Devices and methods for tumor ablation

Abstract

The systems, devices, and methods described herein relate to catheter devices for therapy delivery in tumor therapy applications. In some embodiments, a catheter device includes a shaft defining a lumen and a needle device disposed in the lumen, the needle device having a distal end portion including an exposed electrical conductor, where the distal end portion of the needle device is configured to extend out of the lumen. The needle device may be configured to receive a pulsed voltage waveform and deliver a pulsed electric field via the exposed electrical conductor to ablate surrounding tissue.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 348,215, filed on June 2, 2022, entitled “APPARATUS AND METHODS FOR TUMORABLATION,” the disclosure of which is incorporated by reference in its entirety. Background Art

[0003] The development of tools and methods for the delivery of therapeutics for the treatment of tumors or various forms of cancer in soft tissues continues to be a subject of considerable interest. While in many cases there are various options for tumor treatment, the search continues for the delivery of effective treatments that minimize or eliminate collateral tissue damage and side effects.

[0004] Irreversible electroporation, also known as pulsed field ablation, has been explored before in the context of surgical treatment of tumors. In surgical applications, there is a constant pursuit for the optimal set of tools. In the context of minimally invasive approaches, there is still much work to be done to develop practical and effective minimally invasive tools that simultaneously ensure localized treatment and minimize collateral damage.

[0005] The present disclosure addresses the need for minimally invasive devices for efficiently and effectively delivering pulsed field ablation therapy, particularly for tumor treatment, such as pancreatic cancer or lung tumor treatment. Pulsed field ablation procedures can be performed quickly while minimizing collateral tissue damage common in thermal therapy. At the same time, postoperative healing can be relatively rapid with minimal side effects. Summary of the invention

[0006] The present disclosure discloses tools and devices for minimally invasive access to internal organs for therapy delivery in tumor treatment applications. Specifically, the device of the present disclosure may have one or more lumens for the passage of a needle or tissue puncture device. In some embodiments, the needle may take the form of a wire or a wire-like device. In an embodiment, the distal end of the lumen of the device may have a wedge-shaped portion on one side, which reduces the effective inner diameter of the lumen and limits the direction in which the needle or wire emerges from the lumen of the device. In an embodiment, the shape of the wedge-shaped portion may be curved. When the wire emerges from the lumen in a direction that is generally different from the direction of the long axis of the lumen, the wedge-shaped portion may act as a local support for the wire. In the case of a multi-lumen device with between about 2 and about 8 different lumens, each needle may emerge from its corresponding lumen in a different direction relative to each other and relative to the direction of the long axis of the device.

[0007] In embodiments, the distal end of the shaft of the lumen may be angled away from the long axis of the device on one side to provide an angled exit for the needle. In some embodiments, the angled portion may have straight sides, while in other embodiments it may have curved sides. In embodiments, the device may have multiple such lumens, wherein the distal end of the shaft of each lumen is angled away from the long axis of the device so that each needle may emerge from the corresponding lumen at a different orientation relative to the other needles of the device and relative to the orientation of the long axis of the device.

[0008] In an embodiment, the device can be a catheter device having one or more lumens, the catheter device itself passing through the working channel or instrument channel of the endoscopic device, wherein the endoscopic device is capable of obtaining an image of the catheter device using imaging methods such as optical imaging or ultrasound imaging. Endoscopic imaging methods can be used to guide the placement of the catheter device on the tissue surface, and visualize the passage of the one or more needles when the one or more needles emerge from the catheter device and pierce 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 the needle can be inserted from the catheter device into the duodenal wall to enter the pancreas for subsequent therapy delivery. In an embodiment, the catheter device can be inserted together with the endoscopic device, wherein the endoscopic device is then used to image and guide the placement of the catheter device on the tissue surface and visualize the insertion of the needle. In some embodiments, the catheter device can be deflected so that the orientation of the distal end can be adjusted to achieve appropriate tissue fit.

[0009] In embodiments, a majority of the length of the wire may be insulated with one or more layers of insulating material capable of withstanding a voltage of at least about 500V across its thickness without dielectric breakdown. In embodiments, the insulating material may be in the form of a coating, such as a parylene coating, while in other embodiments, the insulating material may include a polymeric material in tubular form. In embodiments, the distal end of the wire may include a thin, sharp tip to facilitate piercing tissue. In embodiments, a portion of the wire adjacent the distal end may have a slight bend in its free or unstressed state.

[0010] In an embodiment, the distal portion of the wire may be in the shape of a spiral. The spiral or helical portion is attached to the body of the wire in a coaxial manner, i.e., the winding axis of the spiral coincides with the tangent of the wire adjacent to the spiral. In this way, twisting the wire (about its longitudinal axis) as it is advanced produces a screw-like motion of the spiral. When the distal portion of the wire is within the lumen of the device, the spiral is naturally stretched compared to when the wire is in an unstressed state, so that when in the lumen of the device, the helical shape of the wire may have a larger pitch or length between adjacent helical turns than in its free or unstressed state. At the same time, when in the lumen of the device, the winding diameter of the spiral is smaller than in an unstressed state, for example, so as to be accommodated in the lumen of the device.

[0011] In use, the device with the spiral needle is placed in a position close to the surface of the tissue or organ that is expected to be penetrated by the needle. The proximal handle of the device includes a mechanism for screw-type advancement of the wire, for example, so that the user turns a wheel, a knob or other control mechanism to rotate and advance the wire or needle at the same time. In one embodiment, the pitch of the advancement mechanism is consistent with the pitch of the spiral in its unstressed state. The proximal portion of the wire is held in the advancement mechanism in the handle, which acts like a screw with a given pitch. In an embodiment, a single control mechanism can selectively engage any of a plurality of needles via a selection mechanism, such as a slider. In order to advance the wire, the user rotates the knob or other control mechanism, thereby rotating and advancing the wire at the same time. This screw movement naturally advances the wire, and when the wire is exposed from the distal portion of the device, the exposed portion of the needle or wire presents its unstressed spiral shape. This rotation and advancement causes a spiral motion at the distal portion of the needle. On the tissue surface, the spiral motion of the distal portion of the needle is used for puncture, and then the needle is advanced into the tissue; the winding diameter of the spiral portion of the needle inserted into the tissue is now a larger diameter without stress. This allows the inserted helical needle to have a larger effective diameter compared to the coiled or helical diameter within the device shaft. The larger effective diameter helps generate the appropriate electric field for pulsed field ablation delivery.

[0012] In various embodiments, the multiple lumens of the device may carry multiple needles in various combinations of straight or spiral needle threads. In embodiments, the device may have a central lumen surrounded by a set of outer lumens, while in other embodiments, there may be only outer lumens without a central lumen, each of which carries a needle thread in the form of a straight or spiral needle.

[0013] In an embodiment, the catheter device or its main shaft itself can be a needle for percutaneous insertion. In such an embodiment, a large portion of the hollow metal needle shaft can be coated with an insulating layer, such as polyparaxylene, wherein only the distal portion of the needle is electrically exposed. The shaft of the device can contain one or more lumens that also act as an electrical insulator, and an outer needle with a smaller diameter can pass through each such lumen. The smaller needle can also be coated with an insulating layer, such as polyparaxylene, along a large portion of its length. The smaller needle is exposed through an opening adjacent to the distal tip of the main needle shaft in the distal portion of the main needle shaft. The distal needle tip of the main needle shaft is sharpened to a shape that can pierce tissue for insertion. In use, the main needle is placed in an appropriate puncture site for percutaneous insertion, for example, a chest site for treating a lung tumor. Under visual guidance, for example, by means such as computed tomography (CT) imaging, puncture and insertion of the main needle are performed. The main needle is advanced to an area of ​​interest, such as a tumor. Once the main needle enters the tumor, the outer needle is advanced through the opening in the distal shaft of the main needle.

[0014] The main needles and / or subsets of outer needles can then be used for therapy delivery with pulsed field ablation waveforms in a monopolar mode (e.g., all needles have one electrical polarity and a reference patch placed on the subject has the opposite electrical polarity) or a bipolar mode (e.g., two different subsets of needles have opposite electrical polarities).

[0015] The needles or wires in any of the embodiments herein are typically metallic; for example, they may include metal alloys such as nitinol or stainless steel. The needles may be attached or connected to an electrical conductor that is attached to a cable or connector cable for delivering electrical energy from an appropriate generator that can deliver a high voltage pulsed field ablation waveform. Typically, this energy delivery is performed in a monopolar mode or a bipolar mode. In a monopolar mode, a subset of needles has one electrical polarity, while a reference patch placed on the subject has the opposite electrical polarity. In a bipolar mode, two different subsets of needles are energized with opposite electrical polarities. In an embodiment, multiple paired subsets of needles may be energized in a sequential manner to deliver energy. The pulsed field ablation waveform may be monophasic in structure (e.g., each pulse delivered to the electrode pair has the same polarity), or biphasic (e.g., consecutive pulses delivered to the electrode pair have opposite polarities). When the pulsed field ablation waveform is applied, the spatial distribution of the generated electric field determines the area of ​​cell death. Depending on the value of the irreversible electroporation field strength threshold for a given target cell type, cells in spatial regions where the electric field magnitude is greater than the threshold are killed or ablated, while cells in other spatial regions where the electric field magnitude is less than the threshold survive.

[0016] In some embodiments, the catheter device of the present disclosure can have an outer diameter within the approximate range of about 0.5 mm to about 5 mm, including all values ​​and sub-ranges therebetween. In some embodiments, according to an embodiment, the diameter of the needle or wire can have a diameter within the approximate range of about 0.15 mm to about 1.6 mm, including all values ​​and sub-ranges therebetween. In the case of a spiral needle, the pitch of the spiral can be within the approximate range of about 0.1 mm to about 4 mm, including all values ​​and sub-ranges therebetween, and the diameter of the spiral (measured on the winding diameter of the centerline) can be within the approximate range of about 0.3 mm to about 4 mm, including all values ​​and sub-ranges therebetween.

[0017] In some embodiments, a device includes: an axis defining a lumen; and a needle device arranged in the lumen, the needle device having a distal portion including an exposed electrical conductor, the distal portion of the needle device being configured to extend out of the lumen at a non-zero angle relative to the longitudinal axis of the axis, the needle device being configured to receive a pulsed voltage waveform and deliver a pulsed electric field via the exposed electrical conductor to ablate surrounding tissue.

[0018] In some embodiments, a device includes: an axis defining a set of one or more lumens; and a first needle device and a second needle device arranged in the set of lumens, each of the first needle device and the second needle device having a distal portion including an exposed electrical conductor, the distal portions of the first needle device and the second needle device being configured to extend out of the set of lumens at a non-zero angle relative to the longitudinal axis of the axis, the first needle device and the second needle device being configured to receive a pulsed voltage waveform and jointly deliver a pulsed electric field via their respective exposed electrical conductors to ablate surrounding tissue.

[0019] In some embodiments, a device includes: an axis defining a lumen; and a needle device disposed in the lumen, the needle device having a distal portion including an exposed electrical conductor, the distal portion of the needle device having a spiral geometry, the needle device being configured to receive a pulsed voltage waveform and deliver a pulsed electric field via the exposed electrical conductor to ablate surrounding tissue.

[0020] In some embodiments, a device includes: an axis defining a lumen; and a needle device arranged in the lumen, the needle device having a distal portion and a proximal portion, the distal portion including an exposed electrical conductor, the proximal portion being electrically insulated with an insulating material, the insulating material being configured to withstand a voltage of at least about 500 volts without dielectric breakdown, the distal portion of the needle device having a substantially straight geometry, the needle device being configured to receive a pulsed voltage waveform and deliver a pulsed electric field via the exposed electrical conductor to ablate surrounding tissue.

[0021] In some embodiments, a device includes: an axis defining a lumen; a needle device arranged in the lumen, the needle device having a distal portion and a proximal portion, the distal portion including an exposed electrical conductor, the proximal portion being electrically insulated with an insulating material, the insulating material being configured to withstand at least about 500 volts without dielectric breakdown, the distal portion of the needle device having a spiral geometry and being configured to extend outside the lumen, the diameter of the spiral geometry being larger 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 via the exposed electrical conductor to ablate surrounding tissue; and a proximal actuation assembly attached to the axis and the proximal portion of the needle device, the proximal actuation assembly being configured to control relative movement of the needle device relative to a catheter device.

[0022] In some embodiments, a method includes: extending a distal portion of a needle device outside a lumen of a shaft of a catheter device located in an anatomical region of interest, the distal portion of the needle device comprising an exposed electrical conductor; piercing 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 place the distal tip of the needle device at a target location; and applying a voltage pulse to the needle device to deliver pulsed field ablation therapy.

[0023] In some embodiments, a method includes: extending distal portions of a first needle device and a second needle device outside one or more lumens of a shaft of a catheter device located in an anatomical region of interest, the distal portions of the first needle device and the second needle device including exposed electrical conductors; piercing tissue of interest in response to extending the distal portions of the first needle device and the second needle device outside the one or more lumens; moving the distal portions of the first needle device and the second needle device within the tissue of interest to place the distal tips of the first needle device and the second needle device at a target location; and applying voltage pulses to the first needle device and the second needle device to deliver pulsed field ablation therapy. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is a schematic diagram of an endoscope being passed through a subject's stomach and placed in the duodenum.

[0025] Figure 2 An illustration of the abdominal anatomy is provided.

[0026] Figure 3 is a schematic diagram of a single lumen catheter or needle device having a wedge-shaped distal lumen and a needle according to an embodiment.

[0027] Figure 4 is a schematic diagram of a double lumen catheter or needle device having two needles according to an embodiment.

[0028] Figure 5 is a schematic diagram of a single lumen catheter or needle device having an angled nozzle-like distal portion and a needle according to an embodiment.

[0029] Figure 6 A dual lumen catheter device is illustrated with each lumen having an angled nozzle-like distal portion, each lumen having a needle, according to an embodiment.

[0030] Fig. 7A is a schematic diagram of a distal portion of an endoscope having multiple lumens, one of the lumens being used for passage of a catheter device of the present invention, according to an embodiment.

[0031] Figure 7B is an illustration of a catheter device having an outer shaft and two inner lumens, each lumen carrying a needle, according to an embodiment.

[0032] Figure 8 is an illustration of a catheter device having three lumens, each with a needle, according to an embodiment.

[0033] Fig. 9 is an illustration of a catheter device with a needle placed in an organ within a subject, wherein irreversible ablation is delivered in a monopolar mode using a reference patch, according to an embodiment.

[0034] Fig.10 Schematic diagram illustrating a needle thread having a helical distal portion according to an embodiment.

[0035] Fig.11 Schematic diagram illustrates a needle thread having a helical distal portion, wherein the axis of the needle thread is slightly curved adjacent the helical portion, according to an embodiment.

[0036] Fig.12 Schematic diagram illustrates a catheter device having a lumen with an inner wedge-shaped distal lumen and a needle wire with a helical distal portion, wherein the helix emerges just out of the distal end of the catheter device, in accordance with an embodiment.

[0037] Fig.13 A schematic diagram illustrates a catheter device according to an embodiment having a lumen with an internal wedge-shaped distal lumen and a needle wire with a helical distal portion, wherein the helix emerges from the distal end of the device and wherein the portion of the helix outside the catheter shaft presents its unstressed geometry with a larger helix diameter and a smaller pitch.

[0038] Fig.14 Schematic diagram illustrates a catheter device according to an embodiment, which has a lumen with an inner wedge-shaped distal lumen and a needle wire with a helical distal portion, wherein the helix is ​​fully expanded outside the distal end of the device, and wherein the helix presents its unstressed geometry with a larger helix diameter and a smaller pitch.

[0039] Fig.15A , Fig. 15B and Fig. 15C A schematic diagram of a catheter device located near a tissue surface according to an embodiment is provided, wherein a helix is ​​sequentially deployed to penetrate the tissue surface and enter a desired organ anatomy, wherein the helix is ​​fully deployed in the organ below the tissue surface.

[0040] Fig.16 is a schematic diagram of a catheter device located near a tissue surface according to an embodiment, the catheter device having two lumens at a distal end and angled away from a long axis of the catheter, each lumen having a spiral needle wire, wherein both spiral wires are deployed into the tissue surface.

[0041] Fig.17 is a schematic diagram of a catheter device having two lumens, wherein the two lumens are curved away from the long axis of the catheter at the distal end portion thereof, each lumen having a spiral needle line, according to an embodiment.

[0042] Fig.18 is a schematic diagram of a catheter device having a central lumen and two outer lumens, wherein the two outer lumens diverge at a distal end thereof away from the long axis of the catheter at a certain angle, wherein the central lumen carries a spiral needle line and the two outer lumens respectively carry needles according to an embodiment.

[0043] Fig.19 is a schematic diagram of a catheter device having a central lumen and two outer lumens according to an embodiment, wherein the two outer lumens are divided at their distal ends at a certain angle away from the long axis of the catheter, wherein the central lumen has a spiral needle line, and the two outer lumens respectively have needles, and wherein the distal end of each outer lumen is located at a proximal position relative to the distal end of the central lumen.

[0044] Fig. 20A is a schematic diagram of a percutaneous needle device according to an embodiment showing a needle shaft terminating in a distal tip shaped for piercing a tissue surface, the needle shaft having two lumens, each lumen carrying a spiral needle wire.

[0045] Fig. 20B yes Fig. 20A A three-dimensional rendering of the distal portion of the needle shaft of the device shown in FIG.

[0046] Fig.21 is a schematic diagram of a percutaneous needle device according to an embodiment showing a needle shaft terminating in a distal tip shaped for piercing a tissue surface, the needle shaft having two lumens, each with a helical needle wire, wherein the needle shaft and helical wire are fully inserted and engage tissue.

[0047] Fig.22A is a schematic diagram of a catheter device positioned near a tissue interface according to an embodiment, showing a catheter shaft having a lumen with a helical needle thread, wherein the helical needle thread emerges from a distal end of the catheter shaft adjacent to the tissue interface, and wherein the catheter shaft has a compressible electrode mounted adjacent to the distal end of the catheter shaft.

[0048] Fig. 22B is a schematic diagram of a catheter device positioned proximate a tissue interface according to an embodiment, showing a catheter shaft having a lumen with a helical needle thread, wherein the helical needle thread emerges from a distal end of the catheter shaft and penetrates the tissue interface, and wherein the catheter shaft has a compressible electrode mounted adjacent the distal end of the catheter shaft.

[0049] Fig.23is a schematic diagram of a catheter device according to an embodiment showing a catheter shaft having a lumen with a helical needle wire, wherein the helical needle wire protrudes from a distal end of the catheter shaft, and wherein the catheter shaft has a ring electrode mounted adjacent the distal end of the catheter shaft.

[0050] Fig.24 is a schematic diagram of a catheter device according to an embodiment showing a catheter shaft having a lumen with a helical needle wire, wherein the helical needle wire protrudes from a distal end of the catheter shaft, and wherein the catheter shaft has two ring electrodes mounted adjacent the distal end of the catheter shaft.

[0051] Fig.25 is a schematic diagram of a catheter device according to an embodiment showing a catheter shaft having a lumen with a needle device, wherein the needle device protrudes from a distal end of the catheter shaft, and wherein the catheter shaft has a compressible electrode mounted adjacent the distal end of the catheter shaft.

[0052] Fig.26 is a schematic diagram of a catheter device according to an embodiment showing a catheter shaft having a lumen with a needle device, wherein the needle device protrudes from a distal end of the catheter shaft, and wherein the catheter shaft has two ring electrodes mounted adjacent the distal end of the catheter shaft.

[0053] Fig. 27 is a schematic diagram of a clasping device for clasping both the catheter and needle devices of the present disclosure to provide a means for controlled movement of the needle device relative to the catheter device, according to an embodiment.

[0054] Fig.28 is a schematic diagram of a process for making overlapping or contiguous ablation lesions using a catheter device of the present disclosure after creating a first ablation zone, by repositioning the catheter device prior to piercing tissue with a needle thread to allow creation of a second ablation zone that overlaps or is adjacent to the first ablation zone, in accordance with an embodiment. DETAILED DESCRIPTION

[0055] Device embodiments of the present disclosure generally provide a means of deploying the device within a soft tissue structure such as a tumor to deliver irreversible electroporation therapy. In some embodiments, the devices are intended for minimally invasive use (e.g., with or alongside an endoscope) and may be flexible or deflectable devices, while in other embodiments, they may be relatively rigid devices for percutaneous use.

[0056] For the treatment of pancreatic tumors, an endoscope can be used to enter the stomach or duodenum, and then appropriate punctures can be used to enter adjacent organs, such as the pancreas. Figure 1 Endoscope 117 is shown inserted through the subject's mouth and down esophagus 121, positioned at duodenum 123 after passing through stomach 125. This type of positioning may place the endoscope near the pancreas. Figure 2 The diagram illustrates the pancreas 208 relative to the stomach 202 and duodenum 205 within the abdominal anatomy.

[0057] Figure 3 302 or needle device with a wedge-shaped distal lumen and a needle. The distal end of the lumen has a wedge-shaped or wedge-like internal structure 308 that narrows the distal lumen, forcing the needle wire 304 to extend from the distal opening 310 at an angle away from the long axis 313 of the catheter as it is pushed out. In an embodiment, the tip 306 of the wire 304 is shaped as a thin, sharp tip for tissue puncture.

[0058] In embodiments, the catheter apparatus of the present disclosure may have multiple lumens. Figure 4 The diagram illustrates a catheter device having two lumens 401 and 403 with needles 405 and 407, respectively, according to an embodiment. In an embodiment, the lumen walls may be thicker in the portion 411 where they abut each other. Lumens 401 and 403 have wedge-shaped distal portions 412 and 414, respectively, which narrow the respective distal lumens so that needles 405 and 407 emerge distally at an angle away from the long axis 415 of the device and also at an angle relative to each other.

[0059] In embodiments, the lumen of the catheter device may have a distal portion that is angled away from a long axis of the catheter device on at least one side. Figure 5 is a schematic diagram of a single lumen catheter or device 503 having an angled nozzle-like distal portion 505 on one side of the shaft with a needle wire 509 extending from a distal end 515 of the device having a needle tip 511 that is shaped to be sharp for tissue puncture in accordance with an embodiment.

[0060] In embodiments, a catheter device may have two or more lumens with a distal portion on at least one side angled away from a long axis of the catheter device. Figure 6 The diagram illustrates a dual lumen catheter device according to an embodiment, wherein each lumen 602 and 604 has a corresponding angled nozzle-shaped distal portion 612 and 614, each corresponding lumen having a needle 606 and 608. Figure 6 As shown in FIG. 6 , the distal ends 616 and 618 of the respective needles 606 and 608 are angled away from the major axis 630 of the device and are also angled away from each other.

[0061] In embodiments, the catheter device of the present disclosure can itself be passed through the channel of an endoscope. For purposes of illustration and example, Fig. 7AThe distal end portion of an endoscope 701 is shown with multiple lumens 703, 705, and 707. Lumens 703 and / or 705 may be used for passage of optical imaging fibers or cameras or ultrasound imaging catheters. Lumen or channel 707 is shown for passage of a catheter device 709 of the present disclosure. The catheter device 709 itself has two lumens with needles 711 and 713. Figure 7B The distal portion of the catheter device 709 is depicted, wherein the lumens 753 and 755 carry needle lines 711 and 713, respectively. In use, the endoscope 701 is passed through the oral cavity and esophagus to the stomach and / or duodenum and placed adjacent to or near the tissue wall, such as near the pancreas. The catheter 709 is extended under image guidance using optical or ultrasound imaging performed with an appropriate imaging device used with the endoscope and placed in an appropriate position to access a suitable pancreatic site. Needles 711 and 713 extend from the catheter device 709 for piercing the stomach wall and entering the pancreas to access the target tumor site. Once the needle is properly placed in the pancreas, pulsed field ablation is delivered through the needle from a generator connected to the catheter.

[0062] In embodiments, a catheter device may have more than two lumens. Figure 8 is an illustration of a catheter device having three lumens 801, 803, and 805 with needles 811, 813, and 815, respectively, in accordance with an embodiment. It will be appreciated based on this disclosure that devices having other varieties of needles may also be constructed to facilitate a given application.

[0063] The devices disclosed herein are generally positioned so that a given target anatomical structure can be directly accessed from that location initially at the tissue surface, and then the needle is extended to penetrate the tissue surface and enter the organ or anatomical structure where therapy delivery is desired. Fig. 9 906 is a diagram of a catheter device 906 according to an embodiment, which is placed near an anatomical organ 904 in a subject's body 902 (shown in cross section in the figure). Needles 910 and 912 extend from the device lumen to penetrate and enter the organ 904. In one embodiment, the needle can be used as a single joint electrode (i.e., polarized with one electrical polarity) and electrically paired with a reference electrode patch 915 (polarized with the opposite electrical polarity) to deliver pulsed field ablation in a unipolar (also known as monopolar) mode. In other embodiments, needles 910 and 912 can be used as a bipolar electrode pair for bipolar pulsed field ablation delivery. Applying a pulsed field ablation waveform to the electrodes results in the generation of an electric field, and depending on the irreversible electroporation threshold of the tissue, a lesion zone such as an area with a boundary 922 is generated due to ablation. If a larger treatment volume or area is required, needles 910 and 912 can be retracted, the catheter moved and positioned at a different location, needles 910 and 912 inserted into the new location, and therapy delivered at the new location.

[0064] 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 embodiments, 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 convenience and / or suitability for a given application.

[0065] In embodiments, the catheter apparatus of the present disclosure may have a needle wire having a distal portion that is coiled into a helix. Fig.10 Schematic diagram illustrates a needle thread 1002 with a spiral distal portion 1004 according to an embodiment. The spiral portion 1004 is characterized by a pitch 1008 and a winding diameter 1010, and the spiral is arranged so that the axis of the spiral coincides with the tangent of the line at the attachment point 1014 of the spiral. In this way, the twist of the line is directly converted into a rotation of the spiral. In some embodiments, the pitch of the spiral can be in the approximate range of between about 0.1 mm and about 4 mm, including all values ​​and sub-ranges therebetween, and the diameter of the spiral (measured on the winding 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.

[0066] In embodiments, the wire may have a slight bend in the portion adjacent to the distal helix. Fig.11 Schematic diagram illustrates a needle thread 1101 with a spiral distal portion 1107 in accordance with an embodiment, wherein the axis of the thread is slightly bent over a length L1 at an approximate location 1103 adjacent to the spiral portion and is separated from the spiral by a length 1105 (also represented by L2 in the figure). The spiral is arranged so that the axis of the spiral coincides with the tangent of the thread at the attachment point 1112 of the spiral. In this way, the twisting of the thread is directly converted into a rotation of the spiral. In some embodiments, the length L1 of the bend can be approximately between about 3 mm and about 100 mm, including all values ​​and subranges therebetween, and the length L2 can be approximately between about 5 mm and about 100 mm, including all values ​​and subranges therebetween.

[0067] like Fig.12 As shown in the diagram, in some embodiments, a catheter device 1202 can have a lumen with an inner wedge-shaped distal lumen 1210 and a needle 1204 with a helical distal portion 1206, wherein the helix is ​​shown just emerging from the distal end of the device. Within the lumen, the helix is ​​stretched, with a pitch 1214 that is larger than in an unstressed state, and a helix diameter 1216 that is smaller than in an unstressed state.

[0068] Fig.13Schematic diagram illustrating a catheter device 1301 similar in structure and / or function to 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, wherein the helix protrudes from the distal end of the device to a greater extent than Fig.12 As shown in Fig.13 As shown in FIG. 1 , as more of the helix emerges or extends from the distal end of the catheter device 1301, the portion 1307 of the helix outside the catheter shaft assumes its unstressed geometry, which is consistent with the stressed (stretched) state within the lumen (e.g., as shown in FIG. 1 ). Fig.12 Compared to the above, it has a larger spiral diameter 1316 (e.g., a spiral diameter larger than 1216) and a smaller pitch 1314 (e.g., a pitch smaller than 1214).

[0069] Fig.14 The schematic diagram illustrates a catheter device 1401 that is similar in structure and / or function to catheter device 1202, having a lumen with an internal wedge-shaped distal lumen and a needle thread 1403 with a helical distal portion 1405, wherein the helix 1405 is fully expanded outside the distal end of the device, wherein the helix assumes its unstressed geometry, has a larger helix diameter 1416 (e.g., a helix diameter greater than 1216), and a smaller pitch 1414 (e.g., a pitch less than 1214), compared to the stressed (stretched) state of the helix within the lumen.

[0070] Fig.15A , 15B 15C provides a schematic diagram of a catheter device 1520 positioned near a tissue surface 1521, wherein the helical wires are sequentially deployed (1501, 1504, 1507) to penetrate the tissue surface and enter the desired organ anatomy, wherein the helical portion is fully deployed in the organ below the tissue surface, as shown in FIG. Fig. 15C In the case of a right-handed helix (such as Fig.15A , Fig. 15B and Fig. 15C ), the clockwise rotation 1511 of the wire as viewed from the top is used together with the forward motion to advance the spiral needle like a corkscrew and firmly anchor it in the tissue. In practice, the spiral needle is initially partially deployed in a cavity such as the stomach or other tubular anatomical structure, with enough space to allow the distal portion of the spiral to expand when it emerges from the lumen. Subsequently, the spiral needle is advanced and screwed into the tissue, where it assumes its unstressed state with a larger spiral diameter.

[0071] In embodiments, a catheter device may have two or more lumens, each lumen carrying a wire having a helical needle distal portion. Fig.16A catheter device according to an embodiment is depicted having two lumens 1604 and 1606, each angled away from the long axis of the catheter at a distal end, wherein the catheter is positioned at a tissue surface 1602 where penetration is desired. Lumens 1604 and 1606 carry helical needle wires 1612 and 1614, respectively, wherein both helical wires are deployed into the tissue surface 1602. Once properly deployed in an area of ​​interest (e.g., a tumor), irreversible electroporation can be delivered to the needle in a bipolar configuration (with oppositely polarized needles) or a monopolar configuration (with a reference electrode patch as an oppositely polarized electrode).

[0072] In variant embodiments, the catheter device may have more than two lumens, with a variety of spiral needles or a combination of different numbers of straight needles and spiral needles. In other embodiments, the catheter device may have multiple lumens with curved distal end portions.

[0073] Fig.17 A schematic diagram of a catheter device according to an embodiment is shown, wherein the two lumens are curved away from the catheter major axis at their distal end portions over a length 1706, each lumen 1702 and 1704 with a corresponding spiral needle line 1708 and 1710. In an embodiment, the length 1706 can be in the approximate range of about 3 mm to about 60 mm, including all values ​​and subranges therebetween. When fully deployed, the angle between the corresponding spiral axes of the spirals of the needles 1708 and 1710 can be in the approximate range of about 10 degrees to about 75 degrees, including all values ​​and subranges therebetween.

[0074] In an embodiment, the catheter device may have a central lumen surrounded by an outer lumen, wherein the central lumen and the outer lumen carry a straight needle or a spiral needle. Fig.18 The diagram illustrates a catheter device having a central lumen 1805 and two outer lumens 1801 and 1803, wherein the two outer lumens 1801 and 1803 are divided at their distal ends at a certain angle away from the long axis of the catheter, and wherein the central lumen 1805 has a spiral needle line 1813, and the two outer lumens 1801 and 1803 have straight needles 1807 and 1809, respectively.

[0075] As another example of a variant embodiment, Fig.19The diagram illustrates a catheter device having a central lumen 1905 and two outer lumens 1901 and 1903, wherein the two outer lumens 1901 and 1903 diverge at their distal ends at an angle away from the long axis of the catheter, and wherein the central lumen 1905 carries a spiral needle line 1911, and the two outer lumens 1901 and 1903 carry respective needles 1907 and 1909, and wherein the distal end of each outer lumen 1901, 1903 is located at a proximal position spaced apart by a length 1913 relative to the distal end of the central lumen 1905. In embodiments, in practice, the separation length between the central lumen and the outer lumens can be in the range of about 3 mm to about 60 mm, including all values ​​and subranges therebetween, depending on convenience and / or suitability for the application of interest.

[0076] Any of the above embodiments may be in the form of a deflectable catheter, the deflection of the catheter being controlled by mechanisms familiar to those skilled in the art of interventional catheters, such as the use of a pull wire and a control mechanism from within the handle.

[0077] In other embodiments, the catheter device of the present invention may be a percutaneous rigid or semi-rigid needle for piercing tissue and accessing a target site or region to which therapy is to be delivered in minimally invasive surgery performed under image guidance (e.g., by CT imaging). Fig. 20A 2 is a schematic diagram 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 for piercing a tissue surface. The needle shaft has two lumens 2003 and 2005, wherein the lumens carry spiral needle threads 2009 and 2011, respectively. Lumens 2003 and 2005 exit the side of needle shaft 2001 at respective openings 2015 and 2017, from which the spiral needle can be deployed.

[0078] Fig. 20B yes Fig. 20A 3D rendering of the distal end portion of the needle shaft of the device shown in , showing the distal needle portion 2030 and the curved sharp edges 2021 and 2023 defining planes 2032 and 2034. In use, the helices are initially located in their respective lumens. The needle shaft 2001 is used to pierce tissue and is advanced to the area of ​​interest under appropriate image guidance (e.g., by CT imaging). Once the desired site is reached, the spiral needles 2009 and 2011 are advanced.

[0079] Fig.212 is a schematic diagram of a percutaneous needle device according to an embodiment, showing a needle shaft 2100 terminating in a distal tip 2108 shaped to pierce a tissue surface 2112, the needle shaft having two lumens, each of which carries a spiral needle thread 2102 and 2104, wherein the needle shaft and spiral threads 2102 and 2104 are fully inserted into and engage tissue. In such an application, when the distal tip 2108 of the needle shaft 2100 is disposed below the tissue surface 2112, there may not be much difference in geometry between the undeployed (e.g., stretched) state and the deployed (e.g., unstressed) state of the spiral needle, because any expansion / relaxation of the spiral is limited by the tissue. In an embodiment of this use case, the spiral diameter can closely or approximately match the inner diameter of the catheter lumen, or it can be slightly smaller than the inner diameter of the catheter lumen.

[0080] Fig.22A 2 is a schematic diagram of a catheter device 2200 having a catheter shaft 2220 and having a lumen with a spiral needle device or line 2206 according to an embodiment. The catheter device 2200 may have a compressible electrode 2202 mounted adjacent to the distal end of the catheter shaft 2220. In an embodiment, the compressible electrode 2202 may have a collar portion 2204 to facilitate mounting the electrode on the shaft. The collar portion 2204 may be crimped or swaged onto the catheter shaft 2220 in a manner familiar to those skilled in the art. In an embodiment, the compressible electrode 2202 may include a cage-like structure made of a highly elastic conductive material such as nitinol. In the figure, the catheter device 2200 is shown with its distal end located proximal and / or near a tissue interface 2208, wherein the tissue 2210 on the distal side of the interface may be a part of a different anatomical organ. In some clinical applications, the proximal side of the tissue interface may include the interior space of an anatomical passage, for example, a portion of the digestive tract or a portion of the airway or trachea of ​​a lung. As described above, the spiral needle device 2206 is configured such that in its unstressed state, the spiral portion of the spiral needle device 2206 has a spiral diameter that is larger than the inner diameter of the catheter device 2200. When the spiral portion is located inside the catheter shaft 2220, it is stressed or constrained by the catheter shaft 2220, thereby having a spiral diameter that is smaller than the spiral diameter in its unstressed state. Therefore, when the spiral needle device 2206 emerges from the shaft 2220 adjacent to the tissue interface 2208, the diameter of the spiral portion expands. In an embodiment, the distal tip of the spiral needle 2206 is appropriately sharpened to facilitate penetration and advancement into tissue.

[0081] In use, once the tissue interface is engaged (e.g., under ultrasound visualization), the needle device 2206 is simultaneously rotated and advanced such that the needle device 2206 is helically advanced into the tissue. One embodiment of a device for rotating and advancing the needle device 2206 is Fig. 27 and discussed further below. Fig. 22BThe helical needle device is shown fully released or deployed outside of the catheter shaft 2220, such that the helical needle device 2206 is advanced helically into the tissue after penetrating the tissue interface 2208. The figure shows a catheter device 2200 with a shaft electrode 2202, wherein the helical needle 2206 is located in the tissue anatomy distal to the tissue interface 2208. In use, the distal end of the catheter device 2200 is located in the internal anatomical space as previously described, and when the helical needle device 2206 is deployed in the internal space, it expands to its unstressed size when it leaves the catheter shaft 2220. Therefore, the pitch 2225 of the helical portion of the needle device 2206 distal to the distal interface corresponds to the pitch of the needle device 2206 in the unstressed or reference state. In an embodiment, the diameter of the spiral of the spiral needle device 2206 in its unstressed state can be in the range of about 0.5 mm to about 10 mm, including all ranges and values ​​therebetween, and the pitch of the spiral needle device 2206 in its unstressed state can be in the range of about 0.3 mm to about 6 mm, including all ranges and values ​​therebetween. In an embodiment, the length of the spiral in the unstressed state (measured along the central axis of the spiral) can be in the range of about 3 mm to about 50 mm, including all ranges and values ​​therebetween, and any portion of the spiral length can penetrate tissue or organs to deliver ablative therapy.

[0082] Once the needle device 2206 is properly positioned in the tissue of interest for ablation, 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 therapy is delivered in the form of a high voltage pulse applied between the spiral needle device 2206 and the shaft electrode 2202, wherein the two electrodes are electrically configured to have opposite electrical polarities. In an embodiment, the spiral needle device 2206 may include a conductive superelastic material, such as nitinol. Although the spiral portion of the needle device 2206 is conductive, the length of the adjacent spiral portion of the needle device 2206 may be electrically insulated. The shaft electrode 2202 is connected to an insulated lead for conductivity. In an embodiment, ablation therapy delivery may include a high voltage pulse having a voltage difference of at least about 300 volts and up to about 10,000 volts between oppositely polarized electrodes, including all ranges and values ​​therebetween. The potential difference applied between the electrodes causes an electric field to be generated in the tissue. Depending on the applied voltage waveform and tissue type, any tissue subjected to an electric field greater than a threshold value will be killed or ablated by an irreversible electroporation mechanism.

[0083] Fig. 27The diagram illustrates a small part or tool (e.g., a proximal actuation assembly) for the rotation and advancement of a spiral needle thread 2711 (e.g., any spiral needle thread or device described herein) according to an embodiment. The tool can rotate and advance the spiral needle thread so that the spiral distal portion of the needle thread spirally advances into the tissue of interest in a screw-like manner. In an embodiment, a catheter device (e.g., any catheter or catheter device described herein) including a spiral needle thread can be directly positioned in an anatomical region. Alternatively, in other embodiments, the catheter device can pass through a working channel of a main device such as an endoscope or bronchoscope (not shown in the figure) and then be placed in an anatomical region. In an embodiment, the catheter device can be placed under visual guidance (e.g., via optical or ultrasonic imaging) by an endoscope. Once the catheter device is appropriately positioned in the anatomical structure, a first proximal screw 2715 can be inserted on the proximal end of a catheter device 2707 accessible to a user, for example, directly outside the subject's anatomical structure or outside a main device such as an endoscope. The screw 2715 has a longitudinally split screw portion 2719 configured to fit tightly on the catheter 2707 of the catheter device so that it tightly clamps the catheter 2707 when it is screwed into the threaded cavity 2702 of the hub 2700 of the catheter device 2707. The needle thread 2711 extends from the proximal end of the catheter 2707 through the hub 2700. The second proximal screw 2722 can be inserted on the proximal end of the needle thread 2711 together with the hub screw 2728. The screw 2722 has a longitudinally split screw portion 2724 configured to fit tightly on the needle thread 2711 so that it tightly clamps the needle thread 2711 when it is screwed into the threaded cavity 2735 of the hub screw 2728. In this way, the first proximal screw 2715 is effectively fixed to or coupled to the catheter 2707, while the second proximal screw 2722 is effectively fixed to or coupled to the needle thread 2711. When the hub 2700 is held in place, the hub screw 2728 can be screwed into the threaded cavity 2704 in the hub 2700, thereby holding the catheter 2707 in place. Specifically, in use, the distal end of the needle thread is located at the tissue interface, and once ready to be advanced into the tissue, the hub screw 2728 is screwed into the threaded cavity 2704 while the hub 2700 is held in place. In some embodiments, the pitch 2740 of the helical screw 2732 is the same as the pitch 2225 of the needle thread 2711 in its unstressed or reference state (as described above with reference to Fig. 22B2704). Thus, rotating the hub screw 2728 one turn into the threaded cavity 2704 will advance the distal end of the spiral needle wire 2711 into the tissue by one spiral rotation. In this way, the needle wire 2711 can be spirally advanced into the tissue until its distal tip is at a desired or predefined depth in the tissue, such as can be confirmed from an ultrasound image. After being placed at an appropriate target location, high voltage pulsed field ablation therapy (e.g., as previously described) can be delivered by applying high voltage pulses to the needle wire 2711 and to an (electrically paired) shaft electrode (e.g., any shaft electrode described herein). In an alternative embodiment, a reference patch can be electrically paired with the needle wire 2711 for ablation delivery in a monopolar mode. In an embodiment, multiple ablations can be delivered at a given target location. Subsequently, the spiral needle wire 2711 can be retracted by loosening the hub screw 2728, whereupon the spiral needle wire 2711 retracts its path in the tissue and withdraws from the tissue and tissue interface. Optionally, the catheter and / or a host device such as an endoscope or bronchoscope is manipulated to reposition the distal end of the catheter 2707 to access a new target location in the tissue, and the process can be repeated as needed.

[0084] Fig.23 23 is a schematic diagram of a catheter device 2300 according to an embodiment, showing a catheter shaft 2303 having a lumen with a spiral needle or wire 2307. The spiral needle 2307 is shown protruding from the distal end of the catheter shaft 2303. According to an embodiment, the catheter shaft can have a ring electrode 2305 mounted adjacent the distal end of the catheter shaft 2305. The spiral needle 2307 and the shaft electrode 2305 can be electrically paired with opposite electrical polarities and configured as a bipolar electrode pair for pulsed field ablation delivery. The spiral needle 2307 can be inserted into tissue by spiral advancement using a suitable tool at the proximal end of the catheter device 2300, for example, as described with respect to Fig. 27 described.

[0085] Fig.24 is a schematic diagram of a catheter device 2400 according to an embodiment, showing a catheter shaft 2403 having a lumen with a spiral needle or wire 2410. The spiral needle 2410 is shown as protruding from the distal end of the catheter shaft 2403. According to an embodiment, the catheter shaft 2403 can have two ring electrodes 2405 and 2407 mounted adjacent the distal end of the catheter shaft. The spiral needle 2410 and the shaft electrodes 2405 and 2407 can be electrically paired with opposite electrical polarities and configured as a bipolar electrode pair for pulsed field ablation delivery. For example, the spiral needle 2410 can have one electrical polarity, while both electrodes 2405 and 2407 can have opposite electrical polarities. The spiral needle 2410 can be inserted into tissue by spiral advancement using a suitable tool at the proximal end of the catheter device 2400, for example, as described with respect to Fig. 27 described.

[0086] Fig.25 2 is a schematic diagram of a catheter device 2500 according to an embodiment, showing a catheter shaft 2502 having a lumen with a needle device 2506. The needle device 2506 is shown as protruding from the distal end of the catheter shaft 2502. According to an embodiment, the catheter shaft 2502 has a compressible electrode 2504 mounted adjacent 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 to be placed at a target site for delivery of ablative therapy. Once 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 can have an exposed conductive surface or portion disposed outside the distal end of the catheter shaft 2502, with a length ranging from 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. Proximal to the distal exposed conductive portion, the needle device 2506 can be electrically insulated.

[0087] Fig.26 26 is a schematic diagram of a catheter device 2600 according to an embodiment, showing a catheter shaft 2603 having a lumen with a needle device 2608. The needle device 2608 is shown as protruding from the distal end of the catheter shaft. According to an embodiment, the catheter shaft 2603 has ring electrodes 2605 and 2607 mounted adjacent to the distal end of the catheter shaft 2603. The needle device 2608 can be a straight needle configured to penetrate a tissue interface and extend into an anatomical organ to be placed at a target site for delivery of ablative therapy. Once placed at the target site, 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.

[0088] In embodiments, the annular electrodes on the catheter shaft of the present disclosure may have an outer diameter in the range of about 0.5 mm to about 6 mm, including all ranges and values ​​therebetween. In embodiments, the compressible electrodes of the present disclosure, such as Fig.22A The electrodes 2202 and Fig.25The electrode 2504 in the embodiment may have an expanded or unstressed diameter in the range of about 0.6 mm to about 10 mm, including all ranges and values ​​therebetween. When the compressible electrode is arranged in a lumen or channel of another device (e.g., an endoscope) having a smaller diameter, the compressible electrode may be compressed or restricted to the smaller diameter of the other device, and when the electrode is exposed from the lumen or channel of the smaller diameter in the other device, the electrode may expand to its unstressed state diameter. The shaft electrode of the present disclosure is electrically connected to an insulated lead. In an embodiment, the lead and needle device of the shaft electrode may have sufficient insulation to withstand a voltage difference of at least about 500 volts between them without dielectric breakdown. In alternative embodiments, the insulation of the lead and needle devices may withstand 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 10,000 volts between each other without dielectric breakdown.

[0089] Fig.28 28 is a schematic diagram of a process for creating overlapping or consecutive ablation lesions using the device 2801 of the present disclosure, according to an embodiment. The device 2801 can be used to create a first ablation zone 2805. After creating the first ablation zone 2805, the device 2801 can be repositioned before penetrating tissue with a needle device or wire of the device 2801 to allow for the creation of a second ablation zone 2812. The second ablation zone 2812 can overlap or abut the first ablation zone 2805. Fig.28 , the image on the left shows a catheter device 2801 in a first position 2803 in a tissue or organ anatomy 2800, wherein a needle device 2807 penetrates the organ anatomy to create a first ablation zone 2805. Subsequently, the catheter device 2801 is repositioned to a second position 2810, as shown in the image on the right, and the needle device 2807 is inserted into the tissue, thereby creating a second ablation zone 2812 as shown in the figure. The second ablation zone 2812 is adjacent to or overlaps the first ablation zone 2805, thereby ablating a continuous volume of tissue. For example, by overlapping ablation zones 2805 and 2812, the tissue area between arcs 2815 and 2817 is completely ablated.

[0090] The systems, devices, and methods described herein may be embodied in one or more embodiments as described below.

[0091] Embodiment 1: A catheter device having at least one lumen for passage of a needle device, wherein the distal end of the lumen is configured such that the needle device exits the lumen at a non-zero angle relative to the long axis of the catheter at the distal end of the device, and wherein the distal portion of the needle includes an exposed electrical conductor for delivering current to tissue when high voltage is applied.

[0092] 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 a non-zero angle relative to the long axis of the catheter at the distal end of the device, and wherein the distal portion of each needle includes an exposed electrical conductor for delivering current to tissue when a high voltage is applied.

[0093] Example 3: The catheter device of Example 1, wherein the needle engages tissue to deliver high pressure in a monopolar mode.

[0094] Example 4: The catheter device of Example 2, wherein the needle engages tissue to deliver high pressure in a bipolar mode.

[0095] Example 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 a non-zero angle relative to the long axis of the catheter at the distal end of the device, and wherein the distal portion of the needle device is constructed in a helical geometry and includes an exposed electrical conductor for delivering current to tissue when a high voltage is applied.

[0096] Example 6: A catheter device having at least two lumens for passage of 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 a non-zero angle relative to the long axis of the catheter at the distal end of the device, and wherein the distal portion of each needle device is constructed in a helical geometry and includes an exposed electrical conductor for delivering electrical current to tissue when a high voltage is applied.

[0097] Embodiment 7: The catheter apparatus of Embodiment 5, wherein the diameter of the helical geometry of the needle in an unconstrained state is greater than the diameter of the helical geometry of the needle when constrained within the lumen of the catheter.

[0098] Embodiment 8: The catheter apparatus of Embodiment 6, wherein the diameter of the helical geometry of each needle in an unconstrained state is greater than the diameter of the helical geometry of the needle when constrained within the lumen of the catheter.

[0099] Embodiment 9: A catheter device having at least one lumen for passage of a helical tip needle device, wherein a distal portion of the needle device is constructed in a helical geometry and includes an exposed electrical conductor for delivering electrical current to tissue when a high voltage is applied.

[0100] Embodiment 10: The catheter apparatus of Embodiment 9, wherein the diameter of the helical geometry of the needle in an unconstrained state is greater than the diameter of the helical geometry of the needle when constrained within the lumen of the catheter.

[0101] Example 11: A catheter device having at least two lumens for passing a needle device through each lumen, the first lumen having a first needle device having a substantially straight distal geometry, and the second lumen having a second needle device having a distal portion formed in a spiral geometry, wherein the distal portion of each needle device includes an exposed electrical conductor for delivering current to tissue when a high voltage is applied.

[0102] Example 12: The catheter device of Example 11, wherein at least a subset of the needle devices engage tissue to deliver high pressure in a monopolar mode.

[0103] Example 13: The catheter device of Example 11, wherein at least a subset of the needle devices engage tissue to deliver high pressure in a bipolar mode.

[0104] Example 14: The catheter device as described in Example 11, wherein the catheter device is positioned to the anatomical region of interest through a working channel of an endoscope.

[0105] Example 15: The catheter device as described in Example 9, wherein the catheter device is positioned to the anatomical region of interest through a working channel of an endoscope.

[0106] Example 16: The catheter device as described in Example 6, wherein the catheter device is positioned to the anatomical region of interest through a working channel of an endoscope.

[0107] Example 17: The catheter device as described in Example 1, wherein the catheter device is positioned to the anatomical region of interest through a working channel of an endoscope.

[0108] Example 18: The catheter device of Example 11, wherein the diameter of the helical geometry of the second needle device in an unconstrained state is greater than the diameter of the helical geometry of the needle when constrained within the second lumen of the catheter.

[0109] Example 19: A method for delivering high-voltage pulsed field ablation therapy to tissue, comprising positioning a catheter device in an anatomical region of interest, passing a first needle device through a first lumen of the catheter device to pierce the tissue of interest, and 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 pierce the tissue of interest, and advancing the second needle device within the tissue of interest to position its distal tip at a target location, and applying high-voltage pulses to the needle devices to deliver the ablation therapy, wherein the distal portion of each needle device includes an exposed electrical conductor for delivering current to the tissue when the high voltage is applied.

[0110] Embodiment 20: The method of Embodiment 19, wherein the high voltage pulse is applied between the first needle device and the second needle device in a bipolar manner.

[0111] Example 21: The method of Example 19, wherein the distal portion of at least one needle device is constructed in a helical geometry and includes exposed electrical conductors for delivering electrical current to tissue when high voltage is applied.

[0112] Example 22: The method of Example 21, wherein the diameter of the helical geometry of the at least one needle device having a helical distal geometry in an unconstrained state is greater than the diameter of the helical geometry of the needle device when constrained within the lumen of a catheter.

[0113] Example 23: The method of Example 19, wherein the catheter device is positioned at the anatomical region of interest by passing through a channel of the endoscopic device.

[0114] Example 24: A catheter device having an axis and a lumen for passage of a needle device, wherein a longitudinal cross-section of a distal portion of the needle comprises a substantially straight geometry, wherein the distal portion of the needle comprises an exposed electrical conductor for delivering electrical current to tissue when a high voltage is applied so as to deliver pulsed field ablation, and wherein a length of the needle adjacent the distal portion is electrically insulated, wherein the insulation is capable of withstanding at least 500 volts without dielectric breakdown.

[0115] Example 25: The catheter apparatus of Example 24, wherein the distal portion of the shaft of the catheter comprises at least one shaft electrode having an electrical polarity opposite to that of the needle during pulsed field ablation delivery.

[0116] Example 26: The catheter apparatus of Example 25, wherein the shaft electrode has a compressible geometry.

[0117] Example 27: A catheter device having an axis and a lumen for passage of a needle device, wherein a distal portion of the needle has a helical geometry and includes an exposed electrical conductor for transmitting current to tissue when a high voltage is applied to deliver pulsed field ablation, wherein the helical diameter of the helical geometry when the distal portion of the needle extends freely outside the lumen of the catheter device is larger than the helical diameter of the helical geometry when the distal portion of the needle is within the lumen of the catheter device, and wherein a length of the needle adjacent the distal portion is electrically insulated, wherein the insulation is capable of withstanding at least 500 volts without dielectric breakdown.

[0118] Example 28: The catheter apparatus of Example 27, wherein the distal portion of the shaft of the catheter comprises at least one shaft electrode having an electrical polarity opposite to that of the needle during pulsed field ablation delivery.

[0119] Example 29: The catheter apparatus of Example 28, wherein the shaft electrode has a compressible geometry.

[0120] Embodiment 30: A catheter device having an axis and a lumen for passage of a needle device, wherein a distal portion of the needle has a helical geometry and includes an exposed electrical conductor for transmitting electrical current to tissue when a high voltage is applied so as to deliver pulsed field ablation, wherein the helical diameter of the helical geometry when the distal portion of the needle extends freely outside the lumen of the catheter device is greater than the helical diameter of the helical geometry when the distal portion of the needle is within the lumen of the catheter device, wherein a length of the needle adjacent the distal portion is electrically insulated, wherein the insulation is capable of withstanding at least 500 volts without dielectric breakdown, and wherein a clamping device is attached to the proximal portions of both the catheter shaft and the needle device for clamping the catheter and the needle device so as to provide a means for controlled movement of the needle device relative to the catheter device.

[0121] Example 31: The catheter device as described in Example 30, wherein the controlled movement of the needle device includes a helical movement with a pitch equal to the pitch of the distal portion of the needle when freely extended.

[0122] Example 32: A method for delivering high voltage pulsed field ablation therapy to tissue, comprising positioning a catheter device in an anatomical region of interest, passing a needle device through a lumen of the catheter device to pierce the tissue of interest, wherein a distal portion of the needle includes an exposed electrical conductor, 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 therapy.

[0123] Example 33: A method for delivering high voltage pulsed field ablation therapy to tissue, comprising positioning a catheter device in an anatomical region of interest, passing a needle device through a lumen of the catheter device to pierce the tissue of interest, wherein a distal portion of the needle has a spiral geometry and includes an exposed electrical conductor, 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 therapy, wherein moving the needle within the tissue includes a spiral motion.

[0124] Example 34: A method as described in Example 33, wherein the spiral motion is driven by operating a clamping device attached to the proximal portion of both the catheter device and the needle.

[0125] Example 35: A method as described in Example 33, wherein the catheter device is positioned in the anatomical region of interest by passing through a channel of the endoscopic device.

[0126] Although specific examples are provided in the figures for exemplary and illustrative purposes, it should be clear that variations such as different numbers of lumens, straight needles or spiral needles or combinations thereof are also included in the present disclosure. The needle of the catheter device can generally be attached or connected to an electrical conductor that is attached to a cable or connector cable to deliver electrical energy from an appropriate generator that can deliver a high-voltage pulsed field ablation waveform. Typically, this energy delivery is performed in a monopolar mode or a bipolar mode. In the monopolar mode, a subset of the needles has one electrical polarity, while 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 sequentially for energy delivery. The pulsed field ablation waveform can be monophasic in structure (each pulse delivered to the electrode pair has the same polarity) or biphasic (continuous pulses delivered to the electrode pair have opposite polarities). When the pulsed field ablation waveform is applied, the spatial distribution of the generated electric field determines the area of ​​ablation or cell death.

[0127] When using 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 delivering pulsed field ablation at the target site, the needle can be retracted, the device moved to a different location, and the needle can be inserted again, and then pulsed field ablation can be delivered at a second target site. This process can continue until the desired volume of tissue or tumor is treated. In an embodiment, more than one ablation can be delivered at a given target site to potentially enhance the ablation effect.

[0128] As used herein, the terms "about" and / or "approximately" when used in conjunction with values ​​and / or ranges generally refer to values ​​and / or ranges that are close to the values ​​and / or ranges recited. 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. A device comprising: an axis defining a lumen; and a needle device disposed in the lumen, the needle device having a distal portion including an exposed electrical conductor, The distal portion of the needle device is configured to extend out of 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 via the exposed electrical conductor to ablate surrounding tissue.

2. An apparatus according to claim 1, wherein the needle device is configured to operate in a monopolar mode to deliver a pulsed electric field.

3. The device of claim 1, wherein the distal portion of the needle device comprises a spiral geometry.

4. The apparatus of claim 3, wherein the helical geometry is configured to transition from a constrained state to an unconstrained state when the distal portion of the needle device extends out of the lumen.

5. The apparatus of claim 4, wherein the helical geometry in an unconstrained state has a diameter that is larger than a diameter of the helical geometry in a constrained state.

6. The apparatus of any one of claims 1 to 5, wherein the shaft is configured to be positioned through a working channel of an endoscope to an anatomical region of interest.

7. A device comprising: an axis defining a set of one or more lumens; and a first needle device and a second needle device disposed in the set of lumens, each of the first needle device and the second needle device having a distal portion including an exposed electrical conductor, The distal end portions of the first needle device and the second needle device are configured to extend out of the set of lumens at a non-zero angle relative to the longitudinal axis of the shaft, The first needle device and the second needle device are configured to receive the pulsed voltage waveform and to jointly deliver a pulsed electric field via their respective exposed electrical conductors to ablate surrounding tissue.

8. The apparatus of claim 7, wherein the first needle device and the second needle device are configured to operate in a bipolar mode to deliver a pulsed electric field.

9. The apparatus of claim 8, wherein the distal end portions of the first needle device and the second needle device comprise a helical geometry.

10. The apparatus of claim 9, wherein the helical geometry of the distal portion of each of the first needle device and the second needle device is configured to transition from a constrained state to an unconstrained state when the distal portion extends out of the set of lumens.

11. The apparatus of claim 10, wherein the helical geometry of the distal end portion of each of the first needle device and the second needle device in the unconstrained state has a diameter that is larger than a diameter of the helical geometry of the corresponding distal end portion in the constrained state.

12. The apparatus of any one of claims 7-11, wherein the shaft is configured to be positioned to the anatomical region of interest through a working channel of an endoscope.

13. An apparatus comprising: an axis defining a lumen; and a needle device disposed in the lumen, the needle device having a distal portion including an exposed electrical conductor, The distal portion of the needle device has a helical geometry, The needle device is configured to receive a pulsed voltage waveform and deliver a pulsed electric field via the exposed electrical conductor to ablate surrounding tissue.

14. The apparatus of claim 13, wherein the distal portion of the needle device is configured to extend out of the lumen, and The helical geometry is configured to transition from a constrained state to an unconstrained state when a distal portion of the needle device extends out of the lumen.

15. The device of claim 14, wherein the helical geometry in an unconstrained state has a diameter between about 0.5 mm and about 10 mm.

16. The device of claim 14, wherein the helical geometry in an unconstrained state has a pitch between about 0.3 mm and about 6 mm.

17. The device of claim 14, wherein the helical geometry in an unconstrained state has a length between about 3 mm and about 50 mm.

18. The apparatus of claim 14, wherein a length of said needle device adjacent said distal portion is electrically insulated with an insulating material capable of withstanding a voltage of at least about 500 volts without dielectric breakdown.

19. The apparatus of claim 18, further comprising a shaft electrode disposed on a distal portion of the shaft, the shaft electrode and the needle device being configured to have opposite polarities during delivery of the pulsed electric field.

20. The apparatus of claim 19, wherein the shaft electrode has a compressible geometry.

21. The apparatus of claim 13, wherein the needle device is a first needle device, and the apparatus further comprises: A second needle device has a distal portion including an exposed electrical conductor.

22. The apparatus of claim 21, wherein the distal portion of the second needle device has a helical geometry.

23. The apparatus of claim 21, wherein the distal portion of the second needle device has a substantially straight geometry.

24. The apparatus of any one of claims 13 to 23, wherein the shaft is configured to be positioned through a working channel of an endoscope to an anatomical region of interest.

25. An apparatus comprising: an axis defining a lumen; and a needle device disposed in the lumen, the needle device having a distal portion and a proximal portion, the distal portion including an exposed electrical conductor, the proximal portion being electrically insulated with an insulating material, the insulating material being configured to withstand a voltage of at least about 500 volts without dielectric breakdown, The distal portion of the needle device has a substantially straight geometry and is configured to receive a pulsed voltage waveform and deliver a pulsed electric field via the exposed electrical conductor to ablate surrounding tissue.

26. The apparatus of claim 25, further comprising a shaft electrode disposed on a distal portion of the shaft, the shaft electrode and the needle device being configured to have opposite polarities during delivery of the pulsed electric field.

27. The apparatus of claim 26, wherein the shaft electrode has a compressible geometry.

28. An apparatus comprising: an axis defining a lumen; a needle device disposed in the lumen, the needle device having a distal portion and a proximal portion, the distal portion including an exposed electrical conductor, the proximal portion being electrically insulated with an insulating material, the insulating material being configured to withstand a voltage of at least about 500 volts without dielectric breakdown, The distal portion of the needle device has a helical geometry and is configured to extend outside the lumen, the helical geometry having a diameter that is greater when the distal portion extends outside the lumen than when the distal portion is inside the lumen, The needle device is configured to receive a pulsed voltage waveform and deliver a pulsed electric field via the exposed electrical conductor to ablate surrounding tissue; and A proximal actuation assembly is attached to the shaft and a proximal portion of the needle device, the proximal actuation assembly being configured to control relative movement of the needle device with respect to the catheter device.

29. The apparatus of claim 28, wherein the proximal actuation assembly comprises a clamping device configured to clamp the shaft and a proximal portion of the needle device.

30. An apparatus according to any one of claims 28 to 29, wherein the relative movement of the needle device relative to the catheter device includes a helical movement having a pitch equal to the pitch of the helical geometry when the distal portion of the needle device extends outside the lumen.

31. The apparatus of any one of claims 28 to 30, further comprising a generator operably coupled to the needle device and configured to generate a pulsed voltage waveform.

32. A method comprising: extending a distal portion of a needle device outside of a lumen of a shaft of a catheter device located in an anatomical region of interest, the distal portion of the needle device including an exposed electrical conductor; puncturing tissue of interest in response to extending a distal portion of the needle device outside of the lumen; moving a distal portion of the needle device within the tissue of interest to position a distal tip of the needle device at a target location; as well as Voltage pulses are applied to the needle device to deliver pulsed field ablation therapy.

33. The method of claim 32, wherein the distal portion of the needle device comprises a helical geometry, and Moving the distal portion of the needle device includes moving the helical geometry in a helical motion.

34. A method according to any one of claims 32 to 33, wherein movement of the distal portion of the needle is driven by a clamping device attached to the shaft and the proximal portion of the needle device.

35. The method of any one of claims 32 to 34, further comprising positioning the catheter device at the anatomical region of interest by passing the catheter device through a channel of an endoscopic device.

36. A method comprising: extending distal end portions of the first needle device and the second needle device outside of one or more lumens of a shaft of a catheter device located in the anatomical region of interest, the distal end portions of the first needle device and the second needle device including exposed electrical conductors; puncturing tissue of interest in response to extending distal portions of the first needle device and the second needle device outside of the one or more lumens; moving distal portions of the first needle device and the second needle device within the tissue of interest to position distal tips of the first needle device and the second needle device at a target location; and Voltage pulses are applied to the first needle device and the second needle device to deliver pulsed field ablation therapy.

37. The method of claim 36, wherein the voltage pulses are applied to the first needle device and the second needle device in a bipolar mode.

38. The method of claim 36, wherein a distal portion of at least one of the first needle device and the second needle device comprises a helical geometry.

39. The method of claim 38, wherein the helical geometry of at least one of the first needle device and the second needle device is configured to transition from a constrained state to an unconstrained state when extending out of the one or more lumens, The diameter of the spiral geometry in the unconstrained state is greater than the diameter of the spiral geometry in the constrained state.

40. The method of any one of claims 36 to 39, further comprising positioning the catheter device in the anatomical region of interest by passing the catheter device through a channel of an endoscopic device.

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