CN113229930A

CN113229930A - Electrode needle, ablation equipment, ablation method, device and storage medium

Info

Publication number: CN113229930A
Application number: CN202110680764.XA
Authority: CN
Inventors: 汪龙; 衷兴华; 严韩平; 杨克
Original assignee: Hangzhou Vena Anke Medical Technology Co Ltd
Current assignee: Hangzhou Vena Anke Medical Technology Co Ltd
Priority date: 2021-06-18
Filing date: 2021-06-18
Publication date: 2021-08-10
Anticipated expiration: 2041-06-18
Also published as: CN113229930B

Abstract

The embodiment of the application provides an electrode needle, ablation equipment, an ablation method, an ablation device and a storage medium. The electrode needle comprises: the information processing unit is used for being in communication connection with the pulse generator; the conductive needle tube is electrically connected with the pulse generator and used for outputting an irreversible electroporation ablation pulse sequence to the target tissue; and the biological tissue information sensor is at least partially sheathed in the conductive needle tube in an insulating way, is in communication connection with the information processing unit, is used for acquiring biological tissue information of a target tissue and sending the biological tissue information to the information processing unit. The embodiment of the application realizes that the irreversible electroporation ablation pulse sequence is adjusted according to the adaptability of the tumor microenvironment, so that the ablation effect is improved.

Description

Electrode needle, ablation equipment, ablation method, device and storage medium

Technical Field

The application relates to the technical field of medical equipment, in particular to an electrode needle, ablation equipment, an ablation method, an ablation device and a storage medium.

Background

Irreversible electroporation ablation is a new tumor ablation technique that uses high voltage short pulse discharges to cause the membrane of cells to undergo nano-scale perforation, leading to apoptosis, and is therefore considered a "molecular ablation". From the experience of medical clinical feedback, the non-heat-production ablation technology has the advantages that the ablation area is clear in boundary, nerves of an ablated area and important tissue structures such as great vessels, ureters, bronchi, large bile ducts and gastrointestinal walls can be reserved, the ablation is not influenced by heat or cold absorption of blood flow, the ablation time is short, and the like.

Research shows that the effect of electroporation ablation is related to the tumor microenvironment, but the existing irreversible electroporation ablation cannot be adjusted adaptively to the tumor microenvironment, and the ablation effect is limited.

Disclosure of Invention

The application provides an electrode needle, ablation equipment, an ablation method, an ablation device and a storage medium aiming at the defects of the existing mode, and is used for solving the technical problems that in the prior art, irreversible electroporation ablation cannot be adaptively adjusted for a tumor microenvironment, and the ablation effect is limited.

In a first aspect, an embodiment of the present application provides an electrode needle, including:

the information processing unit is used for being in communication connection with the pulse generator;

the conductive needle tube is electrically connected with the pulse generator and used for outputting an irreversible electroporation ablation pulse sequence to the target tissue;

and the biological tissue information sensor is at least partially sheathed in the conductive needle tube in an insulating way, is in communication connection with the information processing unit, is used for acquiring biological tissue information of the target tissue and sending the biological tissue information to the information processing unit.

Optionally, the biological tissue information sensor includes: at least one of a pH sensor assembly, a conductivity sensing assembly and a temperature sensing assembly;

the pH value sensor assembly comprises: the pH value sensing probe is at least partially sheathed in the conductive needle tube in an insulating way, and the pH value converter is in communication connection with the information processing unit; the pH value sensing probe is used for collecting the pH value of a target tissue and transmitting the pH value to the pH value converter, and the pH value converter is used for converting the pH value into pH value information and transmitting the pH value information to the information processing unit;

the conductivity sensing assembly includes: the conductivity sensing probe and the conductivity converter are connected; at least part of the conductivity sensing probe is sleeved in the conductive needle tube in an insulating way, and the conductivity converter is in communication connection with the information processing unit; the conductivity sensing probe is used for acquiring the conductivity of the target tissue and transmitting the conductivity to the conductivity converter, and the conductivity converter is used for converting the conductivity into conductivity information and transmitting the conductivity information to the information processing unit;

the temperature sensing assembly includes: the temperature sensing probe and the temperature converter are connected; at least part of the temperature sensing probe is sleeved in the conductive needle tube in an insulating way, and the temperature converter is in communication connection with the information processing unit; the temperature sensing probe is used for collecting the temperature of the target tissue and transmitting the temperature to the temperature converter, and the temperature converter is used for converting the temperature into temperature information and sending the temperature information to the information processing unit.

Optionally, the electrode needle further comprises: a handle;

one part of the conductive needle tube is sheathed in the handle in an insulating way and is used for being electrically connected with the pulse generator, and the other part of the conductive needle tube is positioned outside the handle and is used for extending into target tissues and outputting an irreversible electroporation ablation pulse sequence; and/or at least one of a pH value converter, a conductivity converter, a temperature converter and an information processing unit is arranged in the handle.

Optionally, the resistance value of the conductive needle tube is not greater than 1 ohm; and/or the material of the conductive needle tube is nickel-titanium alloy or stainless steel.

In a second aspect, embodiments of the present application provide an ablation device, comprising: a pulse generator, and an electrode needle as provided in the above first aspect;

the conductive needle tube in the electrode needle is electrically connected with the pulse generator;

the information processing unit in the electrode needle is connected with the pulse generator in a communication mode.

In a third aspect, embodiments of the present application provide an ablation method, including:

acquiring biological tissue information of a target tissue;

determining an ablation scheme according to the biological tissue information;

according to an ablation protocol, a sequence of irreversible electroporation ablation pulses is output to the target tissue.

Optionally, acquiring biological tissue information of the target tissue includes:

at least one of pH information, conductivity information, and temperature information of the target tissue is obtained.

Optionally, determining an ablation plan from the biological tissue information comprises: and determining an ablation scheme according to one or two of the pH value information, the conductivity information and the temperature information.

Optionally, after outputting the irreversible electroporation ablation pulse sequence to the target tissue according to the ablation plan, the method further comprises:

adjusting the ablation scheme according to the other two or the other one of the pH value information, the conductivity information and the temperature information;

outputting the parameter-adjusted irreversible electroporation ablation pulse sequence to the target tissue according to the adjusted ablation plan.

In a fourth aspect, embodiments of the present application provide an ablation device, comprising:

the information acquisition module is used for acquiring biological tissue information of a target tissue;

the information processing module is used for determining an ablation scheme according to the biological tissue information;

a pulse output module for outputting an irreversible electroporation ablation pulse sequence to the target tissue according to the ablation plan.

In a fifth aspect, embodiments of the present application provide a computer-readable storage medium, on which a computer program is stored, where the computer program, when executed by a processor, implements the ablation method as provided in the third aspect.

The beneficial technological effect that electrode needle and ablation equipment that this application embodiment provided brought includes: the biological tissue information sensor can collect biological tissue information of a target tissue in real time and send the biological tissue information to the information processing unit, the information processing unit can adjust an ablation scheme according to the real-time biological tissue information and control the conductive needle tube to output a corresponding irreversible electroporation ablation pulse sequence to the target tissue, and therefore the irreversible electroporation ablation pulse sequence can be adjusted according to the adaptability of a tumor microenvironment, and the ablation effect is improved.

The ablation method, the ablation device and the storage medium provided by the embodiment of the application have the beneficial technical effects that: in the ablation process, an ablation scheme is determined according to the biological tissue information of the target tissue acquired in real time, and irreversible electroporation ablation is carried out on the target tissue, so that the irreversible electroporation ablation pulse sequence can be adaptively adjusted according to the tumor microenvironment, and the ablation effect is further improved.

Additional aspects and advantages of the present application will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the present application.

Drawings

The foregoing and/or additional aspects and advantages of the present application will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:

fig. 1 is a schematic structural framework diagram of an electrode needle according to an embodiment of the present disclosure;

FIG. 2 is a schematic structural framework diagram of another electrode needle provided in the embodiment of the present application;

fig. 3 is a schematic structural framework diagram of an information processing unit according to an embodiment of the present application;

fig. 4 is a schematic structural diagram of an electrode needle provided in an embodiment of the present application;

FIG. 5 is a schematic cross-sectional view taken along plane A-A of FIG. 4;

FIG. 6 is a schematic cross-sectional view taken along plane B-B of FIG. 4;

fig. 7 is a schematic structural framework diagram of an ablation device according to an embodiment of the present application;

fig. 8 is a schematic flow chart of an ablation method according to an embodiment of the present application;

fig. 9 is a flow chart illustrating a method for deploying an ablation method according to an embodiment of the present application;

fig. 10 is a schematic structural framework diagram of an ablation device according to an embodiment of the present application.

In the figure:

10-an ablation device;

100-electrode needle;

110-an information processing unit; 111-a processor; 112-a bus; 113-a memory; 114-a transceiver; 115-an input unit; 116-an output unit;

120-a conductive needle tube;

130-biological tissue information sensor;

131-a ph sensor assembly; 1311-alkalinity acidity sensing probe; 1312-a ph converter;

132-a conductivity sensing component; 1321-conductivity sensing probe; 1322-a conductivity converter;

133-a temperature sensing component; 1331-a temperature sensing probe; 1332-temperature converter;

140-a handle;

200-a pulse generator;

20-an ablation device; 21-an information acquisition module; 22-an information processing module; 23-pulse output module.

Detailed Description

Reference will now be made in detail to the present application, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the same or similar parts or parts having the same or similar functions throughout. In addition, if a detailed description of the known art is not necessary for illustrating the features of the present application, it is omitted. The embodiments described below with reference to the drawings are exemplary only for the purpose of explaining the present application and are not to be construed as limiting the present application.

It will be understood by those within the art that, unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the prior art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

As used herein, the singular forms "a", "an", "the" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. It will be understood that when an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements may also be present. Further, "connected" or "coupled" as used herein may include wirelessly connected or wirelessly coupled. As used herein, the term "and/or" includes all or any element and all combinations of one or more of the associated listed items.

The inventor of this application discovers that the effect that irreversible electroporation was ablated is relevant with the tumour microenvironment, but current electrode needle only possesses the function of applying irreversible electroporation electric field to the tumour usually, does not possess the ability of perception tumour microenvironment, therefore current irreversible electroporation is ablated and can't make adaptability adjustment to the tumour microenvironment, and the ablation effect receives the restriction.

The application provides an electrode needle, an ablation device, an ablation method, an ablation device and a storage medium, and aims to solve the technical problems in the prior art.

The following describes the technical solutions of the present application and how to solve the above technical problems with specific embodiments.

Based on the same inventive concept, the embodiment of the present application provides an electrode needle 100, and a schematic structural framework of the electrode needle 100 is shown in fig. 1, including but not limited to: an information processing unit 110, a conductive needle tube 120 and a biological tissue information sensor 130.

The information processing unit 110 is used for communication connection with the pulse generator 200.

Electrically conductive needle 120 is adapted to electrically connect to pulse generator 200 and output a sequence of irreversible electroporation ablation pulses to the target tissue.

The biological tissue information sensor 130 is at least partially sheathed in the conductive needle tube 120 in an insulated manner, is in communication connection with the information processing unit 110, and is used for acquiring biological tissue information of a target tissue and sending the biological tissue information to the information processing unit 110.

In this embodiment, the biological tissue information sensor 130 may acquire biological tissue information of a target tissue in real time and send the biological tissue information to the information processing unit 110, and the information processing unit 110 may adjust an ablation scheme according to the real-time biological tissue information and control the conductive needle tube 120 to output a corresponding irreversible electroporation ablation pulse sequence to the target tissue, so that the irreversible electroporation ablation pulse sequence may be adaptively adjusted for a tumor microenvironment, thereby improving an ablation effect.

During the process of outputting the irreversible electroporation ablation pulse sequence to the target tissue by the electrode needle 100: the method is characterized in that permanent nano holes are generated on cell membranes of target tissues (namely tissues of a focus area), substances in cells leak excessively seriously or the cell membranes close excessively and slowly, irreversible damage is caused to the cells, and the cells are killed by disturbing the cell homeostasis, but not necrosis caused by other ablation systems through heat energy or radiation.

Optionally, conductive needle 120 has a resistance value of no greater than 1 ohm. Thus, the conductive needle tube 120 has good conductivity, which is beneficial to outputting the irreversible electroporation ablation pulse sequence.

Optionally, the conductive needle tube 120 is made of nitinol or stainless steel. The electrically conductive needle 120 may have good flexibility to facilitate penetration of biological organs or tissues. For example: 304 stainless steel or 316L stainless steel.

The present application provides in an alternative embodiment an information processing unit 110, the information processing unit 110 shown in fig. 3 including: a processor 111 and a memory 113. Wherein processor 111 and memory 113 are electrically coupled, such as by bus 112.

The Processor 111 may be a CPU (Central Processing Unit), a general-purpose Processor, a DSP (Digital Signal Processor), an ASIC (Application Specific Integrated Circuit), an FPGA (Field-Programmable Gate Array) or other Programmable logic device, a transistor logic device, a hardware component, or any combination thereof. Which may implement or perform the various illustrative logical blocks, modules, and circuits described in connection with the disclosure. The processor 111 may also be a combination of computing functions, e.g., comprising one or more microprocessors, DSPs and microprocessors, and the like.

Bus 112 may include a path that transfers information between the above components. The bus 112 may be a PCI (Peripheral Component Interconnect) bus, an EISA (Extended Industry Standard Architecture) bus, or the like. The bus 112 may be divided into an address bus, a data bus, a control bus, and the like. For ease of illustration, only one thick line is shown in FIG. 3, but this does not mean only one bus or one type of bus.

The Memory 113 may be a ROM (Read-Only Memory) or other type of static storage device that can store static information and instructions, a RAM (random access Memory) or other type of dynamic storage device that can store information and instructions, an EEPROM (Electrically Erasable Programmable Read-Only Memory), a CD-ROM (Compact Disc Read-Only Memory) or other optical Disc storage, optical Disc storage (including Compact Disc, laser Disc, optical Disc, digital versatile Disc, blu-ray Disc, etc.), a magnetic disk storage medium or other magnetic storage device, or any other medium that can be used to carry or store desired program code in the form of instructions or data structures and that can be accessed by a computer, but is not limited to these.

Optionally, the information processing unit 110 may further include a transceiver 114. The transceiver 114 may be used for reception and transmission of signals. The transceiver 114 may allow the information processing unit 110 to communicate with other devices wirelessly or by wire to exchange data. It should be noted that the practical application of the transceiver 114 is not limited to one.

Optionally, the information processing unit 110 may further include an input unit 115. The input unit 115 may be used to receive input numeric, character, image and/or sound information or to generate key signal inputs related to user settings and function control of the information processing unit 110. The input unit 115 may include, but is not limited to, one or more of a touch screen, a physical keyboard, function keys (such as volume control keys, switch keys, etc.), a trackball, a mouse, a joystick, a camera, a microphone, and the like.

Optionally, the information processing unit 110 may further include an output unit 116. The output unit 116 may be used to output or present information processed by the processor 111. The output unit 116 may include, but is not limited to, one or more of a display device, a speaker, a vibration device, and the like.

While FIG. 3 shows information processing unit 110 having various means, it is to be understood that not all of the means shown are required to be implemented or provided. More or fewer devices may alternatively be implemented or provided.

It is noted that the biological tissue information may include at least one of ph information, conductivity information, and temperature information of the microenvironment of the target tissue.

Alternatively, as shown in fig. 2, the biological tissue information sensor 130 of the embodiment of the present application includes: at least one of a ph sensor assembly 131, a conductivity sensor assembly 132, and a temperature sensor assembly 133.

The inventor of this application considers that the effect that irreversible electroporation was ablated is relevant with tumour microenvironment PH (pH valve), but current electrode needle 100 only possesses the function of applying the electroporation electric field to the tumour usually, does not possess the ability of perception tumour microenvironment PH, consequently current irreversible electroporation is ablated and can't make adaptability adjustment to tumour microenvironment PH, and the effect of ablating receives the restriction. To this end, the present application provides one possible implementation manner for the biological tissue information sensor 130 as follows:

as shown in fig. 2, the biological tissue information sensor 130 of the embodiment of the present application includes, but is not limited to: a ph sensor assembly 130.

The ph sensor assembly 130 includes, but is not limited to: and a pH value sensing probe 1311 and a pH value converter 1312 which are connected with each other. As shown in fig. 5 and 6, the ph sensing probe 1311 is at least partially sheathed in the conductive needle tube 120 in an insulated manner, and the ph converter 1312 is in communication connection with the information processing unit 110. The ph sensing probe 1311 is used to collect the ph of the target tissue and transmit the ph to the ph converter 1312, and the ph converter 1312 is used to convert the ph into ph information and transmit the ph information to the information processing unit 110.

In this embodiment, the PH sensing probe 1311 in the PH sensor assembly 130 can acquire the PH of the target tissue in real time and transmit the PH to the PH converter 1312, the PH converter 1312 in the PH sensor assembly 130 can convert the PH into PH information and transmit the PH information to the information processing unit 110, the information processing unit 110 can adjust the ablation scheme according to the real-time PH information, and control the conductive needle tube 120 to output a corresponding irreversible electroporation ablation pulse sequence to the target tissue, that is, adjust the irreversible electroporation ablation pulse sequence according to the PH adaptability of the tumor microenvironment, thereby improving the ablation effect.

Alternatively, the ph sensing probe 1311 may employ: PH sensing probe, model mark OAKTON, usa.

Alternatively, the pH sensing probe 1311 may be partially exposed from the conductive needle 120 or may be located at a port of the conductive needle 120.

Alternatively, the ph converter 1312 may employ a PCB (printed circuit board) that converts the ph (analog signal) into ph information (digital signal).

The inventor of this application considers that, the effect that irreversible electroporation was ablated also is relevant with tumour microenvironment conductivity, but current electrode needle 100 only possesses the function of applying the electroporation electric field to the tumour usually, does not possess the ability of perception tumour microenvironment conductivity, therefore current irreversible electroporation is ablated and can't make adaptability adjustment to tumour microenvironment conductivity, and the effect of ablating receives the restriction. To this end, the present application provides one possible implementation manner for the biological tissue information sensor 130 as follows: as shown in fig. 2, the biological tissue information sensor 130 of the embodiment of the present application includes, but is not limited to: conductivity sensing component 132.

Conductivity sensing component 132 includes, but is not limited to: connected conductivity sensing probe 1321 and conductivity transducer 1322. As shown in fig. 5 and 6, the conductivity sensing probe 1321 is at least partially insulated and sleeved in the conductive needle tube 120, and the conductivity converter 1322 is communicatively connected to the information processing unit 110. Conductivity sensing probe 1321 is configured to collect conductivity of the target tissue and transmit the conductivity to conductivity converter 1322, and conductivity converter 1322 is configured to convert the conductivity into conductivity information and transmit the conductivity information to information processing unit 110.

In this embodiment, the conductivity sensing probe 1321 in the conductivity sensing assembly 132 may acquire the conductivity of the target tissue in real time and transmit the conductivity to the conductivity converter 1322, the conductivity converter 1322 in the conductivity sensing assembly 132 may convert the conductivity into conductivity information and transmit the conductivity information to the information processing unit 110, the information processing unit 110 may adjust the ablation scheme according to the real-time conductivity information, and control the conductive needle tube 120 to output the corresponding irreversible electroporation ablation pulse sequence to the target tissue, so that the irreversible electroporation ablation pulse sequence may be adaptively adjusted according to the conductivity of the tumor microenvironment, thereby improving the ablation effect.

It can be understood that the information processing unit 110 can simultaneously and comprehensively adjust the ablation scheme according to the real-time ph information and the real-time conductivity information, so as to realize comprehensive consideration of the ph and the conductivity of the tumor microenvironment and adaptive adjustment of the irreversible electroporation ablation pulse sequence, thereby improving the ablation effect.

Alternatively, the conductivity sensing probe 1321 may employ: conductivity sensing probe of three qi electrons.

Alternatively, conductivity sensing probe 1321 may be partially exposed from conductive syringe 120 or may be located at a port of conductive syringe 120.

Alternatively, the conductivity converter 1322 may employ a PCB (printed circuit board) that converts conductivity (analog signal) into conductivity information (digital signal).

The inventor of this application considers that, the effect that irreversible electroporation was ablated also is relevant with tumour microenvironment temperature, but current electrode needle 100 only possesses the function of applying the electroporation electric field to the tumour usually, does not possess the ability of perception tumour microenvironment temperature, therefore current irreversible electroporation is ablated and can't make adaptability adjustment to tumour microenvironment temperature, and the effect of ablating receives the restriction. To this end, the present application provides one possible implementation manner for the biological tissue information sensor 130 as follows:

as shown in fig. 2, the biological tissue information sensor 130 of the embodiment of the present application includes, but is not limited to: a temperature sensing component 133.

The temperature sensing component 133 includes, but is not limited to: connected temperature sensing probe 1331 and temperature transducer 1332. As shown in FIGS. 5 and 6, temperature sensing probe 1331 is at least partially housed within conductive needle tube 120 in an insulated manner, and temperature transducer 1332 is communicatively coupled to information processing unit 110. Temperature sensing probe 1331 is used for acquiring the temperature of the target tissue in real time and transmitting the temperature to temperature converter 1332, and temperature converter 1332 is used for converting the temperature into temperature information and transmitting the temperature information to information processing unit 110.

In this embodiment, the temperature sensing probe 1331 in the temperature sensing assembly 133 can acquire the temperature of the target tissue in real time and transmit the temperature to the temperature converter 1332, the temperature converter 1332 in the temperature sensing assembly 133 can convert the temperature into temperature information and transmit the temperature information to the information processing unit 110, the information processing unit 110 can adjust the ablation scheme according to the real-time temperature information and control the conductive needle tube 120 to output the corresponding irreversible electroporation ablation pulse sequence to the target tissue, that is, the irreversible electroporation ablation pulse sequence can be adaptively adjusted according to the temperature of the tumor microenvironment, so as to improve the ablation effect.

It can be understood that the information processing unit 110 can comprehensively adjust the ablation scheme according to the real-time ph information and the real-time temperature information, that is, the ph and the temperature of the tumor microenvironment can be comprehensively considered, and the irreversible electroporation ablation pulse sequence can be adaptively adjusted, so as to improve the ablation effect. The information processing unit 110 can also comprehensively adjust the ablation scheme according to the real-time ph information, the conductivity information and the real-time temperature information, so that the comprehensive consideration of the ph, the conductivity and the temperature of the tumor microenvironment can be realized, the irreversible electroporation ablation pulse sequence can be adaptively adjusted, and the ablation effect can be further improved.

Alternatively, the temperature sensing probe 1331 may employ: TT-K-40 temperature sensing probe.

Alternatively, temperature sensing probe 1331 may be partially exposed from conductive syringe 120 or may be located at a port of conductive syringe 120.

Alternatively, the temperature converter 1332 may employ a PCB (printed circuit board) that converts the temperature (analog signal) into temperature information (digital signal).

The present inventors have considered that the electrode needle 100 needs to be easily held to facilitate an operation such as puncturing by an operator. To this end, the present application provides one possible implementation manner for the electrode needle 100 as follows:

as shown in fig. 4, the electrode needle 100 of the embodiment of the present application further includes, but is not limited to: a handle 140.

One part of the conductive needle tube 120 is sleeved in the handle 140 in an insulating way and is used for being electrically connected with the pulse generator 200, and the other part of the conductive needle tube 120 is positioned outside the handle 140 and is used for extending into target tissues and outputting irreversible electroporation ablation pulse sequences.

In the present embodiment, the handle 140 can be easily held by an operator, so that the operator can easily control the electrode needle 100 when performing operations such as puncturing, and the operability of the electrode needle 100 is improved. Also, the inner space of the handle 140 provides a place for electrical connection between the electrode needle 100 and the pulse generator 200.

Optionally, the handle 140 is made of an insulating material.

Optionally, at least one of the ph converter 131, the conductivity converter 1322, the temperature converter 1332, and the information processing unit 110 is disposed in the handle 140.

The embodiment of the present application provides an ablation device 10, a schematic structural framework diagram of the ablation device 10 is shown in fig. 7, including but not limited to: a pulse generator 200, and any one of the electrode needles 100 provided in the previous embodiments.

The electrically conductive needle tube 120 in the electrode needle 100 is electrically connected to the pulse generator 200.

The information processing unit 110 in the electrode needle 100 is communicatively connected to the pulse generator 200.

In the present embodiment, the pulse generator 200 outputs a sequence of electric pulses to the conductive needle tube 120 in the electrode needle 100, so that the conductive needle tube 120 can generate permanent nanopores on the cell membrane of the target tissue (i.e., the tissue of the focal zone), the leakage of intracellular substances is severe or the cell membrane is closed slowly, the cells are irreversibly damaged, and the cell is killed by disturbing the cell homeostasis, rather than the necrosis caused by other ablation systems through heat energy or radiation.

In some possible embodiments, the information processing unit 110 in the electrode needle 100 is in communication connection with an upper computer, and at this time, the upper computer may implement program update or data backup for the information processing unit 110 in the electrode needle 100, and may also implement remote control for the electrode needle 100, which may further facilitate function expansion of the ablation device 10.

Optionally, the upper computer is in communication connection with the information processing unit 110 in the electrode needle 100 through WIFI (Wireless Fidelity, also called as a mobile hotspot).

Optionally, the upper computer is connected to the information processing unit 110 in the electrode needle 100 in a communication manner through the cloud.

In some possible embodiments, the information processing unit 110 in the electrode needle 100 is connected to an information display device, and the information display device can display to the operator: at least one of biological tissue information of the target tissue, an ablation plan, and specific parameters of the output irreversible electroporation ablation pulse sequence. The timely grasp of the ablation state by an operator is facilitated.

Based on the same inventive concept, the present application provides an ablation method, the flow chart of which is schematically shown in fig. 8, and the method includes, but is not limited to, steps S101 to S103:

s101: biological tissue information of a target tissue is acquired.

Alternatively, the information processing unit 110 in the electrode needle 100 provided in the foregoing embodiment of the present application may be adopted to acquire biological tissue information of the target tissue. The biological tissue information may be obtained from the biological tissue information of the target tissue acquired by the biological tissue information sensor 130 in real time.

Alternatively, the acquiring of the biological tissue information of the target tissue in step S101 may include: at least one of pH information, conductivity information, and temperature information of the target tissue is obtained.

S102: an ablation plan is determined from the biological tissue information.

Alternatively, the information processing unit 110 in the electrode needle 100 provided in the foregoing embodiment of the present application may be used to determine the ablation plan based on the biological tissue information.

Optionally, the ablation plan includes, but is not limited to, a specific type and/or specific parameters of the irreversible electroporation ablation pulse sequence to be output (or formulated).

S103: according to an ablation protocol, a sequence of irreversible electroporation ablation pulses is output to the target tissue.

Alternatively, the information processing unit 110 in the electrode needle 100 provided in the foregoing embodiment of the present application may be adopted to control the pulse generator 200 to generate a corresponding irreversible electroporation ablation pulse sequence according to the ablation plan, and the irreversible electroporation ablation pulse sequence is output to the target tissue by the conductive needle tube 120.

According to the ablation method provided by the embodiment, in the ablation process, the ablation scheme can be determined according to the biological tissue information of the target tissue acquired in real time, and irreversible electroporation ablation is performed on the target tissue, so that the irreversible electroporation ablation pulse sequence can be adaptively adjusted for a tumor microenvironment, and the ablation effect is further improved.

It should be noted that, with the ablation method provided in this embodiment, before acquiring the biological tissue information of the target tissue, irreversible electroporation ablation may be performed on the target tissue according to a preset ablation scheme, that is, after acquiring the biological tissue information of the target tissue, the ablation scheme determined according to the biological tissue information is an adjustment scheme for the preset ablation scheme, so that a matching degree between an irreversible electroporation ablation pulse sequence and a microenvironment of the target tissue may be improved, and an ablation effect may be further improved.

Based on the same inventive concept, the present application provides a deployment method of an ablation method, a flowchart of the deployment method is shown in fig. 9, and the method includes, but is not limited to, steps S201 to S205:

s201: and acquiring the pH value information, conductivity information and temperature information of the target tissue.

Alternatively, the information processing unit 110 in the electrode needle 100 provided in the foregoing embodiment of the present application may be adopted to acquire ph information, conductivity information, and temperature information of the target tissue.

The ph information can be obtained by the ph converter 132 through ph conversion according to the ph of the target tissue acquired by the ph sensing probe 1311 in real time; the conductivity information may be converted by the conductivity converter 1322 based on the conductivity of the target tissue acquired by the conductivity sensing probe 1321 in real time; the temperature information may be converted by temperature converter 1332 from the temperature of the target tissue acquired by temperature sensing probe 1331 in real time.

S202: and determining an ablation scheme according to one or two of the pH value information, the conductivity information and the temperature information.

Alternatively, the information processing unit 110 in the electrode needle 100 provided in the foregoing embodiment of the present application may be used to determine the ablation plan according to one or both of the ph information, the conductivity information, and the temperature information.

In one example, an ablation plan is determined from the ph information.

In one example, an ablation plan is determined based on the ph information and the conductivity information.

In one example, an ablation plan is determined based on the ph information and the temperature information.

In one example, an ablation plan is determined based on the conductivity information and the temperature information.

S203: according to an ablation protocol, a sequence of irreversible electroporation ablation pulses is output to the target tissue.

S204: adjusting the ablation profile based on the other two or another of the pH information, conductivity information, and temperature information.

Alternatively, the information processing unit 110 in the electrode needle 100 provided in the foregoing embodiment of the present application may be adopted to adjust the ablation plan according to the other two or the other one of the ph information, the conductivity information, and the temperature information.

In one example, an adjusted ablation plan is determined from the conductivity information and the temperature information.

In one example, an adjusted ablation plan is determined from the temperature information.

In one example, an adjusted ablation plan is determined from the conductivity information.

In one example, an adjusted ablation plan is determined based on the ph information.

S205: outputting the parameter-adjusted irreversible electroporation ablation pulse sequence to the target tissue according to the adjusted ablation plan.

Alternatively, the information processing unit 110 in the electrode needle 100 provided in the foregoing embodiment of the present application may be adopted to control the pulse generator 200 to generate the irreversible electroporation ablation pulse sequence corresponding to the adjustment parameter according to the adjusted ablation scheme, and the irreversible electroporation ablation pulse sequence of the adjustment parameter is output to the target tissue by the conductive needle tube 120.

In the embodiment, the ablation scheme can be determined and the ablation is implemented according to one or two of the real-time pH value information, the real-time conductivity information and the real-time temperature information of the microenvironment of the target tissue, and then the ablation scheme is adjusted and implemented according to the other two or another kind of real-time information of the microenvironment of the target tissue in the implementation process, so that the adaptation degree of the irreversible electroporation ablation pulse sequence and the microenvironment of the target tissue can be effectively improved, and the ablation effect is further improved.

Based on the same inventive concept, the embodiment of the present application provides an ablation device 20, the structural frame diagram of which is shown in fig. 10, including but not limited to: an information acquisition module 21, an information processing module 22 and a pulse output module 23.

The information acquisition module 21 is used for acquiring biological tissue information of a target tissue.

The information processing module 22 is used to determine an ablation plan based on the biological tissue information.

The pulse output module 23 is used for outputting the irreversible electroporation ablation pulse sequence to the target tissue according to the ablation scheme.

The ablation device 20 provided by the embodiment can determine the ablation scheme according to the biological tissue information of the target tissue acquired in real time in the ablation process, and perform irreversible electroporation ablation on the target tissue, so that the irreversible electroporation ablation pulse sequence can be adjusted according to the adaptability of the tumor microenvironment, and the ablation effect is further improved.

In some possible embodiments, the information acquisition module 21 is configured to, when acquiring biological tissue information of a target tissue, specifically: at least one of pH information, conductivity information, and temperature information of the target tissue is obtained.

In some possible embodiments, the information processing module 22 is configured to determine the ablation plan based on the biological tissue information, and is specifically configured to: and determining an ablation scheme according to one or two of the pH value information, the conductivity information and the temperature information.

In some possible embodiments, after the pulse output module 23 is used to output the irreversible electroporation ablation pulse sequence to the target tissue according to the ablation plan, the information processing module 22 is used to adjust the ablation plan according to another two or another one of the ph information, the conductivity information, and the temperature information. Next, the pulse output module 23 is further configured to: outputting the parameter-adjusted irreversible electroporation ablation pulse sequence to the target tissue according to the adjusted ablation plan.

Based on the same inventive concept, the present application provides a computer-readable storage medium, on which a computer program is stored, which, when executed by a processor, implements various alternative embodiments of the ablation method provided by the present application.

It will be appreciated by those skilled in the art that the computer-readable storage media provided in the embodiments may be any available media that can be accessed by the electronic device and includes, but is not limited to, volatile and non-volatile media, removable and non-removable media. The computer-readable storage medium includes, but is not limited to, any type of disk including, but not limited to, floppy disks, hard disks, optical disks, CD-ROMs, and magneto-optical disks, ROMs, RAMs, EPROMs (Erasable Programmable Read-Only memories), EEPROMs (Electrically Erasable Programmable Read-Only memories), flash memories, magnetic cards, or optical cards. That is, computer-readable storage media include, but are not limited to, any medium that stores or transmits information in a form readable by a device (e.g., a computer).

The embodiments of the present application provide a computer-readable storage medium suitable for various alternative embodiments of any of the above ablation methods, which are not described herein again.

By applying the embodiment of the application, at least the following beneficial effects can be realized:

1. the beneficial technological effect that electrode needle and ablation equipment that this application embodiment provided brought includes: the biological tissue information sensor 130 can acquire biological tissue information of a target tissue in real time and send the biological tissue information to the information processing unit 110, the information processing unit 110 can adjust an ablation scheme according to the real-time biological tissue information and control the conductive needle tube 120 to output a corresponding irreversible electroporation ablation pulse sequence to the target tissue, so that the irreversible electroporation ablation pulse sequence can be adaptively adjusted according to a tumor microenvironment, and an ablation effect is further improved.

2. The ph sensor assembly 131, the conductivity sensing assembly 132 and the temperature sensing assembly 133 can respectively acquire ph information, conductivity information and temperature information in real time, and the information processing unit 110 can comprehensively adjust the ablation scheme according to at least one of the real-time ph information, conductivity information and temperature information and by combining the real-time pressure information, adaptively adjust the irreversible electroporation ablation pulse sequence, and further improve the ablation effect.

3. The ablation method, the ablation device and the storage medium provided by the embodiment of the application have the beneficial technical effects that: in the ablation process, an ablation scheme is determined according to the biological tissue information of the target tissue acquired in real time, and irreversible electroporation ablation is carried out on the target tissue, so that the irreversible electroporation ablation pulse sequence can be adaptively adjusted according to the tumor microenvironment, and the ablation effect is further improved.

Those of skill in the art will appreciate that the various operations, methods, steps in the processes, acts, or solutions discussed in this application can be interchanged, modified, combined, or eliminated. Further, other steps, measures, or schemes in various operations, methods, or flows that have been discussed in this application can be alternated, altered, rearranged, broken down, combined, or deleted. Further, steps, measures, schemes in the prior art having various operations, methods, procedures disclosed in the present application may also be alternated, modified, rearranged, decomposed, combined, or deleted.

In the description of the present application, it is to be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the present application and simplifying the description, but do not indicate or imply that the referred device or element must have a particular orientation, be constructed in a particular orientation, and be operated, and thus should not be construed as limiting the present application.

The terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless otherwise specified.

In the description of the present application, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.

In the description herein, particular features, structures, materials, or characteristics may be combined in any suitable manner in any one or more embodiments or examples.

It should be understood that, although the steps in the flowcharts of the figures are shown in order as indicated by the arrows, the steps are not necessarily performed in order as indicated by the arrows. The steps are not performed in the exact order shown and may be performed in other orders unless explicitly stated herein. Moreover, at least a portion of the steps in the flow chart of the figure may include multiple sub-steps or multiple stages, which are not necessarily performed at the same time, but may be performed at different times, which are not necessarily performed in sequence, but may be performed alternately or alternately with other steps or at least a portion of the sub-steps or stages of other steps.

The foregoing is only a partial embodiment of the present application, and it should be noted that, for those skilled in the art, several modifications and decorations can be made without departing from the principle of the present application, and these modifications and decorations should also be regarded as the protection scope of the present application.

Claims

1. An electrode needle, comprising:

and the biological tissue information sensor is at least partially sheathed in the conductive needle tube in an insulating way, is in communication connection with the information processing unit, is used for acquiring biological tissue information of a target tissue and sending the biological tissue information to the information processing unit.

2. The electrode needle according to claim 1, wherein the biological tissue information sensor includes: at least one of a pH sensor assembly, a conductivity sensing assembly and a temperature sensing assembly;

the pH sensor assembly includes: the pH value sensing probe is at least partially sheathed in the conductive needle tube in an insulating way, and the pH value converter is in communication connection with the information processing unit; the pH value sensing probe is used for collecting the pH value of a target tissue and transmitting the pH value to the pH value converter, and the pH value converter is used for converting the pH value into pH value information and transmitting the pH value information to the information processing unit;

the conductivity sensing assembly includes: the conductivity sensing probe and the conductivity converter are connected; at least part of the conductivity sensing probe is sleeved in the conductive needle tube in an insulating way, and the conductivity converter is in communication connection with the information processing unit; the conductivity sensing probe is used for acquiring the conductivity of target tissues and transmitting the conductivity to the conductivity converter, and the conductivity converter is used for converting the conductivity into conductivity information and transmitting the conductivity information to the information processing unit;

the temperature sensing assembly includes: the temperature sensing probe and the temperature converter are connected; at least part of the temperature sensing probe is sleeved in the conductive needle tube in an insulating way, and the temperature converter is in communication connection with the information processing unit; the temperature sensing probe is used for collecting the temperature of target tissues and transmitting the temperature to the temperature converter, and the temperature converter is used for converting the temperature into temperature information and sending the temperature information to the information processing unit.

3. The electrode needle according to claim 2, further comprising: a handle;

one part of the conductive needle tube is sleeved in the handle in an insulating manner and is electrically connected with the pulse generator, and the other part of the conductive needle tube is positioned outside the handle and is used for extending into the target tissue and outputting an irreversible electroporation ablation pulse sequence; and/or at least one of the pH value converter, the conductivity converter, the temperature converter and the information processing unit is arranged in the handle.

4. The electrode needle according to any one of claims 1 to 3, wherein the resistance value of the conductive needle tube is not more than 1 ohm;

and/or the material of the conductive needle tube is nickel-titanium alloy or stainless steel.

5. An ablation device, comprising: a pulse generator and an electrode needle according to any one of the preceding claims 1-4;

and the information processing unit in the electrode needle is in communication connection with the pulse generator.

6. A method of ablation, comprising:

acquiring biological tissue information of a target tissue;

determining an ablation scheme according to the biological tissue information;

outputting a sequence of irreversible electroporation ablation pulses to the target tissue in accordance with the ablation plan.

7. The ablation method of claim 6, wherein said obtaining biological tissue information of the target tissue comprises:

8. The ablation method of claim 7, wherein determining an ablation plan based on the biological tissue information comprises:

and determining an ablation scheme according to one or two of the pH value information, the conductivity information and the temperature information.

9. The ablation method of claim 8, further comprising, after said outputting a sequence of irreversible electroporation ablation pulses to said target tissue in accordance with said ablation plan:

adjusting the ablation plan according to the other two or the other one of the pH value information, the conductivity information and the temperature information;

outputting the adjusted parameter irreversible electroporation ablation pulse sequence to the target tissue according to the adjusted ablation plan.

10. An ablation device, comprising:

11. A computer-readable storage medium, having stored thereon a computer program, the computer program, when executed by a processor, implementing the ablation method of any of claims 6-9.