Pericardiotomy device and method

Abstract

Several exemplary cutting devices for making an incision through the pericardium or the epicardial layer of the pericardium are described. These examples share the feature of being deployed intravascularly, through the RAA, IVC, SVC, or via a subxiphoid approach.

Description

Technical Field

[0001] The present disclosure provides a pericardiotomy device that introduces one or more incision lengths into the pericardium, such as the pericardial layer, the fibrous layer, and / or adipose tissue, to treat heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) in which the ejection fraction is preserved.

Background Art

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

Summary of the Invention

[0003] In a first embodiment, a pericardial tissue incision device is provided, the device comprising an elongated body having a proximal end and a distal end, a longitudinal axis, and an incision assembly coupled to the distal end, the incision assembly comprising an incision member aligned with the longitudinal axis, at least a portion of the incision member extending reversibly laterally from the incision assembly to engage and incise the pericardial tissue.

[0004] In one aspect, alone or in combination with a previous aspect, the pericardial tissue incision device further comprises an actuator operably coupled to the incision assembly, the actuator moving from a first configuration in which the incision member is disengaged to a second configuration in which the incision member is engaged, in the second configuration, traversing parallel to the longitudinal axis such that the incision member extends laterally.

[0005] In one aspect, alone or in combination with any of the foregoing aspects, the actuator is a rigid rod or a wire.

[0006] In one aspect, alone or in combination with any of the foregoing aspects, the incision member is generally planar.

[0007] In one aspect, alone or in combination with any of the foregoing aspects, the incision member includes a first end and a second end, and the first and second ends are coupled to the incision assembly.

[0008] In one aspect, alone or in combination with any of the foregoing aspects, at least a portion of the incision member is a sharp edge.

[0009] In one aspect, alone or in combination with any of the foregoing aspects, at least a portion of the incision member is energizable with an electric current or radiofrequency energy sufficient to separate pericardial tissue.

[0010] In one aspect, alone or in combination with any of the foregoing aspects, the incision member is a sharp edge having at least a portion thereof energizable with an electric current or radiofrequency energy sufficient to separate pericardial tissue.

[0011] In one aspect, alone or in combination with any of the foregoing aspects, the incision member is strongly flexible.

[0012] In one aspect, alone or in combination with any of the foregoing aspects, the pericardial tissue incision further includes a stabilizing member configured to extend reversibly laterally from an extended body.

[0013] In one aspect, alone or in combination with any of the foregoing aspects, the pericardial tissue incision device further includes a retractable sheath that covers the incision assembly.

[0014] In one aspect, alone or in combination with any of the preceding aspects, at least a portion of the retractable sheath comprises a radiopaque material.

[0015] In one aspect, alone or in combination with any of the preceding aspects, the pericardial tissue incision device further comprises an introducer / dilator adjacent to the distal end of the incision assembly.

[0016] In one aspect, alone or in combination with any of the preceding aspects, the introducer / dilator receives a guidewire.

[0017] In one aspect, alone or in combination with any of the preceding aspects, at least a portion of the introducer / dilator comprises a radiopaque material.

[0018] In one aspect, alone or in combination with any of the preceding aspects, the pericardial tissue incision device further comprises visualization means.

[0019] In one aspect, alone or in combination with any of the preceding aspects, the pericardial incision device is sterilized.

[0020] In a second embodiment, a method is provided for performing it in a subject in need of pericardial tissue incision, the method comprising providing a pericardial device according to any one of the preceding embodiments, introducing the pericardial device into the pericardial cavity, and incising at least a portion of the apical layer of the pericardium along a length and a path.

[0021] In one aspect, alone or in combination with any of the preceding aspects, the pericardial device is introduced subxiphoidally.

[0022] In one aspect, alone or in combination with any of the preceding aspects, the pericardial device is introduced transvascularly.

[0023] In one aspect, alone or in combination with any of the preceding aspects, the pericardial device is introduced transvascularly via the superior vena cava.

[0024] In one aspect, alone or in combination with any of the foregoing aspects, the pericardial device is introduced transvessularly via the inferior vena cava.

[0025] In one aspect, alone or in combination with any of the foregoing aspects, at least a portion of the epicardial layer is incised by reverse cutting along a path and length.

[0026] In one aspect, alone or in combination with any of the foregoing aspects, the method further includes repeating the step of incising the pericardial cavity along different lengths, different paths, or different lengths and different paths.

[0027] In one aspect, alone or in combination with any of the foregoing aspects, the method further includes puncturing from the pericardial cavity and exposing the incision after the introduction step and before the incision step.

[0028] In another embodiment, a method of operating an incision device is provided, the method including providing any of the pericardial devices of the embodiments disclosed herein engaged with a controller, and controlling at least one of rotation of the elongated body, extension and retraction of the incision device or stabilization member, and / or an energy source to the incision device using the controller.

[0029] To understand and view how the present disclosure may be actually implemented, embodiments are described by way of non-limiting examples only with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0030]

Figure 1A

Figure 1B

Figure 1C

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 2E

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

[0031] Several exemplary devices are described for making an incision through the pericardial membrane or epicardial layer of the pericardium. These embodiments share the feature of being deployed intravascularly through the RAA, IVC, SVC, or via a subxiphoid approach.

[0032] As used herein, the terms "pericardial space" and "pericardial cavity" are used interchangeably and include their ordinary and customary meanings to those skilled in the art of medical technology and surgery, and include, for example, the space, cavity, or fluid medium generally disposed between the epicardium and the inner pericardium of the mammalian heart.

[0033] As used herein, the term "pericardial tissue" includes its ordinary and customary meanings to those skilled in the art of medical technology and surgical technology, and includes, for example, tissues related to the pericardium.

[0034] As used herein, unless otherwise specified, the term "epicardial layer" includes at least the serosal layer and the fibrous layer of the epicardium, and optionally, adipose tissue contained between, below, above, or within said layers. Further, the term "epicardial layer" includes its ordinary and customary meanings to those skilled in the art of medical technology and surgical techniques, and includes the ordinary and customary meanings, for example, tissue layers disposed adjacent to and including adipose tissue, within and outside the pericardial cavity, and on the surface of the visceral layer of the pericardium.

[0035] As used herein, the term "incision surface" includes one or more of the edges of a sharp blade, or the surface of an electrode, configured to receive an electric current, or radiofrequency (RF) energy sufficient to ablate, burn, vaporize, or separate tissue. As used herein, the incision surface includes both sharp edges and electrodes.

[0036] As used herein, the terms "reverse incision" and "pullback incision" are used interchangeably and refer to a method involving the presentation of an incision surface to tissue, the method being substantially in the direction toward the proximal end of a multi-lumen device or catheter, including an incision of a surface adjacent to the distal end of the multi-lumen device or catheter, and the application of a directional force sufficient to incise or separate the tissue, for example, a force by pulling the multi-lumen device or catheter while the incision surface is engaged with the tissue.

[0037] As used herein, the term "incision" refers to tissue disruption, e.g., the type of sharp incision associated with a knife blade such as a scalpel blade, or a conductive material sufficient to disrupt tissue, or an electrosurgical device that provides an electric current to an electrode. The term "incision" as used herein includes "filleting", "slicing", and / or the like.

[0038] As used herein, the phrase "incision length" includes an incision, or a non-zero distance of an incision, e.g., starting from a first point, e.g., a target point, and ending at a second point, e.g., an end point. The incision length includes linear, non-linear, and / or multiple linear and / or non-linear lengths that intersect or do not intersect on a curved surface such as the heart or a non-planar perimeter.

[0039] As used herein, the phrases "decompression" and "constraint relaxation" include their ordinary and customary meanings to those of ordinary skill in the medical arts and surgical arts.

[0040] As used herein, the phrase "preserved ejection fraction" includes its ordinary and customary meanings to those of ordinary skill in the medical arts and surgical arts, and includes, for example, a clinical syndrome in which a patient exhibits signs and symptoms of heart failure as a result of elevated left ventricular (LV) filling pressure despite having a normal or near-normal left ventricular (LV) ejection fraction (LVEF; ≧50%).

[0041] As used herein, the phrase "cardiac dysfunction" includes its ordinary and customary meanings to those of ordinary skill in the medical arts and surgical arts, and includes, for example, heart failure or congestive heart failure.

[0042] As used herein, the phrase "pericardial incision device" includes a device having an incision surface, e.g., the edge of a blade or the surface of an energized electrode.

[0043] As used herein, the terms "pericardiotomy assembly" and "incision assembly" are used interchangeably and refer to an assembly that includes a pericardiotomy device.

[0044] As used herein, the term "multi-lumen device" includes a catheter composed of at least one lumen, including medical instruments, devices, or components thereof, such as a pericardiotomy device.

[0045] As used herein, "first," "second," and the like are used only to describe elements that are related to each other and do not in any way enumerate a particular orientation of an article or device. They do not indicate or imply a required or necessary configuration of an article or device, nor do they specify the manner in which an article or device described herein is to be used, arranged, transitioned from a different configuration, or positioned during use.

[0046] As used herein, when an element refers to two structures or layers and is referred to as "adjacent" and "coupled," the two structures or layers are in proximity to each other without an intervening open space therebetween.

[0047] As used herein, when an element is referred to as "coupled" or "adjacent" to another element, the two elements or structures are in proximity to each other, but other elements or intervening elements may be present.

[0048] As used herein, when an element is referred to as "directly coupled" or "direct" to another element, no intervening element is present.

[0049] As used herein, the term "operatively coupled" includes direct coupling, indirect coupling through another component, element, circuit, or structure, and / or indirect coupling between items through intervening items.

[0050] As used herein, the phrase "nerve stimulation device" refers to a device capable of applying an electrical potential to a nerve, such as a pacing probe that stimulates the phrenic nerve to cause an observable respiratory disorder, in order to cause an observable effect that correlates directly or indirectly with the applied potential.

[0051] As used herein, the phrase "nerve detection device" refers to a device that can establish at least some positions or arrangements of a nerve, such as detecting an electric field generated by a nerve and directly or indirectly correlating the position or proximity of the nerve to an impedance sensor, and includes a device that can provide position or proximity information without having, or having substantially no, physical effect or stimulation on the nerve, such as an impedance sensor.

[0052] As used herein, the term "actuator" includes a mechanism for triggering an operation.

[0053] As used herein, the term "controller" includes a device having an actuator.

[0054] As used herein, the phrase "biasing member" includes a device that can be configured in a stored energy state and a released energy state, such as a spring.

[0055] As used herein, the phrase "stabilizing member" includes a device that can be configured to impart stability and / or fixation to a structure or within a structure, such as stabilizing or fixing an incision surface positioned within the pericardial cavity from rolling, twisting, buckling, and / or vibrating before and / or during use.

[0056] As used herein, the phrase "puncture tip" includes a non-traumatic object suitable for puncturing or penetrating tissue without substantial trauma or bleeding near the puncture (picture) or penetration.

[0057] Referring to FIGS. 1A and 1B, the layers of the heart wall of the heart 50 are shown in a state from the inside to the outside as the endocardium 51, myocardium 52, epicardial adipose tissue 57, visceral layer 53 of the serous pericardium, pericardial cavity 54, parietal layer 58 of the serous pericardium 55, and fibrous pericardium 56, and pericardial adipose tissue 59. In one embodiment, the device of the present disclosure is configured to incise a tissue layer that is disposed adjacent to adipose tissue both within and outside the pericardial cavity for introduction into the pericardial cavity 54, contains adipose tissue, and is on the surface of the visceral layer 53 of the pericardium.

[0058] The pericardial tissue incision device of the present disclosure includes a piercing, or puncturing, portion that is designed to first puncture the pericardial membrane. A guide wire, knife, needle, micro-needle, or electric current may be used to form the puncture, or piercing, of the pericardial membrane to enable access of the pericardial incision device to the pericardial cavity. Once the pericardium is punctured, a catheter, or an incision assembly adjacent to the distal end of a multi-lumen, is maneuvered into position within the pericardial cavity and the incision member is enabled to engage the pericardial tissue, and an incision is created as the pericardial tissue incision device is retracted toward the entry point into the pericardial membrane. The incision member may alternatively, or in combination with a sharp edge, utilize RF energy to facilitate the ease of incision and provide some hemostasis of the pericardial membrane.

[0059] Some exemplary pericardial tissue incision devices are shown in the accompanying figures. Hereinafter, the terms "pericardial tissue incision device" and "incision device" shall be used interchangeably. Each incision device is first introduced into the pericardial cavity via a transvascular, or subxiphoid approach.

[0060] Referring to FIGS. 2A-2E, a first exemplary incision device 200 is shown. The incision device 200 includes a selectively active, mechanically sharp edge, or an RF blade. The incision device 200 is also configured for insertion into the pericardial cavity 54 and is operated to a position where incision begins as described above. Thus, referring to FIGS. 2A-2E, the incision device 200 includes an elongated body 129 having a proximal end and a distal end, a longitudinal axis, and an incision assembly 101 coupled to the distal end. The incision device 200 is shown having an introducer / dilator 115 adjacent to the distal end of the incision assembly 101, and the introducer / dilator is configured to receive a guidewire 113. The introducer / dilator 115 may first initially perforate or puncture the pericardial membrane to enable access of the pericardial incision device 200 to the pericardial cavity. This operation may be performed similarly by the guidewire 113, or by an electric current, or with the assistance of the guidewire 113 or an electric current.

[0061] The incision device 200 further includes an incision assembly 101 coupled to the distal end of the elongated body 129. The incision assembly 101 includes an opening 123 that enables the incision member 103 to extend laterally from the elongated body 129 during operation. The lateral movement of the incision member 103 extends beyond the peripheral edge (e.g., the outer diameter of the elongated body 129), exposing the incision member 103 to the external environment of the incision device 200 and bringing it into contact with the pericardial tissue. In one embodiment, the incision member 103 is aligned with the longitudinal axis and at least a portion of the incision member 103 is configured to extend reversibly laterally from the opening 123 to engage the pericardial tissue and incise the pericardial tissue.

[0062] As shown in FIGS. 2B - 2E, the cutting device 200 further comprises an actuator 422 that is operably coupled to the cutting assembly 101 and configured to extend the cutting member 103 laterally from the extended body 129 and expose it (e.g., via the opening 123) to the pericardial tissue. The actuator 422 is configured to translate parallel to or otherwise transversely across the longitudinal axis of the extended body 129. As shown in FIGS. 2C and 2D, the actuator 422 can initially move from a first configuration in which the actuator is disengaged from the cutting member 103. This disengagement allows the cutting assembly 101 (e.g., the cutting member 103) to remain positioned within the extended body 129. As shown in FIG. 2E, the actuator 422 translates parallel to the longitudinal axis of the extended body 129 to a second configuration in which the actuator 422 engages the cutting assembly 101. This engagement with the cutting assembly 101 extends the cutting member 103 laterally through the opening 123 to engage and cut the pericardial tissue as described above.

[0063] The incision member 103 may be substantially planar. The incision member 103 may define a first end and a second end that are coupled to the incision assembly 101. The first and second ends may engage the catheter 129 in a rotational direction (e.g., with respective collars) at points 107a, 107b. In one embodiment, the incision member 103 is strongly flexible. For example, the incision member 103 may include a central portion that is flexible with respect to the first and second ends. When the actuator 422 engages the incision member 103, at least a portion of the incision member 103 deflects or otherwise bends around points 107a, 107b and extends laterally outward from the body 129 that extends through the opening 123. When disengaged from the actuator 422, the incision member 103 returns to an initial or rest configuration (e.g., a first configuration) within the extended body 129 (e.g., below the opening 123 of the incision assembly 101). Although described herein with reference to the deflection of the incision member 103 around points 107a, 107b, the present disclosure contemplates the incision assembly 101 and, thereby, may include any mechanism by which the incision member 103 extends beyond the peripheral edge of the extended body 129.

[0064] In other embodiments, the incision member 103 of the cutting device 200 may not bend to an engaged position (e.g., a second configuration). Alternatively, the incision member 103 may move only between two defined positions, e.g., a deployed position (e.g., a second configuration) and a folded position (e.g., a first configuration). In such embodiments, the incision member 103 may be stiff enough to resist further movement. Such an exemplary incision member 103 may be desirable in implementations where the cutting device 200 is used to cut relatively mobile tissue, such as adipose tissue around the pericardium, because application of force to the cutting device 200 may result in unintended movement of the adipose tissue.

[0065] To incise the pericardial tissue described in this specification, in some embodiments, at least a portion of the incision member 103 is a sharp edge. Additionally, or alternatively, at least a portion of the incision member 103 is energizable with an electric current, or radiofrequency (RF) energy sufficient to separate the pericardial tissue. In one embodiment, the incision member 103 is a sharp edge having at least a portion thereof energizable with an electric current, or RF energy sufficient to separate the pericardial tissue. In any embodiment, the present disclosure contemplates that the incision member 103 comprises any element, or mechanism by which tissue is separated by ablation, burning, vaporization, or other means. In some embodiments, the incision member 103 includes RF alone, or in combination with the embodiments of the incision member 103 described above. The RF wire is selectively insulated along various lengths such that, for example, an insulating region, or non-incising region, maintains contact and position within the pericardial space. Further, several RF wires, for example, two, three, four, or more may be used, with a determined number of wires fixing the incision member 103 in place and one (or more) of the wires contacting the pericardial tissue being activated to make the desired incision. This method may further be adapted to provide a particular shape, or incision pattern, as desired, to achieve an optimal reduction of intracardiac pressure.

[0066] As shown, the incision device 200 further includes a stabilization member 120 configured to extend reversibly laterally from the extended body 129. The stabilization member 120 can be configured to translate or otherwise traverse parallel to the longitudinal axis of the extended body 129 and, in some embodiments, parallel to the actuator 422. As shown in FIG. 2C, the stabilization member 120 can move similarly to the actuator 422 from a first configuration in which the stabilization member 120 is disposed within the extended body 129. As shown in FIGS. 2D-2E, during operation, the stabilization member 120 moves to a second configuration in which it extends laterally outward from the extended body 129, such as through each opening of the extended body 129 aligned with the movement of the stabilization member 120. The stabilization member 120 also extends beyond the peripheral edge of the extended body 129 to contact the pericardial tissue and prevent or otherwise reduce the ability of the incision device 200 to rotate. The relative position of the stabilization member 120 (e.g., radially disposed around the extended body 129 relative to the incision member 103) can vary based on the number of stabilization members 120, the intended depth of the incision, and other factors. The present disclosure contemplates that the stabilization member 120 can include any mechanism for extending beyond the peripheral edge of the extended body 129, such as on the opposite side of the incision member 103. One or two stabilization members 120 can be independently user-controlled by advancing the proximal end of the stabilization member 120 distally and actuating it. In one embodiment, two or more stabilization members 120 are radially positioned around the assembly. In one embodiment, two or more stabilization members 120 are radially spaced approximately 120 degrees apart around the assembly. In one embodiment, two or more stabilization members 120 are aligned on the opposite side of the incision assembly 101. In one embodiment, two or more stabilization members 120 are longitudinally offset from the incision assembly 101 to minimize or eliminate pushing the device through the newly incised slit in the apical layer 55 of the pericardium 60 as it is formed.

[0067] One or more stabilization members 120 may include flexible rods. The stabilization members 120 may extend radially outward from the catheter. Each stabilization member 120 may include a distal end fixed to the distal end of the catheter (i.e., distal to the incision assembly 101), an exposed portion aligned with the incision assembly 101 at each opening, and / or a proximal portion housed within the lumen of the catheter. Advancement of each of the proximal ends may bend the exposed portion radially outward. The exposed portion may include one or more planes (e.g., strips) so that the bending can be controlled to extend at a fixed angle relative to the catheter. Alternatively, the stabilization member 120 may be an inflatable structure such as a balloon that can be inflated with air or a liquid (saline).

[0068] The illustrated incision device 200 further includes a retractable sheath 130 that covers or surrounds the incision assembly 101. In some embodiments, the sheath further includes slits, depressions, grooves, and / or the like, each of which is aligned with a laterally protruding element (e.g., the incision member 103 and / or the exposed portion of the stabilization member 120) described herein. In one embodiment, the sheath 130 includes slits in which the incision member 103 and / or the stabilization member 120 translate to prevent unintentional circumferential movement of these elements. In any embodiment, the incision device 200 includes, additionally or alternatively, a plurality of lumens or other equivalent structures configured to receive or otherwise support the various elements and members described herein. For example, one or more of these lumen structures may cover or support the incision assembly 101 and / or the stabilization member 120 and may also operate to provide a contrast agent, an electric current, and / or the like. In some embodiments, at least a portion of the retractable sheath 130 includes a radiopaque material that is randomly distributed or patterned for visualization using conventional visualization techniques during use.

[0069] The cutting device 200 is configured to sterilize using conventional techniques such as ethylene oxide, electron beam, gamma, and autoclave, as well as chemical sterilization and aseptic packaging techniques.

[0070] Referring to FIG. 3, in some embodiments, the cutting device 200 further comprises visualization means. As shown, the multi-lumen 129 is illustrated without the cutting device 200 for clarity. Such multi-lumen 129 provides light and comprises an optical fiber channel and a lens 807 adjacent to the optical fiber channel 805 to provide an analog or digital image to the multi-lumen 129 which may also have a sheath 809. In one embodiment, the optical channels within the multi-lumen optionally house a lens coupled to an optical fiber cable together with a light source, e.g., an LED. In one embodiment, the method of the present disclosure further comprises obtaining visual information during access to, traversing, exiting, and / or incising the pericardial cavity, optionally using, e.g., the optical channels within the multi-lumen, to house a lens coupled to an optical fiber cable having a light source, e.g., an LED. In some embodiments, the optical fiber channel 805 may operate as a visualization means (e.g., the imaging portion of the operation) as well as a light source.

[0071] Referring to FIGS. 1A, 1B, and 1C, the layers of the heart wall of the heart 50, as shown above, are shown in the state from the inside out as the endocardium 51, myocardium 52, epicardial adipose tissue 57, visceral layer 53 of the serous pericardium, pericardial cavity 54, parietal layer 58 of the serous pericardium 55, and fibrous pericardium 56, and pericardial adipose tissue 59. In one embodiment, the device of the present disclosure is configured to be introduced into the pericardial cavity 54 and incise a tissue layer that is disposed adjacent to and includes adipose tissue inside and outside the pericardial cavity 54 and is on the surface of the inner layer 53 of the pericardium 60.

[0072] In one embodiment, to provide orientation stability to the incision plane of the epicardial layer, OTW introduction is employed for any of the disclosed devices, for example, through a dedicated lumen of a multi-lumen cross-section, or through a "Rapid Exchange" style catheter, or a cannula attached off-center, or a deflection-resistant catheter, and the delivery catheter is randomly distributed or arranged in a pattern for visualization using conventional visualization techniques during use.

[0073] Current ECHO / fluoroscopy may not provide the visualization required for certain access applications of the present disclosure. For example, it may be desirable to consistently and repeatedly obtain guidewire access to the pericardial cavity. Thus, in one embodiment, the multi-lumen device 129 coupled to the incision device of the present disclosure enables a user to observe in real time the advancement of the incision device 200 through various tissue layers until the desired position is reached, including direct visualization as shown in FIG. 3. Changes in tissue layers that are not visible under ECHO / fluoroscopy can be readily distinguishable under direct visualization, among other anatomical features, particularly tissues (vascular access), myocardium / pericardium (intracardiac access), myocardium / pericardium (extrapericardial), etc.

[0074] Referring to FIG. 4, the dissection device 200 can be operated and / or controlled from the outside of the subject using a controller 1000 which can be a handle. The controller 1000 may have a plurality of operation knobs 700, 705, 610, and operation buttons 710, 715 for controlling the multi-routine 129 and various components of the transaction device 200. The knob 700 can be configured to rotate the flexible catheter 129 in response to orientation information derived from fluoroscopy or other visualization means. In some embodiments, the knob 700 can operate, for example, to cause the extension / retraction of the stabilization member 120. The knob 705 may be engaged to activate one or more components on the medical device (e.g., activate the stabilization member(s)). Similarly, the operation buttons 710, 715 may be engaged to activate various components of the multi-routine (e.g., the device can also use RF electrode dissection, and the operation buttons 710, 715 may be used to supply current or RF). Various other controllers are envisioned that would enable the deployment and operation of the aforementioned dissection device. A method of operating the dissection device 200 includes providing the pericardial device 200 engaged with the controller 1000 and controlling, for example, operating any one or combination of the plurality of operation knobs 700, 705, 610, and operation buttons 710, 715 to provide at least one of rotation of the extended body 129 (or a steerable catheter having a steerable segment), dissection member 103, dissection assembly 101, extension, and retraction of the stabilization member 120, and providing energy (e.g., wireless high frequency (RF) to the dissection member having the controller 1000). The aforementioned method is applicable to any previously disclosed dissection device.

[0075] FIGS. 5-7 show various intravascular approaches for delivering the dissection device of the present disclosure into the pericardial cavity 54. Accordingly, FIG. 5 shows the heart 50 viewed separately from the body, having a pericardium 60 or pericardial sac that encloses the myocardium (i.e., epicardium, myocardium, and endocardium). The small space that exists between the myocardium and the pericardium 60 represents the pericardial cavity 54.

[0076] The incision device 200 of the present disclosure can be presented into the pericardial cavity 54. In one example, a suitable site for entering the pericardial cavity 54 is used via the right atrial appendage 38 (RAA). The right atrial appendage 38 is tangentially between the pericardium 60 and the epicardium / pericardial adipose tissue 57. In one embodiment, any of the incision devices 200 of the present disclosure is guided through the right atrium 39 to the right atrial appendage 38 so that when the wall of the right atrial appendage 38 is punctured by the incision device 200, it is substantially performed without the risk of damaging the epicardium or other cardiac tissue, and is positioned substantially parallel to the wall of the pericardium 60. Other access routes to the pericardial cavity, such as direct "puncture" to the SVC or the IVC / coronary sinus (CS), and "puncture" to the pericardium, can be used.

[0077] In some embodiments, the right atrial appendage 38 can be accessed via a conventional great vein route. FIG. 5 shows the entry of any of the devices of the present disclosure into the right atrium 39 via the superior vena cava 24 (SVC). The notch 37 shows the passage of any of the devices of the present disclosure 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 exiting the right atrium 39 at the apex 40.

[0078] FIG. 6 shows an alternative entry of any of the previously disclosed devices into the right atrium 39 via the inferior vena cava 32 (IVC). The notch 36 shows the passage of the catheter 129 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 exiting the right atrium 39 at the apex 40.

[0079] Thus, as an example, the method of the present disclosure includes the following steps. Any of the devices of the present disclosure is manipulated through one of the great veins 24, 32 into the right atrium 39. Once inside the right atrium 39, any of the devices of the present disclosure passes through the right atrial appendage 38. The wall of the right atrial appendage 38 is punctured at the apex 40, and the catheter advances into the pericardial cavity 54. Other transvascular right heart routes to the pericardial cavity are envisioned.

[0080] The wall of the right atrial appendage can be punctured by any of the devices of the present disclosure itself or by an instrument (e.g., a guide wire) passing through the lumen of any of the devices of the present disclosure, such as over a wire. Further, any of the aforementioned devices can pass through the opening in the wall of the atrial appendage into the pericardial space, or an instrument passing through the lumen of any of the devices of the present disclosure can be presented into the pericardial cavity 54. These details depend on the procedure being performed and the type of previously disclosed devices being employed.

[0081] As shown in FIG. 7, a steerable catheter 129 is used and extends through the IVC, through the RA, into the RAA, and then into the pericardial cavity 54. The steerable catheter has a plurality of steerable segments. In some embodiments, the steerable catheter that guides the incision device 200 may have a radius of curvature between about 1 inch and about 5 inches with an arc length between about 90° and about 180°. As shown in FIG. 7, the incision device 200 starts the incision path 175 at the starting point 160 and ends at the ending point 180. At least a portion of the apical layer of the serous pericardium 55, the fibrous pericardium 56, and the pericardial adipose tissue 59 are separated along the incision path 175. In a heart having a dysfunction treatable by this method, one or more incisions along the length separate the pericardium radially around the incision line of the incision path 175 without removal of pericardial tissue. One or more incision paths 175 can be created, and different incision paths of various lengths can be used to reduce pericardial constriction. In one embodiment, the incision path 175 and its length are determined operably. Other incision paths and lengths can be used.

[0082] In one embodiment, the device of the present disclosure further comprises at least one nerve detection device. In one embodiment, the at least one nerve detection device is located on the flexible catheter 129. In one embodiment, the at least one nerve detection device is located adjacent to the incision assembly 101. In one embodiment, the at least one nerve detection device is located on the introducer / dilator 115. In one embodiment, the at least one nerve detection device is located on the incision member 103.

[0083] A kit is provided that includes any one of the medical devices, sheath 130, guidewire 113, and introducer / dilator 115 of the present disclosure.

[0084] Any one of the devices of the present disclosure may further comprise at least one nerve stimulation device. In one embodiment, the at least one nerve stimulation device is located on the catheter 129. In one embodiment, the at least one nerve stimulation device is located adjacent to the cutting device. In one embodiment, the at least one nerve stimulation device is located on the dilator / introducer 115. In one embodiment, the at least one nerve stimulation device is located on the incision surface.

[0085] Certain embodiments of the present disclosure are illustrated with reference to specific combinations of elements, but various other combinations may also be provided without departing from the teachings of the present disclosure. Accordingly, the present disclosure should not be construed as limited to the specific exemplary embodiments described herein and illustrated in the figures, but may also encompass elements of the various illustrated embodiments and combinations of their aspects.

Claims

1. A pericardial tissue dissection device (200), An extended body (129) having a proximal end, a distal end, and a longitudinal axis, The cutting assembly (101) is connected to the distal end, wherein the cutting assembly comprises a cutting member (103) aligned with the longitudinal axis, and at least a portion of the cutting member is configured to extend reversibly laterally from the extended body, A pericardial tissue cutting device, wherein the cutting member comprises a first end and a second end, the first end and the second end being coupled to the cutting assembly.

2. The pericardial tissue incision device according to claim 1, further comprising an actuator (422) operably coupled to the incision assembly, wherein the actuator traverses parallel to the longitudinal axis from a first configuration disengaged from the incision member to a second configuration engaged with the incision member, so that in the second configuration the incision member extends laterally from the extended body.

3. The pericardial tissue cutting device according to claim 2, wherein the actuator is a rigid rod or wire.

4. The pericardial tissue cutting device according to claim 1, wherein the cutting member is generally planar.

5. The pericardial tissue cutting device according to claim 1, wherein at least a portion of the cutting member is a sharp edge, or at least a portion of the cutting member is capable of conducting electric current or radio frequency energy.

6. The pericardial tissue cutting device according to claim 1, wherein the extended body is provided with an opening (123), and the cutting member is configured to extend reversibly laterally from the opening.

7. The pericardial tissue cutting device according to claim 1, wherein the cutting member has a sharp edge having at least a portion thereof that is capable of conducting electric current or radiofrequency energy sufficient to separate pericardial tissue.

8. The pericardial tissue cutting device according to claim 1, wherein the cutting member is rigidly flexible.

9. The pericardial tissue cutting device according to claim 1, further comprising a stabilizing member (120) configured to extend reversibly laterally from the extended main body.

10. The pericardial tissue incision device according to claim 1, further comprising a retractable sheath (130) covering the incision assembly.

11. The pericardial tissue cutting device according to claim 10, wherein at least a portion of the retractable sheath includes a radiopaque material.

12. The pericardial tissue incision device according to claim 1, further comprising an introducer or dilator (115) adjacent to the distal end of the incision assembly.

13. The pericardial tissue incision device according to claim 12, wherein the introducer or the dilator receives a guidewire.

14. The pericardial tissue incision device according to claim 12, wherein at least a portion of the introducer or the expander includes a radiopaque material.

15. The pericardial tissue incision device according to claim 1, further comprising a visualization means.

16. The pericardial tissue cutting device according to claim 1, wherein the pericardial tissue cutting device is sterile.

17. The pericardial tissue dissection device according to claim 1, further comprising a controller (1000) engaged with the dissection assembly.

18. The pericardial tissue cutting device according to claim 17, wherein the controller is configured to provide at least one of the rotation of the extended body, the extension of the cutting device or stabilizing member, and the retraction of the cutting device, and to energize the cutting device.

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