Pulse ablation device, pulse ablation system and control method

Abstract

The invention discloses a pulse ablation device, a pulse ablation system and a control method.The pulse ablation device comprises an energy transmission assembly and an operation assembly, the energy transmission assembly is connected with the operation assembly, the energy transmission assembly comprises a tubular electrode assembly, and the tubular electrode assembly comprises a first tubular electrode and a second tubular electrode; the first tubular electrode and the second tubular electrode are both connected with the operation assembly, the first tubular electrode and the second tubular electrode are coaxially arranged, and the first tubular electrode and the second tubular electrode are electrically connected; the first tubular electrode comprises a first energy transmission interface, the second tubular electrode comprises a second energy transmission interface, and the first energy transmission interface is electrically connected with the second energy transmission interface; a sensing assembly is arranged in the first tubular electrode and / or the second tubular electrode in an insulating mode, and the sensing assembly comprises a position collecting device. By means of the pulse ablation device, pulse electric field energy can be effectively transmitted, the accuracy and stability of interventional ablation are improved, and the ablation effect is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a pulse ablation device, a pulse ablation system and a control method. Background Art

[0002] Existing ablation methods mainly use thermal ablation techniques such as radiofrequency ablation, microwave ablation, cryoablation and focused ultrasound ablation. The above ablation principles are mainly to achieve the purpose of tissue cell necrosis through changes in the temperature around the tissue. However, when the heat sink effect occurs, thermal ablation technology can easily cause damage to healthy tissues such as nerves, lymph nodes, and blood vessels in the ablation area.

[0003] As a non-thermal ablation technology, pulsed electric field ablation technology that uses the theory of irreversible electroporation for treatment has gradually gained attention in clinical applications. The operator inserts the interventional device through skin puncture or natural cavity intervention to the location of the lesion, and then ablates the lesion. Due to the complexity of the intervention area, such as the treatment of lung lesions, the air in the alveoli affects energy transfer, the anatomical structure of the lung bronchi presents multi-level branches and bifurcations, and it is difficult to observe and intervene in the lesion area. This will limit the ablation effect of the lesion, resulting in the accuracy and efficiency of the ablation, thereby affecting the surgical effect. Therefore, when using interventional methods to perform biopsy or ablation on the lesion area, it is crucial to ensure the transmission effect of the pulsed electric field energy and determine the location of the interventional device in the body for accurate surgery. Summary of the invention

[0004] In view of the above problems in the prior art, the present invention discloses a pulse ablation device, a pulse ablation system and a control method, which can effectively transmit pulse electric field energy and improve the accuracy of interventional ablation, thereby improving the ablation effect and success rate. The technical solutions disclosed in the present invention are as follows:

[0005] According to one aspect of the embodiments disclosed in the present invention, there is provided a pulse ablation device, comprising an energy transmission component and an operating component, wherein the energy transmission component and the operating component are connected;

[0006] The energy transmission assembly includes a tubular electrode assembly, the tubular electrode assembly includes a first tubular electrode and a second tubular electrode, the first tubular electrode and the second tubular electrode are both connected to the operating assembly, the first tubular electrode and the second tubular electrode are coaxially arranged, and the first tubular electrode and the second tubular electrode are electrically connected; the first tubular electrode includes a first energy transmission interface, the second tubular electrode includes a second energy transmission interface, and the first energy transmission interface and the second energy transmission interface are electrically connected;

[0007] A sensor component is insulated and arranged inside the first tubular electrode and / or the second tubular electrode, and the sensor component includes a position acquisition device;

[0008] The first tubular electrode is used to transmit pulsed electric field energy to the second tubular electrode, the second tubular electrode is used to perform ablation treatment on the object to be ablated based on the pulsed electric field energy, the position acquisition device is used to acquire intervention position information of the first tubular electrode and / or the second tubular electrode in a target intervention area, and the object to be ablated is located in the target intervention area;

[0009] The pulsed electric field energy is generated by at least one group of pulsed electric field signals, and each group of pulsed electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal.

[0010] Optionally, the energy transmission component further includes an insulating protective tube, the insulating protective tube is coaxially arranged with the first tubular electrode and the second tubular electrode, the insulating protective tube is sleeved on the outside of the target tubular electrode, and the target tubular electrode is the tubular electrode located on the outside of the first tubular electrode and the second tubular electrode;

[0011] The operating assembly includes a fixing portion and a holding assembly, the insulating protective tube is fixedly connected to the fixing portion, the first tubular electrode and the second tubular electrode are connected to the holding assembly, and the first tubular electrode and the second tubular electrode are both electrically insulated from the holding assembly;

[0012] The second tubular electrode comprises an ablation portion and a first connection portion, the first connection portion is fixedly connected to the holding assembly, the ablation portion is connected to the first connection portion, and the ablation portion is located at an end of the second tubular electrode away from the holding assembly.

[0013] Optionally, the holding assembly includes a holding portion and a moving portion, the first tubular electrode is fixedly connected to the holding portion, the first connecting portion is fixedly connected to the moving portion, and the holding portion and the moving portion are connected; the axial stiffness corresponding to the first connecting portion is smaller than that of the ablation portion;

[0014] The moving part moves axially relative to the fixing part, so that the second tubular electrode moves axially relative to the insulating protective tube.

[0015] Optionally, the holding assembly includes a holding portion and a second connecting portion, the first tubular electrode is fixedly connected to the holding portion, the second connecting portion is respectively fixedly connected to the first connecting portion and the fixed portion, and the holding portion and the second connecting portion are connected; the area where the insulating protective tube is located covers the area where the first connecting portion is located.

[0016] Optionally, the ablation portion includes a puncture portion, which is located at one end of the ablation portion away from the holding assembly, and a sound wave reflection structure is provided on the puncture portion, which is used to enhance the echo intensity to enhance the ultrasonic development effect of the puncture portion.

[0017] Optionally, the pulse ablation device further comprises a connecting component, wherein the connecting component is arranged at one end of the holding component, and the other end of the holding component is connected to the first tubular electrode and the second tubular electrode;

[0018] The connection assembly includes a first connection assembly and a second connection assembly, the first connection assembly includes a first connection cable and a first connection joint, one end of the first connection cable is connected to the first tubular electrode, and the other end of the first connection cable is fixedly connected to the first connection joint;

[0019] The second connection component includes a second connection cable and a second connection connector. One end of the second connection cable is connected to the position acquisition device, and the other end of the second connection cable is fixedly connected to the second connection connector.

[0020] Optionally, at least one of the position acquisition devices is insulated and disposed inside the first tubular electrode and / or the second tubular electrode, and the at least one of the position acquisition devices is spaced apart along the axial direction of the first tubular electrode and the second tubular electrode.

[0021] Optionally, the sensing component also includes a temperature collection device, and at least one of the temperature collection devices is arranged at intervals at the target end of the first tubular electrode and / or the second tubular electrode; the target end is an end away from the operating component, and each temperature collection device is used to collect temperature information of the target end.

[0022] Optionally, at least one electrode morphology acquisition device is disposed at intervals on the first tubular electrode and / or the second tubular electrode, and each electrode morphology acquisition device is used to acquire morphology information of the first tubular electrode and / or the second tubular electrode.

[0023] According to another aspect of the disclosed embodiment of the present invention, there is provided a pulse ablation system, comprising a control device and any one of the pulse ablation devices described above, wherein the pulse ablation device comprises a connection component, wherein the connection component comprises a first connection component and a second connection component, wherein the first connection component comprises a first connection joint, wherein the second connection component comprises a second connection joint, and wherein the first connection joint and the second connection joint are plugged into the control device;

[0024] The control device includes a pulse control module, a navigation control module and an ablation control module, the first tubular electrode is connected to the pulse control module via the first connection cable and the first connection connector, the position acquisition device is connected to the navigation control module via the second connection cable and the second connection connector, and the ablation control module is electrically connected to the pulse control module and the navigation control module respectively;

[0025] The navigation control module is used to construct a virtual model according to the intervention position information and the preset image information of the target intervention area to obtain a navigation three-dimensional model and an object three-dimensional model; the navigation three-dimensional model is used to characterize the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the tubular electrode assembly, and the spatial position relationship between the object to be ablated, the tubular electrode assembly and the target intervention area, and the object three-dimensional model is used to characterize the three-dimensional spatial characteristics of the object to be ablated;

[0026] The ablation control module is used to determine the target ablation parameters corresponding to the object to be ablated according to the navigation three-dimensional model, the object three-dimensional model and the preset attribute information of the object to be ablated;

[0027] The pulse control module is used to generate at least one group of pulsed electric field signals based on the target ablation parameters, so that the first tubular electrode transmits pulsed electric field energy to the second tubular electrode, and the second tubular electrode performs ablation on the object to be ablated based on the pulsed electric field energy; each group of pulsed electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal.

[0028] According to another aspect of the disclosed embodiment of the present invention, a pulse ablation control method is provided, which is applied to the above-mentioned pulse ablation system, and the method includes:

[0029] The navigation control module receives the intervention position information of the first tubular electrode and / or the second tubular electrode in the target intervention area acquired by the position acquisition device, and the object to be ablated is located in the target intervention area;

[0030] The navigation control module constructs a virtual model based on the intervention position information and the preset image information of the target intervention area to obtain a navigation three-dimensional model and an object three-dimensional model; the navigation three-dimensional model is used to characterize the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the tubular electrode assembly, and the spatial position relationship between the object to be ablated, the tubular electrode assembly and the target intervention area, and the object three-dimensional model is used to characterize the three-dimensional spatial characteristics of the object to be ablated;

[0031] The ablation control module determines the target ablation parameters corresponding to the object to be ablated according to the navigation three-dimensional model, the object three-dimensional model and the preset attribute information of the object to be ablated, and sends the target ablation parameters to the pulse control module;

[0032] The pulse control module generates the at least one group of pulsed electric field signals based on the target ablation parameters, so that the first tubular electrode transmits pulsed electric field energy to the second tubular electrode, and the second tubular electrode performs ablation treatment on the object to be ablated based on the pulsed electric field energy; each group of pulsed electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal.

[0033] The technical solution provided by the embodiments disclosed in the present invention brings at least the following beneficial effects:

[0034] The pulse ablation device provided by the present invention includes an energy transmission component and an operating component, which are connected to the energy transmission component. The energy transmission component includes a tubular electrode component, which includes a first tubular electrode and a second tubular electrode. The first tubular electrode and the second tubular electrode are both connected to the operating component. The first tubular electrode and the second tubular electrode are coaxially arranged, and the first tubular electrode and the second tubular electrode are electrically connected. The first tubular electrode includes a first energy transmission interface, the second tubular electrode includes a second energy transmission interface, and the first energy transmission interface and the second energy transmission interface are electrically connected. A sensor component is insulated and arranged inside the first tubular electrode and / or the second tubular electrode, and the sensor component includes a position acquisition device. The first tubular electrode is used to transmit pulsed electric field energy to the second tubular electrode, the second tubular electrode is used to ablate the object to be ablated based on the pulsed electric field energy, the position acquisition device is used to acquire the intervention position information of the first tubular electrode and / or the second tubular electrode in the target intervention area, the object to be ablated is located in the target intervention area, wherein the pulsed electric field energy is generated by at least one group of pulsed electric field signals, each group of pulsed electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal. Thus, the pulsed electric field energy can be effectively transmitted, the ablation effect can be improved, and the accuracy and stability of interventional ablation can be improved, thereby improving the success rate of ablation.

[0035] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The drawings herein are incorporated into and constitute a part of the specification, illustrate embodiments consistent with the disclosure of the present invention, and together with the description are used to explain the principles of the disclosure, and do not constitute improper limitations on the disclosure of the present invention.

[0037] Figure 1is a schematic structural diagram of a pulse ablation device provided in an embodiment of the present application;

[0038] Figure 2 is a schematic structural diagram of another pulse ablation device provided in an embodiment of the present application;

[0039] Figure 3 is a schematic structural diagram of a first tubular electrode provided in an embodiment of the present application;

[0040] Figure 4 is a structural schematic diagram of a sensor assembly provided in an embodiment of the present application;

[0041] Figure 5 is a schematic diagram of a pulse electric field signal provided in an embodiment of the present application;

[0042] Figure 6 It is a schematic diagram of a pulse electric field signal provided in an embodiment of the present application at different peak voltage plateau periods;

[0043] Figure 7 is a schematic diagram of another pulse electric field signal provided in an embodiment of the present application;

[0044] Figure 8 is a schematic diagram of another pulse electric field signal provided in an embodiment of the present application at different peak voltage plateau periods;

[0045] Fig. 9 is a schematic diagram of another pulse electric field signal provided in an embodiment of the present application;

[0046] Fig.10 is a schematic diagram of another pulse electric field signal provided in an embodiment of the present application at different peak voltage plateau periods;

[0047] Fig.11 is a schematic structural diagram of a second tubular electrode provided in an embodiment of the present application;

[0048] Fig.12 It is a partial structural schematic diagram of an ablation portion and a first connecting portion provided in an embodiment of the present application;

[0049] Fig.13 is a schematic structural diagram of another second tubular electrode provided in an embodiment of the present application;

[0050] Fig.14 is a schematic diagram of the partial structure of another ablation portion and a first connecting portion provided in an embodiment of the present application;

[0051] Fig.15 is a schematic diagram of the use of a pulse ablation system provided in an embodiment of the present application;

[0052] Fig.16is a schematic diagram of another use of a pulse ablation system provided in an embodiment of the present application;

[0053] Among them, the reference numerals in the figure correspond to: 1-first tubular electrode; 11-insulating layer; 2-second tubular electrode; 21-ablation part; 211-puncture part; 222-acoustic wave reflection structure; 22-first connecting part; 3-insulating protective tube; 4-fixing part; 51-holding part; 511-holding handle; 512-insertion part; 52-moving part; 53-second connecting part; 61-first connecting cable; 62-first connecting connector; 63-second connecting cable; 64-second connecting connector; 7-sensor assembly; 8-control device; 9-object to be ablated; 10-energy transmission assembly. DETAILED DESCRIPTION

[0054] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0055] It should be noted that the "one embodiment" or "embodiment" referred to in the specification of the embodiment of the present application refers to a specific feature, structure or characteristic that can be included in at least one implementation of the present application. It should be understood that in the specification and claims of the embodiment of the present application and the above-mentioned drawings, the orientation or position relationship indicated by the terms "upper", "lower", "top", "bottom", etc. is based on the orientation or position relationship shown in the drawings, which is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. The terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first" and "second" can explicitly or implicitly include one or more of the features. Moreover, the terms "first", "second", etc. are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchangeable where appropriate, so that the embodiments of the present application described here can be implemented in an order other than those illustrated or described here. In addition, in the description of the present embodiment, unless otherwise specified, "plurality" means two or more. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions, for example, a process, method, system or product including a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0056] In order to make the purpose, technical solution and advantages disclosed in the embodiments of the present application more clearly understood, the embodiments of the present application are further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the embodiments of the present application and are not used to limit the embodiments of the present application.

[0057] In the existing tumor treatment methods, ablation techniques such as radiofrequency ablation (RFA), microwave ablation (MWA) or cryoablation rely on the continuous change of tissue temperature to produce cytotoxic effects, but when the heat sink effect occurs, the above ablation techniques can easily cause damage to healthy tissues such as nerves, lymph, blood vessels, and digestive tract in the ablation area. In this case, pulsed electric field ablation technology that uses irreversible electroporation theory for treatment has been applied to minimally invasive ablation of various tissues or tumors as a non-thermal ablation technology in recent years. It is suitable for 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 is significantly increased, causing the extracellular fluid molecules to diffuse into the cell membrane and cause cell death, thereby achieving the purpose of tissue ablation.

[0058] Compared with traditional tissue ablation technology, irreversible electroporation ablation technology has many significant advantages, such as inactivating tissue at the cellular level, not affecting tissue structure and protein activity, accurately controlling the scope of tissue inactivation, generating very little heat during ablation, not having heat deposition, and having little effect on local blood vessels, etc. However, it still has many shortcomings in the treatment of lung tumors, which limits its clinical application. For example, 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; the anatomical structure of the lung bronchi presents multi-level branching and bifurcation, making it difficult to observe and intervene in the lesion area, and the electrode positioning is difficult and time-consuming, which may lead to placement errors. Multiple punctures cause a high risk of complications such as pneumothorax and pleural effusion, which will limit the ablation effect of the tumor. Based on this, the present application provides a pulse ablation device with coaxially arranged inner and outer tubular electrodes, which transmits pulse electric field energy based on the energy transmission interface between the coaxially arranged inner and outer tubular electrodes, and ablates the object to be ablated, effectively transmits the pulse electric field energy, improves the ablation effect, and is provided with a position acquisition device inside the tubular electrode, which can acquire the intervention position of the tubular electrode, thereby improving the accuracy of interventional ablation and increasing the success rate of ablation.

[0059] The following is combined with Figure 1-14 The technical solution in the embodiments of the present application is introduced.

[0060] The present application provides a pulse ablation device, such as Figure 1-2As shown, it includes an energy transmission component 10 and an operating component, and the energy transmission component 10 is connected to the operating component; the energy transmission component 10 includes a tubular electrode component, and the tubular electrode component includes a first tubular electrode 1 and a second tubular electrode 2, and the first tubular electrode 1 and the second tubular electrode 2 are both connected to the operating component, and the first tubular electrode 1 and the second tubular electrode 2 are coaxially arranged, and the first tubular electrode 1 and the second tubular electrode 2 are electrically connected; the first tubular electrode 1 includes a first energy transmission interface, and the second tubular electrode 2 includes a second energy transmission interface, and the first energy transmission interface and the second energy transmission interface are electrically connected; the first tubular electrode 1 and / or a sensing component is insulated and arranged inside the second tubular electrode 2, the sensing component includes a position acquisition device; the first tubular electrode 1 is used to transmit pulsed electric field energy to the second tubular electrode 2, the second tubular electrode 2 is used to perform ablation treatment on the object to be ablated 9 based on the pulsed electric field energy, the position acquisition device is used to acquire intervention position information of the first tubular electrode 1 and / or the second tubular electrode 2 in the target intervention area, the object to be ablated 9 is located in the target intervention area; the pulsed electric field energy is generated by at least one group of pulsed electric field signals, each group of pulsed electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal.

[0061] In a specific embodiment, the object to be ablated 9 may be a diseased tissue that needs to be ablated, such as a tumor, and the target intervention area may be an area where the diseased tissue is located, such as a lung bronchus.

[0062] In a specific embodiment, Figure 3 As shown, the first tubular electrode 1 can be a tubular structure or a mandrel structure. In order to facilitate the delivery of the tubular electrode in different interventional areas, the end of the first tubular electrode 1 away from the operating component (i.e., the head of the first tubular electrode 1) can be set to an arc-shaped structure or a blade-shaped structure. In the embodiment of this specification, the first tubular electrode 1 can be made of a metal material, which can be a metal material with good biocompatibility, such as medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver, etc.; the first tubular electrode 1 can also be made of a composite material, so as to have good bending performance. The composite material can include the above-mentioned metal material and a polymer material. Specifically, the polymer material can include at least one of polyetheramide, nylon, thermoplastic polyurethane, polyimide, polytetrafluoroethylene, etc. The surface of the first tubular electrode 1 close to the second tubular electrode 2 is a conductive matrix, which can be used for electronic transmission and mechanical support. The conductive matrix can have a columnar structure, an annular structure, an arc-shaped structure, etc.

[0063] Specifically, the first tubular electrode 1 may include two parts, one of which is close to the operating component (i.e., the proximal end) and the other is far from the operating component (i.e., the distal end). Compared with the distal end, the proximal end may be a flexible tube structure with lower rigidity, such as a sea wave tube structure, a snake bone structure, a spring structure, a braided tube structure, a bellows structure, etc., so as to achieve delivery in a curved or bifurcated structure during the intervention process. The first tubular electrode 1 may be an integrally formed structure, for example, integrated manufacturing is achieved through processes such as laser cutting; the first tubular electrode 1 may also be manufactured separately by welding, clamping, threading, or other assembly methods to achieve the above-mentioned two parts.

[0064] Specifically, the first tubular electrode 1 and the second tubular electrode 2 are coaxially arranged, and the first tubular electrode 1 and the second tubular electrode 2 can be detachably assembled or fixedly assembled. In the case where the second tubular electrode 2 is sleeved on the outside of the first tubular electrode 1, that is, the first tubular electrode 1 is an inner electrode and the second tubular electrode 2 is an outer electrode, the outer diameter of the inner electrode can be slightly smaller than the inner diameter of the outer electrode, so that the inner electrode and the outer electrode can be detachably assembled by sliding with a small gap. The outer surface of the inner electrode can be the above-mentioned first energy transmission interface, and the inner surface of the outer electrode is the above-mentioned second energy transmission interface. The outer surface of the inner electrode is electrically connected to the inner surface of the outer electrode, so that the pulsed electric field energy sent by the pulse generating device is transmitted from the inner electrode to the outer electrode, so that the outer electrode performs ablation treatment on the object to be ablated 9, and the outer electrode is the ablation electrode. The pulse generating device is used to generate a pulsed electric field signal. The pulse generating device is connected to the inner electrode through a corresponding internal wire (not shown). The pulse generating device sends pulsed electric field energy to the inner electrode through the wire, and the inner electrode is the pulsed electric field energy transmission electrode.

[0065] Specifically, the second tubular electrode 2 can form a current path with the surface electrode attached to the body surface of the object to which the diseased tissue belongs to realize the release of high-frequency pulse electric field energy, or a current path can be formed by at least one pair of second tubular electrodes 2. The outer diameter of the second tubular electrode 2 can be between 15G and 25G.

[0066] Optionally, when the length of the first tubular electrode 1 is greater than that of the second tubular electrode 2 , the first tubular electrode 1 may also be used to perform ablation treatment on the object to be ablated 9 based on pulsed electric field energy.

[0067] Specifically, Figure 3-4As shown, the position acquisition device can be arranged inside the above-mentioned tubular electrode, and an insulating layer 11 can be arranged between the position acquisition device and the inner surface of the tubular electrode located inside. The material of the insulating layer 11 can be a high dielectric strength material, such as polyimide, tetrafluoroethylene, etc. The position acquisition device can be an electromagnetic positioning sensor. During the intervention process of the tubular electrode assembly, the position acquisition device can collect the position coordinates and direction data of the corresponding tubular electrode in the intervention area, so as to facilitate the subsequent reconstruction of the three-dimensional model of the tubular electrode based on the position coordinates and direction data and visualize the presentation, so as to accurately know the intervention position and direction of the tubular electrode during the ablation operation, thereby improving the accuracy and success rate of ablation.

[0068] Optional, such as Figure 4 As shown, at least one position acquisition device is insulated and arranged inside the first tubular electrode 1 and / or the second tubular electrode 2 , and the at least one position acquisition device is arranged at intervals along the axial direction of the first tubular electrode 1 and the second tubular electrode 2 .

[0069] Specifically, at least one position acquisition device is arranged along the axial direction of the first tubular electrode 1 and the second tubular electrode 2 at a preset interval L1, and the preset interval L1 can be set according to actual application requirements. For example, the value range of the preset interval L1 can be 60 mm to 200 mm. Two or more position acquisition devices can be located at the proximal end and distal end of the first tubular electrode 1 and / or the second tubular electrode 2, respectively. Combined with the position information collected by the position acquisition devices located at the above two ends, it is convenient to improve the accuracy of subsequent three-dimensional model reconstruction of the corresponding tubular electrodes, thereby improving the success rate of ablation.

[0070] Optionally, the pulsed electric field energy may be generated by at least one group of pulsed electric field signals, and each group of pulsed electric field signals may include at least one unipolar pulse signal and / or at least one bipolar pulse signal.

[0071] In a specific embodiment, Figure 5 As shown, when each group of pulse electric field signals includes at least one bipolar pulse signal, the bipolar pulse may be composed of a positive pulse and a negative pulse, the positive pulse amplitude may be V1, the negative pulse amplitude may be V3, a first pulse interval T3 may be provided between the positive pulse and the negative pulse of the bipolar pulse, a second pulse interval T4 may be provided between each bipolar pulse, and a group interval T6 may be provided between each pulse group; Figure 6 As shown, the bipolar pulse has a rising edge or a falling edge, or the rising edge and the falling edge exist at the same time, or the width of the rising edge / falling edge is close to the pulse width T1, and the length of the peak voltage plateau period of each bipolar pulse can be any percentage of 0 to 100% of the pulse width T1, wherein, Figure 6The left diagram in the middle is a schematic diagram of a bipolar pulse when the peak voltage plateau period is 80%, and the right diagram is a schematic diagram of a bipolar pulse when the peak voltage plateau period is 100%.

[0072] Specifically, the number of groups of pulse signals, the number of bipolar pulse signals in each group of pulse electric field signals, and the values ​​of the above-mentioned parameters such as pulse amplitude and pulse width can be set according to actual application requirements. For example, the number of groups of pulse signals can be any value from 1 to 5000, the number of bipolar pulse signals in each group of pulse electric field signals can be any value from 1 to 5000, the pulse amplitude can be any one from 2000V to 70000V, the pulse width can be any one from 50ns to 50000ns, and the rising edge and falling edge time of the positive pulse and negative pulse of the bipolar pulse can be any one from 0 to 500ns.

[0073] In a specific embodiment, Figure 7 As shown, when each group of pulse electric field signals includes at least one unipolar pulse signal, the amplitude of the unipolar pulse may be V2, a second pulse interval T4 may be provided between each unipolar pulse, and a group interval T6 may be provided between each group of pulse groups; Figure 8 As shown, the unipolar pulse has a rising edge or a falling edge, or the rising edge and the falling edge exist at the same time, or the width of the rising edge / falling edge is close to the pulse width T2, and the length of the peak voltage plateau period of each unipolar pulse can be any percentage of 0 to 100% of the pulse width T2, wherein, Figure 8 The left diagram in the middle is a schematic diagram of a unipolar pulse when the peak voltage plateau period is 80%, and the right diagram is a schematic diagram of a unipolar pulse when the peak voltage plateau period is 100%.

[0074] Specifically, the number of groups of pulse signals, the number of unipolar pulse signals in each group of pulse electric field signals, and the values ​​of the above-mentioned parameters such as pulse amplitude and pulse width can be set according to actual application requirements. For example, the number of groups of pulse signals can be any value from 1 to 5000, the number of unipolar pulse signals in each group of pulse electric field signals can be any value from 1 to 5000, the pulse amplitude can be any one from 200V to 3000V, the pulse width can be any one from 10μs to 500μs, and the rising edge and falling edge time of the unipolar pulse can be any one from 0 to 500ns.

[0075] In a specific embodiment, Fig. 9As shown, in the case where each group of pulse electric field signals includes at least one unipolar pulse signal and at least one bipolar pulse signal, the unipolar pulse signal may be a low-frequency and low-voltage pulse signal, and the bipolar pulse signal may be a high-frequency and high-voltage pulse signal. The amplitude of the unipolar pulse may be V2, a second pulse interval T4 may be provided between each unipolar pulse, and a group interval T6 may be provided between each pulse group; the bipolar pulse may be composed of a positive pulse and a negative pulse, the positive pulse amplitude may be V1, the negative pulse amplitude may be V3, a first pulse interval T3 may be provided between the positive pulse and the negative pulse of the bipolar pulse, a second pulse interval T4 may be provided between each bipolar pulse, and a group interval T6 may be provided between each pulse group; a pulse repetition interval T5 may be provided between the bipolar pulse and the unipolar pulse.

[0076] like Fig.10 As shown, the unipolar pulse and the bipolar pulse have a rising edge or a falling edge, or the rising edge and the falling edge exist at the same time, or the width of the rising edge / falling edge of the bipolar pulse is close to the pulse width T1, and the width of the rising edge / falling edge of the unipolar pulse is close to the pulse width T2. The length of the peak voltage plateau period of each bipolar pulse can account for any percentage of 0 to 100% of the pulse width T1, and the length of the peak voltage plateau period of each unipolar pulse can account for any percentage of 0 to 100% of the pulse width T2. Among them, Fig.10 The left diagram in the middle is a schematic diagram of a bipolar pulse and a unipolar pulse when the peak voltage plateau period is 80%, and the right diagram is a schematic diagram of a bipolar pulse and a unipolar pulse when the peak voltage plateau period is 100%.

[0077] Specifically, the number of pulse signal groups, the number of bipolar pulse signals in each group of pulse electric field signals, and the values ​​of the above-mentioned pulse amplitude, pulse width and other parameters can be set according to actual application requirements. For details, please refer to the above-mentioned parameter values, which will not be repeated here.

[0078] In an optional embodiment, if Figure 11-14 As shown, the energy transmission component 10 also includes an insulating sheath 3, which is coaxially arranged with the first tubular electrode 1 and the second tubular electrode 2, and is sleeved on the outside of the target tubular electrode, which is the tubular electrode located on the outside of the first tubular electrode 1 and the second tubular electrode 2; the operating component includes a fixing part 4 and a holding component, the insulating sheath 3 and the fixing part 4 are fixedly connected, the first tubular electrode 1 and the second tubular electrode 2 are fixedly connected to the holding component, and the first tubular electrode 1 and the second tubular electrode 2 are both electrically insulated from the holding component; the second tubular electrode 2 includes an ablation part 21 and a first connecting part 22, the first connecting part 22 is fixedly connected to the holding component, the ablation part 21 is connected to the first connecting part 22, and the ablation part 21 is located at the end of the second tubular electrode 2 away from the holding component.

[0079] In a specific embodiment, the connection mode between the gripping assembly and the fixing portion 4 can be determined according to actual application requirements, for example, it can be a fixed connection, a detachable connection, etc. The ablation portion 21 is a hollow tube structure, made of metal materials, such as medical stainless steel, nickel-titanium alloy, etc. The ablation portion 21 and the first connecting portion 22 can be an integrally formed fixed structure.

[0080] In practical applications, during the process of ablating the diseased tissue by the pulse ablation device, the second tubular electrode 2 can be sleeved on the outside of the first tubular electrode 1, and the insulating protective tube 3 can be sleeved on the outside of the second tubular electrode 2. Specifically, the insulating protective tube 3 can be sleeved on the outside of the first connecting portion 22, so that only the extended ablation portion 21 can ablate the lesion area, thereby protecting healthy tissue.

[0081] Optional, such as Fig.12 and Fig.14 As shown, the ablation part 21 includes a puncture part 211, which is located at one end of the ablation part 21 away from the holding assembly, and a sound wave reflection structure 222 is provided on the puncture part 211, and the sound wave reflection structure 222 is used to enhance the echo intensity to enhance the ultrasonic imaging effect of the puncture part 211, such as sandblasting patterns, cross grooves and other structures. Specifically, the puncture part 211 can have an oblique blade structure or a three-blade structure.

[0082] In some embodiments, Figure 1 , Figure 3-4 and Fig.11 As shown, the holding assembly includes a holding portion 51 and a moving portion 52, the first tubular electrode 1 is fixedly connected to the holding portion 51, the first connecting portion 22 is fixedly connected to the moving portion 52, and the holding portion 51 and the moving portion 52 are connected; the axial stiffness corresponding to the first connecting portion 22 is smaller than that of the ablation portion 21; the moving portion 52 can move axially relative to the fixed portion 4, so that the second tubular electrode 2 can move axially relative to the insulating protective tube 3.

[0083] Specifically, the ablation part 21 and the first connection part 22 can form a second tubular electrode 2, the ablation part 21 can be exposed outside the insulating protective tube to ablate the lesion, and the first connection part 22 can be used to support the ablation part 21, and during the transbronchial intervention, the first connection part 22 needs to have good bending performance. Specifically, the first connection part 22 has a lower axial stiffness, and the structure of the first connection part 22 can be a hypotube structure, a snake bone structure, etc. cut by laser.

[0084] In a specific embodiment, the holding portion 51 and the moving portion 52 can be detachably connected, the second tubular electrode 2 is fixedly arranged in the moving portion 52, and the moving portion 52 can be used to push and pull the second tubular electrode 2 to make the ablation portion 21 telescopically move relative to the insulating protective tube 3. Specifically, the moving portion 52 can move relative to the fixed portion 4 along the axial displacement of the tubular electrode, so that the first connecting portion 22 and the insulating protective tube 3 connected to each other slide coaxially, thereby controlling the ablation portion 21 to extend or retract into the lumen of the insulating protective tube 3. During the transbronchial intervention, the moving portion 52 can be first moved to retract the ablation portion 21 into the insulating protective tube 3 to avoid the puncture portion 211 of the ablation portion 21 from contacting the bronchoscope and the inner wall of the trachea to cause damage. After reaching the location of the lesion tissue, the moving portion 52 is moved to extend the ablation portion 21 from the inside of the insulating protective tube 3 to ablate the lesion tissue; at the same time, it can also be used to adjust the exposed length L2 of the ablation portion 21 and adjust the puncture depth.

[0085] Specifically, the surface of the second tubular electrode 2 can be provided with scale markings to indicate the exposed length L2 and puncture depth of the ablation portion 21. The exposed length L2 of the ablation portion 21 can be set according to actual application requirements, for example, it can be 0 to 40 mm; the puncture depth can be set according to the size of the diseased tissue (such as the diameter of the tumor tissue), for example, it can be 5 mm to 30 mm.

[0086] Specifically, the gripping portion 51 may include a gripping handle 511 and an insertion portion 512. The gripping handle 511 is connected to the moving portion 52 through the insertion portion 512. The connection mode may be a fixed connection, a detachable connection, etc. The gripping handle 511 is sealedly connected to the insertion portion 512. The first tubular electrode 1 is fixedly connected to the insertion portion 512. The insertion portion 512 and the gripping handle 511 are sealed with a wire connected to the first tubular electrode 1 and the sensor assembly 7. Specifically, the insertion portion 512 may be a Luer cone structure, such as a 6% outer contour of the distal end of the Luer cone structure (6% Luer cone structure).

[0087] In practical applications, when the pulse ablation device is delivered through a bronchoscope, the gripping handle 511 of the gripping portion 51 is sealed and connected to the insertion portion 512, the first tubular electrode 1 is fixedly arranged in the insertion portion 512, the second tubular electrode 2 is fixedly arranged in the movable portion 52, and the insulating protective tube 3 is fixedly arranged in the fixed portion 4. The second tubular electrode 2 is inserted into the insulating protective tube 3, and the movable portion 52 is not fixedly connected to the fixed portion 4, the first tubular electrode 1 is inserted into the second tubular electrode 2, and the insertion portion 512 is inserted into the movable portion 52, the first tubular electrode 1, the second tubular electrode 2 and the insulating protective tube 3 are coaxially arranged, and the movable portion 52 can slide relative to the fixed portion 4, so that the overall structure of the first tubular electrode 1 and the second tubular electrode 2 is slidably assembled with the insulating protective tube 3. During the intervention process, the operator moves the movable part 52 to retract the ablation part 21 of the second tubular electrode 2 into the insulating protective tube 3 to prevent the puncture part 211 from contacting the bronchoscope and the inner wall of the trachea and causing damage; thereafter, the second tubular electrode 2 is gradually pushed into the bronchoscope channel, and based on the position acquisition device provided in the tubular electrode, the second tubular electrode 2 is guided along the navigation path to quickly reach the diseased tissue for biopsy or ablation treatment with the help of electromagnetic positioning technology.

[0088] In some embodiments, Figure 2 and Figure 13-14 As shown, the holding assembly includes a holding portion 51 and a second connecting portion 53, the first tubular electrode 1 is fixedly connected to the holding portion 51, the second connecting portion 53 is respectively fixedly connected to the first connecting portion 22 and the fixing portion 4, the holding portion 51 and the second connecting portion 53 are connected; the area where the insulating protective tube 3 is located covers the area where the first connecting portion 22 is located.

[0089] Specifically, the first connection portion 22 may be the portion of the second tubular electrode 2 excluding the ablation portion 21, the insulating protective tube 3 is fixedly sleeved on the outside of the first connection portion 22, and the ablation portion 21 extends out without being covered by the insulating protective tube 3. The surface of the ablation portion 21 may be provided with a scale mark for indicating the puncture depth, and the puncture depth of the ablation portion 21 may be set according to the size of the lesion tissue (such as the diameter of the tumor tissue), for example, it may be 5 mm to 30 mm.

[0090] Specifically, the second connecting portion 53 and the fixing portion 4 may be an integrally formed structure, and the gripping handle 511 is connected to the integrally formed structure via the insertion portion 512, and the connection mode may be a fixed connection, a detachable connection, etc. The first tubular electrode 1 is fixedly connected to the insertion portion 512, and the insertion portion 512 and the gripping handle 511 are sealed with a wire connected to the first tubular electrode 1 and the sensor assembly 7. Specifically, the insertion portion 512 may be a Luer connector.

[0091] In practical applications, in the case of a percutaneous pulse ablation device, the gripping handle 511 of the gripping portion 51 is sealed and connected to the insertion portion 512, and the first tubular electrode 1 is fixedly arranged in the insertion portion 512. The second connecting portion 53 is integrally formed with the fixing portion 4, the insulating protective tube 3 is fixedly attached to the surface of the first connecting portion 22 in the second tubular electrode 2 to play an insulating role, the ablation portion 21 extends out without being covered by the insulating protective tube 3, and the second tubular electrode 2 attached with the insulating protective tube 3 is fixed in the fixing portion 4. The first tubular electrode 1 is inserted into the second tubular electrode 2, and the insertion portion 512 is inserted into the fixing portion 4, and the first tubular electrode 1 and the second tubular electrode 2 are coaxially arranged. During the intervention process, the operator moves the gripping portion 51 for percutaneous puncture, and based on the position acquisition device arranged in the tubular electrode, the second tubular electrode 2 is guided by electromagnetic positioning technology to quickly reach the lesion tissue along the navigation path for biopsy or ablation treatment.

[0092] In the embodiments of this specification, if pathological analysis is required before ablation treatment, the first tubular electrode 1 may not be installed first, or after intervention and puncture of the lesion tissue, the first tubular electrode 1 may be removed first, and then multiple biopsies may be taken through the intratubular channel of the second tubular electrode 2, which is less traumatic. In the event of pneumothorax or hemothorax, the intratubular channel of the second tubular electrode 2 may be used to aspirate accumulated air or blood, inject drugs, etc., so that complications can be dealt with in a timely manner. During the biopsy process, the second tubular electrode 2 may be connected to a syringe through the moving part 52 / the second connecting part 53, and a partial in vivo cell sample may be extracted, or during percutaneous biopsy, an automatic biopsy needle or cutting needle may be adapted for tissue sampling, and then these diseased cells or tissues may be subjected to pathological examination to clarify the diagnosis. After completing the above-mentioned biopsy operation, the first tubular electrode 1 can be inserted into the second tubular electrode 2 again for lesion ablation; the intratubular channel of the second tubular electrode 2 can simultaneously meet the needs of biopsy and pulsed electric field energy transmission. Through electromagnetic positioning guidance, the problem of repeated puncture operations required for conventional biopsy and ablation can be significantly reduced, saving operation time and reducing the occurrence of complications.

[0093] Optionally, the pulse ablation device also includes a connecting component, which is arranged at one end of the holding component, and the other end of the holding component is connected to the first tubular electrode 1 and the second tubular electrode 2; the connecting component includes a first connecting component and a second connecting component, the first connecting component includes a first connecting cable 61 and a first connecting connector 62, one end of the first connecting cable 61 is connected to the first tubular electrode 1, and the other end of the first connecting cable 61 is fixedly connected to the first connecting connector 62; the second connecting component includes a second connecting cable 63 and a second connecting connector 64, one end of the second connecting cable 63 is connected to the position acquisition device, and the other end of the second connecting cable 63 is fixedly connected to the second connecting connector 64.

[0094] Specifically, the other end of the first connection cable 61 is electrically connected to the first connection connector 62, the other end of the second connection cable 63 is electrically connected to the second connection connector 64, and one end of the first connection cable 61 is fixed in the gripping handle 511. Specifically, the first connection cable 61 and the second connection cable 63 are electrically connected to the corresponding first tubular electrode 1 and the position acquisition device through the above-mentioned wires, and the wires are arranged inside the gripping handle 511 and the insertion portion 512.

[0095] Optionally, the sensing component also includes a temperature collection device (not shown), and at least one temperature collection device is arranged at intervals at the target end of the first tubular electrode 1 and / or the second tubular electrode 2; the target end is the end away from the operating component, and each temperature collection device is used to collect temperature information of the target end.

[0096] Specifically, the temperature acquisition device may be a temperature sensor, specifically a thermocouple sensor, a thermistor sensor, etc. The temperature acquisition device may be disposed on the inner side of one end of the tubular electrode away from the operating assembly (the tubular electrode head) to acquire the temperature of the tubular electrode head, so as to control the temperature of the diseased tissue area and reduce the damage to the adjacent important blood vessels or nerves caused by heat accumulation.

[0097] Optionally, at least one electrode morphology acquisition device (not shown) is also arranged at intervals on the first tubular electrode 1 and / or the second tubular electrode 2, and each electrode morphology acquisition device is used to collect morphology information of the first tubular electrode 1 and / or the second tubular electrode 2. Specifically, the electrode morphology acquisition device can be a morphology sensing optical fiber.

[0098] It can be seen from the technical solutions provided in the above embodiments of this specification that the pulse ablation device in this specification has the following technical effects:

[0099] The pulse ablation device in this specification includes an energy transmission component and an operating component, the energy transmission component and the operating component are connected, the energy transmission component includes a tubular electrode component, the tubular electrode component includes a first tubular electrode and a second tubular electrode, the first tubular electrode and the second tubular electrode are both connected to the operating component, the first tubular electrode and the second tubular electrode are coaxially arranged, and the first tubular electrode and the second tubular electrode are electrically connected; the first tubular electrode includes a first energy transmission interface, the second tubular electrode includes a second energy transmission interface, and the first energy transmission interface and the second energy transmission interface are electrically connected; the first tubular electrode and / or the second tubular electrode are insulated and provided with a sensor component, and the sensor component includes a position acquisition device. Among them, the first tubular electrode is used to transmit pulse electric field energy to the second tubular electrode, the second tubular electrode is used to perform ablation treatment on the object to be ablated based on the pulse electric field energy, and the position acquisition device is used to collect the intervention position information of the first tubular electrode and / or the second tubular electrode in the target intervention area, and the object to be ablated is located in the target intervention area. In this way, the pulse electric field energy can be effectively transmitted, the ablation effect can be improved, and the accuracy and stability of interventional ablation can be improved, and the success rate of ablation can be improved.

[0100] The following introduces specific embodiments of the present application based on the above technical solution.

[0101] Example 1

[0102] like Figure 1 , Figure 3-4 and Figure 11-12 As shown, a pulse ablation device provided in this embodiment includes an energy transmission component 10 and an operating component, and the energy transmission component 10 is connected to the operating component; the energy transmission component 10 includes a tubular electrode component, and the tubular electrode component includes a first tubular electrode 1 and a second tubular electrode 2, and the first tubular electrode 1 and the second tubular electrode 2 are both connected to the operating component, and the first tubular electrode 1 and the second tubular electrode 2 are coaxially arranged, and the first tubular electrode 1 and the second tubular electrode 2 are electrically connected; the first tubular electrode 1 includes a first energy transmission interface, and the second tubular electrode 2 includes a second energy transmission interface, and the first energy transmission interface and the second energy transmission interface are electrically connected; A sensing component is insulated and arranged inside the first tubular electrode 1 and / or the second tubular electrode 2, and the sensing component includes a position acquisition device; the first tubular electrode 1 is used to transmit pulsed electric field energy to the second tubular electrode 2, and the second tubular electrode 2 is used to perform ablation treatment on the object to be ablated 9 based on the pulsed electric field energy, and the position acquisition device is used to acquire intervention position information of the first tubular electrode 1 and / or the second tubular electrode 2 in the target intervention area, and the object to be ablated 9 is located in the target intervention area; the pulsed electric field energy is generated by at least one group of pulsed electric field signals, and each group of pulsed electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal.

[0103] In a specific embodiment, the object to be ablated 9 may be a diseased tissue that needs to be ablated, such as a tumor, and the target intervention area may be an area where the diseased tissue is located, such as a lung bronchus.

[0104] In a specific embodiment, Figure 3 As shown, the first tubular electrode 1 can be a tubular structure or a mandrel structure. In order to facilitate the delivery of the tubular electrode in different interventional areas, the end of the first tubular electrode 1 away from the operating component (i.e., the head of the first tubular electrode 1) can be set to an arc-shaped structure or a blade-shaped structure. In the embodiment of this specification, the first tubular electrode 1 can be made of a metal material, which can be a metal material with good biocompatibility, such as medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver, etc.; the first tubular electrode 1 can also be made of a composite material, so as to have good bending performance. The composite material can include the above-mentioned metal material and a polymer material. Specifically, the polymer material can include at least one of polyetheramide, nylon, thermoplastic polyurethane, polyimide, polytetrafluoroethylene, etc. The surface of the first tubular electrode 1 close to the second tubular electrode 2 is a conductive matrix, which can be used for electronic transmission and mechanical support. The conductive matrix can have a columnar structure, an annular structure, an arc-shaped structure, etc.

[0105] Specifically, the first tubular electrode 1 may include two parts, one of which is close to the operating component (i.e., the proximal end) and the other is far from the operating component (i.e., the distal end). Compared with the distal end, the proximal end may be a flexible tube structure with lower rigidity, such as a hypotube structure, a snake bone structure, a coiled spring structure, a braided tube structure, a bellows structure, etc., so as to achieve delivery in a curved or bifurcated structure during the intervention process. The first tubular electrode 1 may be an integrally formed structure.

[0106] Specifically, the first tubular electrode 1 and the second tubular electrode 2 are coaxially arranged, and the first tubular electrode 1 and the second tubular electrode 2 can be detachably assembled or fixedly assembled. In the case where the second tubular electrode 2 is sleeved on the outside of the first tubular electrode 1, that is, the first tubular electrode 1 is an inner electrode and the second tubular electrode 2 is an outer electrode, the outer diameter of the inner electrode can be slightly smaller than the inner diameter of the outer electrode, so that the inner electrode and the outer electrode can be detachably assembled by sliding with a small gap. The outer surface of the inner electrode can be the above-mentioned first energy transmission interface, and the inner surface of the outer electrode is the above-mentioned second energy transmission interface. The outer surface of the inner electrode is electrically connected to the inner surface of the outer electrode, so that the pulsed electric field energy sent by the pulse generating device is transmitted from the inner electrode to the outer electrode, so that the outer electrode performs ablation treatment on the object to be ablated 9, and the outer electrode is the ablation electrode. The pulse generating device is used to generate a pulsed electric field signal. The pulse generating device is connected to the inner electrode through a corresponding internal wire (not shown). The pulse generating device sends pulsed electric field energy to the inner electrode through the wire, and the inner electrode is the pulsed electric field energy transmission electrode.

[0107] Specifically, the second tubular electrode 2 can form a current path with the surface electrode attached to the body surface of the object to which the diseased tissue belongs to realize the release of high-frequency pulse electric field energy, or a current path can be formed by at least one pair of second tubular electrodes 2. The outer diameter of the second tubular electrode 2 can be between 15G and 25G.

[0108] Optionally, when the length of the first tubular electrode 1 is greater than that of the second tubular electrode 2 , the first tubular electrode 1 may also be used to perform ablation treatment on the object to be ablated 9 based on pulsed electric field energy.

[0109] Specifically, Figure 3-4 As shown, the position acquisition device can be arranged inside the tubular electrode, and an insulating layer 11 can be arranged between the position acquisition device and the inner surface of the tubular electrode located inside. The material of the insulating layer 11 can be a high dielectric strength material, such as polyimide, tetrafluoroethylene, etc. The position acquisition device can be an electromagnetic positioning sensor.

[0110] Optional, such as Figure 4 As shown, at least one position acquisition device is insulated and arranged inside the first tubular electrode 1 and / or the second tubular electrode 2 , and the at least one position acquisition device is arranged at intervals along the axial direction of the first tubular electrode 1 and the second tubular electrode 2 .

[0111] Specifically, at least one position acquisition device is arranged at a preset interval L1 along the axial direction of the first tubular electrode 1 and the second tubular electrode 2. The preset interval L1 can be set according to actual application requirements. For example, the value range of the preset interval L1 can be 60 mm to 200 mm. Two or more position acquisition devices can be located at the proximal end and the distal end of the first tubular electrode 1 and / or the second tubular electrode 2, respectively.

[0112] In an optional embodiment, if Figure 11-14 As shown, the energy transmission component 10 also includes an insulating sheath 3, which is coaxially arranged with the first tubular electrode 1 and the second tubular electrode 2, and is sleeved on the outside of the target tubular electrode, which is the tubular electrode located on the outside of the first tubular electrode 1 and the second tubular electrode 2; the operating component includes a fixing part 4 and a holding component, the insulating sheath 3 and the fixing part 4 are fixedly connected, the first tubular electrode 1 and the second tubular electrode 2 are fixedly connected to the holding component, and the first tubular electrode 1 and the second tubular electrode 2 are both electrically insulated from the holding component; the second tubular electrode 2 includes an ablation part 21 and a first connecting part 22, the first connecting part 22 is fixedly connected to the holding component, the ablation part 21 is connected to the first connecting part 22, and the ablation part 21 is located at the end of the second tubular electrode 2 away from the holding component.

[0113] In a specific embodiment, the connection mode between the gripping assembly and the fixing portion 4 can be determined according to actual application requirements, for example, it can be a fixed connection, a detachable connection, etc. The ablation portion 21 is a hollow tube structure, made of metal materials, such as medical stainless steel, nickel-titanium alloy, etc. The ablation portion 21 and the first connecting portion 22 can be an integrally formed fixed structure.

[0114] Optional, such as Fig.12 and Fig.14 As shown, the ablation part 21 includes a puncture part 211, which is located at one end of the ablation part 21 away from the holding assembly, and a sound wave reflection structure 222 is provided on the puncture part 211, and the sound wave reflection structure 222 is used to enhance the echo intensity to enhance the ultrasonic imaging effect of the puncture part 211, such as sandblasting patterns, cross grooves and other structures. Specifically, the puncture part 211 can have an oblique blade structure or a three-blade structure.

[0115] In some embodiments, Figure 1 , Figure 3 and Fig.11 As shown, the holding assembly includes a holding portion 51 and a moving portion 52, the first tubular electrode 1 is fixedly connected to the holding portion 51, the first connecting portion 22 is fixedly connected to the moving portion 52, and the holding portion 51 and the moving portion 52 are connected; the axial stiffness corresponding to the first connecting portion 22 is smaller than that of the ablation portion 21; the moving portion 52 can move axially relative to the fixed portion 4, so that the second tubular electrode 2 can move axially relative to the insulating protective tube 3.

[0116] Specifically, the ablation part 21 and the first connection part 22 can form a second tubular electrode 2, the ablation part 21 can be exposed outside the insulating protective tube to ablate the lesion, and the first connection part 22 can be used to support the ablation part 21, and during the transbronchial intervention, the first connection part 22 needs to have good bending performance. Specifically, the first connection part 22 has a lower axial stiffness, and the structure of the first connection part 22 can be a hypotube structure, a snake bone structure, etc. cut by laser.

[0117] Specifically, the surface of the second tubular electrode 2 can be provided with scale markings to indicate the exposed length L2 and puncture depth of the ablation portion 21. The exposed length L2 of the ablation portion 21 can be set according to actual application requirements, for example, it can be 0 to 40 mm; the puncture depth can be set according to the size of the diseased tissue (such as the diameter of the tumor tissue), for example, it can be 5 mm to 30 mm.

[0118] Specifically, the gripping portion 51 may include a gripping handle 511 and an insertion portion 512. The gripping handle 511 is connected to the moving portion 52 through the insertion portion 512. The connection mode may be a fixed connection, a detachable connection, etc. The gripping handle 511 is sealedly connected to the insertion portion 512. The first tubular electrode 1 is fixedly connected to the insertion portion 512. The insertion portion 512 and the gripping handle 511 are sealed with a wire connected to the first tubular electrode 1 and the sensor assembly 7. Specifically, the insertion portion 512 may be a Luer cone structure, such as a 6% outer contour of the distal end of the Luer cone structure (6% Luer cone structure).

[0119] Optionally, the pulse ablation device also includes a connecting component, which is arranged at one end of the holding component, and the other end of the holding component is connected to the first tubular electrode 1 and the second tubular electrode 2; the connecting component includes a first connecting component and a second connecting component, the first connecting component includes a first connecting cable 61 and a first connecting connector 62, one end of the first connecting cable 61 is connected to the first tubular electrode 1, and the other end of the first connecting cable 61 is fixedly connected to the first connecting connector 62; the second connecting component includes a second connecting cable 63 and a second connecting connector 64, one end of the second connecting cable 63 is connected to the position acquisition device, and the other end of the second connecting cable 63 is fixedly connected to the second connecting connector 64.

[0120] Specifically, the other end of the first connection cable 61 is electrically connected to the first connection connector 62, the other end of the second connection cable 63 is electrically connected to the second connection connector 64, and one end of the first connection cable 61 is fixed in the gripping handle 511. Specifically, the first connection cable 61 and the second connection cable 63 are electrically connected to the corresponding first tubular electrode 1 and the position acquisition device through the above-mentioned wires, and the wires are arranged inside the gripping handle 511 and the insertion portion 512.

[0121] The pulse ablation device provided in the above embodiment is suitable for the scenario of delivery via bronchoscope.

[0122] Example 2

[0123] The difference between Example 2 and Example 1 is that the holding assembly and the second tubular electrode 2 are arranged differently. The similarities with Example 1 are not repeated here. The differences between Example 2 and Example 1 are described as follows:

[0124] In some embodiments, Figure 2 and Figure 13-14 As shown, the holding assembly includes a holding portion 51 and a second connecting portion 53, the first tubular electrode 1 is fixedly connected to the holding portion 51, the second connecting portion 53 is respectively fixedly connected to the first connecting portion 22 and the fixing portion 4, the holding portion 51 and the second connecting portion 53 are connected; the area where the insulating protective tube 3 is located covers the area where the first connecting portion 22 is located.

[0125] Specifically, the first connection portion 22 may be the portion of the second tubular electrode 2 excluding the ablation portion 21, the insulating protective tube 3 is fixedly sleeved on the outside of the first connection portion 22, and the ablation portion 21 extends out without being covered by the insulating protective tube 3. The surface of the ablation portion 21 may be provided with a scale mark for indicating the puncture depth, and the puncture depth of the ablation portion 21 may be set according to the size of the lesion tissue (such as the diameter of the tumor tissue), for example, it may be 5 mm to 30 mm.

[0126] Specifically, the second connecting portion 53 and the fixing portion 4 may be an integrally formed structure, and the gripping handle 511 is connected to the integrally formed structure via the insertion portion 512, and the connection mode may be a fixed connection, a detachable connection, etc. The first tubular electrode 1 is fixedly connected to the insertion portion 512, and the insertion portion 512 and the gripping handle 511 are sealed with a wire connected to the first tubular electrode 1 and the sensor assembly 7. Specifically, the insertion portion 512 may be a Luer connector.

[0127] The pulse ablation device provided in the above embodiment is suitable for percutaneous delivery scenarios.

[0128] The present application also provides a pulse ablation system. Figure 15-16 As shown, it includes a control device 8 and the above-mentioned pulse ablation device, the pulse ablation device includes a connecting component, the connecting component includes a first connecting component and a second connecting component, the first connecting component includes a first connecting connector 62, the second connecting component includes a second connecting connector 64, the first connecting connector 62 and the second connecting connector 64 are plugged into the control device 8; the control device 8 includes a pulse control module, a navigation control module and an ablation control module, the first tubular electrode 1 is connected to the pulse control module through a first connecting cable 61 and a first connecting connector 62, the position acquisition device is connected to the navigation control module through a second connecting cable 63 and a second connecting connector 64, and the ablation control module is electrically connected to the pulse control module and the navigation control module respectively.

[0129] Among them, the navigation control module is used to construct a virtual model according to the intervention position information and the preset image information of the target intervention area to obtain a navigation three-dimensional model and an object three-dimensional model; the navigation three-dimensional model is used to characterize the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the tubular electrode assembly, and the spatial position relationship between the object to be ablated 9, the tubular electrode assembly and the target intervention area, and the object three-dimensional model is used to characterize the three-dimensional spatial characteristics of the object to be ablated 9; the ablation control module is used to determine the target ablation parameters corresponding to the object to be ablated 9 according to the navigation three-dimensional model, the object three-dimensional model and the preset attribute information of the object to be ablated 9; the pulse control module is used to generate at least one group of pulsed electric field signals based on the target ablation parameters, so that the first tubular electrode 1 transmits pulsed electric field energy to the second tubular electrode 2, and the second tubular electrode 2 ablates the object to be ablated 9 based on the pulsed electric field energy; each group of pulsed electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal.

[0130] Specifically, the preset attribute information of the object to be ablated 9 may include the location information, morphological information and size information of the diseased tissue, etc. The above attribute information can be collected by performing imaging examinations (such as chest computed tomography (CT) or magnetic resonance imaging (MRI)) on the patient before the operation. The navigation control module can be used to determine the location information and surrounding structures of the diseased tissue based on the acquired CT or MRI images, and construct a three-dimensional model of the object to be ablated 9 and the intervention area, so as to help pre-plan the path of the ablation treatment and obtain the ablation parameters and ablation range. In addition, during the treatment process, based on the position information of the tubular electrode collected by the position acquisition device, a three-dimensional model of the first tubular electrode 1 and the second tubular electrode 2 is constructed through spatial coordinates and visualized. According to the relative position of the tubular electrode and the diseased tissue, blood vessels and other structures, the placement position of the tubular electrode is determined, so that it is accurately placed to maximize the destruction of the cells of the diseased tissue.

[0131] Specifically, the pulse ablation system may further include an ablation control device, which includes the control device 8, and the first connection connector 62 and the second connection connector 64 are plugged into the control device 8. The device may also include a display screen for displaying required images during surgery.

[0132] Specifically, the specific setting of the pulse electric field signal can refer to the above embodiment, which will not be repeated here.

[0133] The embodiment of the present application further provides a pulse ablation control method, which is applied to the above-mentioned pulse ablation system, and the method includes:

[0134] The navigation control module receives the intervention position information of the first tubular electrode 1 and / or the second tubular electrode 2 in the target intervention area acquired by the position acquisition device, and the object to be ablated 9 is located in the target intervention area;

[0135] The navigation control module constructs a virtual model based on the intervention position information and the preset image information of the target intervention area to obtain a navigation three-dimensional model and an object three-dimensional model; the navigation three-dimensional model is used to characterize the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the tubular electrode assembly, and the spatial position relationship between the object to be ablated 9, the tubular electrode assembly and the target intervention area, and the object three-dimensional model is used to characterize the three-dimensional spatial characteristics of the object to be ablated 9;

[0136] The ablation control module determines the target ablation parameters corresponding to the object to be ablated 9 according to the navigation three-dimensional model, the object three-dimensional model and the preset attribute information of the object to be ablated 9, and sends the target ablation parameters to the pulse control module;

[0137] The pulse control module generates at least one group of pulsed electric field signals based on the target ablation parameters, so that the first tubular electrode 1 transmits pulsed electric field energy to the second tubular electrode 2, and the second tubular electrode 2 performs ablation on the ablation object 9 based on the pulsed electric field energy; each group of pulsed electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal. Specifically, the specific setting of the pulsed electric field signal can be referred to the above embodiment, which will not be repeated here.

[0138] In practical applications, when pulse ablation of tumors in the bronchus of the lung is required, before surgery, the patient is usually subjected to imaging examinations such as chest CT or MRI to obtain detailed information such as the location, size, and morphology of the tumor. Afterwards, the acquired CT or MRI images are used to analyze the location of the tumor and surrounding structures. Navigation planning software is used to perform three-dimensional reconstruction of the lungs to help plan the path of pulse ablation treatment and calculate the optimal ablation parameters and theoretical ablation range. Furthermore, during the operation, an electromagnetic navigation system is used for image guidance, and the electromagnetic signal of the electromagnetic positioning sensor in the first tubular electrode 1 is received by an external magnetic field generator for precise positioning, and a virtual three-dimensional model of the first tubular electrode 1 and the second tubular electrode 2 is constructed through spatial coordinates, and the relative position of the tubular electrode and structures such as the tumor and blood vessels is displayed in real time to ensure accurate placement around the tumor to maximize the destruction of cancer cells. Next, under the guidance of the navigation system, the operator needs to choose the shortest possible puncture path, avoid anatomical structures such as ribs, blood vessels, and interlobular fissures, and detect and mark the surface puncture points. After routine disinfection and the use of sterile cloth, the surgeon will insert at least one ablation tubular electrode into the patient's body and place it precisely around the tumor. The number and placement of the electrodes will be determined according to the size and shape of the tumor. The placement of the electrodes requires a high degree of real-time electrode positioning accuracy. During the operation, the final electrode placement is confirmed by CT image fusion positioning technology to ensure the best electrode placement effect. When the tubular electrode used for ablation treatment is placed in place, the electric pulse is tested to observe the muscle contraction and ECG synchronization. After confirming that the electrical impedance of the tissue is within an acceptable range, the ablation treatment is performed based on the obtained ablation parameters. High-frequency electric pulses are applied to the tumor area, changing the permeability of the cell membrane and causing cell death. The non-thermal properties of irreversible electroporation ablation (IRE) enable it to destroy cancer cells while minimizing the impact on surrounding normal tissues. In addition, a CT scan is performed in time after the ablation operation 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 there are no complications such as severe bleeding and pneumothorax, and the pulse ablation device is removed.

[0139] It should be noted that the above-mentioned sequence of the embodiments of the present application is for description only and does not represent the advantages and disadvantages of the embodiments. The above-mentioned specific embodiments of this specification are described. Other embodiments are within the scope of the attached claims. In some cases, the actions or steps recorded in the claims can be performed in an order different from that in the embodiments and still achieve the desired results. In addition, the processes depicted in the drawings do not necessarily require the specific order or continuous order shown to achieve the desired results. In some embodiments, multitasking and parallel processing are also possible or may be advantageous.

[0140] Each embodiment in this specification is described in a progressive manner, and the same or similar parts between the embodiments can be referred to each other, and each embodiment focuses on the differences from other embodiments. In particular, for the device embodiment, since it is basically similar to the method embodiment, the description is relatively simple, and the relevant parts can be referred to the partial description of the method embodiment.

[0141] A person skilled in the art will understand that all or part of the steps to implement the above embodiments may be accomplished by hardware or by instructing related hardware through a program, and the program may be stored in a computer-readable storage medium, and the above-mentioned storage medium may be a read-only memory, a disk or an optical disk, etc.

[0142] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A pulse ablation device, characterized in that: It includes an energy transmission component and an operating component, wherein the energy transmission component is connected to the operating component; The energy transmission assembly includes a tubular electrode assembly, the tubular electrode assembly includes a first tubular electrode and a second tubular electrode, the first tubular electrode and the second tubular electrode are both connected to the operating assembly, the first tubular electrode and the second tubular electrode are coaxially arranged, and the first tubular electrode and the second tubular electrode are electrically connected; the first tubular electrode includes a first energy transmission interface, the second tubular electrode includes a second energy transmission interface, and the first energy transmission interface and the second energy transmission interface are electrically connected; A sensor component is insulated and arranged inside the first tubular electrode and / or the second tubular electrode, and the sensor component includes a position acquisition device; The first tubular electrode is used to transmit pulsed electric field energy to the second tubular electrode, the second tubular electrode is used to perform ablation treatment on the object to be ablated based on the pulsed electric field energy, the position acquisition device is used to acquire intervention position information of the first tubular electrode and / or the second tubular electrode in a target intervention area, and the object to be ablated is located in the target intervention area; The pulsed electric field energy is generated by at least one group of pulsed electric field signals, and each group of pulsed electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal.

2. The pulse ablation device according to claim 1, characterized in that: The energy transmission assembly further includes an insulating protective tube, which is coaxially arranged with the first tubular electrode and the second tubular electrode, and is sleeved on the outside of a target tubular electrode, wherein the target tubular electrode is the tubular electrode located on the outside of the first tubular electrode and the second tubular electrode; The operating assembly includes a fixing portion and a holding assembly, the insulating protective tube is fixedly connected to the fixing portion, the first tubular electrode and the second tubular electrode are connected to the holding assembly, and the first tubular electrode and the second tubular electrode are both electrically insulated from the holding assembly; The second tubular electrode comprises an ablation portion and a first connection portion, the first connection portion is fixedly connected to the holding assembly, the ablation portion is connected to the first connection portion, and the ablation portion is located at an end of the second tubular electrode away from the holding assembly.

3. The pulse ablation device according to claim 2, characterized in that: The holding assembly comprises a holding portion and a moving portion, the first tubular electrode is fixedly connected to the holding portion, the first connecting portion is fixedly connected to the moving portion, and the holding portion and the moving portion are connected; the axial rigidity corresponding to the first connecting portion is smaller than that of the ablation portion; The moving part moves axially relative to the fixing part, so that the second tubular electrode moves axially relative to the insulating protective tube.

4. The pulse ablation device according to claim 2, characterized in that: The holding assembly includes a holding portion and a second connecting portion, the first tubular electrode is fixedly connected to the holding portion, the second connecting portion is fixedly connected to the first connecting portion and the fixing portion respectively, and the holding portion and the second connecting portion are connected; the area where the insulating protective tube is located covers the area where the first connecting portion is located.

5. The pulse ablation device according to claim 2, characterized in that: The ablation part includes a puncture part, which is located at one end of the ablation part away from the holding component. The puncture part is provided with a sound wave reflection structure, which is used to enhance the echo intensity to enhance the ultrasonic imaging effect of the puncture part.

6. The pulse ablation device according to claim 2, characterized in that: The pulse ablation device further comprises a connecting component, wherein the connecting component is arranged at one end of the holding component, and the other end of the holding component is connected to the first tubular electrode and the second tubular electrode; The connection assembly includes a first connection assembly and a second connection assembly, the first connection assembly includes a first connection cable and a first connection joint, one end of the first connection cable is connected to the first tubular electrode, and the other end of the first connection cable is fixedly connected to the first connection joint; The second connection component includes a second connection cable and a second connection connector. One end of the second connection cable is connected to the position acquisition device, and the other end of the second connection cable is fixedly connected to the second connection connector.

7. The pulse ablation device according to claim 1, characterized in that: At least one position acquisition device is insulated and arranged inside the first tubular electrode and / or the second tubular electrode, and at least one position acquisition device is arranged at intervals along the axial direction of the first tubular electrode and the second tubular electrode.

8. The pulse ablation device according to claim 1, characterized in that: The sensing component also includes a temperature collection device, and at least one of the temperature collection devices is arranged at intervals at the target end of the first tubular electrode and / or the second tubular electrode; the target end is an end away from the operating component, and each temperature collection device is used to collect temperature information of the target end.

9. The pulse ablation device according to claim 1, characterized in that: At least one electrode morphology acquisition device is also arranged at intervals on the first tubular electrode and / or the second tubular electrode, and each electrode morphology acquisition device is used to acquire morphology information of the first tubular electrode and / or the second tubular electrode.

10. A pulse ablation system, characterized in that: The device comprises a control device and the pulse ablation device according to any one of claims 1 to 9, wherein the pulse ablation device comprises a connection component, wherein the connection component comprises a first connection component and a second connection component, wherein the first connection component comprises a first connection joint, wherein the second connection component comprises a second connection joint, and wherein the first connection joint and the second connection joint are plugged into the control device; The control device includes a pulse control module, a navigation control module and an ablation control module, the first tubular electrode is connected to the pulse control module via the first connection cable and the first connection connector, the position acquisition device is connected to the navigation control module via the second connection cable and the second connection connector, and the ablation control module is electrically connected to the pulse control module and the navigation control module respectively; The navigation control module is used to construct a virtual model according to the intervention position information and the preset image information of the target intervention area to obtain a navigation three-dimensional model and an object three-dimensional model; the navigation three-dimensional model is used to characterize the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the tubular electrode assembly, and the spatial position relationship between the object to be ablated, the tubular electrode assembly and the target intervention area, and the object three-dimensional model is used to characterize the three-dimensional spatial characteristics of the object to be ablated; The ablation control module is used to determine the target ablation parameters corresponding to the object to be ablated according to the navigation three-dimensional model, the object three-dimensional model and the preset attribute information of the object to be ablated; The pulse control module is used to generate at least one set of pulsed electric field signals based on the target ablation parameters, so that the first tubular electrode transmits pulsed electric field energy to the second tubular electrode, and the second tubular electrode performs ablation treatment on the object to be ablated based on the pulsed electric field energy; Each group of pulse electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal.

11. A pulse ablation control method, characterized in that: Applied to the pulse ablation system of claim 10, the method comprising: The navigation control module receives the intervention position information of the first tubular electrode and / or the second tubular electrode in the target intervention area acquired by the position acquisition device, and the object to be ablated is located in the target intervention area; The navigation control module constructs a virtual model based on the intervention position information and the preset image information of the target intervention area to obtain a navigation three-dimensional model and an object three-dimensional model; the navigation three-dimensional model is used to characterize the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the tubular electrode assembly, and the spatial position relationship between the object to be ablated, the tubular electrode assembly and the target intervention area, and the object three-dimensional model is used to characterize the three-dimensional spatial characteristics of the object to be ablated; The ablation control module determines the target ablation parameters corresponding to the object to be ablated according to the navigation three-dimensional model, the object three-dimensional model and the preset attribute information of the object to be ablated, and sends the target ablation parameters to the pulse control module; The pulse control module generates the at least one group of pulsed electric field signals based on the target ablation parameters, so that the first tubular electrode transmits pulsed electric field energy to the second tubular electrode, and the second tubular electrode performs ablation treatment on the object to be ablated based on the pulsed electric field energy; each group of pulsed electric field signals includes at least one unipolar pulse signal and / or at least one bipolar pulse signal.

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