Pericardial cutting device and method

Abstract

A medical device (500) is described and disclosed that includes an incision assembly coupled to the distal end of a catheter (129) and an introducer coupled to and projecting from the incision assembly. Also described and disclosed is a method for improving cardiac function in a subject having cardiac dysfunction, the method including forming at least one incision length through the pericardium and reducing the pressure exerted by the pericardium on the heart.

Description

Technical Field

[0001] The present disclosure is directed to devices and methods for cutting the pericardium. The devices and methods are generally applicable in treating heart failure, for example, heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF), by introducing one or more incisions, for example, into the wall layer of the pericardium.

Background Art

[0002] Although pericardial constraint is a normal physiological process, in some patients, such as those with heart failure with preserved ejection fraction (HFpEF), it becomes excessive and the right ventricle uses up the space during filling, and as a result, in these patients, the left ventricle is compressed during physical activity and becomes overpressurized. The increased pressure in the left ventricle causes backflow into the lungs, and these patients experience significant dyspnea when attempting minimal activity (dyspnea on exertion). Dyspnea on exertion is the most common symptom in HFpEF patients and is generally the most common cause of hospitalization in HF patients. Currently, there are no treatment options specifically targeting pericardial constraint for HFpEF patients.

Summary of the Invention

[0003] In an example, a medical device for forming a longitudinal incision in the pericardium is provided, the device including a flexible catheter including at least one lumen, a longitudinal axis, a proximal end, and a distal end, and an incision device assembly having at least one opening coupled to the distal end of the flexible catheter.

[0004] In another example, a method for improving the cardiac function of a heart of a subject having cardiac dysfunction is provided, the method including forming at least one incision length penetrating the pericardium and reducing the pressure exerted by the pericardium on the heart. In one example, the cardiac dysfunction has a preserved ejection fraction.

[0005] In another example, a medical device is provided that includes a catheter having a distal end, at least one lumen, and a longitudinal axis, and an incision assembly coupled to the distal end of the catheter.

[0006] In an exemplary embodiment, a medical device is provided. The medical device includes an incision assembly configured to be operably coupled to the distal end of the catheter. The incision assembly includes an incision opening defined along the incision assembly. The medical device also includes a retractable cutting device disposed within the incision opening. The retractable cutting device includes a first incision member including at least one cutting surface. The first incision member defines a first member distal end and a first member proximal end. The first member proximal end is rotatably mounted proximate to the distal end of the incision opening. The retractable cutting device also includes a second incision member defining a second member distal end and a second member proximal end. The second member distal end is attached to the first incision member at the second member proximal end. The retractable cutting device is configured to transition between a retracted position and a deployed position. When the retractable cutting device is in the retracted position, the first incision member is positioned within the incision opening. When the retractable cutting device is in the deployed position, at least a portion of the first incision member protrudes from the incision opening.

[0007] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one cutting surface of the first incision member includes at least one internal cutting surface or cutting tip.

[0008] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one of the at least one cutting surface of the first incision member is an electrode.

[0009] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, one or more of the at least one cutting surface of the first incision member includes a monopolar electrode or a bipolar electrode.

[0010] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one cutting surface of the first cutting member includes a blunt blade.

[0011] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the second cutting member includes at least one cutting surface, and at least one cutting surface of the second cutting member faces in an opposite direction to at least one of the at least one cutting surface of the first cutting member.

[0012] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device includes one or more suction lumens defined along the incision assembly, and the suction lumen provides a suction force in a direction in which the first cutting member expands from the incision opening.

[0013] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the one or more suction lumens include a first suction lumen defined along the longitudinal axis of the incision assembly and a second suction lumen parallel to the first suction lumen in the direction of the longitudinal axis of the incision assembly.

[0014] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes one or more orientation markers provided on the cutting device, the one or more orientation markers indicate the direction of cutting by the cutting device, and the one or more orientation markers are radiopaque.

[0015] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device includes a camera provided via a camera lumen within the catheter, and the camera can provide one or more images of the retractable cutting device.

[0016] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device includes one or more electrical wires configured to provide an electric current to one or more cut surfaces of the first cutting member, and the one or more electrical wires provide a biasing force to the first cutting member.

[0017] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the electrical wire includes a torsion spring configured to provide a biasing force to the first cutting member.

[0018] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device includes an actuator rod in communication with the second member distal end of the second cutting member, and the actuator rod is configured to move the first cutting member and the second cutting member.

[0019] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device includes a yoke attached to the second member distal end of the second cutting member, and the yoke is configured to receive a force from the actuator rod or is configured to receive a biasing force applied to the actuator rod.

[0020] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device includes a sheath configured to movably cover the incision opening.

[0021] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the sheath is configured to provide a counterforce to a biasing force caused by one or more electrical wires in instances where the sheath at least partially covers the incision opening.

[0022] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one cutting surface of the first cutting member includes a first internal cutting surface and a second internal cutting surface, both the first internal cutting surface and the second internal cutting surface are electrodes, and the impedance between the first internal cutting surface and the second internal cutting surface indicates a case where the material is cut by the first internal cutting surface and the second internal cutting surface.

[0023] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device includes a controller attached to the incision assembly or to the retractable cutting device.

[0024] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the controller is configured to provide at least one of suction to one or more suction lumens, movement of the first and second cutting members between a retracted position and a deployed position, movement of the incision assembly, energy supply to the cutting device, and movement of one or more stabilization members.

[0025] In another exemplary embodiment, a method for operating a medical device is provided. The method includes providing a medical device as any of the above medical devices and having a controller. The method also includes controlling at least one of supplying a suction force to one or more suction lumens, moving the first and second cutting members between a retracted position and a deployed position, moving the incision assembly, supplying energy to the cutting device, and moving one or more stabilization members.

[0026] In another exemplary embodiment, a medical device is provided for forming a longitudinal incision within the pericardium. The medical device includes a catheter having at least one lumen, a longitudinal axis, a proximal end, and a distal end. The medical device also includes an incision device operably coupled to the distal end of the catheter. The medical device further includes a biasing member operably coupled to the incision device, the biasing member being configured to laterally project at least a portion of the incision device through at least one opening in the distal portion of the catheter.

[0027] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the catheter is operable.

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

[0029] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one lumen includes a guidewire lumen extending through the incision device.

[0030] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the incision device is radiopaque.

[0031] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision device includes a rigid housing and a cutting surface received by the rigid housing. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the rigid housing is made of metal, polymer, ceramic, or a combination thereof.

[0032] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the biasing member is disposed within the incision device. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the biasing member applies a rotational force, i.e., torque, to the cutting surface.

[0033] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes an actuator coupled to the biasing member.

[0034] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes a guide wire slidably disposed within the guide wire lumen.

[0035] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes a non-traumatic tapered tip including a lumen. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the lumen of the non-traumatic tapered tip slidably receives the guide wire. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the non-traumatic tapered tip is radiopaque.

[0036] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes a sheath, and the distal end of the sheath is configured to be slidably disposed on the catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the distal end of the sheath is radiopaque. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the sheath further includes at least one opening adjacent to the distal end of the sheath.

[0037] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the distal end of the sheath is movable transversely along the catheter so as to be aligned with at least one opening of the catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one opening of the sheath is movable transversely along the catheter so as to cover or not cover at least one opening of the catheter.

[0038] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the distal end of the sheath and at least a portion at at least one opening of the catheter are radiopaque so as to align the distal end of the sheath with at least one opening of the catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the periphery at at least one opening of the sheath and at least a portion of the periphery at at least one opening of the catheter are radiopaque so as to align the corresponding openings with each other.

[0039] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one opening of the sheath is movable transversely so as to be aligned with at least one opening of the catheter, whereby a cutting plane can project transversely through both the sheath and the catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one opening of the sheath is movable transversely so as to be aligned with at least one opening of the catheter, whereby an actuator can project a cutting plane transversely through both the sheath and the catheter.

[0040] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes one or more stabilization members disposed adjacent to at least one opening of the catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, one or more stabilization members project reversibly laterally at positions radially spaced apart by about 120 degrees around the catheter.

[0041] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, one or more stabilization members are made of wire, loop, or shape memory metal. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, one or more stabilization members are one or more inflatable structures.

[0042] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the distal end of the sheath is movable transversely along the catheter so as not to cover at least one opening of the catheter, thereby enabling one or more stabilization members to project laterally through one or more openings of the catheter.

[0043] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the distal end of the sheath enables the cut surface and one or more stabilization members to project laterally through one or more openings of the catheter, either simultaneously or sequentially. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, one or more stabilization members are operably coupled to an actuator.

[0044] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, one or more openings of the sheath are configured to be laterally movable along the catheter, whereby it is possible for an actuator to project one or more stabilizing members laterally through both the catheter and the sheath. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the actuator projects the cutting device and one or more stabilizing members laterally, either simultaneously or sequentially, through one or more openings of the catheter and one or more openings of the sheath.

[0045] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the cutting device includes at least one electrode. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the cutting surface includes an electrode. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the electrode is a wire.

[0046] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the wire is shaped as one or more arcs projecting laterally through the catheter along the longitudinal axis.

[0047] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the cutting surface includes a scalpel. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the scalpel includes an electrode.

[0048] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one electrode is electrically connectable to a source of high-frequency energy or current sufficient to cut, separate, shear, or evaporate a portion of the wall-side layer.

[0049] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes a second electrode adjacent to the cutting device. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the second electrode is operably coupled to a source of high frequency energy or current.

[0050] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, when protruding laterally, the cutting plane is oriented away from the distal end of the catheter and towards the proximal end of the catheter (i.e., is proximally oriented). In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the cutting plane is reversibly adjustable over an angular range, transversely to the longitudinal axis of the catheter.

[0051] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the angular range is reversibly adjustable to provide a scissor cutting action.

[0052] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes at least one nerve detection device. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve detection device is disposed on a catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve detection device is disposed adjacent to an incision device. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve detection device is disposed on a dilator. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve detection device is disposed on a cut surface.

[0053] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes at least one nerve stimulation device. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve stimulation device is disposed on a catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve stimulation device is disposed adjacent to an incision device. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve stimulation device is disposed on a dilator. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve stimulation device is disposed on a cut surface.

[0054] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, there is provided a kit comprising a medical device, a sheath, a guide wire, and a dilator, in any of the exemplary embodiments.

[0055] In another example, a medical device is provided. The medical device includes a flexible catheter including a distal end, at least one lumen, and a longitudinal axis. The medical device also includes an incision assembly coupled to the distal end of the catheter. The medical device further includes a non-traumatic tapered tip.

[0056] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the flexible catheter is operable. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the flexible catheter is radiopaque. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one lumen includes a guidewire lumen.

[0057] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly includes a housing, an opening within the housing, and a cutting surface. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the incision assembly is radiopaque. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the housing of the incision assembly is radiopaque.

[0058] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly includes a lumen operably coupled to the guidewire lumen. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the non-traumatic tapered tip includes a lumen operably coupled to the guidewire lumen.

[0059] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the flexible catheter, the incision assembly, and the non-invasive tapered tip are configured to slidably receive a guide wire. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly is configured to be introduced onto the guide wire.

[0060] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly has a first configuration in which the cutting surface is received within the incision assembly and a second configuration in which the cutting surface projects laterally outward from the incision assembly.

[0061] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly is operably coupled to a controller, and the controller is disposed adjacent to the proximal end of the flexible catheter.

[0062] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly includes a biasing member operably coupled to the cutting surface. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the biasing member is operably coupled to the controller.

[0063] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the biasing member applies a force or torque to the cutting surface. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the force or torque is configured to cause rotation. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the biasing member is a spring or a band. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the spring is a torsion spring or a compression spring. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the spring is a torsion spring combined with a compression spring. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the torsion spring is a double torsion spring.

[0064] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly further includes a pivot pin that secures a torsion spring, alone or combined with a compression spring, to the proximal end of the blade within the incision assembly.

[0065] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the double torsion spring spans the cutting surface. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the cutting surface is biased to rotate laterally outwardly through at least one opening of the flexible catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the cutting surface is biased to pivotally rotate laterally outwardly from the flexible catheter.

[0066] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the cutting surface has a rounded distal end. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the cutting surface has a sharp distal end, and the sharp distal end is configured to puncture pericardial tissue from within the pericardial space.

[0067] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the cutting surface is inclined between its distal end and proximal end. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the angle between the distal end and the proximal end of the cutting surface is an acute angle. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the cutting surface forms an acute angle between its distal end and the outer surface of the flexible catheter.

[0068] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the angle between the cutting surface and the outer surface of the flexible catheter is configured to receive at least a portion of the pericardial tissue.

[0069] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the housing includes an anti-buckling mechanism. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the anti-buckling mechanism includes a spring axially aligned with the longitudinal axis of the flexible catheter.

[0070] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly further includes an electrically conductive wire operably coupled to the housing. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the electrically conductive wire is operably coupled to a controller.

[0071] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of each side of the cut surface is independently coupled to a source of current or RF.

[0072] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly further includes at least one stabilization member. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one stabilization member is operably coupled to a controller. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one stabilization member projects reversibly laterally from the incision assembly. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the controller projects the cut surface and / or at least one stabilization member laterally, simultaneously or sequentially, through one or more apertures of a flexible catheter.

[0073] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one stabilization member projects reversibly laterally, radially spaced apart by about 120 degrees around the incision assembly. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one stabilization member is a wire, loop, shape memory metal, or a drawn fill tube (DFT) wire. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one stabilization member is an inflatable structure.

[0074] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes at least one nerve detection device. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve detection device is disposed on a flexible catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve detection device is disposed adjacent to the incision assembly. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve detection device is disposed on the introducer. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve detection device is disposed on the cut surface.

[0075] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the medical device also includes at least one nerve stimulation device. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve stimulation device is disposed on a flexible catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve stimulation device is disposed adjacent to the incision assembly. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve stimulation device is disposed on the introducer. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least one nerve stimulation device is disposed on the cut surface.

[0076] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the non-invasive tapered tip is made radiopaque.

[0077] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the cutting plane is oriented away from the distal end of the flexible catheter and toward the proximal end of the flexible catheter. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly is configured to reversibly pivot the cutting plane from a protruding configuration to a retracted configuration to provide a scissor-like action.

[0078] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly has a first configuration in which the cutting plane is covered by the distal end of the sheath and a second configuration in which the cutting plane protrudes laterally when the sheath moves longitudinally and transversely away from the incision assembly.

[0079] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the distal end of the sheath is made radiopaque to align the distal end of the sheath with the incision assembly.

[0080] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, at least a portion of the cutting plane includes an electrode and the cutting plane is pivotably protrudable to expose the electrode to the pericardial tissue. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the cutting plane includes an electrode and the cutting plane is partially pivotably protrudable such that at least a portion of the electrode is hidden from the pericardial tissue.

[0081] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the electrode is a wire. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the wire is shaped as one or more arcs protruding laterally from the flexible catheter along the longitudinal axis.

[0082] In another example, a medical device is provided. The medical device includes a elongate body including a distal end, at least one lumen, and a longitudinal axis. The medical device also includes an incision assembly coupled to the distal end of the catheter. The medical device further includes a first radiopaque marker disposed around the elongate body. The medical device still further includes a second radiopaque marker disposed around the incision assembly. The medical device also includes a first configuration in which the first radiopaque marker and the second radiopaque marker are in proximity to each other, and a second configuration in which the first radiopaque marker and the second radiopaque marker are spatially separated from each other.

[0083] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly is pivotally connected to the elongate body.

[0084] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly includes an incision member. In some exemplary embodiments, alone or in combination with any of the previous exemplary embodiments, the incision member is a blade, an electrode, or a combination of a blade and an electrode.

[0085] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly includes a non-invasive tapered tip. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the non-invasive tapered tip is an electrode.

[0086] In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the incision assembly is operably coupled to a controller. In some exemplary embodiments, alone or in combination with any of the above exemplary embodiments, the device is sterilized. BRIEF DESCRIPTION OF THE DRAWINGS

[0087] To understand and confirm the embodiments in which the present disclosure can be actually implemented, in the following, for each example, with reference to the accompanying drawings, it will be described by way of non-limiting examples only.

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[0088] The present disclosure provides a catheter-based therapy, referred to as transcatheter pericardial release (TAPR), which can improve the outcomes of patients with cardiac dysfunction, such as HFpEF or HFrEF, and reduce HF readmissions associated therewith, by forming incisions or openings in the pericardium to relieve pericardial constriction. In one example, the present disclosure provides a pericardial cutting device having a hidden / proximal-facing cutting surface 105 for accessing and modifying a subject's pericardium for the purpose of relieving pericardial constriction and / or resolving cardiac dysfunction. The present disclosure further provides a method for treating cardiac dysfunction using the devices of the present disclosure.

[0089] As used herein, the terms "pericardial space" and "pericardial cavity" are used interchangeably and include the ordinary and customary meaning to those skilled in the medical and surgical arts, and include, for example, a space, cavity, or liquid medium, such as that disposed generally between the parietal pericardium and the visceral pericardium of a mammalian heart.

[0090] As used herein, the term "pericardial tissue" encompasses the ordinary and customary meaning to those skilled in the medical and surgical arts, and includes, for example, tissues related to the pericardium.

[0091] As used herein, unless otherwise specified, the term "parietal layer" includes at least the serous layer of the parietal pericardium and the fibrous layer of the parietal pericardium, and further optionally includes adipose tissue such as that contained between, below, above, or within these layers. Further, the term "parietal layer" encompasses the ordinary and customary meaning to those skilled in the medical and surgical arts, and includes, for example, a tissue layer that is disposed adjacent to and encompasses adipose tissue both inside and outside the pericardial cavity, and is disposed over the surface layer of the visceral layer of the pericardium.

[0092] As used herein, the term "cutting surface" includes one or more of the edge of a sharp blade and the electrode surface configured to receive sufficient current or radiofrequency (RF) energy to excise, cauterize, vaporize, or separate tissue. The cutting surface can include both the sharp edge and the electrode.

[0093] As used herein, the terms "retrograde cutting" and "pull-back cutting" are used interchangeably and refer to a method that includes presenting a cutting surface adjacent to the distal end of a catheter device or catheter to tissue and applying a directional force sufficient to cut or separate the tissue, the directional force being substantially in the direction toward the proximal end of the catheter device or catheter, such as by pulling the catheter device or catheter with the cutting surface engaged with the tissue.

[0094] As used herein, the term "cutting" is understood to refer to tissue disruption, such as an incision by sharp cutting of the type associated with, for example, a knife blade such as a scalpel blade, or an electrosurgical device that supplies a current sufficient to disrupt tissue to a conductive material or an electrode. As used herein, the term "cutting" includes "cutting," "slicing," and the like.

[0095] As used herein, the phrase "incision length" encompasses a non-zero distance related to a cut or incision, for example, a non-zero distance that starts from a first point forming a target point and ends at a second point forming an access point, for example. The incision length can be a linear length, a non-linear length, or a plurality of linear lengths and / or a plurality of non-linear lengths, and can intersect or not intersect a curved or non-flat surface such as the heart.

[0096] As used herein, the phrases "reduction of pressure" and "reduction of restraint" encompass the ordinary and customary meanings to those skilled in the medical art and surgical art.

[0097] As used herein, the phrase "ejection fraction is maintained" encompasses the ordinary and customary meanings to those skilled in the medical art and surgical art, and includes, for example, a clinical syndrome in which a patient exhibits signs and symptoms of heart failure as a result of high left ventricular (LV) filling pressure despite a normal or near-normal left ventricular (LV) ejection fraction (LVEF; ≧50 percent).

[0098] As used herein, the phrase "decreased ejection fraction" encompasses the ordinary and customary meaning to those of ordinary skill in the medical arts and surgical arts, and includes, for example, a clinical syndrome in which a patient exhibits a left ventricular ejection fraction (LVEF) of 40% or less, along with progressive left ventricular dilation and adverse cardiac remodeling and / or mitral valve insufficiency, and includes an impairment of ventricular filling or blood ejection or both.

[0099] As used herein, the phrase "cardiac dysfunction" encompasses the ordinary and customary meaning to those of ordinary skill in the medical arts and surgical arts, and includes, for example, heart failure, congestive heart failure, HFpEF, or HFrEF.

[0100] As used herein, the phrase "incision device" includes a device having a cutting surface, such as a device having a blade edge or an energized electrode surface.

[0101] As used herein, the phrases "pericardiotomy assembly" and "incision assembly" are used interchangeably and refer to an assembly that includes an incision device.

[0102] As used herein, the phrase "transcatheter device" includes a catheter configured to have at least one lumen, such as including, for example, an incision device, a guide wire, an optical fiber, a contrast fluid lumen, a stabilization member, etc., including medical instruments, medical devices, or components thereof.

[0103] As used herein, the terms "first", "second" and the like are used merely to describe elements that are related to each other, and in no way mean to describe a particular orientation of an article or device, nor to indicate or imply an orientation required or demanded for an article or device, nor to indicate or imply a configuration required or demanded for an article or device, nor to identify the manner in which the articles or devices described herein are used, deployed, transitioned from different configurations, or positioned during use.

[0104] As used herein, when referring to two structures or two layers, when components are referred to as "adjacent" and "coupled", those two structures or those two layers are considered to be in proximity to each other without an intervening open space therebetween.

[0105] As used herein, when a component is referred to as "coupled" or "adjacent" to another component, those two components or those two structures are in proximity to each other, but other components, i.e., intervening components, may be present.

[0106] As used herein, when a component is referred to as "directly coupled" or "directly adjacent" to another component, no other component, i.e., intervening component, is present.

[0107] As used herein, the term "operatively coupled" includes direct coupling, indirect coupling through another component, member, circuit, or structure, and / or indirect coupling between members through an intervening member.

[0108] As used herein, the phrase "nerve stimulation device" encompasses a device that can apply a potential to a nerve and can cause an observable effect that is directly or indirectly correlated with the applied potential, such as, for example, a pacing probe stimulating the phrenic nerve to cause an observable respiratory disorder.

[0109] As used herein, the phrase "nerve detection device" encompasses a device that can identify the position or location of at least a portion of a nerve and can provide position information or proximity information without or substantially without a physical influence or stimulation on the nerve, such as, for example, an impedance sensor for detecting an electric field generated by a nerve and an impedance sensor that directly or indirectly correlates the position or proximity of the nerve to the impedance sensor.

[0110] As used herein, the term "actuator" encompasses a mechanism for causing an action.

[0111] As used herein, the term "controller" encompasses a device having an actuator.

[0112] As used herein, the phrase "biasing member" encompasses a device that can be configured to accumulate energy and release energy, such as, for example, a spring.

[0113] As used herein, the phrase "stabilizing member" encompasses a device that can be configured to stabilize or fix a structure or within a structure, such as, for example, to prevent a cut surface positioned within the pericardial cavity from rolling, twisting, buckling, and / or vibrating before or during use.

[0114] As used herein, the phrase "puncturing tip" includes non-traumatic articles suitable for puncturing or penetrating tissue without substantially traumatizing or bleeding in the vicinity of the puncture or penetration.

[0115] Referring to FIGS. 1A, 1B, 1C, and portions 1B, 1C, the layers of the heart wall of the heart 50 are illustrated, and the layers, from the inside out, are the endocardium 51, myocardium 52, epicardial adipose tissue 57, visceral layer of the serous pericardium 53, pericardial cavity 54, parietal layer of the serous pericardium 55, fibrous pericardium 56, and pericardial adipose tissue 59. In one example, the device of the present disclosure is configured to be introduced into the pericardial cavity 54 and is disposed adjacent to and includes the adipose tissue inside and outside the pericardial cavity and is further configured to cut the tissue layer disposed entirely on the surface layer of the visceral layer 53 of the pericardium.

[0116] The pericardial tissue cutting device of the present disclosure includes a perforating portion, i.e., a puncturing portion, designed to first puncture the pericardium. To form a perforation or puncture in the pericardium to enable the pericardial cutting device to access the pericardial cavity, a guide wire, a knife, or an electric current may be used. After the pericardium is punctured, an incision assembly adjacent to the distal end of the catheter or the catheter is manipulated to a position within the pericardial cavity, whereby the incision member can engage the pericardial tissue and an incision length is formed. The incision member may alternatively or in combination with a sharp edge facilitate cutting by utilizing RF energy and may provide some hemostasis of the pericardium. The incision length can be formed sub-sternally or transvascularly by advancing the cutting device distally while making a cut from the initial introduction position into the pericardial cavity (forward cutting). Alternatively, the incision length can be formed by traversing the cutting device distally from the initial introduction position into the pericardial cavity and then moving it back in the reverse direction toward the introduction position while making a cut (reverse cutting). Thus, the pericardial cutting device of the present disclosure is configured to accommodate either a forward cutting method or a reverse cutting method.

[0117] Some examples related to pericardial tissue cutting devices are illustrated in the accompanying drawings and disclosed herein. Hereinafter, the terms "pericardial tissue cutting device" and "cutting device" shall be used interchangeably. Each cutting device will first be introduced into the pericardial cavity via a transvascular approach or a subxiphoid approach.

[0118] Referring to the drawings as a whole, in one example, the medical device of the present disclosure includes a flexible catheter 129 having a distal end, at least one lumen, and a longitudinal axis, an incision assembly 101 coupled to the distal end of the catheter, and a non-invasive tip (e.g., introducer 115) coupled to the incision assembly 101 and protruding from the incision assembly 101. In one example, the exemplary medical device of the present disclosure is deployed using a hollow needle / introducer / dilator kit. In one example, at least a portion of the tip of the flexible catheter 129 is radiopaque. In one example, at least a portion of the tip of the incision assembly 101 is radiopaque.

[0119] As an example of a replacement possibility, a medical device for forming a longitudinal incision in the pericardium will be described. The device includes a flexible catheter 129, which has at least one lumen, a longitudinal axis, a proximal end, and a distal end along the longitudinal axis. In one example, an incision device assembly 101 having at least one opening 136 is coupled to the flexible catheter 129. A biasing member 117 is operably coupled to the incision device and functions to project at least a portion of the incision device laterally through at least one opening of the incision device assembly 101. In one example, a dilator is used adjacent to the distal end of the flexible catheter 129. In one example, the device forms a longitudinal incision having an incision length in the parietal layer of the pericardium. The incision device includes at least one cutting surface. The cutting surface can be a knife or scalpel, or an electrode. In one example, at least a portion of the opening 136 is radiopaque.

[0120] Cutting surface 105 may include a blade 103 and / or may include an electrode (e.g., cutting tip 125). In one example, the device of the present disclosure has a hidden / proximally oriented cutting surface 105 that can be controlled by the user and is controlled by a controller and / or an actuator.

[0121] Cutting surface 105 may be or may include (alternatively, may contain) a blade 103, one or more RF electrodes for electro-surgical cutting, or both. In one example, a single RF electrode (e.g., cutting tip 125) may be provided at or near a hinge of the cutting surface 105, which is, for example, a monopolar configuration.

[0122] In one example, one electrode may be located at / on the cut surface 105, and another electrode may be located at / on the body of the device, which is, for example, a two - electrode configuration. In one example, the blade 103 itself may function as an RF electrode. In one example, RF is used to sufficiently weaken the tissue. Although the cut surface 105 is not the blade 103, nevertheless, by clamping or cauterizing, the cut surface 105 can sufficiently cut the tissue weakened by RF.

[0123] Referring to FIGS. 2A - 2B, the cut surface 105 of the device 100 may be biased to an extended configuration as shown. In this case, the device has a cable 112 passing through the housing 110, and this cable 112 functions to pull the blade 103 into the incision assembly 101 by being pulled, whereby the cut surface 105 can be maintained in a retracted configuration within the housing of the device.

[0124] Referring to FIGS. 3A - 3B, a device 200 is shown. In this case, the cut surface 105 and the blade 103 can be expanded using energy storage means (e.g., a first biasing member 117). For example, the energy storage means (e.g., a first biasing member 117) can be a torsion spring or a leaf spring, and / or a compression spring that cooperates to ensure smooth movement can be used. The blade 103 can be inclined as shown.

[0125] Referring to FIGS. 4A-4C, device 250 is shown in a non-deployed configuration and a deployed configuration. Device 250 has a blade 103 that expands laterally within assembly 101 at the distal end of a flexible catheter (not shown). Blade 103 is operably coupled to pin 107. Device 250 has an actuator 121 that, when controlled by the user, causes blade 103 to expand laterally. In this case, reverse cutting will be performed by a proximally oriented cutting plane 105. The incision assembly 101 in one example is configured to be deployed using a hollow needle / introducer / dilator / guidewire kit for introduction into the pericardial cavity 54 as described below. Guidewire 113 is supplied through assembly 101 and a non-invasive tip (e.g., introducer 115). Assembly 101 can be configured for over-the-wire (OTW), and introducer 115 can be an offset / rapid exchange guide lumen / channel for forward movement over guidewire 113. Device 250 further includes a stabilization member 120 that is independently controlled by the user. By moving drive rod 121 distally toward introducer 115, stabilization member 120 will expand laterally by a predetermined distance from assembly 101. In one example, catheter 129 is a multi-lumen catheter. In one example, stabilization member 120 is a wire that exits from a short gap in the multi-lumen catheter proximal to incision assembly 101, but instead of returning into the catheter, its distal end is fixed to the outer shell of the distal incision assembly, thereby extending the stabilization member more distally to provide greater support and / or greater stability. In one example, the wire is a distending fill tube (DFT) wire that can be observed within the patient's body by a conventional imaging device.

[0126] In order to avoid the stabilization wire from deflecting due to the generation of a forward pushing force along the multi-lumen catheter, an alternative design can be adopted such that each stabilization wire is passed through a thin-walled tube and forms an independent assembly extending through a dedicated lumen within the multi-lumen catheter. In such a configuration, the tube is fixed to the multi-lumen catheter at its proximal end, while the distal end of the wire is fixed to the tube. When pushed in, the wire will expand outward through the synchronized openings of both the tube and the catheter, but the required pushing force remains within the stabilization wire and its associated tube assembly while extending the multi-lumen catheter 129, so it does not exert other forces or deflect the multi-lumen catheter 129.

[0127] In one example, two or more stabilizing members 120 are arranged radially around the assembly 101. In one example, two or more stabilizing members 120 are arranged radially around the assembly 101 and are spaced apart by approximately 120 degrees. In one example, two or more stabilizing members 120 are longitudinally offset from the cut surface 105 to minimize or eliminate the device being pushed through the slit when a new slit is formed by cutting in the pericardium. The stabilizing member 120 can be a flexible rod or strip, or can be an inflatable structure such as a balloon that can be inflated by air or a liquid (saline). In one example, the stabilizing member 120 is an inflatable structure such as a balloon that can be inflated by air or a liquid (saline) and is used in combination with an RF cutting device. In one example, the stabilizing member 120 is an inflatable structure such as a balloon that can be inflated by air or a liquid (saline) and is used in combination with an RF cutting device to absorb heat from the RF cutting device and reduce or eliminate thermal damage to tissue in proximity to the energized RF cutting device. Thus, in one example, the stabilizing member 120 is an inflatable structure such as a balloon and can be constructed from a thermally conductive material and / or a heat-absorbing material and is inflatable by a thermally conductive fluid and / or a heat-absorbing fluid, or can include one or more thermally conductive layers and / or heat-absorbing layers that cover at least a portion of the inflatable structure, such as a portion of the inflatable structure that is proximal to the tissue. Examples of thermally conductive materials or heat-absorbing materials or fluids include thermally conductive paints, thermally conductive epoxies or thermally conductive silicone coatings, or thermally phase-changing materials (PCMs). In one example, the inflatable structure functions as a heat sink during operation of the RF cutting device.

[0128] Referring to FIGS. 5A - 5C, in one example, device 300 is shown in both a non - deployed configuration and a deployed configuration. Device 300 has a cutting surface 105 and a blade 103. The cutting surface 105 includes at least one RF electrode (e.g., cutting tip 125) that is closer to the hinge or pivot pin 107 compared to the cutting surface 105. The operator can select which cutting surface to use at any point in the procedure when using device 300. For example, when the blade 103 is fully extended laterally and pulled to contact the tissue, the RF electrode (e.g., cutting tip 125) will be in the operating position (e.g., the position where the cutting surface 105 is in contact with the device body). Device 301 in FIG. 5C shows an incision assembly 101 coupled to the distal end of the flexible catheter 129 and the introducer 115.

[0129] Alternatively, as shown in FIGS. 6A - 6C, device 300 can be switched to a mode where only the blade 103 is such that the cutting surface 105 is only partially extended as shown in FIG. 6A, so that the blade 103 is in the operating position (e.g., the cutting surface 105 is in contact with or located under the device body). The blade 103, either alone or in combination with an electrode (e.g., cutting tip 125), can be controlled by the user to provide a scissor - like motion where the blade 103 is driven in a proximal - distal direction from the flexible catheter 129 or the incision assembly 101 as shown in FIGS. 6B - 6C. Whether RF or the blade 103 is used, the surrounding tissue is protected due to the hidden / proximal - oriented configuration of the cutting surface 105.

[0130] Referring to FIGS. 7A - 7F, an exemplary pericardial tissue cutting device 350 for forming a longitudinal incision in the pericardium is shown. Exemplary medical devices such as device 350 may use a "sliding" action and / or a "scissor" action to cut along the wall of the pericardial cavity. In the "sliding" action, the cutting assembly 101 is moved along the pericardium while the first cutting member 124 and the second cutting member are maintained in a fixed position (e.g., the angle between the first cutting member 124 and the second cutting member 126 is fixed). The "scissor" action is an example where the first cutting member 124 and the second cutting member 126 can move relative to each other during the cutting process (e.g., the angle between the first cutting member 124 and the second cutting member 126 is not fixed and can move to generate a scissor force on the tissue).

[0131] Device 350 includes a cutting assembly 101 having a longitudinal axis and at least one opening 136. The cutting assembly 101 is operably coupled to the distal end of an elongate body 129 such as a flexible catheter and / or a steerable catheter or a catheter.

[0132] The cutting assembly 101 includes a first cutting member 124 having a proximal end 124a and a distal end 124b, and the proximal end of the first cutting member 124 is pivotally connected to the cutting assembly 101. A second cutting member 126 having a proximal end 126a and a distal end 126b is shown, and the proximal end of the second cutting member 126 is pivotally connected to the first cutting member 124. A first biasing member 117 operably coupled to the proximal end 124a of the first cutting member 124 and a second biasing member 119 operably coupled to the distal end 126b of the second cutting member 126 provide reciprocating and / or reversible movement for the two cutting members 124, 126 (scissor blades) that can be controlled by the user. Alternatively, the two cutting members 124, 126 may be maintained in a fixed position during the cutting process. The two cutting members 124, 126 can be sharp blades, RF electrodes, or a combination thereof.

[0133] Device 350 is adaptably coupled to a controller 1000, which will be described in more detail below. In one example, the controller 1000 is operably coupled to the second cutting member 126 via an actuator rod 121 that functions to reciprocally drive, for example, two cutting members 124, 126. In one example, the first cutting member 124 includes a first cutting surface that is closely proximate to a second cutting surface of the second cutting member 126 so as to provide sufficient shearing and / or sliding action to cut pericardial tissue. As shown, the first cutting member 124 and the second cutting member 126 are axially aligned along the longitudinal axis of the cutting assembly 101. The distal end 124b of the first cutting member 124 is laterally reversibly adjustable at various angles with respect to the longitudinal axis of the cutting assembly 101 so as to provide sufficient shearing and / or sliding action to cut pericardial tissue.

[0134] The proximal end 124a of the first cutting member 124 is pivotally connected to the cutting assembly 101 at a first connection point 106, and the proximal end 126a of the second cutting member 126 is pivotally connected to the cutting assembly 101 at a second connection point 104. The distal end of the second cutting member 126 is pivotally connected to the first cutting member 124 at a third connection point 108. As shown, the third connection point 108 is located between the first connection point 106 and the distal end 124b of the first cutting member 124; for example, point 108 is spatially separated from the pivot point 106.

[0135] A first biasing member 117 is operably coupled to the cutting assembly 101 and to the proximal end of the first cutting member 124. The first biasing member 117 applies a rotational force, i.e., torque, to the first cutting member 124, causing the distal end of the first cutting member 124 to project laterally through the opening 136 of the cutting assembly 101. A second biasing member 119 applies a pushing force, i.e., a spring force, to the distal end 126b of the second cutting member 126, pushing the distal end 126b of the second cutting member 126 longitudinally toward the first biasing member 117.

[0136] In this configuration, the distal end 126b of the second cutting member 126 is reversibly adjustable parallel to the longitudinal axis of the cutting assembly 101. With the distal end 126b of the second cutting member 126 operably connected to the actuator rod 121, the controller controls the translational movement of the distal end 126b via the actuator rod 121, thereby providing reciprocating movement of the two cutting members 124, 126 against one or both of the biasing forces of the biasing members 117, 119. The first biasing member 117 can be at least one of a torsion spring and a compression spring. The second biasing member 119 can be a spring.

[0137] As shown in FIG. 7E, the distal end 126b of the second cutting member 126 is operably connected to the yoke 309, where the yoke includes a yoke lumen 305 that receives the distal end 126b of the second cutting member 126. In one example, at least a portion of the actuator rod 121 is disposed within the yoke lumen 305.

[0138] The cutting device 350 can further include a sheath (not shown) that can slide transversely across the outer diameter of the cutting assembly 101. Thus, by using the sheath, a first configuration is provided in which the sheath is positioned over at least one opening 136 of the cutting assembly 101, in which the sheath prevents the lateral protrusion of the first cutting member 124 from the cutting assembly 101 against the biasing by the first biasing member 117.

[0139] Any cutting device further includes a second configuration in which at least one opening of the cutting assembly 101 is not covered and the first cutting member 124 protrudes laterally through at least one opening 136 of the cutting assembly 101.

[0140] In one example, the cutting device is driven by an operation of a controller to apply a tensile force to the actuator rod 121 so as to move the distal end 126b of the second cutting member 126 parallel to the longitudinal axis of the cutting assembly 101 against the force by the second biasing member 119.

[0141] In one example, the distal end 124b of the first cutting member 124 includes a conductive tip 125 operably coupled to an independent source of high-frequency energy or high-frequency current. In this aspect, by including a non-conductive element 123 (e.g., an insulating surface) that electrically insulates the tip 125 from the first cutting member 124, the tip 125 can operate independently of the first cutting member 124. In this configuration, the opposite surface of the first cutting member 124 is independently operably coupled to an independent source of high-frequency energy or high-frequency current via wires 134, 135. In one example, the controller is configured to operate the source of high-frequency energy or high-frequency current independently with respect to the first cutting member 124, with respect to the second cutting member 126, and with respect to the conductive tip 125.

[0142] In any cutting device, the first cutting member 124 includes an electrode.

[0143] The cutting device 350 can have one or more stabilizing members 120 disposed adjacent to at least one opening of the cutting assembly 101. In one example, the one or more stabilizing members 120 are radially spaced apart by about 120 degrees and project reversibly laterally around the cutting assembly 101. The one or more stabilizing members 120 can be a wire, a loop, a shape memory metal, or one or more inflatable structures. In one example, the one or more stabilizing members 120 prevent rotation of the cutting assembly 101 about the longitudinal axis.

[0144] Referring to FIGS. 8A-8F, an exemplary cutting device 400 is illustrated in a non-deployed configuration and a deployed configuration using a sheath 130 positioned over the flexible catheter 129 and the incision assembly 101. The distal end 132 of the sheath 130 can be retracted from the assembly 101, thereby allowing the cutting device to expand laterally from the assembly opening 136. As shown, the blade 103 is expanded through the assembly opening 136 with the distal end 132 of the sheath 130 moved. Referring to FIGS. 8D-8F, the device 400 is illustrated with the stabilizing member 120 expanding laterally from an additional assembly opening 136' simultaneously with the cutting device when retracting the sheath 130, or with the stabilizing member 120 expanding laterally by the user independently controlling the deployment via the controller / actuator rod 121. Alternatively, the cutting device can be coupled to the actuator and / or controller for deployment by the user after retracting the sheath 130 and after retracting the cut surface after cutting, or, by a passive biasing force, can cause the release of the cutting device upon retraction of the sheath 130 after cutting, and by moving the sheath forward, the sheath can engage and cover a portion of the cut surface for subsequent removal of the device.

[0145] Referring to FIGS. 9A - 9C, an exemplary cutting device 450 is illustrated in a non - deployed configuration and a deployed configuration using a sheath 130 positioned over a flexible catheter 129 and an incision assembly 101. The sheath 130 includes at least one sheath opening 138, which can be retracted from the assembly 101 and aligned with the assembly opening 136, enabling the cutting device to expand laterally from the sheath opening. When the sheath 130 is retracted, the stabilization member 120 disclosed above can be used, such that the cutting device expands laterally simultaneously from an additional assembly opening 136' at the same time as the sheath is retracted, or expands laterally by the user independently controlling the deployment via a controller rod / actuator. In one example, after retracting the sheath 130 and after retracting the cut surface after cutting, the cutting device can be coupled to the actuator 121 for deployment by the user. By moving the sheath forward, the sheath can engage and cover a portion of the cut surface to subsequently remove the device. Alternatively, a passive biasing force can cause the release of the cutting device when the sheath 130 is retracted and after cutting. By using the distal end 138' of the sheath opening 138, the sheath 130 can be further retracted and engaged against the back of the cutting device for retracting the cutting device and for removal after cutting. In one example, at least a portion of the sheath opening 138 is radiopaque.

[0146] In one example, the sheath opening 138 partially overlaps the assembly opening 136 when the cutting device is in a retracted configuration. Such overlap can minimize the retraction distance required to drive the lateral expansion of the cutting device by the distal end 138' of the sheath opening 138 and / or the retraction of the cutting device.

[0147] Referring to FIGS. 10A - 10C, the cutting device of the present disclosure can be advanced through the pericardial cavity 54 of interest in a mode such as a folding pocket knife, with the cutting surface 105 retracted against / into the housing of the device, i.e., the assembly 101, i.e., in a non - deployed configuration. However, unlike a folding pocket knife where the blade can pivot 180 degrees, the cutting surface 105 in the device of the present disclosure is configured to expand laterally (and parallelly) from the housing, i.e., the assembly 101, or from the catheter, at an angle of about 90 degrees or less in its deployed configuration. Thus, in one example, when fully expanded, the cutting surface 105 in the device of the present disclosure forms an acute angle with respect to the body of the device and / or with respect to the flexible catheter 129 used to introduce the device into the pericardial cavity 54. Thus, for example, when the cutting surface 105 in the cutting device of the present disclosure is presented, the cutting surface forms an angle of about 90 degrees or less (e.g., less than 90 degrees, less than 80 degrees, less than 70 degrees, less than 60 degrees, less than 50 degrees, less than 40 degrees, or less) with respect to the flexible catheter 129.

[0148] Referring to FIG. 10A, a method for using a cutting device 400 is shown, in which a flexible catheter 129 having an incision assembly 101 and an introducer 115 is advanced through a punctured introducer hole or access point 140, through the pericardium, and into the pericardial cavity 54 (e.g., over a guidewire 113), and is in an undeployed configuration within / under the pericardium and advanced to a cutting start site, i.e., a target site 142 (located at the distal end of the path to be cut). In one example, as shown in FIGS. 10B and 10C, the guidewire 113 is withdrawn from the pericardial cavity 54, and then the cutting surface 105 or RF electrode is expanded and the cutting device 400 is retracted along the cutting path, i.e., the cutting is performed with the cutting device 400 in a deployed configuration, e.g., while pulling the device back toward the punctured introducer hole along the guidewire 113. Thus, the forward movement of the device before cutting is performed, for example, using the guidewire 113, by advancing the distal end of the device outside the pericardium at the cutting start site 142 at a time before the cutting surface 105 is expanded outside the pericardium.

[0149] In the above method, the cutting surface 105 is configured to return outside the pericardium at the cutting start site 142 so that the cutting surface 105 can traverse the pericardial tissue to be cut.

[0150] Alternatively, referring to FIGS. 11A - 11C, when the cutting device 600 is positioned inside the pericardial cavity 54 and the blade 103 and the cutting plane 105 expand laterally, a portion of the blade 103 having a sharp tip that is derived from or “punctures” out of the pericardial cavity 54 is used. When the cutting device 600 is pulled such that the sharp tip engages the inner surface of the pericardium and punctures through the inner surface of the pericardium, the cutting plane 105 can be presented to the pericardial tissue, for example, to the wall - side layer 55. In one example, a blade with a sharp tip can also be configured to bluntly expand so as to minimize or eliminate position loss or slippage during cutting (e.g., reverse cutting) by maintaining a portion of the blade above the pericardium. Additionally, one or more extension portions from the tip of the blade can function as radiopaque markers indicating “binding” of tissue, such as that which may result from being overly pulled before a through - cut is achieved, for example. In one example, the silhouette of the back of the blade may be selectively isolated to avoid resection damage to adjacent anatomical structures (as it may be driven to achieve an exit puncture).

[0151] The stabilization member 120 can expand laterally simultaneously or subsequently, for example, to assist in puncturing the pericardium with the sharp tip of the blade 103 or, alternatively or in combination, to assist in reverse cutting the pericardium. The cutting can be achieved, similar to a letter - opener, by simply slicing the pericardium by pulling the device with the cutting plane 105 in an expanded state.

[0152] Alternatively or additionally, the cutting can be achieved / facilitated / enhanced by contracting and then re - expanding the cutting plane 105, similar to scissors. The body of the device may have complementary cutting surfaces (not shown) as described above to facilitate the scissor effect.

[0153] Figures 12A, 12B, and 12C illustrate an exemplary cutting device 600 having a jackknife configuration in which a puncture can be made from the pericardial cavity 54 using RF or current, and a set of cutting electrodes and / or a set of sharp edges are configured to cut at least the wall-side layer 55 in the reverse direction. The cutting device 600 has an elongate body 129 including a distal end. The incision assembly 101 can be coupled to the distal end of the catheter. A first radiopaque marker 152 can be disposed around the elongate body 129. A second radiopaque marker can be disposed around the incision assembly 101. The cutting device 600 is configured to transition between a first configuration (FIG. 12A) in which the first radiopaque marker 152 and the second radiopaque marker 151 are positioned in proximity to each other and a second configuration (FIGS. 12B and 12C) in which the first radiopaque marker 152 and the second radiopaque marker 151 are spatially separated from each other. As shown, the cutting device 600 has an incision assembly 101 pivotally coupled to the distal end of the elongate body 129 (catheter or catheter) at a pivot pin 107. The incision assembly 101 of the cutting device 600 includes an incision member 162, a tapered non-traumatic tip (e.g., introducer 115), and an optional puncture member 161 for puncturing and / or cutting the wall-side layer 55. In one example, the incision member 162 is a sharp edge and / or an RF electrode electrically coupled to a controller via a conductive wire 162'. The optional puncture member 161 can be an RF electrode electrically coupled to the controller via a conductive wire 161' that supplies independently controlled current or RF energy between the incision member 162 and the puncture member 161. The cutting device 600 as shown includes a plurality of spatially separable radiopaque markers 151, 152 to visualize the puncture from the pericardial cavity 54 and to visualize the spatial relationship between the incision member 162 and the elongate body 129 during the procedure.Optionally, the elongate body 129 can include a third cutting member (not shown) that is reversibly proximate to the cutting member 162 for an additional cutting effect. The third cutting member can be independently controlled using current or RF energy between one or both of the cutting member 162 and the piercing member 161.

[0154] Referring to FIGS. 13A and 13C-13E, an exemplary device 800 is illustrated in which an RF cutting plane 127 driven by a user is employed at the distal end of the flexible catheter 129. The RF cutting plane 127 can be disposed within the assembly 101 having appropriate electrical supply and insulation for use. The introducer 115 is disposed distally from the assembly 101 and can pass over the guidewire as described above. In one example, a single arc wire is used at the same position where the blade 103 is disposed or positioned around the device in other configurations and can be expanded laterally through the assembly opening 136 by a controller. In one example, the wire is configured to carry current independently and is electrically coupled only to the blade or only to the piercing member insulated from the blade, while the assembly 101 and / or the catheter 129 function as insulators. The stabilization member 120 can be expanded laterally simultaneously or subsequently as described above.

[0155] Referring to FIG. 13B, device 850 is shown having a plurality of arcuate wires 127' along flexible catheter 129. In one example, the plurality of arcuate wires 127' along flexible catheter 129 are substantially collinear with each other and with respect to the longitudinal axis of device 850, as shown. The plurality of arcuate wires 127' along flexible catheter 129 provide, in one example, a single segment cut of a predetermined incision length. The plurality of arcuate wires 127' along flexible catheter 129 provide, in one example, selective and independent control with respect to which arc is active at which time and / or with respect to a corresponding independent current load. The plurality of arcuate wires 127' along flexible catheter 129 selectively apply energy along the entire path of the arc, simultaneously, sequentially, or randomly, in one example. The plurality of arcuate wires 127' along flexible catheter 129 provide, in one example, a greater consistency of energy along the overall path (as opposed to a single wire, which may apply different amounts of energy in different regions of the wire). The plurality of arcuate wires 127' along flexible catheter 129 provide, in one example, a cut of multiple segments, for example, by cutting one segment at a time, when the arc positions are pre - arranged to perform continuous cutting, perforation, etc. Stabilization member 120 can expand laterally, simultaneously or subsequently, as described above with respect to device 600.

[0156] Referring to FIGS. 14A - 14C, a method for using device 800 is shown, in which introduction into the pericardial cavity 54 is performed at access point 140, device 800 is advanced to the cut site in a non - deployed configuration, and at the cut site, cutting surface 127 is placed in a deployed configuration and expanded laterally from opening 136 of incision assembly 101, and sufficient current or RF is supplied to cut through wall - side layer 55. Stabilization member 120 can expand laterally, simultaneously (to assist in breaking through the pericardium using current or RF) or subsequently, as described above.

[0157] Referring to FIGS. 14D - 14F, a method for using device 850 is shown, where introduction into the pericardial cavity 54 is performed at access point 140, and device 850 is advanced to the cut site or to a site where the cut length is desired, and at those sites, a plurality of cut planes (e.g., wires 127, 127') are expanded laterally from the opening 136 of the incision assembly 101, providing an extended cut length L that can be continuous or segmented / perforated while device 850 remains substantially stationary within pericardial cavity 54. Stabilization member 120 can be deployed simultaneously with cut planes 127, 127' (to assist in breaking through the pericardium) as described above, or can be expanded laterally thereafter.

[0158] Referring to FIGS. 15A - 15B, an exemplary controller 1000 is shown, which has a handle 260 and drive buttons 122, 122' for operably coupling to the incision device, for example, for retracting the sheath 130 and actuator rod 121 and expanding the stabilization member 120 via rod 121. In one example, controller 1000 facilitates various potential operations regarding each component of incision assembly 101, including an actuator / clamp for opening and closing the distal blade, which can be achieved by a suitable mechanism configured to pull / push the rod. In one example, a mechanism is provided for releasing / retracting a balloon / nitinol component that functions to stabilize incision assembly 101 and its components, including the cut plane, and apply opposing pressures. Controller 1000 may include one or more buttons 122, 122' used to operate and control the electrosurgical features of the device, such as current and RF.

[0159] Referring to FIG. 15C, any of the cutting devices disclosed above can be operated and / or controlled from outside the subject using an alternative controller 1100 that can be a handle. The controller 1100 may have a plurality of drive knobs 700, 705, 610 and drive buttons 710, 715 for controlling the catheter 129 and for controlling various components of the cutting device. The knob 700 may be configured to rotate the flexible catheter 129 in response to orientation information determined by fluoroscopy or other visualization means. The knob 705 may function to activate one or more components on the medical device (e.g., drive a stabilization member). Similarly, the drive buttons 710, 715 may function to activate various components of the catheter (e.g., the device may also use RF electrode cutting and the drive buttons 710, 715 may be used to supply current or RF) and to activate control members of the guide wire. Various other controllers are envisioned that would enable the deployment and operation of the cutting devices described above.

[0160] In one example, the device of the present disclosure is configured to be introduced into the pericardial cavity 54 and is disposed adjacent to and includes the adipose tissue inside and outside the pericardial cavity 54 and is further configured to cut a tissue layer disposed entirely on the surface layer of the visceral layer 53 of the pericardium 60.

[0161] In one example, OTW introduction is employed with any of the devices disclosed above, whether through a dedicated lumen of the catheter cross-section, through a "rapid exchange" style catheter, through a cannula attached off-center, or through a deflection-resistant catheter, for example, to provide directional stability of the cutting plane with respect to the direction of the parietal layer. In one example, the delivery catheter includes radiopaque materials randomly dispersed or arranged in a pattern for visualization using conventional visualization techniques during use.

[0162] Current echocardiography / fluoroscopy may not be able to provide the visualization necessary for certain access applications related to the cutting devices of the present disclosure. For example, it may be desirable to perform guide wire access to the pericardial cavity consistently and repeatedly. Thus, in one example, a catheter device 129 coupled to the cutting device of the present disclosure includes direct visualization as shown in FIG. 16. In this direct visualization, the user can observe in real time the forward movement of any cutting device in the present disclosure as it progresses through various tissue layers until it reaches the desired location. Changes in tissue layers that cannot be seen with echocardiography / fluoroscopy, such as tissue / blood flow (vascular access), myocardium / pericardium (pericardial cavity access), myocardium / pericardium (epicardial access), and other anatomical features, may be readily distinguishable in direct visualization.

[0163] Thus, in one example, the device of the present disclosure described above further includes a light channel within the catheter for accommodating a lens coupled to an optical fiber cable and optionally a light source such as an LED. In one example, the method of the present disclosure uses a light channel for accommodating a lens coupled to an optical fiber cable within the catheter and optionally a light source such as an LED to obtain visual information during access across the pericardial cavity, during derivation, and / or during cutting.

[0164] As shown in FIG. 16, catheter 129, shown without a pericardial cutting device for clarity, includes an optical fiber channel and a lens 807 adjacent to the optical fiber channel 805, which supplies light and provides an analog or digital image within catheter 129 and may have a sheath 809.

[0165] In one example, a puncture for delivering a guide wire into the pericardial cavity 54 is performed through cardiac tissue via a transvascular approach. When a transvascular approach via the RAA, IVC, or SVC is employed, an occlusion device (e.g., an occluder) may be subsequently introduced for hemostasis at the end of the procedure. In one example, the occlusion device includes outwardly or radially oriented splines such as those deployed in an expanded configuration. When the guide catheter is removed, the splines or radial members of the occlusion device contract inwardly towards the unstressed state of the cutting device to close, occlude, and / or seal the opening. Thus, the occlusion device is designed such that the pericardial cutting device can pass through and enter into the pericardial space.

[0166] The following exemplary description regarding occlusion relates to a transvascular approach via the RAA, IVC, or SVC using any of the cutting devices described above. In one example, a hollow needle is used to deliver a wire through cardiac tissue into the pericardial space. If the outer diameter of the cutting device is greater than 7Fr, an occlusion device, i.e., an occluder, can be introduced for hemostasis at the end of the procedure. The occlusion device, i.e., the occluder, in one example includes outwardly or radially oriented splines such as those deployed in an expanded configuration. When the guide catheter is removed, the splines or radial members of the occlusion device contract inwardly towards the unstressed state of the cutting device to close and seal the opening. The occlusion device is designed such that the pericardial cutting device can pass through and enter into the pericardial space.

[0167] Figures 17 and 18 illustrate an exemplary intravascular approach for delivering the cutting device of the present disclosure into the pericardial cavity 54. Thus, Figure 17 shows the heart 50 having a pericardium 60 (i.e., epicardium, myocardium, endocardium) or pericardial sac that surrounds the myocardium, separated from the body and illustrated. The small space existing between the myocardium and the pericardium 60 represents the pericardial cavity 54.

[0168] The cutting device of the present disclosure can be presented to the pericardial cavity 54. In one example, the right atrial appendage 38 (RAA), which is a site suitable for introduction into the pericardial cavity 54, is used. The right atrial appendage 38 is tangentially located between the pericardium 60 and the epicardium / epicardial adipose tissue 57. In one example, any device of the present disclosure can be guided into the right atrial appendage 38 via the right atrium 39 and arranged substantially parallel to the wall of the pericardium 60, so that the wall of the right atrial appendage 38 can be perforated by any device of the present disclosure without substantially bearing the risk of damaging the epicardium or other cardiac tissue. Other access routes to the pericardial cavity can be used, for example, direct "puncture" from the SVC or IVC / coronary sinus (CS), and "puncture" into the pericardium can be used. Various techniques can be used, including the use of a percutaneous intravascular approach utilizing a catheter, a needle, and / or a high-frequency energy path from within these structures into the pericardial space for derivation from the heart and vascular structures.

[0169] In some examples, the right atrial appendage 38 is accessed via a conventional great vein route. FIG. 17 illustrates the manner in which any device of the present disclosure is introduced into the right atrium 39 via the superior vena cava 24 (SVC). The cutting section 37 shows that any device of the present disclosure passes through the superior vena cava 24, the right atrium 39, and the right atrial appendage 38. The distal tip of the catheter 129 is shown as being led out from the right atrium 39 at the apex 40.

[0170] FIG. 18 illustrates the manner in which any device disclosed above is alternatively introduced into the right atrium 39 via the inferior vena cava 32 (IVC). The cutting section 36 shows that the catheter 129 passes through the inferior vena cava 32, the right atrium 39, and the right atrial appendage 38. The distal tip of the catheter 129 is shown as being led out from the right atrium 39 at the apex 40.

[0171] Thus, by way of example, a method for reducing pericardial constriction of a subject in need thereof using any device of the present disclosure is provided by the following steps. Any device of the present disclosure is manipulated through either the superior vena cava 24, 32 into the right atrium 39. After being introduced inside the right atrium 39, any device of the present disclosure is introduced into the right atrial appendage 38. The wall of the right atrial appendage 38 is punctured at the apex 40 and the catheter is advanced into the pericardial cavity 54. Other transvascular right heart routes to the pericardial cavity 54 are also envisioned. Further, routes through the left atrial appendage, coronary sinus, and right ventricle are envisioned with respect to transvascular access to the pericardial cavity 54.

[0172] Note that the wall of the right atrial appendage can be perforated by the device itself of any device of the present disclosure or by an instrument (e.g., a guide wire) that has passed through the lumen of any device of the present disclosure, such as an over-the-wire. Further, any device disclosed above may pass through the opening in the wall of the atrial appendage into the pericardial space, or an instrument that has passed through the lumen of any device of the present disclosure may be presented into the pericardial cavity 54. These details will depend on the procedure being performed and the type of device being used with respect to the devices disclosed above.

[0173] As shown in FIG. 19, by using any device of the present disclosure, a cutting path having a length can be formed within the pericardium, for example, within the parietal layer 55. Thus, a catheter 129, for example, a steerable catheter, can be employed, which can pass through the IVC, through the RA, be introduced into the RAA, and then extend into the pericardial cavity 54. The catheter 129 can have one or more steerable segments for guiding any device of the present disclosure, and its radius of curvature is set to be about 1 inch (about 25.4 mm) to about 5 inches (about 127 mm), and the arc length is set to be about 90° to about 180°. As illustrated in FIG. 21, any device of the present disclosure can be disposed within the pericardial cavity 54, start the cutting path 175 at the starting point 160, and end at the end point 180 of the length. At least a part of the parietal layer 55 of the serous pericardium, the fibrous pericardium 56, and the pericardial adipose tissue 59 are separated along the cutting path 175. In a heart having a dysfunction treatable by this method, by means of one or more incisions along the length, without removing the pericardial tissue and while reducing pericardial constriction, the pericardium is separated around the cutting line formed by the incision or cutting path 175, for example, around the periphery of the heart. One or more cutting paths 175 can be formed, and by using different cutting paths with various lengths, pericardial constriction can be reduced. In one example, the cutting path 175 and its length are determined prior to the surgery. Other cutting paths and other lengths can also be used.

[0174] In one example, the device of the present disclosure further includes at least one nerve detection device. In one example, at least one nerve detection device is disposed on the flexible catheter 129. In one example, at least one nerve detection device is disposed adjacent to the incision assembly 101. In one example, at least one nerve detection device is disposed on the incision blade 103.

[0175] Any device of the present disclosure can further include at least one nerve stimulation device. In one example, at least one nerve stimulation device is disposed on a flexible catheter 129. In one example, at least one nerve stimulation device is disposed adjacent to the incision assembly 101. In one example, at least one nerve stimulation device is disposed adjacent to the blade 103.

[0176] The pericardiotomy device and / or catheter and / or sheath of the present disclosure can be configured such that the overall outer diameter (O.D.) introduced into the pericardial cavity is from about 6 Fr (2 mm) to about 30 Fr (10 mm). In one example, the pericardiotomy device and / or catheter and / or sheath of the present disclosure can be configured such that the overall outer diameter (O.D.) introduced into the pericardial cavity is from about 6 Fr (2 mm) to about 20 Fr (6.67 mm). The pericardiotomy device and / or catheter and / or sheath can be configured such that the overall outer diameter (O.D.) introduced into the pericardial cavity is from about 6 Fr (2 mm) to about 15 Fr (5 mm). In one example, the pericardiotomy device and / or catheter and / or sheath of the present disclosure can be configured such that the overall outer diameter (O.D.) introduced into the pericardial cavity is from about 6 Fr (2 mm) to about 12 Fr (4 mm). In one example, the pericardiotomy device and / or catheter and / or sheath of the present disclosure can be configured such that the overall outer diameter (O.D.) introduced into the pericardial cavity is about 10 Fr (3.33 mm).

[0177] Any device disclosed above is configured for aseptic manufacturing and aseptic packaging, ethylene oxide sterilization or autoclave sterilization, or high-energy sterilization such as, for example, electron beam sterilization, gamma ray sterilization, or ultraviolet sterilization.

[0178] Referring to FIGS. 20A - 20H, an exemplary pericardial tissue cutting device (also referred to as "medical device 500") for forming a longitudinal incision in the pericardium is provided. The longitudinal incision may be completed by a "sliding" action or a "scissor" action, as illustrated. Exemplary medical devices such as device 500 may use a "sliding" action and / or a "scissor" action to cut along the wall of the pericardial cavity. In the "sliding" action, the cutting assembly 101 is moved along the pericardium while the first cutting member 124 and the second cutting member are maintained in a fixed position (e.g., the angle between the first cutting member 124 and the second cutting member 126 is fixed). The "scissor" action is an example where the first cutting member 124 and the second cutting member 126 can move relative to each other during the cutting process (e.g., the angle between the first cutting member 124 and the second cutting member 126 is not fixed and can move to generate a scissor force on the tissue).

[0179] Device 500 includes a cutting assembly 101 having a longitudinal axis and at least one opening 136. The opening 136 may include an opening top defined at the top of the cavity defined by the opening and an opening bottom defined at the bottom of the cavity defined by the opening. The cutting assembly 101 is operably coupled to the distal end of an elongate body 129 such as a flexible catheter and / or a steerable catheter or a catheter.

[0180] The cutting assembly includes a first cutting member 124 having a proximal end 124a and a distal end 124b, and the proximal end of the first cutting member 124 is pivotally connected to the cutting assembly. As shown in the figure, a second cutting member 126 having a proximal end 126a and a distal end 126b may also be provided, and the proximal end of the second cutting member 126 is pivotally connected to the first cutting member 124. A first biasing member 117 operably coupled to the proximal end 124a of the first cutting member 124 and a second biasing member 119 operably coupled to the distal end 126b of the second cutting member 126 provide reciprocating and / or reversible movement for the two cutting members 124, 126 (scissor blades) that can be controlled by the user.

[0181] As described herein, the first cutting member 124 and the second cutting member 126 may transition between a retracted position (first configuration) and a deployed position (second configuration). The retracted position is the position where the first cutting member 124 and the second cutting member 126 are disposed inside the opening 136. The deployed position is the position where the first cutting member 124 at least partially protrudes from the opening 136. The cutting assembly 101 may have various positions where the first cutting member 124 and the second cutting member 126 can be located in the deployed position. For example, the height of the protruding portion of the first cutting member 124 from the opening 136 may be adjusted and / or locked in place. The height may be based on the tissue to be cut.

[0182] The two incision members 124, 126 may include a sharp blade, an RF electrode, or a combination thereof. For example, the first incision member 124 may include a cutting tip 125 and one or more internal cutting surfaces (e.g., internal cutting surfaces 205A, 205B). Each of the cutting tip 125 and / or one or more internal cutting surfaces (e.g., internal cutting surfaces 205A, 205B in FIGS. 25A-25H and internal cutting surface 205 in FIGS. 25A-25C) may include an electrode, a blade, a sharp edge, and / or the like configured to cut human tissue. In various embodiments, each of the cutting tip 125 and / or the internal cutting surface (e.g., internal cutting surfaces 205A, 205B in FIGS. 25A-25H and internal cutting surface 205 in FIGS. 25A-25C) may have a monopolar RF electrode or a bipolar RF electrode. In various embodiments, the cutting tip 125 may be a monopolar RF electrode (e.g., the cutting tip 125 may be a monopolar RF electrode of only the edge to reduce the risk to surrounding tissue during the cutting process). In various embodiments, the internal cutting surface (e.g., internal cutting surfaces 205A, 205B in FIGS. 25A-25H and internal cutting surface 205 in FIGS. 25A-25C) may be a bipolar RF electrode (e.g., the internal cutting surface may have an electrode designed to cut the incision while moving). The impedance may be measured between the internal cutting surfaces 205A, 205B, whereby it may be confirmed that cutting is occurring by monitoring the impedance during cutting (e.g., the tissue being cut provides impedance between the internal cutting surfaces 205A, 205B).

[0183] Additionally or alternatively, the first incision member 124 may have a blunt blade 201 instead of or in addition to the internal cutting surfaces 205a, 205b. In this case, the blunt blade 201 may contact the pericardial wall and may extend the incision by the moving force of the incision assembly 101. The blunt blade 201 may provide real-time cutting confirmation because the incision can be more easily observed by the operator.

[0184] The second cutting member 126 may also include a cutting surface (e.g., facing the direction of the internal cutting surface). The cutting surface may be a sharp blade, an RF electrode, or a combination thereof.

[0185] The incision assembly may also have one or more orientation markers 215 used to monitor the position of the incision assembly 101. The orientation markers 215 may be radiopaque markers visible via one or more imaging devices. In various embodiments, the orientation markers 215 may be configured in a pattern indicating the orientation of the incision assembly. As shown, the incision assembly has three triangular orientation markers 215 such that the triangle indicates the direction in which cutting can occur. Thus, the operator may determine the orientation in which the incision assembly 101 is located and also determine into which surrounding tissue the first cutting member 124 may extend.

[0186] Device 500 is adaptively coupled to a controller 1000, which is described in more detail below. In one example, the controller 1000 is operably coupled to the second cutting member 126 via an actuator rod 121 (shown in FIG. 20D) that functions to drive, for example, the two cutting members 124, 126. In various embodiments, as shown in FIG. 20D, the actuator rod 121 may be attached to a spring (second biasing member 119) to dampen the movement of the cutting member 126. Additionally, a yoke 309 (having an internally located yoke biasing member 225) may be configured between the spring and the second cutting member 126 for stability during movement of the actuator rod 121.

[0187] In one example, the first cutting member 124 includes a first cutting surface that is closely and proximately disposed relative to a second cutting surface of the second cutting member 126 so as to provide sufficient scissor action for cutting pericardial tissue. As shown, the first cutting member 124 and the second cutting member 126 are axially aligned along the longitudinal axis of the cutting assembly 101. The distal end 124b of the first cutting member 124 is reversibly adjustable at an angle range laterally with respect to the longitudinal axis of the cutting assembly 101 so as to provide sufficient scissor action for cutting pericardial tissue.

[0188] The proximal end 124a of the first cutting member 124 is pivotally connected to the cutting assembly 101 at a first connection point (indicated by pin 107), and the proximal end 126a of the second cutting member 126 is pivotally connected to the cutting assembly 101 at a second connection point 104. The distal end of the second cutting member 126 is pivotally connected to the first cutting member 124 at a third connection point 108. As shown, the third connection point 108 is located between the first connection point 106 and the distal end 124b of the first cutting member 124. For example, point 108 is spatially separated from the pivot point 106.

[0189] The first biasing member 117 is operably coupled to the cutting assembly 101 and to the proximal end of the first cutting member 124. The first biasing member 117 applies a rotational force, i.e., torque, to the first cutting member 124 and projects the distal end of the first cutting member 124 laterally through the opening 136 of the cutting assembly 101. The second biasing member 119 applies a pushing force, i.e., a spring force, to the distal end 126b of the second cutting member 126 via the yoke 309 and pushes the distal end 126b of the second cutting member 126 longitudinally toward the first biasing member 117.

[0190] In this configuration, the distal end 126b of the second incision member 126 is reversibly adjustable parallel to the longitudinal axis of the incision assembly 101. With the distal end 126b of the second incision member 126 operably coupled to the actuator rod 121 (e.g., connected to the actuator rod 121 via the yoke 309 and contacting the second biasing member 119 driven by the actuator rod 121), the controller controls the translational movement of the distal end 126b via the actuator rod 121, thereby providing reciprocating movement of the two incision members 124, 126 against one or both of the biasing forces of the biasing members 117, 119. The first biasing member 117 can be at least one of a torsion spring and a compression spring. In various embodiments, the first biasing member 117 may be assisted or replaced by a biasing effect caused by one or more electrical wires 134, 135 (e.g., as shown, the electrical wires 134, 135 may also provide a biasing force). The second biasing member 119 can be a spring.

[0191] As shown in FIGS. 20C and 20D, the distal end 126b of the second incision member 126 is operably connected to the yoke 309, where the yoke is configured to receive the distal end 126b of the second incision member 126. The yoke 309 may have an internal yoke biasing member 225 disposed within the yoke 309 to move along the yoke 309 when the yoke 309 moves (e.g., in response to contact with the second biasing member 119).

[0192] The medical device 500 can further include a sheath (not shown), which can slide transversely over the outer diameter of the incision assembly 101. Thus, by using the sheath, a first configuration is provided in which the sheath is positioned over at least one opening 136 of the incision assembly 101, in which configuration the sheath prevents the lateral protrusion of the first cutting member 124 from the incision assembly 101 against the biasing by the first biasing member 117 and / or the electrical wires 134, 135. The medical device in any embodiment herein may also have a second configuration. In such a second configuration, at least one opening of the incision assembly 101 is not covered, and the first cutting member 124 protrudes laterally through at least one opening 136 of the incision assembly 101.

[0193] In one example, the cutting device is driven by the operation of a controller to apply a tensile force to the actuator rod 121 to move the distal end 126b of the second cutting member 126 parallel to the longitudinal axis of the incision assembly 101 against the force by the second biasing member 119. During this operation, the proximal end 126a of the second cutting member 126 reduces the lateral protrusion of the first cutting member 124 by pulling and then releasing the actuator rod 121 against the force by the first biasing member 117 and / or the electrical wires 134, 135, resulting in a scissor action.

[0194] In one example, the distal end 124b of the first incision member 124 includes a cutting tip 125. In various embodiments, the cutting tip 125 may be a conductive tip operably coupled to an independent source of high-frequency energy or high-frequency current. In this way, by including a non-conductive element 123 that electrically insulates the tip 125, the tip 125 can operate independently of the first incision member 124. In this configuration, the opposite surface of the first incision member 124 is independently operably coupled to an independent source of high-frequency energy or high-frequency current via wires 134, 135. In one example, the controller is configured to independently operate a source of high-frequency energy or high-frequency current with respect to the first incision member 124, with respect to the second incision member 126, and with respect to the conductive tip 125.

[0195] The cutting device 500 may have one or more stabilization members disposed adjacent to at least one opening of the incision assembly 101. In one example, the one or more stabilization members radially spaced apart by about 120 degrees and reversibly project laterally around the incision assembly. The one or more stabilization members can be a wire, a loop, a shape memory metal, or one or more inflatable structures. In one example, the one or more stabilization members prevent rotation of the incision assembly 101 about the longitudinal axis.

[0196] In various embodiments, the medical device 500 may have one or more suction devices. For example, the suction lumens 210A, 210B may be disposed on the incision assembly 101). In various embodiments, the incision assembly 101 has one or more suction lumens 210A, 210B. The suction lumens 210A, 210B may be configured to provide a suction force that can engage the wall of the pericardial cavity 54. In various embodiments, the suction lumens 210A, 210B can provide sufficient force to maintain a tight contact between the incision assembly 101 and the wall of the pericardial cavity, yet still allow the incision assembly 101 to be moved along the pericardial cavity (e.g., to enable the formation of an incision). Thus, the suction lumens 210A, 210B can provide a constant and / or substantially constant suction force in the direction of the wall of the pericardial cavity, yet do not necessarily have to maintain contact between the suction lumens 210A, 210B and the wall of the pericardial cavity. In various embodiments, the suction force through the suction lumens 210A, 210B may be applied at the time of formation of the initial incision (e.g., in an example where the first cutting member begins to protrude from the opening 136 and the cutting tip 125 begins to form an incision in the wall of the pericardial cavity). At the time of formation of the incision, the suction force may be maintained (e.g., may be maintained constant during movement of the incision assembly), or may be reduced, or may be terminated (e.g., the incision assembly 101 may be capable of maintaining positioning along the incision by the shearing effect of the first cutting member 124 and the second cutting member 126).

[0197] In various embodiments, the suction lumens 210A, 210B may be parallel to the opening 136 of the incision assembly 101, or may be adjacent in other ways. Although the illustrated embodiment shows two suction lumens 210A, 210B, various embodiments may have more or fewer suction lumens (e.g., more suction lumens may be provided to provide a greater suction force and greater stability).

[0198] In various embodiments, the length of the openings for the suction lumens 210A, 210B may be shorter than the longitudinal length at the opening 136. Alternatively, the openings of the suction lumens 210A, 210B may be equal to or greater than the longitudinal length of the opening 136. In various embodiments, a given suction lumen may have a plurality of openings provided in the incision assembly (e.g., parallel to the opening 136). In various embodiments, the first suction lumen 210A and the second suction lumen 210B may be disposed on opposite sides of the opening 136. In various embodiments, the first suction lumen 210A and the second suction lumen 210B may be disposed parallel to each other along the opening 136. For example, the first suction lumen 210A and the second suction lumen 210B may be disposed at the same position along the longitudinal direction of the incision assembly 101 on opposite sides of the opening 136.

[0199] One or more suction lumens 210A, 210B may include one or more suction cups provided inside the suction lumen and configured to engage the wall of the pericardial cavity 54. One or more suction lumens 210A, 210B may be housed inside the opening in a given suction lumen and / or may protrude from the opening of a given suction lumen. In various embodiments, the suction cups of the suction lumens 210A, 210B may be folded into the interior of a given suction lumen 210A, 210B for transport. For example, in an example where a sheath covers the openings of the suction lumens 210A, 210B, the suction cups may be folded. The suction cups described herein may be of any material provided in addition to the incision assembly 101 and assist in suction between the incision assembly 101 and the wall of the pericardial cavity.

[0200] One or more suction lumens 210A, 210B may be connected to a vacuum source via a lumen provided in the catheter 129. The vacuum source may provide a suction force acting on the wall of the pericardial cavity to the one or more suction lumens. The suction force may be sufficient to maintain the position of the incision assembly 101 during the cutting process. The various stabilization members described herein may also assist the one or more suction lumens 210A, 210B in maintaining their connection to the pericardial cavity (e.g., the stabilization member may engage the wall on the opposite side of the pericardial cavity). The suction force may be driven by a controller such as the controller described herein and / or may be controlled in other ways.

[0201] In various embodiments, the suction lumens 210A, 210B may be provided as cavities within the incision assembly 101 (e.g., cavities connected to the vacuum source described above). Additionally, the suction lumens 210A, 210B may include one or more materials that assist in the suction between the suction lumen and the pericardial wall. For example, one or more of the suction lumens 210A, 210B may have a suction cup configured to engage the wall of the pericardial cavity 54. Various other materials may be provided to assist in the suction between the suction lumens 210A, 210B and the wall of the pericardial cavity 54.

[0202] Suitable materials for the exemplary suction cups provided within the suction lumens 210A, 210B include, but are not limited to, thermoplastic elastomers, EPDM rubber, thermosetting rubber, polysilicon, polysiloxane, polyurethane, polyvinyl chloride, styrene-ethylene-butylene-styrene, and polytetrafluoroethylene and its derivatives and copolymers, as well as blends thereof. For example, the suction lumens 210A, 210B may be suction cups formed from silicone.

[0203] When the incision assembly 101 is positioned within the pericardial cavity 54, the incision assembly may be transitioned from a retracted position to a deployed position as described herein. The first incision member 124 (e.g., via the tip 125) may pierce the pericardial tissue using a blade, using an electrode, and / or using the like, thereby enabling an incision to be formed along the pericardial tissue (e.g., the wall side layer 55). The incision is made by the first incision member 124 and / or the second incision member 126 using a blade, an electrode, and / or a combination thereof. The incision length may be based on the length of the cut surface 310. As shown, the catheter 129 maintains the same position within the pericardial cavity 54 based on a suction device and / or a stabilizing member. Thus, the incision may be a linear incision that is the length of the cut surface 310 acting on the wall side layer 55. The multi-lumen catheter 129 remains stationary within the pericardial cavity 54 during the incision by the cut surface.

[0204] When the intended incision is complete, the cut surface 310 is returned to the retracted position. The stabilizing member may be moved to the stabilizing retracted position. The suction force supplied to the suction lumens 210A, 210B may be decreased, whereby the suction between the suction device and the wall side layer will disappear. The sheath may be moved to cover the incision opening 136. Thereby, the multi-lumen catheter can be removed from the human body without exposing any blade.

[0205] Referring now to FIG. 21, various embodiments provide various lumens in the incision assembly 101 to which a catheter is to be connected. Thus, the catheter is operably coupled to the incision assembly 101. Thus, the catheter 129 may have the same lumen configuration as the incision assembly 101. The catheter 129 may be a multi-lumen catheter. The catheter may have one or more lumens for the various operations described herein. For example, the lumens provided within the catheter and carried over into the incision assembly 101 may include suction lumens 210A, 210B, a camera lumen 302 (e.g., for receiving a camera), an electrode lumen (e.g., a lumen for receiving electrical wires 134, 135), a drive rod lumen (e.g., a lumen for receiving a drive rod (not shown) and a second biasing member 119), and / or various other lumens for operating the incision assembly 101, the catheter, and / or the like. For example, an optical channel or lumen (e.g., the camera lumen 302) may be provided within the catheter to accommodate a lens coupled to an optical fiber cable and optionally a light source such as an LED. In one example, the method of the present disclosure further includes obtaining visual information during access across the pericardial cavity, during derivation, and / or during dissection using an optical channel for accommodating a lens coupled to an optical fiber cable and optionally a light source such as an LED within the catheter. The camera and / or light source may be sized to fit within a medical device. For example, the camera and / or light source may have a diameter of 1 millimeter or less.

[0206] For the various operations described herein, various other lumens may be provided and / or used. Additionally, the catheter may have one or more lumens not used in the operations herein (e.g., the catheter may be a universal multi-lumen catheter having additional lumens not necessary for the operations herein).

[0207] Referring to FIG. 22, an exemplary controller 1000 is shown, which has a handle 260 and drive buttons 122, 122' operably coupled to various embodiments of medical devices (e.g., medical device 500, medical device 600, medical device 650, etc.). For example, the controller 1000 may be used to drive and / or otherwise control, for example, the actuator rod 121, the retraction of the sheath 130, the suction lumen, the guide wire, the expansion of the stabilization member 120 via the rod 121, etc. In various embodiments, the controller 1000 facilitates various potential operations related to each component of the incision assembly 101, including biasing / clamping for opening and closing the distal blade, which can be achieved by a suitable mechanism configured to pull / push the rod. In various embodiments, a mechanism is provided for supplying suction force to one or more suction lumens 210A, 210B. In various embodiments, a mechanism is provided for releasing / retrieving a balloon / nitinol component that functions to stabilize the incision assembly 101 and its components, including the cutting surface, and apply opposing pressures. The controller 1000 may include one or more buttons 122, 122' used to operate and control the electrosurgical features of the device, such as current and / or RF, etc.

[0208] The controller 1000 may also have one or more drive knobs 700, 705 for controlling the catheter 129 and for controlling various components of the cutting device. The knob 700 may be configured to rotate the flexible catheter 129 in response to orientation information determined by fluoroscopy or other visualization means. The knob 705 may function to activate one or more components on the medical device (e.g., supply suction force to the suction lumen, drive the stabilization member, etc.). Various other controllers are envisioned that would enable the deployment and operation of the cutting device described above.

[0209] A method for operating a medical device 100 includes providing a medical device 100 equipped with a controller, and using a controller 1000 to control, for example, operate, any one or combination of a drive knob and / or a drive button to provide at least one of suction for one or more suction lumens, movement of a first cutting member and a second cutting member between a retracted position and a deployed position, movement of a cutting assembly, energy supply to a cutting device, and movement of one or more stabilizing members. The above method is applicable to any cutting device disclosed above.

[0210] Here, referring to FIG. 23, an exploded view of a cutting device according to various embodiments is provided. Unless otherwise noted, the medical device 650 shown in FIGS. 23, 24A-24C, 25A-25C, 26A-26B, 27, and 28A-28C includes various components and / or various functions related to the medical device 500 described with reference to FIGS. 20A-20H.

[0211] As shown in the figure, the cutting assembly 101 may include a first cutting member 124 and a second cutting member 126 operably coupled to each other. In this case, by moving the second cutting member 126 (via the yoke 309 and a drive rod (not shown)), the movement of the first cutting member 124 is caused (for example, a scissor effect as described herein is caused). Additionally, the cutting assembly 101 may include electrical wires 134, 135 that can supply current to one or more electrodes (for example, the internal cutting surface 205 and the tip 125). The electrical wires 134, 135 may also provide a biasing force to the first cutting member 124 (for example, push the first cutting member 124 out of the opening 136).

[0212] In various embodiments, the incision assembly may have two separate incision assembly components 101A, 101B configured to engage with each other. As shown in FIG. 23, the yoke 309 may define one or more channels configured to engage with one or more grooves of the incision assembly components 101A, 101B. Thus, the yoke 309 may be movable along the incision channel (inside the opening 136) of the incision assembly. Thus, the second incision member 126 is moved based on the movement of the yoke 309 as described herein.

[0213] The suction lumens 210A, 210B may be provided within the incision assembly components 101A, 101B. For example, the first suction lumen 210A may be provided within the first incision assembly component 101A and the second suction lumen 210B may be provided within the second incision assembly component 101B.

[0214] Now referring to FIGS. 24A, 24B, and 24C, various views of a first incision member 124 in various embodiments, such as the medical device 650 shown in FIG. 23, are provided. The first incision member 124 shown in FIGS. 24A, 24B, and 24C may be used in various different embodiments described herein unless otherwise noted. As shown, the first incision member may include a non-conductive element 123 configured to receive a cutting tip 125 and one or more internal cutting surfaces 205 (e.g., electrodes). The non-conductive element 123 may be made of an insulating material (e.g., ceramic). The non-conductive element may be made of ceramic based on the dielectric strength of the ceramic and the minimal thermal conductivity.

[0215] The internal cut surface 205 is configured to be received by a cavity within the non-conductive element 123. The non-conductive element 123 may also have one or more cavities (e.g., wire cavity 251) for receiving the electrical wires 134, 135. For example, the end of the electrical wire 134 is connected to the internal cut surface 205 and additionally provides a biasing force to the wire cavity 251. The non-conductive element 123 may also define a cavity for receiving the cutting tip 125 (e.g., the cutting tip 125 may be at least partially disposed within the non-conductive element 123 with the edge of the tip 125 protruding at the distal end of the first incision member 124).

[0216] Referring now to FIGS. 25A-25C, FIG. 25A shows an exploded view of another embodiment of an exemplary medical device 650 (e.g., an incision assembly). FIG. 25B illustrates an enlarged view of the connection between the electrical wires 134, 135 and the internal cut surface 205 and the cutting tip 125. FIG. 25C illustrates the incision assembly in a deployed position. The medical device 650 may have the same or similar internal configuration as the medical device 600 described above with reference to FIG. 23.

[0217] In various embodiments, the incision assembly components 101A, 101B may define different protruding portions and / or receiving portions for attaching the introducer 115 on the upper surface. For example, the incision assembly components 101A, 101B may have protruding portions of different shapes (e.g., FIG. 25A has different shapes for the protruding portions compared to FIG. 26A). In various embodiments, the introducer 115 may have an internal introducer 115A attached thereto. Additionally, the introducer (and the internal introducer 115A) may have an opening configured to allow a guide wire to pass therethrough, as described in various embodiments herein.

[0218] Referring to FIG. 25B, an enlarged view regarding the electrical connection is provided for each of one or more electrodes (e.g., internal cut surface 205 and cutting tip 125) in the medical device shown in FIG. 25A. As described herein, an electrical wire may supply current to a given electrode (e.g., internal cut surface 205 and / or cutting tip 125). The electrical wires 134, 135 may also include a biasing member (e.g., a spring as shown in FIG. 25B) for providing an opening force to the first cutting member 124.

[0219] Referring to FIGS. 26A and 26B, exemplary medical devices according to various embodiments are shown. FIG. 26A illustrates an exploded view of an exemplary medical device. As shown, the medical device of FIG. 26A may have components described herein with reference to any embodiment (e.g., FIG. 25A). Additionally, the introducer 115 may vary in various embodiments. For example, the introducer 115 shown in FIG. 26A has an inner introducer 115A. Each of the introducer and the inner introducer 115A may include an opening (e.g., a continuation of the guide wire lumen described herein) through which a guide wire (e.g., guide wire 113 shown in various embodiments) can pass.

[0220] Now, referring to FIG. 27, the connection between the electrical wires 134, 135 and the internal cut surface 205 and the cutting tip 125 according to various embodiments is shown. This configuration may be used in various embodiments. As shown, the cutting tip 125 may be an electrode. Additionally or alternatively, the cutting tip 125 may include a sharp edge or a blade structure. The cutting tip 125 in the deployed state is configured to contact the wall of the pericardial cavity 54, thereby forming an incision in the wall of the pericardial cavity. After an initial incision is made, the incision may continue until at least a portion of the internal cut surface 205 is exposed to the wall of the pericardial cavity. In such an example, the current supplied to the cutting tip 125 may be stopped (or may be continued for a short period of time).

[0221] The internal cutting surface 205 may include blades, sharp edges, electrodes, and / or other cutting surfaces and may be used to continue the incision along the wall of the pericardial cavity. The cutting surface on the second cutting member 126 may also be used to continue the incision (e.g., the scissor cutting effect described herein). The currents supplied to the cutting tip 125 and the internal cutting surface 205 may be independently controlled (e.g., the current may be supplied to the cutting tip 125 for forming an initial incision opening, but may be supplied only to the internal cutting surface 205 when the cutting assembly 101 moves along the incision opening).

[0222] As described above, in an exemplary embodiment, the cutting tip 125 may be a monopolar RF electrode and the internal cutting surface 205 may be a bipolar RF electrode.

[0223] Additionally, FIGS. 28A, 28B, and 28C illustrate the connections between the electrical wires 134, 135 and the cutting tip 125 and the internal cutting surface 205 within the first cutting member 124, and further illustrate the configurations of the cutting tip 125, the non-conductive element 123, and the internal cutting surface 205. The first cutting member 124 shown in FIGS. 28-28C may be used in various embodiments described herein. Additionally, the configuration of the first cutting member 124 in FIGS. 28A-28C may be substantially the same as that of the first cutting member 124 in FIGS. 24A-24C.

[0224] In various embodiments, one or more electrical wires 134, 135 may include a biasing member such as a spring. As shown, the electrical wires 134, 135 may include coiled wires that also function as springs. In such embodiments, the electrical wires 134, 135 may provide a force to the first cutting member 124 in a direction opposite to the openings 136 in various embodiments (e.g., provide an opening force to move the first cutting member 124 to the deployed position).

[0225] In certain embodiments of the present disclosure, although specific combinations of components are illustrated with reference to each other, various other combinations may also 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 drawings, but rather, conversely, may encompass combinations of components in various illustrated embodiments and aspects thereof.

Claims

1. A medical device, comprising: An incision assembly configured to be operably coupled to the distal end of a catheter, the incision assembly including an incision opening defined along the incision assembly; A retractable cutting device disposed within the incision opening; A first incision member including at least one cutting surface, the at least one cutting surface facing away from the distal end of the catheter and toward the proximal end of the catheter, the first incision member defining a first member distal end and a first member proximal end, the first member proximal end being rotatably attached in proximity to the distal end of the incision opening; A second incision member defining a second member distal end and a second member proximal end, the second member distal end being attached to the first incision member at the second member proximal end; The retractable cutting device is configured to transition between a retracted position and a deployed position, and when the retractable cutting device is in the retracted position, the first incision member is positioned within the incision opening; When the retractable cutting device is in the deployed position, at least a portion of the first incision member protrudes from the incision opening.

2. The medical device according to claim 1, wherein the at least one cutting surface of the first incision member includes at least one internal cutting surface or a cutting tip.

3. The medical device according to claim 1 or claim 2, wherein at least one of the at least one cutting surface of the first incision member is an electrode.

4. The medical device according to any one of claims 1 to 3, wherein one or more of the at least one cutting surface of the first incision member include a monopolar electrode or a bipolar electrode.

5. The medical device according to any one of claims 1 to 4, wherein the at least one cutting surface of the first incision member includes a blunt blade.

6. The medical device according to any one of claims 1 to 5, wherein the second incision member includes at least one cutting surface, and the at least one cutting surface of the second incision member faces in an opposite direction to at least one of the at least one cutting surface of the first incision member.

7. Further comprising one or more suction lumens defined along the incision assembly, the suction lumen providing a suction force in a direction in which the first incision member expands from the incision opening, the medical device according to any one of claims 1 to 6.

8. The one or more suction lumens include a first suction lumen defined along the longitudinal axis of the incision assembly and a second suction lumen parallel to the first suction lumen in the direction of the longitudinal axis of the incision assembly, the medical device according to any one of claims 1 to 7.

9. Further comprising one or more orientation markers provided on the incision assembly, the one or more orientation markers indicating the direction of cutting by the incision assembly, the one or more orientation markers being radiopaque, the medical device according to any one of claims 1 to 8.

10. Further comprising a camera provided via a camera lumen within the catheter, the camera capable of providing one or more images of the retractable cutting device, the medical device according to any one of claims 1 to 9.

11. Further comprising one or more electrical wires configured to provide an electric current to one or more of the at least one cutting surface of the first incision member, the one or more electrical wires providing a biasing force to the first incision member, the medical device according to any one of claims 1 to 10.

12. At least one of the one or more electrical wires includes a torsion spring configured to provide the biasing force to the first incision member, the medical device according to any one of claims 1 to 11.

13. Further comprising an actuator rod communicating with the distal end of the second member of the second incision member, the actuator rod configured to move the first incision member and the second incision member, the medical device according to any one of claims 1 to 12.

14. Further comprising a yoke attached to the distal end of the second member of the second incision member, the yoke configured to receive a force from the actuator rod or configured to receive a biasing force applied to the actuator rod, the medical device according to any one of claims 1 to 13.

15. The medical device according to any one of claims 1 to 14, further comprising a sheath configured to movably cover the incision opening.

16. The sheath is configured to provide a counterforce against the biasing force caused by the one or more electrical wires in an example where the sheath at least partially covers the incision opening. The medical device according to any one of claims 1 to 15.

17. The at least one cutting surface of the first cutting member includes a first internal cutting surface and a second internal cutting surface, both the first internal cutting surface and the second internal cutting surface being electrodes, and the impedance between the first internal cutting surface and the second internal cutting surface indicates a case where the material is being cut by the first internal cutting surface and the second internal cutting surface. The medical device according to any one of claims 1 to 16.

18. The medical device according to any one of claims 1 to 17, further comprising a controller attached to the incision assembly or to the retractable cutting device.

19. The controller is configured to provide at least one of suction to the one or more suction lumens, movement of the first cutting member and the second cutting member between the retracted position and the deployed position, movement of the incision assembly, energy supply to the incision assembly, and movement of one or more stabilizing members. The medical device according to any one of claims 1 to 18.

20. A method for operating a medical device, comprising: providing a medical device according to any one of claims 1 to 19, to which a controller is attached; controlling at least one of supplying a suction force to the one or more suction lumens, moving the first cutting member and the second cutting member between the retracted position and the deployed position, moving the incision assembly, supplying energy to the incision assembly, and moving one or more stabilizing members.

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