Irreversible electroporation probe system and method

Abstract

The ablation system includes a retractable sheath including a lumen, a first electrode within the lumen, and a pre-bent telescopic tube extendable from the lumen and including a second electrode, the first electrode and the second electrode configured to apply electric field energy to target tissue of a patient.

Description

[Technical Field]

[0001] This application claims the benefit of U.S. Patent Application No. 17 / 933,266, filed September 19, 2022, which is incorporated herein by reference for all purposes as if fully set forth herein. [Background technology]

[0002] The present disclosure relates to an irreversible electroporation probe, more particularly to an irreversible electroporation probe system including two electrodes, and a method of using the same to perform irreversible electroporation therapy.

[0003] Irreversible electroporation (IRE) is a non-thermal ablative therapy technique that uses high-voltage, low-energy direct current pulses to induce cell death. Thermal ablation techniques, such as radiofrequency ablation, microwave ablation, and cryoablation, have several applications in oncology but have limitations. IRE overcomes some of these limitations.

[0004] IRE is a tissue ablation technique that delivers micro- to millisecond-duration electrical pulses to unwanted tissue, resulting in cell necrosis through irreversible cell membrane permeabilization. IRE only affects cell membranes and does not affect other structures within the tissue.

[0005] Ablation therapy based on the IRE principle uses extremely strong, ultrashort electric fields to destroy the cell membranes of target cells (such as tumors and cancerous tissue). During treatment, the electric field is applied between at least two needle-like probes containing electrodes, which must be positioned parallel to the target area. At least two probes are required to form the treatment area, but more probes can be used depending on the size of the lesion or target region. Additional probes can be positioned parallel to each other at different locations on the 3D target area. In this case, electrical energy is delivered between two probes at a time. IRE has been successfully used to treat liver cancer, prostate cancer, and pancreatic cancer, and research is underway for other treatments.

[0006] Correct placement of the electrode probe prior to ablation is critical for successful ablation. Traditionally, IRE is performed under general anesthesia using image guidance (CT or ultrasound). Probe insertion must be repeated several times until the correct position is achieved. After probe placement using image guidance, a three-dimensional (3D) CT scan can be obtained to confirm the probe position and the distance between each pair. Accurate positioning of IRE probes is time-consuming and expensive. Therefore, improved IRE probes that are less invasive and allow for more accurate and rapid positioning are needed.

[0007] [Disclosure Summary] In various embodiments of the present disclosure, systems and methods are provided that are less invasive than conventional IRE treatments that require the use of more probes. The IRE ablation probe system of the present disclosure includes at least two electrodes within a single device used for IRE treatment, eliminating the need for two separate probes, each with one electrode.

[0008] The IRE ablation probe system of the present disclosure may also include an imaging sensor. Thus, the systems and methods of the present disclosure can obtain image information representing the progress of the IRE ablation therapy during a procedure. This information represents an improvement over existing conventional treatment methods by providing real-time feedback regarding the ablation of the target tissue during treatment. This information can improve the effectiveness of the treatment and reduce the likelihood of subsequent treatments being performed. The systems and methods of the present disclosure can assist medical professionals in determining whether all or a desired portion of the target tissue has been destroyed during treatment. Furthermore, the systems and methods of the present disclosure can reduce and / or limit harm to healthy tissue that may be located near the target tissue.

[0009] In some embodiments, ultrasound imaging can be incorporated into the IRE probe systems of the present disclosure. In some embodiments, all-optical imaging can be integrated into the IRE probe systems of the present disclosure. The imaging sensor within the IRE probe system can provide imaging data of the ablation volume that is not possible with existing handheld or external imaging probes.

[0010] Additionally, embodiments of the present disclosure may be embodied as methods, examples of which are provided. The acts performed as part of the method may be ordered in any suitable manner. Thus, while acts may be shown as sequential in an example embodiment, embodiments may be constructed in which acts are performed in a different order than shown, including some acts performed simultaneously.

[0011] In one embodiment of the present disclosure, the ablation system can include a retractable sheath including a lumen, a first electrode within the lumen, a bendable telescopic tube extendable from the lumen and including a second electrode, the first electrode and the second electrode configured to deliver electric field energy to a target tissue of a patient.

[0012] In one embodiment, when the retractable sheath is retracted, the first electrode is exposed. The sheath may be retractable, steerable, or deflectable.

[0013] The bendable telescoping tube may be pre-bent at two opposing 90 degree angles.

[0014] In another embodiment, the bendable telescoping tube may be pre-bent at 180 degrees.

[0015] The second electrode may be extendable from a bendable extension tube.

[0016] When the flexible telescopic tube is extended from the lumen and the second electrode is extended from the flexible telescopic tube, the first electrode and the second electrode can be arranged parallel to each other. The flexible telescopic tube can be bent or pre-bent and telescopic.

[0017] In embodiments of the present disclosure, a bendable telescopic tube can be selected from a kit to meet specific needs for treatment. Based on pre-operative planning (e.g., through simulation), the desired path of the second electrode relative to the size and field strength of the target area can be determined. This pre-operative planning allows for the selection of a telescopic tube appropriate for treatment. Such a kit can include bendable or pre-bent telescopic tubes of different sizes and shapes. For example, the telescopic tube can be pre-bent into a "U" shape, including a 180-degree bend. In another embodiment, rather than being pre-bent, the telescopic tube can be steerable. That is, the telescopic tube can be bent or manipulated by (i) a medical professional assisted by image guidance, or (ii) a robotic control device or mechanism using controlled actuators. While 90-degree and 180-degree bends are suitable for telescopic tube shapes, the telescopic tube can have various other shapes and contours as desired for a particular clinical application or treatment. The telescopic tube can be any shape, as long as the two electrodes are parallel to each other during use.

[0018] In one embodiment, the ablation system may further include an imaging sensor positioned to obtain image data of the target tissue. In one aspect, the imaging sensor is configured to operate simultaneously with the operation of the first and second electrodes. The imaging sensor may be provided, for example, by an ultrasound transducer. Alternatively, or in addition, the imaging sensor may be an electronic ultrasound transducer, an all-optical ultrasound transducer, a piezoelectric transducer (PZT), a capacitive micromachined ultrasound transducer (CMUT), a silicon photonics-based ultrasound transducer, or a piezoelectric polyvinylidene fluoride (PVDF)-based transducer. In other examples, other imaging sensors may be used. In other examples, the IRE probe system of the present disclosure may be used with other sensors, such as an external ultrasound transducer or other sensors positioned adjacent to the target region. In other examples, the IRE probe system of the present disclosure may include multiple sensors. Multiple imaging sensors may provide improved coverage of the target region and a more accurate representation of the damaged tissue during ablation compared to conventional procedures using only a single imaging sensor.

[0019] In some embodiments, simultaneous imaging and ablation may be impossible or undesirable because the electric field generated between the electrodes of an IRE probe system may interfere with a nearby imaging sensor. In such cases, ablation and imaging may be alternated. In other examples, such as when the imaging sensor is configured as an all-optical ultrasonic sensor, the imaging and ablation functions may be performed simultaneously because there is no interference between the electric field energy and the all-optical ultrasonic sensor operation. In some embodiments of the present disclosure, an imaging sensor can be rigidly fixed to each IRE probe system. This integration allows the imaging sensor and IRE probe electrodes to automatically and physically register with each other, minimizing mismatch and allowing the ablation volume to be directly overlaid on the imaged ablation volume. By integrating the imaging sensor into the IRE probe system, there is no need to separately position a separate imaging sensor relative to the ablation volume. Because the imaging sensor is automatically positioned in close proximity to the ablation volume when the IRE probe system is positioned over the target area, no special requirements are placed on the imaging sensor's power and sensitivity. The imaging sensor's power, sensitivity, and / or other operating parameters are predetermined and easily configurable. Therefore, the IRE probe system offers various improvements over existing systems and devices. For example, the IRE probe system can simultaneously perform sensing / imaging and ablation. Furthermore, integrating image processing capabilities into the IRE probe system enables cost-effective implementation and reduces the complexity of IRE ablation treatments. Furthermore, improved image data can be collected, resulting in more effective ablation treatments. This may improve the likelihood of ablating the target tissue in the target area during a single treatment, minimizing or reducing harm to surrounding and / or healthy tissue. The imaging sensor may be disposed within the lumen and coupled to the imaging generator via a connector. In some examples, if the imaging sensor is an all-optical ultrasound transducer, the connector may be an optical fiber. In other examples, if other imaging sensor technologies are used, such as an electronic ultrasound sensor, the imaging sensor may be connected to the imaging generator via a cable routed through the lumen. In yet another example, the connector and / or cable may be disposed and routed along the sheath within a separate conduit structure.

[0020] In another embodiment of the present disclosure, an ablation system includes a retractable sheath including a lumen; a first bendable telescopic tube extendable from the lumen and including a first electrode; and a second bendable telescopic tube extendable from the lumen and including a second electrode, wherein the first electrode and the second electrode are configured to deliver electric field energy to a target tissue of a patient.

[0021] Preferably, the first bendable telescopic tube and the second bendable telescopic tube are each bent at 90 degrees.

[0022] Optionally, the first electrode is extendable from a first flexible telescopic tube and the second electrode is extendable from a second flexible telescopic tube.

[0023] Preferably, when the first bendable telescopic tube extends from the lumen, the first electrode extends from the first bendable telescopic tube, the second bendable telescopic tube extends from the lumen, and the second electrode extends from the second bendable telescopic tube, the first electrode and the second electrode are arranged parallel to each other.

[0024] In another embodiment of the present disclosure, a method of performing irreversible electroporation (IRE) therapy includes retracting a sheath of an IRE probe system positioned at or near a target tissue of a patient, extending a first bendable telescopic tube from a lumen of the IRE probe system, extending a first electrode from the first bendable telescopic tube, and passing an electric field between the first electrode and a second electrode of the IRE probe system parallel to the first electrode to ablate the target tissue in a first direction.

[0025] In one embodiment, the method may further include retracting the first electrode; retracting the first bendable telescopic tube, extending the sheath, rotating the IRE probe system, re-extending the first bendable telescopic tube from the lumen of the IRE probe system, re-extending the first electrode from the first bendable telescopic tube; and passing an electric field between the first electrode and the second electrode to ablate the target tissue in a second direction.

[0026] Alternatively or additionally, the method may further include extending a second bendable telescopic tube from the lumen of the IRE probe system and extending a second electrode from the second bendable telescopic tube.

[0027] In another embodiment, the method may further include retracting the first electrode and the second electrode, retracting the first bendable telescopic tube and the second bendable telescopic tube, extending the sheath, rotating the IRE probe system, re-extending the first bendable telescopic tube from the lumen of the IRE probe system, re-extending the first electrode from the first telescopic tube, re-extending the second telescopic tube from the lumen of the IRE probe system, re-extending the second electrode from the second telescopic tube, and applying an electric field between the first electrode and the second electrode to ablate the target tissue from a second direction.

[0028] In another embodiment, the method of the present invention may further comprise obtaining imaging data from an imaging sensor of the IRE probe system.

[0029] In another aspect, the method of the present disclosure may further include simultaneously passing an electric field between the first electrode and the second electrode and acquiring imaging data from the imaging sensor.

[0030] The above and other features, elements, characteristics, steps, and advantages of the present disclosure will become more apparent from the following detailed description of preferred embodiments of the invention, which proceeds with reference to the accompanying drawings.

[0031] Features and advantages of the present disclosure will be more fully disclosed in or made apparent by the following detailed description of exemplary embodiments, in which like numbers refer to like parts, and when considered in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0032] [Figure 1] FIG. 1 shows a first embodiment of the present invention, which is configured as a heat pump cycle. [Figure 2] FIG. 2 shows a second embodiment of the present invention, which is configured as a heat pump cycle. [Figure 3] FIG. 3 shows a third embodiment of the present invention, which is configured as a heat pump cycle. [Figure 4] FIG. 4 is a side view of another exemplary ablation probe system according to the present disclosure. [Figure 5] FIG. 5 is a side view of another exemplary ablation probe system according to the present disclosure. [Figure 6] FIG. 6 is a side view illustrating an alternative configuration of the ablation probe system of FIG. [Figure 7] FIG. 7 is a side view of another exemplary ablation probe system according to the present disclosure. [Figure 8] FIG. 8 is a side view of another exemplary ablation probe system according to the present disclosure. [Figure 9] FIG. 9 is a flowchart of an example method of performing ablation therapy according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0033] The description of the preferred embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description of these disclosures. While the present disclosure is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are herein described in detail. Objects and advantages of the claimed subject matter will become more apparent from the following detailed description of these exemplary embodiments taken in conjunction with the accompanying drawings.

[0034] However, it should be understood that the present disclosure is not intended to be limited to the particular forms disclosed. Rather, the present disclosure covers all modifications, equivalents, and alternatives falling within the spirit and scope of these exemplary embodiments. The terms "coupled," "coupled," "operably coupled," "operably connected," and the like, should be understood broadly to refer to the connection of devices or components together in any manner, whether mechanical, electrical, wired, wireless, or otherwise, such that the connection enables the associated devices or components to operate (e.g., communicate) with each other as intended by that relationship.

[0035] In this disclosure, the singular forms "a," "an," and "the" include plural references, and reference to a specific numerical value includes at least that particular value unless the context clearly dictates otherwise. When values ​​are expressed as approximations, the use of the antecedent "about" will understand that the particular value forms another embodiment. As used herein, "about X" (where X is a numerical value) preferably refers to ±10% of the referenced value. For example, the expression "about 8" preferably refers to a value between 7.2 and 8.8. Where present, all ranges are inclusive and combinable. For example, if a range of "1 to 5" is recited, the recited range should be interpreted as including ranges such as "1 to 4," "1 to 3," "1 to 2," "1 to 2 and 4 to 5," "1 to 3 and 5," "2 to 5," etc. Furthermore, when a list of options is explicitly provided, such a list may be interpreted to mean that any of the options may be excluded, for example, by a negative limitation in the claims. For example, when a range of "1 to 5" is recited, the recited range can be interpreted as including situations in which any of 1, 2, 3, 4, or 5 is negatively excluded. Thus, the recitation of "1 to 5" can be interpreted as "1 and 3 to 5, but not 2," or simply as "excluding 2." It is intended that any components, elements, attributes, or steps affirmatively described herein can be explicitly excluded in the claims, regardless of whether such components, elements, attributes, or steps are listed as alternatives or listed alone.

[0036] The disclosed IRE probe can reduce the number of probes required during an IRE procedure. Inserting IRE probes into tissue is invasive, so fewer probes are desirable. Inserting fewer probes into a patient means fewer probes are likely to cause bleeding, tissue damage, or other undesirable effects. Furthermore, using image guidance to properly align the IRE probe's parallel electrodes for treatment requires time from medical professionals. Each IRE probe of the present invention can include two electrodes that are automatically positioned parallel to one another. This can expedite the IRE procedure and reduce the patient's anesthesia time.

[0037] Electrode-equipped IRE probes are often used in treatments targeting unwanted tissue, such as tumors or cancer cells. During such procedures, a first IRE probe can be inserted into the body and positioned at or near the target tissue. A second IRE probe can be inserted into the body and positioned on the opposite side of the target tissue, with the electrodes of the second IRE probe parallel to those of the first IRE probe. This is shown in Figure 1, where two needle-shaped probes, with positive and negative electrodes 10 and 11, are positioned through tissue 12 parallel to each other about a target region 13. A generator (not shown) delivers high-voltage, low-energy direct current through the probes 10 and 11, which are connected to the generator. At least two monopolar probes are required to create a treatment region, but additional probes can be used depending on the size of the lesion or target region. Additional probes can be positioned parallel to each other at different locations in the 3D target region. Thus, by simultaneously driving the two electrodes of the IRE probe, electric fields can be created around the target tissue in different directions.

[0038] To be inserted into tissue, IRE probes have a sharp tip. This tip pierces a path to the treatment location. In general, IRE probes must be rigid enough to penetrate tissue, but not too thick, to facilitate advancement and reduce complications during probe advancement, e.g., due to bleeding. Therefore, it is usually not possible to provide a flexible IRE probe that curves or follows a curved path to bypass critical areas. If a critical area, such as an organ or blood vessel, is injured by the IRE probe, this can increase the risk of bleeding and unwanted tissue damage from the intervention.

[0039] 2 illustrates one embodiment of an IRE probe system 20 of the present disclosure. IRE probe system 20 can include a sheath 21 having a lumen 25, a first electrode 22, a retractable tube 23, and a second electrode 24. As shown, retractable tube 23 with first electrode 22 and second electrode 24 can be positioned within lumen 25. Sheath 21 can be retractable, steerable, or deflectable.

[0040] In use, as shown in FIG. 3, the IRE probe system 20 can be inserted into tissue and positioned to one side of the target region 30. The IRE probe system 20 can be steered along the vascular channel or using imaging or electric field measurements to fine-tune its placement. The sheath 21 can be retracted to expose the first electrode 22. The telescopic tube 23 can be bendable or a two-fold sheath that can be pre-bent and then extended. FIG. 3 shows that the telescopic tube 23 can initially extend through the opening 26 in a direction perpendicular to the extension direction of the first electrode 22 and continue to extend into a pre-bent "S" shape that includes two opposing 90-degree bends. The second electrode 24 can be extended from the telescopic tube 23 such that the first electrode 22 and the second electrode 24 automatically position themselves parallel to each other with respect to the target region 30.

[0041] The telescopic tube 23 can be selected from a kit to suit the specific needs of the treatment. Based on pre-operative planning (e.g., through simulation), the desired path of the second electrode 24 with respect to the size of the target area and the field strength can be determined. As a result of this pre-operative planning, the appropriate telescopic tube for the treatment can be selected. Such a kit can include bendable or pre-bent telescopic tubes 23 in different sizes or shapes. For example, in another embodiment of the present invention, the telescopic tube can be pre-bent into a "U" shape, as shown in FIG. 4.

[0042] Figure 4 shows an IRE probe system 20 similar to that shown in Figures 2 and 3. Descriptions of features that are the same as those described with respect to Figures 2 and 3 are omitted for the sake of brevity. However, the IRE probe system 20 shown in Figure 4 includes a telescoping tube 27 that is pre-bent into a "U" shape that includes a 180-degree bend.

[0043] 4 shows that the IRE probe system 20 can be inserted into tissue and positioned to one side of the target region 30. The sheath 21 can be retracted to expose the first electrode 22. The telescopic tube 27 can initially extend from the opening 26 in a direction perpendicular to the extension of the first electrode 22 and continue to extend in a pre-bent "U" shape below the target region 30. The second electrode 24 can be extended from the telescopic tube 27 such that the first electrode 22 and the second electrode 24 automatically position themselves parallel to each other with respect to the target region 30.

[0044] In another embodiment, not shown, rather than being pre-bent, as discussed with respect to Figures 3 and 4, the telescopic tube with the electrodes at its tip can be steerable, i.e., the telescopic tube can be bent and manipulated by a control device or mechanism that can be actuated by (i) a medical professional aided by image guidance, or (ii) a robot using controlled actuators.

[0045] 5 illustrates another embodiment of an IRE probe system 50 of the present disclosure that includes two retractable tubes with electrodes. The IRE probe system 50 can include a sheath 51 having a lumen 52, a tip 59, a first retractable tube 53, a second retractable tube 54, a first electrode 55, and a second electrode 56. As shown, the first retractable tube 53 and the second retractable tube 54 can be positioned within the lumen 52. The sheath 51 can be retractable, steerable, or deflectable.

[0046] In use, as shown in FIG. 6, the IRE probe system 50 can be inserted into tissue and positioned to one side of the target region 30. The IRE probe system 50 can be steered along the vascular channel or using imaging or electric field measurements to fine-tune its placement. The sheath 51 can be retracted to expose the first and second openings 61 and 62, respectively. The telescopic tubes 53 and 54 can be pre-bent or pre-bendable sheaths that can be extended. FIG. 6 shows that the first telescopic tube 53 can be bent 90 degrees from the first opening 61 in a direction perpendicular to the extension of the tip 59. Similarly, the second telescopic tube 54 can be bent 90 degrees from the second opening 62 in a direction perpendicular to the extension of the tip 59. The first electrode 55 and the second electrode 56 are then extended from the respective elastic tubes 53 , 54 , and the first electrode 55 and the second electrode 56 are automatically positioned parallel to each other with respect to the target area 30 .

[0047] Although 90-degree and 180-degree bends in the telescopic tube configuration are shown, the telescopic tube can have a variety of other shapes or contours as desired for a particular clinical application or treatment. The telescopic tube can be any shape that allows the two electrodes to be parallel to each other when in use.

[0048] In other embodiments, the IRE probe system of any of the disclosed embodiments disclosed herein can include an imaging sensor in addition to the ablation electrodes, as shown, for example, in Figures 7 and 8. Such an IRE probe system can enable multiple functions to be performed during an IRE ablation treatment, such as both ablation and imaging.

[0049] For example, Figure 7 illustrates an IRE probe system 70 that is similar to the IRE probe system 20 illustrated in Figure 2. As shown in Figure 7, the IRE probe system 70 may include a sheath 71 having a lumen 75, a first electrode 72, a retractable tube 73, and a second electrode 74. However, the IRE probe system 70 may also include an imaging sensor 77.

[0050] In another embodiment, Figure 8 illustrates an IRE probe system 80 that is similar to IRE probe system 50 illustrated in Figure 5. As shown in Figure 8, IRE probe system 80 can include a sheath 81 having a lumen 82, a first retractable tube 83, a second retractable tube 84, a first electrode 85, and a second electrode 86. IRE probe system 80 can also include an imaging sensor 87.

[0051] The imaging sensors 77, 87 can be, for example, ultrasonic transducers. In various embodiments, the imaging sensors 77, 87 can be electronic ultrasonic transducers, all-optical ultrasonic transducers, piezoelectric transducers (PZT), capacitive micromachined ultrasonic transducers (CMUT), silicon photonics-based ultrasonic transducers, or piezoelectric polyvinylidene fluoride (PVDF)-based transducers. In other examples, other imaging sensors can be used.

[0052] When IRE probe systems 70, 80 are positioned for ablation, their respective imaging sensors 77, 87 are positioned adjacent to the target region. This positioning allows a single IRE probe system to perform both ablation and imaging. In other embodiments, IRE probe systems 70, 80 can be used with other sensors, such as external ultrasound transducers or other sensors, positioned adjacent to the target region. In other embodiments (not shown), IRE probe systems 70, 80 can include multiple sensors. Multiple imaging sensors can provide improved coverage of the target region and a more accurate representation of the tissue damaged during ablation compared to conventional procedures using only a single imaging sensor.

[0053] In some embodiments, simultaneous imaging and ablation may be impossible or undesirable because the electric field generated between the electrodes of an IRE probe system may interfere with a nearby imaging sensor. In such cases, ablation and imaging may be alternated. In other examples, such as when the imaging sensor is configured as an all-optical ultrasound sensor, imaging and ablation functions may be performed simultaneously because there is no interference between the electric field energy and the all-optical ultrasound sensor operation. The imaging sensors 77, 87 in this embodiment may be configured as all-optical ultrasound transducers capable of simultaneous ablation and ultrasound imaging. All-optical transducers use pulsed or modulated light to generate ultrasound waves via the photoacoustic effect and may be less susceptible to electromagnetic noise than non-optical transducers that convert electrical energy to ultrasound energy.

[0054] In some embodiments, the imaging sensors 77, 87 can be rigidly affixed to the respective IRE probe systems 70, 80. This integration automatically physically registers the imaging sensors 77, 87 and the IRE probe electrodes with respect to each other, minimizing mismatch and allowing the ablation volume to be directly overlaid on the imaged ablation volume. By integrating the imaging sensors 77, 87 into the IRE probe systems 70, 80, a separate imaging sensor need not be positioned relative to the ablation volume. Because the imaging sensors 77, 87 are automatically positioned immediately adjacent to the ablation volume when the IRE probe systems 70, 80 are positioned at the target region 30, no special requirements are placed on the power and sensitivity of the imaging sensors 77, 87. The power, sensitivity, and / or other operating parameters of the imaging sensors 77, 87 are predetermined and easily configurable. Thus, the IRE probe systems 70, 80 offer various improvements over existing systems and devices. For example, the IRE probe systems 70, 80 can simultaneously perform sensing / imaging and ablation. The integration of imaging capabilities into the IRE probe systems 70, 80 also provides for cost-effective implementation and reduces the complexity of IRE ablation treatments. Furthermore, ablation treatments may be performed more effectively due to the improved imaging data that may be collected. This may improve the likelihood that targeted tissue within the target region 30 will be ablated during a single treatment, minimizing or reducing harm to surrounding and / or healthy tissue.

[0055] As previously mentioned, the IRE probe systems 70 and 80 are capable of simultaneous treatment and imaging. The all-optical ultrasound transducer can simultaneously operate the electrodes and imaging sensor. Conventional piezoelectric transducers (PZT), capacitive micromachined ultrasound transducers (CMUT), and piezoelectric polyvinylidene fluoride (PVDF)-based sensors cannot provide data for visualizing the ablation area during treatment due to electromagnetic interference. Integrating imaging sensors 77, 87 into the IRE probe systems 70, 80 as all-optical ultrasound transducers and / or silicon photonics-based ultrasound transducers can improve visualization of the ablation area compared to conventional treatments. The all-optical ultrasound transducer and / or silicon photonics-based ultrasound transducer can enable electromagnetic interference-free detection of ultrasound during ablation treatment.

[0056] The imaging sensors 77, 87 may be disposed within the respective lumens 72, 82 and coupled to the imaging generator via connectors. In some embodiments, if the imaging sensors 77 or 87 are all-optical ultrasound transducers, the connectors may be optical fibers. In other embodiments, if other imaging sensor technologies are used, such as electronic ultrasound sensors, the imaging sensors 77, 87 may be connected to the imaging generator via cables routed through the lumens 72, 82. In yet another example, the connectors and / or cables may be disposed and routed within separate conduit structures along the sheaths 71, 81.

[0057] In any of the previously described embodiments or configurations, the retractable tube containing the electrodes can be retracted after a first IRE ablation procedure in a first target area volume, and the IRE probe system can then be rotated a predetermined angle, and the retractable tube and electrodes can be re-extended into the tissue to perform a second ablation in a second direction in the target area volume. This can be repeated as needed to treat the target area. In this manner, the coverage of the target area of ​​the IRE probe system can be significantly expanded without additional skin incisions, removal and reinsertion of the same IRE probe, or the use of multiple IRE probes. This is less invasive, more timely, and more efficient than traditional IRE ablation procedures.

[0058] In any of the previously described embodiments or configurations, the IRE probe system can be moved or advanced manually or using a robotic system. In particular, the robotic system can specify the speed and direction of movement of the IRE probe system toward the treatment location. If the IRE probe system includes a bendable tip, the robotic system can be designed to deform the IRE probe system to accommodate the bending of the tip or to adjust the alignment of the tip to the treatment location through the bend. In other words, the tip of the IRE probe can be advanced with the robotic system so as to be aligned with the direction of the treatment location. In this manner, the direction of movement of the IRE probe can be at least partially predetermined by the robotic system.

[0059] An example of a method 90 for performing IRE ablation therapy is shown in Figure 9. The example method 90 can be performed using any one of the IRE probe systems described above. While one or more example IRE probe systems are used to illustrate the following method 90, it should be understood that the method 90 is not limited to the specific examples detailed below, and that other alternative embodiments and examples of the IRE probe system of the present disclosure may also be used. The order of the steps described may vary depending on the IRE probe system used and the treatment condition, and some steps may be omitted as being optional.

[0060] Method 90 can begin at step S1, in which a sheath for an IRE probe system is retracted. Although not shown, prior to performing step S1, the IRE probe system is positioned at or near a region of target tissue requiring IRE ablation therapy. The distal end of the IRE probe system can be inserted into a patient, for example, to a treatment location adjacent the target tissue.

[0061] In step S2, a first bendable telescopic tube can be extended from the lumen of the IRE probe system. The first bendable telescopic tube can be as previously described and can be pre-bent to include a 90-degree bend, two opposing 90-degree bends, a 180-degree bend, or any other suitable shape or angle.

[0062] In step S3, the first electrode can be extended from the first bendable telescopic tube, such that the first electrode is parallel to the second electrode of the IRE probe system.

[0063] In step S4, a second bendable telescopic tube can be extended from the lumen of the IRE probe system. The second bendable telescopic tube can be as previously described and can be pre-bent to include a 90 degree bend, or any other suitable shape or angle.

[0064] In step S5, the second electrode can be extended from the second bendable telescopic tube, such that the second electrode is parallel to the first electrode of the IRE probe system.

[0065] In step S6, an electric field can be applied between a first electrode and a second electrode of the IRE probe system to ablate the target tissue in a first direction between the first electrode and the second electrode. One of the first and second electrodes is a positive electrode, and the other of the first and second electrodes is a negative electrode. The first and second electrodes can be energized with a short, high-voltage, low-energy pulse to create an electric field between the two electrodes, killing cells (i.e., the target tissue) between the electrodes.

[0066] In step S7, imaging data can be acquired. The imaging data can be acquired from a first direction relative to the target tissue. The imaging data can be acquired from an imaging sensor disposed in the IRE probe system. The first imaging data can provide imaging information from one side or both sides of the target tissue.

[0067] Method 90 can be performed using an IRE probe system that includes an all-optical ultrasound transducer as an imaging sensor. In this case, steps S6 and S7 can be performed simultaneously. The all-optical ultrasound transducer can acquire imaging data simultaneously while the first and second electrodes are energized to generate an electric field.

[0068] In step S8, the first electrode is stored in the first expandable tube.

[0069] In step S9, the first bendable telescopic tube can be retracted into the lumen of the IRE probe system.

[0070] If the second electrode extends from the second bendable telescopic tube, the second electrode may be retracted into the second bendable telescopic tube in step S10.

[0071] If the second bendable telescopic tube extends from the lumen, the second bendable telescopic tube can also be stored in the lumen in step S11.

[0072] In step S12, the sheath of the IRE probe system may be expanded, which closes any openings in the IRE probe system to protect internal components and minimize features of the IRE probe system that may cause mechanical interference with surrounding tissue during removal of the IRE probe system from the patient or during step S11.

[0073] In step S13, a decision is made whether to continue treatment. If it is decided to discontinue treatment, the method ends and the IRE probe system can be removed from the patient. If it is decided to continue treatment, the method can proceed to step S14.

[0074] In step S14, the IRE probe system can be rotated. The IRE probe system can be rotated a predefined amount. The degree of rotation can be defined during pre-treatment planning or as a result of image information acquired and processed by a medical professional during treatment.

[0075] After rotation in step S14, steps S1-S13 can be repeated to ablate the target tissue from a second direction. Rotating the IRE probe system and extending the electrodes from that new direction results in the first and second electrodes having different orientations relative to the target tissue volume. The electric field applied between the two electrodes also affects the target tissue volume from different directions. This method has the advantage of allowing treatment of larger target tissue volumes without using multiple IRE probes or repeatedly inserting and removing the IRE probe in different positions to treat the same target tissue volume.

[0076] Steps S1-S14 are repeated as necessary to ablate the target tissue before terminating the described method and removing the IRE probe system from the patient.

[0077] It should be understood that the foregoing description is only illustrative of the present invention. Various alternatives and modifications may be devised by those skilled in the art without departing from the invention. Accordingly, the present invention is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the appended claims.

Claims

1. 1. An ablation system comprising: a retractable sheath including an internal lumen; a first electrode within the lumen; a flexible telescopic tube extendable from the lumen and including a second electrode; the first electrode and the second electrode are configured to apply electric field energy to a target tissue of a patient; Ablation system.

2. The ablation system of claim 1 , wherein the first electrode is exposed when the retractable sheath is retracted.

3. The ablation system of claim 1 or 2, wherein the bendable telescopic tube is pre-bent at two opposing 90 degree angles.

4. The ablation system of claim 1 or 2, wherein the bendable telescopic tube is pre-bent at 180 degrees.

5. 10. The ablation system of claim 1, wherein the second electrode is extendable from the bendable telescopic tube.

6. 6. The ablation system of claim 5, wherein when the flexible telescopic tube is extended from the lumen and the second electrode is extended from the flexible telescopic tube, the first electrode and the second electrode are positioned parallel to each other.

7. 10. The ablation system of claim 1, further comprising an imaging sensor positioned to acquire image data of the target tissue.

8. The ablation system of claim 7 , wherein the imaging sensor is configured to operate simultaneously with operation of the first and second electrodes.

9. 1. An ablation system comprising: a retractable sheath including an inner lumen; a first flexible telescoping tube extendable from the lumen and including a first electrode; and a second flexible telescopic tube extendable from the lumen and including a second electrode; the first electrode and the second electrode are configured to apply electric field energy to a target tissue of a patient; an ablation system comprising:

10. 10. The ablation system of claim 9, wherein the first flexible telescopic tube and the second flexible telescopic tube are each pre-bent at 90 degrees.

11. the first electrode is extendable from the first bendable telescopic tube; and The ablation system of claim 9 or 10, wherein the second electrode is extendable from the second bendable telescopic tube.

12. when the first flexible telescopic tube extends from the lumen, the first electrode extends from the first flexible telescopic tube, the second flexible telescopic tube extends from the lumen, and the second electrode extends from the second flexible telescopic tube, the first electrode and the second electrode are arranged parallel to each other; The ablation system of claim 11 .

13. The ablation system of any one of claims 9 to 12, further comprising an imaging sensor positioned to acquire imaging data of the target tissue.

14. The ablation system of claim 13 , wherein the imaging sensor is configured to operate simultaneously with operation of the first and second electrodes.

15. 1. A method of performing irreversible electroporation (IRE) therapy, comprising: retracting a sheath of the IRE probe system to be positioned at or near the target tissue of the patient; extending a first bendable telescoping tube from a lumen of the IRE probe system; extending a first electrode from the first bendable telescopic tube; and energizing an electric field between the first electrode and a second electrode of the IRE probe system parallel to the first electrode to ablate the target tissue in a first direction; A method comprising:

16. storing the first electrode; storing the first bendable telescopic tube; extending the sheath; rotating the IRE probe system; re-extending the first bendable telescoping tube from the lumen of the IRE probe system; re-extending the first electrode from the first bendable telescopic tube; and energizing an electric field between the first electrode and the second electrode to ablate the target tissue in a second direction; 16. The method of claim 15, further comprising:

17. extending a second bendable telescoping tube from the lumen of the IRE probe system; extending the second electrode from the second flexible telescopic tube; 17. The method of claim 15 or 16, further comprising:

18. storing the first electrode and the second electrode; storing the first flexible telescopic tube and the second flexible telescopic tube; extending the sheath; rotating the IRE probe system; re-extending the first bendable telescoping tube from the lumen of the IRE probe system; re-extending the first electrode from the first bendable telescopic tube; re-extending the second retractable telescoping tube from the lumen of the IRE probe system; re-extending the second electrode from the second telescopic tube; and energizing an electric field between the first electrode and the second electrode to ablate the target tissue in a second direction; 20. The method of claim 17 further comprising:

19. The method of any one of claims 15 to 18, further comprising the step of acquiring imaging data from an imaging sensor of the IRE probe system.

20. 20. The method of claim 19, further comprising simultaneously energizing the electric field between the first electrode and the second electrode and acquiring imaging data from the imaging sensor.

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