Patent Application
20240407835
The present invention relates generally to methods and devices usable to deliver energy within the body of a patient. More specifically, the present invention is concerned with a radiofrequency perforation apparatus.
Devices currently exist for creating a puncture, channel, or perforation within a tissue located in a body of a patient. One such device is the Brockenbrough™ Needle, which is commonly used to puncture the atrial septum of the heart. This device is a stiff elongate needle, which is structured such that it may be introduced into a body of the patient via the femoral vein and directed towards the heart. This device relies on the use of mechanical force to drive the sharp tip through the septum.
Alternatively, radiofrequency perforation apparatuses have been developed, whereby the septal perforation is accomplished by the application of focused radiofrequency energy to the septal tissue via an electrode at the distal end of a relatively thin conductive probe.
Against this background, there exists a continuing need in the industry to provide improved radiofrequency perforation devices and methods. An object of the present invention is therefore to provide such a radiofrequency perforation apparatus.
Example 1 is a transseptal access system comprising a radiofrequency perforation device including a core, a functional tip coupled to a distal end of the core, and a conductor extending along a length of the core; wherein the conductor is insulated along a portion of its length and is electrically coupled to the functional tip.
Example 2 is the transseptal access system of Example 1 the core further comprising a core lumen.
Example 3 is the transseptal access system of Example 1 the radiofrequency perforation device further comprising an outer coil wound around a distal portion of the core.
Example 4 is the transseptal access system of Example 3 further comprising a second electrode, wherein the outer coil is electrically coupled to the second electrode.
Example 5 is the transseptal access system of Example 1 wherein the core is a hypotube.
Example 6 is the transseptal access system of Example 1 wherein the core is made from a non-conductive material.
Example 7 is the transseptal access system of Example 1 wherein the conductor is made from a conductive material and at least one of an outer surface of the core and an inner surface of the core is at least partially covered by an insulating material.
Example 8 is the transseptal access system of Example 3 wherein the outer coil is positioned on the distal most portion of the radiofrequency perforation device proximal to the functional tip.
Example 9 is the transseptal access system of Example 3 wherein the outer coil includes an outer insulative layer.
Example 10 is the transseptal access system of Example 3 wherein the outer coil includes an inner conductive layer.
Example 11 is the transseptal access system of Example 1 wherein the core includes a helical groove extending along an outer surface and further wherein the conductor is disposed at least partially in and along the helical groove.
Example 12 is the transseptal access system of Example 3 wherein the outer coil is made from a radiopaque metal material covered by an insulating layer.
Example 13 is the transseptal access system of Example 3 wherein the outer coil is made from a polymeric material doped with a radiopaque material.
Example 14 is the transseptal access system of Example 1 wherein the core is selected from the group consisting of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyetheretherketone (PEEK), polyethylene terephthalate (PET), and polyimide.
Example 15 is the transseptal access system of Example 1 wherein the conductor is selected from the group consisting of copper, platinum iridium, copper cladded stainless steel, platinum core stainless steel, tungsten copper alloy, and molybdenum copper alloy.
Example 16 is a transseptal access system comprising a radiofrequency perforation device including a core, a functional tip coupled to a distal end of the core, and a conductor extending along a length of the core; wherein the conductor is insulated along a portion of its length and is electrically coupled to the functional tip.
Example 17 is the transseptal access system of Example 16 the core further comprising a core lumen.
Example 18 is the transseptal access system of Example 16 the radiofrequency perforation device further comprising an outer coil wound around a distal portion of the core.
Example 19 is the transseptal access system of Example 18 further comprising a second electrode, wherein the outer coil is electrically coupled to the second electrode.
Example 20 is the transseptal access system of Example 16 wherein the core is a hypotube.
Example 21 is the transseptal access system of Example 16 wherein the core is made from a non-conductive material.
Example 22 is the transseptal access system of Example 16 wherein the conductor is made from a conductive material and at least one of an outer surface of the core and an inner surface of the core is at least partially covered by an insulating material.
Example 23 is the transseptal access system of Example 18 wherein the outer coil is positioned on the distal most portion of the radiofrequency perforation device proximal to the functional tip.
Example 24 is the transseptal access system of Example 16 wherein the core includes a helical groove extending along an outer surface and further wherein the conductor is disposed at least partially in and along the helical groove.
Example 25 is the transseptal access system of Example 18 wherein the outer coil is made from a radiopaque metal material covered by an insulating layer.
Example 26 is the transseptal access system of Example 18 wherein the outer coil is made from a polymeric material doped with a radiopaque material.
Example 27 is the transseptal access system of Example 16 wherein the core is selected from the group consisting of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyetheretherketone (PEEK), polyethylene terephthalate (PET), and polyimide.
Example 28 is the transseptal access system of Example 16 wherein the conductor is selected from the group consisting of copper, platinum iridium, copper cladded stainless steel, platinum core stainless steel, tungsten copper alloy, and molybdenum copper alloy.
Example 29 is a transseptal access system comprising a radiofrequency perforation device including a core having a core lumen, a functional tip coupled to a distal end of the core, a conductor extending along a length of the core, and an outer coil wound around a distal portion of the core; wherein the conductor is insulated along a portion of its length and is electrically coupled to the functional tip.
Example 30 is the transseptal access system of Example 29 further comprising a second electrode, wherein the outer coil is electrically coupled to the second electrode.
Example 31 is the transseptal access system of Example 29 wherein the core is a hypotube, and wherein the core is made from a non-conductive material.
Example 32 is the transseptal access system of Example 29 wherein the conductor is made from a conductive material and at least one of an outer surface of the core and an inner surface of the core is at least partially covered by an insulating material.
Example 33 is the transseptal access system of Example 29 wherein the outer coil is positioned on the distal most portion of the radiofrequency perforation device proximal to the functional tip.
Example 34 is the transseptal access system of Example 29 wherein the core includes a helical groove extending along an outer surface and further wherein the conductor is disposed at least partially in and along the helical groove.
Example 35 is the transseptal access system of Example 29 wherein the outer coil is made from a radiopaque metal material covered by an insulating layer, and wherein the outer coil is made from a polymeric material doped with a radiopaque material.
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
Various medical procedures have been developed for diagnosing or treating physiological ailments originating within the left atrium 60 and associated structures. Exemplary such procedures include, without limitation, deployment of diagnostic or mapping catheters within the left atrium 60 for use in generating electroanatomical maps or diagnostic images thereof. Other exemplary procedures include endocardial catheter-based ablation (e.g., radiofrequency ablation, pulsed field ablation, cryoablation, laser ablation, high frequency ultrasound ablation, and the like) of target sites within the chamber or adjacent vessels (e.g., the pulmonary veins and their ostia) to terminate cardiac arrythmias such as atrial fibrillation and atrial flutter. Still other exemplary procedures may include deployment of left atrial appendage (LAA) closure devices. Of course, the foregoing examples of procedures within the left atrium 60 are merely illustrative and in no way limiting with respect to the present disclosure.
The medical procedure 10 illustrated in
In the illustrated embodiment, the transseptal access system 50 includes an introducer sheath 100, a dilator 105 having a dilator body 107 and a tapered distal tip portion 108, and a radiofrequency (RF) perforation device 110 having distal end portion 112 terminating in a tip electrode 115. As shown, in the assembled use state illustrated in
Subsequently, the user may position the distal end of the dilator 105 against the atrial septum 75, which can be done under imaging guidance. The RF perforation device 110 is then positioned such that electrode 115 is aligned with or protruding slightly from the distal end of the dilator 105. The dilator 105 and the RF perforation device 110 may be dragged along the atrial septum 75 and positioned, for example against the fossa ovalis of the atrial septum 75 under imaging guidance. A variety of additional steps may be performed, such as measuring one or more properties of the target site, for example an electrogram or ECG (electrocardiogram) tracing and/or a pressure measurement, or delivering material to the target site, for example delivering a contrast agent. Such steps may facilitate the localization of the tip electrode 115 at the desired target site. In addition, tactile feedback provided by medical RF perforation device 110 is usable to facilitate positioning of the tip electrode 115 at the desired target site.
With the tip electrode 115 and dilator 105 positioned at the target site, energy is delivered from an energy source, e.g., an RF generator, through the RF perforation device 110 to the tip electrode 115 and the target site. In some embodiments, the energy is delivered at a power of at least about 5 W at a voltage of at least about 75 V (peak-to-peak), and functions to vaporize cells in the vicinity of the tip electrode 115, thereby creating a void or perforation through the tissue at the target site. The user then applies force to the RF perforation device 110 so as to advance the tip electrode 115 at least partially through the perforation. In these embodiments, when the tip electrode 115 has passed through the target tissue, that is, when it has reached the left atrium 60, energy delivery is stopped. In some embodiments, the step of delivering energy occurs over a period of between about 1 s and about 5 s.
With the tip electrode 115 of the RF perforation device 110 having crossed the atrial septum 75, the dilator 105 can be advanced forward, with the tapered distal tip portion 107 operating to gradually enlarge the perforation to permit advancement of the distal end of the sheath 100 into the left atrium 60.
In some embodiments, the distal end portion 112 of the RF perforation device 110 may be pre-formed to assume an atraumatic shape such as a J-shape or pigtail shape. Examples of such RF perforation devices can be found, for example, in U.S. patents application Ser. No. 16/445,790 and Ser. No. 16/346,404 assigned to Baylis Medical Company, Inc. The aforementioned pre-formed shapes can advantageously function to minimize the risk of unintended contact between the tip electrode 115 and tissue within the left atrium 60, and can also operate to anchor the distal end portion 112 within the left atrium 60 during subsequent procedural steps. For example, in embodiments, the RF perforation device 110 can be structurally configured to function as a delivery rail for deployment of a relatively larger bore therapy delivery sheath and associated dilator(s). In such embodiments, the dilator 105 and the sheath 100 are withdrawn following deployment of the distal end portion 112 of the RF perforation device into the left atrium 60. The anchoring function of the pre-formed distal end portion 112 inhibits unintended retraction of the distal end portion 112, and corresponding loss of access to the perforated site on the atrial septum 75, during such withdrawal.
The present disclosure describes novel devices and methods for providing transseptal access to the left atrium 60 using radiofrequency energy. As will be explained in greater detail herein, the embodiments of the present disclosure describe a layered core insulated guidewire that may simplify the means of providing electrical connectivity between the radiofrequency puncture device and radiofrequency energy generator, while providing enhanced manipulability by the user.
As can be further seen from
In embodiments, the proximal portion 260 of the RF perforation device 210 has an electrically insulated outer surface. As such, the proximal portion 260 can be handled directly by the user when the RF perforation device 210 is energized. In the illustrated embodiment, the proximal portion 260 is of a unitary construction formed entirely of an electrically insulative material. One exemplary class of materials for construction of the proximal portion can include various grades of polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), among others. In embodiments, the proximal portion 260 can further include reinforcing elements, e.g., a polymeric braid or coil, to enhance the structural properties, e.g., stiffness, torque transfer capability, and the like.
In the illustrated embodiment, the distal portion 266 is electrically conductive and is capable of transferring radiofrequency energy supplied by an external RF generator to the functional tip 270 for subsequent delivery to the target tissue in a transseptal crossing procedure, as described above. Any biocompatible electrically conductive material may be selected for construction of the distal portion 266. Exemplary materials may include stainless steel, nickel-titanium alloy, and the like. Further, for ease of illustration, the distal portion 266 is depicted in
Additionally, in embodiments, the distal portion 266 can be constructed in multiple segments, e.g., a solid rod or hypotube in the regions nearest the proximal portion 260, and a coiled structure more distally to provide enhanced flexibility and torqueability. In embodiments, the distal portion can have a composite construction, e.g., a solid or tubular core conductor surrounded by a wire coil. Additionally in the illustrated embodiment, the proximal and distal portions 260, 266 are substantially isodiametric, although this is not a strict requirement in all embodiments.
In embodiments, as shown, the RF perforation device 310 further includes a conductor 374 that is insulated along a portion of its length and is electrically coupled to the tip electrode 370 and delivers RF energy to the tip electrode. In embodiments, the distal end portion 366 also includes a core 372 having a core lumen 378 extending longitudinally over the core 372. In embodiments, the functional tip 370 is coupled to the most distal end portion of the core 372. In embodiments, as shown in
In embodiments, the core 372 is nonconductive. In the illustrated embodiments, the core 372 is of a unitary construction formed entirely of an electrically insulative material. One exemplary class of electrically insulative materials for construction of the core 372 can include various grades of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyetheretherketone (PEEK), polyethylene terephthalate (PET), polyimide, among others. In embodiments, if the conductor 374 is itself insulated, the core 372 may be made from a hypotube, coil, braid, or polymer sleeve. An exemplary class of materials for the construction of the hypotube or metal coil wire of the core 372 may include various grades of stainless steel, nitinol, MP35N®, or Inconel. Any biocompatible electrically conductive material may be selected for construction of the conductor 374. Exemplary materials for construction of the conductor 374 may include copper, platinum iridium, copper cladded stainless steel, platinum core stainless steel, tungsten copper alloy, and molybdenum copper alloy, and the like. Furthermore, the conductor 374 within the lumen 378 is a thin insulated conductor. The hypotube or coil wires may be insulated from the core 372 and/or made from a non-conductive material.
Thus, in embodiments, the outer coil may include an outer insulative layer 376 and an inner conductive layer 377. Exemplary materials of the outer insulative layer 376 may include various grades of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyetheretherketone (PEEK), polyethylene terephthalate (PET), polyimide, among others. Exemplary materials of the inner conductive layer 377 may include copper, platinum iridium, copper cladded stainless steel, platinum core stainless steel, tungsten copper alloy, and molybdenum copper alloy, and the like.
In embodiments, the distal end portion 366 of the RF perforation device 310 may only include the conductor 374 delivering RF energy to the tip electrode 370 and the outer coil 375 providing insulation with its outer insulative layer 376 with no need for the core 372. Additionally, in embodiments, the core 372 may be made from a metal hypotube or coil wires with the coil 375 wound around the distal end portion of the wire near the functional tip 370 to provide radiopacity. Radiopacity is the state or degree of being opaque to X-rays or other radiation. In embodiments, the outer coil 375 may be made from a radiopaque metal covered with an insulated layer or made from a polymer doped with a radiopaque material. In embodiments, the outer coil wires 375 can be insulated to add another layer of protection from voltage leakage, but still have an inner metallic core to provide structural support and radiopacity.
In embodiments, as illustrated in
In embodiments, the distal end portion 366 of the RF perforation device 310 may also include a second ring electrode 371, as illustrated in
Generally, in embodiments, the core 372, a structural member, is insulated from the conductor, 374, an inner conductive member, to provide good rail support with better dielectric insulative properties. In embodiments, the conductive material of the conductor 374 allows the RF energy to be applied to the functional tip electrode 370 for ablation. In embodiments, either the core 372 (with spiral groove) or the coil wires 375 would provide the rail support to deliver adjunct devices over the wire 374. In further embodiments, the smaller insulated conductor allows the RF energy to be fed through the smaller insulated wire instead of the entire larger core. This provides a safety feature as the entire core does not then need to be insulated with as thick of an insulative layer. In embodiments, this multiple layers of insulation on the inner core 372 and outer coiled wires 375 provides a high dielectric potential to the energized conductor 374 that may be used in any energized guidewire for ablation or stimulation. In other embodiments, the inner core 372 and the outer coiled wires 375 may be used for sensing.
Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.
The present application claims priority to U.S. Provisional Application No. 63/507, 169 entitled “LAYERED CORE INSULATED GUIDEWIRE,” filed Jun. 9, 2023, the disclosure of which is incorporated herewith by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63507169 | Jun 2023 | US |
