Soft Tissue Access Support Device and Method

Abstract

An apparatus and method for providing access support, the apparatus including an elongated body and a support tube slidably disposed within the elongated body, the apparatus having a first configuration and a second configuration such that access to the apparatus can be achieved through the support tube. A method of delivering the apparatus is also disclosed.

Description

Technical Field

[0001] The present disclosure is directed to devices and methods for accessing soft tissues, such as, for example, the ear, blood vessels, the inner wall of the membrane, the pericardium, etc., and provides a support structure for subsequent deployment of the device with reduced or eliminated additional traumatic injury to the soft tissue and minimized or eliminated bleeding or fluid drainage.

Background Art

[0002] To facilitate procedures such as pericardial constriction, trans-wall ablation procedures, valve replacement, and repair, access to various compartments of the mammalian body, such as the pericardial cavity, typically requires puncturing and insertion of devices into soft tissues such as, for example, the right atrium (RA), right atrial appendage (RAA), coronary sinus (CS), pericardium, etc. Subsequent manipulation of such devices after puncturing such tissues can result in trauma to the punctured tissues, which requires hemostasis.

Summary of the Invention

[0003] In one embodiment, a soft tissue access support device is provided, the device comprising an elongated body having a distal end and a proximal end along a longitudinal axis defining a lumen, the distal end of the body being coupled to a sealing member, and a support tube having a distal end and a proximal end along the longitudinal axis, the distal end of the support tube being coupled to a fixing member, the support tube being slidably disposed within the elongated body, wherein the elongated body is configured to facilitate the placement of a sealing member that can sealingly engage a portion of a first surface of the soft tissue, and when the support tube slides from a first sliding position to a second sliding position, the support tube enters an access opening within the soft tissue, and a fixing member attached to the distal end of the support tube engages a second opposing surface of the soft tissue.

[0004] In one aspect, the elongated body is a multi-lumen catheter. In another aspect, alone or in combination with any of the preceding aspects, the elongated body is steerable. In another aspect, alone or in combination with any of the preceding aspects, the support tube is a multi-lumen catheter. In another aspect, alone or in combination with any of the preceding aspects, the support tube is steerable.

[0005] In another aspect, alone or in combination with any of the preceding aspects, the fixation member comprises one or more anchors. In another aspect, alone or in combination with any of the preceding aspects, the one or more anchors comprise inflatable devices. In another aspect, alone or in combination with any of the preceding aspects, the fixation member is two or more reversibly foldable, radially expanding shape memory legs.

[0006] In another aspect, alone or in combination with any of the preceding aspects, the sealing member is a thermoplastic or thermosetting, elastic, low compression set material. In another aspect, alone or in combination with any of the preceding aspects, the sealing member is selected from thermoplastic elastomers, EPDM rubber, thermosetting rubber, polysilicon, polysiloxane, polyurethane, polyvinyl chloride, styrene-ethylene-butylene-styrene, polytetrafluoroethylene, and their derivatives, copolymers, and blends. In another aspect, alone or in combination with any of the preceding aspects, the sealing member is an O-ring. In one embodiment, the sealing member is an inflatable O-ring.

[0007] In another aspect, the soft tissue is selected from an ear, a blood vessel, an inner membranous wall, or a pericardium, and the pericardium has a cranial layer surrounding a pericardial cavity. In one aspect, the elongated body is configured to sealingly engage a portion of a first surface of the pericardium to facilitate placement of the sealing member, and when the support tube slides from a first sliding position to a second sliding position, the support tube enters an access opening of the pericardium, and a fixing member attached to the distal end of the support tube engages a portion of a second opposing surface of the cranial layer such that the sealing member and the fixing member form a seal against the access opening of the pericardium.

[0008] In another aspect, alone or in combination with any of the preceding aspects, the device further comprises an incision device coupled to the distal end of the catheter. In another aspect, alone or in combination with any of the preceding aspects, the incision device comprises a blade, or an electrode, or a combination capable of incising soft tissue.

[0009] In another aspect, alone or in combination with any of the preceding aspects, the elongated body, the support tube, the sealing member, the fixing member, or the incision device comprises a radiopaque material distributed randomly or arranged in a pattern. In another aspect, alone or in combination with any of the preceding aspects, the device is sterilized.

[0010] In a second embodiment, a soft tissue access support device is provided, the device comprising an elongated body having a distal end and a proximal end along a longitudinal axis defining a lumen, and a support tube having a distal end and a proximal end along the longitudinal axis, the distal end being coupled to a fixing member, the support tube being slidably disposed within the elongated body, in a first configuration, both the elongated body and the support tube engage a portion of a first surface of the soft tissue, and in a second configuration, the fixing member engages at least a portion of a second opposing surface of the soft tissue in a firm manner.

[0011] In one aspect, the elongated body is a multi-lumen catheter. In another aspect, alone or in combination with any of the preceding aspects, the elongated body is steerable. In another aspect, alone or in combination with any of the preceding aspects, the support tube is a multi-lumen catheter. In another aspect, alone or in combination with any of the preceding aspects, the support tube is steerable.

[0012] In another aspect, alone or in combination with any of the preceding aspects, the fixation member comprises an anchor. In another aspect, alone or in combination with any of the preceding aspects, the anchor comprises a helical coil.

[0013] In another aspect, alone or in combination with any of the preceding aspects, the fixation member engages both the first surface of the soft tissue and at least a portion of the second opposing surface.

[0014] In another aspect, alone or in combination with any of the preceding aspects, the access opening in the soft tissue is defined by a tunnel extending from the first surface of the soft tissue to the second opposing surface, and the fixation member engages the second opposing surface of the soft tissue and at least a portion of the tunnel defining the access opening.

[0015] In another aspect, alone or in combination with any of the preceding aspects, the support member is slidably received through a helical coil.

[0016] In another aspect, alone or in combination with any of the preceding aspects, the elongated body comprises a plurality of converging tapered segments. In another aspect, alone or in combination with any of the preceding aspects, the plurality of tapered segments are separated by the support tube in a second configuration.

[0017] In another aspect, alone or in combination with any of the foregoing aspects, the soft tissue is the pericardium having a parietal layer surrounding the pericardial cavity, the elongated body is configured to engage a portion of the first surface of the pericardium, and the support tube is configured such that, in a second configuration, the fixation member engages firmly with at least a portion of the second opposing surface of the parietal layer.

[0018] In another aspect, alone or in combination with any of the foregoing aspects, the device further comprises a pericardiotomy device coupled to the distal end of the catheter. In another aspect, alone or in combination with any of the foregoing aspects, the pericardiotomy device comprises a blade, or an electrode, or a combination capable of incising pericardial tissue.

[0019] In another aspect, alone or in combination with any of the foregoing aspects, the elongated body, the support tube, the fixation member, or the incision device comprises a radiopaque material distributed randomly or arranged in a pattern. In another aspect, alone or in combination with any of the foregoing aspects, the device is sterilized.

[0020] In a third embodiment, a method is provided, the method comprising: (i) presenting the distal end of a soft tissue access support device according to any one of the preceding claims; (ii) slidably extending a support tube from the soft tissue access support device and through an opening in the first surface of the soft tissue; (iii) presenting a fixation member to at least a portion of the opposing surface of the soft tissue; and (iv) coupling the soft tissue access support device to the soft tissue.

[0021] In one aspect, the method further comprises introducing the device through the support tube into the soft tissue. In another aspect, alone or in combination with any of the foregoing aspects, the method further comprises introducing the device through the fixation member into the soft tissue.

[0022] In another aspect, alone or in combination with any of the foregoing aspects, the step of activating the sealing member includes the steps of storing the support tube and compressing a portion of the soft tissue between the sealing member and the fixation member.

[0023] In another aspect, alone or in combination with any of the foregoing aspects, the fixation member comprises one or more anchors. In another aspect, alone or in combination with any of the foregoing aspects, the one or more anchors comprise an inflatable device. In another aspect, alone or in combination with any of the foregoing aspects, the anchor comprises a helical coil. In another aspect, alone or in combination with any of the foregoing aspects, the fixation member is two or more shape memory legs that reversibly expand radially.

[0024] In another aspect, alone or in combination with any of the foregoing aspects, the elongated body is a steerable catheter. In another aspect, alone or in combination with any of the foregoing aspects, the support tube is a steerable catheter.

[0025] In another aspect, alone or in combination with any of the foregoing aspects, the method further includes a pericardial access device coupled to the distal end of the catheter. In another aspect, alone or in combination with any of the foregoing aspects, the pericardiotomy device comprises a blade or an electrode.

[0026] In another aspect, alone or in combination with any of the foregoing aspects, the sealing member is an elastic low-compression permanent set polymer. In another aspect, alone or in combination with any of the foregoing aspects, the sealing member is selected from thermoplastic elastomers, EPDM rubber, thermosetting rubber, polysilicon, polysiloxane, polyurethane, polyvinyl chloride, styrene-ethylene-butylene-styrene, polytetrafluoroethylene, and their derivatives, copolymers, and blends.

[0027] In another aspect, alone or in combination with any of the foregoing aspects, the soft tissue access support device is presented under the xiphoid process relative to the first surface. In another aspect, alone or in combination with any of the foregoing aspects, the soft tissue access support device is introduced transvessely to the first surface. In another aspect, alone or in combination with any of the foregoing aspects, the soft tissue access support device is presented transvessely to the first surface via the superior vena cava. In another aspect, alone or in combination with any of the foregoing aspects, the soft tissue access support device is presented transvessely to the first surface via the inferior vena cava. In another aspect, alone or in combination with any of the foregoing aspects, the soft tissue access support device is presented transvessely to the first surface via the coronary sinus. In another aspect, alone or in combination with any of the foregoing aspects, the method further includes providing access to at least one cavity through the soft tissue.

[0028] In a fourth embodiment, a method of operating an incision device is provided, the method including: (i) providing a soft tissue access support device according to any one of the foregoing aspects; (ii) slidably extending a support tube from the soft tissue access support device; and (iii) operating a fixing member with a controller.

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

[0030]

Figure 1A

Figure 1B

Figure 1C

Figure 2

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 5

Figure 6

Figure 7

Figure 8

DETAILED DESCRIPTION OF THE INVENTION

[0031] The present disclosure provides access through soft tissue, for example, to enable access to medical devices having mechanical support, and to maintain hemostasis and / or contribute to hemostasis or provide sufficient hemostasis during operation of such devices during a medical procedure. The present disclosure also provides access through soft tissue via a transcatheter device approach without the need to leave behind an occluder or other hemostatic implant. The access devices of the present disclosure provide reinforcement for various medical devices that pierce soft tissue, such as a membrane, such as the pericardial membrane, muscle tissue, etc., or are pierced through soft tissue. The access support devices of the present disclosure provide access through a reinforcing structure fixed to the tissue around the puncture site, thus enabling the introduction of the device and subsequent operation of such device without causing further trauma to the puncture site and / or stress and strain.

[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 medical arts and surgery, including, for example, a space, cavity, or liquid 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 medical arts and surgical arts, including, for example, tissue associated with the pericardium.

[0034] As used herein, unless otherwise specified, the term "epicardial layer" includes at least the serosal and fibrous layers 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 medical arts and surgical arts, including tissue layers that are disposed adjacent to and include adipose tissue, such as within and outside the pericardial cavity and on the surface of the visceral layer of the pericardium, in the ordinary and customary sense.

[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 radio frequency (RF) energy, sufficient to ablate, cauterize, vaporize, or separate tissue. 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 a direction toward the proximal end of a multi-lumen device, or catheter, and 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 cut or separate tissue, such as a force by pulling on 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, such as the type of sharp incisional cut associated with a knife blade, such as a scalpel blade, or an electrosurgical device that provides an electric current to a conductive material, or electrode, sufficient to disrupt tissue. As used herein, the term "incision" includes "filleting", "slicing", and / or the like.

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

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

[0040] As used herein, the phrase "preserved ejection fraction" includes its ordinary and customary meaning to those of ordinary skill in the medical arts and surgical arts, and includes, for example, clinical syndromes in which a patient exhibits signs and symptoms of heart failure as a result of elevated left ventricular (LV) filling pressures 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 meaning 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 "pericardiotomy device" includes a device having a cutting surface, such as the edge of a blade or the surface of an energized electrode.

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

[0044] As used herein, the phrase "transcatheter device" includes a catheter composed of at least one lumen that includes a medical instrument, device, or a component 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 are not meant to enumerate a particular orientation of an article or device, nor to indicate or imply a required or necessary configuration of an article or device, nor to specify the manner in which the articles or devices described herein are to be used, arranged, transitioned from different configurations, 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 and indirect couplings through another component, element, circuit, or structure, and / or indirect couplings 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 to cause an observable effect that is directly or indirectly correlated with the applied potential, for example, a pacing probe that stimulates the phrenic nerve to cause an observable respiratory disorder.

[0051] As used herein, the phrase "nerve detection device" refers to a device that can establish the position or placement of at least a portion of a nerve, for example, detect an electric field generated by a nerve, and provide position or proximity information that has no or substantially no physical effect or stimulation on the nerve, such as an impedance sensor for directly or indirectly correlating the position or proximity of a nerve to 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, for example.

[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 by stabilizing or fixing a cut surface positioned within the pericardial cavity from rolling, twisting, buckling, and / or vibrating, for example, before and / or during use.

[0056] As used herein, "delta pulmonary capillary wedge pressure Δ(PCWP)" is the difference between the pulmonary capillary wedge pressure (PCWP) measured with a volume load (i.e., leg elevation and / or fluid administration) and the PCWP at rest.

[0057] As used herein, the phrase "puncture tip" includes a non-traumatic object suitable for puncturing or penetrating tissue without substantial trauma or bleeding to or from the vicinity of the puncture (picture) or penetration.

[0058] Referring to FIGS. 1A and 1B, the layers of the heart wall of the heart 50 are shown in the 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, apical 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 arranged adjacent to adipose tissue inside and outside the pericardial cavity 54, includes adipose tissue, and is on the surface of the visceral layer 53 of the pericardium for introduction into the pericardial cavity 54.

[0059] Referring to FIGS. 2, 3A, and 3B, the soft tissue access support device 100 is shown having an elongated body 130 with a distal end and a proximal end along a longitudinal axis that defines a lumen, the distal end being coupled to a sealing member 150. The distal end of the elongated body 130 is a puncturing device and is shown with an introducer / dilator 115 configured to receive a guidewire 113 that can provide initial access to the soft tissue used by the access support device 100.

[0060] A support tube 125 having a distal end and a proximal end along the longitudinal axis is coupled to a fixing member 146 at its distal end. The support tube 125 is slidably disposed within the elongated body 130. In a first sliding position, a portion of the sealing member 150 and a first surface 55A of the pericardium (used interchangeably with the first surface and the front surface) are sealingly engaged. In a second sliding position, a portion of the fixing member 146 and an opposing surface 55B of the pericardium are fixedly engaged. In one embodiment, the support tube 125 slides forward through the first surface 55A and the opposing surface 55B, and the fixing member 146 is deployed and / or activated. Thereafter, the support tube 125 is slid rearward so that the fixing member 146 and the sealing member 150 grip and / or sandwich the pericardium and provide a secure configuration for extending the support tube 125.

[0061] The elongated body 130 can be a multi-lumen catheter. The elongated body 130 can be steerable. In one embodiment, the support tube 125 is a multi-lumen catheter having a lumen 139 for slidably receiving / extending the fixing member 146. The support tube 125 can be steerable. As shown in FIG. 3B, the fixing member 146 includes one or more anchors 145, such as shape memory legs that expand reversibly and self-radiantly. In another embodiment, the one or more anchors 146 can include an inflatable device, such as a balloon, that can be in an O-ring shape.

[0062] The sealing member 150 can be any medical grade thermoplastic or thermosetting elastomer, a low compression set material. In one embodiment, the sealing member 150 is selected from thermoplastic elastomers, EPDM rubber, thermosetting rubber, polysilicon, polysiloxane, polyurethane, polyvinyl chloride, styrene-ethylene-butylene-styrene, polytetrafluoroethylene, and their derivatives, copolymers, and mixtures. In another embodiment, the sealing member 150 is an O-ring.

[0063] As shown in FIG. 2, the pericardiotomy device 101 is coupled to the distal end of the catheter 129. The pericardial penetration device 101 can include a blade, or an electrode, or a combination that can incise pericardial tissue. Various pericardiotomy devices can be used when they have an outer diameter smaller than the inner diameter of the support tube 125. Referring to FIG. 3B, the catheter 129 and the pericardiotomy device 101 can be deployed over the wire (OTW) using a guide wire 113 received by the lumen of a multi-lumen catheter.

[0064] Referring to FIGS. 4A and 4B, a perspective view of the soft tissue access support device 100 shows the first and opposing surfaces 55A, 55B (the pericardial surfaces of the fixed member 146 around the deployed and opposing surfaces 55B of the support tube, respectively) being shown through to provide access to the pericardial cavity 54 of the flexible catheter 129 coupled to the pericardiotomy device 101 at its distal end.

[0065] Referring to FIG. 5, an alternative access support device 200 is shown to have an elongated body 130 having a distal end and a proximal end along a longitudinal axis defining a lumen. The distal end of the elongated body 130 is configured to be followed by a set of introducer / dilators 115 that prepare an entry site for receiving the body 130. A support tube 125 having a distal end and a proximal end along the longitudinal axis, the distal end of which is coupled to a fixing member 246, is slidably disposed within the lumen of the elongated body 130. In a first configuration, both the introducer and the support tube 125 engage a portion of the first surface 55A of the pericardium. In a second configuration, the fixing member 246 engages firmly with a portion of the first surface 55A and the opposing surface 55B of the pericardium.

[0066] In one embodiment, the elongated body 130 of the access device 200 is a multi-lumen catheter. The elongated body 130 may be steerable. The elongated body 130 may be a multi-lumen catheter.

[0067] In one embodiment, the support tube 125 of the access support device 200 is a multi-lumen catheter. The support tube 125 may be steerable.

[0068] In one embodiment, the fixing member 146 includes an anchor 246 for fixing the elongated body 130 around the tissue. As shown in FIG. 5, the anchor 246 includes a helical coil terminated by a tip 247 configured to engage the tissue and bias the anchor 246 against the tissue upon rotation. As shown, the fixing member 246 engages helically with a portion of the first surface 55A and the opposing surface 55B of the pericardium. Rotation of the anchor 246 can be achieved using a screw-like controller or other control device known in the art.

[0069] The support tube 125 of the access support device 200 is configured to be slidably received through a helical coil. The access support device 200 may further include a pericardiotomy device 101 coupled to the distal end of a catheter 129 configured to be traversed through the support tube 125 and the helical coil for introduction into a cavity or space such as, for example, a pericardial cavity, aorta, atrial appendage, or coronary sinus.

[0070] In one embodiment, the sheath 130 includes a plurality of tapered segments 116 configured to coalesce together around a guide wire in a first configuration and to provide separation and additional stabilization and / or support in a second configuration. In one embodiment, the plurality of tapered segments are separated by the support tube 125 in the second configuration.

[0071] In some embodiments, fluoroscopy is used to visualize the position of the access support devices 100, 200, the support tube 125, and / or the pericardiotomy device 101 as they advance toward the heart. Visualization can be enhanced by incorporating radiopaque markers that are randomly distributed or patterned on or within one or more of the components of the access support device. In one embodiment, the cannula is visualized from a first left oblique view at approximately 35° - 40°. In one embodiment, the user may inject a contrast agent solution through the catheter 129 or through the lumen 139 of the support tube 125 during deployment.

[0072] Some or all of the medical devices (e.g., transcatheter devices, pericardiotomy assemblies, pericardiotomy devices, access support devices, guide wires, and controllers) may be sterilized for use. Sterilization includes aseptic sterilization. The medical devices may be sterilized using various sterilization techniques such as electron beam sterilization, gamma sterilization, ethylene oxide sterilization, autoclave sterilization, chemical sterilization, and / or the like. Further, one or more of the materials used in the medical devices may have antibacterial properties.

[0073] Figure 6 shows the heart 50 as an exemplary soft tissue target as seen separated from the body, using the access support device of the present disclosure. The pericardium 60 or pericardial sac encloses the myocardium (i.e., the epicardium, myocardium, and endocardium). The small space existing between the myocardium and the pericardium 60 represents the pericardial cavity 54.

[0074] In one example, the access support device of the present disclosure can be presented to the pericardium 60 via the right atrial appendage 38 (RAA), which is a suitable site for entering the pericardial cavity 54. The right atrial appendage 38 is tangent to the pericardium 60 and the epicardium / pericardial adipose tissue 57 and is between them. In one embodiment, the access support device 100 of the present disclosure is positioned substantially parallel to the wall of the pericardium 60 via the right ventricle 39 so that when the wall of the right atrial appendage 38 is punctured by the device, it can be performed substantially without the risk of damaging the epicardium or other heart tissue and is guided to the right atrial appendage 38.

[0075] The right atrial appendage 38 can be accessed via a conventional venous lumen route. Figure 6 shows the presentation of the access support devices 100, 200 to the right ventricle 39 via the superior vena cava 24. The notch 37 shows the passage of the cutting device 101 of the access support devices 100, 200 through the superior vena cava 24, the right ventricle 39, and the right atrial appendage 38. The distal tip of the catheter 129 is shown exiting the right atrial appendage 38 at the apex 40.

[0076] Figure 7 shows an alternative presentation of any of the previously disclosed access support devices to the right ventricle 39 via the inferior vena cava 32. The notch 36 shows the passage of the catheter 129 through the inferior vena cava 32, the right ventricle 39, and the right atrial appendage 38. The distal tip of the catheter 129 is shown exiting the right atrial appendage 38 at the apex 40.

[0077] Accordingly, as an example, the method of the present disclosure includes the following steps. The access support devices 100, 200 are manipulated downstream through one of the aorta 24, 32 to the right ventricle 39. When presented to the right ventricle 39, the fixation members 146, 246 and / or the sealing members 150 fix the access support devices 100, 200 so that the incision device 101 or another device can enter the right atrial appendage 38. The wall of the right atrial appendage 38 is punctured at the apex 40, and the catheter 129 advances into the pericardial cavity 54 together with the incision device 101 or other device. Other transvascular right heart pathways to the pericardial cavity 54 and other soft tissue targets are envisioned.

[0078] Note that the wall of the right atrial appendage can be initially punctured by the access support devices 100, 200 themselves or by an instrument (e.g., a guide wire) passing through the lumen of the device, 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 the device can be presented into the pericardial cavity 54. These details depend on the procedure being performed and the type of previously disclosed devices being used.

[0079] Referring to FIG. 8, the use of the access support devices 100, 200 and subsequent placement of the incision device 101 are shown by a transvascular entry from the pericardial cavity 54 to the starting point 160 through the entry point 180 of the right atrial appendage 38, and the creation of the incision 175 in the supraclavicular layer returns to the entry point 180. The access support devices 100, 200 can be presented to the pericardium 60 using a subxiphoid approach. Other incision paths, lengths, and approaches can be used.

[0080] Accordingly, provided is a method of accessing soft tissue, such as pericardial tissue, e.g., deploying a pericardiotomy device 101 using the access support devices 100, 200 of the present disclosure. The method includes: (i) presenting the distal end of the access support devices 100, 200 to a first surface 55A of the pericardium; (ii) slidably extending a support tube 125 from the access support devices 100, 200 through a portion of the first surface 55A; (iii) presenting a sealing member 150 or a fixing member 146, 246 to at least a portion of an opposing surface 55B of the pericardium; and (iv) coupling the access support devices 100, 200 to the pericardium. In one embodiment, the method further includes introducing the pericardiotomy device 101 into the pericardial cavity through the support tube 125.

[0081] In one embodiment, introducing the pericardiotomy device 101 into the pericardial cavity passes through the fixing members 146, 246. Referring to the access support device 100, activating the sealing member 150 involves retracting the support tube 125 and compressing a portion of the pericardium between the sealing member 150 and the fixing member 146. The support tube 125 and the extended body 130 having the cutting device 101 may extend through the fixing member 146, e.g., through a helical coil for accessing the pericardial cavity 54.

[0082] Referring to the access support device 200, the support tube 125 having the fixing member 246 is presented to the first surface 55A of the pericardium, and the fixing member 246 is fixed to the opposing surface 55B through the pericardium. The support tube 125 and the extended body 130 having the cutting device 101 may extend through the fixing member 146, e.g., through a helical coil for accessing the pericardial cavity 54.

[0083] In one embodiment, the access support devices 100, 200 are presented under the xiphoid process on the first surface 55A to perform one or more incisions aligned along a path, to introduce a pericardial penetration device, and to provide reduction of pericardial constriction. In one embodiment, the pericardial access support devices 100, 200 are introduced transvascularly onto the first surface 55A. As an example, the access support devices 100, 200 may be presented transvascularly onto the first surface 55A via the superior vena cava, or the access support devices 100, 200 may be presented transvascularly onto the first surface 55A via the inferior vena cava. In other embodiments, the access support devices 100, 200 may be presented transvascularly onto the first surface 55A via the coronary sinus.

[0084] In one embodiment, for orientation stability of the incision surface, to provide orientation stability of the overhead layer, OTW introduction is used, for example, as a delivery catheter, through a dedicated lumen of a trans-catheter cross-section, or "Rapid Exchange" style catheter, or an off-center attachment cannula, or a deflection-resistant catheter, in any of the access support devices 100, 200 disclosed above.

[0085] The access support devices 100, 200 can be used in combination with any soft tissue incision device, such as a device using blades, current-carrying wires, or combinations thereof.

[0086] Exemplary pericardial incision devices that can be used with the access support devices of the present disclosure are not limited and may include, for example, known devices for accessing the pericardium by either a sub-xiphoid approach or transvascularly.

[0087] In one embodiment, the introducer / dilator 115 comprises a puncture tip as a kit. In one embodiment, at least a portion of the puncture tip is radiopaque. In one embodiment, at least a portion of the incision device 101 is radiopaque. In one embodiment, at least a portion of the incision device 101 is radiopaque.

[0088] In one embodiment, the access support device further comprises at least one nerve proximity device. In one embodiment, the at least one nerve proximity device is a nerve detection device. In one embodiment, the at least one nerve detection device is located on the extended body 130. In one embodiment, the at least one nerve detection device is located adjacent to the pericardiotomy device 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 provides a proximity indication of at least a portion of a nerve, for example, the phrenic nerve. The at least one nerve detection device can be an impedance sensor or other electric field detection device that can provide a visual, auditory, and / or tactile indication to the user that the pericardiotomy device is in proximity to at least a portion of the nerve.

[0089] In one embodiment, the at least one nerve proximity device is at least one nerve stimulation device. In one embodiment, the at least one nerve stimulation device is located on the extended body 130. In one embodiment, the at least one nerve stimulation device is located adjacent to the pericardiotomy device 101. In one embodiment, the at least one nerve stimulation device is located on the introducer / dilator 115. In one embodiment, the at least one nerve stimulation device provides a proximity indication of at least a portion of a nerve, for example, the phrenic nerve. The at least one nerve stimulation device can be an electrical lead or other electrical discharge device that can provide a visual indication to the user, such as a change in the patient's breathing when in proximity to the phrenic nerve, that the pericardiotomy device is in proximity to at least a portion of the nerve.

[0090] In one embodiment, the access support devices 100, 200 of the present disclosure described above further include an optical channel within a transcatheter 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 optionally uses a light source, such as an LED, and, for example, an optical channel within a transcatheter to house a lens coupled to an optical fiber cable, and further includes the step of acquiring visual information during access to, crossing of, withdrawal from, and / or incision of the pericardial cavity 54.

[0091] In one embodiment, the access support devices 100, 200 of the present disclosure described above further include signal induction capabilities for presentation to the pericardium. Examples of signal induction capabilities may include echocardiogram, impedance, and electrical signals.

[0092] The access support device may be configured such that the overall outer diameter (O.D.) is from about 6 Fr (2 mm) to about 30 Fr (10 mm). The support tube 125 of the access support devices 100, 200 of the present disclosure may be configured such that the overall outer diameter (O.D.) is from about 6 Fr (2 mm) to about 20 Fr (6.67 mm). The catheter 129 of the access support devices 100, 200 of the present disclosure may be configured such that the overall outer diameter (O.D.) introduced into the pericardial cavity is from about 6 Fr (2 mm) to about 15 Fr (5 mm). The catheter 129 of the access support devices 100, 200 of the present disclosure may be configured such that the overall outer diameter (O.D.) introduced into the pericardial cavity is from about 6 Fr (2 mm) to about 12 Fr (4 mm). The catheter 129 of the access support devices 100, 200 of the present disclosure may be configured such that the overall outer diameter (O.D.) introduced into the pericardial cavity is about 10 Fr (3.33 mm).

[0093] A kit is provided that includes a pericardial incision device, a sheath, a guide wire 113, and a puncture tip.

[0094] While specific embodiments of the present disclosure are illustrated with reference to specific combinations of elements, various other combinations may 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 shown in the figures, but may also include elements of various illustrated embodiments and combinations of those aspects.

Description of the Reference Numerals

[0095] 100 Soft tissue access support device, 101 Incision device, 125 Support tube, 130 Extended body, 139 Lumen, 145 Anchor, 146, 246 Fixing member, 150 Sealing member

Claims

1. A soft tissue access support device, An extended body having a distal end and a proximal end along a longitudinal axis defining a lumen, wherein the distal end of the extended body is connected to a sealing member, A support tube having a distal end and a proximal end along its longitudinal axis, wherein the distal end of the support tube is connected to a fixing member, and the support tube is slidably disposed within the extended body, A soft tissue access support device in which the support tube is configured to slide from a first sliding position to a second sliding position.

2. The soft tissue access support device according to claim 1, wherein the extended body is a multi-lumen catheter, or the extended body is steerable.

3. The soft tissue access support device according to claim 1 or 2, wherein the support tube is a multi-lumen catheter, or the support tube is steerable.

4. The soft tissue access support device according to claim 1 or 2, wherein the fixing member comprises an anchor.

5. The soft tissue access support device according to claim 4, wherein one or more of the anchors are equipped with an inflatable device.

6. The soft tissue access support device according to claim 1 or 2, wherein the fixing member is a shape memory leg that expands radially in a reversibly foldable manner, comprising two or more reversibly foldable shape memory legs.

7. The soft tissue access support device according to claim 1 or 2, wherein the sealing member is a low compression set material of thermoplastic or thermosetting elastomer.

8. The soft tissue access support device according to claim 1 or 2, wherein the sealing member is an O-ring, or the sealing member is an expandable O-ring.

9. The soft tissue access support device according to claim 1 or 2, further comprising a cutting device attached to the distal end of the catheter.

10. The soft tissue access support device according to claim 9, wherein the cutting device comprises a blade, an electrode, or a combination thereof.

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