Pericardiotomy device having an aspiration device

Abstract

A medical device is provided. The medical device includes a multi-lumen catheter. The device also includes an incision device operably coupled to the distal end of the multi-lumen catheter. The incision device includes an incision channel defined along the incision device. The device further includes one or more suction devices adjacent to the incision channel. The device still further includes an incision surface disposed within the incision channel. The incision surface is configured to move between a contracted position and a deployed position. When the incision surface is in the contracted position, the incision surface is disposed within the incision channel. When the incision surface is in the deployed position, the incision surface at least partially protrudes from the incision channel.

Description

Technical Field

[0001] The present disclosure is directed to devices and methods for pericardiotomy. The devices and methods are generally applicable to the treatment of heart failure (e.g., heart failure with preserved ejection fraction (HFpEF), or heart failure with reduced ejection fraction (HFrEF)) by introducing one or more incisions into the pericardium (e.g., the parietal lamina).

Background Art

[0002] Pericardial constraint is a normal physiological process that becomes excessive in some patients with heart failure, for example, with preserved ejection fraction (HFpEF), and causes insufficient right heart volume at fullness, thereby compressing and overpressurizing the left heart during physical activity in these patients. When left heart pressure increases, (blood) returns to the lungs, causing these patients to experience significant dyspnea (dyspnea on exertion) when attempting minimal activity. 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 constraint.

Summary of the Invention

Means for Solving the Problems

[0003] In one embodiment, a medical device is provided for creating an incision extending within the pericardium. The device includes a multi-lumen catheter including at least one lumen, a longitudinal axis, a proximal end, and a distal end. The device includes an incision device operably coupled to the distal end of the multi-lumen catheter. The incision device includes an incision channel defined along the incision device. The device also includes one or more suction devices adjacent to the incision channel. The one or more suction devices are configured to engage pericardial tissue. The device further includes an incision surface disposed within the incision channel. The incision surface is configured to move between a retracted position and a deployed position. When the incision surface is in the retracted position, the incision surface is disposed within the incision channel. When the incision surface is in the deployed position, the incision surface at least partially protrudes from the incision channel.

[0004] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the device also includes an incision device activation mechanism configured to move the incision surface between a retracted position and a deployed position within the human body. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more suction devices are positioned in a row along the incision channel. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more suction devices are positioned in a first row and a second row, each of the first row and the second row being on opposite sides of the incision channel.

[0005] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the first row of one or more suction devices and the second row of one or more suction devices are parallel. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the first row of one or more suction devices and the second row of one or more suction devices each have the same number of suction devices. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the first row of one or more suction devices defines a first row length, the second row of one or more suction devices defines a second row length, and at least one of the first row length or the second row length is the same length as the incision length of the incision surface.

[0006] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the first row of one or more suction devices defines a first row length, the second row of one or more suction devices defines a second row length, and the first row length and the second row length are the same length as the incision length of the incision surface. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the first row of one or more suction devices defines a first row length, the second row of one or more suction devices defines a second row length, and at least one of the first row length or the second row length is a length greater than the incision length of the incision surface.

[0007] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the first row of one or more suction devices defines a first row length, the second row of one or more suction devices defines a second row length, and the first row length and the second row length are lengths greater than the incision length of the incision surface. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, one or more suction devices are configured to receive a suction force after a catheter is placed within the pericardium of a human body.

[0008] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the suction force is received from a vacuum source connector. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the vacuum source connector is a tube connected to a vacuum source. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the vacuum source is a vacuum.

[0009] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is configured to be movable between a retracted position and a deployed position after disposing an incision device within the pericardium of a human body. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is a blade.

[0010] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is an electrode. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface comprises a blade and an electrode. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the electrode is configured to receive an electric current and / or radiofrequency energy to ablate, cauterize, vaporize, and / or separate tissue.

[0011] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is a wire. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is a shape memory wire configured to move into a deployed position after moving a sheath. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the wire in the deployed position defines a protrusion from an incision channel, and the electrode is positioned on the wire adjacent to a base of the protrusion.

[0012] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the wire comprises a drawn filled tube. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the wire includes a core within a shell, and the shell is less conductive than the core.

[0013] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the wire includes a core within a shell, the shell is nitinol, and the core is silver. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision plane comprises a nitinol frame.

[0014] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, after the incision is formed within the pericardium, at least a portion of the incision plane extends through the incision. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision plane is connected to an energy source connector that electrically drives the incision plane. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the energy source connector is a wire connected to an energy source. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the energy source is a battery or a generator.

[0015] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the multi-lumen catheter is steerable. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the multi-lumen catheter is radiopaque. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the device includes an introducer positioned near the distal end of the multi-lumen catheter. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the introducer is radiopaque.

[0016] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one lumen includes a guidewire lumen. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the device includes a guidewire slidably positioned within the guidewire lumen.

[0017] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is positioned to incise tissue after being positioned within the human body when the incision surface is in the deployed position. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, when the incision surface projects laterally, it faces away from the distal end of the multi-lumen catheter and towards the proximal end.

[0018] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, when the incision surface projects laterally, it is substantially parallel to the multi-lumen catheter. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, when the incision surface moves between the retracted position and the deployed position, it remains substantially parallel to the longitudinal axis along the multi-lumen catheter.

[0019] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the device includes one or more stabilization members configured to maintain a multi-lumen catheter at a given location within the human body. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more stabilization members are configured to move between a stabilization collapsed position and a stabilization deployed position. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more stabilization members are moved from the stabilization collapsed position to the stabilization deployed position after the multi-lumen catheter has been positioned within the human body.

[0020] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more stabilization members are wires, loops, or shape memory metals. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more stabilization members are one or more inflatable structures. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more stabilization members are positioned at approximately 180 degrees from the incision plane when the incision plane is in the deployed position.

[0021] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the device includes a sheath configured to movably cover the incision channel. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the sheath is configured to cover the incision channel when the multi-lumen catheter is not positioned within the human body. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the sheath is radiopaque.

[0022] In some exemplary embodiments, alone or in combination with any of the foregoing 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 foregoing exemplary embodiments, the sheath is configured to removably cover one or more suction devices. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the sheath is configured to removably cover one or more stabilization members.

[0023] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the sheath is configured to removably cover the incision site. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the sheath is configured to removably cover at least two of one or more suction devices, one or more stabilization members, or the incision site. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the sheath is configured to removably cover one or more suction devices, one or more stabilization members, and the incision site.

[0024] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the sheath includes at least one opening adjacent to the distal end of the sheath. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the distal end of the sheath is transversely cuttable along the multi-lumen catheter so as to be aligned with at least one opening of the multi-lumen catheter.

[0025] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the distal end of the sheath and at least a portion of at least one opening of the multi-lumen catheter are radiopaque, aligning the distal end of the sheath and at least one opening of the multi-lumen catheter. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion around at least one opening of the sheath and at least a portion around at least one opening of the multi-lumen catheter are radiopaque, aligning each of their openings.

[0026] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, one or more openings of the sheath are transversable along the multi-lumen catheter, enabling an actuator to project one or more stabilizing members laterally through both the multi-lumen catheter and the sheath. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the actuator moves the incision plane and one or more stabilizing members through one or more openings of the multi-lumen catheter and one or more openings of the sheath, either simultaneously or sequentially.

[0027] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the incision plane is reversibly adjustable laterally with respect to the longitudinal axis of the multi-lumen catheter between various angles. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, a plurality of radiopaque markers are provided along the edge of the incision channel, and the position of the incision plane can be determined based on the radiopaque markers.

[0028] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the incision device is radiopaque. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of one or more suction devices is radiopaque. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of one or more stabilization members is radiopaque.

[0029] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of at least two of the incision device, one or more suction devices, or one or more stabilization members is radiopaque. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the incision device, one or more suction devices, and one or more stabilization members is radiopaque.

[0030] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is configured to have sufficient force to puncture the pericardial tissue when the incision surface is moved from the retracted position to the deployed position. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is assisted in incising into the pericardium by the suction force of one or more suction devices. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is assisted in incising into the pericardium by the force provided by one or more stabilization members.

[0031] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is assisted in incising into the pericardium by the suction force of one or more suction devices and the force provided by one or more stabilization members.

[0032] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the incision device comprises an electrode. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the incision surface comprises an electrode. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the electrode is a wire. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the wire is shaped as one or more arcs that project laterally through a multi-lumen catheter along a longitudinal axis.

[0033] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface comprises a scalpel. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface comprises a needle. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the needle on the incision surface can be moved between a retracted position and a deployed position.

[0034] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the scalpel comprises an electrode. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the needle comprises an electrode. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one electrode is electrically coupleable to a source of high frequency energy or current sufficient to cut, separate, clamp, or evaporate a portion of a wall side plate.

[0035] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device is sterilized. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device can be sterilized by gamma sterilization. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device can be sterilized by ethylene oxide sterilization. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device can be sterilized by autoclave sterilization. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device can be sterilized by electron beam sterilization.

[0036] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the cutting 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 foregoing exemplary embodiments, the device includes at least one nerve detection device. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one nerve detection device is located on a multi-lumen catheter. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one nerve detection device is located adjacent to the cutting device. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one nerve detection device is located on the puncture tip. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one nerve detection device is located on the cutting surface.

[0037] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the apparatus includes at least one nerve stimulation device. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one nerve stimulation device is located on a multi-lumen catheter. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one nerve stimulation device is located adjacent to a cutting device. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one nerve stimulation device is located on a puncture tip. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one nerve stimulation device is located on a cutting surface.

[0038] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the kit is provided including a medical device, a guide wire, and a puncture tip.

[0039] In another example, a method of creating an incision extending within the pericardium is provided. The method includes placing a multi-lumen catheter within a human. The multi-lumen catheter includes at least one lumen, a longitudinal axis, a proximal end, and a distal end. The method also includes positioning a cutting device within the pericardium. The cutting device is operably coupled to the distal end of the multi-lumen catheter, and the cutting device includes a cutting channel defined along the cutting device. The method also includes providing a suction force to one or more suction devices adjacent to the cutting channel. The one or more suction devices are configured to engage pericardial tissue. The method further includes moving a cutting surface disposed within the cutting channel from a retracted position to a deployed position. When the cutting surface is in the retracted position, the cutting surface is disposed within the cutting channel. When the cutting surface is in the deployed position, the cutting surface protrudes at least partially from the cutting channel. The incision is made into the wall siding of the pericardium after movement of the cutting surface into the deployed position.

[0040] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, one or more suction devices engage the wall side plate when an incision is made by the incision plane. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, creating at least one incision length through the pericardium causes a reduction in the pressure applied to the heart by the pericardium. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision length is made in at least one of the wall side plate or the fibrous layer of the pericardium. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision length is made in adipose tissue or fat deposits. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one incision length is along the length or perimeter of only the wall side plate of the pericardium. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one incision length is made in the wall side plate from the front to the back of the heart. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one incision length is made in the wall side plate from the posterior base to the apex of the heart.

[0041] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one incision length is made in the wall side plate from the posterior right atrium to the apex of the heart. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one incision length is made in the wall side plate from the left ascending aorta to the apex of the heart. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one incision length is made in the wall side plate from the right ascending aorta to the apex of the heart. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least one incision length is made transversely around the heart in the wall side plate.

[0042] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method includes piercing the pericardial tissue and providing an access point into the pericardial space before creating the incision length. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method includes providing sub-xiphoid access to the pericardium prior to piercing. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method includes providing transvascular access to the pericardium prior to piercing.

[0043] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method includes moving the incision surface from the deployed position to the retracted position before removing the incision device from the pericardium. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method includes piercing into the pericardium by an introducer. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method includes inserting a guide wire into the pericardial space after piercing. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method includes stabilizing the incision device within the pericardium.

[0044] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision device is stabilized by one or more stabilization members. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more stabilization members are configured to move between a stabilized retracted position and a stabilized deployed position. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more stabilization members are moved from a stabilized retracted position to a stabilized deployed position after the multi-lumen catheter has been positioned within the human body. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more stabilization members are wires, loops, or shape memory metals.

[0045] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more stabilization members are one or more inflatable structures.

[0046] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method includes moving a sheath from a first position covering an incision channel to a second position exposing the incision channel. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the sheath is configured to cover the incision channel when the multi-lumen catheter is not positioned within the human body. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, one or more openings of the sheath are transversable along the multi-lumen catheter, enabling an actuator to project one or more stabilization members laterally through both the multi-lumen catheter and the sheath.

[0047] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method includes sterilizing the incision device. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision device is sterilized by electron beam sterilization. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision device is sterilized by gamma sterilization. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision device is sterilized by ethylene oxide sterilization. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision device is sterilized by autoclave sterilization.

[0048] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method also includes determining the position of the incision device within the pericardium by ultrasound. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, creating at least one incision length is determined in response to a signal indicative of a reduction in cardiac restraint.

[0049] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, creating at least one incision length is determined in response to a signal indicative of a reduction in cardiac restraint and creating at least one incision length is repeated. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method also includes, after creating at least one incision length, confirming the position of the distal end of the multi-lumen catheter device and repeating the step of creating at least one incision length in response to a signal indicative of a reduction in cardiac restraint and confirming the position of the distal end.

[0050] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method also includes moving a dissection plane between a contracted position and a deployed position within a human body. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, each of the one or more suction devices is a suction cup.

[0051] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, a vacuum source is provided to each of the one or more suction devices. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more suction devices are positioned in a row along a dissection channel. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more suction devices are positioned in a first row and a second row, each of the first row and the second row being on opposite sides of the dissection channel. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the first row of the one or more suction devices and the second row of the one or more suction devices are parallel.

[0052] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the first row of the one or more suction devices and the second row of the one or more suction devices each have the same number of suction devices. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the first row of the one or more suction devices defines a first row length, the second row of the one or more suction devices defines a second row length, and at least one of the first row length or the second row length is the same length as the dissection plane length of the dissection plane.

[0053] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, a first row of one or more suction devices defines a first row length, a second row of one or more suction devices defines a second row length, and the first row length and the second row length are the same length as the incision length of the incision surface. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, a first row of one or more suction devices defines a first row length, a second row of one or more suction devices defines a second row length, and at least one of the first row length or the second row length is a length greater than the incision length of the incision surface.

[0054] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, a first row of one or more suction devices defines a first row length, a second row of one or more suction devices defines a second row length, and the first row length and the second row length are lengths greater than the incision length of the incision surface.

[0055] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the suction force is received from a vacuum source connector. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the vacuum source connector is a tube connected to a vacuum source.

[0056] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is a blade. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is an electrode. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface comprises a blade and an electrode. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the electrode is configured to receive current and / or radiofrequency energy to ablate, burn, vaporize, and / or separate tissue.

[0057] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the method also includes providing an electric current to the incision surface. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is a wire. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is a shape memory wire configured to move into a deployed position after the sheath is moved. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, when the wire in the deployed position defines a protrusion from the incision channel, the electrode is positioned on the wire adjacent to the base of the protrusion.

[0058] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, after the incision is formed within the pericardium, at least a portion of the incision surface extends through the incision. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is connected to an energy source connector that electrically drives the incision surface. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the energy source connector is a wire connected to an energy source. In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the energy source is a battery or a generator.

[0059] In another exemplary embodiment, a medical device is provided. The medical device includes an incision device operably coupled to the distal end of a catheter. The incision device includes an incision channel defined along the incision device. The medical device also includes one or more suction devices adjacent to the incision channel. The one or more suction devices are configured to engage pericardial tissue. The medical device further includes an incision surface disposed within the incision channel. The incision surface is configured to move between a retracted position and a deployed position. When the incision surface is in the retracted position, the incision surface is disposed within the incision channel. When the incision surface is in the deployed position, the incision surface at least partially protrudes from the incision channel.

[0060] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device also includes an incision device actuation mechanism configured to move the incision surface between a retracted position and a deployed position.

[0061] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more suction devices are positioned in a row along the incision channel.

[0062] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the one or more suction devices are positioned in a first row and a second row, each of the first row and the second row being on opposite sides of the incision channel.

[0063] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the first row of the one or more suction devices and the second row of the one or more suction devices are parallel.

[0064] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, a first row of one or more suction devices defines a first row length, a second row of one or more suction devices defines a second row length, and at least one of the first row length or the second row length is the same length as the incision length of the incision surface.

[0065] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, a first row of one or more suction devices defines a first row length, a second row of one or more suction devices defines a second row length, and at least one of the first row length or the second row length is a length greater than the incision length of the incision surface.

[0066] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the suction force is received from a vacuum source connector.

[0067] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is configured to be movable between a contracted position and a deployed position after the incision device is disposed.

[0068] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the incision surface is at least one of a blade or an electrode.

[0069] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the electrode is configured to receive current and / or radio frequency energy to ablate, burn, vaporize, and / or separate tissue.

[0070] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the catheter is steerable.

[0071] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, at least a portion of the medical device is radiopaque.

[0072] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device also includes an introducer positioned near the distal end of the cutting device.

[0073] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device also includes one or more stabilization members configured to maintain the cutting device in a given position.

[0074] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device also includes a sheath configured to movably cover the cutting channel.

[0075] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device is sterilized.

[0076] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the medical device also includes a controller engaged with the cutting device.

[0077] In some exemplary embodiments, alone or in combination with any of the foregoing exemplary embodiments, the controller is configured to provide at least one of suction to one or more suction devices, movement of the blade between a retracted position and a deployed position, movement of a retractable cutting device along the cutting device, energy to the cutting device, or movement of one or more stabilization members.

[0078] In another exemplary embodiment, a method of operating a medical device is provided. The method includes providing a medical device of any of the embodiments disclosed herein in engagement with a controller. The method also includes controlling at least one of the supply of suction to one or more suction devices, the movement of a blade between a retracted position and a deployed position, the movement of a retractable incision device along an incision device, the supply of energy to an incision device, or the movement of one or more stabilization members.

[0079] To understand and view how the present disclosure may be actually implemented, embodiments will be described by way of non-limiting examples only with reference to the accompanying drawings.

Brief Description of the Drawings

[0080]

Figure 1A

Figure 1B

Figure 1C

Figure 2A

Figure 2B

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 5

Figure 6

Figure 7

[0081] The present disclosure provides a catheter-based therapy called transcatheter alleviation of pericardial restraint (TAPR) that can reduce pericardial restraint by incising or opening the pericardium for the purpose of improving the outcome of patients with heart failure, such as HFpEF or HFrEF, and reducing HF recurrence associated therewith. In one embodiment, the present disclosure provides an apparatus having a hidden / intermediate-facing incision surface for accessing and modifying the pericardium of a subject to reduce pericardial restraint and / or resolve heart failure. The present disclosure further provides a method of treating heart failure using the apparatus of the present disclosure.

[0082] 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 medical arts and surgery, including, for example, the space, cavity or liquid medium generally disposed between the parietal and visceral pericardium of the mammalian heart.

[0083] As used herein, the term "pericardial tissue" includes its ordinary and customary meanings to those skilled in the medical arts and surgical arts, including, for example, tissue associated with the pericardium.

[0084] As used herein, the term "parietal lamina" includes, unless otherwise specified, at least the serosal and fibrous layers of the parietal pericardium and, optionally, adipose tissue contained between, below, above, or within said layers. Further, the term "parietal lamina" includes its ordinary and customary meaning to those of skill in the medical arts and surgical arts and generally refers to a tissue layer that is disposed adjacent to adipose tissue, for example, within and outside the pericardial cavity and on the surface of the visceral lamina of the pericardium, and includes adipose tissue.

[0085] As used herein, the term "pericardial constriction" includes any term that indicates underfilling caused by excessive force from the pericardium.

[0086] As used herein, the term "incision surface" includes one or more of the edge of a sharp blade or the surface of an electrode configured to receive sufficient electrical current or radiofrequency (RF) energy to ablate, burn, vaporize, or separate tissue. The incision surface can include both a sharp edge and an electrode.

[0087] As used herein, the terms "reverse incision" and "pullback incision" are used interchangeably and refer to a method involving the presentation of a cutting surface to tissue, the method referring to the cutting of a surface adjacent to the distal end of a multi-lumen catheter device or catheter and the application of a directional force sufficient to cut or separate tissue, the directional force being substantially in a direction toward the proximal end of the multi-lumen catheter device or catheter, for example, by pulling the multi-lumen catheter device or catheter while the cutting surface is engaged with the tissue.

[0088] As used herein, the term "incision" refers to tissue disruption, such as a knife blade, e.g., a scalpel blade, or a sharp cutting incision of the type associated with an electrosurgical device that provides an electric current to a conductive material or electrode sufficient to disrupt tissue. The term "incision" as used herein includes "filleting", "slicing", and / or the like.

[0089] As used herein, the term "incision length" includes a non-zero distance of a cut or incision that, for example, begins at a first point (e.g., a target point) and ends at a second point (e.g., an end point). The incision length can be linear, non-linear, and / or a plurality of linear and / or non-linear lengths that intersect or do not intersect around a curved surface or non-planar perimeter such as the heart.

[0090] As used herein, the terms "decompression" and "constraint relaxation" include their ordinary and customary meanings to those skilled in the medical arts and surgical arts.

[0091] As used herein, the phrase "reduced ejection fraction" includes its ordinary and customary meaning to those skilled 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 a normal or near-normal left ventricular (LV) ejection fraction (LVEF, ≧50%).

[0092] As used herein, the phrase "reduced ejection fraction" includes its ordinary and customary meaning to those skilled in the medical arts and surgical arts, and includes, for example, a clinical syndrome associated with ventricular filling impairment, or blood ejection impairment, or both, in which a patient exhibits a left ventricular ejection fraction (LVEF) of 40% or less, progressive left ventricular dilation, and / or adverse cardiac remodeling, and / or mitral valve insufficiency.

[0093] As used herein, the term "cardiac dysfunction" includes its ordinary and customary meaning to those skilled in the medical arts and surgical arts, and includes, for example, heart failure or congestive heart failure.

[0094] As used herein, the term "incision device" includes a device having an incision surface, such as the edge of a blade or the surface of an energized electrode.

[0095] As used herein, the terms "pericardiotomy assembly" and "incision assembly" are used interchangeably and refer to an assembly that includes a pericardiotomy device.

[0096] As used herein, the term "multilumen catheter device" includes a catheter configured with at least one lumen, including a medical instrument, a medical device, or a component thereof, such as a pericardiotomy device.

[0097] As used herein, "first," "second," and the like are used only to describe elements in relation to each other and are in no way meant to enumerate a specific orientation of an article or device, nor to indicate or imply a required or requested orientation of an article or device, nor to indicate or imply a required or requested configuration of an article or device, nor to specify the manner in which the articles or devices described herein are used, arranged, transitioned from different configurations, or positioned during use.

[0098] As used herein, when an element is referred to as two structures or layers and is said to be "adjacent" and "coupled," the two structures or layers are in proximity to each other without an intervening open space therebetween.

[0099] As used herein, when an element is said to be "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.

[0100] As used herein, when an element is said to be "directly coupled" or "direct" to another element, no other elements or intervening elements are present.

[0101] As used herein, the term "operatively coupled" includes direct coupling, and indirect coupling through another component, element, circuit, or structure, and / or indirect coupling between items through intervening items.

[0102] As used herein, the term "nerve stimulation device" refers to a device capable of applying a potential to a nerve, such as a pacing probe that stimulates the phrenic nerve and causes an observable respiratory disorder, in order to cause an observable effect that is directly or indirectly correlated with the applied potential.

[0103] As used herein, the term "nerve detection device" refers to a device capable of establishing the position or placement of at least a portion of a nerve and providing position or proximity information that has no or substantially no physical effect or stimulation on the nerve, such as an impedance sensor that detects an electric field generated by a nerve and directly or indirectly correlates the position or proximity of the nerve to the impedance sensor.

[0104] As used herein, the term "actuator" includes a mechanism for triggering an operation.

[0105] As used herein, the term "controller" includes a device having an actuator.

[0106] As used herein, the term "biasing member" includes a device that can be configured in a stored energy state and a released energy state, such as a spring.

[0107] As used herein, the term "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 a cut surface positioned within the pericardial cavity from rolling, twisting, buckling, and / or vibrating, for example, before or during use.

[0108] As used herein, the term "puncture tip" includes a non-traumatic object suitable for puncturing or penetrating tissue without substantial trauma or bleeding in the vicinity of the puncture (picture) or penetration.

[0109] Several exemplary incision devices for making an incision through the pericardium or the parietal plate of the pericardium are described herein. These embodiments share the feature that they can be delivered intravascularly through the right atrial appendage (RAA), inferior vena cava (IVC), superior vena cava (SVC), coronary sinus (CS), right atrium (RA), left atrial appendage (LAA), or right ventricle (RV). Alternatively, the device can be delivered into the pericardial cavity through a subxiphoid approach via catheter access.

[0110] Referring to FIGS. 1A, 1B, 1C, and Section 1B, the layers of the heart wall of the heart 50 are shown, from the inside out, as the endocardium 51, myocardium 52, epicardial adipose tissue 57, serous pericardium visceral plate 53, pericardial cavity 54, serous pericardium parietal plate 55, and fibrous pericardium 56, and pericardial adipose tissue 59. In one embodiment, the device of the present disclosure is configured for introduction into the pericardial cavity 54 and for incising a tissue layer generally disposed adjacent to and including adipose tissue within and outside the pericardial cavity and on the surface of the visceral plate 53 of the pericardium.

[0111] Referring now to FIGS. 2A, 2B, and 3, in one embodiment, the retractable incision device 300 of the present disclosure includes a flexible catheter 129 having a distal end, at least one lumen, and a longitudinal axis, an incision device 140 coupled to the distal end of the catheter, and an introducer 115 coupled to and protruding from the incision device 140. In one embodiment, the introducer 115 includes a puncture tip. In one embodiment, at least a portion of the distal end of the flexible catheter 129 is radiopaque. In one embodiment, at least a portion of the distal end of the incision assembly (e.g., the sharp edge of the incision surface 310) is radiopaque. In one embodiment, at least a portion of the distal end of the introducer 115 is radiopaque.

[0112] The incision device 140 defines an incision channel 120 (shown in FIG. 3) configured to receive a retractable incision device. While the incision surface 310 of the retractable incision device is shown in FIG. 2B, various other retractable incision devices discussed herein can also be disposed within the incision channel. The retractable incision device can be moved along the incision channel by an internal actuator (e.g., an incision device movement actuator). Further, the incision surface 310 of the retractable incision device 300 can be held in a retracted position by a sheath (e.g., the retractable incision device 300 can be formed from a shape memory material that protrudes from the incision channel when the sheath does not cover the retractable incision device).

[0113] FIG. 2A illustrates the incision surface 310 of the retractable incision device 300 in the retracted position. As discussed herein, the incision surface 310 is configured to move between a contracted position and a deployed position. In the contracted position, the incision surface 310 is disposed within the incision channel (e.g., does not protrude from the incision channel). In the deployed position, the incision surface 310 at least partially protrudes from the incision channel. Thus, in the deployed position, the incision surface 310 is exposed from the catheter.

[0114] FIG. 2B illustrates the incision surface 310 of the retractable incision device 300 in the deployed position. As discussed herein, the incision surface 310 is configured to move between a contracted position and a deployed position. In the contracted position, the incision surface 310 is disposed within the incision channel (e.g., does not protrude from the incision channel). In the deployed position, the incision surface at least partially protrudes from the incision channel. As discussed in more detail herein, the device 100 can have one or more stabilizing members 205 configured to maintain the position of the incision device 140 during deployment.

[0115] The various embodiments of the medical device discussed herein may have a stabilizing member 205. The stabilizing member 205 can be independently user-controlled by advancing the actuating wire distally towards the tip of the introducer 115 such that the member 205 extends laterally away from the multi-lumen catheter. In one embodiment, two or more stabilizing members 205 are positioned radially around the assembly. In one embodiment, two or more stabilizing members 205 are positioned radially around the assembly and spaced apart by approximately 120 degrees. In one embodiment, two or more stabilizing members 205 are longitudinally offset from the incision plane and minimize or eliminate pushing the device through the newly incised slit in the wall side plate 55 of the pericardium 60 as it is formed. The stabilizing member 205 can be a flexible rod or strip, or an inflatable structure such as a balloon that can be inflated with air or liquid (saline).

[0116] One or more stabilizing members 205 are configured to move between a stabilizing retracted position and a stabilizing deployed position after the multi-lumen catheter is positioned within the human body.

[0117] The medical device 100 may also include a sheath configured to movably cover the incision channel. The sheath is configured to cover the incision channel when the multi-lumen catheter is not positioned within the human body. After the multi-lumen catheter is positioned (e.g., the incision device is located at the location where the incision of the wall side plate 55 of the pericardium 60 is made), the sheath may be actuated to expose the incision channel. In some embodiments, the sheath may not be movable and simply have a slit that allows the knife to be pushed out. The sheath can also hold one or more stabilizing members in a stabilizing storage position during movement (e.g., the sheath moves to expose the stabilizing member(s) after placement in the pericardium).

[0118] As shown in FIG. 3, the incision device 140 includes a retractable incision device 300. The retractable incision device 300 includes one or more suction devices 305 and an incision surface 310. The one or more suction devices 305 can be suction cups configured to engage the wall of the pericardial cavity 54. As shown, the one or more suction devices 305 can include one or more rows of suction devices adjacent to the incision channel 120. For example, the medical device may have two rows on opposite sides of the incision channel 120. Each of the rows of suction devices 305 can be at least as long as the incision surface 310 (e.g., the suction devices 305 may align the incision channel with respect to at least the length of the incision surface 310).

[0119] The rows of suction device(s) 305 may be folded with respect to each other for transport. For example, the suction device(s) 305 may be folded when a sheath covers the suction device(s) 305.

[0120] The one or more suction devices 305 can be connected to a vacuum source by a vacuum source connector 320. The vacuum source connector 320 provides a suction force to the one or more suction devices 305 that engages the wall of the pericardial cavity. The suction force can be sufficient to maintain the position of the catheter 129 during the incision process (as discussed with reference to FIGS. 4A - C). The stabilization member 205 shown in FIG. 2B can also assist the one or more suction devices 305 in maintaining their connection to the pericardial cavity (e.g., the stabilization member 205 can engage the opposing walls of the pericardial cavity).

[0121] Suitable materials for the suction device 305 can include, but are not limited to, thermoplastic elastomers, EPDM rubber, thermosetting rubber, polysilicon, polysiloxane, polyurethane, polyvinyl chloride, styrene - ethylene - butylene - styrene, and polytetrafluoroethylene, derivatives, copolymers, and mixtures thereof. For example, the suction device(s) 305 can be suction cup(s) made of silicone.

[0122] The incision surface 310 can be any means that causes an incision within the wall side plate 55. The incision surface 310 can be a needle that moves between a contracted position and a deployed position. In such embodiments, the needle can include a sharp edge configured to puncture the wall side plate 55 of the pericardium. The incision surface 310 can also be a blade configured to cause an incision. The needle can be moved through the needle lumen of the catheter 129. The needle may be curved to engage the wall side plate 55. The needle can advance along the needle lumen after placement of the cutting device within the pericardial cavity 54. The catheter 129 may also have a wire lumen having a guide wire that provides additional stability to the catheter and the cutting device.

[0123] The incision surface 310 can be linear to cause a linear incision. The suction device(s) 305 maintains the position of the cutting device 140 and enables the incision to be linear. In some cases, the sharp edge of the incision surface 310 may be curved such that when moved into the deployed position (e.g., the incision surface 310 is curved towards the wall side plate 55), the blade is able to puncture the pericardial tissue (e.g., puncture into the wall side plate 55). The incision surface 310 is structured to have sufficient force to puncture the pericardial tissue when the incision surface 310 moves from the contracted position to the deployed position. The incision surface 310 may face away from the distal end and towards the proximal end of the multi-lumen catheter (e.g., when the incision surface 310 is curved) when protruding laterally (e.g., in the deployed position).

[0124] Additionally, or alternatively, the incision surface 310 can be an electrode configured to receive sufficient electrical current or radiofrequency (RF) energy to ablate, burn, vaporize, or separate tissue. For example, as shown in FIG. 3, the incision surface 310 can be connected to an electrical power source by an electrical supply connector 315. The electrical current provided by the incision surface 310 can be turned off and on by a controller (e.g., the electrical current provided to the incision surface 310 can be provided after positioning the catheter within the pericardial cavity 54). In some embodiments, the incision surface 310 may have both a sharp edge and an electrode.

[0125] The incision surface 310 is fixed along the longitudinal axis such that the incision surface 310 moves only along the transverse axis. The incision surface 310 can be manually moved between a retracted position and a deployed position (e.g., the incision surface 310 may have an actuator attached thereto, and the actuator moves the incision surface 310 along the transverse direction (e.g., is exposed from the catheter in the deployed position). The movement of the incision surface 310 can also be restricted by a sheath that maintains the position of the incision surface 310 within the incision channel. After moving the sheath (e.g., along the catheter 129, in the direction of the proximal end of the catheter 129), the incision surface 310 is no longer restricted and expands into the deployed position. In such embodiments, the incision surface 310 can be a shape memory material and / or an actuated spring.

[0126] In various embodiments, a controller can be provided to actuate the various mechanisms discussed herein. For example, the controller can be a handle having one or more actuation knobs and / or buttons for controlling the catheter and / or its components. For example, the controller can actuate a vacuum source provided to one or more suction devices 305, actuate the supply of an electric current provided to the incision surface 310 (e.g., by the electrical source connector 315), actuate the movement of the retractable cutting device 300, actuate the movement of the catheter, actuate the movement of one or more stabilizing members, and / or actuate the like.

[0127] A method of operating a medical device 100 includes providing the medical device 100 in engagement with a controller and controlling the medical device 100 by, for example, operating any one or a combination of an actuation knob and / or an actuation button to provide at least one of suction to one or more suction devices, movement of a blade between a retracted position and a deployed position, movement of a retractable cutting device along a cutting device, supply of energy to a cutting device, or movement of one or more stabilizing members by the controller. The foregoing method is applicable to any previously disclosed cutting device.

[0128] One or more components of the medical device can be radiopaque so that the medical device can be visualized within the human body using ultrasound. In various embodiments, portions of the retractable cutting device, multi-lumen catheter, and / or introducer can be radiopaque.

[0129] Part or all of the medical device can be sterilized for use. The medical device can be sterilized using various sterilization methods such as electron beam sterilization, gamma sterilization, ethylene oxide sterilization, autoclave sterilization, aseptic manufacturing / packaging. Further, one or more materials used in the medical device may have antibacterial properties or an antibacterial coating.

[0130] The pericardiotomy device, and / or catheter, and / or sheath can be configured such that the total outer diameter (O.D.) introduced into the pericardial cavity is from about 6 Fr (2 mm) to about 30 Fr (10 mm). The pericardiotomy device, and / or catheter, and / or sheath can be configured such that the total outer diameter (O.D.) introduced into the pericardial cavity is from about 6 Fr (2 mm) to about 20 Fr (6.67 mm). The pericardial penetration device, and / or catheter, and / or sheath can be configured such that the total outer diameter (O.D.) introduced into the pericardial cavity is from about 6 Fr (2 mm) to about 15 Fr (5 mm). The pericardial penetration device, and / or catheter, and / or sheath can be configured such that the total outer diameter (O.D.) introduced into the pericardial cavity is from about 6 Fr (2 mm) to about 12 Fr (4 mm). The pericardial penetration device, and / or catheter, and / or sheath can be configured such that the total outer diameter (O.D.) introduced into the pericardial cavity is about 10 Fr (3.33 mm).

[0131] Figures 4A - 4C illustrate the deployed medical device 100. In one embodiment, the device 100 is deployed subxiphoid through percutaneous access, which can be achieved, for example, by directing a needle in a subxiphoid process towards the pericardial cavity or into the patient through a surgical incision in the chest. In another embodiment, the device 100 is deployed intravascularly through the right ventricle. The medical device 100 can advance through the pericardial cavity 54 of the subject in an undeployed configuration where the incision surface 310 is in a retracted position within the incision channel.

[0132] Initial access to the pericardial cavity 54 can be achieved by the introducer 115. Once the medical device is positioned within the pericardial cavity 54, the sheath 130 may cover the incision channel. Since the multi - lumen catheter is positioned within the pericardial cavity 54 at the incision site, the sheath 105 may be removed as shown in FIG. 4A. The sheath can expose the incision device 140, which is still in the retracted position.

[0133] As shown in FIG. 4A, one or more suction devices 305 are configured to engage the wall of the pericardial cavity 54 (e.g., the wall side plate 55). When the sheath is removed (if a sheath is provided), the one or more suction devices 305 receive the suction force from the suction source as described above with reference to FIG. 3. The one or more suction devices 305 engage the pericardial tissue and maintain the incision device 140 against the wall of the pericardial cavity 54 (e.g., as shown in FIG. 4A, the incision device 140 can be substantially parallel to the wall side plate 55).

[0134] As shown in FIG. 4B, one or more stabilization members 205 are also deployed to engage the visceral side plate 53 (e.g., on opposite walls of the pericardial cavity from the aspiration device(s) 305). The stabilization member(s) 205 also maintain the catheter position within the pericardial cavity 54. The stabilization member 205 can be independently user-controlled by advancing the actuation wire distally toward the tip of the introducer 115, which extends the stabilization member 205 laterally away from the medical device 100. The stabilization member 205 can be a flexible rod or strip, or an inflatable structure such as a balloon that can be inflated with air or liquid (saline).

[0135] After positioning the cutting device 140 within the pericardial cavity 54, the cutting surface 310 can be moved from a retracted position to a deployed position as discussed herein. The cutting surface 310 penetrates into the pericardial tissue (e.g., the parietal side plate 55) so as to be able to make an incision along the pericardial tissue using a blade, electrode, and / or the like. The incision length may be based on the length of the cutting surface 310. As shown, the catheter 129 maintains the same position within the pericardial cavity 54 due to the aspiration device(s) and / or the stabilization member(s) 205. Thus, the incision can be a linear incision that is the length of the cutting surface 310 engaging the parietal side plate 55. The multi-lumen catheter 129 remains stationary within the pericardial cavity 54 during the incision by the cutting surface.

[0136] At least a portion of the cutting surface 310 can function as a radiopaque marker that indicates “gathering” of tissue, e.g., due to being overly pulled before a through-incision is achieved. In one embodiment, the back silhouette of the cutting surface can be selectively insulated (since it can be activated to achieve an exit puncture) to avoid ablation damage to adjacent anatomical structures.

[0137] After completing the intended incision, the incision surface 310 returns to the retracted position. The stabilization member(s) 205 can be moved to the stabilization retracted position. The suction force provided by the suction device(s) 305 can be reduced to dissipate the suction between the suction device(s) and the wall side plate. The sheath can be moved to cover the incision channel. Next, the multi-lumen catheter can be removed from the human body without exposing the blade.

[0138] In one embodiment, the puncture for delivering the guide wire into the pericardial cavity is performed through the heart tissue. If a transvascular approach via the RAA, IVC, or SVC is employed, the closure device can then be introduced at the end of the procedure for hemostasis. In one embodiment, the closure device includes outwardly or radially oriented splines deployed in an expanded configuration. When the guide catheter is removed, the splines or radial members of the closure device contract inwardly towards a stress-free state to close, occlude, and / or seal the opening. The closure device is designed such that the pericardiotomy device can pass through and enter the pericardial space.

[0139] In one embodiment, OTW delivery is used for any of the previously disclosed devices, whether through a multi-lumen catheter cross-section, or a "Rapid Exchange" style catheter, or an off-centered attached cannula, or a dedicated lumen of a deflection-resistant catheter, in order to provide the orientation stability of the incision surface to the orientation stability of the wall side plate. In one embodiment, the delivery catheter includes a randomly distributed or pattern-placed radiopaque material for visualization using conventional visualization techniques during use.

[0140] Current ECHO / fluoroscopy may not provide the visualization necessary for certain access applications of the disclosed incision device, for example, where it may be desirable to obtain consistent and repeated guidewire access to the pericardial cavity. Thus, in one embodiment, a multi-lumen catheter 129 coupled to the disclosed incision device includes direct visualization that allows a user to observe in real time the advancement of any of the disclosed incision devices across various tissue layers until a desired position is reached. Changes in tissue layers that may not be visible under ECHO / fluoroscopy can be readily distinguishable under direct visualization, among other anatomical features, such as tissue / blood flow (vascular access), myocardium / pericardium (pericardial cavity access), myocardium / pericardium (epicardial), etc.

[0141] Thus, in one embodiment, the disclosed device discussed above further comprises a light channel within the multi-lumen catheter for optionally housing a lens coupled to an optical fiber cable, together with a light source, such as an LED. In one embodiment, the disclosed method further comprises obtaining visual information during access to, traversing, exiting, and / or incising the pericardial cavity, using, for example, the light channel within the multi-lumen catheter, to optionally house a lens coupled to an optical fiber cable, together with a light source, such as an LED.

[0142] In one embodiment, the puncture for delivering a guidewire into the pericardial cavity 54 is performed through cardiac tissue via a transvascular approach. If a transvascular approach through the RAA, IVC, or SVC is employed, a closure device (e.g., occluder) may then be introduced at the end of the procedure for hemostasis. In one embodiment, the closure device includes outwardly, or radially oriented splines deployed in an expanded configuration. When the guide catheter is removed, the splines, or radial members of the closure device contract inwardly towards a stress-free state of the incision device to close, occlude, and / or seal the opening. The closure device is designed such that the pericardial incision device can pass through and enter the pericardial space.

[0143] The following exemplary occlusion description relates to a transvascular approach through the RAA, IVC, SVC, or CS using one of the foregoing incision devices (e.g., incision device 140). In one embodiment, the introducer / dilator 115 delivers a wire through the heart tissue and into the pericardial cavity. A closure or occlusion device is introduced during the surgery for hemostasis. The closure or occlusion device in one embodiment includes outwardly or radially oriented splines deployed in an expanded configuration. When the guide catheter is removed, the splines, or radial members, of the closure device contract inwardly towards a stress-free state of the incision device to close and seal the opening. The closure device is designed such that the pericardial incision device can pass through and enter the pericardial space.

[0144] Figures 5 and 6 show exemplary intravascular approaches for delivering the incision device of the present disclosure into the pericardial cavity 54. Accordingly, FIG. 5 shows the heart 50 viewed in isolation from the body, having a pericardium 60 or pericardial sac that surrounds the myocardium (i.e., epicardium, myocardium, endocardium). The small space that exists between the myocardium and the pericardium 60 represents the pericardial cavity 54.

[0145] The incision device of the present disclosure can be presented into the pericardial cavity 54. In one embodiment, access is used via the right atrial appendage 38 (RAA), a site suitable for entering the pericardial cavity 54. The right atrial appendage 38 is tangential to and between the pericardium 60 and the epicardium / pericardial adipose tissue 57. In one embodiment, any of the devices of the present disclosure is guided through the right ventricle 39 into the right atrial appendage 38 such that the wall of the right atrial appendage 38 is positioned substantially parallel to the wall of the pericardium 60 so as to be punctured by any of the devices of the present disclosure with substantially no risk of damaging the epicardium or other heart tissue. Other access routes to the pericardial cavity, such as direct "puncture" of the SVC, or the IVC / coronary sinus (CS), and "puncture" into the pericardium can be used.

[0146] In some embodiments, the right atrial appendage 38 is accessed via a conventional vena cava route. FIG. 5 illustrates the entry of any of the devices of the present disclosure into the right atrium 39 via the superior vena cava 24 (SVC). Notch 37 indicates 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 catheter 129 is shown exiting the right atrium 39 at apex 40.

[0147] FIG. 6 illustrates an alternative entry of any of the previously disclosed devices into the right atrium 39 via the inferior vena cava 32 (IVC). Notch 36 indicates the passage of catheter 129 through the inferior vena cava 32, the right atrium 39, and the right atrial appendage 38. The distal tip of catheter 129 is shown exiting the right atrium 39 at apex 40.

[0148] Thus, as an example, a method of reducing pericardial constriction in a subject in need thereof using any of the devices of the present disclosure is provided by the following steps. Any of the devices of the present disclosure is maneuvered into the right atrium 39 through one of the vena cavae 24, 32. Once inside the right atrium 39, any of the devices of the present disclosure enters into the right atrial appendage 38. The wall of the right atrial appendage 38 is punctured at apex 40 and the catheter is advanced into the pericardial cavity 54. Other transvascular right heart routes to the pericardial cavity 54 are envisioned. Additionally, the left atrial appendage, coronary sinus, and right ventricular routes are envisioned for transvascular access to the pericardial cavity 54.

[0149] Note that the wall of the right atrial appendage can be punctured, for example, over a wire, with any of the devices of the present disclosure itself or with an instrument (e.g., a guidewire) passing through the lumen of any of the devices of the present disclosure. Further, any of the aforementioned devices can enter into the pericardial space through an opening in the wall of the atrial appendage 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 device being employed.

[0150] As shown in FIG. 7, using any of the devices of the present disclosure, for example, in the parietal pericardium 55, an incision path of the length of the pericardium can be created. Therefore, using the catheter 129, for example, a steerable catheter, it can extend through the IVC, through the RA, and into the RAA, and then, for example, into the pericardial cavity 54. The catheter 129 can have one or more steerable segments that guide any of the devices of the present disclosure with an arc length of about 90 degrees to about 180 degrees and a radius of curvature of about 1 inch to about 5 inches. As illustratively shown in FIG. 7, any of the devices of the present disclosure can be positioned in the pericardial cavity 54, start the incision path 175 at the starting point 160, and end at the length end point 180. At least a portion of the parietal pericardium wall 55, and 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 radially separate the pericardium around the incision line of the incision path 175 without removing pericardial tissue and with a reduction in pericardial restriction. One or more incision paths 175 can be created, and different incision paths of various lengths can be used to reduce pericardial restriction. In one embodiment, the incision path 175 and its length are determined preoperatively. Other incision paths and lengths can be used.

[0151] In one embodiment, the device of the present disclosure further comprises at least one nerve detection device. In one embodiment, at least one nerve detection device is located on the flexible catheter 129. In one embodiment, at least one nerve detection device is located adjacent to the cutting device. In one embodiment, at least one nerve detection device is located on the dilator / introducer 115. In one embodiment, at least one nerve detection device is located on the incision surface.

[0152] Any one of the devices of the present disclosure can further comprise at least one nerve stimulation device. In one embodiment, the at least one nerve stimulation device is located on a flexible 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.

[0153] In one embodiment, the device of the present disclosure discussed above further comprises an optical channel in a multi-lumen catheter for optionally housing a lens coupled to an optical fiber cable, together with a light source, such as an LED. In one embodiment, the method of the present disclosure further comprises obtaining visual information during access to the pericardial cavity, traversing the pericardial cavity, exiting and / or making an incision, for example using the optical channel in a multi-lumen catheter, to optionally house a lens coupled to an optical fiber cable, together with a light source, such as an LED.

[0154] A kit is provided that includes any one of the medical devices, sheaths, guidewires, and puncture tips of the present disclosure.

[0155] Although specific embodiments of the present disclosure are illustrated with reference to specific combinations of elements, various other combinations can also be provided without departing from the teachings of the present disclosure. Therefore, the present disclosure should not be construed as limited to the specific exemplary embodiments described herein and illustrated in the figures, but can also include combinations of elements and aspects of the various illustrated embodiments.

Claims

1. A medical device (100) for making an incision in the pericardium, wherein the device is A dissection device (140) operably coupled to the distal end of a catheter (129), the dissection device (140) comprising a dissection channel (120) defined along the dissection device, A plurality of suction devices (305) adjacent to the incision channel, wherein the plurality of suction devices are configured to engage with pericardial tissue, and the plurality of suction devices are positioned in a line along the incision channel, The cutting surface (310) is located within the cutting channel and is configured to move between a contracted position and an expanded position. When the incision surface is in the contracted position, the incision surface is located within the incision channel, A medical device wherein, when the incision surface is in the deployed position, the incision surface protrudes at least partially from the incision channel.

2. The medical device according to claim 1, further comprising an incision device actuator mechanism configured to move the incision surface between the contracted position and the expanded position.

3. The medical device according to claim 1 or 2, wherein the plurality of suction devices are positioned in a first row and a second row, and each of the first row and the second row is on the opposite side of the incision channel.

4. The medical device according to claim 3, wherein the first row of the plurality of suction devices and the second row of the plurality of suction devices are parallel.

5. The medical device according to claim 3 or 4, wherein the first row of the plurality of suction devices defines the length of the first row, the second row of the plurality of suction devices defines the length of the second row, and at least one of the length of the first row or the length of the second row is the same length as the length of the incision surface.

6. The medical device according to claim 3 or 4, wherein the first row of the plurality of suction devices defines a first row length, the second row of the plurality of suction devices defines a second row length, and at least one of the first row length or the second row length is greater than the length of the incision surface.

7. The medical device according to claim 1, wherein the suction force is received from the vacuum source connector (320).

8. The medical device according to claim 1, wherein the cutting surface is configured to be movable between the contracted position and the expanded position after the cutting device has been positioned.

9. The medical device according to claim 1, wherein the cutting surface is at least one of a blade or an electrode.

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

11. The medical device according to claim 1, wherein the catheter is steerable.

12. The medical device according to claim 1, wherein at least a portion of the medical device is radiopaque.

13. The medical device according to claim 1, further comprising an introducer (115) positioned near the distal end of the incision device.

14. The medical device according to claim 1, further comprising one or more stabilizing members (205) configured to maintain the cutting device in a given position.

15. The medical device according to claim 1, further comprising a sheath (130) configured to movably cover the incision channel.

16. The medical device according to claim 1, further comprising a controller engaged with the cutting device.

17. The medical device according to claim 1, wherein the controller is configured to provide at least one of the following: suction to one or more suction devices, movement of a blade between a retracted position and an extended position, movement of the cutting device along the cutting device, energy to the cutting device, or movement of one or more stabilizing members.

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