Flexible pulse energy delivery device and intrusive pulse ablation method

Abstract

The invention discloses a flexible pulse energy delivery device and an interventional ablation method. The device comprises an electrode assembly, a flexible tube body assembly, a control assembly and an ablation system. The electrode assembly is configured to transmit pulse energy to a target focus in an organ for electroporation ablation, and the flexible tube body assembly is configured to transfer the electrode assembly to a first distance range of the target focus; the electrode assembly is arranged at the head end and / or the surface of the flexible pipe body assembly and moves and abuts against the flexible pipe body assembly. A positioning sensor in the flexible tube body assembly is used for obtaining position information of the electrode assembly, and the ablation system establishes a three-dimensional image according to the position information. According to the scheme, through real-time electromagnetic positioning navigation guidance, the electrode arrangement and conveying difficulty is reduced; unipolar and bipolar mode ablation can be carried out, the influence of tissue impedance on a formed ablation loop is small, and pulse energy is controllable; the conveying direction of the catheter can be flexibly adjusted, and the success rate of the irreversible electroporation ablation operation is increased.

Description

Technical Field

[0001] The present invention relates to the medical field, and in particular to a flexible pulse energy delivery device and an interventional pulse ablation method. Background Art

[0002] A large number of patients with non-small cell lung cancer (NSCLC) or extrathoracic malignancies with lung metastases require minimally invasive ablation therapy because their tumors cannot be safely removed surgically due to unfavorable tumor location, multifocal disease, or potential comorbidities.

[0003] Irreversible electroporation ablation (IRE) is a new tissue ablation technique in which doctors puncture the skin, guide the treatment instrument to the location of the tumor, and then treat the tumor with the ablation instrument.

[0004] In the process of studying related technologies, the inventors found that existing IRE products have many deficiencies in the treatment of lung tumors, which has limited clinical application. First, 2 to 6 electrodes need to be placed in or around the tumor, which is very time-consuming and may lead to errors in needle placement. At the same time, multiple punctures cause a high risk of complications such as pneumothorax and pleural effusion. Secondly, the ablation electrodes must be placed accurately and in parallel to generate a sufficiently strong electric field. On the one hand, the angle of the electrode may cause overcurrent at the position where the electrodes are close, resulting in unnecessary Joule heating; on the other hand, incomplete ablation may occur at the position where the electrodes are far apart. It is very challenging to place electrodes in parallel in the chest due to the obstruction of the ribs. Finally, the air in the alveoli of the lungs is an excellent insulator for electric current, which significantly affects the energy transfer between the electrodes, limits the degree of ablation of lung cancer tissue outside the electrode, and leads to an overestimation of the ablation area. In addition, for tumors that are difficult to observe or difficult to enter, the positioning of the electrode needle may be very difficult. The above-mentioned deficiencies lead to a low success rate of irreversible electroporation ablation surgery. Summary of the invention

[0005] The present invention aims to at least solve the technical problems existing in the prior art. To this end, the first aspect of the present invention provides a flexible pulse energy delivery device, which includes an electrode assembly, a flexible tube assembly, a control assembly and an ablation system; wherein:

[0006] The electrode assembly is configured to transmit pulse energy to a target lesion in an organ for electroporation ablation, and the flexible tube assembly is configured to move the electrode assembly to a first distance range of the target lesion; the flexible tube assembly is electrically connected to the control assembly, the control assembly is electrically insulated from the electrode assembly, and the control assembly is communicatively connected to the ablation system to achieve pulse energy transmission and data transmission;

[0007] The electrode assembly is arranged at the head end and / or the surface of the flexible tube assembly, and the electrode assembly is arranged axially along the flexible tube assembly, and can move and stick with the flexible tube assembly; the electrode assembly includes at least one electrode, and the electrode is used to contact the target lesion; when the number of the electrode is one, the electrode and the surface electrode attached to the body surface form an ablation circuit to perform monopolar mode ablation; when the number of the electrodes is two or more, the polarities of adjacent electrodes are opposite, and an ablation circuit is formed between the two electrodes to perform bipolar mode ablation;

[0008] The flexible tube body assembly includes a positioning sensor for obtaining position information of the electrode assembly and transmitting the position information to the ablation system so that the ablation system establishes a three-dimensional image of the electrode assembly and the target lesion according to the position information; the three-dimensional image includes real-time position information of the electrode assembly.

[0009] Optionally, when the number of electrodes is two or more, an insulating gap is provided between adjacent electrodes, and the width of the insulating gap is at least twice the length of the electrode; an ablation area is formed between adjacent electrodes, and the ablation area covers the edge of the lesion.

[0010] Optionally, each electrode in the electrode assembly comprises an introduction portion, a main body portion and a connection portion; the outer contour of the introduction portion is arc-shaped or conical, the main body portion is used to abut against the lesion, and the connection portion is provided with a groove structure for fixed connection with the flexible tube body assembly;

[0011] The outer surface of the electrode assembly is smooth, and the material of the outer surface of the electrode assembly has biocompatibility, corrosion resistance and developability;

[0012] The electrode assembly is in the shape of a cylindrical structure, a tubular structure or an expandable structure.

[0013] Optionally, the flexible pipe body assembly is composed of an adjustable bend, a support portion and a stress diffusion portion; the adjustable bend is located at the first end of the flexible pipe body assembly, and the electrode assembly is arranged on the adjustable bend; the surface of the adjustable bend is a low-hardness polymer material; the first end of the flexible pipe body assembly is an end of the flexible pipe body assembly away from the control assembly;

[0014] The first end of the support part is connected to the adjustable bend part, and the second end of the support part is connected to the stress diffusion part; the support part is a composite reinforced tube structure, and the tube body hardness of the support part is greater than the tube body hardness of the adjustable bend part; the interior of the support part is a single-cavity structure, which is used to lead the wires, pull wires and connecting wires of the sensor assembly passing through the flexible tube body assembly to the control assembly;

[0015] The stress diffusion portion is arranged at the connection between the support portion and the control component.

[0016] Optionally, a plurality of channels are provided inside the adjustable bend, and the channels include a guide wire cavity, a wire pulling cavity, and a functional cavity;

[0017] The wire cavity is provided with wires of the electrode assembly, and the wires of different polarities are insulated and arranged;

[0018] A pull wire is installed in the pull wire cavity, the first end of the pull wire is fixed to the pull wire cavity, the second end of the pull wire is slidably matched with the pull wire cavity, and the one-way bending of the adjustable bending part is achieved by pulling the pull wire through the control component; the first end of the pull wire is the end far from the control component, and the second end of the pull wire is the end close to the control component;

[0019] A sensor assembly is insulated and installed in the functional cavity, and the sensor assembly includes a positioning sensor and / or a morphology sensing optical fiber and / or a temperature sensor. The positioning sensor is used to collect position data of the electrode assembly, the morphology sensing optical fiber is used to collect morphology data of the electrode assembly, and the temperature sensor is used to collect temperature data of the electrode assembly.

[0020] Optionally, the adjustable bending portion is a unidirectional bending structure or a bidirectional bending structure; when the adjustable bending portion is a unidirectional bending structure, the number of the pull-wire cavity is one, which is arranged outside the central axis of the adjustable bending portion; when the adjustable bending portion is a bidirectional bending structure, the number of the pull-wire cavity is two, and the two pull-wire cavities are symmetrically arranged on both sides of the central axis of the adjustable bending portion.

[0021] Optionally, when the sensor assembly includes the positioning sensor, at least one positioning sensor is arranged at one end of the adjustable bend close to the manipulation assembly; the positioning sensor realizes three-dimensional modeling of the electrode assembly in space according to relative position information with the electrode;

[0022] When the sensor assembly includes the temperature sensor, at least one temperature sensor is arranged on the surface of the connection portion between the electrode and the flexible tube assembly to monitor the temperature data of the ablation area in real time and feed the temperature data back to the ablation system.

[0023] Optionally, the control assembly includes a rotating wheel mechanism and a connector assembly, and the control assembly drives the pull wire to move unilaterally axially back and forth through the rotating wheel mechanism to achieve bending adjustment of the adjustable bending portion;

[0024] The connector assembly includes a pulse cable and a pulse connector, a sensor cable and a sensor connector; the pulse cable and the pulse connector are electrically connected to the electrode assembly; the sensor cable and the sensor connector are electrically connected to the sensor assembly; the pulse connector and the sensor connector are communicatively connected to the ablation system.

[0025] Optionally, the pulse energy is composed of a plurality of pulse groups, the pulse group includes at least one sub-pulse, and the sub-pulse is a bipolar pulse;

[0026] The bipolar pulse is composed of a positive pulse and a negative pulse, the voltage amplitude range of the bipolar pulse is 2000V to 70000V; the first pulse width of the bipolar pulse is 50ns to 50000ns; a first pulse interval and a second pulse interval are provided between the positive pulse and the negative pulse; and an inter-group period is provided between the pulse groups;

[0027] The number of the bipolar pulses is 1 to 5000; the number of the pulse groups is 1 to 5000;

[0028] The bipolar pulse has a rising edge and / or a falling edge, and the difference between the width of the rising edge and the falling edge and the pulse width of the first pulse is less than a preset first threshold; the duration of the rising edge and the falling edge is 0 to 500 ns;

[0029] The percentage of the length of the peak voltage plateau period of a single sub-pulse to the pulse width of the first pulse is 0-100%.

[0030] Optionally, the sub-pulse is a unipolar pulse;

[0031] The voltage amplitude range of the unipolar pulse is 200V to 3000V, the second pulse width of the unipolar pulse is 10μs to 500μs; a third pulse interval is provided between the unipolar pulses; and an inter-group period is provided between the pulse groups;

[0032] The number of the unipolar pulses is 1 to 5000; the number of the pulse groups is 1 to 5000;

[0033] The unipolar pulse has a rising edge and / or a falling edge, and the difference between the width of the rising edge and the falling edge and the pulse width of the second pulse is less than the first threshold; the duration of the rising edge and the falling edge is 0 to 500 ns;

[0034] The percentage of the length of the peak voltage plateau period of a single sub-pulse to the pulse width of the second pulse is 0-100%.

[0035] Optionally, the pulse energy is composed of multiple pulse groups, each of which contains at least one high-frequency and high-voltage sub-pulse and one low-frequency and low-voltage sub-pulse, the high-frequency and high-voltage sub-pulse is the bipolar pulse, and the low-frequency and low-voltage sub-pulse is the unipolar pulse.

[0036] A second aspect of the present invention provides an interventional pulse ablation method, which is applied to an ablation system of a flexible pulse energy delivery device, wherein the flexible pulse energy delivery device is the device described in the first aspect, and the method comprises:

[0037] Acquire a target lesion image, and acquire the position of the target lesion and surrounding tissue structure from the target lesion image;

[0038] According to the location of the target lesion and the surrounding tissue structure, a three-dimensional reconstruction of the organ where the target lesion is located is performed to obtain a three-dimensional image of the organ and the target lesion, and the ablation parameters and ablation range for ablation treatment of the target lesion are calculated using the three-dimensional image;

[0039] After the electrode assembly and the flexible tube assembly of the flexible pulse energy delivery device are delivered to the organ, an external magnetic field generator is used to excite the electromagnetic signal of the sensor assembly in the electrode assembly to obtain real-time position information of the electrode assembly;

[0040] Constructing a mapping model of the electrode assembly in the three-dimensional image according to the position information of the electrode assembly, and displaying the relative position of the electrode assembly and the target lesion in real time in the mapping model;

[0041] Determining a target path for the electrode assembly to reach the target lesion according to the relative position;

[0042] Displaying the target path in the three-dimensional image so that the user can place the electrode assembly within a first distance range of the target lesion along the target path under the guidance of navigation information generated by the electromagnetic signal;

[0043] The target lesion is ablated using the electrode assembly according to the ablation parameters and the ablation range.

[0044] Optionally, determining a target path for the electrode assembly to reach the target lesion according to the relative position includes:

[0045] Determining the type of the target lesion, the type of the target lesion including a first lesion with a bronchial passage accessible inside the lesion and a second lesion located outside the bronchus;

[0046] If the target lesion is the first lesion, planning a target path for the electrode assembly to reach the target lesion along the bronchial pathway;

[0047] If the target lesion is the second lesion, the location of the high-risk tissue structure and the location of the anatomical crack in the organ are determined based on the previously performed puncture, and the target path of the electrode assembly to reach the target lesion is planned while avoiding the location of the high-risk tissue structure and the location of the anatomical crack.

[0048] The embodiments of the present invention have the following beneficial effects:

[0049] A flexible pulse energy delivery device provided by an embodiment of the present invention comprises an electrode assembly, a flexible tube assembly, a control assembly and an ablation system; wherein the electrode assembly is configured to transmit pulse energy to a target lesion in an organ for irreversible electroporation ablation, and the flexible tube assembly is configured to move the electrode assembly to a first distance range of the target lesion; the flexible tube assembly is electrically connected to the control assembly, the control assembly is electrically insulated from the electrode assembly, and the control assembly is communicatively connected to the ablation system to achieve pulse energy transmission and data transmission; the electrode assembly is arranged at the head end and / or surface of the flexible tube assembly, and the electrode assembly is arranged axially along the flexible tube assembly and can be moved along with the flexible tube assembly. The flexible tube body assembly moves and sticks to the target lesion; the electrode assembly includes at least one electrode, and the electrode is used to contact the target lesion; when the number of the electrode is one, the electrode and the surface electrode attached to the body surface form an ablation circuit to perform monopolar mode ablation; when the number of the electrodes is two or more, the polarities of adjacent electrodes are opposite, and an ablation circuit is formed between the two electrodes to perform bipolar mode ablation; the flexible tube body assembly includes a positioning sensor for obtaining the position information of the electrode assembly and transmitting the position information to the ablation system, so that the ablation system establishes a three-dimensional image of the electrode assembly and the target lesion according to the position information; the three-dimensional image includes real-time position information of the electrode assembly. The flexible tube body assembly of the present scheme transfers the electrode assembly to within a first distance range of the target lesion, so that the ablation electrode can accurately reach the target lesion, and through real-time electromagnetic positioning navigation guidance, electrode delivery planning can be achieved, reducing the difficulty of electrode arrangement and delivery; and the number of electrodes is at least one, and monopolar mode ablation can be performed, as well as bipolar mode ablation. The ablation circuit formed is less affected by tissue impedance, and the pulse energy is controllable; in addition, the head end of the flexible catheter assembly has a bending function, which can flexibly adjust the catheter delivery direction, so as to achieve delivery to target lesions that are difficult to observe and enter, and make the tumor visible, findable, and fully covered, thereby improving the success rate of irreversible electroporation ablation surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] Figure 1 is a schematic diagram of the use of a flexible pulse energy delivery device provided by an embodiment of the present invention;

[0051] Figure 2 A schematic diagram of the structure of a flexible pulse energy delivery device provided by an embodiment of the present invention;

[0052] Figure 3 A schematic diagram of the structure of an electrode assembly provided in an embodiment of the present invention;

[0053] Figure 4 A schematic diagram of a bipolar mode ablation area provided in an embodiment of the present invention;

[0054] Figure 5 A schematic structural diagram of a first electrode provided in an embodiment of the present invention;

[0055] Figure 6 A schematic diagram of the structure of an adjustable bend provided in an embodiment of the present invention;

[0056] Figure 7 A cross-sectional view of an adjustable bend provided in an embodiment of the present invention;

[0057] Figure 8 A flowchart of the steps of an interventional pulse ablation method provided by an embodiment of the present invention;

[0058] Fig. 9 A schematic diagram of a rising edge and a falling edge provided by an embodiment of the present invention;

[0059] Fig.10 One of the schematic diagrams of a unipolar pulse provided by an embodiment of the present invention;

[0060] Fig.11 A second schematic diagram of a unipolar pulse provided by an embodiment of the present invention;

[0061] Fig.12 A third schematic diagram of a unipolar pulse provided by an embodiment of the present invention;

[0062] Fig.13 One of the schematic diagrams of a coordinated pulse composed of a bipolar pulse and a unipolar pulse provided by an embodiment of the present invention;

[0063] Fig.14 A second schematic diagram of a coordinated pulse composed of a bipolar pulse and a unipolar pulse provided in an embodiment of the present invention;

[0064] Fig.15 A third schematic diagram of a coordinated pulse consisting of a bipolar pulse and a unipolar pulse provided in an embodiment of the present invention;.

[0065] Fig.16 A flowchart of the steps of an interventional pulse ablation method provided by an embodiment of the present invention. DETAILED DESCRIPTION

[0066] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0067] In the following, the terms "first" and "second" are used for descriptive purposes only and are not to be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the embodiments of the present disclosure, unless otherwise specified, "multiple" means two or more. In addition, the use of "based on" or "according to" means openness and inclusiveness, because the process, steps, calculations or other actions "based on" or "according to" one or more of the conditions or values ​​may be based on additional conditions or values ​​beyond the described values ​​in practice.

[0068] According to global cancer statistics in 2020, lung cancer is the leading cause of cancer death, accounting for approximately 1.8 million deaths, and the lungs are one of the most important target organs for metastatic disease due to hematogenous, lymphatic, and transpleural spread.

[0069] Surgical lobectomy remains the treatment of choice for patients with early-stage non-small cell lung cancer. A significant number of patients with non-small cell lung cancer (NSCLC) or extrathoracic malignancies with pulmonary metastases cannot be safely removed surgically due to unfavorable tumor location, multifocal disease, or underlying comorbidities and require minimally invasive ablative therapies. Stereotactic ablative radiation is considered an effective treatment modality in this patient population, although it may be contraindicated in some patients with prior radiation, comorbidities, or central tumors. Percutaneous ablative approaches are available but are often associated with significant morbidity. A number of endoscopic ablative techniques are being evaluated, such as radiofrequency ablation (RFA), microwave ablation (MWA), or cryoablation. These ablative techniques rely on sustained changes in tissue temperature to produce cytotoxic effects and have been reported to be highly effective in treating both primary and metastatic disease. However, safety or efficacy concerns prohibit their use in patients with tumors adjacent to major blood vessels, bile ducts, large airways, nerves, digestive tracts, or urinary tracts. With a more favorable safety profile and the ability to potentially provide both diagnostic and staging information in a single procedure, there is strong rationale for the development of bronchoscopic ablative modalities.

[0070] Irreversible electroporation ablation (IRE) is a new tissue ablation technique in which doctors puncture the skin, guide the treatment instrument to the location of the tumor, and then treat the tumor with the ablation instrument.

[0071] Irreversible electroporation ablation is applicable to many tumor types, including liver cancer, lung cancer, kidney cancer, etc. When biological tissue is in a high-intensity electric field, the permeability of the cell membrane in the tissue increases significantly, causing the extracellular fluid molecules to diffuse into the cell membrane and cause cell death, thereby achieving the purpose of tissue ablation. This is mainly because the bilayer of lipids in the cell membrane breaks down in a high-intensity electric field, and the bilayer of lipids changes with the change of electric field intensity, action time, pulse cycle and number, which may change from early reversible electroporation to irreversible electroporation. In recent years, it has been applied to minimally invasive ablation of various tissues or tumors. Compared with traditional tissue ablation technology, IRE tissue ablation technology has many significant advantages, such as IRE inactivates tissue at the cellular level, does not affect tissue structure and protein activity, and can accurately control the scope of tissue inactivation; and IRE generates very little heat during ablation, there is no heat sinking phenomenon, and the effect on local blood vessels is very small; IRE ablation time is short, reducing tissue surgical exposure time and less infectious complications. In addition, during ablation, medical imaging methods such as computed tomography (CT), ultrasound, and magnetic resonance imaging can be used to locate the ablation range, monitor the treatment in real time, and observe the postoperative efficacy, making the IRE ablation range more precise and protecting normal tissues to the greatest extent.

[0072] The inventors discovered during their research on related technologies that existing IRE products have the following deficiencies in the treatment of lung tumors, which limits their clinical applications.

[0073] 1) Two to six electrodes need to be placed in or around the tumor, which is very time-consuming and may lead to needle placement errors. At the same time, multiple punctures have a high risk of complications such as pneumothorax and pleural effusion.

[0074] 2) The ablation electrodes must be placed precisely and in parallel to generate a sufficiently strong electric field, with an ideal needle spacing of 15 to 20 mm. On the one hand, the angle of the electrodes may cause overcurrent at locations where the electrodes are close, resulting in unnecessary Joule heating; on the other hand, incomplete ablation may occur at locations where the electrodes are far apart. Placing electrodes in parallel in the chest is extremely challenging due to the obstruction of the ribs.

[0075] 3) The air in the alveoli of the lungs is an excellent insulator for electric current, which significantly affects the energy transfer between electrodes, limits the degree of ablation of lung cancer tissue outside the electrodes, and leads to an overestimation of the ablation area.

[0076] These IRE-specific deficiencies may result in lower technical success rates compared with other ablation techniques. In particular, positioning of the electrode needle may be difficult for difficult-to-view or difficult-to-access tumors.

[0077] In order to solve the problems of difficult IRE percutaneous ablation arrangement, more complications and inaccurate electrode positioning in the prior art, especially for lung tumors that are difficult to observe or difficult to enter, the present invention proposes a flexible pulse energy delivery device that can be delivered via a bronchoscope for local bipolar mode ablation, which is less affected by tissue impedance, has a safe and controllable ablation zone, and has slight effects on nerve and muscle jitters. By introducing adjustable electrode bends and an electromagnetic positioning three-dimensional navigation system, the location of tumors and important structures can be determined in real time, and the ablation electrodes can be accurately delivered to the interior of the tumor for ablation, thereby reducing postoperative complications, reducing the frequency of intraoperative CT confirmation, and improving the ablation success rate of irreversible electroporation.

[0078] Figure 1 A schematic diagram of the use of a flexible pulse energy delivery device provided in an embodiment of the present invention.

[0079] like Figure 1 As shown, the flexible pulse energy delivery device includes an electrode assembly 1 , a flexible tube assembly 2 , a steering assembly 3 and an ablation system 4 .

[0080] The electrode assembly 1 is configured to deliver nanosecond and / or microsecond pulse energy to the target lesion for irreversible electroporation ablation to achieve conformal ablation of target lesions of different shapes and types. At least one electrode in the electrode assembly 1 contacts the target lesion; when only one electrode contacts the lesion, an energy release loop is formed with the surface electrode to achieve local irreversible electroporation ablation of small lesions; when two or more electrodes contact the lesion, bipolar mode ablation can be achieved. The bipolar mode forms an energy release loop between adjacent electrodes, and a larger ablation range can be achieved under the same energy parameters, with less impact on adjacent nerves and muscle jitters.

[0081] The flexible tube body component 2 is configured to deliver the electrode component 1 to the target lesion through the bronchoscope channel. The head end of the flexible tube body component 2 has a flexible radial bending function to ensure that the electrode is delivered in a curved or bifurcated lumen.

[0082] like Figure 1 As shown, the electrode assembly 1 has been delivered to the target lesion in the lung via the bronchus by the flexible tube assembly 2 .

[0083] Figure 2 A schematic structural diagram of a flexible pulse energy delivery device provided in an embodiment of the present invention.

[0084] like Figure 2As shown, the electrode assembly 1 is arranged at the head end and / or the surface of the flexible tube body assembly 2. The electrode assembly 1 is arranged at equal intervals along the axial direction of the flexible tube body assembly 2, and can move and adhere to different branch segments of the peripheral bronchus along with the flexible tube body assembly 2; the flexible tube body assembly 2 is electrically connected to one end of the control assembly 3, and the flexible tube body assembly 2 realizes the head end bending operation through the control assembly 3.

[0085] Reference Figure 2 , the electrode assembly 1 passes through the wire ( Figure 2 (not shown) is electrically connected to the ablation system 4; the electrode assembly 1 and the flexible tube body assembly 2 are electrically insulated; the electrode assembly 1 is arranged at equal intervals along the axial direction of the flexible tube body assembly 2, and the surface area of ​​each electrode is consistent, and the initial diameter of the electrode assembly 1 is preferably 4Fr to 7Fr.

[0086] The other end of the control component 3 is connected to the ablation system 4 through a connector to achieve pulse energy transmission and / or position data monitoring and / or temperature data monitoring to complete precise local lesion ablation.

[0087] The ablation system 4 is specifically an electronic device such as a computer, which is used to send pulse energy, receive monitoring data and electromagnetic signals from sensors, etc., and to perform three-dimensional modeling of the target lesion and electrode assembly based on the received monitoring data and electromagnetic signals, and display them on the screen.

[0088] Figure 3 A schematic structural diagram of an electrode assembly provided in an embodiment of the present invention.

[0089] like Figure 3 As shown, the electrode assembly 1 is arranged axially along the flexible tube assembly 2; when the number of electrodes in the electrode assembly 1 is one, such as the first electrode 101 or the second electrode 102, monopolar mode ablation can be performed; at this time, the first electrode 101 or the second electrode 102 and the surface electrode ( Figure 1 (not shown) to form an ablation loop; preferably, the electrode length ranges from 2 mm to 10 mm;

[0090] Optionally, the electrode assembly 1 is arranged at equal intervals along the axial direction of the flexible tube body assembly 2; when the number of electrodes of the electrode assembly 1 is greater than one, such as the first electrode 101, the second electrode 102 and / or the third electrode 103, bipolar mode ablation can be performed, the adjacent electrodes have opposite polarities, and an ablation circuit can be formed between the two electrodes.

[0091] The flexible tube body assembly 2 includes a developing ring and a positioning sensor, and has intraoperative visualization functions such as developing and / or real-time navigation positioning, which facilitates the adjustment and confirmation of the electrode position through X-ray and / or electromagnetic navigation during the operation. Specifically, the flexible tube body assembly 2 obtains the position information of the electrode assembly 1 located thereon, and transmits the position information to the ablation system 4. The ablation system 4 performs three-dimensional reconstruction of the electrode assembly and the target lesion according to the position information to obtain a three-dimensional image of the electrode assembly and the target lesion. The three-dimensional image and the real-time position of the electrode assembly are displayed on the screen of the ablation system. The user uses the control assembly to adjust the position of the flexible tube body assembly and bend the head end according to the real-time position of the electrode assembly, thereby achieving electrode position adjustment.

[0092] In a preferred embodiment of the present invention, the electrode assembly 1 and the flexible tube body assembly 2 can be delivered via bronchoscope intervention for the treatment of peripheral lung nodules or tumors. Specifically, when the location of the lesion has been confirmed before surgery, the electrode assembly 1 and the flexible tube body assembly 2 can be inserted into the bronchoscope channel. Then, the flexible tube body assembly 2 is guided along the optimal path to quickly reach the lesion site with the help of electromagnetic positioning technology, and the electrode assembly 1 is delivered into the lesion, and finally the relative position of the electrode and the lesion is confirmed by CT imaging for ablation. If the location of the lesion is not confirmed before surgery, it can be delivered in conjunction with a guide sheath, and the adapted guide sheath is pre-pushed to the vicinity of the lesion through electromagnetic navigation, and the flexible tube body assembly 2 is withdrawn, and the location of the lesion is further confirmed by a radial ultrasound probe and tissue biopsy, and then the flexible tube body assembly 2 is exchanged and inserted to locate the lesion through CT imaging for ablation.

[0093] In summary, the embodiments of the present invention have the following beneficial effects:

[0094] 1) The electrode assembly can be delivered through the bronchus for bipolar ablation. The ablation range is less affected by tissue impedance, overcoming the difficulty of placing the needle for percutaneous puncture ablation with the Nanoknife and the problem of incomplete ablation due to the influence of air in the lungs. At the same time, the electrode realizes bipolar ablation, the pulse energy is controllable, the damage to adjacent nerves and blood vessels is small, and there are fewer postoperative complications.

[0095] 2) Integrate electromagnetic positioning sensors and other sensing modules in the flexible catheter assembly to collect and communicate information about electrode position, shape, and temperature. Through real-time electromagnetic positioning navigation and guidance, electrode delivery planning can be achieved, reducing the difficulty of electrode placement and delivery.

[0096] 3) The tip of the flexible catheter assembly has a bending function, which can flexibly adjust the delivery direction of the catheter to achieve delivery to lesions at larger angles in the periphery of the lungs, making the tumor visible, findable, and fully covered, thereby improving the success rate of irreversible electroporation surgery.

[0097] In some possible embodiments, when the number of electrodes is two or more, an insulating gap is provided between adjacent electrodes, and the width of the insulating gap is at least twice the length of the electrode; an ablation area is formed between adjacent electrodes, and the ablation area covers the edge of the lesion.

[0098] like Figure 3 As shown, an insulating gap L1 is provided between adjacent electrodes. Preferably, the insulating gap L1 is 2 times or more of the electrode length to avoid sparking or short circuit failures between adjacent electrodes during ablation. Preferably, the insulating gap L1 of the electrode assembly 1 is 4 mm to 20 mm, and the total length L2 of the electrode assembly 1 is 10 mm to 40 mm.

[0099] Figure 4 A schematic diagram of the bipolar mode ablation area provided in an embodiment of the present invention.

[0100] like Figure 4 As shown, during bipolar mode ablation, adjacent electrodes of the electrode assembly 1 can be ablated in different zones or ablated synchronously according to the axial lengths of different lesions to achieve different ablation lengths.

[0101] Reference Figure 4 The first electrode 101 and the second electrode 102 form a first ablation area A1, and the second electrode 102 and the third electrode 103 form a second ablation area A2. The first ablation area A1 and / or the second ablation area A2 need to completely cover the edge of the lesion, and preferably the shortest distance L3 between the edge of the ablation area and the edge of the lesion is greater than or equal to 5 mm.

[0102] In some possible embodiments, each electrode in the electrode assembly 1 includes an introduction portion 1010, a main body portion 1011 and a connecting portion 1012; the outer contour of the introduction portion 1010 is arc-shaped or conical, the main body portion 1011 is used to abut against the lesion, and the connecting portion 1012 is provided with a groove structure for fixed connection with the flexible tube body assembly 2; the outer surface of the electrode assembly 1 is smooth, and the outer surface material of the electrode assembly 1 has biocompatibility, corrosion resistance and developability; the shape of the electrode assembly 1 is a cylindrical structure, a tubular structure or an expandable structure.

[0103] Figure 5 A schematic structural diagram of a first electrode provided in an embodiment of the present invention.

[0104] like Figure 5 As shown, the first electrode 101 in the electrode assembly 1 is provided with an introduction portion 1010, a main body portion 1011 and a connecting portion 1012; the outer contour of the introduction portion 1010 is preferably arc-shaped or conical, so as to facilitate penetrating into the narrower sections of the bronchus and the inside of the lesion; the main body portion 1011 is used to fully adhere to the lesion; the connecting portion 1012 is provided with a groove structure to achieve a fixed connection with the flexible tube body assembly 2.

[0105] The outer surface of the electrode assembly 1 is polished, and the edge is smooth and burr-free. It is preferably made of materials with excellent biocompatibility, corrosion resistance and developing properties, such as stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver and the like.

[0106] Optionally, in order to fit the first peripheral lesion and achieve a radially uniform ablation range, the electrode assembly 1 preferably has a cylindrical structure and / or a tubular structure.

[0107] Optionally, in order to meet the ablation requirements of different cavity diameters, the electrode assembly 1 can also be an expandable structure, such as a woven mesh structure, a sac structure, a spline structure, etc.; the expanded diameter of the electrode assembly 1 is 1.5 mm to 20 mm.

[0108] In some possible embodiments, the flexible pipe body assembly 2 is composed of an adjustable bend 201, a support portion 202 and a stress diffusion portion 203; the adjustable bend 201 is located at the first end of the flexible pipe body assembly 2, and the electrode assembly 1 is arranged on the adjustable bend 201; the surface of the adjustable bend 201 is a low-hardness polymer material; the first end of the flexible pipe body assembly 2 is the end of the flexible pipe body assembly 2 away from the control assembly 3; the first end of the support portion 202 is connected to the adjustable bend 201, and the second end of the support portion 202 is connected to the stress diffusion portion 203; the support portion 202 is a composite reinforced tube structure, and the tube body hardness of the support portion 202 is greater than the tube body hardness of the adjustable bend 201; the interior of the support portion 202 is a single-cavity structure, which is used to lead the wires, pull wires and connecting wires of the sensor assembly passing through the flexible pipe body assembly 2 to the control assembly 3; the stress diffusion portion 203 is arranged at the connection between the support portion 202 and the control assembly 3.

[0109] Reference Figure 2 The flexible pipe body assembly 2 consists of an adjustable bending portion 201 , a supporting portion 202 and a stress diffusion portion 203 .

[0110] The adjustable bend 201 is located at the first end of the flexible tube assembly 2, and the electrode assembly 1 is arranged on it. The surface of the adjustable bend 201 is a polymer material with low hardness, preferably polyetheramide, nylon, thermoplastic polyurethane, polytetrafluoroethylene, etc., to achieve flexible delivery in curved or bifurcated anatomical structures. The first end of the flexible tube assembly is the end of the flexible tube assembly away from the control assembly.

[0111] The first end of the support portion 202 is connected to the adjustable bend portion 201, and the second end thereof is connected to the control component 3; the support portion 202 is preferably a composite reinforced tube structure such as a braided tube and a spring tube; the support portion 202 has a higher tube body hardness than the adjustable bend portion 201; the interior of the support portion 202 is a single-cavity structure, which is used to lead the wires, pull wires, sensor components, etc. in the flexible tube body component 2 to the control component 3; a stress diffusion portion 203 is provided at the connection between the support portion 202 and the control component 3.

[0112] The interior of the support portion 202 is a single-cavity structure, which is used to lead the wires, pull wires and connecting wires of the sensor assembly passing through the flexible tube body assembly 2 to the control assembly 3 .

[0113] The steering assembly 3 is electrically insulated from the electrode assembly 1 , and is electrically connected to the ablation device 4 via the connector assembly 12 of the steering assembly 3 .

[0114] In some possible implementations, the adjustable bend 201 has multiple channels opened inside, including a guide wire cavity, a pull wire cavity, and a functional cavity;

[0115] The wire cavity is provided with wires of the electrode assembly, and the wires of different polarities are insulated and arranged;

[0116] A pull wire 210 is installed in the pull wire cavity, the first end of the pull wire 210 is fixed to the pull wire cavity, the second end of the pull wire 210 is slidably matched with the pull wire cavity, and the one-way bending of the adjustable bending portion is achieved by pulling the pull wire through the control component; the first end of the pull wire 210 is the end far from the control component, and the second end of the pull wire 210 is the end close to the control component;

[0117] A sensor assembly 211 is insulated and installed in the functional cavity. The sensor assembly 211 includes a positioning sensor and / or a morphology sensing optical fiber and / or a temperature sensor. The positioning sensor is used to collect position data of the electrode assembly, the morphology sensing optical fiber is used to collect morphology data of the electrode assembly, and the temperature sensor is used to collect temperature data of the electrode assembly.

[0118] Figure 6 A schematic structural diagram of an adjustable bend provided in an embodiment of the present invention.

[0119] like Figure 6 As shown, a plurality of channels are provided inside the adjustable bend 201, including a wire cavity C1, a wire pulling cavity C2, and a functional cavity C3.

[0120] The wire cavity C1 is provided with wires of the electrode assembly 1 , and wires of different polarities are insulated from each other.

[0121] A pull wire 210 is installed in the pull wire cavity C2, a first end of the pull wire 210 is fixed to the pull wire cavity C2, and a second end thereof is slidably matched with the pull wire cavity C2. By pulling the pull wire 210, the adjustable bending portion 201 can be bent in one direction.

[0122] The first end of the pull wire 210 is an end far from the control component 3 , and the second end of the pull wire 210 is an end close to the control component 3 .

[0123] Preferably, the length of the adjustable bend 201 is 30 mm to 70 mm, and the unidirectional bending angle is 0° to 180°.

[0124] A sensor assembly 211 is insulated and installed in the functional cavity C3. The sensor assembly 211 includes but is not limited to a positioning sensor and / or a morphology sensing optical fiber and / or a temperature sensor, and is used to perform real-time monitoring of position data and / or electrode morphology data and / or temperature data of the electrode assembly 1.

[0125] In some possible embodiments, the adjustable bend 201 is a unidirectional bend structure or a bidirectional bend structure; when the adjustable bend 201 is a unidirectional bend structure, the number of the pull wire cavity is one, which is arranged outside the central axis of the adjustable bend 201; when the adjustable bend 201 is a bidirectional bend structure, the number of the pull wire cavity is two, and the two pull wire cavities are symmetrically arranged on both sides of the central axis of the adjustable bend 201.

[0126] Specifically, one-way bending means that it can only bend in one direction, and two-way bending means that it can bend in two directions.

[0127] Reference Figure 6 When the adjustable bend 201 is a unidirectional bending structure, the number of the wire pulling cavity C2 is one, which is arranged outside the central axis of the adjustable bend 201; when the adjustable bend 201 is a bidirectional bending structure, the number of the wire pulling cavity C2 is two, and the two wire pulling cavities C2 are symmetrically arranged on both sides of the central axis of the adjustable bend 201.

[0128] In order to improve the effect and efficiency of one-way bending adjustment and two-way bending adjustment, the wire drawing cavity C2 may be arranged outside the central axis and close to the inner surface of the adjustable bending portion.

[0129] In some possible embodiments, when the sensor assembly 211 includes the positioning sensor, at least one positioning sensor is arranged at one end of the adjustable bend close to the control assembly; the positioning sensor realizes three-dimensional modeling of the electrode assembly in space based on the relative position information with the electrode; when the sensor assembly 211 includes the temperature sensor, at least one temperature sensor is arranged on the surface of the connection between the electrode and the flexible tube body assembly to monitor the temperature data of the ablation area in real time, and feed back the temperature data to the ablation system.

[0130] Figure 7 A cross-sectional view of an adjustable bend provided in an embodiment of the present invention.

[0131] When the sensor assembly 211 includes a positioning sensor, at least one positioning sensor is arranged at an end away from the operating assembly 3 to collect position and direction data of the electrode assembly 1 .

[0132] like Figure 7 As shown, the distance between the positioning sensor and the first electrode 101 is L4, and the distance between the positioning sensor and the second electrode 102 is L5. In this way, according to the position information collected by the positioning sensor, the position information of the first electrode 101 and the position information of the second electrode 102 can be calculated, thereby realizing the three-dimensional model reconstruction of the electrode assembly 1 in space.

[0133] The positioning sensor is insulated and isolated from the electrode assembly 1 by high dielectric strength materials such as polyimide and tetrafluoroethylene. The positioning sensor is preferably a 5DOF or 6DOF electromagnetic positioning sensor, which can measure the spatial position coordinates of the electrode assembly 1 in real time, and transmit the position and direction data to the interface of the ablation system 4, so as to realize the visualization of the electrode assembly position information.

[0134] In some possible implementations, when the sensor assembly 101 includes a temperature sensor, at least one temperature sensor is arranged on the surface of the connection portion 1021 of the first electrode 101 to monitor the temperature of the ablation area in real time, and to feed back to the ablation system 4 for energy regulation, so as to control the temperature of the ablation area tissue and reduce the thermal damage to the adjacent important blood vessels or nerves caused by heat accumulation. The temperature sensor is preferably a thermocouple sensor, a thermistor sensor, etc.

[0135] In some possible implementations, the control assembly 3 includes a rotating wheel mechanism 301 and a connector assembly 302. The control assembly 3 drives the pull wire to move unilaterally axially back and forth through the rotating wheel mechanism 301 to achieve bending adjustment of the adjustable bend 201.

[0136] The connector assembly 302 includes a pulse cable W1 and a pulse connector L1, a sensor cable W2 and a sensor connector L2; the pulse cable W1 and the pulse connector L1 are electrically connected to the electrode assembly 1; the sensor cable W2 and the sensor connector L2 are electrically connected to the sensor assembly 211; the pulse connector L1 and the sensor connector L2 are communicatively connected to the ablation system 4.

[0137] Specifically, refer to Figure 7 and Figure 2 The connecting portion 1021 of the first electrode 101 is connected to the pull wire 210 .

[0138] The control assembly 3 includes a rotating wheel mechanism 301 , and the control assembly 3 drives the pull wire 210 to move back and forth axially on one side through the rotating wheel mechanism 301 , thereby realizing bending adjustment of the adjustable bending portion 201 .

[0139] Reference Figure 2 The control component 3 includes a connector component 302, and the connector component 302 includes a pulse cable W1 and a pulse connector L1, a sensor cable W2 and a sensor connector L2; the pulse cable W1 and the pulse connector L1 are electrically connected to the electrode component 1; the sensor cable W2 and the sensor connector L2 are electrically connected to the sensor component 211; the pulse connector L1 and the sensor connector L2 are communicatively connected to the ablation system 4.

[0140] In a possible embodiment, the pulse energy is composed of multiple pulse groups, each of which contains at least one sub-pulse, and the sub-pulse is a bipolar pulse; the bipolar pulse is composed of a positive pulse and a negative pulse, and the voltage amplitude range of the bipolar pulse is 2000V~70000V; the first pulse width of the bipolar pulse is 50ns~50000ns; a first pulse interval and a second pulse interval are provided between the positive pulse and the negative pulse; an inter-group period is provided between the pulse groups; the number of the bipolar pulses is 1~5000; the number of the pulse groups is 1~5000; the bipolar pulse has a rising edge and / or a falling edge, and the difference between the width of the rising edge and the falling edge and the first pulse width is less than a preset first threshold; the duration of the rising edge and the falling edge is 0~500ns; the length of the peak voltage plateau period of a single sub-pulse accounts for 0~100% of the first pulse width.

[0141] Figure 8 A schematic diagram of a bipolar pulse provided by an embodiment of the present invention.

[0142] like Figure 8As shown in the figure, V1 represents the positive pulse amplitude, V3 represents the negative pulse amplitude. T1 represents the first pulse width of the bipolar pulse, T3 and T4 represent the first pulse interval and the second pulse interval between the positive pulse and the negative pulse, respectively. T6 represents the inter-group period between pulse groups. N1 represents the inter-group period, and N3 represents the number of pulse groups.

[0143] The bipolar pulse is composed of a positive pulse amplitude V1 and a negative pulse amplitude V3, and the voltage amplitude range is preferably 2000 V to 70000 V. The first pulse width T1 of the bipolar pulse is preferably 50 ns to 50000 ns.

[0144] The number of bipolar pulses N1 is preferably 1 to 5000; the number of pulse groups N3 is preferably 1 to 5000;

[0145] Fig. 9 A schematic diagram of a rising edge and a falling edge provided by an embodiment of the present invention.

[0146] like Fig. 9 As shown, V1 represents the positive pulse amplitude, V3 represents the negative pulse amplitude, the rising edge refers to the stage where the pulse amplitude rises, the falling edge refers to the stage where the pulse amplitude falls, and the plateau period refers to the stage between the rising edge and the falling edge.

[0147] The bipolar pulse has a rising edge or a falling edge, or a rising edge and a falling edge at the same time. The width of the rising edge or the falling edge is close to the first pulse width T1; the rising edge and falling edge time of the positive pulse and the negative pulse of the bipolar pulse is 0 to 500ns, and the length of the peak voltage plateau period of a single sub-pulse accounts for 0 to 100% of the first pulse width T1.

[0148] In a possible embodiment, the sub-pulse is a unipolar pulse; the voltage amplitude range of the unipolar pulse is 200V~3000V, and the second pulse width of the unipolar pulse is 10μs~500μs; a third pulse interval is provided between the unipolar pulses; an inter-group period is provided between the pulse groups; the number of the unipolar pulses is 1~5000; the number of the pulse groups is 1~5000 groups; the unipolar pulse has a rising edge and / or a falling edge, and the difference between the width of the rising edge and the falling edge and the pulse width of the second pulse is less than the first threshold; the duration of the rising edge and the falling edge is 0~500ns; the length of the peak voltage plateau period of a single sub-pulse accounts for 0 to 100% of the second pulse width.

[0149] Fig.10 This is one of the unipolar pulse schematic diagrams provided in an embodiment of the present invention.

[0150] like Fig.10As shown, V2 represents the amplitude voltage, T2 represents the second pulse width of the unipolar pulse, T4 represents the third pulse interval between the unipolar pulses, T6 represents the group interval, N2 represents the number of pulses, and N3 represents the number of pulse groups.

[0151] Fig.11 The second schematic diagram of a unipolar pulse provided by an embodiment of the present invention.

[0152] like Fig.11 As shown, it is a unipolar pulse when the length of the peak voltage plateau period accounts for 100% of the second pulse width.

[0153] Fig.12 The third schematic diagram of a unipolar pulse provided by an embodiment of the present invention.

[0154] like Fig.12 As shown, it is a unipolar pulse when the length of the peak voltage plateau period accounts for 80% of the second pulse width.

[0155] In a possible implementation, the pulse energy is composed of multiple pulse groups, each of which includes a high-frequency and high-voltage sub-pulse and a low-frequency and low-voltage sub-pulse, the high-frequency and high-voltage sub-pulse is the bipolar pulse, and the low-frequency and low-voltage sub-pulse is the unipolar pulse.

[0156] Fig.13 One of the schematic diagrams of a coordinated pulse consisting of a bipolar pulse and a unipolar pulse provided in an embodiment of the present invention.

[0157] like Fig.13 As shown, the high-frequency high-voltage pulse is 2000V to 70000V. The low-frequency low-voltage pulse is 200V to 3000V. V1 represents the voltage value of the high-frequency high-voltage pulse, T1 represents the pulse width of the high-frequency high-voltage pulse, T3 represents the first pulse interval, T4 represents the second pulse interval. T5 represents the repeated pulse interval. T6 represents the group interval. N1 represents the number of sub-pulses of the high-frequency high-voltage pulse.

[0158] V2 represents the voltage value of the low-frequency and low-voltage pulse, T2 represents the pulse width of the low-frequency and low-voltage pulse, N2 represents the number of sub-pulses of the low-frequency and low-voltage pulse, and N3 represents the number of pulse groups.

[0159] Wherein, the bipolar pulse is composed of a positive pulse amplitude V1 and a negative pulse amplitude V3, and the voltage amplitude range is preferably 2000V to 70000V; the pulse width T1 of the bipolar pulse is preferably 50ns to 50000ns; a first pulse interval T3 is provided between the positive pulse and the negative pulse of the bipolar pulse; a second pulse interval T4 is provided between the bipolar pulses; optionally, the number of bipolar pulses N1 is preferably 1 to 5000; optionally, the amplitude voltage V2 of the unipolar pulse is preferably 200V to 3000V;

[0160] The pulse width T1 of the unipolar pulse is preferably 10μs to 500μs; a second pulse interval T4 is provided between the unipolar pulses; an inter-group period T6 is provided between pulse groups; the number N2 of unipolar pulses is preferably 1 to 5000; the number N3 of pulse groups is preferably 1 to 5000; the number N3 of pulse groups is preferably 1 to 5000; a pulse repetition interval T5 is provided between bipolar pulses and unipolar pulses; an inter-group period T6 is provided between pulse groups.

[0161] The unipolar pulse and the bipolar pulse have a rising edge or a falling edge, or a rising edge and a falling edge exist at the same time, and the width of the rising edge or the falling edge is close to the pulse width T1; preferably, the rising edge and the falling edge time of the sub-pulse are 0 to 500ns, and the length of the peak voltage plateau period of a single sub-pulse accounts for 0 to 100% of the pulse width T1 or T2.

[0162] Fig.14 The second schematic diagram of a coordinated pulse composed of a bipolar pulse and a unipolar pulse provided in an embodiment of the present invention.

[0163] like Fig.14 As shown, it is a cooperative pulse when the percentage of the peak voltage plateau period to the pulse width is 100%.

[0164] Fig.15 The third schematic diagram of a coordinated pulse composed of a bipolar pulse and a unipolar pulse provided in an embodiment of the present invention.

[0165] like Fig.15 As shown, it is a cooperative pulse when the length of the peak voltage plateau period accounts for 80% of the pulse width.

[0166] Fig.16 A flowchart of the steps of an invasive pulse ablation method provided by an embodiment of the present invention. The method is applied to Figure 2 The ablation system in the flexible pulse energy delivery device, the method comprising:

[0167] Step 101: Acquire a target lesion image, and acquire the position of the target lesion and surrounding tissue structure from the target lesion image.

[0168] Before treatment, the user will undergo imaging examinations such as CT (Computed Tomography) or MRI (Nuclear Magnetic Resonance) of the diseased organ to obtain a CT image or MRI image, which is the target lesion image. The image recognition algorithm is used to identify the target lesion from the target lesion image, and obtain information such as the location and surrounding structure of the target lesion, as well as the size and shape of the target lesion.

[0169] Step 102: Perform three-dimensional reconstruction of the organ where the target lesion is located according to the location of the target lesion and the surrounding tissue structure to obtain a three-dimensional image of the organ and the target lesion, and use the three-dimensional image to calculate ablation parameters and ablation range for ablation treatment of the target lesion.

[0170] Navigation planning software is used to perform three-dimensional reconstruction of the lungs to help plan the path of IRE treatment, and the ablation zone simulation software is used to calculate the optimal ablation parameters and theoretical ablation range.

[0171] Step 103: After the electrode assembly and the flexible tube assembly of the flexible pulse energy delivery device are delivered to the organ, an external magnetic field generator is used to stimulate the electromagnetic signal of the sensor assembly in the electrode assembly to obtain real-time position information of the electrode assembly.

[0172] During treatment, the external magnetic field generator of the ablation system 4 sends electromagnetic waves in a certain area to stimulate the sensor assembly 211 in the electrode assembly 1 to generate an induced electromagnetic signal, so as to accurately position the electrode assembly according to the electromagnetic signal.

[0173] Step 104: construct a mapping model of the electrode assembly in the three-dimensional image based on the position information of the electrode assembly, and display the relative position of the electrode assembly and the target lesion in real time in the mapping model.

[0174] Based on the position information and spatial structure of the electrode assembly 1, a mapping model of the electrode assembly 1 is constructed to display in real time the relative positions of the electrode assembly 1 and the target lesion, as well as high-risk tissues, anatomical cracks and other structures in the body.

[0175] Step 105: Determine a target path for the electrode assembly to reach the target lesion based on the relative position.

[0176] Based on the relative positions of the electrode assembly 1 and the target lesion, as well as structures such as blood vessels in the body, a target path for the electrode assembly 1 to reach the target lesion is calculated while avoiding high-risk tissues, anatomical cracks and other structures in the body.

[0177] Step 106: Display the target path in the three-dimensional image so that the user can place the electrode assembly within a first distance range of the target lesion along the target path under the guidance of the navigation information generated by the electromagnetic signal.

[0178] Under the guidance of the navigation information, the user places the electrode assembly within the first distance range of the target lesion according to the target path displayed in the three-dimensional image. Specifically, the electrode assembly 1 and the flexible tube assembly 2 of the flexible pulse energy delivery device are delivered into the organ through the bronchoscope, and the electrode assembly 1 reaches the periphery of the target lesion.

[0179] The number and placement of electrodes will be determined based on the size and shape of the target lesion. Electrode placement requires a high degree of real-time electrode positioning accuracy. During surgery, CT image fusion positioning technology is used to confirm the final electrode placement to ensure the best electrode placement effect.

[0180] Step 107: Perform ablation treatment on the target lesion using the electrode assembly according to the ablation parameters and the ablation range.

[0181] Once the electrode assembly 1 is in place, the electrical pulses are tested to observe the muscle contraction and ECG synchronization. After confirming that the electrical impedance of the tissue is within an acceptable range, ablation is performed using the optimal ablation parameters.

[0182] Specifically, nanosecond and / or microsecond electrical pulses are used to perform ablation within the ablation range calculated in the previous step, and the electrical pulses change the permeability of organelles and / or cell membranes, leading to cell death. The non-thermal properties of IRE enable it to destroy cancer cells while minimizing the impact on surrounding normal tissues.

[0183] After the ablation operation, a CT scan is performed immediately to confirm that the real-time ablation range completely covers the tumor area. After the ablation is completed, a CT scan is performed again to confirm that no complications such as severe bleeding and pneumothorax occur, and the flexible pulse energy delivery device is removed.

[0184] In an embodiment of the present invention, the flexible tube body assembly moves the electrode assembly to within a first distance range of the target lesion, so that the ablation electrode can accurately reach the target lesion, and through real-time electromagnetic positioning navigation guidance, the electrode delivery planning is realized, reducing the difficulty of electrode arrangement and delivery; and the number of electrodes is at least one, and monopolar mode ablation can be performed, and bipolar mode ablation can also be performed. The ablation circuit formed is less affected by tissue impedance, and the pulse energy is controllable; in addition, the head end of the flexible catheter assembly has a bending function, which can flexibly adjust the catheter delivery direction, so as to achieve delivery to target lesions that are difficult to observe and enter, and make the tumor visible, findable, and fully covered, thereby improving the success rate of irreversible electroporation ablation surgery.

[0185] In some possible implementations, determining a target path for the electrode assembly to reach the target lesion according to the relative position in step 105 includes:

[0186] Step 1051, determining the type of the target lesion, wherein the type of the target lesion includes a first lesion with an inlet bronchial passage and a second lesion outside the bronchus;

[0187] Step 1052: If the target lesion is the first lesion, planning a target path for the electrode assembly to reach the target lesion along the bronchial pathway;

[0188] Step 1053: If the target lesion is the second lesion, the location of the high-risk tissue structure and the location of the anatomical crack in the organ are determined based on the previously performed puncture, and the target path of the electrode assembly to reach the target lesion is planned while avoiding the location of the high-risk tissue structure and the location of the anatomical crack.

[0189] In step 1051 to step 1053, the types of target lesions include a first lesion with an accessible bronchial passage inside the lesion and a second lesion outside the bronchus.

[0190] The methods for determining the target path for the two different lesions are different. Since the first lesion has a bronchus that can be entered, the path planning can be selected along the bronchial pathway. For the second lesion outside the bronchus, lung parenchyma puncture is required to establish a channel in advance, and the path planning needs to avoid the location of high-risk tissue structures and anatomical cracks.

[0191] Among them, high-risk tissue structures refer to high-risk tissues such as blood vessels and nerves, while anatomical cracks refer to oblique cracks, horizontal cracks, etc. that separate the lower lobe, middle lobe and upper lobe of the lungs.

[0192] Those skilled in the art can understand that all or part of the processes in the above-mentioned embodiment methods can be completed by instructing the relevant hardware through a computer program, and the computer program can be stored in a non-volatile computer-readable storage medium. When the computer program is executed, it can include the processes of the embodiments of the above-mentioned methods. Among them, any reference to memory, storage, database or other media used in the embodiments provided in this application can include non-volatile and / or volatile memory. Non-volatile memory may include read-only memory (ROM), programmable ROM (PROM), electrically programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM) or flash memory. Volatile memory may include random access memory (RAM) or external cache memory. As an illustration and not limitation, RAM is available in many forms, such as static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), synchronous link (Synchlink) DRAM (SLDRAM), memory bus (Rambus) direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and memory bus dynamic RAM (RDRAM).

[0193] Those skilled in the art will readily appreciate other embodiments of the present disclosure after considering the specification and practicing the invention disclosed herein. This application is intended to cover any variations, uses, or adaptations of the present disclosure that follow the general principles of the present disclosure and include common knowledge or customary techniques in the art that are not disclosed in the present disclosure. The specification and examples are intended to be exemplary only, and the true scope and spirit of the present disclosure are indicated by the following claims.

[0194] It should be understood that the present disclosure is not limited to the exact structures that have been described above and shown in the drawings, and that various modifications and changes may be made without departing from the scope thereof. The scope of the present disclosure is limited only by the appended claims.

Claims

1. A flexible pulse energy delivery device, characterized in that: The device comprises an electrode assembly, a flexible tube assembly, a control assembly and an ablation system; wherein, The electrode assembly is configured to transmit pulse energy to a target lesion in an organ for electroporation ablation, and the flexible tube assembly is configured to move the electrode assembly to a first distance range of the target lesion; the flexible tube assembly is electrically connected to the control assembly, the control assembly is electrically insulated from the electrode assembly, and the control assembly is communicatively connected to the ablation system to achieve pulse energy transmission and data transmission; The electrode assembly is arranged at the head end and / or the surface of the flexible tube assembly, and the electrode assembly is arranged axially along the flexible tube assembly, and can move and stick with the flexible tube assembly; the electrode assembly includes at least one electrode, and the electrode is used to contact the target lesion; when the number of the electrode is one, the electrode and the surface electrode attached to the body surface form an ablation circuit to perform monopolar mode ablation; when the number of the electrodes is two or more, the polarities of adjacent electrodes are opposite, and an ablation circuit is formed between the two electrodes to perform bipolar mode ablation; The flexible tube body assembly includes a positioning sensor for obtaining position information of the electrode assembly and transmitting the position information to the ablation system so that the ablation system establishes a three-dimensional image of the electrode assembly and the target lesion according to the position information; the three-dimensional image includes real-time position information of the electrode assembly.

2. The device according to claim 1, characterized in that When the number of the electrodes is two or more, an insulating gap is provided between adjacent electrodes, and the width of the insulating gap is at least twice the length of the electrode; an ablation area is formed between adjacent electrodes, and the ablation area covers the edge of the lesion.

3. The device according to claim 1, characterized in that Each electrode in the electrode assembly includes an introduction portion, a main body portion and a connection portion; the outer contour of the introduction portion is an arc or a cone, the main body portion is used to abut against the lesion, and the connection portion is provided with a groove structure for fixed connection with the flexible tube body assembly; The outer surface of the electrode assembly is smooth, and the material of the outer surface of the electrode assembly has biocompatibility, corrosion resistance and developability; The electrode assembly is in the shape of a cylindrical structure, a tubular structure or an expandable structure.

4. The device according to claim 1, characterized in that The flexible pipe body assembly is composed of an adjustable bend, a support portion and a stress diffusion portion; the adjustable bend is located at the first end of the flexible pipe body assembly, and the electrode assembly is arranged on the adjustable bend; the surface of the adjustable bend is a low-hardness polymer material; the first end of the flexible pipe body assembly is the end of the flexible pipe body assembly away from the control assembly; The first end of the support part is connected to the adjustable bend part, and the second end of the support part is connected to the stress diffusion part; the support part is a composite reinforced tube structure, and the tube body hardness of the support part is greater than the tube body hardness of the adjustable bend part; the interior of the support part is a single-cavity structure, which is used to lead the wires, pull wires and connecting wires of the sensor assembly passing through the flexible tube body assembly to the control assembly; The stress diffusion portion is arranged at the connection between the support portion and the control component.

5. The device according to claim 4, characterized in that The adjustable bend is provided with a plurality of channels inside, the channels including a guide wire cavity, a wire pulling cavity, and a functional cavity; The wire cavity is provided with wires of the electrode assembly, and the wires of different polarities are insulated and arranged; A pull wire is installed in the pull wire cavity, the first end of the pull wire is fixed to the pull wire cavity, the second end of the pull wire is slidably matched with the pull wire cavity, and the one-way bending of the adjustable bending part is achieved by pulling the pull wire through the control component; the first end of the pull wire is the end far from the control component, and the second end of the pull wire is the end close to the control component; A sensor assembly is insulated and installed in the functional cavity, and the sensor assembly includes a positioning sensor and / or a morphology sensing optical fiber and / or a temperature sensor. The positioning sensor is used to collect position data of the electrode assembly, the morphology sensing optical fiber is used to collect morphology data of the electrode assembly, and the temperature sensor is used to collect temperature data of the electrode assembly.

6. The device according to claim 5, characterized in that The adjustable bending portion is a unidirectional bending structure or a bidirectional bending structure; when the adjustable bending portion is a unidirectional bending structure, the number of the wire pulling cavity is one, which is arranged outside the central axis of the adjustable bending portion; when the adjustable bending portion is a bidirectional bending structure, the number of the wire pulling cavity is two, and the two wire pulling cavities are symmetrically arranged on both sides of the central axis of the adjustable bending portion.

7. The device according to claim 5, characterized in that When the sensor assembly includes the positioning sensor, at least one positioning sensor is arranged at one end of the adjustable bend close to the manipulation assembly; the positioning sensor realizes three-dimensional modeling of the electrode assembly in space based on the relative position information with the electrode; When the sensor assembly includes the temperature sensor, at least one temperature sensor is arranged on the surface of the connection portion between the electrode and the flexible tube assembly to monitor the temperature data of the ablation area in real time and feed the temperature data back to the ablation system.

8. The device according to claim 5, characterized in that The control assembly includes a rotating wheel mechanism and a connector assembly, and the control assembly drives the pull wire to move back and forth axially on one side through the rotating wheel mechanism to achieve bending adjustment of the adjustable bending part; The connector assembly includes a pulse cable and a pulse connector, a sensor cable and a sensor connector; the pulse cable and the pulse connector are electrically connected to the electrode assembly; the sensor cable and the sensor connector are electrically connected to the sensor assembly; the pulse connector and the sensor connector are communicatively connected to the ablation system.

9. The device according to claim 1, characterized in that The pulse energy is composed of a plurality of pulse groups, each of which includes at least one sub-pulse, and the sub-pulse is a bipolar pulse; The bipolar pulse is composed of a positive pulse and a negative pulse, the voltage amplitude range of the bipolar pulse is 2000V to 70000V; the first pulse width of the bipolar pulse is 50ns to 50000ns; a first pulse interval and a second pulse interval are provided between the positive pulse and the negative pulse; and an inter-group period is provided between the pulse groups; The number of the bipolar pulses is 1 to 5000; the number of the pulse groups is 1 to 5000; The bipolar pulse has a rising edge and / or a falling edge, and the difference between the width of the rising edge and the falling edge and the pulse width of the first pulse is less than a preset first threshold; the duration of the rising edge and the falling edge is 0 to 500 ns; The percentage of the length of the peak voltage plateau period of a single sub-pulse to the pulse width of the first pulse is 0-100%.

10. The device according to claim 9, characterized in that The sub-pulse is a unipolar pulse; The voltage amplitude range of the unipolar pulse is 200V to 3000V, the second pulse width of the unipolar pulse is 10μs to 500μs; a third pulse interval is provided between the unipolar pulses; and an inter-group period is provided between the pulse groups; The number of the unipolar pulses is 1 to 5000; the number of the pulse groups is 1 to 5000; The unipolar pulse has a rising edge and / or a falling edge, and the difference between the width of the rising edge and the falling edge and the pulse width of the second pulse is less than the first threshold; the duration of the rising edge and the falling edge is 0 to 500 ns; The percentage of the length of the peak voltage plateau period of a single sub-pulse to the pulse width of the second pulse is 0-100%.

11. The device according to claim 10, characterized in that The pulse energy is composed of multiple pulse groups, each of which contains at least one high-frequency and high-voltage sub-pulse and one low-frequency and low-voltage sub-pulse. The high-frequency and high-voltage sub-pulse is the bipolar pulse, and the low-frequency and low-voltage sub-pulse is the unipolar pulse.

12. An interventional pulse ablation method, characterized in that: An ablation system applied to a flexible pulse energy delivery device, wherein the flexible pulse energy delivery device is a device as claimed in any one of claims 1 to 8, and the method comprises: Acquire a target lesion image, and acquire the position of the target lesion and surrounding tissue structure from the target lesion image; According to the location of the target lesion and the surrounding tissue structure, a three-dimensional reconstruction of the organ where the target lesion is located is performed to obtain a three-dimensional image of the organ and the target lesion, and the ablation parameters and ablation range for ablation treatment of the target lesion are calculated using the three-dimensional image; After the electrode assembly and the flexible tube assembly of the flexible pulse energy delivery device are delivered to the organ, an external magnetic field generator is used to excite the electromagnetic signal of the sensor assembly in the electrode assembly to obtain real-time position information of the electrode assembly; Constructing a mapping model of the electrode assembly in the three-dimensional image according to the position information of the electrode assembly, and displaying the relative position of the electrode assembly and the target lesion in real time in the mapping model; Determining a target path for the electrode assembly to reach the target lesion according to the relative position; Displaying the target path in the three-dimensional image so that the user can place the electrode assembly within a first distance range of the target lesion along the target path under the guidance of navigation information generated by the electromagnetic signal; The target lesion is ablated using the electrode assembly according to the ablation parameters and the ablation range.

13. The method according to claim 12, characterized in that Determining a target path for the electrode assembly to reach the target lesion according to the relative position includes: Determining the type of the target lesion, the type of the target lesion including a first lesion with a bronchial passage accessible inside the lesion and a second lesion located outside the bronchus; If the target lesion is the first lesion, planning a target path for the electrode assembly to reach the target lesion along the bronchial pathway; If the target lesion is the second lesion, the location of the high-risk tissue structure and the location of the anatomical crack in the organ are determined based on the previously performed puncture, and the target path of the electrode assembly to reach the target lesion is planned while avoiding the location of the high-risk tissue structure and the location of the anatomical crack.

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