Patent Application
20250082427
The disclosure is generally directed to systems and devices for providing a means to access space between layers of tissue.
The pericardium, also referred to as the pericardial sac, is double-layered tissue that surrounds the heart and provides it protection. The outer layer of the pericardium is the fibrous pericardium formed of strong connective tissue and the inner layer is the serious pericardium formed of a serous membrane. Between the pericardium and the heart is the pericardial space, which a lubricous space that allows the heart to function without friction.
Heart failure is condition in which the heart muscle pumps a low ejection fraction of blood, resulting in poor blood circulation. While there are various causes of heart failure, the elastic pericardium can contribute to the low ejection fraction by exerting a compressive force on the heart myocardium. Thus, one way to increase to improve heart function is to relieve the compressive force provided by the pericardium.
A system for accessing an inner space between two tissues can comprise a helical coil within a catheter system. The helical coil is able to move along an axis in the distal direction such that it can be exposed out of the catheter system to perform a procedure. The helical coil is capable of turning such that the helical can penetrate and traverse a tissue. The system for accessing an inner space can further comprise a gas supply and/or vacuum. The gas supply can release gas within an inner space to displace one or both tissues to create more space therein. A vacuum can help hold a tissue and provide a resistance force for the helical coil to penetrate and traverse a tissue. A vacuum can also be utilized to remove the gas released within the inner space. A tool, prosthetic, or other device can be entered into the inner space to perform a procedure or treatment.
In one implementation, a transcatheter system comprises an outer sheath, an inner sheath, and a helical coil in connection with the inner sheath. The helical coil and the inner sheath are within the outer sheath. The helical coil and the inner sheath are capable of bidirectionally moving along an axis, independently of the outer sheath.
In some aspects, alone or in combination with any of the previous aspects, the system further comprises a nosecone connected to the outer sheath at the distal end. The nosecone is capable of opening to expose the helical coil.
In some aspects, alone or in combination with any of the previous aspects, the nosecone comprises a sensor for detecting a change in local environment.
In some aspects, alone or in combination with any of the previous aspects, the helical coil comprises at least one-half revolutions.
In some aspects, alone or in combination with any of the previous aspects, the helical coil comprises an axial distance of at least 2 mm.
In some aspects, alone or in combination with any of the previous aspects, the helical coil comprises a sensor at the distal end of the coil for detecting a change in local environment.
In some aspects, alone or in combination with any of the previous aspects, the system further comprises a gas supply system within the outer sheath. The gas supply system comprises a release port at a distal end, a gas supply at a proximal end, and a connection line therebetween.
In some aspects, alone or in combination with any of the previous aspects, the helical coil comprises a lumen. The connection line comprises the lumen of the helical coil. The release port is located at or proximal to the distal tip of the helical coil.
In some aspects, alone or in combination with any of the previous aspects, the system further comprises a vacuum.
In some aspects, the gas supply system is also a vacuum system.
In some aspects, alone or in combination with any of the previous aspects, the system further comprises a tool, a prosthetic, or a medicinal delivery device. The tool, the prosthetic, or the medicinal delivery device is within the outer sheath and is capable of bidirectionally moving along an axis, independently of the outer sheath.
In some aspects, alone or in combination with any of the previous aspects, the tool, the prosthetic, or the medicinal delivery device is capable of traversing through an inner circumference of the helical coil when traversed therethrough when moved bidirectionally along the axis.
In some aspects, alone or in combination with any of the previous aspects, the system further comprises a control system at a proximal end of the transcatheter system. The control system is capable of distally advancing and proximally retrieving the outer sheath.
In some aspects, alone or in combination with any of the previous aspects, the control system is further capable of distally advancing and proximally retrieving the helical coil.
In some aspects, alone or in combination with any of the previous aspects, the control system is further capable of rotating the helical coil.
In some aspects, alone or in combination with any of the previous aspects, the helical coil is sterilized.
In one implementation, a method comprises traversing a helical coil through a recipient to a procedural site via a transcatheter system. The transcatheter system comprises an outer sheath, an inner sheath, and a helical coil in connection with the inner sheath. The helical coil and the inner sheath are within the outer sheath. When the helical coil comes within proximity of the procedural site, the method further comprises distally advancing and exposing the helical coil out of the outer sheath such that the helical coil contacts a surface of a first tissue. The method further comprises rotating the helical coil such that the helical penetrates and traverses the first tissue. The helical coil is rotated until it traverses completely through the first tissue and is within an inner space between the first tissue and a second tissue.
In some aspects, alone or in combination with any of the previous aspects, the complete traversal through the first tissue and into the inner space is determined or is approximated by a visualization method.
In some aspects, alone or in combination with any of the previous aspects, the complete traversal through the first tissue and into the inner space is determined or is approximated by the amount of rotation of the helical coil.
In some aspects, alone or in combination with any of the previous aspects, the complete traversal through the first tissue and into the inner space is determined or is approximated by a sensor on the helical coil capable of detecting a change in local environment.
In some aspects, alone or in combination with any of the previous aspects, the method further comprises creating more access space within the inner space by displacing one of or both of the first tissue and the second tissue.
In some aspects, alone or in combination with any of the previous aspects, the first tissue is displaced by pulling the helical coil back in the proximal direction.
In some aspects, alone or in combination with any of the previous aspects, the transcatheter system further comprises a gas supply system within the outer sheath. The gas supply system comprises a release port at a distal end, a gas supply at a proximal end, and a connection line therebetween. The more access space within the inner space is created by releasing gas within the inner space to displace one of or both of the first tissue and the second tissue.
In some aspects, alone or in combination with any of the previous aspects, the transcatheter system further comprises a vacuum system within the outer sheath, and the method further comprises removing the gas within the inner space via the vacuum system.
In some aspects, alone or in combination with any of the previous aspects, the transcatheter system further comprises a vacuum system within the outer sheath, and prior to the rotation of the helical coil, the method further comprises grasping the first tissue via the vacuum.
In some aspects, alone or in combination with any of the previous aspects, the transcatheter system further comprises a tool within the outer sheath and the method further comprises distally advancing and exposing the tool out of the outer sheath, traversing the tool through the first tissue into the inner space, and performing a procedure with the tool within the inner space.
In some aspects, the transcatheter system further comprises a prosthetic within the outer sheath, and the method further comprises distally advancing and exposing the prosthetic out of the outer sheath, traversing the prosthetic through the first tissue into the inner space, and installing the prosthetic within the inner space.
In some aspects, alone or in combination with any of the previous aspects, the transcatheter system further comprises a medicinal delivery device within the outer sheath, and the method further comprises In some aspects, distally advancing and exposing the medicinal delivery device out of the outer sheath, traversing the medicinal delivery device through the first tissue into the inner space, and releasing a medicine from the medicinal delivery device within the inner space.
In some aspects, alone or in combination with any of the previous aspects, the transcatheter system further comprises a nosecone attached to the distal end of the outer sheath, and prior to exposing the helical coil, the method further comprises opening the nosecone.
In some aspects, alone or in combination with any of the previous aspects, the nosecone is opened by the distal advancement of the helical coil.
In some aspects, alone or in combination with any of the previous aspects, the first tissue is a pericardium and the second tissue is a myocardium.
In some aspects, alone or in combination with any of the previous aspects, the pericardium is reached via a subxiphoid approach.
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 disclosure and should not be construed as a complete recitation of the scope of the disclosure.
The current disclosure details systems and devices for accessing and creating space between two tissues. The systems and devices can utilize a catheter design for minimal invasiveness within the body. Accordingly, systems and devices can comprise a catheter that provides a means for translocating tools for accessing and creating space between two tissue layers. Further, the catheter can provide a means for translocating tools to the space between the two layers to perform a procedure therein.
Systems and devices are directed to catheter systems that further comprise a helical coil, which can be utilized to traverse the outer tissue of the two tissues. Once traversed, a gas supply system can be utilized to supply a gas to the space between the two tissues. The gas can be utilized to displace one or both of the tissues to create a space therebetween. In some instances, the helical coil contains a hollowed lumen and release port, which can be connected to a gas supply in order to supply the gas to the space between the two tissues. The catheter system can further comprise a tool, a prosthetic, medication, or any other device or composition to be delivered into the inner space between the two tissues. Exemplary tools include a cutting tool, an electrophysiology tool, a suturing system, a sensor, a visualization enhancing tool (e.g., camera or radiopaque device), or any other tool that can fit within the catheter and would be desired by the clinician to be delivered to the inner space between two tissues. Exemplary prosthetics include a stent, a valve, a patch, sutures, staples, an implantable sensor, or any other prosthetic that can fit within the catheter and would be desired by the clinician to be delivered to the inner space between two tissues. Exemplary medications include antibiotics, analgesics, wound healing medication, anti-cancer medication, immunostimulant, immunosuppressant, or any other medication that can be delivered via catheterization and would be desired by the clinician to be delivered to the inner space.
The described systems, devices, and methods should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed systems and devices, alone and in various combinations and sub-combinations with one another. The disclosed systems, devices, and methods are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed systems, devices, and methods require that any one or more specific advantages be present or problems be solved.
Various examples of space accessing systems and components thereof are disclosed herein, and any combination of these examples 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 specific combination is not explicitly described. Likewise, the different constructions and features of space accessing systems can be mixed and matched, such as by combining any tool for entering into the inner space, any system for providing displacement gas, and any device, or composition to be utilized within the space, even if not explicitly disclosed. In short, individual components of the disclosed systems can be combined unless mutually exclusive or physically impossible.
Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods, systems, and apparatus can be used in conjunction with other systems, methods, and apparatus.
The terms “proximal” and “distal” as used throughout the description relate to a catheter system axis, in which the end where the procedure is performed is the distal end and the opposite end where the catheter system is controlled is the proximal end. Accordingly, the distal end of the catheter system is the leading end that first traverses into the body and first reaches the procedure site. Conversely, the proximal end of the catheter system is the portion that remains extracorporeal. Likewise, a distal movement along the catheter axis would be movement of a component in a direction towards a site of procedure and a proximal movement along the catheter axis would be movement of a component in an opposite direction. Although these terms have a relationship with a site of procedure, it is to be understood that these terms are used for reference and the site of procedure does not need to be present when interpreting the components or movements of the devices and systems described herein.
Various systems and devices for accessing an inner space between two tissues are utilized for the purpose of performing a procedure within a recipient. Recipients
include (but are not limited to) patients, animal models, cadavers, or anthropomorphic phantoms. Accordingly, in addition to methods of treating patients, the systems and devices can be utilized in training or other practice procedures upon animal models, cadavers, or anthropomorphic phantoms.
The described systems and devices can be sterilized, which can be performed using gamma irradiation, gas plasma, aldehydes, ethylene oxide, and/or e-beam. The systems or devices can be further treated with a formaldehyde bioburden reduction process. After preparation, the systems and devices can be stored within a container, which can be hermetically sealed or otherwise kept sterile.
Systems and devices for accessing an inner space between two tissues can comprise a catheter system such that it can be utilized within minimally invasive procedures. The systems and devices can comprise a means for traversing the outer layer into the inner space between the two layers. The systems and devices can further comprise a gas-supply system to provide a gas to the inner space to displace one or both tissues to create an accessible space between the two tissues. The systems and devices can further comprise a tool, a prosthetic, a medication, or other device or composition to be transported to the inner space.
The systems and devices for accessing an inner space can be utilized on any two tissues in which an inner space can be accessed. In many instances, the systems and devices are utilized to access an inner space between connective tissue and muscular tissue. One such example an inner space to be accessed is the pericardial space between the pericardium and the myocardium. The pericardium is a connective tissue that surrounds the muscular heart tissue. Any catheter approach can be utilized to reach the two tissues and inner space. For example, a subxiphoid approach can be utilized to access the pericardial space.
Provided in
Helical coil 101 can be advanced along an axis in the distal and/or proximal direction. Helical coil can be advanced by any capable means within a transcatheter system. As shown in
Helical coil 101 can comprise a number of revolutions; a revolution being one full circle of a helical turn. Generally, at least one half of a revolution can be provided such that coil can be twisted through an outer tissue into an inner space. In some instances, the number of revolutions corresponds to the axial distance per revolution and the tissue depth to be traversed. For example, the thickness human pericardial tissue is approximately between 2 mm and 3 mm. In some instances, an axial distance per revolution can be 1 mm and thus at least 2 or 3 turns are provided such that the helical coil can traverse through the pericardial thickness to reach the inner pericardial space. Further, having a precise axial distance of per revolution can allow the clinician to approximate the distance traversed through the tissue. For example, when the axial distance per revolution is 1 mm, the clinician can know that one 1 to 1.5 turns reaches approximately half way through the pericardium and that 2 to 3 turns reaches approximately the inner space. Based on the foregoing, in various instances, the helical coil comprises at least one-half revolutions and further comprises a number of revolutions with an axial distance between each revolution such that the number of revolutions allows the helical coil to completely traverse the thickness of the tissue to be traversed.
In various implementations, the helical coil has between 0.5 and 15 revolutions. In some particular implantations, the helical coil has 0.5. revolutions, 1.0 revolutions, 1.5 revolutions, 2.0 revolutions, 2.5 revolutions, 3.0 revolutions, 3.5 revolutions, 4.0 revolutions, 4.5 revolutions, 5.0 revolutions. 5.5 revolutions, 6.0 revolutions, 6.5. revolutions, 7.0 revolutions, 7.5 revolutions, 8.0 revolutions, 8.5 revolutions, 9.0 revolutions, 9.5 revolutions, 10.0 revolutions, 10.5 revolutions, 11.0 revolutions. 11.5 revolutions, 12.0 revolutions, 12.5 revolutions, 13.0 revolutions, 13.5 revolutions, 14.0 revolutions. 14.5 revolutions, or 15.0 revolutions.
In various implementations, the helical coil has an axial distance of 0.5 mm and 10 mm between each revolution. In some particular implantations, the helical coil has an axial distance of 0.5 mm between each revolution, an axial distance of 1.0 mm between each revolution, an axial distance of 1.5 mm between each revolution, an axial distance of 2.0 mm between each revolution, an axial distance of 2.5 mm between each revolution, an axial distance of 3.0 mm between each revolution, an axial distance of 3.5 mm between each revolution, an axial distance of 4.0 mm between each revolution, an axial distance of 5.5 mm between each revolution, an axial distance of 5.0 mm between each revolution, an axial distance of 6.5 mm between each revolution, an axial distance of 6.0 mm between each revolution, an axial distance of 7.5 mm between each revolution, an axial distance of 7.0 mm between each revolution, an axial distance of 8.5 mm between each revolution, an axial distance of 8.0 mm between each revolution, an axial distance of 8.5 mm between each revolution, an axial distance of 9.0 mm between each revolution, an axial distance of 9.5 mm between each revolution, or an axial distance of 10.0 mm between each revolution.
The diameter of helical coil 101 can vary. Generally, the outer diameter is less than an outer catheter diameter such and maintains a low profile when traversing the body. In some instances, the inner diameter is large enough such that it has space to allow a tool, a prosthetic, or another device to pass therethrough (as described in greater detail below).
In various implementations, the helical coil has an outer diameter between about 2 mm and about 5 mm. In some particular 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 particular 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.
The axial length of helical coil 101 can vary. Generally, the axial length is long enough to completely traverse the tissue but short enough to easily transit through the body in the minimally invasive procedure. As described in an earlier example, the thickness human pericardial tissue is approximately between 2 mm and 3 mm, however some tissues can be approximately 1 mm. To assure easy transit through the body, the axial length should not be longer than 20 mm.
In various implementations, the helical coil has an axial length between about 1 mm and about 20 mm. In some particular implementations, the helical coil has an axial length of 1.0 mm, an axial length of 1.5 mm, an axial length of 2.0 mm, an axial length of 2.5 mm, an axial length of 3.0 mm, an axial length of 3.5 mm, an axial length of 4.0 mm, an axial length of 4.5 mm, an axial length of 5.0 mm, an axial length of 6.0 mm, an axial length of 6.5 mm, an axial length of 7.0 mm, an axial length of 7.5 mm, an axial length of 8.0 mm, an axial length of 8.5 mm, an axial length of 9.0 mm, an axial length of 9.5 mm, an axial length of 10.0 mm, an axial length of 11.0 mm, an axial length of 11.5 mm, an axial length of 12.0 mm, an axial length of 12.5 mm, an axial length of 13.0 mm, an axial length of 13.5 mm, an axial length of 14.0 mm, an axial length of 14.5 mm, an axial length of 15.0 mm, an axial length of 16.0 mm, an axial length of 16.5 mm, an axial length of 17.0 mm, an axial length of 17.5 mm, an axial length of 18.0 mm, an axial length of 18.5 mm, an axial length of 19.0 mm, an axial length of 19.5 mm, or an axial length of 20.0 mm.
In some implementations, the helical coil includes a sensor at the distal end of the coil. In some implementations, the sensor detects a change in local environment, such as (for example) contacting the first tissue, traversing the first tissue, exiting the first tissue, entering into the inner 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 connection through the delivery transcatheter system or via radio-frequency transmission (e.g., RFID).
Several implementations of a system for accessing and creating space between two tissues utilizes a gas supply system to provide gas between the two tissues to displace one or both tissues via the gas. As shown in
Although
In some implementations, a gas supply system utilizes the helical coil to supply the gas to the inner space, as shown in
Any gas capable of being released within human 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.
In some implementations, a vacuum system is provided in a system for accessing and creating space between two tissues. The vacuum system can utilize the same ports, connection lines, and/or machinery as the gas supply system or the vacuum system can utilize its a separate set of one or more ports, a separate set of one or more connection lines, or separate machinery as the gas supply system. In several implementations, the vacuum system is utilized to remove gas (or other fluids or debris) from the inner space between the two tissues. In some implementations, the vacuum system is utilized to grasp tissue by sucking it inward, which can provide the helical coil a resistance force to penetrate and/or traverse tissue.
In some implementations, system for accessing the inner space between two tissues does not include a gas supply system or a vacuum system. In these implementations, the helical coil is utilized penetrate and traverse the outer tissue to reach the inner space between the two tissues. To create more space within the inner space, the helical coil can be pulled back in the proximal direction such that the outer tissue is pulled away from the inner tissue.
The system for accessing space between two tissues can be delivered through the body via a catheter and transcatheter system. As shown in
At the distal end of outer sheath 113 is a nosecone 115 angled to facilitate traversing through the body. The nosecone of the catheter system is capable of opening to allow the inner contents (e.g., helical coil) to be advanced therethrough. Provided in
In some implementations, the nosecone includes a sensor at the distal end of the cone. In some implementations, the sensor detects a change in local environment, such as (for example) traversing through the body, and/or contacting the tissue. In some embodiments, the sensor detects electrical impedance. The sensor can transmit data via connection through the delivery transcatheter system or via radio-frequency transmission (e.g., RFID).
The catheter system extends proximally to a control system, as is appreciated in the art of transcatheter procedures. A clinician can utilize 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 in the axial and distal direction in reference to the outer sheath. The control system can be utilized to turn the helical coil such that it can penetrated and traverse through tissue. The control system can further comprise a means for regulating the gas supply and/or vacuum such that gas can be transferred and released from the distal release port and/or vacuumed from the distal port. The control system can further comprise a means for controlling a set of one or more optional tools to be utilized upon accessing an inner space between two tissues.
In some implementations, a system for accessing an inner space between two tissue layers further comprises a tool, a prosthetic, a device for delivery of medication, or any other device or composition to be delivered into the inner space between the two tissues. As shown in
Exemplary tools include a cutting tool, an electrophysiology tool, a suturing system, a sensor, a visualization enhancing tool (e.g., camera or radiopaque device), or any other tool that can fit within the catheter and would be desired by the clinician to be delivered to the inner space between two tissues. Exemplary prosthetics include a stent, a valve, a patch, sutures, staples, an implantable sensor, or any other prosthetic that can fit within the catheter and would be desired by the clinician to be delivered to the inner space between two tissues. Exemplary medications include antibiotics, analgesics, wound healing medication, anti-cancer medication, immunostimulant, immunosuppressant, or any other medication that can be delivered via catheterization and would be desired by the clinician to be delivered to the inner space.
While a specific configuration of a system for accessing the inner space between two tissues is described above with reference to
The exemplary systems for accessing the inner space between two tissues of the disclosure can be utilized in a catheter system. In many instances, an incision is made the body and the catheter system is inserted therein in order to reach the site of the procedure. In instances in which the pericardial space is to be accessed, a subxiphoid approach can be utilized. Once the catheter system reaches the site procedure, the catheter can open up such that the helical coil can be advanced distally to come into contact with the tissue. At that point, the helical coil can be utilized to traverse the tissue to reach the inner space. In some instances, the method is view contemporaneously via a visualization method, such as (for example) sonography.
Provided in
Upon contact with the surface of tissue layer 301, segments 117 of nosecone 115 can be opened outwardly allowing the distal advancement of helical coil 101 (
Helical coil 101 continues to turn until it comes in contact with the surface of a second tissue 303 (
When helical 101 contacts tissue 303, a gas supply system releases gas into inner space 305 resulting in a displacement or lifting of tissue 301 (
This application is a continuation application of International Patent Application No. PCT/US2023/023878, filed May 30, 2023, which claims the benefit of both U.S. Provisional Application No. 63/347,466, filed May 31, 2022, and U.S. Provisional Application No. 63/481,099 filed Jan. 23, 2023, the entireties of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63481099 | Jan 2023 | US | |
| 63347466 | May 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/023878 | May 2023 | WO |
| Child | 18957497 | US |
