038] In some exemplary embodiments, alone or in combination with any previous embodiment, the medical device includes one or more stabilizing members located adjacent to at least one opening of the transcatheter.

[0039] In some exemplary embodiments, alone or in combination with any of the previous embodiments, one or more stabilizing members reversibly protrude laterally about the circumference of the transcatheter, radially spaced approximately 120 degrees apart.

[0040] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the one or more stabilizing members are wires, loops, or shape memory metals.

[0041] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the one or more stabilizing members are one or more expandable structures.

[0042] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the distal end of the sheath is traversable along the trans-catheter to expose at least one opening in the trans-catheter and to allow one or more stabilizing members to protrude laterally through the one or more openings in the trans-catheter.

[0043] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the distal end of the sheath simultaneously or sequentially allows the cutting surface and one or more stabilizing members to protrude laterally through one or more openings in the transcatheter.

[0044] In some exemplary embodiments, alone or in combination with any of the previous embodiments, one or more stabilizing members are operably coupled to an actuator.

[0045] In some exemplary embodiments, alone or in combination with any of the previous embodiments, one or more openings in the sheath are traversable along the trans-catheter enabling an actuator to cause one or more stabilizing members to protrude laterally through both the trans-catheter and the sheath.

[0046] In some exemplary embodiments, alone or in combination with any previous embodiment, the actuator simultaneously or sequentially causes the cutting device and one or more stabilizing members to protrude laterally through one or more openings in the transcatheter and one or more openings in the sheath.

[0047] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least a portion of the lancing device includes an electrode.

[0048] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least a portion of the cutting surface includes an electrode.

[0049] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the electrodes are wires.

[0050] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the wires are shaped as one or more arcs that project laterally through the transcatheter along the longitudinal axis.

[0051] In some exemplary embodiments, alone or in combination with any previous embodiments, the cutting surface comprises a scalpel.

[0052] In some exemplary embodiments, alone or in combination with any previous embodiments, at least a portion of the scalpel includes an electrode.

[0053] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one electrode can be electrically coupled to a source of radio frequency energy or current sufficient to cut, separate, pinch, or vaporize a portion of the mural layer.

[0054] In some exemplary embodiments, alone or in combination with any previous embodiment, the medical device includes a second electrode adjacent to the cutting device.

[0055] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the second electrode is operably coupled to a source of radio frequency energy or electrical current.

[0056] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the cutting surface, when projecting laterally, faces away from the distal end and toward the proximal end of the transcatheter.

[0057] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least a portion of the cutting plane is reversibly adjustable laterally between a range of angles relative to the longitudinal axis of the transcatheter.

[0058] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the range of angles is reversibly adjustable to provide a scissor incision of the parietal layer tissue.

[0059] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the medical device includes at least one neural sensing device.

[0060] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural sensing device is located on the transcatheter.

[0061] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural sensing device is located adjacent to the cutting device.

[0062] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural sensing device is located on the distal tip.

[0063] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural detection device is located on the dissection plane.

[0064] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the medical device includes at least one neurostimulator.

[0065] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural sensing device is located on the transcatheter.

[0066] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural sensing device is located adjacent to the cutting device.

[0067] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural sensing device is located on the distal tip.

[0068] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural detection device is located on the dissection plane.

[0069] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the medical device includes at least one neurostimulator.

[0070] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neurostimulator is located on a transcatheter.

[0071] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neurostimulator device is located adjacent to the cutting device.

[0072] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neurostimulator is located on the distal tip.

[0073] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neurostimulator is located on the dissection plane.

[0074] In some exemplary embodiments, alone or in combination with any previous embodiment, the kit includes a medical device, a sheath, a guidewire, and a distal tip.

[0075] In another aspect, the invention encompasses a method of improving cardiac function in a heart of a subject having cardiac dysfunction, the method comprising creating at least one incision length through the pericardium and reducing pressure applied by the pericardium to the heart.

[0076] In some exemplary embodiments, alone or in combination with any of the previous embodiments, creating at least one incision length through the pericardium causes a reduction in pressure exerted by the pericardium on the heart.

[0077] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the incision length is created in at least one of the parietal layer or fibrous layer of the pericardium.

[0078] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the incision length is created within adipose tissue or fat deposits.

[0079] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one incision length is along the length or circumference of only the parietal layer of the pericardium.

[0080] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one incision length is made in the parietal layer from the anterior to the posterior of the heart.

[0081] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one incision length is made in the parietal layer from the posterior base to the apex of the heart.

[0082] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one incision length is made in the parietal layer from the posterior right atrium to the apex of the heart.

[0083] In some exemplary embodiments, alone or in combination with any previous embodiment, at least one incision length is made in the parietal layer from the left superior vena cava to the apex of the heart.

[0084] In some exemplary embodiments, alone or in combination with any previous embodiment, at least one incision length is made in the parietal layer from the right superior aorta to the apex of the heart.

[0085] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one incision length is made in the parietal layer laterally around the circumference of the heart.

[0086] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes puncturing the pericardial tissue to provide an access point into the pericardial cavity prior to creating the incision length.

[0087] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes providing subxiphoid access to the pericardium prior to puncture.

[0088] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes providing transvascular access to the pericardium prior to puncture.

[0089] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes inserting a guidewire into the pericardial space after puncture.

[0090] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes advancing a dilator over the guidewire and into the pericardial space.

[0091] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes inserting a guidewire or dilator into the pericardial tissue and then advancing a transcatheter device over the guidewire into the pericardial cavity, the transcatheter device having a proximal end, a distal end, and a longitudinal axis.

[0092] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the transcatheter device includes a dissection device.

[0093] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the transcatheter device includes a pericardiotomy assembly.

[0094] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the pericardiotomy assembly includes a cutting device.

[0095] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes sterilizing the lancing device.

[0096] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the lancing device is sterilized via e-beam sterilization.

[0097] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the lancing device is sterilized via gamma sterilization.

[0098] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the lancing device is sterilized via ethylene oxide sterilization.

[0099] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the lancing device is sterilized via autoclave sterilization.

[0100] In some exemplary embodiments, alone or in combination with any previous embodiment, the cutting device is selected from the group consisting of a scalpel, a mechanical cutting device, an electrosurgical device, a reversibly retractable knife blade, and combinations thereof.

[0101] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the method includes obtaining visual information.

[0102] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes advancing a sheath over the trans-catheter device and into the pericardial space.

[0103] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes advancing the transcatheter device into the pericardial space and then forming an opening from within the pericardial space through at least the parietal layer.

[0104] In some exemplary embodiments, alone or in combination with any of the previous embodiments, forming the opening through the mural layer is performed using a scalpel, a mechanical dissection device, an electrosurgical device, a reversibly retractable knife blade, or a combination thereof.

[0105] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes, after creating an opening in the parietal layer, introducing a scalpel, a mechanical dissection device, an electrosurgical device, or a reversibly retractable knife blade into the opening, where the scalpel, mechanical dissection device, electrosurgical device, or a reversibly retractable knife blade reverse dissects the pericardium.

[0106] In some embodiments, the method includes stabilizing a portion of the transcatheter device within the pericardial space after advancing the transcatheter device into the pericardial space.

[0107] In some exemplary embodiments, alone or in combination with any previous embodiment, stabilizing includes deploying one or more stabilizing members, the one or more stabilizing members protruding laterally from the trans-catheter device.

[0108] In some exemplary embodiments, alone or in combination with any of the previous embodiments, one or more stabilizing members abut the distal end of the trans-catheter device.

[0109] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the one or more stabilizing members are selected from a wire, a loop, or a shape memory metal.

[0110] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the one or more stabilizing members are one or more expandable structures.

[0111] In some exemplary embodiments, alone or in combination with any previous embodiments, the method includes stabilizing the trans-catheter device within the pericardial space and then fixing a portion of the trans-catheter device within the pericardial space.

[0112] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes stabilizing the transcatheter device within the pericardial space and then creating an opening through the parietal layer from within the pericardial space using a scalpel, a mechanical dissection device, an electrosurgical device, or a reversibly retractable knife blade.

[0113] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes, after stabilizing the transcatheter device, fixing a portion of the transcatheter device within the pericardial space before or during either or both of creating an opening through the mural layer and creating the incision length.

[0114] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes introducing a scalpel, mechanical cutting device, electrosurgical device, or reversibly retractable knife blade into an opening, the scalpel, mechanical cutting device, electrosurgical device, or reversibly retractable knife blade positioned for reverse dissection.

[0115] In some exemplary embodiments, alone or in combination with any of the previous embodiments, an electrosurgical device includes a cutting surface having one or more electrodes.

[0116] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes introducing a scalpel, a mechanical dissection device, an electrosurgical device, or a reversibly retractable knife blade into the opening and then creating at least one incision length by cutting, punching, scissoring, and / or shearing.

[0117] In some exemplary embodiments, alone or in combination with any previous embodiment, at least one incision length begins at an opening and ends at an access point.

[0118] In some exemplary embodiments, alone or in combination with any of the previous embodiments, generating at least one incision length includes generating a plurality of incision lengths.

[0119] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the multiple incision lengths are separated from one another.

[0120] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one of the multiple incision lengths intersect with one another.

[0121] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes, after creating at least one incision length, cauterizing at least a portion of the incision length.

[0122] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes advancing the transcatheter device into the pericardial space and then probing to locate the nerve.

[0123] In some exemplary embodiments, alone or in combination with any previous embodiment, the probing determines whether at least a portion of the phrenic nerve is in proximity to the cutting device.

[0124] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the probing includes a neurostimulator.

[0125] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the probing includes a neural detection device.

[0126] In some exemplary embodiments, alone or in combination with any of the previous embodiments, generating at least one incision length is determined in response to a signal indicative of a reduction in cardiac constraint.

[0127] In some exemplary embodiments, alone or in combination with any previous embodiment, generating the at least one incision length is determined in response to a signal indicative of a reduced cardiac constraint, and the method includes repeating generating the at least one incision length.

[0128] In some exemplary embodiments, alone or in combination with any previous embodiment, the method includes, after generating the at least one incision length, verifying the location of a distal end of the trans-catheter device, and in response to a signal indicative of a decrease in cardiac constraint, repeating the steps of generating the at least one incision length and verifying the location of the distal end.

[0129] In yet another aspect, the present invention encompasses a medical device including a flexible catheter and a cutting device. In some exemplary embodiments, alone or in combination with any previous embodiment, the flexible catheter includes a distal end, at least one lumen, and a longitudinal axis. Additionally or alternatively, the cutting device is operably coupled to the distal end of the transcatheter. In some exemplary embodiments, alone or in combination with any previous embodiment, the cutting device includes a base portion including a distal end, the base portion extending in a distal direction substantially parallel to the longitudinal axis. Additionally or alternatively, the cutting device includes an upper portion extending in a proximal direction substantially parallel to the longitudinal axis. In some exemplary embodiments, alone or in combination with any previous embodiment, the cutting device includes a connecting portion joining the upper portion to a distal end of the base portion such that the base portion, the upper portion, and the connecting portion form a closed space. Additionally or alternatively, the cutting device includes an electrode oriented toward the closed space.

[0130] In some exemplary embodiments, alone or in combination with any previous embodiments, the base portion, the top portion, and the connecting portion are formed from one or more wires, and the connecting portion includes a bend in the one or more wires.

[0131] In some exemplary embodiments, alone or in combination with any previous embodiment, the base portion, top portion, and connecting portion are formed from one or more wires, and the one or more wires are adjacent an enclosed space and include a core within a shell, and the electrodes are formed by removing a portion of the shell.

[0132] In some exemplary embodiments, alone or in combination with any previous embodiment, the connecting portion includes a sliding joint that allows the distance between the top portion and the base portion to be increased and decreased.

[0133] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the electrodes are configured to receive electrical current and / or radio frequency energy to ablate, burn, vaporize, and / or separate tissue.

[0134] In some exemplary embodiments, alone or in combination with any previous embodiments, the electrode is a first electrode and the medical device includes a second electrode.

[0135] In some exemplary embodiments, alone or in combination with any previous embodiment, the electrode is a first electrode positioned on the base portion and the medical device includes a second electrode positioned on an opposing side of the first electrode and oriented toward the enclosed space.

[0136] In some exemplary embodiments, alone or in combination with any previous embodiment, the electrode is a positive electrode and the medical device includes a negative electrode oriented toward the enclosed space.

[0137] In some exemplary embodiments, alone or in combination with any previous embodiment, the electrode is a positive electrode and the medical device includes a negative electrode oriented toward the enclosed space, and the positive electrode and the negative electrode are oriented in the same direction toward the enclosed space.

[0138] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the flexible catheter is steerable.

[0139] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least a portion of the flexible catheter is radiopaque.

[0140] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the at least one lumen includes a guidewire lumen.

[0141] In some exemplary embodiments, alone or in combination with any previous embodiment, the lancing assembly includes a housing, an opening in the housing, and a lancing surface.

[0142] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least a portion of the lancing assembly is radiopaque.

[0143] In some exemplary embodiments, alone or in combination with any previous embodiments, at least a portion of the periphery of the opening in the housing of the lancing assembly is radiopaque.

[0144] In some exemplary embodiments, alone or in combination with any previous embodiment, the dissection assembly includes a lumen operably coupled to the guidewire lumen.

[0145] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the distal tip includes a lumen operably coupled to the guidewire lumen.

[0146] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the flexible catheter, the cutting assembly, and the distal tip slidably receive a guidewire.

[0147] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the dissection assembly is configured for introduction over a guidewire.

[0148] In some exemplary embodiments, alone or in combination with any previous embodiment, the lancing assembly has a first configuration having a lancing surface received within the lancing assembly and a second configuration in which the lancing surface projects laterally outward from the lancing assembly.

[0149] In some exemplary embodiments, alone or in combination with any previous embodiment, the lancing assembly is operably coupled to a controller, the controller being positioned adjacent the proximal end of the flexible catheter.

[0150] In some exemplary embodiments, alone or in combination with any previous embodiment, the lancing assembly includes a biasing member operably coupled to the lancing surface.

[0151] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the biasing member is operably coupled to the controller.

[0152] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the biasing member applies a force, or torque, to the lancing surface.

[0153] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the force or torque is rotational.

[0154] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the biasing member is a spring or a band.

[0155] In some exemplary embodiments, alone or in combination with any previous embodiment, the spring is a torsion spring or a compression spring.

[0156] In some exemplary embodiments, alone or in combination with any previous embodiment, the spring is a torsion spring in combination with a compression spring.

[0157] In some exemplary embodiments, alone or in combination with any previous embodiment, the torsion spring is a double torsion spring.

[0158] In some exemplary embodiments, alone or in combination with any previous embodiment, the cutting assembly includes a pivot pin that secures a torsion spring, alone or in combination with a compression spring, and the proximal end of the scalpel is within the cutting assembly.

[0159] In some exemplary embodiments, alone or in combination with any of the previous embodiments, a dual torsion spring spans the cut plane.

[0160] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the cutting surface is biased to rotate laterally outward through at least one opening in the flexible catheter.

[0161] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the cutting surface is biased to pivotally rotate laterally outwardly from the flexible catheter.

[0162] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the cutting surface has a rounded distal end.

[0163] In some exemplary embodiments, alone or in combination with any previous embodiment, the cutting surface has a sharpened distal end, the sharpened distal end configured to puncture pericardial tissue from within the pericardial cavity.

[0164] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the cutting surface is angled between its distal end and its proximal end.

[0165] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the angle is an acute angle.

[0166] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the cutting plane forms an acute angle between its distal end and the exterior surface of the flexible catheter.

[0167] In some exemplary embodiments, alone or in combination with any previous embodiment, the angle between the incision plane and the exterior surface of the flexible catheter is configured to receive at least a portion of the pericardial tissue.

[0168] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the housing includes an anti-buckle mechanism.

[0169] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the anti-buckle mechanism includes a spring axially aligned with the longitudinal axis of the flexible catheter.

[0170] In some exemplary embodiments, alone or in combination with any previous embodiment, the lancing assembly includes a conductive wire operably coupled to the housing.

[0171] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the conductive wires are operably coupled to the controller.

[0172] In some exemplary embodiments, alone or in combination with any previous embodiment, at least a portion of the cutting surface is coupled to a conductive wire.

[0173] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the lancing assembly includes at least one stabilizing member.

[0174] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one stabilizing member is operably coupled to the controller.

[0175] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one stabilization member reversibly protrudes laterally from the lancing assembly.

[0176] In some exemplary embodiments, alone or in combination with any previous embodiment, the controller simultaneously or sequentially causes the cutting surface and at least one stabilizing member to protrude laterally through one or more openings in the flexible catheter.

[0177] In some exemplary embodiments, alone or in combination with any previous embodiment, at least one stabilization member reversibly projects laterally at approximately 120 degrees radially spaced apart about the circumference of the lancing assembly.

[0178] In some exemplary embodiments, alone or in combination with any previous embodiment, the at least one stabilizing member is a wire, a loop, or a shape memory metal.

[0179] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one stabilizing member is an expandable structure.

[0180] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the medical device includes at least one neural sensing device.

[0181] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural sensing device is located on a flexible catheter.

[0182] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural detection device is located adjacent to the lancing assembly.

[0183] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural sensing device is located on the distal tip.

[0184] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neural detection device is located on the dissection plane.

[0185] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the medical device includes at least one neurostimulator.

[0186] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neurostimulator is located on a flexible catheter.

[0187] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neurostimulator is located adjacent to the dissection assembly.

[0188] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neurostimulator is located on the distal tip.

[0189] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least one neurostimulator is located on the dissection plane.

[0190] In some exemplary embodiments, alone or in combination with any of the previous embodiments, at least a portion of the distal tip is radiopaque.

[0191] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the cutting surface faces away from the distal end of the flexible catheter and toward the proximal end.

[0192] In some exemplary embodiments, alone or in combination with any previous embodiment, the cutting assembly is configured to reversibly pivot the cutting surface from a protruding configuration to a retracted configuration to provide a scissors-like action on the pericardial tissue.

[0193] In some exemplary embodiments, alone or in combination with any previous embodiment, the cutting assembly has a first configuration with a cutting surface covered by the distal end of the sheath and a second configuration in which the cutting surface protrudes laterally as the sheath traverses longitudinally from the cutting assembly.

[0194] In some exemplary embodiments, alone or in combination with any previous embodiments, at least a portion of the distal end of the sheath is radiopaque to align the sheath and the distal end of the cutting assembly.

[0195] In some exemplary embodiments, alone or in combination with any previous embodiment, at least a portion of the cutting surface includes an electrode, and the cutting surface is pivotally protrudable such that the electrode is exposed to the pericardial tissue.

[0196] In some exemplary embodiments, alone or in combination with any previous embodiment, the cutting surface includes an electrode, and the cutting surface is pivotally protrudable in part such that at least a portion of the electrode is hidden from the pericardial tissue.

[0197] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the electrodes are wires.

[0198] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the wire is shaped as one or more arcs that project laterally from the flexible catheter along the longitudinal axis.

[0199] In some exemplary embodiments, alone or in combination with any previous embodiment, a medical instrument for creating an incision in tissue, such as the pericardium, is provided, the apparatus comprising a transcatheter configured for a location below the tissue, such as within the pericardial cavity, and an incision device operably coupled to a distal end of the transcatheter, the incision device configured to form an incision in the tissue upon contact with the tissue, such as a parietal layer.

[0200] In order to understand and see how the present disclosure may be put into practice, exemplary embodiments will now be described, by way of non-limiting exemplary embodiments only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0201] [Figure 1A] FIG. 1A is a cross-sectional view of a four-chamber heart. [Figure 1B] FIG. 1B is an enlarged view of section 1B of FIG. 1A illustrating the layers of the heart wall, including the pericardial cavity. [Figure 2A] 2A-2C show an exemplary medical device as disclosed and described herein. [Figure 2B] 2A-2C show an exemplary medical device as disclosed and described herein. [Figure 2C] 2A-2C show an exemplary medical device as disclosed and described herein. [Figure 3A] 3A and 3B show the exemplary medical device of FIGS. 2A-2C deployed within the pericardial space, as disclosed and described herein. [Figure 3B] 3A and 3B show the exemplary medical device of FIGS. 2A-2C deployed within the pericardial space, as disclosed and described herein. [Figure 4A] 4A and 4B show an exemplary dissection device as disclosed and described herein deployed within the pericardial space. [Figure 4B] 4A and 4B show an exemplary dissection device as disclosed and described herein deployed within the pericardial space. [Diagram 5] FIG. 5 shows an exemplary dissection device as disclosed and described herein deployed within the pericardial space. [Figure 6A] 6A and 6B show an exemplary control device for delivering a dissection device as disclosed and described herein. [Figure 6B] 6A and 6B show an exemplary control device for delivering a dissection device as disclosed and described herein. [Figure 7] FIG. 7 is a simplified diagram of the trans-catheter approach to the pericardial space as disclosed and described herein. [Figure 8] FIG. 8 is a simplified diagram of an alternative trans-catheter approach to the pericardial space as disclosed and described herein. [Figure 9] FIG. 9 is a simplified diagram of the parietal layer incision length and incision path as disclosed and described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0202] The present disclosure provides a catheter-based therapy, termed Transcatheter Reduction of Pericardial Restriction (TAPR), that can reduce pericardial constraint by dissecting or opening the pericardium with the goal of improving patient outcomes from cardiac dysfunction, e.g., HFpEF or HFrEF, and reducing associated HF remission. The present disclosure, in one embodiment, provides a device with a hidden / medial-facing dissection surface for accessing and modifying a subject's pericardium to reduce pericardial constraint and / or resolve cardiac dysfunction. The present disclosure further provides a method of treating cardiac dysfunction using the device of the present disclosure.

[0203] As used herein, the terms "pericardial space" and pericardial cavity are used interchangeably and include their ordinary and accustomed meanings to those of skill in the medical and surgical arts, including, for example, the space, cavity, or liquid medium generally located between the parietal and visceral pericardium of the mammalian heart.

[0204] As used herein, the phrase "pericardial tissue" includes its ordinary and accustomed meaning to those of skill in the medical and surgical arts, including, for example, tissue associated with the pericardium.

[0205] As used herein, unless otherwise specified, the phrase "parietal layer" includes at least the serosal and fibrous layers of the parietal pericardium, and optionally the adipose tissue contained between, below, above, or within such layers. Additionally, the phrase "parietal layer" includes its ordinary and customary meaning to those of ordinary skill in the medical and surgical arts, including, for example, tissue layers located within and outside the pericardial cavity, and on the surface of the visceral layer of the pericardium, generally adjacent to and including adipose tissue.

[0206] As used herein, the phrase "cutting surface" includes one or more of the edges of a sharpened blade or the surface of an electrode configured to receive electrical current or radio frequency energy (RF) sufficient to ablate, burn, vaporize, or separate tissue. A cutting surface can include both sharpened edges and electrodes.

[0207] As used herein, the phrases "reverse cutting" and "pullback cutting" are used interchangeably and refer to a method involving the presentation of a cutting surface to tissue, cutting a surface adjacent the distal end of the trans-catheter device or catheter, and the application of a directional force sufficient to cut or separate the tissue, the force being substantially in a direction toward the proximal end of the trans-catheter device or catheter, e.g., by pulling on the trans-catheter device or catheter while the cutting surface is engaged with the tissue.

[0208] As used herein, the term "incision" should be understood to refer to tissue destruction, e.g., sharp cutting incisions of the type associated with a knife blade, such as a scalpel blade, or an electrosurgical device that provides electrical current to an electrode or conductive material sufficient to destroy tissue. As used herein, the term "cutting" includes "filleting," "slicing," and / or the like.

[0209] As used herein, the phrase "incision length" includes, for example, a non-zero distance of cut or incision beginning at a first point, e.g., a target point, and terminating at a second point, e.g., an access point. The incision length can be a straight line, a non-linear line, or multiple straight and / or non-linear lengths that may or may not intersect around a curved surface, such as the heart, or a non-planar surface.

[0210] As used herein, the terms "reduced pressure" and "relief of constraint" include their ordinary and accustomed meanings to those of ordinary skill in the medical and surgical arts.

[0211] As used herein, the phrase "reduced ejection fraction" includes its ordinary and customary meaning to those of ordinary skill in the medical and surgical arts, including, for example, the clinical syndrome in which a patient exhibits signs and symptoms of heart failure as a result of high left ventricular (LV) filling pressures despite a normal or near-normal LV ejection fraction (LVEF; > 50%).

[0212] As used herein, the phrase "reduced ejection fraction" includes its ordinary and customary meaning to those of ordinary skill in the medical and surgical arts, such as, for example, impaired ventricular filling or emptying of blood, or both, and includes the clinical syndrome in which patients exhibit a left ventricular ejection fraction (LVEF) of 40% or less and are accompanied by progressive left ventricular dilation and adverse cardiac remodeling and / or mitral valve insufficiency.

[0213] As used herein, the phrase "cardiac dysfunction" includes the ordinary and accustomed meaning to those of skill in the medical and surgical arts, including, for example, heart failure or congestive heart failure.

[0214] As used herein, the phrase "cutting device" includes devices that have a cutting surface, such as the edge of a blade or the surface of an electrode.

[0215] As used herein, the phrases "pericardiotomy assembly" and "otomy assembly" are used interchangeably and refer to an assembly that includes a totomy device.

[0216] As used herein, the phrase "transcatheter device" includes a medical instrument, device, or component thereof, such as a catheter comprised of at least one lumen that contains a cutting device.

[0217] As used herein, the terms "first," "second," and the like are used only to describe elements relative to one another and are not meant to enumerate in any way a particular orientation of an article or device, but are used to indicate or imply a necessary or required orientation of the article or device, to indicate or imply a necessary or required configuration of the article or device, or to designate how an article or device described herein may be used, positioned, transitioned from a different configuration, or positioned during use.

[0218] As used herein, when elements are referred to as "adjacent" and "coupled" when referring to two structures or layers, the two structures or layers are adjacent to one another with no intervening open space between them.

[0219] As used herein, when an element is referred to as "attached" or "adjacent" to another element, the two elements or structures are in close proximity to one another but there are other elements or intervening elements present.

[0220] As used herein, when an element is referred to as being "directly connected to" or "directly adjacent to" another element, there are no other or intervening elements present.

[0221] As used herein, the term "operably coupled" includes direct couplings and indirect couplings via another component, element, circuit, or structure, and / or indirect couplings between items via intervening items.

[0222] As used herein, the phrase "neural stimulator" includes a device capable of applying an electrical potential to a nerve to cause an observable effect that directly or indirectly correlates with the applied electrical potential, e.g., a pacing probe that stimulates the phrenic nerve to cause an observable respiratory disorder.

[0223] As used herein, the phrase "neural sensing device" includes devices that can establish the location or configuration of at least a portion of a nerve and provide location or proximity information with no or substantially no physical effect or stimulation on the nerve, such as an impedance sensor to, for example, detect an electric field generated by the nerve and directly or indirectly correlate the location or proximity of the nerve to the impedance sensor.

[0224] As used herein, the term "actuator" includes a mechanism for triggering an action.

[0225] As used herein, the term "controller" includes a device that has an actuator.

[0226] As used herein, the phrase "biasing member" includes devices, such as, for example, springs, that are configurable into a stored energy state and a released energy state.

[0227] As used herein, the phrase "stabilizing member" includes devices that can be configured to provide stability and / or fixation of a device to or within a structure, such as, for example, stabilizing or fixing a cutting surface positioned within the pericardial space against rolling, twisting, buckling, and / or vibration prior to and / or during use.

[0228] As used herein, the phrase "distal tip" includes an atraumatic object suitable for puncturing or penetrating tissue without substantial trauma to or bleeding from the vicinity of the puncture or penetration.

[0229] 1A and 1B, section 1B is shown with the layers of the heart wall of heart 50 being, from inside to outside, endocardium 51, myocardium 52, visceral pericardium 53, pericardial cavity 54, parietal pericardium 55, and fibrous pericardium 56. In some exemplary embodiments, alone or in combination with any of the previous embodiments, the presently disclosed device is configured to incise parietal pericardium 55, and / or fibrous pericardium 56, and / or parietal layers for introduction into pericardial cavity 54.

[0230] As used herein, unless otherwise specified, the phrase "parietal layer" includes at least the serosal and fibrous layers of the parietal pericardium, and optionally the adipose tissue contained between, below, above, or within such layers. Additionally, the phrase "parietal layer" includes its ordinary and customary meaning to those of ordinary skill in the medical and surgical arts, including, for example, tissue layers located within and outside the pericardial cavity, and on the surface of the visceral layer of the pericardium, generally adjacent to and including adipose tissue.

[0231] With general reference to the figures, the medical device includes a flexible catheter 129 having a distal end, at least one lumen, and a longitudinal axis, cutting devices 300, 400, 450, and 500 coupled to the distal end of the catheter 129, and a distal tip 115 coupled to and projecting from the cutting devices 300, 400, 450, and 500. In one example, the distal tip 115 includes a distal tip. In some exemplary embodiments, alone or in combination with any previous embodiment, at least a portion of the flexible catheter 129 tip is radiopaque. Additionally or alternatively, at least a portion of the cutting devices 300, 400, 450, and 500 are radiopaque. For example, at least a portion of the distal tip 115 is radiopaque. In some exemplary embodiments, alone or in combination with any of the previous embodiments, the cutting device 300, 400, 450, and 500 includes one or more electrodes configured to receive electrical current and / or radio frequency energy to ablate, burn, vaporize, and / or separate tissue. Additionally or alternatively, the cutting device 300, 400, 450, and 500 includes one or more blades for piercing and / or cutting tissue. In some exemplary embodiments, alone or in combination with any of the previous embodiments, the cutting device 300, 400, 450, and 500 includes one or more electrodes and one or more blades, where at least one of the electrodes is positioned on and / or adjacent to at least one cutting surface of the blade. Additionally or alternatively, the cutting device 300, 400, 450, and 500 includes one or more electrodes and one or more blades, where at least one of the electrodes is electrically isolated from at least one of the blades.

[0232] Some or all of the medical device is sterilized for use. The medical device is sterilized using a variety of sterilization techniques, such as electron beam sterilization, gamma sterilization, ethylene oxide sterilization, autoclave sterilization, and / or the like. Additionally, one or more materials used in the medical device have antimicrobial properties. The pericardiotomy device, and / or catheter, and / or sheath may be configured such that the total outer diameter (OD) introduced into the pericardial space is about 6 Fr (2 mm) to about 30 Fr (10 mm).

[0233] In some exemplary embodiments, alone or in combination with any of the previous embodiments, a medical instrument is used to incise the parietal pericardium 55 and / or fibrous pericardium 56 in a series of iterative steps after the medical instrument is positioned within the pericardial cavity 54. For example, an exemplary method of dissecting the parietal pericardium 55 and / or fibrous pericardium 56 includes the steps of positioning a dissection device adjacent to an initial portion of the parietal pericardium 55 and / or fibrous pericardium 56, stimulating tissue adjacent to the dissection device to determine whether the dissection device is in proximity to a portion of the phrenic nerve, measuring the impedance of the tissue adjacent to the dissection device to determine a thickness of the tissue, adjusting a level of current and / or radio frequency energy applied to the tissue by the dissection device based on the determined thickness, applying a level of current and / or radio frequency energy to the dissection device to ablate, burn, vaporize, and / or separate the tissue, repositioning the dissection device adjacent to another portion of the parietal pericardium 55 and / or fibrous pericardium 56 that is itself adjacent to the initial portion, and repeating the steps of stimulating, measuring, adjusting, applying current and / or radio frequency energy, and repositioning. In this manner, the medical device is safely and precisely advanced through the parietal pericardium 55, fibrous pericardium 56, and surrounding tissue without damaging the phrenic nerve, without applying excessive current and / or radio frequency energy, and / or without having to be incised, and without damaging other tissue adjacent to the parietal pericardium 55 and / or fibrous pericardium 56.

[0234] Additionally or alternatively, the method includes clamping and / or closing a portion of the tissue (e.g., including the parietal pericardium 55 and / or the fibrous pericardium 56) using the cutting device after positioning the cutting device and prior to applying the electrical current and / or radio frequency energy to the cutting device. In this regard, clamping and / or closing a portion of the tissue reduces the surface cross-section of the tissue over which the electrical current and / or radio frequency energy is applied and / or driven, which increases the efficiency and / or effectiveness of the cutting and allows for focusing of the electrical current and / or radio frequency energy.

[0235] As shown in Figures 2A-2C, an exemplary medical device 200 for creating an incision in the pericardium includes a trans-catheter 129 (e.g., a flexible catheter), a distal tip 115, and an incision device 300. The trans-catheter 129 includes at least one lumen, a longitudinal axis, a proximal end, and a distal end. The distal tip 115 is adjacent the distal end of the trans-catheter 129 and includes a body having an exterior surface and a distal opening. The medical device 200 is deployed within the pericardial space 54 in a manner similar to other medical devices described herein.

[0236] As shown in FIGS. 2A-2C, the dissection device 300 is operably coupled to the distal end of the transcatheter 129. The dissection device 300 includes a wire 127 including a first end secured to an exterior surface of the body of the distal tip 115 and a second end extending through a distal opening of the body of the distal tip 115. The wire 127 includes an electrode 128. In some exemplary embodiments, alone or in combination with any of the previous embodiments, the electrode 128 is configured to receive electrical current and / or wireless radio frequency energy to ablate, burn, vaporize, and / or separate tissue. Additionally or alternatively, the electrode 128 may have any length (e.g., along the wire 127). For example, the electrode 128 has a length sufficient to accommodate the cross-sectional thickness of the parietal pericardium 55 and / or fibrous pericardium 56 such that the electrode 128 completely ablates, burns, vaporizes, and / or separates tissue in the cross-section of the parietal pericardium 55 and / or fibrous pericardium 56.

[0237] As shown in FIG. 2A, the wire 127 has a first configuration in which a portion of the wire 127 extending from its first end to the distal opening of the body of the distal tip 115 touches (contacts, abuts, is connected to) an exterior surface of the body. As shown in FIG. 2B and FIG. 2C, the wire 127 has a second configuration in which a portion of the wire 127 extending from its first end to the distal opening of the body of the distal tip 115 forms a shape including a protrusion that extends substantially perpendicular to the longitudinal axis of the trans-catheter 129. For example, as shown in FIG. 2B and FIG. 2C, the protrusion extends in an upward direction. As also shown in FIG. 2B and FIG. 2C, when in the second configuration, the electrode 128 of the wire 127 is positioned proximal to the protrusion (e.g., between the protrusion and the trans-catheter 129, adjacent to the base of the protrusion, and / or the like). Although the illustrated embodiment shows the protrusions extending substantially vertically, it is understood that the protrusions can be configured in a variety of different positions and at different angles relative to the longitudinal axis of the transcatheter through manipulation of the biasing member (discussed below).

[0238] 2A-2C, the medical device 200 includes a biasing member 126, such as an actuation rod operably coupled to a second end of a wire 127. The biasing member 126 is configured to advance at least a portion of the wire 127 through a distal opening of the body of the distal tip 115 to move the wire 127 from a first configuration to a second configuration. For example, as shown in FIGS. 2A and 2B, advancing the biasing member in a distal direction parallel to the longitudinal axis advances the wire 127 through the distal opening of the body of the distal tip 115 to move the wire 127 from the first configuration to the second configuration. In some exemplary embodiments, alone or in combination with any previous embodiment, biasing member 126 is connected to a second end of wire 127, and when biasing member 126 moves in a distal direction parallel to the longitudinal axis, biasing member 126 urges the second end of wire 127 toward a distal opening of the body of distal tip 115 such that a longer length of wire 127 extends beyond the distal opening and allows wire 127 to assume the shape of the second configuration. Additionally or alternatively, biasing member 126 is configured to pull at least a portion of wire 127 through the distal opening of the body of distal tip 115 to move wire 127 from the second configuration to the first configuration.

[0239] 2A-2C, medical device 200 includes a guidewire 113 that feeds through transcatheter 129 and through a distal opening in the body of distal tip 115. Guidewire 113 is first deployed within pericardial space 54, and then medical device 200 is advanced over guidewire 113 to a desired location within pericardial space 54 to create one or more incisions.

[0240] As shown in Figures 2A-2C, the medical device 200 includes one or more stabilizing members 120 extending outwardly from the trans-catheter 129. For example, as shown in Figure 2C, the one or more stabilizing members 120 extend through an opening in the trans-catheter 129 after another biasing member 121, such as another actuation rod, controller rod, and / or actuation wire, is advanced in a distal direction parallel to the longitudinal axis of the trans-catheter 129. The one or more stabilizing members 120 stabilize the medical device 200 within the pericardial space 54 by pushing against the visceral pericardium 53 and / or parietal pericardium 55 such that the medical device 200 creates an incision in the parietal pericardium 55 and / or fibrous pericardium 56 in a controlled manner.

[0241] In some exemplary embodiments, alone or in combination with any previous embodiment, one or more stabilizing members 120 are independently user controlled by advancing biasing member 121 distally toward distal tip 115 to cause one or more stabilizing members 120 to extend laterally a distance from the assembly. In some exemplary embodiments, alone or in combination with any previous embodiment, two or more stabilizing members 120 are positioned radially around the assembly. For example, two or more stabilizing members 120 are positioned radially about the assembly about 120 degrees apart. In some exemplary embodiments, alone or in combination with any previous embodiment, two or more stabilizing members 120 are longitudinally offset from electrode 128 to minimize or eliminate pushing dissection device 300 through a freshly dissected slit in the pericardium as it is formed. Stabilizing member 120 includes an expandable structure such as a flexible rod, flexible strip, and / or a balloon that can be inflated with air and / or liquid (e.g., saline).

[0242] In some exemplary embodiments, alone or in combination with any of the previous embodiments, wire 127 comprises a drawn filled tube. For example, wire 127 comprises a core within a shell, where the shell is less conductive than the core. As another example, wire 127 comprises a core within a shell, where the shell is Nitinol and the core is silver. As yet another example, wire 127 comprises a core within a shell, where a portion of the shell is removed to expose the core, thereby forming electrode 128.

[0243] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the wire 127 includes a frame, and the electrodes 128 and conductive wires are attached to the frame. For example, the wire 127 includes a frame having a rectangular cross section. As another example, the wire 127 includes a Nitinol frame.

[0244] In some exemplary embodiments, alone or in combination with any of the previous embodiments, wire 127 is shaped to form a second configuration. For example, wire 127 is shaped such that wire 127 assumes the shape of the second configuration when wire 127 is not under tension, but may still be placed under tension and become substantially straight. In some exemplary embodiments, alone or in combination with any of the previous embodiments, wire 127 comprises a shape memory metal.

[0245] 3A and 3B show the medical device 200 deployed within the pericardial space 54, beneath the parietal pericardium 55 and fibrous pericardium 56. As shown in FIG. 3A, an opening is formed in the parietal pericardium 55 and fibrous pericardium 56 (e.g., by the electrode 128, by a blade (not shown) of the medical device 200, by another medical device (not shown), and / or the like) and after the wire 127 assumes the shape of the second configuration, a protrusion extends through the parietal pericardium 55 and fibrous pericardium 56. Additionally, and as also shown in FIG. 3A, the electrode 128 is positioned adjacent to a proximal end of the opening in the parietal pericardium 55 and fibrous pericardium 56 as the protrusion extends through the parietal pericardium 55 and fibrous pericardium 56.

[0246] In this manner, the second configuration, in which the protrusions extend perpendicular to the longitudinal axis of the trans-catheter 129, allows an operator of the medical device 200 to position the protrusions within the opening and receive tactile and / or visual feedback (e.g., via fluoroscopy and / or the like) indicating the positioning of the wire 127 and / or electrode 128 relative to the already-formed opening in the parietal pericardium 55 and fibrous pericardium 56. Furthermore, such tactile and / or visual feedback ensures to the operator that the electrode 128 (i) is properly positioned to continue to dissect the parietal pericardium 55 and fibrous pericardium 56, and (ii) is not positioned to be within the opening and / or to dissect other tissue upon activation.

[0247] As shown in Fig. 3B, the electrode 128 is provided with electrical current and / or radio frequency energy to ablate, burn, vaporize, and / or separate the parietal pericardium 55 and fibrous pericardium 56 to enlarge the opening. Also shown in Fig. 3B, the medical device 200 is moved in a proximal direction (e.g., along the guidewire 113) with the protrusions providing tactile and / or visual feedback to the operator regarding the positioning of the wire 127 and / or electrode 128 relative to the edges of the opening in the parietal pericardium 55 and fibrous pericardium 56. In this manner, the medical device 200 is moved in either a continuous or stepwise motion in a proximal direction to continue to enlarge the opening in the parietal pericardium 55 and fibrous pericardium 56 to enlarge the opening by actuation of the electrode 128, while the protrusions of the wire 127 provide tactile and / or visual feedback to the operator regarding the positioning of the wire 127 and / or electrode 128.

[0248] 4A and 4B show exemplary dissection devices 400 and 450 for creating an incision in the pericardium. Each of dissection devices 400 and 450 is deployed within pericardial cavity 54 in a manner similar to other medical devices described herein. Additionally, each of dissection devices 400 and 450 is part of a medical device and is deployed using a flexible catheter.

[0249] As shown in Figures 4A and 4B, each of the dissection devices 400 and 450 includes a base portion 401, a connecting portion 403, and a top portion 405. In some exemplary embodiments, alone or in combination with any previous embodiment, as shown in Figures 4A and 4B, the base portion 401 includes a distal end and extends in a distal direction substantially parallel to the longitudinal axis. Additionally or alternatively, as shown in Figures 4A and 4B, the top portion 405 extends in a proximal direction substantially parallel to the longitudinal axis. As also shown in Figures 4A and 4B, the connecting portion 403 joins the top portion 405 to the distal end of the base portion 401. In other words, the base portion 401 and the top portion 405 are substantially parallel to each other and are joined together by the connecting portion 403.

[0250] 4A and 4B, the base portion 401, the connecting portion 403, and the top portion 405 form a closed space 407 for receiving a portion of the parietal pericardium 55 and the fibrous pericardium 56. In this regard, after an incision is made in the parietal pericardium 55 and the fibrous pericardium 56, the top portion 405 extends upwardly through the incision and is positioned above the upper surfaces of the parietal pericardium 55 and the fibrous pericardium 56, while the base portion 401 remains positioned below the lower surfaces of the parietal pericardium 55 and the fibrous pericardium 56 (i.e., within the pericardial cavity 54). Alternatively, after an incision is made in the parietal pericardium 55 and fibrous pericardium 56, the upper portion 405 extends downward through the incision and is positioned below the lower surfaces of the parietal pericardium 55 and fibrous pericardium 56 (i.e., within the pericardial cavity 54), while the base portion 401 remains positioned above the upper surfaces of the parietal pericardium 55 and fibrous pericardium 56.

[0251] As shown in Figures 4A and 4B, a portion of the parietal pericardium 55 and the fibrous pericardium 56 are positioned within the closed space 407. In some exemplary embodiments, alone or in combination with any previous embodiment, as shown in Figures 4A and 4B, each of the cutting devices 400 and 450 includes a sliding joint 411 that joins the base portion 401 and the top portion 405 such that the distance between the top portion 405 and the base portion 401 increases and decreases. In other words, the sliding joint 411 allows the height of the closed space 407 to be increased or decreased. For example, such a sliding joint 411 allows each of the cutting devices 400 and 450 to accommodate parietal pericardium 55 and fibrous pericardium 56 of different thicknesses within the closed space 407.

[0252] As shown in FIG. 4A and FIG. 4B, the dissection device 400 includes a first electrode 413 positioned on the base portion 401 and oriented toward the enclosed space 407. Also shown in FIG. 4A, the dissection device 400 includes a second electrode 415 positioned on the top portion 405 and oriented toward the enclosed space 407 (e.g., on the opposite side of the first electrode 413). In some exemplary embodiments, alone or in combination with any previous embodiment, the first electrode 413 and the second electrode 415 have opposite charges. For example, as shown in FIG. 4A, the first electrode 413 is a negative electrode and the second electrode 415 is a positive electrode. As will be understood by one of ordinary skill in the art, in some exemplary embodiments, alone or in combination with any previous embodiment, the first electrode 413 is a positive electrode and the second electrode 415 is a negative electrode. Additionally, the lancing device 400 may include only one electrode or more than two electrodes (e.g., three electrodes, four electrodes, five electrodes, six electrodes, and / or the like). As shown by comparing Figures 4A and 4B, the first electrode 413 and the second electrode 415 have different lengths in different exemplary embodiments.

[0253] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the first electrode 413 and the second electrode 415 are used to measure the impedance of tissue positioned within the confined space 407. For example, after a portion of the parietal pericardium 55 and / or fibrous pericardium 56 is positioned within the confined space 407, the first electrode 413 and the second electrode 415 are used as impedance sensors to determine the thickness and / or composition of the tissue. Additionally or alternatively, the level of current and / or radio frequency energy applied to the tissue by the dissection device is adjusted based on the impedance measurements taken by the first electrode 413 and the second electrode 415.

[0254] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the first electrode 413 and the second electrode 415 are laterally offset, as opposed to being vertically offset, as shown in Figures 4A and 4B. For example, the first electrode 413 and the second electrode 415 are positioned on the connecting portion 403 and are offset relative to each other in the vertical direction of the cross-sectional view shown in Figures 4A and 4B. Additionally or alternatively, the incision device 400 includes another electrode positioned on the upper portion 405 facing in the upward orientation direction shown in Figures 4A and 4B, such that the other electrode is used to create an initial opening in the parietal pericardium 55 and the fibrous pericardium 56 through which the upper portion 405 extends. In some exemplary embodiments, alone or in combination with any of the previous embodiments, a guidewire is used to pierce the parietal pericardium 55 and the fibrous pericardium 56 to create an initial opening in the upper portion 405.

[0255] In some exemplary embodiments, alone or in combination with any previous embodiment, the first electrode 413 and the second electrode 415 are configured to receive electrical current and / or radio frequency energy to ablate, burn, vaporize, and / or separate tissue, such as the parietal pericardium 55 and the fibrous pericardium 56. Because the first electrode 413 and the second electrode 415 are positioned within and oriented toward the enclosed space 407, the first electrode 413 and the second electrode 415, when energized, ablate, burn, vaporize, and / or separate only tissue within the enclosed space 407. In other words, by including the enclosed space 407 and an electrode oriented toward the enclosed space 407, each of the incision devices 400 and 450 protects tissue adjacent to the parietal pericardium 55 and the fibrous pericardium 56 from damage.

[0256] In some exemplary embodiments, alone or in combination with any of the previous embodiments, an operator of the cutting device 400 or cutting device 450 activates the first electrode 413 and / or the second electrode 415 to ablate, burn, vaporize, and / or separate tissue of the parietal pericardium 55 and the fibrous pericardium 56. The operator then advances the cutting device 400 or cutting device 450 to position a new portion of the parietal pericardium 55 and the fibrous pericardium 56 within the enclosed space 407 (e.g., by pulling the cutting device 400 or cutting device 450 to the left in the orientation shown in Figures 4A and 4B). In this regard, the shape of each of the cutting devices 400 and 450 provides tactile and / or visual feedback indicative of the positioning of the parietal pericardium 55 and the fibrous pericardium 56 relative to the enclosed space 407, the first electrode 413, and / or the second electrode 415. For example, if the operator advances dissection device 400 or dissection device 450 too far (e.g., too far to the left in the orientation shown in FIGS. 4A and 4B ), the undissected portions of parietal pericardium 55 and fibrous pericardium 56 will abut connecting portion 403, preventing further advancement of dissection device 400 or dissection device 450. Such tactile and / or visual feedback ensures to the operator that first electrode 413 and / or second electrode 415 (i) are properly positioned to continue dissecting parietal pericardium 55 and fibrous pericardium 56, and (ii) that first electrode 413 and / or second electrode 415 are not positioned to dissect other tissue upon activation.

[0257] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the first electrode 413 and the second electrode 415 are configured to provide monopolar wireless radio frequency energy to tissue within the enclosed space 407. In this regard, current flows from the first electrode 413 to heat tissue adjacent to the first electrode 413. Similarly, current flows from the second electrode 415 to heat tissue adjacent to the second electrode 415.

[0258] Additionally or alternatively, the first electrode 413 and the second electrode 415 are configured to provide bipolar wireless radio frequency energy to tissue within the enclosed space 407. In this regard, current flows from the first electrode 413 to the second electrode 415, heating only and / or primarily the tissue between the first electrode 413 and the second electrode 415. Alternatively, current flows from the second electrode 415 to the first electrode 413, heating only and / or primarily the tissue between the first electrode 413 and the second electrode 415.

[0259] 5 illustrates an exemplary dissection device 500 for creating an incision in the pericardium. Dissection device 500 is deployed within pericardial cavity 54 in a manner similar to other medical devices described herein. Furthermore, dissection device 500 is part of the medical device and is deployed using a flexible catheter.

[0260] As shown in FIG. 5, the dissection device 500 includes a base portion 501, a connecting portion 503, and a top portion 505. In some exemplary embodiments, alone or in combination with any previous embodiment, as shown in FIG. 5, the base portion 501 includes a distal end and extends in a distal direction substantially parallel to the longitudinal axis. Additionally or alternatively, and as shown in FIG. 5, the top portion 505 extends in a proximal direction substantially parallel to the longitudinal axis. As also shown in FIG. 5, the connecting portion 503 joins the top portion 505 to the distal end of the base portion 501. In other words, the base portion 501 and the top portion 505 are substantially parallel to each other and are joined together by the connecting portion 503.

[0261] 5, the base portion 501, the connecting portion 503, and the top portion 505 form a closed space 507 for receiving a portion of the parietal pericardium 55 and the fibrous pericardium 56. In this regard, after an incision is made in the parietal pericardium 55 and the fibrous pericardium 56, the top portion 505 extends upwardly through the incision and is positioned above the upper surfaces of the parietal pericardium 55 and the fibrous pericardium 56, while the base portion 501 remains positioned below the lower surfaces of the parietal pericardium 55 and the fibrous pericardium 56 (i.e., within the pericardial cavity 54). Alternatively, after an incision is made in the parietal pericardium 55 and fibrous pericardium 56, the upper portion 505 extends downward through the incision and is positioned below the lower surfaces of the parietal pericardium 55 and fibrous pericardium 56 (i.e., within the pericardial cavity 54), while the base portion 501 remains positioned above the upper surfaces of the parietal pericardium 55 and fibrous pericardium 56. As shown in FIG.

[0262] 5, dissection device 500 is formed from a first wire 509 and a second wire 511 within an outer sheath 513, with connecting portion 503 including bends in first wire 509 and second wire 511. In some exemplary embodiments, alone or in combination with any previous embodiment, first wire 509 provides rigidity to dissection device 500 and is formed from a harder material than second wire 511. Additionally or alternatively, second wire 511 provides an electrical path for electrical current and / or radio frequency energy and is formed from a conductive material.

[0263] In some exemplary embodiments, alone or in combination with any previous embodiment, the first wire 509 and / or the second wire 511 are flexible and / or shaped. For example, the first wire 509 and / or the second wire 511 are shaped such that the first wire 509 and / or the second wire 511 assume a bent shape on itself, as shown in FIG. 5, when the first wire 509 and / or the second wire 511 are not under tension, but may still be placed under tension so as to be substantially straight. Such exemplary embodiments may facilitate the deployment of the incision device 500 into the pericardial space 54 and / or the removal of the incision device 500 from the pericardial space 54.

[0264] In some exemplary embodiments, alone or in combination with any previous embodiment, the outer sheath 513 is wrapped around and maintains the relative positioning of the first wire 509 and the second wire 511. Additionally, the outer sheath 513 electrically insulates a majority of the second wire 511. In this regard, a portion of the outer sheath 513 is removed and / or omitted such that the exposed section of the second wire 511 forms an electrode 515 oriented toward the enclosed space 507.

[0265] Although the dissection device 500 shown in FIG. 5 includes only a single electrode 515, the dissection device 500, in some exemplary embodiments, alone or in combination with any of the previous embodiments, includes multiple electrodes (e.g., formed by removing and / or omitting a portion of the outer sheath 513 to expose the second wire 511). Additionally or alternatively, the dissection device 500 also includes one or more electrodes formed using the first wire 509 (e.g., by removing and / or omitting a portion of the outer sheath 513 to expose the first wire 509). In some exemplary embodiments, alone or in combination with any of the previous embodiments, the first wire 509 and / or the second wire 511 include a core within a shell, and one or more electrodes are formed by removing a portion of the shell.

[0266] In some exemplary embodiments, alone or in combination with any previous embodiment, the electrode 515 is configured to receive electrical current and / or wireless radio frequency energy to ablate, burn, vaporize, and / or separate tissue, such as the parietal pericardium 55 and the fibrous pericardium 56. Because the electrode 515 is positioned within and oriented toward the enclosed space 507, the electrode 515 can only ablate, burn, vaporize, and / or separate tissue within the enclosed space 507 when energized. In other words, by including the enclosed space 507 and one or more electrodes oriented toward the enclosed space 507, the incision device 500 can protect tissue adjacent to the parietal pericardium 55 and the fibrous pericardium 56 from damage.

[0267] In some exemplary embodiments, alone or in combination with any of the previous embodiments, an operator of the dissection device 500 may activate the electrode 515 to ablate, burn, vaporize, and / or separate tissue of the parietal pericardium 55 and fibrous pericardium 56. The operator may then advance the dissection device 500 to position a new portion of the parietal pericardium 55 and fibrous pericardium 56 within the enclosed space 507 (e.g., by pulling the dissection device 500 to the left in the orientation shown in FIG. 5 ). In this regard, the shape of the dissection device 500 provides tactile and / or visual feedback indicative of the positioning of the parietal pericardium 55 and fibrous pericardium 56 relative to the enclosed space 507 and / or the electrode 515. For example, if the operator advances dissection device 500 too far (e.g., too far to the left in the orientation shown in FIG. 5 ), the undissected portions of parietal pericardium 55 and fibrous pericardium 56 will abut connecting portion 503 and prevent further advancement of dissection device 500. Such tactile and / or visual feedback assures the operator that electrode 515 (i) is properly positioned to continue dissecting parietal pericardium 55 and fibrous pericardium 56 and that electrode 515 (ii) is not positioned such that it may dissect other tissue upon activation.

[0268] 6A and 6B, the controller 1000 is shown having a handle 160, actuation buttons 122, 122' for operatively coupling with the cutting device, for example, to activate one or more electrodes, extend wires, extend stabilizing members via biasing members, etc. In one embodiment, the controller 1000 enables operation of various potential operations of the cutting devices 300, 400, 450, and 500, including extending and / or retracting wires, which may be accomplished by a suitable mechanism configured to pull / push rods. In one embodiment, there is a mechanism used to release / retrieve the balloon / nitinol components, which function to stabilize and apply counter pressure to the cutting devices 300, 400, 450, and 500 and their components. The controller 1000 includes one or more buttons used to operate and control the electrosurgical features of the device.

[0269] Figure 6A illustrates wire 127 as part of one or more of the cutting devices, medical devices, and / or cutting devices shown and described herein with respect to Figures 2A-2C, 3A-3B, 4A-4B, and 5, which are coupled to and / or compatible with controller 1000. Additionally, Figures 6A and 6B illustrate a particular controller 1000, medical device, and / or cutting device shown and described herein with respect to Figures 2A-2C, 3A-3B, 4A-4B, and 5, which are coupled to and / or compatible with other controllers (e.g., from different manufacturers, vendors, distributors, and / or the like).

[0270] As shown in FIG. 6B, the handle 260 may have one or more internal components for transmitting input received through the handle (e.g., by engaging the actuation button 122, 122′) to the catheter (and dissection device on the catheter). For example, the actuation rod 123 may include an electrical connector that connects the actuation button 122, 122′ to the catheter (e.g., to provide current to the electrode(s), to move the catheter, to deploy the dissection device, etc.). Additionally, the actuation rod 123 may be used to move the catheter (e.g., if the handle 260 includes an actuation knob for controlling the catheter, the actuation rod 123 may be moved (e.g., rotated and / or translated along the longitudinal axis of the handle 260) to move the catheter).

[0271] In one embodiment, at least one incision length is made in the pericardium of the heart. At least one incision length in a heart having a dysfunction treatable by the present method may separate the pericardium radially around the incision line without the need for removal of pericardial tissue. Other incision lengths and paths may be used. Combinations of incision lengths and paths, as well as combinations of incision lengths and paths with one or more of partial pericardial removal, drainage, and other pericardial treatments, may be used.

[0272] In one embodiment, the generation of the at least one incision length is determined in response to a signal indicative of a reduced cardiac constraint. In one embodiment, the generation of the at least one incision length is determined in response to a signal indicative of a reduced cardiac constraint, and repeating the generation of the at least one incision length. In one embodiment, the disclosed method includes verifying a location of a distal end of the trans-catheter device after generating the at least one incision length, and repeating the steps of generating the at least one incision length and verifying a location of the distal end in response to a signal indicative of a reduced cardiac constraint.

[0273] In one embodiment, the puncture for delivering the guidewire into the pericardial space 54 is performed through the cardiac tissue in a transvascular approach. If a transvascular approach through the RAA, IVC, or SVC is employed, a closure device (e.g., an occluder) is then introduced for hemostasis at the end of the procedure. In one embodiment, the closure device includes outwardly, or radially oriented splines deployed in an expanded configuration. When the guide catheter is removed, the splines, or radial members, of the closure device retract inwardly toward the unstressed state of the incision device to close, occlude, and / or seal the opening. The closure device is designed to allow a pericardiotomy device to pass through and enter the pericardial space.

[0274] The following exemplary occlusion description relates to a transvascular approach through the RAA, IVC, or SVC using one of the aforementioned incision devices 100, 200, 300, 400, 450, and 500. In one embodiment, the distal tip 115 delivers a wire through the cardiac tissue and into the pericardial cavity. The closure or occlusion device is introduced for hemostasis during the procedure. The closure or occlusion device in one example includes outwardly or radially oriented splines deployed in an expanded configuration. When the guide catheter is removed, the splines or radial members of the closure device contract inwardly toward the unstressed state of the incision device to close and seal the opening. The closure device is designed to allow the pericardiotomy device to pass through and enter the pericardial cavity.

[0275] 7 and 8 show an exemplary endovascular approach for delivering the dissection device of the present disclosure to the pericardial space 54. Thus, FIG. 7 shows the heart 50 viewed separate from the body with the pericardium 60, or pericardial sac, encasing the myocardium (i.e., epicardium, myocardium, and endocardium). The small space that exists between the myocardium and the pericardium 60 represents the pericardial space 54.

[0276] The dissection device of the present disclosure may be presented to the pericardial space 54. In one example, it is used via the right atrial appendage 38 (RAA), which is a preferred site for entering the pericardial space 54. The right atrial appendage 38 is tangential to and between the pericardium 60 and the epicardial / pericardial adipose tissue 57. In one embodiment, any of the devices of the present disclosure are guided into the right atrial appendage 38 via the right atrium 39, such that the wall of the right atrial appendage 38 is positioned substantially parallel to the wall of the pericardium 60 to be punctured by any of the devices of the present disclosure with substantially no risk of damaging the epicardium or other cardiac tissue. Other access routes to the pericardial space may be used, such as direct "puncture" of the SVC or IVC / coronary sinus (CS), and "puncture" of the pericardium.

[0277] In some exemplary embodiments, alone or in combination with any of the previous embodiments, the right atrial appendage 38 is accessed via a traditional vena cava route. Figure 7 illustrates the entry of any of the disclosed devices into the right atrium 39 via the superior vena cava 24 (SVC). Cutaway 37 illustrates the passage of any of the disclosed devices through the superior vena cava 24, the right atrium 39, and the right atrial appendage 38. The distal tip of catheter 129 is shown exiting the right atrium 39 at apex 40.

[0278] 8 illustrates an alternative entry of any of the previously disclosed devices into the right atrium 39 via the inferior vena cava 32 (IVC). Cutaways 36 indicate the passage of a catheter 129 through the inferior vena cava 32, the right atrium 39, and the right atrial appendage 38. The distal tip of catheter 129 is shown exiting the right atrium 39 at apex 40.

[0279] Thus, by way of example, a method of using any of the disclosed devices to reduce pericardial constraint in a subject in need thereof is provided by the following steps: Any of the disclosed devices is maneuvered into the right atrium 39 through one of the vena cava 24, 32. Once inside the right atrium 39, any of the disclosed devices is passed into the right atrial appendage 38. The wall of the right atrial appendage 38 is punctured at the apex 40 and a catheter is advanced into the pericardial space 54. Other transvascular right heart routes to the pericardial space 54 are envisioned. Additionally, left atrial appendage, coronary sinus, and right ventricular routes are envisioned for transvascular access to the pericardial space 54.

[0280] It should be noted that the wall of the right atrial appendage is punctured, e.g., passed over the wire, with any of the presently disclosed devices themselves, or with an instrument passing through a lumen of any of the presently disclosed devices (e.g., a guidewire). Additionally, any of the previously disclosed devices are passed through an opening in the wall of the atrial appendage into the pericardial space, or an instrument passing through a lumen of any of the presently disclosed devices is presented within the pericardial space 54. These details will depend on the procedure being performed and the type of previously disclosed device being used.

[0281] As shown in FIG. 9, any of the devices of the present disclosure can be used to create a dissection path of the length of the pericardium, for example, at the parietal layer 58. Thus, a catheter 129, for example, a steerable catheter, can be used to extend through the IVC, through the RA, into the RAA, for example, and then into the pericardial cavity 54. The catheter 129 has one or more steerable segments that guide any of the devices of the present disclosure with an arc length of between about 90° and about 180° and a radius of curvature of between about 1 inch and about 5 inches. As exemplarily shown in FIG. 9, any of the devices of the present disclosure (e.g., 100, 200, 300, 400, 450, and 500) can be positioned within the pericardial cavity 54 and begin the dissection path 175 at the starting point 160 and end at the end point 180 of the length. The parietal layer 55 of the serous pericardium, and the fibrous pericardium 56, and at least a portion of the pericardial adipose tissue 57 are separated along the dissection path 175. One or more incisions along the length of a heart having a dysfunction treatable with this method radially separates the pericardium around the incision line of incision path 175 without removal of pericardial tissue and with reduced pericardial restriction. One or more incision paths 175 can be made and different incision paths of various lengths can be used to reduce pericardial constraint. In one embodiment, the incision path 175 and its length are determined prior to surgery. Other incision paths and lengths can be used.

[0282] In one embodiment, the device of the present disclosure includes at least one neural sensing device. In one embodiment, the at least one neural sensing device is located on the flexible catheter 129. In one embodiment, the at least one neural sensing device is located adjacent to the cutting device. In one embodiment, the at least one neural sensing device is located on the distal tip 115. In one embodiment, the at least one neural sensing device is located adjacent to an electrode.

[0283] Any one of the devices of the present disclosure may further include at least one neurostimulator. In one embodiment, the at least one neurostimulator is located on the flexible catheter 129. In one embodiment, the at least one neurostimulator is located adjacent to the cutting device. In one embodiment, the at least one neurostimulator is located on the distal tip 115. In one embodiment, the at least one neurostimulator is located adjacent to the electrode.

[0284] In one embodiment, the device of the present disclosure discussed above includes an optical channel in the trans-catheter for housing a lens coupled to the fiber optic cable, optionally with a light source, e.g., an LED. In one embodiment, the method of the present disclosure further includes obtaining visual information during accessing, traversing, exiting, and / or dissecting the pericardial space, e.g., using an optical channel in the trans-catheter for housing a lens coupled to the fiber optic cable, optionally with a light source, e.g., an LED.

[0285] Kits are provided that include any one of the medical devices, sheaths, guidewires, and distal tips of the present disclosure.

[0286] Although certain exemplary embodiments of the present disclosure have been illustrated with reference to particular combinations of elements, various other combinations may be provided without departing from the teachings of the present disclosure. Thus, the present disclosure should not be construed as being limited to the specific exemplary embodiments described herein and illustrated in the figures, but may encompass combinations of elements of the various illustrated exemplary embodiments, and aspects thereof.

Claims

1. A medical device for creating an incision in tissue such as the pericardium, wherein the device is A transcatheter comprising at least one lumen, a proximal end, and a distal end, The distal tip of the transcatheter adjacent to the distal end, comprising a body having an outer surface and a distal opening, A cutting device operably coupled to the distal end of the transcatheter, wherein the cutting device is A cutting device comprising a wire, the first end of which is fixed to the outer surface of the main body at the distal tip, the second end of which is extended through the distal opening of the main body at the distal tip, and an electrode, A medical device equipped with the following features.

2. The aforementioned wire, A first configuration wherein a portion of the wire, extending from the first end of the wire to the distal opening of the main body at the distal tip, contacts the outer surface of the main body. The medical device according to claim 1, comprising a second configuration, wherein (i) the portion of the wire extending from the first end of the wire to the distal opening of the body at the distal tip forms a shape including a projection extending with respect to the longitudinal axis of the transcatheter, and (ii) the electrode is positioned proximal to the projection.

3. The medical device according to claim 2, further comprising a biasing member operably coupled to the second end of the wire, the biasing member configured to advance at least a portion of the wire through the distal opening of the body at the distal end, thereby configuring the wire into the first configuration and the second configuration.

4. The medical device according to claim 3, wherein the biasing member is configured to retract at least a portion of the wire through the distal opening of the body at the distal tip, thereby moving the wire from the second configuration to the first configuration within a range of angles including an angle substantially perpendicular to the longitudinal axis of the transcatheter.

5. The medical device according to claim 1, wherein the electrode is configured to receive electric current and / or radio frequency energy to ablate, burn, vaporize, and / or separate tissue.

6. The medical device according to claim 2, wherein the projection extends through the incision when the wire is in the second configuration after an incision has been formed in the tissue and when the incision device is positioned beneath the tissue.

7. The medical device according to claim 2, wherein when the wire is in the second configuration, the electrode is positioned on the wire adjacent to the base of the protrusion.

8. The aforementioned wire is as follows: Wires including DFTs, A wire having a core inside a shell, wherein the shell is a wire with lower conductivity than the core. A wire having a core inside a shell, wherein the shell is made of nitinol and the core is made of a conductive material such as silver. A wire having a core inside a shell, wherein the electrode is formed by removing a portion of the shell, A wire comprising a frame, wherein the electrode and the wire are attached to the frame, A wire having a frame with a rectangular cross-section, or A medical device according to claim 1, which is one of the wires having a nitinol frame.

9. The medical device according to claim 1, wherein at least one lumen is configured to receive a guidewire extending through the cutting device.

10. The medical device according to claim 3, wherein the biasing member applies rotational force or torque to the cutting surface of the cutting device.

11. The medical device according to claim 9, wherein the distal tip has a lumen movably coupled to the lumen of the guidewire, and the lumen of the distal tip slidably receives the guidewire.

12. The medical device according to claim 1, further comprising a sheath, the sheath being slidably positioned on the transcatheter and having a distal end transverse along the transcatheter, and at least one opening in the sheath being aligned with the at least one opening of the transcatheter, thereby allowing the incision surface to protrude laterally through both the sheath and the transcatheter.

13. The medical device according to claim 12, further comprising one or more stabilizing members located adjacent to the at least one opening of the transcatheter.

14. The medical device according to claim 13, wherein one or more stabilizing members protrude reversibly in the lateral direction at a radial distance of approximately 120 degrees from the transcatheter.

15. The medical device according to claim 13, wherein the distal end of the sheath is transverse along the transcatheter, exposing the at least one opening of the transcatheter, and allowing one or more stabilizing members to protrude laterally through the one or more openings of the transcatheter.

16. The medical device according to claim 1, wherein the wire is shaped as one or more arcs that protrude laterally through the transcatheter along the longitudinal axis.

17. The medical device according to claim 1, wherein at least a portion of the incision surface is reversibly adjustable laterally with respect to the longitudinal axis of the transcatheter within a range of angles.

18. The medical device according to claim 1, further comprising at least one nerve detection device.

19. The aforementioned wire, A base portion having a distal end, wherein the base portion extends in a distal direction substantially parallel to the longitudinal axis, An upper portion extending in a proximal direction substantially parallel to the longitudinal axis, A connecting portion comprising the base portion, the upper portion, and a connecting portion that joins the upper portion to the distal end of the base portion such that the connecting portion forms a closed space, The medical device according to claim 1, wherein the electrodes are oriented toward the closed space.

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