Pulse monitoring method, device and apparatus for pulse ablation therapy

Abstract

The embodiments of the present application provide a pulse monitoring method, device and equipment for pulse ablation therapy. The pulse monitoring method for pulse ablation therapy includes: outputting a first pulse sequence and a second pulse sequence to the target biological tissue; obtaining a feedback signal after the second pulse sequence is output to the target biological tissue; and determining whether the termination condition of the first pulse sequence is met based on the feedback signal. The pulse monitoring equipment for pulse ablation therapy includes: a pulse generating circuit, a control unit and a monitoring unit; the control unit is communicatively connected to the pulse generating circuit; the monitoring unit is communicatively connected to the control unit, and is used to obtain the feedback signal after the second pulse sequence is output to the target biological tissue, and output the feedback signal to the control unit. The embodiments of the present application can monitor the ablation status of the target biological tissue in real time during the pulse ablation process to guide the progress of pulse ablation.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and more specifically, to a pulse monitoring method, device, and apparatus for pulse ablation therapy. Background Art

[0002] Pulse ablation is an emerging biological tissue ablation technology that can be applied to clinical diseases such as tumor ablation, cardiac tissue ablation, and hyperplastic tissue ablation.

[0003] Currently, there is no method for real-time monitoring and evaluation of the ablation effect on target biological tissues during pulse ablation, and thus the progress of pulse ablation cannot be guided according to the state changes of the target biological tissues. Summary of the Invention

[0004] In response to the shortcomings of existing methods, this application proposes a pulse monitoring method, device and equipment for pulse ablation treatment to solve the technical problem that the existing technology cannot guide the process of pulse ablation according to changes in biological tissues.

[0005] In a first aspect, embodiments of the present application provide a pulse monitoring method for pulse ablation therapy, comprising:

[0006] outputting a first pulse sequence and a second pulse sequence to the target biological tissue; wherein the voltage of the second pulse sequence is smaller than the voltage of the first pulse sequence, and the first pulse sequence is used to ablate the target biological tissue;

[0007] obtaining a feedback signal after the second pulse sequence is output to the target biological tissue;

[0008] determining, based on the feedback signal, whether a termination condition of the first pulse sequence is satisfied;

[0009] When it is determined that the termination condition of the first pulse sequence is satisfied, outputting the first pulse sequence is stopped.

[0010] In one possible implementation, outputting a first pulse sequence and a second pulse sequence to a target biological tissue includes:

[0011] A first designed number of first pulse sequences and a second designed number of second pulse sequences are alternately output to the target biological tissue.

[0012] In one possible implementation, the first pulse sequence includes at least one pulse, and the second pulse sequence includes at least one pulse.

[0013] In one possible implementation, the first pulse sequence includes nanosecond pulses, or the first pulse sequence includes nanosecond pulses and microsecond pulses;

[0014] The second pulse train includes microsecond pulses.

[0015] In one possible implementation, the voltage of the first pulse train is greater than 500 volts and no greater than 15 kilovolts;

[0016] And / or, the voltage of the second pulse train is no greater than 500 volts.

[0017] In one possible implementation, obtaining a feedback signal after the second pulse sequence is output to the target biological tissue includes:

[0018] After the second pulse sequence is output to the target biological tissue, obtaining the real-time voltage and real-time current of the feedback circuit corresponding to the target biological tissue;

[0019] And, determining whether a termination condition of the first pulse sequence is satisfied according to the feedback signal, comprising:

[0020] Determine the real-time impedance value of the target biological tissue according to the real-time voltage and real-time current of the feedback circuit;

[0021] Determine whether the real-time impedance value is less than the designed impedance value; or display the real-time impedance value and determine whether a termination instruction for the first pulse sequence is received.

[0022] And, when it is determined that the termination condition of the first pulse sequence is satisfied, stopping outputting the first pulse sequence comprises:

[0023] When it is determined that the real-time impedance value is less than the designed impedance value, the output of the first pulse sequence is stopped; or when it is determined that a termination instruction for the first pulse sequence is received, the output of the first pulse sequence is stopped.

[0024] In one possible implementation, displaying the real-time impedance value includes at least one of the following:

[0025] Displaying a real-time impedance value curve, where the real-time impedance value curve includes at least two real-time impedance values ​​in a designed time period;

[0026] The real-time impedance value is displayed in correspondence with the biological indicator information of the target biological tissue; the biological indicator information includes at least one of the following: heart rate, blood pressure, and blood oxygen concentration.

[0027] In a second aspect, an embodiment of the present application provides a pulse monitoring device for pulse ablation therapy, comprising:

[0028] a pulse output module, configured to output a first pulse sequence and a second pulse sequence to a target biological tissue; wherein a voltage of the second pulse sequence is smaller than a voltage of the first pulse sequence, and the first pulse sequence is configured to ablate the target biological tissue;

[0029] an acquisition module, configured to acquire a feedback signal after the second pulse sequence is output to the target biological tissue;

[0030] The processing module is used to determine whether a termination condition of the first pulse sequence is met according to the feedback signal; when it is determined that the termination condition of the first pulse sequence is met, stop outputting the first pulse sequence.

[0031] In a third aspect, an embodiment of the present application provides a pulse monitoring device for pulse ablation therapy, comprising: a pulse generating circuit, a control unit, and a monitoring unit;

[0032] a control unit, communicatively connected to the pulse generating circuit, configured to control the pulse generating circuit to output a first pulse sequence and a second pulse sequence to the target biological tissue, wherein the voltage of the first pulse sequence is greater than the voltage of the second pulse sequence, and the first pulse sequence is used to ablate the target biological tissue; and, based on a feedback signal forwarded by the monitoring unit, determining whether a termination condition of the first pulse sequence is satisfied; and, when it is determined that the termination condition of the first pulse sequence is satisfied, outputting a termination instruction for the first pulse sequence to the pulse generating circuit;

[0033] The monitoring unit is in communication with the control unit and is used for obtaining a feedback signal after the second pulse sequence is output to the target biological tissue, and outputting the feedback signal to the control unit.

[0034] In one possible implementation, the pulse generating circuit includes a first pulse generating circuit for outputting a first pulse sequence and a second pulse generating circuit for outputting a second pulse sequence;

[0035] The first pulse generating circuit and the second pulse generating circuit are integrated on the same circuit board.

[0036] In one possible implementation, the first pulse generating circuit includes at least one stage of first pulse generating units electrically connected in sequence;

[0037] The first pulse generating unit is electrically connected to the control unit and is configured to be turned on under the control of the control unit to output a first pulse sequence to the target biological tissue.

[0038] In one possible implementation, the second pulse generating circuit includes at least one stage of second pulse generating units electrically connected in sequence;

[0039] The second pulse generating unit is electrically connected to the control unit and is configured to be turned on under the control of the control unit to output a second pulse sequence to the target biological tissue.

[0040] In a fourth aspect, an embodiment of the present application provides a computer-readable storage medium having a computer program stored thereon, which, when executed by a pulse monitoring device for pulse ablation therapy, implements the pulse monitoring method for pulse ablation therapy as in the first aspect.

[0041] The beneficial technical effects brought about by the technical solutions provided by the embodiments of the present application include at least:

[0042] The pulse monitoring method for pulse ablation therapy according to an embodiment of the present application can output a first pulse sequence and a second pulse sequence to the target biological tissue, and determine whether the termination condition of the first pulse sequence is met based on the feedback signal after the second pulse sequence is output to the target biological tissue. That is, during the pulse ablation process, the ablation status of the target biological tissue can be determined based on the feedback signal, and the changes in the target biological tissue during the pulse ablation process can be monitored in real time. When it is determined that the termination condition of the first pulse sequence is met, the output of the first pulse sequence is stopped. That is, the embodiment of the present application can guide the process of pulse ablation according to the state change of the biological tissue. After determining that the pulse ablation effect is achieved, the output of the first pulse sequence for biological tissue ablation is stopped, thereby achieving the goal of guiding the process of pulse ablation according to the ablation status of the target biological tissue.

[0043] Additional aspects and advantages of the present application will be given in part in the following description, which will become apparent from the following description, or will be learned through practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] The above and / or additional aspects and advantages of the present application will become apparent and easily understood from the following description of the embodiments in conjunction with the accompanying drawings, in which:

[0045] Figure 1 A schematic structural diagram of a pulse monitoring device for pulse ablation therapy provided in an embodiment of the present application;

[0046] Figure 2 A schematic structural diagram of another pulse monitoring device for pulse ablation therapy provided in an embodiment of the present application;

[0047] Figure 3 A schematic diagram of a circuit structure of a pulse monitoring device for pulse ablation therapy provided in an embodiment of the present application;

[0048] Figure 4 A flow chart of a pulse monitoring method for pulse ablation therapy provided in an embodiment of the present application;

[0049] Figure 5 A pulse sequence output waveform diagram provided in an embodiment of the present application;

[0050] Figure 6 A schematic diagram of a pulse monitoring device for pulse ablation therapy provided in an embodiment of the present application.

[0051] Reference numerals:

[0052] 10- Pulse monitoring equipment for pulse ablation therapy;

[0053] 100 - pulse generating circuit, 110 - first pulse generating circuit, 111 - first pulse generating unit, 120 - second pulse generating circuit, 121 - second pulse generating unit;

[0054] 200-control unit;

[0055] 300- monitoring unit;

[0056] 310 - first Pearson coil, 320 - second Pearson coil;

[0057] R Load -load;

[0058] U H -First power supply, U L - a second power source;

[0059] 400-display unit;

[0060] 500-Alarm unit. DETAILED DESCRIPTION

[0061] The present application is described in detail below. Examples of embodiments of the present application are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar components or components having the same or similar functions. In addition, if the detailed description of the known technology is not necessary for the features of the present application shown, it will be omitted. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application and are not to be construed as limiting the present application.

[0062] It will be understood by those skilled in the art that, unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which this application belongs. It should also be understood that terms such as those defined in common dictionaries should be understood to have meanings consistent with their meanings in the context of the prior art and will not be interpreted in an idealized or overly formal sense unless specifically defined as herein.

[0063] It will be understood by those skilled in the art that, unless expressly stated otherwise, the singular forms "a", "an", "said" and "the" used herein may also include the plural forms. It should be further understood that the term "comprising" used in the specification of the present application refers to the presence of the features, integers, steps, operations, elements and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof. It should be understood that when we refer to an element as being "connected" or "coupled" to another element, it may be directly connected or coupled to the other element, or there may be intermediate elements. In addition, "connected" or "coupled" as used herein may include wireless connections or wireless couplings. The term "and / or" used herein includes all or any units and all combinations of one or more associated listed items.

[0064] The inventors of this application have discovered through research that, in the existing pulse ablation process, real-time monitoring and evaluation of the pulse ablation effect has not yet been considered, so changes in biological tissues during the ablation process cannot be obtained, and thus there is no basis for accurately guiding the pulse ablation process.

[0065] The inventors of this application further discovered that existing pulse ablation technologies mostly focus solely on lesion localization, with no publicly available methods or techniques capable of real-time monitoring of the pulse ablation process. Furthermore, existing pulse generators require additional monitoring equipment or independent modules to implement monitoring capabilities. Therefore, further research is needed to achieve monitoring capabilities for pulse ablation.

[0066] The pulse monitoring method, device and equipment for pulse ablation therapy provided in this application are intended to solve the above technical problems in the prior art.

[0067] The following describes in detail the technical solution of the present application and how the technical solution of the present application solves the above-mentioned technical problems with specific embodiments.

[0068] The present invention provides a pulse monitoring device 10 for pulse ablation therapy. Figure 1 As shown, the pulse monitoring device 10 for pulse ablation therapy includes: a pulse generating circuit 100 , a control unit 200 and a monitoring unit 300 .

[0069] The control unit 200 is communicatively connected to the pulse generating circuit 100, and is used to control the pulse generating circuit 100 to output a first pulse sequence and a second pulse sequence to the target biological tissue, wherein the voltage of the first pulse sequence is greater than the voltage of the second pulse sequence, and the first pulse sequence is used to ablate the target biological tissue; based on the feedback signal forwarded by the monitoring unit 300, it is determined whether the termination condition of the first pulse sequence is met; when it is determined that the termination condition of the first pulse sequence is met, a termination instruction for the first pulse sequence is output to the pulse generating circuit 100.

[0070] The monitoring unit 300 is communicatively connected to the control unit 200 , and is configured to obtain a feedback signal after the second pulse sequence is output to the target biological tissue, and output the feedback signal to the control unit 200 .

[0071] The pulse generating circuit 100 of the pulse monitoring device 10 for pulse ablation treatment in the embodiment of the present application can output a first pulse sequence and a second pulse sequence to the target biological tissue under the control of the control unit 200. The control unit 200 determines whether the termination condition of the first pulse sequence is met based on the feedback signal of the monitoring unit 300. That is, during the pulse ablation process, the control unit 200 can determine the ablation status of the target biological tissue based on the feedback signal, and monitor the ablation status of the target biological tissue in real time during the pulse ablation process.

[0072] The control unit 200 of the embodiment of the present application can guide the process of pulse ablation according to the changes in biological tissue. After determining that the pulse ablation effect is achieved, it outputs a termination instruction for the first pulse sequence, so that the control unit 200 controls the pulse generating circuit 100 to stop outputting the first pulse sequence for biological tissue ablation, thereby guiding the process of pulse ablation according to the changes in biological tissue.

[0073] The pulse monitoring device 10 for pulse ablation therapy in the embodiment of the present application integrates the two functions of pulse ablation and monitoring into one device, and does not require additional monitoring devices or independent modules, and is easy to use and operate.

[0074] Optionally, the target biological tissue includes a portion of a human body to be ablated.

[0075] Alternatively, see Figure 2 As shown, the pulse monitoring device 10 for pulse ablation therapy further includes a display unit 400 , which is in communication with the control unit 200 and is used to display real-time impedance values.

[0076] Optionally, the display unit 400 is also used to display a real-time impedance value curve, which includes at least two real-time impedance values ​​in a designed time period, or displays the real-time impedance value in correspondence with the biological indicator information of the target biological tissue; the biological indicator information includes at least one of the following: heart rate, blood pressure, and blood oxygen concentration.

[0077] Optionally, the display unit 400 may be a display screen for displaying information such as real-time impedance values, real-time impedance value curves, or biological indicator information.

[0078] Alternatively, see Figure 2 As shown, the pulse monitoring device 10 for pulse ablation therapy further includes an alarm unit 500, which is in communication with the control unit 200 and is configured to issue an alarm when the biometric information exceeds a predetermined threshold. The alarm may include emitting an alarm sound and / or outputting an alarm message to the control unit 200. The control unit 200 is configured to output a termination instruction for the first pulse sequence upon receiving the alarm message.

[0079] In some embodiments, see Figure 3 As shown, the pulse generating circuit 100 includes a first pulse generating circuit 110 for outputting a first pulse sequence and a second pulse generating circuit 120 for outputting a second pulse sequence.

[0080] The first pulse generating circuit 110 and the second pulse generating circuit 120 are integrated on the same circuit board.

[0081] The embodiment of the present application integrates the first pulse generating circuit 110 and the second pulse generating circuit 120 on the same circuit board, so that one circuit board can output the first pulse sequence and the second pulse sequence, taking into account both ablation and monitoring functions.

[0082] In some embodiments, see Figure 3 As shown, the first pulse generating circuit 110 includes at least one stage of first pulse generating units 111 electrically connected in sequence.

[0083] The first pulse generating unit 111 is electrically connected to the control unit 200 and is configured to be turned on under the control of the control unit 200 to output a first pulse sequence to the target biological tissue.

[0084] Alternatively, see Figure 3 As shown, each stage of the first pulse generating unit 111 includes a first capacitor, a first switching device, and a first diode. The first terminal of the first capacitor is electrically connected to the first terminal of the first switching device; the anode and cathode of the first diode are electrically connected to the second terminal of the first capacitor and the second terminal of the first switching device, respectively; and the control terminal of the first switching device is electrically connected to the control unit 200.

[0085] Optionally, when the first pulse generating circuit 110 is discharging, the control unit 200 controls the first switching device of the first pulse generating unit 111 to be turned on.

[0086] Alternatively, see Figure 3 As shown, the first pulse generating circuit 110 further includes at least one second diode; the first end of the first capacitor of the first-stage first pulse generating circuit 110 is connected to the first power supply U through at least one second diode. H The anode of the second diode is used to connect to the first power supply U H The cathode of the second diode is electrically connected to the first end of the first capacitor of the first-stage first pulse generating circuit 110.

[0087] Alternatively, see Figure 3 As shown, the first pulse generating circuit 110 further includes at least one third diode, the anode and cathode of the third diode being electrically connected to two adjacent first pulse generating units 111. The anode and cathode of the third diode are electrically connected to the first end of the first switching device of the previous stage and the first end of the first capacitor of the next stage, respectively.

[0088] In some embodiments, see Figure 3 As shown, the second pulse generating circuit 120 includes at least one stage of second pulse generating units 121 electrically connected in sequence.

[0089] The second pulse generating unit 121 is electrically connected to the control unit 200 and is configured to be turned on under the control of the control unit 200 to output a second pulse sequence to the target biological tissue.

[0090] Alternatively, see Figure 3 As shown, the second pulse generating unit 121 includes a second capacitor, a second switching device and a fourth diode; the first end of the second capacitor is electrically connected to the first end of the second switching device; the positive pole and the negative pole of the fourth diode are electrically connected to the second end of the second capacitor and the second end of the second switching device, respectively, and the control end of the second switching device is electrically connected to the control unit 200.

[0091] Optionally, when the second pulse generating circuit 120 is discharging, the control unit 200 controls the second switching device of the second pulse generating unit 121 to be turned on.

[0092] Optionally, the termination instruction of the first pulse sequence includes an instruction output by the control unit 200 to control the second switching device to be disconnected.

[0093] Alternatively, see Figure 3 As shown, the second pulse generating circuit 120 further includes at least one fifth diode; the anode of the fifth diode is used to connect to the second power supply U LThe negative electrode is electrically connected to the first end of the second capacitor of the first-stage second pulse generating unit 121.

[0094] Alternatively, see Figure 3 As shown, the second pulse generating circuit 120 further includes at least one sixth diode, the anode and cathode of the sixth diode being electrically connected to the adjacent second pulse generating unit 121. The anode and cathode of the sixth diode are electrically connected to the first end of the second switching device of the previous stage and the first end of the second capacitor of the next stage, respectively.

[0095] Alternatively, see Figure 3 As shown, the monitoring unit 300 includes a first Pearson coil 310, a second Pearson coil 320 and a first resistor R1. The first end of the first Pearson coil 310 is connected to the first resistor R1, which is grounded. The second end of the first Pearson coil 310 is connected to the first end of the second Pearson coil 320. The second end of the second Pearson coil 320 is electrically connected to both the first pulse generating circuit 110 and the second pulse generating circuit 120. The feedback circuit is the second pulse generating circuit 120 and the load R1. Load The loop formed.

[0096] Optionally, the functions of the first Pearson coil 310 are: first, there is a discharge channel for the pulse generated when the discharge circuit is not discharging; second, the resistance of the coil is roughly between 10-100 kΩ (kilo-ohms), which can be used for real-time voltage monitoring. The second Pearson coil 320 is used to measure current.

[0097] Optionally, when the second pulse generating circuit 120 is connected to the load R Load When the feedback circuit is formed by electrical connection, the first Pearson coil 310 and the second Pearson coil 320 are used as two sampling points for collecting the real-time voltage and real-time current on the feedback circuit.

[0098] As an example, see Figure 3 As shown, a pulse generating circuit 100 is provided with a power supply and a load R Load And the schematic diagram of the electrical connection of the monitoring unit, the first power supply U H The power supply circuit is a high-voltage nanosecond pulse generating circuit, and the second power supply U L The power supply circuit is a low-voltage microsecond pulse generating circuit, which serves as a feedback circuit. The second power supply U L The power supply circuit includes two-stage second pulse generating units 121, and the output voltage amplitude is 0-500V (volts). H The power supply circuit may include twenty-stage first pulse generating units 111 capable of generating high-voltage nanosecond pulses of 0-15 kV (kilovolts).

[0099] Optionally, in this embodiment, in the low-voltage microsecond pulse generating circuit, capacitor C1, switch device T1 and diode D1 form a second pulse generating unit 121, capacitor C2, switch device T2 and diode D2 form a second pulse generating unit 121, diode D7 serves as the sixth diode, and diode D6 serves as the fifth diode.

[0100] Optionally, in this embodiment, in the high-voltage nanosecond pulse generating circuit, capacitor C3, switch device T3, and diode D3 form a first pulse generating unit 111; capacitor C4, switch device T4, and diode D4 form a first pulse generating unit 111; capacitor Cn, switch device Tn, and diode Dn form a first pulse generating unit 111. Diode D8, diode D9, diode D10, diode D11, and diode D12 are all second diodes; diode D9, diode D10, diode D11, and diode D12 are connected in series in sequence; and diode D13 is a third diode.

[0101] Optionally, the switching device used in the low-voltage microsecond pulse generating circuit is a MOSFET (Metal-Oxide-Semiconductor Field-Effect Transistor), and the switching device used in the high-voltage nanosecond pulse generating circuit is an IGBT (Insulated Gate Bipolar Transistor).

[0102] Based on the same inventive concept, the present invention provides a pulse monitoring method for pulse ablation therapy, see Figure 3 As shown, the pulse monitoring method for pulse ablation therapy includes: steps S401 to S404.

[0103] S401 , outputting a first pulse sequence and a second pulse sequence to a target biological tissue; the voltage of the second pulse sequence is smaller than the voltage of the first pulse sequence, and the first pulse sequence is used to ablate the target biological tissue.

[0104] The second pulse sequence output to the target biological tissue in the embodiment of the present application is used to reflect the state of the target biological tissue in real time and monitor the ablation status of the target biological tissue during the pulse ablation process, so as to guide the progress of pulse ablation according to the ablation status of the target biological tissue.

[0105] Optionally, the pulse generating circuit 100 outputs a first pulse sequence and a second pulse sequence to the target biological tissue.

[0106] In some embodiments, outputting the first pulse sequence and the second pulse sequence to the target biological tissue includes: alternately outputting a first designed number of first pulse sequences and a second designed number of second pulse sequences to the target biological tissue.

[0107] Optionally, the pulse generating circuit 100 alternately outputs a first designed number of first pulse sequences and a second designed number of second pulse sequences to the target biological tissue.

[0108] Optionally, the first design quantity and the second design quantity are the same or different. For example, when the first design quantity and the second design quantity are both 1, one first pulse sequence and one second pulse sequence are output alternately. For another example, when the first design quantity is 3 and the second design quantity is 1, after outputting three first pulse sequences, one second pulse sequence is output, and the cycle continues.

[0109] The embodiment of the present application can alternately output the first pulse sequence and the second pulse sequence, so that the second pulse sequence is output in each cycle. The monitoring of the ablation status of the target biological tissue is real-time, so that changes in the target biological tissue can be responded to immediately.

[0110] In some embodiments, the first pulse train includes at least one pulse and the second pulse train includes at least one pulse.

[0111] Optionally, the first pulse sequence has only one type of pulse, the second pulse sequence has only one type of pulse, and the voltage of the pulses of the first pulse sequence is higher than the voltage of the pulses of the second pulse sequence.

[0112] In some embodiments, the first pulse sequence includes nanosecond pulses, or the first pulse sequence includes nanosecond pulses and microsecond pulses; and the second pulse sequence includes microsecond pulses.

[0113] Optionally, when the first pulse sequence includes nanosecond pulses and microsecond pulses, the microsecond pulses are also used to ablate the target biological tissue.

[0114] In some embodiments, the voltage of the first pulse train is greater than 500 volts and no greater than 15 kilovolts, and / or the voltage of the second pulse train is no greater than 500 volts.

[0115] As an example, see Figure 5 As shown, the horizontal axis is time, and the vertical axis is pulse voltage. The first pulse sequence is a high-voltage nanosecond pulse, and the second pulse sequence is a low-voltage microsecond pulse. High-voltage nanosecond pulses and low-voltage microsecond pulses are output alternately. The high-voltage nanosecond pulses are used to ablate the target biological tissue, while the low-voltage microsecond pulses are used to monitor the ablation status of the target biological tissue.

[0116] Optionally, the current range of the high-voltage nanosecond pulse is 0-300A (ampere), and the pulse duration is 200-1000 nanoseconds. The current range of the low-voltage microsecond pulse is 0-100A (ampere), and the pulse duration is 10-300 microseconds.

[0117] S402: Acquire a feedback signal after the second pulse sequence is output to the target biological tissue.

[0118] Optionally, the monitoring unit 300 obtains a feedback signal after the second pulse sequence is output to the target biological tissue, and outputs the feedback signal to the control unit 200 .

[0119] In some embodiments, obtaining a feedback signal after the second pulse sequence is output to the target biological tissue includes:

[0120] After the second pulse sequence is output to the target biological tissue, the real-time voltage and real-time current of the feedback circuit corresponding to the target biological tissue are obtained.

[0121] S403: Determine whether a termination condition of the first pulse sequence is met according to the feedback signal.

[0122] Optionally, the monitoring unit 300 outputs a feedback signal to the control unit 200 , and the control unit 200 determines whether a termination condition of the first pulse sequence is met according to the feedback signal.

[0123] The inventors of this application have discovered through research that cells in biological tissues are densely packed and arranged in neat rows, and that individual cells can be considered basic building blocks with a certain impedance. After high-voltage nanosecond pulse ablation, some cells rupture, inevitably causing a change in the impedance between the two electrodes. Generally, the higher the degree of tissue ablation, the lower the impedance. Therefore, impedance can, to a certain extent, reflect the degree of tissue ablation.

[0124] Based on the above considerations, in some embodiments, determining whether a termination condition of the first pulse sequence is satisfied according to the feedback signal includes:

[0125] Determine the real-time impedance value of the target biological tissue according to the real-time voltage and real-time current of the feedback circuit;

[0126] Determine whether the real-time impedance value is less than the designed impedance value; or display the real-time impedance value and determine whether a termination instruction for the first pulse sequence is received.

[0127] In some embodiments, determining whether a termination condition of the first pulse sequence is satisfied according to the feedback signal includes:

[0128] The control unit 200 determines the real-time impedance value of the target biological tissue according to the real-time voltage and real-time current of the feedback circuit;

[0129] The control unit 200 determines whether the real-time impedance value is less than the designed impedance value; alternatively, the display unit 400 displays the real-time impedance value, and the control unit 200 determines whether a termination instruction for the first pulse sequence is received.

[0130] Optionally, the designed impedance value is a value obtained by medical personnel based on an ablation test. When the real-time impedance value is less than the designed impedance value, it is determined that the ablation expectation is achieved.

[0131] Optionally, the calculation process of the real-time impedance value is as shown in expression (1):

[0132]

[0133] U in is the real-time voltage of the input pulse; I m is the real-time current; Z is the calculated real-time impedance value. The calculated real-time impedance value is equivalent to the equivalent impedance value of the target biological tissue and can accurately reflect the ablation status of the target biological tissue.

[0134] In some embodiments, displaying real-time impedance values ​​includes:

[0135] A real-time impedance value curve is displayed, where the real-time impedance value curve includes at least two real-time impedance values ​​in a designed time period.

[0136] Optionally, real-time impedance values ​​are displayed, including:

[0137] The display unit 400 displays a real-time impedance value curve, which includes at least two real-time impedance values ​​in a designed time period.

[0138] Optionally, real-time impedance values ​​are displayed, allowing physicians to determine whether to stop the first pulse sequence for ablation based on these values. In practice, physicians can use their experience and the current state of the tissue to determine whether ablation should continue or terminate. Displaying real-time impedance values ​​closes the entire medical process, providing physicians with a reliable basis for decision-making and enhancing ablation effectiveness.

[0139] Optionally, displaying the real-time impedance value includes: displaying the real-time impedance value in correspondence with biological indicator information of the target biological tissue; the biological indicator information includes at least one of the following: heart rate, blood pressure, and blood oxygen concentration.

[0140] Optionally, displaying the real-time impedance value includes: the display unit 400 displays the real-time impedance value corresponding to the biological indicator information of the target biological tissue; the biological indicator information includes at least one of the following: heart rate, blood pressure, and blood oxygen concentration.

[0141] Optionally, displaying the real-time impedance value and determining whether a termination instruction for the first pulse sequence is received comprises:

[0142] When the biometric information is greater than the designed threshold, an alarm is issued, which includes emitting an alarm sound and / or outputting an alarm message. Upon receiving the alarm message, the control unit 200 outputs a termination instruction for the first pulse sequence.

[0143] Optionally, displaying the real-time impedance value and determining whether a termination instruction for the first pulse sequence is received comprises:

[0144] When the biometric information is greater than the designed threshold, the alarm unit 500 issues an alarm prompt.

[0145] The embodiment of the present application can monitor the patient's biometric information while performing ablation on the patient's target biological tissue, thereby avoiding danger to the patient during the ablation process and further ensuring the ablation effect.

[0146] S404 : When it is determined that the termination condition of the first pulse sequence is met, stop outputting the first pulse sequence.

[0147] Optionally, when determining that the termination condition of the first pulse sequence is satisfied, the control unit 200 stops outputting the first pulse sequence, including:

[0148] When it is determined that the real-time impedance value is less than the designed impedance value, the output of the first pulse sequence is stopped; or when it is determined that a termination instruction for the first pulse sequence is received, the output of the first pulse sequence is stopped.

[0149] Optionally, when it is determined that a termination condition of the first pulse sequence is satisfied, stopping outputting the first pulse sequence includes:

[0150] When the control unit 200 determines that the real-time impedance value is less than the designed impedance value, the control unit 200 outputs a termination instruction for the first pulse sequence to the pulse generating circuit 100, and controls the pulse generating circuit 100 to stop outputting the first pulse sequence; or, when the control unit 200 determines that a termination instruction for the first pulse sequence is received, the control unit 200 controls the pulse generating circuit 100 to stop outputting the first pulse sequence.

[0151] Optionally, when it is determined that the real-time impedance value is not less than the designed impedance value, the first pulse sequence is continuously output for ablation until the real-time impedance value is less than the designed impedance value. When it is determined that the real-time impedance value is less than the designed impedance value, the ablation expectation is achieved, and the first pulse sequence can be continuously output for ablation of the target biological tissue.

[0152] Based on the above technical solution, the present embodiment treats the target biological tissue as an electrical network. When the second pulse sequence is input into the target biological tissue, the response of the target biological tissue to this stimulus is measured in a feedback circuit. Based on the stimulus and response, the equivalent real-time impedance value of the biological tissue can be determined, and the effectiveness of the pulse ablation can be evaluated based on the numerical value of the real-time impedance value.

[0153] The embodiment of the present application can calculate the real-time impedance value of the target biological tissue based on the real-time voltage and real-time current, and guide the pulse ablation process of medical personnel based on whether the single pulse ablation of the real-time impedance value achieves the expected tissue ablation degree.

[0154] Based on the same inventive concept, the present invention provides a pulse monitoring device for pulse ablation therapy, see Figure 6 As shown, the pulse monitoring device 60 for pulse ablation therapy includes: a pulse output module 610 , an acquisition module 620 and a processing module 630 .

[0155] The pulse output module 610 is used to output a first pulse sequence and a second pulse sequence to the target biological tissue; the voltage of the second pulse sequence is lower than the voltage of the first pulse sequence, and the first pulse sequence is used to ablate the target biological tissue;

[0156] The acquisition module 620 is used to acquire a feedback signal after the second pulse sequence is output to the target biological tissue;

[0157] The processing module 630 is configured to determine, based on the feedback signal, whether a termination condition of the first pulse sequence is satisfied; and stop outputting the first pulse sequence when it is determined that the termination condition of the first pulse sequence is satisfied.

[0158] Optionally, the pulse output module 610 is further configured to alternately output a first designed number of first pulse sequences and a second designed number of second pulse sequences to the target biological tissue.

[0159] Optionally, the acquisition module 620 is further configured to acquire the real-time voltage and real-time current of the feedback circuit corresponding to the target biological tissue after the second pulse sequence is output to the target biological tissue.

[0160] Optionally, the processing module 630 is further configured to determine the real-time impedance value of the target biological tissue based on the real-time voltage and real-time current of the feedback circuit; determine whether the real-time impedance value is less than the designed impedance value; or display the real-time impedance value and determine whether a termination instruction for the first pulse sequence is received.

[0161] Optionally, the processing module 630 is further configured to display a real-time impedance value curve, which includes at least two real-time impedance values ​​in a designed time period, or to display the real-time impedance value in correspondence with the biological indicator information of the target biological tissue; the biological indicator information includes at least one of the following: heart rate, blood pressure, blood oxygen concentration,

[0162] Optionally, the processing module 630 is further configured to stop outputting the first pulse sequence when it is determined that the real-time impedance value is less than the designed impedance value; or stop outputting the first pulse sequence when it is determined that a termination instruction for the first pulse sequence is received.

[0163] Based on the same inventive concept, an embodiment of the present application provides a computer-readable storage medium on which a computer program is stored. When the computer program is executed by a pulse monitoring device 10 for pulse ablation therapy, it implements a pulse monitoring method for pulse ablation therapy as in any embodiment of the present application.

[0164] The computer-readable medium of the embodiment of the present application can be a computer-readable signal medium or a computer-readable storage medium or any combination of the above two. The computer-readable storage medium can be, for example, but not limited to, a system, device or component of electricity, magnetism, light, electromagnetic, infrared, or semiconductor, or any combination of the above. More specific examples of computer-readable storage media can include, but are not limited to: an electrical connection with one or more wires, a portable computer disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the above.

[0165] The computer-readable medium of the embodiments of the present application can be any tangible medium containing or storing a program that can be used by or in combination with an instruction execution system, device, or component. In the present application, a computer-readable signal medium may include a data signal propagated in baseband or as part of a carrier wave, which carries a computer-readable program code. This propagated data signal can take a variety of forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above. The computer-readable signal medium can also be any computer-readable medium other than a computer-readable storage medium, which can send, propagate, or transmit a program for use by or in combination with an instruction execution system, device, or component. The program code contained on the computer-readable medium can be transmitted using any appropriate medium, including but not limited to: wires, optical cables, RF (radio frequency), etc., or any suitable combination of the above.

[0166] By applying the embodiments of the present application, at least the following beneficial effects can be achieved:

[0167] (1) The pulse monitoring method for pulse ablation therapy according to the embodiment of the present application can determine the ablation status of the target biological tissue according to the feedback signal during the pulse ablation process, and monitor the ablation status of the target biological tissue in real time during the pulse ablation process. When it is determined that the termination condition of the first pulse sequence is met, the output of the first pulse sequence is stopped. That is, the embodiment of the present application can guide the progress of pulse ablation according to the changes in the biological tissue. After it is determined that the pulse ablation effect is achieved, the output of the first pulse sequence for biological tissue ablation is stopped, thereby guiding the progress of pulse ablation according to the changes in the target biological tissue.

[0168] (2) The embodiment of the present application can alternately output the first pulse sequence and the second pulse sequence, so that the second pulse sequence is output in each cycle. The monitoring of the ablation status of the target biological tissue is real-time, so that changes in the target biological tissue can be responded to immediately.

[0169] (3) When the embodiment of the present application performs ablation on the target biological tissue of the patient, the patient's biometric information can be monitored simultaneously to avoid danger to the patient during the ablation process and further ensure the ablation effect.

[0170] (4) The embodiments of the present application can obtain the real-time impedance value of the target biological tissue based on the real-time voltage and real-time current, and guide the pulse ablation process of medical personnel based on whether the single pulse ablation of the real-time impedance value achieves the expected tissue ablation degree.

[0171] (5) In the embodiment of the present application, the first pulse generating circuit 110 and the second pulse generating circuit 120 are integrated on the same circuit board, so that one circuit board can output the first pulse sequence and the second pulse sequence, taking into account both ablation and monitoring functions.

[0172] (6) The pulse monitoring device 10 for pulse ablation therapy in the embodiment of the present application integrates the two functions of pulse ablation and monitoring into one device, and does not require additional monitoring devices or independent modules, making it easy to use and operate.

[0173] Those skilled in the art will appreciate that the steps, measures, and schemes in the various operations, methods, and processes discussed in this application may be interchanged, modified, combined, or deleted. Furthermore, other steps, measures, and schemes in the various operations, methods, and processes discussed in this application may also be interchanged, modified, rearranged, decomposed, combined, or deleted. Furthermore, steps, measures, and schemes in the prior art that are similar to those disclosed in this application may also be interchanged, modified, rearranged, decomposed, combined, or deleted.

[0174] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature specified as "first" or "second" may explicitly or implicitly include one or more of such features. Throughout this application, unless otherwise specified, "plurality" means two or more.

[0175] It should be understood that although the steps in the flowcharts of the accompanying drawings are shown in sequence as indicated by the arrows, these steps are not necessarily executed in the order indicated by the arrows. Unless otherwise specified herein, there is no strict order restriction on the execution of these steps, and they can be executed in other orders. Moreover, at least some of the steps in the flowcharts of the accompanying drawings may include multiple sub-steps or multiple stages, and these sub-steps or stages are not necessarily executed at the same time, but can be executed at different times, and their execution order is not necessarily sequential, but can be executed in turn or alternately with other steps or at least a portion of the sub-steps or stages of other steps.

[0176] The above description is only part of the implementation methods of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application. These improvements and modifications should also be regarded as the scope of protection of the present application.

Claims

1. A pulse monitoring device for pulse ablation therapy, characterized in that: include: Pulse generating circuit, control unit and monitoring unit; The control unit is communicatively connected to the pulse generating circuit, and is used to control the pulse generating circuit to alternately output a first pulse sequence and a second pulse sequence to the target biological tissue, wherein the voltage of the first pulse sequence is greater than the voltage of the second pulse sequence, the first pulse sequence is used to ablate the target biological tissue, and the first pulse sequence includes nanosecond pulses, or the first pulse sequence includes nanosecond pulses and microsecond pulses; The second pulse sequence includes microsecond pulses; and determining whether a termination condition of the first pulse sequence is satisfied based on a feedback signal forwarded by the monitoring unit; When it is determined that the termination condition of the first pulse sequence is satisfied, outputting a termination instruction for the first pulse sequence to the pulse generating circuit; wherein the pulse generating circuit includes a first pulse generating circuit for outputting the first pulse sequence and a second pulse generating circuit for outputting the second pulse sequence, the first pulse generating circuit and the second pulse generating circuit being integrated on the same circuit board and being independent of each other; The monitoring unit is communicatively connected to the control unit, and is used to obtain a feedback signal after the second pulse sequence is output to the target biological tissue, and output the feedback signal to the control unit; the feedback signal includes the real-time voltage and real-time current of the feedback circuit corresponding to the target biological tissue; the monitoring unit includes a first Pearson coil, a second Pearson coil and a first resistor, the first end of the first Pearson coil is connected to the first resistor, the first resistor is grounded, the second end of the first Pearson coil is connected to the first end of the second Pearson coil, and the second end of the second Pearson coil is electrically connected to the first pulse generating circuit and the second pulse generating circuit; the feedback circuit is a loop formed by the second pulse generating circuit and the load, the first Pearson coil is used to provide a discharge channel for the pulse generated when the discharge circuit is not discharging, and can also be used for real-time voltage monitoring, and the second Pearson coil is used to measure current.

2. The pulse monitoring device for pulse ablation therapy according to claim 1, characterized in that: The first pulse generating circuit comprises at least one stage of first pulse generating units electrically connected in sequence; The first pulse generating unit is electrically connected to the control unit and is configured to be turned on under the control of the control unit to output the first pulse sequence to the target biological tissue.

3. The pulse monitoring device for pulse ablation therapy according to claim 1, characterized in that: The second pulse generating circuit includes at least one stage of second pulse generating units electrically connected in sequence; The second pulse generating unit is electrically connected to the control unit and is configured to be turned on under the control of the control unit to output the second pulse sequence to the target biological tissue.

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