Apparatus and Method for Tumor Ablation

Abstract

The systems, devices, and methods described herein relate to catheter devices for therapy delivery in tumor treatment applications. In some embodiments, the catheter device includes a shaft defining a lumen and a needle device disposed within the lumen, the needle device having a distal portion that includes an exposed conductor, the distal portion of the needle device being configured to extend from the lumen. The needle device can be configured to receive a pulsed voltage waveform and deliver a pulsed electric field through the exposed conductor to ablate surrounding tissue.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the priority and benefit of U.S. Provisional Patent Application No. 63 / 348,215, entitled "APPARATUS AND METHODS FOR TUMOR ABLATION", filed on June 2, 2022, the disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] The development of tools and methods for therapeutic delivery for the treatment of tumors or various forms of cancer in soft tissue remains a subject of much interest. In many cases, various options for tumor treatment are available, but there is an ongoing investigation into the effective delivery of treatment that minimizes or eliminates associated tissue damage and side effects.

[0003] Irreversible electroporation, also known as pulsed field ablation, has been previously considered in relation to surgical treatment of tumors. In surgical applications, the search for an optimal toolset is ongoing. In the context of minimally invasive approaches, much is being done to develop effective minimally invasive tools that are usable while ensuring local treatment that minimizes associated damage.

[0004] The present disclosure addresses the need for minimally invasive devices for the efficient and effective delivery of pulsed field ablation therapy, particularly for tumor treatment such as the treatment of pancreatic cancer or lung tumors. Pulsed field ablation procedures can be rapid while minimizing the associated tissue damage often seen in heat - based treatments. At the same time, healing after treatment can be relatively rapid with minimal side effects.

Summary of the Invention

[0005] The present disclosure discloses tools and devices for minimally invasive access to internal organs for therapeutic delivery in tumor treatment applications. Specifically, the devices of the present disclosure can have one or more lumens for the passage of a needle or tissue piercing device. In some embodiments, the needle can take the form of a wire or wire-like device. In an embodiment, the distal end of the lumen of the device can have a wedge-shaped portion on one side that reduces the effective inner diameter of the lumen and constrains the orientation in which the needle or wire emerges from the device lumen. In an embodiment, the wedge-shaped portion can be curved. This wedge-shaped portion can function as a local support for the wire when the wire emerges from the lumen in a direction generally different from the orientation of the long axis of the lumen. In the case of a multi-lumen device having from about 2 to about 8 separate lumens, each needle can emerge from its respective lumen in an orientation different from the others and from the orientation of the long axis of the device.

[0006] In an embodiment, the distal end of the shaft of the lumen can be angled away from the long axis of the device on one side so as to present an angled exit for the needle. In some embodiments, the angled portion can have a straight edge, while in other embodiments it can have a curved edge. In an embodiment, the device can have a plurality of such lumens, and the distal end of the shaft of each lumen is angled away from the long axis of the device such that each needle can emerge from its respective lumen in an orientation different from the other needles of the device and from the orientation of the long axis of the device.

[0007] In an embodiment, the device can be a catheter device having one or more lumens that pass through the working channel or instrument channel of an endoscope device, and the endoscope device can acquire an image of the catheter device using an imaging modality such as optical imaging or ultrasound imaging. The endoscope imaging modality can be used to guide the placement of the catheter device on the tissue surface and visualize the passage of one or more needles as they emerge from the catheter device and penetrate the tissue surface or enter an adjacent anatomical organ. For example, the catheter device can be placed in the stomach or duodenum via an endoscope, and a needle can be inserted from the catheter device into the duodenal wall to enter the pancreas for subsequent treatment delivery. In an embodiment, the catheter device can be inserted along the endoscope device, and the endoscope device is then used to image and guide the placement of the catheter device on the tissue surface and visualize the needle insertion. The catheter device can be deflectable in some embodiments such that the orientation of the distal end can be adjusted for suitable tissue juxtaposition.

[0008] In an embodiment, a substantial portion of the length of the wire can be insulated with one or more insulating layers that can withstand a voltage of at least about 500 V across its thickness without dielectric breakdown. In an embodiment, the insulator can be in the form of a coating such as a parylene coating, and in other embodiments, the insulator can include a polymeric material in a tubular form. In an embodiment, the distal end of the wire can include a fine and sharp tip for easily penetrating tissue. In an embodiment, the portion of the wire proximal to the distal portion can have a slight bend in its free or stress-free state.

[0009] In an embodiment, the distal portion of the wire can be helical. The helix or helical portion is attached to the body of the wire in a coaxial manner, i.e., the axis of the helix's winding coincides with the tangent to the wire immediately proximal to the helix. In this way, advancing the wire (around its longitudinal axis) twists the wire, generating a screw-like motion of the helix. When the distal portion of the wire is within the lumen of the device, the helix is naturally stretched compared to when the wire is in a stress-free state. As a result, the helical shape of the wire can have a pitch or length greater than that in the free or stress-free state between successive turns of the helix when it is within the lumen of the device. At the same time, the diameter of the helix's turns is smaller than that in the stress-free state when it is within the lumen of the device, for example, to fit within the lumen of the device.

[0010] In use, a device having a helical needle is positioned immediately proximal to the surface of the tissue or organ desired to be penetrated by the needle. The proximal handle of the device includes a mechanism for the screw-like advancement of a wire, such that, for example, a user can rotate a wheel, knob, or other control mechanism to simultaneously rotate and advance the wire or needle. In one embodiment, the pitch of the advancement mechanism matches the pitch of the helix in a stress-free state. The proximal portion of the wire is retained within the advancement mechanism in the handle that functions like a screw of a given pitch. In embodiments, a single control mechanism can selectively engage any one of a plurality of needles via a selection mechanism, such as a slider. To advance the wire, the user rotates a knob or other control mechanism, whereby the wire is simultaneously rotated and advanced. This screwing motion naturally advances the wire, and as the wire emerges from the distal portion of the device, the emerging portion of the needle or wire assumes its stress-free helical shape. Such rotation and advancement induces a corkscrew motion at the distal portion of the needle. At the tissue surface, the corkscrew motion of the distal portion of the needle serves to pierce the needle and then advance the needle into the tissue, and the coil diameter of the helical portion of the needle inserted into the tissue is here a larger diameter that is not under stress. This provides for a larger effective diameter of the inserted helical needle as compared to the coil diameter or helical diameter inside the device shaft. The larger effective diameter can assist in generating a suitable electric field for pulsed field ablation delivery.

[0011] In various embodiments, the plurality of lumens of the device can carry a number of needles in the form of various combinations of straight needles or helical needle wires. In embodiments, the device can have a central lumen surrounded by a set of outer lumens, although in other embodiments there can be only outer lumens without a central lumen, and each lumen carries a needle wire in the form of either a straight needle or a helical needle.

[0012] In an embodiment, the catheter device or its main shaft can itself be a needle for percutaneous insertion. In such an embodiment, a substantial portion of the hollow metal needle shaft can be coated with an insulating layer such as parylene, leaving only the distal portion of the needle electrically exposed. The shaft of the device can have one or more lumens that also function as electrical insulators, and smaller diameter outer needles can pass through each such lumen. The smaller needles can also be coated with an insulating layer such as parylene along a significant portion of their length. The smaller needles emerge through an opening within the distal portion of the main needle shaft proximal to the distal tip of the main needle shaft. The distal needle tip of the main needle shaft is sharpened to a shape that enables it to pierce tissue for insertion. In use, the main needle is positioned at an appropriate puncture site for percutaneous insertion, such as a chest site for the treatment of a lung tumor. The puncture is made and the main needle is inserted under visual guidance through a modality such as computed tomography (CT) imaging. The main needle is advanced into the region of interest, such as a tumor. Once the main needle is within the tumor, the outer needle is advanced through the opening within the distal shaft of the main needle.

[0013] A subset of the main needle and / or the outer needles can then be used for the delivery of a pulsed field ablation waveform in either a monopolar mode (e.g., all needles have one electrical polarity and a reference patch having the opposite electrical polarity is placed on the subject) or a bipolar mode (e.g., two different subsets of needles have opposite electrical polarities).

[0014] The needles or wires in any of the embodiments of this specification are generally metallic and can include, for example, metal alloys such as nitinol or stainless steel. The needles can be attached to or connected to a conductor that is attached to a cable or connector cable for delivering electrical energy from a suitable generator capable of delivering a high voltage pulsed field ablation waveform. Generally, such energy delivery is performed in either a monopolar mode or a bipolar mode. In the monopolar mode, a subset of the needles has one electrical polarity and a reference patch placed on the subject has the opposite electrical polarity. In the bipolar mode, two different subsets of the needles are energized with opposite electrical polarities. In an embodiment, multiple paired subsets of the needles can be energized in a sequential manner for energy delivery. The pulsed field ablation waveform can be either in a single-phase (e.g., all pulses delivered to an electrode pair have the same polarity) or a two-phase structure (e.g., consecutive pulses delivered to an electrode pair have opposite polarities). When the pulsed field ablation waveform is applied, the resulting spatial distribution of the electric field determines the zone of cell death. Depending on the value of the irreversible electroporation electric field strength threshold for a given target cell type, cells within the spatial zone where the magnitude of the electric field is greater than the threshold are killed or ablated, and cells within other spatial zones where the magnitude of the electric field is less than the threshold survive.

[0015] In some embodiments, the catheter device of the present disclosure can have an outer diameter in the approximate range of about 0.5 mm to about 5 mm (including all values and sub-ranges therebetween). In some embodiments, the needles or wires can have a diameter in the approximate range of about 0.15 mm to about 1.6 mm (including all values and sub-ranges therebetween), depending on the embodiment. In the case of helical needles, the pitch of the helix can be in the approximate range of about 0.1 mm to about 4 mm (including all values and sub-ranges therebetween), and the diameter of the helix (measured as the coil diameter of the centerline) can be in the approximate range of about 0.3 mm to about 4 mm (including all values and sub-ranges therebetween).

[0016] In some embodiments, the device includes a shaft defining a lumen and a needle device disposed within the lumen. The needle device has a distal portion including an exposed conductor, and the distal portion of the needle device is configured to extend from the lumen at a non-zero angle relative to the longitudinal axis of the shaft. The needle device is configured to receive a pulsed voltage waveform and deliver a pulsed electric field through the exposed conductor to cauterize surrounding tissue.

[0017] In some embodiments, the device includes a shaft defining a set of one or more lumens and first and second needle devices disposed within the set of lumens. Each of the first and second needle devices has a distal portion including an exposed conductor, and the distal portions of the first and second needle devices are configured to extend from the set of lumens at a non-zero angle relative to the longitudinal axis of the shaft. The first and second needle devices are configured to receive a pulsed voltage waveform and collectively deliver a pulsed electric field through their respective exposed conductors to cauterize surrounding tissue.

[0018] In some embodiments, the device includes a shaft defining a lumen and a needle device disposed within the lumen. The needle device has a distal portion including an exposed conductor, and the distal portion of the needle device has a helical shape. The needle device is configured to receive a pulsed voltage waveform and deliver a pulsed electric field through the exposed conductor to cauterize surrounding tissue.

[0019] In some embodiments, the device includes a shaft defining a lumen and a needle device disposed within the lumen. The needle device has a distal portion including an exposed conductor and a proximal portion electrically insulated by an insulator configured to withstand a voltage of at least about 500 volts without dielectric breakdown. The distal portion of the needle device has a substantially linear shape. The needle device is configured to receive a pulsed voltage waveform and deliver a pulsed electric field through the exposed conductor to cauterize surrounding tissue.

[0020] In some embodiments, the device includes a shaft defining a lumen and a needle device disposed within the lumen, the needle device having a distal portion including an exposed conductor and a proximal portion electrically insulated by an insulator configured to withstand a voltage of at least about 500 volts without dielectric breakdown, the distal portion of the needle device having a helical shape and being configured to extend outside the lumen, the helical shape having a greater diameter when the distal portion extends outside the lumen than when the distal portion is inside the lumen, the needle device being configured to receive a pulsed voltage waveform and deliver a pulsed electric field through the exposed conductor to ablate surrounding tissue, and a proximal actuation assembly attached to the shaft and the proximal portion of the needle device and configured to control relative movement of the needle device with respect to the catheter device.

[0021] In some embodiments, the method includes extending a distal portion of a needle device outside a lumen of a shaft of a catheter device positioned in an anatomical region of interest, the distal portion of the needle device including an exposed conductor, puncturing the tissue of interest in response to extending the distal portion of the needle device outside the lumen, moving the distal portion of the needle device within the tissue of interest to position a distal tip of the needle device at a target location, and applying a voltage pulse to the needle device to deliver a pulsed field ablation treatment.

[0022] In some embodiments, the method includes extending distal portions of first and second needle devices outside one or more lumens of a shaft of a catheter device positioned in an anatomical region of interest, the distal portions of the first and second needle devices including exposed conductors, puncturing the tissue of interest in response to extending the distal portions of the first and second needle devices outside the one or more lumens, moving the distal portions of the first and second needle devices within the tissue of interest to position distal tips of the first and second needle devices at a target location, and applying a voltage pulse to the first and second needle devices to deliver a pulsed field ablation treatment.

Brief Description of the Drawings

[0023]

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BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The device embodiments of the present disclosure generally provide means for deploying a device within a soft tissue structure such as a tumor for delivery of irreversible electroporation therapy. In some embodiments, the devices are intended for minimally invasive use (e.g., with or in parallel with an endoscope) and may be flexible or deflectable devices, while in other embodiments, they can be relatively rigid devices intended for percutaneous use.

[0025] For the treatment of pancreatic tumors, endoscopic access to the stomach or duodenum can be obtained, and then access to adjacent organs such as the pancreas can be obtained by appropriate puncture. FIG. 1 shows an endoscope 117 inserted below the esophagus 121 through a symmetric mouth so as to be positioned in the duodenum 123 after passing through the stomach 125. This type of positioning allows the endoscope to be placed near the pancreas. FIG. 2 shows the pancreas 208 relative to the stomach 202 and duodenum 205 within the abdominal anatomical structure.

[0026] FIG. 3 is a schematic diagram of the distal portion of a single lumen catheter 302 or a needle device having a wedge-shaped distal lumen, along with a needle, according to an embodiment. The distal end of the lumen has a wedge or wedge-shaped internal structure 308 that narrows the distal lumen and is angled away from the catheter longitudinal axis 313 so as to extend from the distal opening 310 when the needle wire 304 is extruded. In an embodiment, the tip 306 of the wire 304 is shaped into a fine and sharp tip for tissue puncture.

[0027] In an embodiment, the catheter device of the present disclosure can have a plurality of lumens. FIG. 4 shows a catheter device having two lumens 401 and 403 that respectively carry needles 405 and 407, according to an embodiment. In an embodiment, the lumen walls can be thicker at portions 411 where they abut each other. Lumens 401 and 403 each have a wedge-shaped distal portion 412 and 414 that narrow their respective distal lumens, such that needle wires 405 and 407 emerge from angled distal ends that are angled away from the long axis 415 of the device and are also angled with respect to each other.

[0028] In an embodiment, the lumen of the catheter device can have a distal end portion that is angled away from the long axis of the device on at least one side. FIG. 5 is a schematic view of a single lumen catheter or device 503 having an angled nozzle-like distal portion 505 on one side of the shaft that carries a needle wire 509 extending from the distal end 515 of the device having a needle tip 511 that is sharply formed for tissue puncture, according to an embodiment.

[0029] In an embodiment, the catheter device can have more than two lumens having distal end portions that are angled away from the long axis of the device on at least one side. FIG. 6 shows a double lumen catheter device, according to an embodiment, in which each lumen 602 and 604 has a respective angled nozzle-like distal portion 612 and 614 and each respective lumen carries a needle 606 and 608. As shown in FIG. 6, the distal ends 616 and 618 of each respective needle 606 and 608 are angled away from the long axis 630 of the device and are also angled away from each other.

[0030] In an embodiment, the catheter device of the present disclosure can itself pass through the channel of an endoscope. FIG. 7A shows, for illustrative and exemplary purposes, the distal portion of an endoscope 701 having a plurality of lumens 703, 705, and 707. Lumens 703 and / or 705 can be used for the passage of an optical imaging fiber or camera or an ultrasonic imaging catheter. Lumen or channel 707 is shown as being used for the passage of the catheter device 709 of the present disclosure. The catheter device 709 itself has two lumens that carry needle wires 711 and 713. FIG. 7B shows the distal portion of the catheter device 709 having lumens 753 and 755 that carry needle wires 711 and 713, respectively. In use, the endoscope 701 is passed through the mouth and esophagus into the stomach and / or duodenum and positioned adjacent to, or near, the tissue wall, for example, near the pancreas. The catheter 709 is extended under image guidance from optical or ultrasonic imaging performed using a suitable imaging device used with the endoscope and positioned in a suitable location for access to a suitable pancreatic site. Needles 711 and 713 are extended from the catheter device 709 and used to pierce the stomach wall and enter the pancreas to access the target tumor site. Once the needles are properly positioned within the pancreas, pulsed field ablation is delivered through the needles from a generator connected to the catheter.

[0031] In an embodiment, the catheter device can have three or more lumens. FIG. 8 is a diagram of a catheter device having three lumens 801, 803, and 805 that carry needles 811, 813, and 815, respectively, according to an embodiment. It will be appreciated that, based on the present disclosure, devices having other diverse needles can also be constructed to be convenient for a given application.

[0032] The devices disclosed herein are generally positioned such that a given target biological structure can be accessed directly from its location at an initial tissue surface, and then a needle extends through the tissue surface and into an organ or anatomical structure where treatment delivery is desired. FIG. 9 is a diagram of a catheter device 906 positioned adjacent to an anatomical organ 904 within a subject body 902, according to an embodiment (shown in the figure as a cross-sectional view). Needles 910 and 912 extend from a device lumen so as to penetrate into the organ 904. In one embodiment, the needles are used as a single bonding electrode (i.e., polarized with one electrical polarity) and can be electrically paired with a reference electrode patch 915 (polarized with the opposite electrical polarity) to deliver pulsed field ablation in monopolar (also called monopolar) mode. In other embodiments, needles 910 and 912 can be used as a bipolar electrode pair for bipolar pulsed field ablation delivery. Application of the pulsed field ablation waveform to the electrodes results in the generation of an electric field, and a damage zone, such as a zone with a boundary 922, is generated as a result of the ablation, depending on the tissue irreversible electroporation threshold. If a larger treatment volume or area is desired, needles 910 and 912 can be retracted, the catheter can be moved and positioned at a different location, needles 910 and 912 can be inserted at the new location, and treatment can be delivered at the new location.

[0033] In some embodiments, the catheter device of the present invention can have an outer diameter in the approximate range of about 0.5 mm to about 5 mm (including all values and sub-ranges therebetween). In an embodiment, the needle or wire can have a diameter in the approximate range of about 0.15 mm to about 1.6 mm (including all values and sub-ranges therebetween), depending on the convenience and / or suitability for a given application.

[0034] In an embodiment, the catheter device of the present disclosure can have a needle wire having a distal portion wound as a helix. FIG. 10 schematically shows a needle wire 1002 having a helical distal portion 1004 according to an embodiment. The helical portion 1004 is characterized by a pitch 1008 and a coil diameter 1010, and the helix is arranged such that the axis of the helix coincides with the tangent of the wire at the attachment point 1014 of the helix. In this way, the twist of the wire is directly converted into the winding of the helix. In some embodiments, the pitch of the helix can be in an approximate range between about 0.1 mm and about 4 mm (including all values and sub-ranges therebetween), and the diameter of the helix (measured on the coil diameter of the center line) can be in an approximate range between about 0.3 mm and about 4 mm (including all values and sub-ranges therebetween).

[0035] In an embodiment, the wire can have a slight bend in a proximal portion of the distal helix. FIG. 11 schematically shows a needle wire 1101 having a helical distal portion 1107 with a slight bend within the shaft of the wire over a length L1 at an approximate location 1103 that is proximal to the helical portion and separated from the helix by a length 1105 (also shown as L2 in the figure). The helix is arranged such that the axis of the helix coincides with the tangent of the wire at the attachment point 1112 of the helix. In this way, the twist of the wire is directly converted into the winding of the helix. In some embodiments, the length L1 of the bent portion can be in the range of about 3 mm to about 100 mm (including all values and sub-ranges therebetween), and the length L2 can be in the range of about 5 mm to about 100 mm (including all values and sub-ranges therebetween).

[0036] As shown in FIG. 12, in some embodiments, the catheter device 1202 can have a lumen having an internal wedge-shaped distal lumen 1210 and a needle wire 1204 having a helical distal portion 1206, and the helix is shown to just emerge from the distal end of the device. Within the lumen, the helix is extended, its pitch 1214 is greater than in the stress-free state, while the helix diameter 1216 is smaller than in the stress-free state.

[0037] Figure 13 schematically shows a catheter device 1301 that is structurally and / or functionally similar to the catheter device 1202, having a lumen with an internal wedge-shaped distal lumen 1311 and a needle wire 1303 with a helical distal portion 1305, where the helix emerges from the distal end of the device to a greater extent than that shown in FIG. 12. As shown in FIG. 13, with more helices emerging or extending from the distal end of the catheter device 1301, the portion of the helix 1307 outside the catheter shaft assumes a stress-free shape with a larger helix diameter 1316 (e.g., a helix diameter larger than 1216) and a smaller pitch 1314 (e.g., a pitch smaller than pitch 1214) compared to the stress (stretch) state of the helix within the lumen (such as that described with reference to FIG. 12).

[0038] Figure 14 schematically shows a catheter device 1401 that is structurally and / or functionally similar to the catheter device 1202, having a lumen with an internal wedge-shaped distal lumen, a needle wire 1403 with a helical distal portion 1405, a helix 1405 fully deployed outside the distal end of the device, and a helix that assumes a stress-free shape with a larger helix diameter 1416 (e.g., a helix diameter larger than 1216) and a smaller pitch 1414 (e.g., a pitch smaller than pitch 1214) compared to the stress (stretch) state of the helix within the lumen.

[0039] Figures 15A, 15B, and 15C provide a schematic view of a catheter device 1520 positioned near the tissue surface 1521, where the helical wire penetrates the tissue surface and the helical portion is continuously deployed to enter the desired organ anatomical structure in a fully deployed state within the organ directly beneath the tissue surface, as shown in Figure 15C (1501, 1504, 1507). In the case of a clockwise helix (as shown in Figures 15A, 15B, and 15C), the clockwise rotation 1511 of the wire as viewed from above, together with the forward movement, advances the helical needle like a corkscrew and acts to firmly anchor it within the tissue. In practice, the helical needle is first partially deployed within a cavity such as within the stomach or other tubular anatomical structure, and there is sufficient spatial clearance to allow for the expansion of the distal portion of the helix when it emerges from the lumen. Next, the helical needle is advanced and screwed into the tissue to a stress-free state with a larger helical diameter.

[0040] In an embodiment, the catheter device can have two or more lumens, each carrying a wire having a distal portion of a helical needle. Figure 16 shows a catheter device having two lumens 1604 and 1606 according to an embodiment, each angled away from the catheter longitudinal axis at the distal end, and the catheter is positioned on the tissue surface 1602 through which penetration is desired. Lumens 1604 and 1606 each carry a helical needle wire 1612 and 1614, and both helical wires are deployed into the tissue surface 1602. Once appropriately deployed in the region of interest (e.g., a tumor), irreversible electroporation can be delivered to the needles either in a bipolar configuration (needles polarized with opposite polarities) or a monopolar configuration (having a reference electrode patch as an electrode polarized oppositely).

[0041] In an alternative embodiment, the catheter device can have three or more lumens having a plurality of helical needles, or a combination of a different number of straight needles and helical needles. In other embodiments, the catheter device can have a plurality of lumens with curved distal portions.

[0042] FIG. 17 shows a schematic view of a catheter device having two lumens 1702 and 1704 according to an embodiment, the two lumens curving away from the catheter longitudinal axis at their distal portions over a length 1706, and each lumen 1702 and 1704 carrying a respective helical needle wire 1708 and 1710. In an embodiment, the length 1706 can be in an approximate range between about 3 mm and about 60 mm (including all values and sub-ranges therebetween). When fully deployed, the angle between the respective helical axes of the helices of needles 1708 and 1710 can be in an approximate range between about 10 and about 75 degrees (including all values and sub-ranges therebetween).

[0043] In an embodiment, the catheter device can have a central lumen surrounded by an outer lumen, and the central and outer lumens can carry either a straight or helical needle. For example, FIG. 18 shows a catheter device having a central lumen 1805 and two outer lumens 1801 and 1803, the two outer lumens 1801 and 1803 being angled away from the catheter longitudinal axis at their distal portions, the central lumen 1805 carrying a helical needle wire 1813, and the two outer lumens 1801 and 1803 each carrying a straight needle 1807 and 1809, respectively.

[0044] As another example of an alternative embodiment, FIG. 19 shows a catheter device having a central lumen 1905 and two outer lumens 1901 and 1903, the two outer lumens 1901 and 1903 being angled away from the catheter longitudinal axis at their distal portions, the central lumen 1905 carrying a helical needle wire 1911, the two outer lumens 1901 and 1903 each carrying a respective needle 1907 and 1909, and the distal end of each outer lumen 1901 and 1903 being located at a proximal position separated by a length 1913 from the distal end of the central lumen 1905. The separation length between the central and outer lumens can, in an embodiment, be in the range of about 3 mm to about 60 mm (including all values and sub-ranges therebetween), depending in practice on the convenience and / or suitability for the application of interest.

[0045] Any of the above embodiments may be in the form of a deflectable catheter having catheter deflection controlled from a control mechanism within the handle and by mechanisms such as the use of pull wires well known to those of skill in the art of interventional catheters.

[0046] In other embodiments, the catheter device of the present invention can be a percutaneous rigid or semi-rigid needle for accessing a target site or region where treatment is delivered in minimally invasive surgical procedures performed under image guidance, for example, using CT imaging, by piercing tissue. For example, FIG. 20A shows a schematic view of a percutaneous needle device according to an embodiment, showing a needle shaft 2001 terminating in a distal tip having curved sharp edges 2021 and 2023 shaped to pierce the tissue surface. The needle shaft has two lumens 2003 and 2005, which carry helical needle wires 2009 and 2011, respectively. The lumens 2003 and 2005 exit from the side of the needle shaft 2001 at respective openings 2015 and 2017, from where the helical needles can be deployed.

[0047] FIG. 20B is a three-dimensional rendering of the distal portion of the needle shaft of the device shown in FIG. 20A, showing the distal needle portion 2030 and the curved sharp edges 2021 and 2023 bounding flat surfaces 2032 and 2034. In use, the helical wires are initially within their respective lumens. The needle shaft 2001 is used to pierce tissue and is advanced into the region of interest under appropriate image guidance, for example, using CT imaging. Once the desired site is reached, the helical needles 2009 and 2011 are advanced.

[0048] FIG. 21 is a schematic view of a percutaneous needle device showing a needle shaft 2100 terminated by a distal tip 2108 shaped to pierce tissue surface 2112, the needle shaft having two lumens, each lumen carrying helical needle wires 2102 and 2104, the needle shaft and helical wires 2102 and 2104 being fully inserted into and engaged within the tissue. In such applications where the distal tip 2108 of the needle shaft 2100 is positioned below the tissue surface 2112, there may be little difference in the geometry between the non-deployed (e.g., extended) state and the deployed (e.g., stress-free) state of the helical needle since any expansion / relaxation of the helix is restricted by the tissue. In embodiments for this use case, the helical diameter can be closely or approximately matched to the inner diameter of the catheter lumen, or can be slightly smaller than the inner diameter of the catheter lumen.

[0049] Figure 22A is a schematic diagram of a catheter device 2200 having a catheter shaft 2220 and a lumen carrying a helical needle device or wire 2206, according to an embodiment. The catheter device 2200 can have a compressible electrode 2202 mounted proximal to the distal end of the catheter shaft 2220. In an embodiment, the compressible electrode 2202 can have a collar portion 2204 to facilitate mounting of the electrode onto the shaft. The collar portion 2204 can be crimped or swaged onto the catheter shaft 2220 in a manner well known to those skilled in the art. In an embodiment, the compressible electrode 2202 can include a cage-like structure made of a highly elastic conductive material such as nitinol, for example. In the figure, the catheter device 2200 is shown with its distal end positioned proximal to and / or adjacent to a tissue interface 2208, and the tissue 2210 on the distal side of the interface can be part of a separate anatomical organ. In some clinical applications, the proximal side of the tissue interface can include the internal space of an anatomical passageway, such as part of the digestive tract or part of the airway of the lung or tracheal tube. As described above, the helical needle device 2206 is configured such that in its stress-free state, the helical portion of the helical needle device 2206 has a helical diameter larger than the inner diameter of the catheter device 2200. When the helical portion is inside the catheter shaft 2220, the helical portion is stressed or constrained by the catheter shaft 2220 and has a helical diameter smaller than the helical diameter in the stress-free state. Thus, when the helical needle device 2206 emerges from the shaft 2220 proximal to the tissue interface 2208, the helical portion expands in diameter. In an embodiment, the distal tip of the helical needle wire 2206 is suitably sharpened to facilitate penetration and advancement into tissue.

[0050] When the tissue interface is engaged during use (e.g., under ultrasonic visualization), the needle device 2206 is rotated and advanced simultaneously such that the needle device 2206 is advanced spirally into the tissue. One embodiment of a device for rotating and advancing the needle device 2206 is illustrated in FIG. 27 and discussed further below. FIG. 22B shows a helical needle device fully deployed outside the catheter shaft 2220 such that the helical needle device 2206 is advanced spirally into the tissue after penetrating the tissue interface 2208. This figure shows a catheter device 2200 having a shaft electrode 2202, and the helical needle 2206 is disposed within the tissue anatomical structure distal to the tissue interface 2208. During use, the distal end of the catheter device 2200 is positioned within the internal anatomical space as described above, and when the helical needle device 2206 is deployed within the internal space, it expands to its stress-free dimension when exiting the catheter shaft 2220. Thus, the pitch 2225 of the helical portion of the needle device 2206 distal to the distal interface corresponds to the helical pitch of the needle device 2206 in its stress-free or reference state. In embodiments, the helical diameter of the helical needle device 2206 in the stress-free state can be in the range of about 0.5 mm to about 10 mm (including all ranges and values therebetween), and the helical pitch of the helical needle device 2206 in the stress-free state can be in the range of about 0.3 mm to about 6 mm (including all ranges and values therebetween). In embodiments, the length of the helix (measured along the central axis of the helix) in the stress-free state can be in the range of about 3 mm to about 50 mm (including all ranges and values therebetween), and any portion of the helix length can penetrate the tissue or organ for delivery of ablation therapy.

[0051] When the needle device 2206 is properly positioned in the tissue of interest to be ablated, in an embodiment, the internal anatomical space where the shaft electrode 2202 is located can be filled with saline or a similar conductive fluid. The ablation treatment is delivered in the form of high voltage pulses applied between the helical needle device 2206 and the shaft electrode 2202, and these two electrodes are electrically configured with opposite electrical polarities. In an embodiment, the helical needle device 2206 can include a conductive superelastic material such as nitinol, for example. The helical portion of the needle device 2206 is conductive, but the length of the needle device 2206 proximal to the helical portion can be electrically insulated. The shaft electrode 2202 is connected to an insulating lead wire for electrical conduction. In an embodiment, the ablation treatment delivery can include high voltage pulses having a voltage difference of at least about 300 volts to about 10,000 volts (including all ranges and values therebetween) between the oppositely polarized electrodes. Due to the potential difference applied between the electrodes, an electric field is generated within the tissue. Depending on the applied voltage waveform and tissue type, any tissue subjected to an electric field greater than the threshold is killed or cauterized by the mechanism of irreversible electroporation.

[0052] FIG. 27 shows a widget or tool (e.g., a proximal actuation assembly) for rotation and advancement of a helical needle wire 2711 (e.g., any of the helical needle wires or devices described herein). The tool can rotate and advance the helical needle wire such that the helical distal portion of the needle wire screws spirally into the tissue of interest. In embodiments, a catheter device (e.g., any of the catheters or catheter devices described herein) including the helical needle wire may be positioned directly within an anatomical region. Alternatively, in other embodiments, the catheter device can be passed through the working channel of a primary device, such as an endoscope or bronchoscope (not shown), and then positioned within the anatomical region. In embodiments, the catheter device can be positioned under visual guidance (e.g., via optical or ultrasound imaging) through an endoscope. Once the catheter device is properly positioned within the anatomical structure, a first proximal screw 2715 can be inserted onto the proximal end of the catheter device 2707 accessible to the user, e.g., directly outside the subject's anatomical structure or outside a primary device such as an endoscope. The screw 2715 has a longitudinally split screw portion 2719 configured to closely fit onto the catheter 2707 of the catheter device so as to firmly grip the catheter 2707 when screwed into the threaded cavity 2702 of the hub 2700 of the catheter device 2707. The needle wire 2711 extends out from the proximal end of the catheter 2707 through the hub 2700. A second proximal screw 2722 can be inserted onto the proximal end of the needle wire 2711 together with a hub screw 2728. The screw 2722 has a longitudinally split screw portion 2724 configured to closely fit onto the needle wire 2711 so as to firmly grip the needle wire 2711 when screwed into the threaded cavity 2735 of the hub screw 2728. In this way, the first proximal screw 2715 is effectively fixed or coupled to the catheter 2707, and the second proximal screw 2722 is effectively fixed or coupled to the needle wire 2711.When the hub screw 2728 is screwed into the threaded cavity 2704 within the hub 2700, the hub 2700 can be held in a fixed position, thereby enabling the catheter 2707 to be held in a fixed position. Specifically, during use, the distal end of the needle wire is positioned at the tissue interface. Once it is ready to be advanced into the tissue, while the hub 2700 is held in a fixed position, the hub screw 2728 is screwed into the threaded cavity 2704. In some embodiments, the pitch 2740 of the helical screw 2732 is the same as the helical pitch 2225 of the needle wire 2711 in a stress-free or constrained state (shown and described above with reference to FIG. 22B). Thus, one full rotation of the hub screw 2728 into the threaded cavity 2704 of the hub advances the distal end of the helical needle wire 2711 by one helical turn into the tissue. In this way, the needle wire 2711 can be advanced helically into the tissue until its distal tip reaches a desired or predetermined depth within the tissue, which can be confirmed, for example, from an ultrasonic image. After being placed at an appropriate target location, high-voltage pulsed-field ablation therapy can be delivered (as described above, for example) by applying a high-voltage pulse to the needle wire 2711 and the shaft electrode (electrically paired, e.g., any of the shaft electrodes described herein). In an alternative embodiment, a reference patch can be electrically paired with the needle wire 2711 for ablation delivery in monopolar mode. In embodiments, multiple ablations can be delivered to a given target location. Subsequently, the helical needle wire 2711 can be retracted by loosening the hub screw 2728. Thereafter, the helical needle wire 2711 retraces its path within the tissue and is withdrawn from the tissue and the tissue interface. Optionally, the primary device, such as a catheter and / or an endoscope or bronchoscope, is manipulated to reposition the distal end of the catheter 2707 for access to a new target location within the tissue, and the process can be repeated as desired.

[0053] FIG. 23 is a schematic diagram of a catheter device 2300 showing a catheter shaft 2303 having a lumen carrying a helical needle or wire 2307. The helical needle 2307 is shown protruding from the distal end of the catheter shaft 2303. The catheter shaft can, according to an embodiment, have a ring electrode 2305 mounted proximal to the distal end of the catheter shaft 2305. The helical needle 2307 and the shaft electrode 2305 are electrically paired with opposite electrical polarities and can be configured as a bipolar electrode pair for pulsed field ablation delivery. The helical needle 2307 can be inserted into tissue, for example, by helical advancement using a suitable tool at the proximal end of the catheter device 2300 as described with respect to FIG. 27.

[0054] FIG. 24 is a schematic diagram of a catheter device 2400 showing a catheter shaft 2403 having a lumen carrying a helical needle or wire 2410. The helical needle 2410 is shown protruding from the distal end of the catheter shaft 2403. The catheter shaft 2403 can, according to an embodiment, have two ring electrodes 2405 and 2407 mounted proximal to the distal end of the catheter shaft. The helical needle 2410 and the shaft electrodes 2405 and 2407 are electrically paired with opposite electrical polarities and can be configured as a bipolar electrode pair for pulsed field ablation delivery. For example, the helical needle 2410 can have one electrical polarity and the electrodes 2405 and 2407 can both have opposite electrical polarities. The helical needle 2410 can be inserted into tissue, for example, by helical advancement using a suitable tool at the proximal end of the catheter device 2400 as described with respect to FIG. 27.

[0055] FIG. 25 is a schematic view of a catheter device 2500 showing a catheter shaft 2502 having a lumen carrying a needle device 2506, according to an embodiment. The needle device 2506 is shown protruding from the distal end of the catheter shaft 2502. The catheter shaft 2502 has, according to an embodiment, a compressible electrode 2504 mounted proximal to the distal end of the catheter shaft 2502. The needle device 2506 can be a straight needle configured to penetrate a tissue interface and extend into an anatomical organ for placement at a target site for delivery of ablation therapy. When placed at the target location, the needle device 2506 and the shaft electrode 2504 can be electrically paired with opposite electrical polarities and configured as a bipolar electrode pair for pulsed field ablation delivery. In an embodiment, the needle device 2506 is disposed beyond the distal end of the catheter shaft 2502 and can have an exposed conductive surface or portion having a length in the range of about 3 mm to about 50 mm (including all ranges and values therebetween). In an embodiment, the maximum diameter of the exposed conductive portion of the needle device 2506 can be in the range of about 0.1 mm to about 2.5 mm (including all ranges and values therebetween). In an embodiment, the distal exposed conductive portion of the needle device 2506 can include a superelastic material such as nitinol, for example. Proximal to the distal exposed conductive portion, the needle device 2506 can be electrically insulated.

[0056] FIG. 26 is a schematic diagram of a catheter device 2600 showing a catheter shaft 2603 having a lumen carrying a needle device 2608, according to an embodiment. The needle device 2608 is shown protruding from the distal end of the catheter shaft. The catheter shaft 2603 has ring electrodes 2605 and 2607 mounted proximal to the distal end of the catheter shaft 2603, according to an embodiment. The needle device 2608 can be a straight needle configured to penetrate a tissue interface and extend into an anatomical organ for placement at a target site for delivery of ablation therapy. When placed at the target location, the needle device 2608 and the shaft electrodes 2605 and 2607 can be electrically paired with opposite electrical polarities and configured as a bipolar electrode pair for pulsed field ablation delivery.

[0057] In embodiments, the ring electrodes on the catheter shaft of the present disclosure can have an outer diameter in the range of about 0.5 mm to about 6 mm (including all ranges and values therebetween). In embodiments, for example, the compressible electrodes of the present disclosure, such as electrode 2202 of FIG. 22A and electrode 2504 of FIG. 25, can have an expanded or stress-free diameter in the range of about 0.6 mm to about 10 mm (including all ranges and values therebetween). When a compressible electrode is placed within the lumen or channel of another device (e.g., an endoscope) having a smaller diameter, the compressible electrode can be compressed or restricted to the smaller diameter of the other device, and as the electrode emerges from inside the smaller diameter lumen or channel within the other device, the electrode can expand to its stress-free state diameter. The shaft electrodes of the present disclosure are electrically connected to insulated lead wires. In embodiments, the lead wires of the shaft electrodes and the needle device can have sufficient insulation to maintain a voltage difference of at least about 500 volts between them without dielectric breakdown. In alternative embodiments, the insulators of the lead wires and the needle device can maintain a voltage difference of up to about 2000 volts, up to about 3000 volts, up to about 4000 volts, up to about 6000 volts, or up to about 10000 volts between each other without dielectric breakdown.

[0058] Figure 28 is a schematic diagram of a process for causing overlapping or adjacent ablation damage using the device 2801 of the present disclosure according to an embodiment. The device 2801 can be used to generate a first ablation zone 2805. After generating the first ablation zone 2805, the device 2801 can be repositioned before tissue penetration by the needle device or wire of the device 2801 to enable the generation of a second ablation zone 2812. The second ablation zone 2812 can overlap or be adjacent to the first ablation zone 2805. In FIG. 28, the left image shows the catheter device 2801 at a first position 2803 within the tissue or organ anatomical structure 2800, and the needle device 2807 is penetrating the organ anatomical structure to generate the first ablation zone 2805. Thereafter, the catheter device 2801 is repositioned to a second position 2810 as shown in the right image, the needle device 2807 is inserted into the tissue, and the second ablation zone 2812 is generated as shown in the figure. The second ablation zone 2812 is adjacent to or overlaps the first ablation zone 2805, such that adjacent volumes of tissue are cauterized. For example, the region of tissue between arcs 2815 and 2817 is completely cauterized by the overlapping ablation zones 2805 and 2812.

[0059] The systems, devices, and methods described herein can be embodied in one or more embodiments as described below.

[0060] Embodiment 1: A catheter device having at least one lumen for passage of a needle device, wherein a distal end of the lumen is configured such that the needle device exits the lumen at the distal end of the device at a non-zero angle with respect to the long axis of the catheter, and a distal portion of the needle includes an exposed conductor for passage of current to tissue upon application of a high voltage.

[0061] Embodiment 2: A catheter device having at least two lumens for passage of a needle device through each lumen, wherein the distal end of at least one lumen is configured such that the needle device exits the lumen at the distal end of the device at a non-zero angle with respect to the longitudinal axis of the catheter, and the distal portion of each needle includes an exposed conductor for passage of current to tissue when a high voltage is applied.

[0062] Embodiment 3: The catheter device according to Embodiment 1, wherein the needle engages tissue for high voltage delivery in monopolar mode.

[0063] Embodiment 4: The catheter device according to Embodiment 2, wherein the needle engages tissue for high voltage delivery in bipolar mode.

[0064] Embodiment 5: A catheter device having at least one lumen for passage of a helical tip needle device, wherein the distal end of the lumen is configured such that the needle device exits the lumen at the distal end of the device at a non-zero angle with respect to the longitudinal axis of the catheter, the distal portion of the needle device is configured in a helical shape, and includes an exposed conductor for passage of current to tissue when a high voltage is applied.

[0065] Embodiment 6: A catheter device having at least two lumens for passing a helical tip needle device through each lumen, wherein the distal end of at least one lumen is configured such that the needle device exits the lumen at the distal end of the device at a non-zero angle with respect to the longitudinal axis of the catheter, the distal portion of each needle device is configured in a helical shape, and includes an exposed conductor for passage of current to tissue when a high voltage is applied.

[0066] Embodiment 7: The catheter device according to Embodiment 5, wherein the diameter of the helical shape of the needle in the unconstrained state is larger than the diameter of the helical shape of the needle when constrained within the lumen of the catheter.

[0067] Embodiment 8: The catheter device according to Embodiment 6, wherein the diameter of the helical shape of each needle in the unconstrained state is larger than the diameter of the helical shape of that needle when constrained within the lumen of the catheter.

[0068] Embodiment 9: A catheter device having at least one lumen for passage of a helical tip needle device, wherein the distal portion of the needle device is configured in a helical shape and includes an exposed conductor for passage of current to tissue when a high voltage is applied.

[0069] Embodiment 10: The catheter device according to Embodiment 9, wherein the diameter of the helical shape of the needle in the unconstrained state is larger than the diameter of the helical shape of the needle when constrained within the lumen of the catheter.

[0070] Embodiment 11: A catheter device having at least two lumens for passing a needle device through each lumen, wherein the first lumen carries a first needle device having a substantially linear distal geometry, the second lumen carries a second needle device having a helical-shaped distal portion thereof, and the distal portion of each needle device includes an exposed conductor for passage of current to tissue when a high voltage is applied.

[0071] Embodiment 12: The catheter device according to Embodiment 11, wherein at least a subset of the needle devices engage tissue for high voltage delivery in monopolar mode.

[0072] Embodiment 13: The catheter device according to Embodiment 11, wherein at least a subset of the needle devices engage tissue for high voltage delivery in bipolar mode.

[0073] Embodiment 14: The catheter device according to Embodiment 11, wherein the catheter device is positioned in an anatomical region of interest through the working channel of an endoscope.

[0074] Embodiment 15: The catheter device according to Embodiment 9, wherein the catheter device is positioned in the anatomical region of interest through the working channel of the endoscope.

[0075] Embodiment 16: The catheter device according to Embodiment 6, wherein the catheter device is positioned in the anatomical region of interest through the working channel of the endoscope.

[0076] Embodiment 17: The catheter device according to Embodiment 1, wherein the catheter device is positioned in the anatomical region of interest through the working channel of the endoscope.

[0077] Embodiment 18: The catheter device according to Embodiment 11, wherein the diameter of the helical shape of the second needle device in the unconstrained state is larger than the diameter of the helical shape of the needle when constrained within the second lumen of the catheter.

[0078] Embodiment 19: A method for delivering high-voltage pulsed-field ablation therapy to tissue, comprising positioning a catheter device in the anatomical region of interest, passing a first needle device through a first lumen of the catheter device to puncture the tissue of interest, advancing the first needle device within the tissue of interest to position its distal tip at a target location, passing a second needle device through a second lumen of the catheter device to puncture the tissue of interest, advancing the second needle device within the tissue of interest to position its distal tip at a target location, and applying a high-voltage pulse to the needle device to deliver ablation therapy, wherein the distal portion of each needle device includes an exposed conductor for passage of current to the tissue during high-voltage application.

[0079] Embodiment 20: The method according to Embodiment 19, wherein the high-voltage pulse is applied in a bipolar manner between the first needle device and the second needle device.

[0080] Embodiment 21: The method according to Embodiment 19, wherein the distal portion of at least one of the needle devices is configured in a helical shape and includes an exposed conductor for passage of current to the tissue during high-voltage application.

[0081] Embodiment 22: The method according to embodiment 21, wherein the diameter of the helical shape of at least one needle device having a non-constrained helical distal shape is greater than the diameter of the helical shape of the needle device when constrained within the lumen of the catheter.

[0082] Embodiment 23: The method according to embodiment 19, wherein the catheter device is positioned in the region of anatomical interest by passing through the channel of an endoscopic device.

[0083] Embodiment 24: A catheter device having a shaft and a lumen for passage of a needle device, wherein the longitudinal section of the distal portion of the needle comprises a substantially linear shape, the distal portion of the needle comprises an exposed conductor for passage of current to tissue during application of a high voltage for pulsed field ablation delivery, and the length of the needle proximal to the distal portion is electrically insulated using an insulator capable of withstanding a voltage of at least 500 volts without breakdown.

[0084] Embodiment 25: The catheter device according to embodiment 24, wherein the distal portion of the catheter shaft comprises at least one shaft electrode having an electrical polarity opposite to that of the needle during pulsed field ablation delivery.

[0085] Embodiment 26: The catheter device according to embodiment 25, wherein the shaft electrode has a compressible geometry.

[0086] Embodiment 27: A catheter device having a shaft and a lumen for passage of a needle device, wherein the distal portion of the needle has a helical shape and includes an exposed conductor for passage of current to tissue upon application of a high voltage for pulsed field ablation delivery, the helical diameter of the helical shape being larger than the helical diameter of the helical shape when the distal portion of the needle is inside the lumen of the catheter device when the distal portion of the needle extends freely outside the lumen of the catheter device, and the length of the needle proximal to the distal portion being electrically insulated using an insulator capable of withstanding a voltage of at least 500 volts without dielectric breakdown.

[0087] Embodiment 28: The catheter device according to embodiment 27, wherein the distal portion of the catheter shaft includes at least one shaft electrode having an electrical polarity opposite to that of the needle during pulsed field ablation delivery.

[0088] Embodiment 29: The catheter device according to embodiment 28, wherein the shaft electrode has a compressible geometry.

[0089] Embodiment 30: A catheter device having a shaft and a lumen for passage of a needle device, wherein the distal portion of the needle has a helical shape and includes an exposed conductor for passage of current to tissue upon application of a high voltage for pulsed field ablation delivery, the helical diameter of the helical shape being larger than the helical diameter of the helical shape when the distal portion of the needle is inside the lumen of the catheter device when the distal portion of the needle extends freely outside the lumen of the catheter device, and the length of the needle proximal to the distal portion being electrically insulated using an insulator capable of withstanding a voltage of at least 500 volts without dielectric breakdown, and a gripping device is attached to the proximal portions of both the catheter shaft and the needle device for gripping the catheter and the needle device so as to provide means for controlled movement of the needle device relative to the catheter device.

[0090] Embodiment 31: The catheter device of Embodiment 30, wherein the controlled movement of the needle device includes a helical movement having a helical pitch equal to the helical pitch of the distal portion of the needle when the needle extends freely.

[0091] Embodiment 32: A method for delivering a high-voltage pulsed-field ablation treatment to tissue, comprising positioning a catheter device in an anatomical region of interest, passing a needle device having a distal portion of a needle including an exposed conductor through the lumen of the catheter device to puncture the tissue of interest, moving the needle device within the tissue of interest to position its distal tip at a target location, and applying a high-voltage pulse to the needle device to deliver the pulsed-field ablation treatment.

[0092] Embodiment 33: A method for delivering a high-voltage pulsed-field ablation treatment to tissue, comprising positioning a catheter device in an anatomical region of interest, passing a needle device having a distal portion of a needle with a helical shape and including an exposed conductor through the lumen of the catheter device to puncture the tissue of interest, moving the needle device within the tissue of interest to position its distal tip at a target location, and applying a high-voltage pulse to the needle device to deliver the pulsed-field ablation treatment, wherein moving the needle within the tissue includes a helical movement.

[0093] Embodiment 34: The method according to Embodiment 33, wherein the helical movement is driven by operating a gripping device attached to the proximal portions of both the catheter device and the needle.

[0094] Embodiment 35: The method according to Embodiment 33, wherein the catheter device is positioned in the anatomical region of interest by passing through a channel of an endoscopic device.

[0095] Specific examples are provided in the figures for illustrative and explanatory purposes, but it should be apparent that variant forms such as different numbers of lumens, straight or helical needles, or combinations thereof are included in the present disclosure. The needles of the catheter device are generally attached or connectable to a conductor that is attached to a cable or connector cable for the delivery of electrical energy from a suitable generator capable of delivering a high voltage pulsed field ablation waveform. Generally, such energy delivery is performed in either a monopolar or bipolar mode. In the monopolar mode, a subset of the needles has one electrical polarity and a reference patch placed on the subject has the opposite electrical polarity. In the bipolar mode, two different subsets of the needles are energized with opposite electrical polarities. In embodiments, multiple paired subsets of the needles can be energized in a sequential manner for energy delivery. The pulsed field ablation waveform can be either single phase (all pulses delivered to the electrode pair have the same polarity) or two phase (successive pulses delivered to the electrode pair have opposite polarities). When the pulsed field ablation waveform is applied, the resulting spatial distribution of the electric field determines the zone of ablation or cell death.

[0096] In the use of the catheter device of the present invention, various types of image guidance, such as ultrasound, optical or CT image guidance, can be used to visualize the catheter and confirm target access during positioning. After pulsed field ablation delivery at the target site, the needles can be retracted, the device can be moved to a different location, the needles can be reinserted, and subsequently pulsed field ablation delivery at a second target site can be performed. This process can continue until the desired volume of tissue or tumor is treated. In embodiments, two or more ablations can be delivered to a given target site for potential enhancement of the ablation effect.

[0097] As used herein, the terms "about" and / or "approximately", when used in conjunction with a numerical value and / or range, generally refer to a numerical value and / or range that is close to the recited numerical value and / or range. In some cases, the terms "about" and "approximately" may mean within ±10% of the recited value. For example, in some cases, "about 100 [units]" may mean within ±10% of 100 (e.g., 90 to 110). The terms "about" and "approximately" may be used interchangeably.

Claims

1. It is a system, A catheter device including a shaft and a needle, A handle is coupled to the proximal end of the shaft, The system includes a pulse generator configured to be coupled to the catheter device, The needle is positioned through the lumen of the shaft and is slidable relative to the shaft, thereby allowing the needle to advance distally beyond the shaft and penetrate into the tissue site, the shaft includes a first electrode having a compressible geometric shape in the distal portion of the shaft, and the needle includes a second electrode at its distal end, The pulse generator is configured to generate and deliver a biphasic voltage pulse to the catheter device such that the first electrode is activated with a first polarity and the second electrode is activated with a second polarity opposite to the first polarity, thereby delivering electroporation to the tissue zone of the tissue site.

2. The system according to claim 1, wherein the needle is configured to transition from a first configuration in which the distal end of the needle is located within the lumen of the shaft to a second configuration in which the distal end of the needle advances distally beyond the shaft and penetrates into the tissue site.

3. The system according to claim 1, wherein the two-phase voltage pulse has an amplitude of at least about 700 volts.

4. The system according to claim 1, further comprising a lead wire, wherein the first electrode includes at least one collar portion fixedly attached to the shaft and attached to the lead wire.

5. The system according to claim 4, wherein the lead wire is an electrically insulated lead wire having an insulating layer, the insulating layer being configured to withstand at least about 300 volts across the thickness of the insulating layer without dielectric breakdown.

6. The system according to claim 1, wherein the needle includes an insulating layer covering substantially a large portion of the outer surface of the needle, and the second electrode is an exposed conductive portion at the distal end of the needle.

7. The system according to claim 6, wherein the insulating layer is configured to withstand at least about 300 volts over the thickness of the insulating layer without dielectric breakdown.

8. The system according to claim 1, further comprising a fluid delivery lumen configured to deliver fluid near the tissue zone during or after electroporation of the tissue zone.

9. The system according to claim 1, wherein the shaft has an outer diameter between approximately 1 mm and approximately 6 mm.

10. The system according to claim 1, wherein the needle is configured to extend about 60 mm beyond the distal end of the shaft when fully extended.

11. It is a system, A catheter device comprising a shaft and a needle, wherein the shaft defines a lumen configured to slidably receive the needle, the shaft includes a first electrode in its distal portion and has a compressible geometric shape, the needle includes a second electrode at its distal end, and the needle is configured to transition from a first configuration in which the distal end of the needle is within the lumen of the shaft to a second configuration in which the distal end of the needle advances distally beyond the shaft and penetrates into a tissue site, A system comprising: a pulse generator configured to be coupled to the catheter device, wherein the pulse generator is configured to generate and deliver voltage pulses to the catheter device such that electroporation is delivered to the tissue zone of the tissue site by the first electrode and the second electrode.

12. The system according to claim 11, further comprising a handle coupled to the proximal end of a catheter shaft, the handle configured to transition the needle from the first configuration to the second configuration.

13. The system according to claim 11, wherein the voltage pulse has an amplitude of at least about 700 volts.

14. The system according to claim 11, further comprising a lead wire, wherein the first electrode includes at least one collar portion fixedly attached to the shaft and attached to the lead wire.

15. The system according to claim 14, wherein the lead wire is an electrically insulated lead wire having an insulating layer, the insulating layer being configured to withstand at least about 300 volts across the thickness of the insulating layer without dielectric breakdown.

16. The system according to claim 11, wherein the needle includes an insulating layer covering substantially a large portion of the outer surface of the needle, and the second electrode is an exposed conductive portion at the distal end of the needle.

17. The system according to claim 16, wherein the insulating layer is configured to withstand at least about 300 volts over the thickness of the insulating layer without dielectric breakdown.

18. The system according to claim 11, further comprising a fluid delivery lumen configured to deliver fluid near the tissue zone during or after electroporation of the tissue zone.

19. The system according to claim 11, wherein the shaft has an outer diameter between approximately 1 mm and approximately 6 mm.

20. The system according to claim 11, wherein the needle is configured to extend about 60 mm beyond the distal end of the shaft when fully extended.

21. The system according to claim 11, wherein the pulse generator is configured to generate and deliver a biphasic voltage pulse to the catheter device such that the electroporation is delivered by activating the first electrode with a first polarity and activating the second electrode with a second polarity opposite to the first polarity.

22. It is a method, Positioning a catheter device, which includes a shaft and a needle slidably disposed within the lumen of the shaft, near a tissue site, The first electrode, positioned in the distal portion of the shaft, is transitioned from a compression configuration to an expansion configuration. The process involves transitioning the needle from a first configuration in which the distal tip of the needle is within the lumen of the shaft to a second configuration in which the needle advances distally beyond the distal end of the shaft and the distal tip of the needle is inserted into a tissue site, wherein the distal end of the needle includes a second electrode. A method comprising: delivering voltage pulses to the first electrode and the second electrode such that electroporation is delivered to a tissue zone of the tissue site by the first electrode and the second electrode.

Images