Systems and devices for accessing the space between tissue layers

Abstract

A system and apparatus for accessing an internal space between two tissues are provided. The system may include a helical coil within a catheter delivery system. The helical coil can be delivered to a treatment site and at that point rotated to penetrate and traverse the tissue to reach the internal space. The system may further include a gas supply system for providing gas to assist in displacing one or both of the tissues to create more access space within the internal space between the two tissues. Tools, prostheses, or other devices can be moved into the internal space via the catheter system and procedures can be performed therein.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Patent Application No. 63 / 347,466, filed May 31, 2022, and U.S. Patent Application No. 63 / 481,099, filed January 23, 2023, each of which is hereby incorporated by reference in its entirety.

[0002] The present disclosure generally relates to systems and devices for providing means to access the space between tissue layers.

Background Art

[0003] The pericardium, also called the pericardial sac, is a double - layer tissue that surrounds the heart and provides protection for the heart. The outer layer of the pericardium is the fibrous pericardium formed from strong connective tissue, and the inner layer is the serous pericardium formed from serosa. There is a pericardial space between the pericardium and the heart, which is a lubricating space that allows the heart to function without friction.

[0004] Heart failure is a condition in which the myocardium pumps a low ejection fraction of blood, resulting in poor blood circulation. There are various causes of heart failure, but a rigid pericardium can contribute to a low ejection fraction by applying compressive force to the heart myocardium. Thus, one way to increase to improve heart function is to relieve the compressive force provided by the pericardium.

Summary of the Invention

[0005] A system for accessing the internal space between two tissues may comprise a helical coil within a catheter system. The helical coil can move distally along the axis so as to be exposed from the catheter system to perform a procedure. The helical coil can rotate such that the helix can penetrate and traverse the tissue. The system for accessing the internal space may further comprise a gas supply and / or a vacuum. The gas supply can release gas into the internal space to move one or both of the tissues and create more space therein. The vacuum can help hold the tissue and provide a resistance force for the helical coil to penetrate and traverse the tissue. The vacuum can also be used to remove the gas released into the internal space. Tools, patches, or other devices can be introduced into the internal space to perform a procedure or treatment.

[0006] In one implementation, the trans-catheter system comprises an outer sheath, an inner sheath, and a helical coil connected to the inner sheath. The helical coil and the inner sheath are within the outer sheath. The helical coil and the inner sheath can move bidirectionally along the axis independently of the outer sheath.

[0007] In some embodiments, alone or in combination with any of the foregoing embodiments, the system further includes a nose cone connected to the outer sheath at the distal end. The nose cone can be opened to expose the helical coil.

[0008] In some embodiments, alone or in combination with any of the foregoing embodiments, the nose cone comprises a sensor for detecting a change in the local environment.

[0009] In some embodiments, alone or in combination with any of the foregoing combinations, the helical coil includes at least a half rotation.

[0010] In some embodiments, alone or in combination with any of the foregoing embodiments, the helical coil includes an axial distance of at least 2 mm.

[0011] In some embodiments, alone or in combination with any of the foregoing embodiments, the helical coil is provided with a sensor at its distal end for detecting changes in the local environment.

[0012] In some embodiments, alone or in combination with any of the foregoing embodiments, the system further includes a gas supply system within the outer sheath. The gas supply system includes a discharge port at the distal end, a gas supply at the proximal end, and a connecting line therebetween.

[0013] In some embodiments, alone or in combination with any of the foregoing embodiments, the helical coil has a lumen. The connecting line has the lumen of the helical coil. The discharge port is located at or proximal to the distal tip of the helical coil.

[0014] In some embodiments, alone or in combination with any of the foregoing embodiments, the system further includes a vacuum.

[0015] In some embodiments, the gas supply system is also a vacuum system.

[0016] In some embodiments, alone or in combination with any of the foregoing embodiments, the system further includes a tool, a prosthesis, or a drug delivery device. The tool, prosthesis, or drug delivery device is within the outer sheath and is capable of moving bidirectionally along the axis independently of the outer sheath.

[0017] In some embodiments, alone or in combination with any of the foregoing embodiments, the tool, prosthesis, or drug delivery device is capable of traversing through the inner circumference of the helical coil when moving bidirectionally along the axis and when traversing through it.

[0018] In some embodiments, alone or in combination with any of the foregoing embodiments, the system further comprises a control system at a proximal end of the transcatheter system. The control system is capable of advancing the outer sheath distally and retracting it proximally.

[0019] In some embodiments, alone or in combination with any of the foregoing embodiments, the control system is further capable of advancing the helical coil distally and retracting it proximally.

[0020] In some embodiments, alone or in combination with any of the foregoing embodiments, the control system is further capable of rotating the helical coil.

[0021] In some embodiments, alone or in combination with any of the foregoing embodiments, the helical coil is sterilized.

[0022] In one implementation, the method includes passing a helical coil through a recipient, via a transcatheter system, across a treatment site. The transcatheter system includes an outer sheath, an inner sheath, and a helical coil connected to the inner sheath. The helical coil and the inner sheath are within the outer sheath. When the helical coil enters the vicinity of the treatment site, the method further includes advancing and exposing the helical coil distally from the outer sheath such that the helical coil contacts the surface of a first tissue. The method further includes rotating the helical coil such that the helical coil penetrates and traverses the first tissue. The helical coil is rotated until it completely traverses through the first tissue and is within an internal space between the first tissue and a second tissue.

[0023] In some embodiments, alone or in combination with any of the foregoing embodiments, the complete traversal into the internal space through the first tissue is determined or approximated by a visualization method.

[0024] In some embodiments, alone or in combination with any of the foregoing embodiments, the complete traversal into the internal space through the first tissue is determined or approximated by the amount of rotation of the helical coil.

[0025] In some embodiments, alone or in combination with any of the foregoing embodiments, the complete traversal into the internal space through the first tissue is determined or approximated by sensors on the helical coil that can detect changes in the local environment.

[0026] In some embodiments, alone or in combination with any of the foregoing embodiments, the method further includes creating more access space within the internal space by displacing one or both of the first tissue and the second tissue.

[0027] In some embodiments, alone or in combination with any of the foregoing embodiments, the first tissue is displaced by pulling back the helical coil in the proximal direction.

[0028] In some embodiments, alone or in combination with any of the foregoing embodiments, the transcatheter system further includes a gas supply system within the outer sheath. The gas supply system includes a discharge port at the distal end, a gas supply at the proximal end, and a connecting line therebetween. More access space within the internal space is created by discharging gas within the internal space to displace one or both of the first tissue and the second tissue.

[0029] In some embodiments, alone or in combination with any of the foregoing embodiments, the transcatheter system further includes a vacuum system within the outer sheath, and the method further includes removing gas within the internal space via the vacuum system.

[0030] In some embodiments, alone or in combination with any of the foregoing embodiments, the trans-catheter system further comprises a vacuum system within the outer sheath, and prior to rotation of the helical coil, the method further comprises gripping a first tissue through the vacuum.

[0031] In some embodiments, alone or in combination with any of the foregoing embodiments, the trans-catheter system further comprises a tool within the outer sheath, and the method further comprises advancing and exposing the tool distally from the outer sheath, traversing the tool through the first tissue into the inner space, and performing a treatment using the tool within the inner space.

[0032] In some embodiments, the trans-catheter system further comprises a prosthesis within the outer sheath, and the method further comprises advancing and exposing the prosthesis distally from the outer sheath, traversing the prosthesis through the first tissue into the internal space, and attaching the prosthesis within the internal space. In some embodiments, alone or in combination with any of the foregoing embodiments, the trans-catheter system further comprises a drug delivery device within the outer sheath, and the method further comprises, in some embodiments, advancing the drug delivery device distally and exposing it from the outer sheath, traversing the drug delivery device through the first tissue into the inner space, and releasing a drug from the drug delivery device within the inner space.

[0033] In some embodiments, alone or in combination with any of the foregoing embodiments, the trans-catheter system further comprises a nose cone attached to the distal end of the outer sheath, and prior to exposing the helical coil, the method further comprises opening the nose cone.

[0034] In some embodiments, alone or in combination with any of the foregoing embodiments, the nose cone is opened by distal advancement of the helical coil.

[0035] In some embodiments, alone or in combination with any of the foregoing embodiments, the first tissue is the pericardium and the second tissue is the myocardium.

[0036] In some embodiments, alone or in combination with any of the foregoing embodiments, the pericardium is accessed via a subxiphoid approach.

[0037] The description and claims will be more fully understood with reference to the following figures and data graphs, which are presented as examples of the present disclosure and should not be construed as a complete enumeration of the scope of the present disclosure.

Brief Description of the Drawings

[0038]

Figure 1A

Figure 1B

Figure 1C

Figure 2

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 3E

Figure 3F

[0039] The present disclosure shows details of a system and apparatus for accessing the space between two tissues and creating a space. The system and apparatus can utilize catheter design to minimize invasiveness within the body. Thus, the system and apparatus can comprise a catheter that provides means for translocating a tool for accessing the space between two tissue layers and creating a space. Further, the catheter can provide means for translocating a tool into the space between two layers and performing a procedure therein.

[0040] The systems and devices are directed to a catheter system that further includes a helical coil that can be used to traverse the outer tissue of two tissues. Once traversed, a gas supply system can be used to supply gas into the space between the two tissues. The gas can be used to displace one or both of the tissues, creating a space therebetween. In some instances, the helical coil includes a hollow lumen and an outlet port that can be connected to a gas supply to supply gas into the space between the two tissues. The catheter system can further include tools, prosthetics, drugs, or any other device or composition to be delivered into the internal space between the two tissues. Exemplary tools include cutting tools, electrophysiology tools, suture systems, sensors, visualization enhancement tools (e.g., cameras, or radiopaque devices), or any other tool desired by a clinician that can fit within the catheter and be delivered into the internal space between the two tissues. Exemplary prosthetics include stents, valves, patches, sutures, staples, implantable sensors, or any other prosthetic desired by a clinician that can fit within the catheter and be delivered into the internal space between the two tissues. Exemplary drugs include antibiotics, analgesics, wound healing agents, anti-cancer drugs, immunostimulants, immunosuppressants, or any other drug that can be delivered via catheter insertion and is desired by a clinician to be delivered into the internal space.

[0041] The methods, systems, and devices described should never be construed as limiting. Instead, this disclosure is directed to all novel and non-obvious features and aspects of the various disclosed systems and devices, alone and in various combinations and sub-combinations thereof. The disclosed methods, systems, and devices are not limited to any specific aspect, feature, or combination thereof, and the disclosed methods, systems, and devices do not require the presence of any one or more specific advantages or the solving of any problems.

[0042] Various embodiments of a spatial access system and its components are disclosed herein, and any combination of these embodiments can be made, unless specifically excluded. For example, a helical coil device can be used with any catheter system or any gas supply system, even if a particular combination is not explicitly described. Similarly, different structures and features of the spatial access system can be mixed and adapted, for example, by combining any tool for entering the internal space, any system for providing a displacement gas, and any device or composition utilized within the space, even if not explicitly disclosed. In summary, the individual components of the disclosed system can be combined, unless otherwise distinct, mutually exclusive, or physically impossible.

[0043] Some operations of the disclosed methods are described in a particular sequential order for presentation convenience, but it should be understood that this description method includes permutations, unless a particular order is required by the specific words described below. For example, operations described sequentially may, in some cases, be permuted or even executed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various aspects in which the disclosed methods, systems, and devices can be used in combination with other systems, methods, and devices.

[0044] As used throughout this specification, the terms "proximal" and "distal" relate to the catheter system axis, with the end where the procedure is performed being the distal end and the opposite end where the catheter system is controlled being the proximal end. Thus, the distal end of the catheter system is the tip that first traverses within the body and first reaches the surgical site. Conversely, the proximal end of the catheter system is the portion that remains outside the body. Similarly, distal movement along the catheter axis is movement in the direction towards the treatment site of the component, and proximal movement along the catheter axis is movement in the opposite direction of the component. These terms have a relationship with the site of the procedure, but it should be understood that these terms are used for reference and the site of the procedure need not be present when interpreting the components or movement of the devices and systems described herein.

[0045] For the purpose of performing procedures within a recipient, various systems and devices are utilized to access the internal space between two tissues. Recipients include, but are not limited to, patients, animal models, cadavers, or anthropomorphic phantoms. Thus, in addition to methods for treating patients, the systems and devices can be utilized in training or other practice procedures on animal models, cadavers, or human phantoms.

[0046] The described systems and devices can be sterilized, which can be performed using gamma irradiation, gas plasma, aldehydes, ethylene oxide, and / or electron beam. The system or device can further be processed in a formaldehyde bioburden reduction process. After preparation, the systems and devices can be stored in a container, which can be hermetically sealed or otherwise remain sterilized.

[0047] Systems and Devices for Accessing the Inner Space between Two Tissues A system and apparatus for accessing an internal space between two tissues can comprise a catheter system and, as a result, can be utilized within a minimally invasive procedure. The system and apparatus can include means for traversing an outer layer into the internal space between two layers. The system and apparatus can further comprise a gas supply system for providing gas into the internal space to displace one or both of the tissues to create an accessible space between the two tissues. The system and apparatus can further include tools, prosthetics, pharmaceuticals, or other devices or compositions that are transported into the internal space.

[0048] A system and apparatus for accessing an internal space can be utilized on any two tissues that provide access to the internal space. Often, the system and apparatus are utilized to access an internal space between connective tissue and muscle tissue. In one such example, the internal space accessed is the pericardial space between the pericardium and the myocardium. The pericardium is the connective tissue that surrounds the muscular heart tissue. Any catheter approach can be utilized to reach the two tissues and the internal space. For example, a subxiphoid approach can be utilized to access the pericardial cavity.

[0049] Figures 1A, 1B, and 1C are an example of a system for accessing the internal space between two tissues, and the system is utilized with a transcatheter system. The system includes a helical coil 101 and a gas supply system. As shown, the gas supply system includes a lumen 103 within the helical coil 101, a set of discharge ports 105, a gas supply (not shown), and a connection line 107 for connecting the gas supply to the inner lumen and the discharge ports. The helical coil 101 provides a means for traversing the outer tissue of the two tissues such that the discharge ports 105 can enter the internal space between the two tissues. The gas supply system provides a means for providing gas within the internal space to displace one or both of the tissues to create an accessible space between the two tissues. The helical coil 101 may comprise a sharp tip 109 that can puncture or traverse tissue.

[0050] The helical coil 101 can advance along its axis in a distal and / or proximal direction. The helical coil can be advanced by any capable means within the transcatheter system. As shown in FIGS. 1A - 1C, an inner sheath 111 is connected to the proximal end of the helical coil 101. Advancing the inner sheath 111 pushes the helical coil 101 in the distal direction, and retracting the inner sheath pulls the helical coil in the proximal direction.

[0051] The helical coil 101 can include a rotation rate that includes a rotation that is one complete circle of a helical rotation. Generally, at least half of a rotation can be provided such that the coil can be twisted into the internal space through the outer tissue. In some cases, the rotation rate corresponds to the axial distance per rotation and the depth of the tissue traversed. For example, the thickness of the human pericardial tissue is between approximately 2 mm and 3 mm. In some cases, the axial distance per rotation can be 1 mm, and thus at least 2 or 3 rotations are provided so that the helical coil can reach the inner pericardial space across the thickness of the pericardium. Further, by having an exact axial distance per rotation, a clinician can approximate the distance across the tissue. For example, if the axial distance per rotation is 1 mm, the clinician can recognize that 1 - 1.5 rotations reach approximately halfway through the pericardium and 2 - 3 rotations reach nearly the inner space. Based on the foregoing, in various cases, the helical coil includes at least half a rotation and further includes a number of rotations with an axial distance between each rotation such that the helical coil can completely traverse the thickness of the tissue traversed by the number of rotations.

[0052] In various implementations, the helical coil has between 0.5 and 15 rotations. In some specific implants, the helical coil has 0.5 rotation, 1.0 rotation, 1.5 rotations, 2.0 rotations, 2.5 rotations, 3.0 rotations, 3.5 rotations, 4.0 rotations, 4.5 rotations, 5.0 rotations, 5.5 rotations, 6.0 rotations, 6.5 rotations, 7.0 rotations, 7.5 rotations, 8.0 rotations, 8.5 rotations, 9.0 rotations, 9.5 rotations, 10.0 rotations, 10.5 rotations, 11.0 rotations, 11.5 rotations, 12.0 rotations, 12.5 rotations, 13.0 rotations, 13.5 rotations, 14.0 rotations, 14.5 rotations, or 15.0 rotations.

[0053] In various implementations, the helical coil has an axial distance of 0.5 mm to 10 mm between each rotation. In some specific implants, the helical coil has an axial distance of 0.5 mm between each rotation, an axial distance of 1.0 mm between each rotation, an axial distance of 1.5 mm between each rotation, an axial distance of 2.0 mm between each rotation, an axial distance of 2.5 mm between each rotation, an axial distance of 3.0 mm between each rotation, an axial distance of 3.5 mm between each rotation, an axial distance of 4.0 mm between each rotation, an axial distance of 5.5 mm between each rotation, an axial distance of 5.0 mm between each rotation, an axial distance of 6.5 mm between each rotation, an axial distance of 6.0 mm between each rotation, an axial distance of 7.5 mm between each rotation, an axial distance of 7.0 mm between each rotation, an axial distance of 8.5 mm between each rotation, an axial distance of 8.0 mm between each rotation, an axial distance of 8.5 mm between each rotation, an axial distance of 9.0 mm between each rotation, an axial distance of 9.5 mm between each rotation, or an axial distance of 10.0 mm between each rotation.

[0054] The diameter of the helical coil 101 can vary. Generally, the outer diameter is smaller than the outer catheter diameter and maintains a low profile when crossing the body. In some cases, the inner diameter is large enough to have a space that allows a tool, prosthesis, or another device to pass through it (as will be described in more detail below).

[0055] In various implementations, the helical coil has an outer diameter between about 2 mm and about 5 mm. In some specific implementations, the helical coil has an outer diameter of 2.0 mm, an outer diameter of 2.5 mm, an outer diameter of 3.0 mm, an outer diameter of 3.5 mm, an outer diameter of 4.0 mm, an outer diameter of 4.5 mm, or an outer diameter of 5.0 mm. In various implementations, the helical coil has an inner diameter between about 1 mm and about 4 mm. In some specific implementations, the helical coil has an inner diameter of 1.0, an inner diameter of 1.5 mm, an inner diameter of 2.0 mm, an inner diameter of 2.5 mm, an inner diameter of 3.0 mm, an inner diameter of 3.5 mm, or an inner diameter of 4.0 mm.

[0056] The axial length of the helical coil 101 can vary. Generally, the axial length is long enough to completely traverse the tissue but short enough to easily pass through the body in a minimally invasive procedure. As described in the foregoing embodiments, the thickness of the human pericardial tissue is between approximately 2 mm and 3 mm, although some tissues may be approximately 1 mm. To ensure easy movement through the body, the axial length should not exceed 20 mm.

[0057] In various implementations, the helical coil has an axial length between about 1 mm and about 20 mm. In some specific implementations, the helical coil has an axial length of 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm, 9.0 mm, 9.5 mm, 10.0 mm, 11.0 mm, 11.5 mm, 12.0 mm, 12.5 mm, 13.0 mm, 13.5 mm, 14.0 mm, 14.5 mm, 15.0 mm, 16.0 mm, 16.5 mm, 17.0 mm, 17.5 mm, 18.0 mm, 18.5 mm, 19.0 mm, 19.5 mm, or 20.0 mm.

[0058] In some implementations, the helical coil includes a sensor at the distal end of the coil. In some implementations, the sensor detects changes in the local environment, such as (for example) contacting the first tissue, traversing the first tissue, exiting the first tissue, entering the internal space between tissues, contacting the second tissue, and / or traversing the second tissue. In some embodiments, the sensor detects electrical impedance. The sensor can transmit data via a connection through a delivery catheter system or via wireless radio frequency transmission (e.g., RFID).

[0059] Some implementations of the system for accessing and creating a space between two tissues utilize a gas supply system to provide gas between the two tissues and move the gas through one or both of the tissues. As shown in FIGS. 1A - 1C, the gas supply system can include an inner lumen 103 within the helical coil 101 and an outlet port 105 on the coil. The gas supply system further includes a connection line 107 for connecting the outlet port 105 to a gas supply at the proximal end of the connection line. The connection line can be any type of tube or pipe capable of providing a sealed connection between the gas supply and the outlet port. In many implementations, the connection line is composed of a flexible material so that the delivery system can bend or curve with the transcatheter delivery system as it traverses through the body to the sites of the two tissues being accessed.

[0060] It should be understood that FIGS. 1A - 1C show an outlet port 105 at the tip of the helical coil 101, and the outlet port can be provided at any location along the coil. In some implementations, the outlet port is provided near the distal end of the helical coil so that when the distal end of the coil reaches the space between the two tissues, gas from the gas supply can be released into that space.

[0061] In some implementations, as shown in FIGS. 1A - 1C, the gas supply system utilizes a helical coil to provide gas to the internal space. However, it should be understood that the gas supply system can be completely or partially independent from the helical coil. Thus, in some implementations, the gas supply incorporates a discharge port and / or a connection line that is independent of the helical coil. In some implementations, the gas supply discharge port can move in the distal direction and / or the proximal direction along the axis. In some implementations, the gas supply discharge port can be pushed into the internal space between the two tissues such that gas can be discharged therein.

[0062] Any gas that can be discharged within the human body can be utilized. In some implementations, the gas is a biocompatible gas such as (for example) carbon dioxide. In some implementations, the gas is an inert gas such as (for example) nitrogen.

[0063] In some implementations, a vacuum system is provided to the system to access the space between the two tissues and create a space. The vacuum system can utilize the same ports, connection lines, and / or machinery as the gas supply system, or the vacuum system can utilize a separate set of one or more ports, a separate set of one or more connection lines, or a separate machinery from the gas supply system. In some implementations, the vacuum system is utilized to remove gas (or other fluid, or debris) from the internal space between the two tissues. In some implementations, the vacuum system is utilized to grip the tissue by sucking the tissue inward, which can provide resistance to the helical coil for penetrating and / or traversing the tissue.

[0064] In some implementations, a system for accessing the internal space between two tissues does not include a gas supply system or a vacuum system. In these implementations, the helical coil is utilized to penetrate and traverse the outer tissue to reach the internal space between the two tissues. The helical coil can be pulled back in the proximal direction so that the outer tissue is pulled away from the inner tissue to create more space within the internal space.

[0065] A system for accessing the space between two tissues can be delivered through the body via a catheter and a transcatheter system. As shown in FIGS. 1A - 1C, the catheter system includes an outer sheath 113 that surrounds the helical coil 101 and extends along the axis.

[0066] At the distal end of the outer sheath 113, there is a nose cone 115 that is angled to facilitate traversing through the body. The nose cone of the catheter system can open to allow the internal contents (e.g., the helical coil) to advance through it. FIG. 2 provides an exemplary view of the catheter system with the nose cone 115 open to allow the helical coil 101 to advance proximally from the outer sheath 113. The nose cone 115 includes a number of segments 117 having a sharp angle at the distal end, such that the segments can form a conical nose cone when closed (FIG. 1A) and can further open as the helical coil 101 advances distally (FIG. 2).

[0067] In some implementations, the nose cone includes a sensor at the distal end of the cone. In some implementations, the sensor detects changes in the local environment, such as (for example) traversing the body and / or contacting the tissue. In some embodiments, the sensor detects electrical impedance. The sensor can transmit data via a connection through the delivery transcatheter system or via wireless radio frequency transmission (e.g., RFID).

[0068] The catheter system extends proximally with respect to the control system, as understood in the technical field of transcatheter procedures. A clinician can use the control system to advance the transcatheter system through the body to the site where the procedure is to be performed. Further, the control system can advance and retract the helical coil axially and distally with respect to the outer sheath. The control system can be utilized to rotate the helical coil so as to penetrate and traverse through tissue. The control system can further comprise means for regulating gas supply and / or vacuum such that gas can be moved and released from the distal discharge port and / or can be made into a vacuum from the distal port. The control system can further comprise means for controlling a set of one or more optional tools utilized when accessing the internal space between two tissues.

[0069] In some implementations, the system for accessing the internal space between two tissue layers further includes a tool, a prosthesis, a device for drug delivery, or any other device or component to be delivered within the internal space between two tissues. As shown in FIGS. 1A - 1C, within the central lumen of the inner sheath 111, there is a tool 119 that can move distally or proximally along the axis. In many implementations, the tool is appropriately sized to fit within the inner lumen of the inner sheath and / or within the inner circumference of the helical coil and moves distally and / or proximally with respect to the helical coil. Thus, in some instances, the tool, prosthesis, or drug delivery device is pushed distally beyond the helical coil so as to be able to enter the internal space between two tissues. In some instances, the tool, prosthesis, or drug delivery device includes a sharp edge at the distal end so as to be able to cut through tissue to reach the internal space.

[0070] Exemplary tools include cutting tools, electrophysiological tools, suturing systems, sensors, visualization enhancement tools (e.g., cameras, or radiopaque devices), or any other tool desired by a clinician that can fit within a catheter and be delivered to the internal space between two tissues. Exemplary prostheses include stents, valves, patches, sutures, staples, implantable sensors, or any other prosthesis desired by a clinician that can fit within a catheter and be delivered to the internal space between two tissues. Exemplary agents include antibiotics, analgesics, wound healing agents, anti-cancer drugs, immunostimulants, immunosuppressants, or any other agent that can be delivered via catheter insertion and is desired by a clinician to be delivered to the internal space.

[0071] The specific configuration of the system for accessing the internal space between two tissues is described above with reference to FIGS. 1A - 1C, and it should be readily understood that the various configurations of the system for accessing the internal space between two tissues can be implemented in any of the various combinations of components. Thus, the specific configuration of the system for accessing the internal space between two tissues described herein is not limited to any particular configuration, but rather can be implemented in any configuration that can access the internal space between two tissues.

[0072] Method of Use An exemplary system for accessing the internal space between two tissues of the present disclosure can be utilized with a catheter system. In many cases, an incision is made in the body and the catheter system is inserted therein to reach the site of the procedure. In cases of accessing the pericardial cavity, a subxiphoid approach can be utilized. When the catheter system reaches the site of the procedure, the catheter can be opened so that the helical coil can advance distally and contact the tissue. At that point, the helical coil can be utilized to traverse the tissue and reach the internal space. In some cases, the method is visualized simultaneously via a visualization method such as, for example, sonography.

[0073] In FIGS. 3A-3F, an exemplary method is provided that utilizes a system for accessing an internal space between two tissues. FIG. 3A shows a catheter system approaching a first tissue layer 301. The nose cone 115 can advance distally until it contacts the surface of the tissue layer 301. In some implementations, the nose cone can incorporate a sensor at its distal end so that the sensor can sense contact with the tissue layer.

[0074] Upon contact with the surface of the tissue layer 301, the segment 117 of the nose cone 115 can be opened outwardly, allowing the distal advancement of the helical coil 101 (FIG. 3B). In some implementations, the helical coil 101 advancing distally pushed the segment 117 open. The helical coil 101 can advance distally until it contacts the surface of the tissue layer 301, at which point the distal tip of the helical coil can be rotated so that the helical coil penetrates and traverses the tissue (FIG. 3C).

[0075] The helical coil 101 continues to rotate until it contacts the surface of the second tissue 303 (FIG. 3D). In some cases, the contact of the helical coil 101 with the surface of the tissue 303 is determined by a sensor (e.g., an electrical impedance sensor). In some cases, the contact of the helical coil 101 with the surface of the tissue 303 is determined by knowing the thickness of the first tissue and the number of rotations required to completely traverse it. In some cases, the contact of the helical coil 101 with the surface of the tissue 303 is determined by a visualization method (e.g., sonography).

[0076] When the helix 101 contacts the tissue 303, the gas supply system releases gas into the internal space 305, resulting in displacement or lifting of the tissue 301 (FIG. 3E). Alternatively, or in addition to the gas release, the catheter system can be moved in the proximal direction to lift the tissue 301. The displacement or lifting of the tissue 301 creates more access space within the internal space 305, at which point the tool 119 can enter the internal space (FIG. 3F). In some cases, the tool 119 includes a sharp edge at the distal end to penetrate the tissue 301 and reach the internal space 305.

Claims

1. A system for accessing the internal space between two organizations, A transcatheter system comprising a transcatheter system having an outer sheath, an inner sheath, and a helical coil connected to the inner sheath, wherein the helical coil and the inner sheath are located within the outer sheath, and the helical coil and the inner sheath can move bidirectionally along an axis independently of the outer sheath.

2. The system according to claim 1, further comprising a nose cone connected to the outer sheath at its distal end, wherein the nose cone can be opened to expose the helical coil.

3. The system according to claim 2, wherein the nose cone is equipped with a sensor for detecting changes in the local environment.

4. The system according to claim 1, wherein the helical coil includes at least half a rotation.

5. The system according to claim 1, wherein the helical coil includes an axial distance of at least 2 mm.

6. The system according to claim 1, wherein the helical coil is equipped with a sensor at its distal end for detecting changes in the local environment.

7. The system according to claim 1, further comprising a gas supply system within the outer sheath, wherein the gas supply system comprises a discharge port at the distal end, a gas supply at the proximal end, and a connecting line between them.

8. The system according to claim 7, wherein the helical coil has a lumen and the discharge port is located at the distal end of the helical coil or proximal to the distal end.

9. The system according to claim 1, further comprising a vacuum system.

10. The system according to claim 1, further comprising a tool, prosthesis, or drug delivery device, wherein the tool, prosthesis, or drug delivery device is located within the outer sheath, is movable bidirectionally along an axis, is independent of the outer sheath, and can traverse through the inner circumference of the helical coil when moving bidirectionally along the axis and traversing through it.

11. The transcatheter system is further provided with a control system at its proximal end, the control system being able to advance the outer sheath distally and withdraw it proximally, the control system being able to advance the helical coil distally and retract it proximally, and / or The system according to claim 1, wherein the control system can further rotate the helical coil.

12. Transcatheter device, A transcatheter device comprising an outer sheath, an inner sheath, and a helical coil connected to the inner sheath, wherein the helical coil and the inner sheath are located within the outer sheath, and the helical coil and the inner sheath are independently movable bidirectionally along the axis of the transcatheter device, apart from the outer sheath.

13. The apparatus according to claim 12, further comprising a nose cone connected to the outer sheath at its distal end, wherein the nose cone opens to expose the helical coil.

14. The apparatus according to claim 13, wherein the nose cone is equipped with a sensor.

15. The apparatus according to claim 12, wherein the helical coil includes at least half a turn, or the helical coil includes at least 2 mm in axial distance.

16. The apparatus according to claim 12, wherein the helical coil is provided with a sensor at the distal end of the helical coil.

17. The apparatus according to claim 12, wherein the helical coil has a lumen.

18. The apparatus according to claim 12, further comprising at least one of a tool, a prosthesis, or a drug delivery device, wherein the tool, the prosthesis, or the drug delivery device is located within the outer sheath and is movable bidirectionally along the axis of the transcatheter device, the tool, the prosthesis, or the drug delivery device is traversable bidirectionally through the inner circumference of the helical coil, and / or a control system is capable of advancing the outer sheath distally and retracting it proximally.

19. The apparatus according to claim 18, wherein the control system advances the helical coil distally and retracts it proximal, and / or rotates the helical coil.

20. The apparatus according to any one of claims 12 to 19, wherein the helical coil is sterilized.

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