The present invention relates generally to medical devices and in particular to medical devices for delivering electroporation therapy.
Electroporation therapy involves the application of an electrical field to cell membranes to increase the permeability of the cell membrane. In some applications, electroporation is utilized to permanently damage or destroy targeted cells, which is referred to as irreversible electroporation (IRE) therapy. One of the benefits of IRE therapy is that it allows targeted cells to be damaged or ablated while leaving neighboring cells unaffected. IRE therapy is applicable to any procedure in which it is desirable to ablate tissue, including for example cancer therapy and/or cardiac ablation therapy to mitigate/cease certain arrhythmic conditions, including but limited to ectopic atrial tachycardia, atrial fibrillation, and atrial flutter.
In particular, IRE therapy stands to serve as an alternative to traditional cardiac ablation techniques. It is suspected that the primary cause of atrial arrhythmia is stray electrical signals within the left or right atrium of the heart. Traditional cardiac ablation therapy requires the delivery of ablative energy (e.g., radio frequency (rf) energy, lasers, etc.) to the cardiac tissue. The ablative energy—thermal energy—damages the cardiac tissue and disrupts the undesirable electrical pathways causing the arrhythmic condition.
IRE therapy allows for the targeted ablation of cardiac tissue to create the desired lesions—and therefore disruption of the undesirable electrical pathways—without the introduction of thermal energy that accompanies traditional ablative therapies.
According to one aspect, an electroporation catheter includes a shaft having a proximal end and a distal end and an electroporation assembly located at the distal end of the shaft. The electroporation assembly may include at least a first electrode and a non-conductive portion, the non-conductive portion having a first end and a second end, wherein the first end is connected to the shaft and wherein the second end extends radially outward from the first end.
According to another aspect, a method of delivering electroporation therapy to a patient, wherein the method includes introducing a catheter into the patient, the catheter including a shaft having proximal end attached to a handle and a distal end that includes an electroporation assembly. The method may further includes navigating the electroporation assembly in an undeployed state to a desired tissue site, wherein the electroporation assembly includes at least a first electrode and a non-conductive portion attached on a first end to the shaft and a second, unattached end. At the desired tissue site, the electroporation assembly is deployed, wherein deployment of the electroporation assembly includes allowing the second, unattached end of the non-conductive portion to extend radially outward into contact with the desired tissue site. Electroporation pulses are then delivered to the first electrode.
The disclosed invention is directed to a catheter that includes a shaft and an electroporation assembly. The shaft includes a proximal end and a distal end, wherein the electroporation assembly is connected to the distal end of the shaft. The electroporation assembly includes at least a first electrode and a non-conductive portion, wherein the non-conductive portion is connected on a first end to the shaft and extends radially outward from the shaft to a second end. The non-conductive portion prevents the formation of a low-impedance path between the first electrode and a second electrode—wherever located—that does not include the tissue to be treated. That is, deploying the non-conductive portion adjacent the tissue to be treated ensures that the electrical path formed between the electrodes delivering the pulses includes the tissue located adjacent the non-conductive portion.
Electroporation pulses delivered by the electroporation assembly 120 are generated by electroporation generator 104. In some embodiments, the magnitude, duration and number of pulses delivered may be modified by the electroporation generator 104. Additional information on generation and delivery of electroporation pulses is provided in U.S. Pat. Appl. 62/704,920, filed on Jun. 3, 2020, titled “SYSTEM AND METHOD FOR IRREVERSIBLE ELECTROPORATION”, the teachings and content of which are hereby incorporated by reference in their entirety. Electroporation generator 104 is coupled to interface connector 124 of catheter 102 via cables 126. Electroporation pulses delivered to handle 102 are communicated via the shaft 114 to electroporation assembly 120. In addition, in some embodiments catheter 102 includes one or more sensors (e.g., magnetic, electric, optical, etc.) positioned along the shaft 114 for providing sensor inputs to the computer system 106. In some embodiments the same electrodes utilized to generate the electroporation pulses are also utilized to collect electrical signals (e.g., electrocardiogram signals, impedance signals, etc.) and are therefore provided to the computer system 106 via electroporation generator 104. In other embodiments, the sensed signals—whether electrical, magnetic, or optical—may be provided directly to computer system 106 (i.e., cables 126 may be coupled directly to computer system 106 rather than via electroporation generator 104).
In some embodiments, computer system 106 includes storage 128 capable of storing computer readable instructions and an electronic control unit (ECU 130) capable of executing computer readable instructions. In some embodiments, computer system 106 communicates bi-directionally with input/output 108 and further displays information via display 110. In some embodiments, computer system 106 controls generation and delivery of electroporation pulses by electroporation generator 104. This may include modifying one or more of the amplitude (i.e., intensity), duration, and number of pulses delivered by the electroporation generator 104.
In addition, computer system 106 may utilize the one or more sensed signals—whether electric, magnetic, or optical—as inputs to enable one or more functions including visualization, navigation, and/or mapping. For example, the one or more sensed signals may be utilized to visualize the location of the catheter within the patient's body as well as to aid in navigating the catheter through the patient's vasculature to the desired location within the patient's body. In some embodiments, electrical signals (e.g., electrocardiogram signals) sensed by electrodes associated with the electroporation assembly 120 may be utilized to map the propagation of electrical signals within the patient's heart or to verify that disruptive signals have been blocked following delivery of electroporation pulses. In some embodiments, a surface electrode 134 is utilized for receiving electrical signals and/or providing electrical signals to the body to be received by one or more electrodes located on the electroporation assembly 120. For example, an electrical signal generated at surface electrode 134 (or two or more surface electrodes) may be detected by one or more electrodes located at the distal end 116 of the catheter 102 within the patient's body. In other embodiments, surface electrode 134 may act as a return path for electrical signals delivered to the electroporation assembly 120—including as a return for electroporation pulses delivered by electroporation generator 104 to the electroporation assembly 120.
In some embodiments one or more sensed signals are utilized to verify the position of the electroporation assembly 120 relative to the tissue to be electroporated. In particular, in some embodiments one or more sensed signals are utilized to verify that the electrical path between electrodes located on the electroporation assembly 120 includes the tissue selected to receive electroporation therapy. For example, in some embodiments a low impedance path between the electrodes located on the electroporation assembly 120 is utilized to detect a conductive path through the adjacent pool of blood—and which as a result does not include the higher impedance path through the tissue selected to receive electroporation treatment. In response, the electroporation assembly 120 may be repositioned and the electrical path between respective electrodes may be tested again.
Referring now to
In some embodiments, the electroporation assembly 120′ is located at a distal end 116 of a shaft 114 (as shown in
Electroporation therapy includes the delivery or one or more electrical pulses between a first and second electrode. For example, in the embodiment shown in
In some embodiments, the non-conductive portion 206 is comprised of a uniform non-conductive material (i.e., insulative material). Depending on the application the non-conductive portion 206 may be comprised of compliant or non-compliant materials. For example, in some embodiments the non-conductive portion 206 may be fabricated using one or more of silicone, polyurethane, rubber, and/or a non-conductive polymer, each of which is compliant and non-conductive. One benefit of utilizing a compliant material is that it allows the non-conductive portion 206 to be deformed/compressed in an undeployed state to allow the non-conductive portion to fit within a sheath 218 as shown in
Referring now to
As described above, in some embodiments the electroporation assembly 120″ is located at a distal end 116 of a shaft 114 (as shown in
The geometry of the electroporation assembly 120″ shown in
Referring now to
In some embodiments, electroporation pulses are delivered between electrode 402 and electrode 410 or between electrode 404 and electrode 410. The conductive path formed between either of the electrodes 402, 404 and the electrode 410 located on an outer surface 408 of non-conductive portion 406 is forced by the presence of non-conductive portion 406 to include tissue located adjacent to the non-conductive portion 406. In other embodiments, based on wherein the first end 412 of the non-conductive portion 406 is connected to the shaft 400 relative to the first electrode 402 and/or second electrode 404, the third electrode 410 may be located on an inner surface of the non-conductive portion 406. The key is that the conductive path formed between the two electrodes selected to deliver the electroporation pulses is forced by the presence of the non-conductive portion 406 to include the tissue located adjacent the non-conductive portion 406.
As discussed above, the non-conductive portion 406 may be compliant or non-compliant. In some embodiments, a benefit of utilizing a compliant material is the ability to deform/compress the non-conductive portion 406 to a smaller diameter that allows the non-conductive portion 406 to fit within a sheath (not shown) in a manner similar to that shown in
At step 502, the electroporation assembly in an undeployed state is navigated to a desired tissue site within the patient. For example,
At step 504, having reach the target tissue site, the electroporation assembly is deployed. Examples of the electroporation assembly in the deployed state are shown in
At step 506, electroporation pulses are delivered via the electroporation assembly. For example, in some embodiments the electroporation assembly includes first and second electrode utilized to deliver the electroporation pulses, wherein the non-conductive portion ensures that the conductive path between the electrodes includes the tissue to be treated. In other embodiments, the electroporation assembly may include only a single electrode, with the other electrode located separately from the electroporation assembly.
While the invention has been described with reference to an exemplary embodiment(s), it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment(s) disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.
The following are non-exclusive descriptions of possible embodiments of the present invention.
According to one aspect, an electroporation catheter includes a shaft having a proximal end and a distal end and an electroporation assembly located at the distal end of the shaft. The electroporation assembly includes at least a first electrode and a non-conductive portion, the non-conductive portion having a first end and a second end, wherein the first end is connected to the shaft and wherein the second end extends radially outward from the first end.
The device of the preceding paragraph can optionally include, additionally and/or alternatively any one or more of the following features, configurations, and/or additional components.
For example, in some embodiments, the non-conductive portion may be cone-shaped having an apex at the first end connected to the shaft.
In some embodiments, the non-conductive portion may extend away from the shaft in a distal direction from the first end to the second end.
In some embodiments, the electroporation assembly may further includes a second electrode, wherein the second electrode may be proximally located along the shaft relative to the first electrode and wherein the first end of the non-conductive portion may be connected to the shaft between the first electrode and the second electrode.
In some embodiments, the non-conductive portion may extend in a proximal direction toward the shaft from the first end to the second end.
In some embodiments, the electroporation assembly may further include a second electrode located on an outer surface of the non-conductive portion, wherein the second electrode may be located proximal to the first end of the non-conductive portion.
In some embodiments, the non-conductive portion may be a sleeve.
In some embodiments, the non-conductive portion may be movable between an undeployed state and a deployed state, wherein a radius of the non-conductive portion is greater in the deployed state.
In some embodiments, the non-conductive portion may be passively deployed via removal of a sheath located on an outer periphery of the non-conductive portion.
In some embodiments, the non-conductive portion may be actively deployed via a mechanism having a first end coupled to the electroporation assembly and a second end connected to a handle located on the proximal end of the shaft.
In some embodiments, the non-conductive portion may be comprised, at least in part, of a compliant, non-conductive material.
In some embodiments, the non-conductive portion may be comprised, at least in part, of a memory shape material.
In some embodiments, the compliant, non-conductive material may be comprised of one or more of silicone, polyurethane, rubber, and/or a non-conductive polymer.
In some embodiments, the non-conductive portion may be comprised of a non-compliant, non-conductive material.
According to another aspect, a method of delivering electroporation therapy to a patient, wherein the method includes introducing a catheter into the patient, the catheter including a shaft having proximal end attached to a handle and a distal end that includes an electroporation assembly. The method may further includes navigating the electroporation assembly in an undeployed state to a desired tissue site, wherein the electroporation assembly includes at least a first electrode and a non-conductive portion attached on a first end to the shaft and a second, unattached end. At the desired tissue site, the electroporation assembly is deployed, wherein deployment of the electroporation assembly includes allowing the second, unattached end of the non-conductive portion to extend radially outward into contact with the desired tissue site. Electroporation pulses are then delivered to the first electrode.
The method of the preceding paragraph can optionally include, additionally and/or alternatively any one or more of the following steps.
For example, in some embodiments, the electroporation assembly may be passively deployed by removing a sheath surrounding the non-conductive portion of the electroporation assembly.
In some embodiments, the electroporation assembly may be actively deployed by activating a mechanism in the handle to cause the second end of non-conductive portion to expand radially outward.
In some embodiments, an edge associated with the second end of the non-conductive portion may be brought into contact with the tissue to be treated, wherein the tissue to be treated is approximately planar.
In some embodiments, an outer surface of the non-conductive portion may be brought into contact with the tissue to be treated, wherein the tissue to be treated is tubular.
In some embodiments, wherein the electroporation therapy may be an irreversible electroporation therapy.
This application claims priority to U.S. Provisional Application No. 63/070,706, filed Aug. 26, 2020, and titled “DEVICE AND METHOD FOR DELIVERING ELECTROPORATION THERAPY”, which is incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/046811 | 8/20/2021 | WO |
Number | Date | Country | |
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63070706 | Aug 2020 | US |