Catheter devices and systems for pulsed electric field ablation therapy

Abstract

The systems, devices, and methods described herein relate to catheter devices for therapy delivery. In some embodiments, the catheter device includes an inflatable electrode and a needle, where the needle is advanceable distal to a distal end of the inflatable electrode and insertable into a tissue site. The distal end of the inflatable electrode and the needle can be configured to deliver electroporation to the tissue site.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 574,637, filed April 4, 2024, entitled "Catheter Device and System for Pulsed Electric Field Ablation Therapy," the disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure describes catheter devices and systems for delivering pulsed electric field ablation therapy via interventional medical procedures. Background Technology

[0004] Pulsed-field ablation has emerged as a potentially useful ablation modality, having been investigated in several oncology applications and recently proven successful in cardiac ablation for the treatment of arrhythmias. This non-thermal ablation modality can be tissue-selective and minimize collateral damage, while also resulting in a natural healing process that preserves the extracellular matrix and overall tissue integrity after ablation. While devices and waveforms suitable for cardiac ablation have been previously envisioned, there is a need for new devices and tools that may be better suited for use in the context of ablation for the treatment of tumors in other types of soft tissue, such as, for example, pancreatic tissue. Attached Figure Description

[0005] Figure 1 The illustration shows a catheter system according to an embodiment of the present disclosure.

[0006] Figure 2 The illustration shows a catheter with a needle and basket-shaped electrode according to an embodiment.

[0007] Figure 3 The illustration shows a basket electrode of a catheter system according to an embodiment.

[0008] Figure 4 The illustration shows the passage of the catheter device of the present disclosure through an endoscope according to an embodiment.

[0009] Figure 5 The illustration shows a catheter system according to an embodiment of the present disclosure, wherein an outer sheath is included as part of the catheter system.

[0010] Figure 6 The illustration shows a catheter system according to an embodiment of the present disclosure, wherein an outer sheath is included as part of the catheter system.

[0011] Figure 7 The illustration shows an ultrasound endoscope or echo endoscope, according to an embodiment, passing through an anatomical pathway and positioned with its distal end close to the region of interest.

[0012] Figure 8This is a flowchart depicting a method of delivering treatment using a catheter system as described herein, according to an embodiment. Detailed Implementation

[0013] The device embodiments disclosed herein provide device construction and configuration for delivering electroporation or pulsed field ablation therapy to ablate soft tissue tumors. In embodiments, these devices are intended for minimally invasive use and can be used through the working channel of an endoscopic instrument.

[0014] Figure 1The illustration depicts a catheter system according to an embodiment of the present disclosure. The catheter system includes a catheter 102 having a shaft 101 on its distal portion, wherein an electrode 105 is mounted on the shaft 101, and the shaft 101 includes an inner lumen 117. In some embodiments, the inner lumen 117 may be formed or defined by a wall of the shaft 101. In some embodiments, the inner lumen 117 may be formed or defined by an inner tube or shaft of the shaft 101. The wall or other structure defining the inner lumen 117 may be made of an electrically insulating material, such as, for example, a polymeric electrically insulating material, such as nylon, PEEK, polyurethane, or similar polymeric materials known in the medical device industry. A needle 103 is disposed within the lumen 117 and may comprise a metallic material, such as, for example, stainless steel or nitinol, and may be insulated over a large portion of its proximal portion by a layer of electrically insulating material (such as, for example, PEEK, PFE, parylene, etc.). The electrically insulating material covering the needle 103 may terminate at a distal end 113. The distal portion 115 of the needle, extending beyond the insulating layer at its distal end 113, is electrically exposed and has a sharp tip for insertion into tissue and serves as an electrode for high-voltage pulse delivery for pulsed electric field ablation. Electrode 105 is in the form of a self-expanding basket and may comprise a hyperelastic material, such as, for example, nitinol. In embodiments, electrode 105 may comprise a braided structure in the form of a braid formed from nitinol yarn or tape, or in alternative embodiments, electrode 105 may comprise a pattern cut from a tube, having portions removed by laser etching or cutting to form a tubular structure with struts. Electrode 105 has a proximal end 107 (here the electrode is attached to the shaft 101 of the catheter) and a distal end 109. The diameter of the distal end 109 of electrode 105 is larger than the diameter of the proximal end 107. An electrical conductor (not shown) is connected to the proximal end 107 of electrode 105. The conductor is insulated with a high dielectric strength material (e.g., a material capable of withstanding at least about 500 volts in its thickness without dielectric breakdown). The needle 103 is electrically connected near its proximal end or in the catheter handle (not shown) to a wire similarly insulated with a high dielectric strength material (e.g., a material capable of withstanding a voltage of at least about 500 volts in its thickness without dielectric breakdown). The distal portion 115 of the needle and the basket electrode 105 can be configured or used as a bipolar electrode pair for high-voltage pulse delivery for pulsed electric field ablation therapy, wherein a voltage in the range of about 500 volts to about 10,000 volts (including all subranges and values ​​therein) can be applied to the bipolar electrode pair in the form of high-voltage electrical pulses.In embodiments, the wire coupled to electrode 105 and the wire coupled to needle 103 may be configured to deliver voltage waveforms such as those described in International (PCT) Patent Application No. PCT / US2023 / 025064, filed June 12, 2023, entitled “Apparatus, System, and Method for Soft Tissue Ablation”, or in U.S. Patent Application No. 18 / 976,095, filed December 10, 2024, entitled “Apparatus, System, and Method for Soft Tissue Ablation,” the disclosure of which is incorporated herein by reference.

[0015] The wall or other structure defining the lumen 117 may be configured to extend through the longitudinal length of the conduit 102 and through at least a portion of the basket electrode 105. For example, in some embodiments, the wall or other structure defining the lumen 117 may extend the entire longitudinal length of the basket electrode 105. In such embodiments, the wall or other structure defining the lumen 117 may be configured to provide insulation and / or prevent contact between portions of the basket electrode 105 and / or between the needles 103. Alternatively, the lumen 117 may be configured to terminate at the proximal end of the basket electrode 105.

[0016] In some embodiments, the needle 103 may include one or more indentations, grooves, cuts, or other acoustic markings 120 along a portion of its length, which can be visualized via ultrasound imaging (e.g., using an echo-endoscopy as described herein). For example, a series of grooves may be provided on the distal portion 115 of the needle 103 to facilitate visualization of the needle under ultrasound imaging.

[0017] Figure 2 The illustration shows a catheter system according to an embodiment, which includes a catheter 207, a needle 211, and a basket electrode 220 located at the distal end of the catheter shaft. Figure 2 The catheter system shown can be used with Figure 1The catheter systems shown are structurally and / or functionally similar. For example, catheter 207 may be structurally and / or functionally similar to catheter 102, needle 211 may be structurally and / or functionally similar to needle 103, and basket electrode 220 may be structurally and / or functionally similar to electrode 105. In embodiments, needle 211 extends distally beyond basket electrode 220 by a length 215, which may be between approximately 5 mm and approximately 80 mm, including all subranges and values ​​therein. In some embodiments, the distance by which needle 211 extends distally beyond basket electrode 220 may depend on the target anatomy, the location of the lesion, the shape of the lesion, and / or the size of the lesion. The range of motion of the proximal portion of needle 211 at the handle (not shown) of the device is limited such that the distal extension of needle 211 extends no more than approximately 80 mm beyond the catheter by a length 215. The distal portion of needle 211 (e.g., along its length 213) is electrically exposed to act as an electrode, while the proximal length of needle 213 is electrically insulated with a high dielectric strength material (e.g., a material capable of withstanding at least 500 volts without dielectric breakdown in its thickness). In embodiments, the exposed length 213 of needle 211 can be in the range of approximately 5 mm to approximately 50 mm, including all subranges and values ​​therein. In embodiments, when the extended length 215 of needle is at least approximately 5 mm, ablation delivery (e.g., pulsed field ablation) can be enabled on systems that deliver high-voltage pulses to the exposed portion 213 of needle 211 and basket electrode 220. This can be achieved, for example, by means of properly positioning electrical contacts in a catheter handle (not shown). For example, electrical contacts configured to couple needle 211 and / or basket electrode 220 to a generator for delivering high-voltage electrical pulses can couple them when needle 211 and / or basket electrode 220 are each at a relative distance from each other (e.g., when needle 211 has extended the necessary distance from basket electrode 220). In some embodiments, such electrical contacts may not couple needle 211 and / or basket electrode 220 to the generator when needle 211 has not yet extended the predetermined distance from the distal end of basket electrode 220 (e.g., when needle 211 has not yet extended at least about 5 mm beyond the distal end of basket electrode 220).

[0018] Figure 3 A basket electrode 302 in an expanded or stress-free state according to an embodiment is schematically depicted, showing a proximal end 305 of the basket electrode having a diameter d1 and a distal end 307 of the basket electrode having a diameter d2, and the basket electrode having a length L. Figure 3The basket electrode 302 shown may be structurally and / or functionally similar to other basket electrodes disclosed herein, including, for example, basket electrodes 105 and / or 220. In embodiments, the proximal electrode diameter d1 may be in the range of approximately 0.5 mm to approximately 10 mm, including all subranges and values ​​therein. In embodiments, the distal electrode diameter d2 may be in the range of approximately 0.8 mm to approximately 20 mm, including all subranges and values ​​therein. In embodiments, the ratio of the distal diameter to the proximal diameter (d2 / d1) is at least 1.1. For example, in embodiments, the ratio d2 / d1 may be in the range of approximately 1.1 to approximately 20, including all subranges and values ​​therein. In embodiments, the length L of the basket electrode may be in the range of approximately 2 mm to approximately 20 mm, including all subranges and values ​​therein.

[0019] like Figure 3 As shown, when expanded or stress-free, the basket electrode 302 can be configured to be tapered or have a tapered or quasi-tapered shape along its longitudinal length. For example, the basket electrode 302 can be configured to gradually increase in diameter from its proximal diameter d1 to its distal diameter d2. Although the basket electrode 302 is shown as having a tapered structure, it is understood that the basket electrode described herein can be configured to have other shapes and / or configurations. For example, the basket electrode can have a stepped structure, such as including a proximal portion having a first diameter d1 and a distal portion having a second diameter d2, and one or more stepped diameter increases between the proximal and distal portions.

[0020] Figure 3 The basket electrode 302 shown (and other basket electrodes described herein) can be configured to transition between a first state (e.g., a compressed or unexpanded state) and a second state (e.g., an expanded, uncompressed, or stress-free state). For example, as per [reference to...] Figure 4 and Figure 5 As shown and described, the basket electrode can be compressed within a lumen (e.g., the lumen of sheath 503, or the working channel 404 of endoscope 400) for delivery to a target site, and then extends distally out of the sheath so that it can expand to its deployed state. In the deployed state, the basket electrode can be configured to deliver pulsed field ablation, for example, as described above, via the electrically exposed portion of a needle. In embodiments, the basket electrode 302 comprises or is formed of a hyperelastic material (such as, for example, nitinol), and / or may include a braided structure, for example, in the form of a braid formed of nitinol yarn or tape. In alternative embodiments, the basket electrode 302 may include a pattern cut from a tube (e.g., a nitinol tube), portions of which are laser-etched or cut away to form a tubular, expandable structure with struts.

[0021] Figure 4A schematic illustration shows a passage through an endoscope for a catheter system or device of the present disclosure according to an embodiment. Endoscope 400 may be, for example, an echo endoscope or an echo-endoscope. The figure illustrates an endoscope 400 having a lumen 402 through which an electrical connection 410 to an ultrasound transducer 408 is formed. Alternatively or additionally, the endoscope may have a lumen for access to optical components, or an optical fiber or cable 430. The optical fiber or cable 430 may be configured to couple to an optical imaging element or camera, for example, to enable the capture of optical images of patient anatomy near the distal end of the endoscope 400. The tip of the optical fiber or cable 430 may include imaging components such as lenses, optical filters, etc. The endoscope also has a working channel 404 through which a catheter system or device 406 of the present disclosure is configured to emerge distally from the working channel 404. The catheter system or device 406 may be compatible with other catheter systems or devices disclosed herein (including, for example,...). Figure 1 and Figure 2 Those shown are structurally and / or functionally similar. The catheter 406 has a basket electrode 414 (e.g., structurally and / or functionally similar to basket electrodes 105, 220, or 302) at its distal end of its axis (e.g., structurally and / or functionally similar to axis 101). A needle 416 (e.g., structurally and / or functionally similar to needles 103, 211) can extend from the catheter 406 to puncture tissue and reach the desired target anatomical structure under ultrasound and / or optical visualization provided by the ultrasound transducer 408 and / or optical imaging. In embodiments, the optical imaging modality of the endoscope can generally be used for the initial placement of the endoscope, and subsequently, the ultrasound imaging modality can be used to visualize the deployment and placement of the needle 416. The optical imaging modality can provide visualization of the patient's anatomy (e.g., a portion of the duodenum), allowing the endoscope 400 and / or catheter system 406 to be navigated to sites adjacent to the tissue or organ to be treated (e.g., pancreas, liver, kidney, or other adjacent organs). Then, the ultrasound imaging modality can provide visualization of tissue structures and / or organs located below or adjacent to the site.

[0022] Figure 5 An embodiment of the catheter system of the present disclosure according to an embodiment is illustrated, wherein an outer sheath or shaft is included as part of the catheter system. Figure 5 The catheter system shown can be used with other catheter systems or devices disclosed herein (including, for example, Figure 1 , Figure 2 and Figure 4 Those shown are similar in structure and / or function. However, Figure 5 The catheter system shown may include an outer sheath or a shaft. Figure 5A catheter system 501 is shown, comprising an outer sheath 503 through which a catheter 505 (e.g., an inner shaft) is inserted. The catheter 505 may have a basket electrode 507 disposed at its distal end (e.g., structurally and / or functionally similar to basket electrodes 105, 220, 302, 414). In embodiments, the electrode 507 comprises a hyperelastic material, such as, for example, nitinol, and may include a braided structure, for example, in the form of a braid formed from nitinol threads or strips. In alternative embodiments, the electrode 507 may include a pattern cut from a tube, portions of which are laser-etched or cut away to form a tubular structure with struts. The electrode 507 is flexible and compressible, allowing it to deform to fit within the sheath 503. To deploy the basket electrode 507, the catheter 505 is pushed proximally such that the distal end of the catheter and the electrode 507 emerge from the distal end 511 of the sheath 503 (e.g., extending distally to the distal end of the sheath 503). As electrode 507 emerges from sheath 503, electrode 507 automatically returns to its expanded or conical shape, for example, as shown in the example. Figure 3 Electrode 302 in Figure 4 As indicated by electrode 414, etc. In some embodiments, the distal end of basket electrode 507 may extend distally from the distal end of sheath 503 between approximately 3 mm and approximately 30 mm, including all subranges or values ​​therebetween. Needle 520 (e.g., structurally and / or functionally similar to needles 103, 211, 416) may be configured to pass through the inner lumen of catheter 505 and may extend beyond the distal end of electrode 507, for example, between approximately 5 mm and approximately 80 mm, including all subranges and values ​​therebetween. Figure 5 As shown, the distal portion 515 of the needle 520 has a sharp tip for piercing tissue. This distal portion 515 is conductive and comprises a metallic material, such as, for example, stainless steel or nitinol. The proximal portion of the needle up to the proximal end 513 of the distal portion is electrically insulated by a layer of electrically insulating material (such as, for example, PEEK, PFE, parylene, etc.). The electrode 507 is connected to an electrical conductor insulated with a high dielectric strength material (e.g., a material capable of withstanding at least about 500 volts over its thickness without dielectric breakdown). The needle 520 is electrically connected near its proximal end or in the catheter handle (not shown) to an electrical conductor similarly insulated with a high dielectric strength material (e.g., a material capable of withstanding at least about 500 volts over its thickness without dielectric breakdown).

[0023] Figure 6 An embodiment of the catheter system of the present disclosure according to an embodiment is illustrated, wherein an outer sheath is included as part of the catheter system. Figure 6 The catheter system shown can be used with other catheter systems or devices disclosed herein (including, for example, Figure 1 , Figure 2 , Figure 4and Figure 5 Those shown are similar in structure and / or function. Specifically, Figure 6 It shows Figure 5 The basket electrode is in an expanded state or configuration, for example, after the basket electrode has extended beyond the distal end of the sheath.

[0024] Figure 6 A conduit system is depicted having an outer sheath 607 (e.g., structurally and / or functionally similar to sheath 503), through which a conduit 609 can pass. The conduit 609 has an extended basket-shaped electrode 611 disposed at its distal end (e.g., structurally and / or functionally similar to basket electrodes 105, 220, 302, 414, 507). When the conduit is pushed forward such that the basket electrode 611 extends beyond the distal end of sheath 607, the electrode 611 freely expands and takes on its original or stress-free partially conical shape, as shown by 611, wherein the distal end of the basket electrode has a larger diameter than its proximal end. This can be related to... Figure 3 The basket-shaped electrode 302 in the example is described similarly. Figure 6 As shown, needle 613 (e.g., structurally and / or functionally similar to needles 103, 211, 416, 520) may extend through the catheter and basket electrode 611 to appear distal beyond the basket electrode 611. In embodiments, the catheter system (including the outer sheath 607) may pass through the working channel of the endoscope as a single unit. Although needle 613 is shown passing through electrode 611, in alternative embodiments, needle 613 may pass through the inner lumen or inner cavity of catheter 609, and the inner lumen may extend to or near the distal portion of basket electrode 611. For example, this relates to... Figure 1 The lumen 117 in the middle is depicted and described.

[0025] In use, once the sheath 607 is positioned at or near the distal end of the endoscopic channel, the catheter (e.g., catheters 505, 609, or any other catheter described herein) can be moved forward to deploy the basket electrode (e.g., 105, 220, 302, 414, 507, 611). The endoscope can be appropriately connected to position the basket facing the desired orientation. Once the basket electrode is thus deployed (e.g., extended to its deployed state), the needle (e.g., 103, 211, 416, 520, 613) can be extended to the desired anatomical target location, for example, by means of visualization using ultrasound imaging from an ultrasound transducer, if necessary.

[0026] In some embodiments, the annular space defined between the inner surface of the sheath 607 and the outer surface (or axis) of the catheter 609 can be used to deliver fluid or other reagents to the area surrounding the expandable electrode 611. For example, the annular space can be configured to deliver a conductive fluid (such as saline) to the area surrounding the expandable electrode 611, for example, to surround or substantially surround the expandable electrode 611 with fluid. In use, when the needle tip is deployed in a tissue structure or organ and the expandable electrode 611 is positioned outside but near the tissue structure, the fluid ensures the establishment of a conductive path between the expandable electrode 611 and the needle tip. This ensures that pulsed field ablation therapy can be effectively delivered to the target area of ​​the tissue structure.

[0027] Figure 7The illustration schematically depicts an ultrasound endoscope or echo endoscope passing through an anatomical pathway according to an embodiment, with its distal end positioned close to the region of interest. Specifically, the figure shows an endoscope 702 (e.g., structurally and / or functionally similar to endoscope 400) passing through an anatomical pathway 700. A catheter system 704 of this disclosure (e.g., structurally and / or functionally similar to any catheter system or device described herein) passes through the working channel of endoscope 702, and the distal portion of the catheter of catheter system 704 extends from the distal end of endoscope 702. The extension of catheter system 704 may include a basket electrode 706 (e.g., structurally and / or functionally similar to basket electrodes 105, 220, 302, 414, 507, 611). Endoscope 702 also has an ultrasound transducer 718 disposed at its distal end (e.g., structurally and / or functionally similar to ultrasound transducer 408). Endoscope 702 is placed in a region of interest with a surface boundary 712. For example, the endoscope may be placed in the stomach or duodenum. Needle 708 passes through the catheter and extends to pierce the surface boundary 712 and enter an adjacent organ 714 (e.g., pancreas, liver, lung, or other soft tissue organ). The extension of needle 708 can be performed under visualization (e.g., from an ultrasound transducer that can generate an image region 722 displayed on a monitor or screen). Needle 708 can be visualized on such an image, and needle 708 can be guided toward an anatomical region of interest, such as region 725 in organ 714 (e.g., this could be a tumor in the pancreas, liver, lung, etc., where it is desired to deliver an ablation therapy such as pulsed field ablation). Once needle 708 is properly positioned, pulsed field ablation therapy can be delivered in the form of high-voltage pulses delivered to a bipolar electrode pair comprising needle electrode 708 and basket electrode 706. Such high-voltage pulses have voltage amplitudes in the range of approximately 500V to approximately 10,000V, including all subranges and values ​​therein, as described, for example, in International (PCT) Patent Application No. PCT / US2023 / 025064 and U.S. Patent Application No. 18 / 976,095, the foregoing of which are incorporated herein by reference.

[0028] Figure 8 The use of the endoscopic devices and catheter systems described herein (e.g., according to embodiments) is depicted. Figure 4 and Figure 7 The endoscopic device and / or shown Figures 1-7Method 800 (of any of the catheter systems and / or components shown). At 802, the catheter system may optionally be positioned within the working channel of the endoscope device. Alternatively, the catheter system may be positioned outside the endoscope device, for example, along or adjacent to the endoscope device. In some embodiments, the catheter system may be used without an endoscope device. At 804, the endoscope device and / or catheter system may be positioned near a tissue site, for example, by navigating the endoscope device and / or catheter system through a body lumen or cavity. The tissue site may include a tissue mass, nodule, or tumor or other element requiring treatment, such as in the pancreas, liver, kidney, lung, etc. In some embodiments, the catheter system may include an expandable electrode (e.g., any basket electrode described herein). As the endoscope device is navigated to the tissue site, the expandable electrode may remain in an undeployed or restrained state within the working channel and / or outer sheath of the endoscope device. In some embodiments, the endoscopic device may be configured to provide image guidance for positioning the catheter system at a target site (e.g., via any of the ultrasound transducers and / or optical imaging components described herein). For example, the endoscopic device may include an optical fiber (e.g., fiber 430) that can provide a view of the patient's anatomy (e.g., a portion of the duodenum) as the device is navigated to a specific site within the patient's anatomy.

[0029] At 806, if the catheter system is positioned within the working channel of the endoscope, the catheter system can extend from the working channel. Alternatively or additionally, the catheter of the catheter system can extend distally relative to the outer sheath of the catheter system to deploy or expand the expandable electrode. As described above, the catheter system may include a needle. At 808, the needle of the catheter system can extend distally from the expandable electrode, allowing the distal penetrating tip of the needle to be inserted into the tissue site. In some embodiments, the needle may include one or more markings (e.g., marking 120) that enable visualization of the needle via ultrasound as it extends. Thus, ultrasound imaging can be used to ensure proper deployment and positioning of the needle within the target tissue (e.g., an organ adjacent to the duodenum).

[0030] Optionally, at 809, a fluid, such as a conductive fluid, may be delivered to the region surrounding the expandable electrode. In some embodiments, a sheath (e.g., sheath 607) and a catheter (e.g., catheter 609) may define an annular space configured to deliver fluid or other reagents to the region surrounding the expandable electrode. In some embodiments, a working channel of the endoscope (or another channel of the endoscope) may be configured to deliver fluid or other reagents to the region surrounding the expandable electrode. In some embodiments, one or more separate devices (e.g., another catheter) may be configured to deliver fluid or other reagents to the region surrounding the expandable electrode. Once delivered, the fluid may be configured to surround the expandable electrode to provide or establish at least a portion of a conductive path between the expandable electrode and the tip of the needle. For example, the fluid may ensure that any hollow, empty space (e.g., a portion of the duodenum) within a body lumen where the expandable electrode is located is filled with fluid and thus able to conduct current. The needle may be inserted into adjacent or neighboring tissue structures or organs, which may include conductive tissue structures and fluids. The fluid surrounding the expandable electrode and the conductive tissue or fluid in the adjacent tissue structure can together provide or establish a conductive path between the expandable electrode and the tip of the needle, thereby enabling effective and / or efficient delivery of pulsed field ablation.

[0031] At 810, via the distal tip of the expandable electrode and needle, the catheter system can apply pulsed field ablation or electroporation to a tissue region at the tissue site. For example, the generator can be configured to deliver a voltage waveform to the catheter device to energize one or more electrodes of the catheter device to deliver electroporation. In some embodiments, the generator can be configured to cause one or more electrodes to generate an electric field with a strength sufficient to cause irreversible electroporation or pulsed field ablation. In some embodiments, the generator can be configured to cause the electrodes to reversibly electroporate the tissue.

[0032] In some embodiments, the catheter system can be repeatedly applied with electroporation once or multiple times. For example, electroporation can be repeated at a given site as needed to enhance the ablation effect. In some embodiments, the catheter system can be moved to one or more additional sites (814: yes) to deliver electroporation to those sites. For each new site, at 820, the catheter system can be withdrawn into the working channel of the endoscope and / or the needle can be withdrawn into the catheter shaft, and at 804, the endoscope and / or the catheter system can be moved to a new tissue site. In some cases, the needle can be withdrawn in steps corresponding to different needle extensions, with ablation delivered at each step or extension. The process of inserting the needle into the tissue site and delivering electroporation can then be repeated at 806-814. In some embodiments, the catheter device can be moved between 1 to about 15 different sites. When the procedure is complete, i.e., there are no longer any tissue sites requiring ablation (814: No), if the catheter system was delivered via the working channel of the endoscope, the catheter system may optionally be retracted into the working channel at 816, and the entire assembly including the endoscope and the catheter system may be removed from the patient at 818. In embodiments where the catheter system is used independently of the endoscope, the needle may be retracted into the catheter shaft and / or the expandable electrode may be retracted into the outer sheath, and the catheter system may be removed from the patient at 818.

[0033] As will be understood, each of 802-818 can be performed via image guidance. For example, an endoscopic device may be configured to capture images of a tissue site or a catheter system and / or its components to ensure proper positioning of the catheter system and / or its components prior to delivery of electroporation. In some embodiments, the endoscopic device may be an echo endoscope and may include an ultrasound transducer that provides ultrasound imaging, for example, to confirm insertion of the needle of the catheter system into the tissue site. In some embodiments, the endoscopic device may include an imaging channel through which an imaging device may extend to capture images of the tissue site and / or the catheter system. In some embodiments, a separate imaging device or mechanism may be used to view and confirm the position of the catheter system relative to the tissue and the delivery of electroporation. In some embodiments, an imaging device (such as one extending through the endoscopic device or positioned separately near the tissue site) may be configured to be deflected, for example, to capture different views around the tissue site. Imaging modalities may include direct optical imaging, ultrasound imaging, or other imaging modalities commonly employed in the art.

[0034] Although specific examples have been provided in the figures for illustrative and explanatory purposes, it should be clear that variations such as different numbers of lumens, different numbers of electrodes, different electrode diameters, conduit and wire diameters, different electrode and shaft materials can be constructed without restriction and based on the teachings of this document.

[0035] Furthermore, various inventive concepts can be embodied in one or more methods, examples of which have been provided. Actions performed as part of a method can be ordered in any suitable manner. Thus, embodiments can be constructed in which actions are performed in a different order than illustrated, which may include performing some actions simultaneously, even if they are shown as consecutive actions in the illustrative embodiments.

[0036] As used herein, the terms “about” and / or “approximately” when used with numerical values ​​and / or ranges generally refer to those numerical values ​​and / or ranges that are close to the stated numerical value and / or range. In some cases, the terms “about” and “approximately” may mean within ±10% of the stated value. For example, in some cases, “about 100 [units]” may mean within ±10% of 100 (e.g., from 90 to 110). The terms “about” and “approximately” may be used interchangeably.

Claims

1. An apparatus comprising: An outer shaft defining a first lumen; An inner shaft, which is disposed within the first cavity and extends relative to the outer shaft, defines a second cavity; An expandable electrode is disposed at the distal end of the inner shaft, and the expandable electrode is configured to have a tapered shape with a diameter increasing from the proximal end of the expandable electrode to the distal end of the expandable electrode. as well as A needle disposed within the second lumen and extendable relative to the inner axis, the needle comprising an electrically exposed distal tip and an electrically insulated portion proximal to the distal tip, the distal tip of the needle being insertable into a tissue site. When (1) the inner shaft extends relative to the outer shaft such that the expandable electrode is located distal to the distal end of the outer shaft and (2) the needle extends relative to the inner shaft such that the distal tip of the needle is located distal to the distal end of the inner shaft, the expandable electrode and the distal tip of the needle are configured to deliver electroporation to the tissue region at the tissue site.

2. The apparatus of claim 1, further comprising: A first wire, configured to couple the expandable electrode to the generator; as well as A second lead wire is configured to couple the needle to a generator, such that the generator can deliver pulse waveforms to the expandable electrode and the needle so that the expandable electrode and the needle function as a bipolar electrode pair.

3. The apparatus of claim 2, wherein the first and second conductors are electrically insulated conductors having an insulating layer configured to withstand at least about 300 volts over the thickness of the insulating layer without dielectric breakdown.

4. The device of claim 1, wherein the expandable electrode is formed of a hyperelastic material.

5. The device of claim 1, wherein the second lumen extends along a portion of the expandable electrode.

6. The apparatus of any one of claims 1-5, wherein the expandable electrode has a first diameter at its proximal end and a second diameter at its distal end, and the ratio of the second diameter to the first diameter is at least about 1.

1.

7. The apparatus of claim 6, wherein the ratio of the second diameter to the first diameter is between about 1.1 and about 20.

8. The device according to any one of claims 1-5, wherein the needle is configured to extend relative to the inner axis such that the distal tip of the needle is located at a distance of at most about 80 mm from the distal end of the expandable electrode.

9. The apparatus of any one of claims 1-5, wherein the expandable electrode and the distal tip of the needle are configured to deliver electroporation to ablate the tissue region.

10. The apparatus of any one of claims 1-5, wherein when the inner shaft extends relative to the outer shaft such that the expandable electrode is located distal to the distal end of the outer shaft, the expandable electrode is configured to automatically change from a first unexpanded configuration to a second expanded configuration having the tapered shape.

11. A system comprising: The catheter system includes the device as described in any one of claims 1-10; as well as An endoscope, wherein the endoscope defines a working channel, The catheter system described herein can be placed within the working channel.

12. The system of claim 11, wherein the endoscope includes an ultrasound transducer configured to provide ultrasound imaging to facilitate visualization of the needle insertion target site.

13. The system of claim 11, wherein the endoscope includes an optical imaging lens and a camera configured to provide optical imaging to facilitate placement of the catheter system near the target site.

14. The system of any one of claims 1-5, wherein the outer shaft and the inner shaft define an annular space between them configured to deliver fluid to a region surrounding the expandable electrode.

15. A system comprising: An endoscope, wherein the endoscope defines a working channel; as well as A catheter system slidably disposed within the working channel, the catheter system comprising: The catheter defines a lumen; An expandable electrode, disposed at the distal end of the catheter, is capable of transitioning from an unexpanded state within the working channel to an expanded state extending from the working channel. In the expanded state, the expandable electrode has a tapered shape with its diameter increasing distally. A needle slidably disposed within the lumen, the needle being configured to extend distal to the distal end of the expandable electrode, the needle including an electrically exposed distal tip and an electrically insulated portion proximal to the distal tip, the distal tip of the needle being configured to be inserted into a tissue site.

16. The system of claim 15, wherein the endoscope further comprises an ultrasound transducer configured to provide ultrasound imaging to facilitate visualization of one or more portions of the catheter system and / or patient anatomy.

17. The system of claim 15, wherein the endoscope further comprises a lumen configured to accommodate an optical imaging device capable of facilitating visualization of one or more portions of the catheter system and / or patient anatomy.

18. The system of claim 15, wherein the catheter system further includes a sheath, and the catheter of the catheter system is disposed within the sheath.

19. The system of any one of claims 15-18, wherein the expandable electrode is formed of a hyperelastic material.

20. The system of any one of claims 15-18, wherein the expandable electrode has a first diameter at its proximal end and a second diameter at its distal end, and the ratio of the second diameter to the first diameter is at least about 1.

1.

21. The system of claim 20, wherein the ratio of the second diameter to the first diameter is between about 1.1 and about 20.

22. The system of any one of claims 15-18, wherein the needle is configured to extend relative to the catheter such that the distal tip of the needle is located at a distance of at most about 80 mm from the distal end of the expandable electrode.

23. The system of any one of claims 15-18, wherein the expandable electrode and the distal tip of the needle are configured to deliver electroporation to ablate the tissue region surrounding the tissue site.

24. The system of claim 23, wherein, The expandable electrode and the distal tip of the needle are configured to be polarized with opposite polarities to deliver electroporation into the tissue region.

25. A method comprising: The catheter system is positioned near the tissue site, the catheter system comprising a needle and an expandable electrode having a tapered shape; The needle is extended distally beyond the distal end of the expandable electrode to insert the distal tip of the needle into the tissue site, the distal tip of the needle being electrically exposed. as well as A voltage pulse is delivered to the distal tip of the expandable electrode and the needle to electroporate the tissue region at the tissue site.

26. The method of claim 25, further comprising: The catheter system is inserted through the working channel of the endoscope; as well as The endoscopic device is navigated to the tissue site to position the catheter system near the tissue site.

27. The method of claim 26, further comprising: The ultrasound transducer of the endoscopic device is used to capture views of a portion of the catheter system and the patient's anatomy near the tissue site to confirm the placement of the catheter system.

28. The method of claim 25, wherein delivering the voltage pulse comprises delivering the voltage pulse using the expandable electrode and the distal tip of the needle having opposite polarities.

29. The method of claim 28, wherein the voltage pulse has an amplitude of at least about 700 volts.

30. The method of any one of claims 25-29, wherein the tissue region is a first tissue region, and further comprises: After delivering the voltage pulse, the needle is retracted from the tissue site; Move the catheter system to the second tissue site; The needle is extended to the second tissue site; as well as A voltage pulse is delivered to the distal tip of the expandable electrode and the needle to electroporate the tissue region at the second tissue site.

31. The method of any one of claims 25-29, wherein delivering the voltage pulse to the distal tip of the expandable electrode and the needle comprises delivering the voltage pulse to generate a pulsed electric field to ablate tissue in the tissue region.

32. The method of any one of claims 25-29, wherein the tissue site is located in an organ, said organ being one of the following: pancreas, liver, or kidney.

33. The method of any one of claims 25-29, further comprising delivering fluid through an annular space defined between the inner and outer axes of the catheter system, such that the fluid surrounds the expandable electrode and is configured to establish at least a portion of a conductive pathway between the expandable electrode and the distal tip of the needle when the distal tip of the needle has been inserted into the tissue site.

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