CN116531083B - Pulse ablation system - Google Patents

Pulse ablation system Download PDF

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Publication number
CN116531083B
CN116531083B CN202310797265.8A CN202310797265A CN116531083B CN 116531083 B CN116531083 B CN 116531083B CN 202310797265 A CN202310797265 A CN 202310797265A CN 116531083 B CN116531083 B CN 116531083B
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electrode
ablation
module
electrodes
control module
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CN116531083A (en
Inventor
曹海朋
王超文
张银伟
周磊
史胜凤
薛卫
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Shanghai Antaike Medical Technology Co ltd
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Shanghai Antaike Medical Technology Co ltd
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Priority to CN202311147272.XA priority Critical patent/CN117084778A/en
Priority to CN202310797265.8A priority patent/CN116531083B/en
Priority to CN202311150471.6A priority patent/CN117100386A/en
Publication of CN116531083A publication Critical patent/CN116531083A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206Generators therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00613Irreversible electroporation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00839Bioelectrical parameters, e.g. ECG, EEG
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00875Resistance or impedance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape

Abstract

The invention relates to the technical field of medical equipment, in particular to a pulse ablation system, which comprises an energy supply module, a high-voltage pulse generation module, an impedance detection module, a pulse ablation catheter and a control module, wherein the energy supply module is connected with the high-voltage pulse generation module; the energy supply module is configured to supply energy to the high-voltage pulse generation module; the high voltage pulse generation module is configured to send a high voltage pulse signal to the pulse ablation catheter; a pulse ablation catheter comprising a number of ablation electrodes, the ablation electrodes comprising an outer electrode and an inner electrode, at least a portion of the ablation electrodes configured as working electrodes that receive high voltage pulse signals and perform ablation treatment on target tissue; the impedance detection module is configured to select paired ablation electrodes and detect impedance values between the paired ablation electrodes, at least one of the paired ablation electrodes being a working electrode; the control module is configured to receive the impedance value and evaluate a degree of abutment of the working electrode with the target tissue. The invention does not need to additionally increase electrodes and sensors, and has high detection speed and high precision.

Description

Pulse ablation system
Technical Field
The invention relates to the technical field of medical instruments, in particular to a pulse ablation system.
Background
The current application of pulsed electric field ablation techniques using irreversible electroporation is a global hot spot in atrial fibrillation therapy. The pulse electric field ablation has the technical advantage that the traditional thermal effect is incomparable, and the cell selectivity of the pulse electric field ablation can effectively avoid the damage of esophagus and phrenic nerve in the pulmonary vein isolation ablation process. In order to be able to form an effective ablation depth, the field intensity distribution area of the pulsed electric field formed by the catheter must be maximized and an effective abutment of the ablation electrode against the tissue ensured.
The prior art has the problems that the low-voltage pulse detection or the sensor detection is used for detecting the leaning state, the former needs to emit certain ablation power, real-time detection cannot be realized, the sensor element needs to be added, and the signal needs to be fed back through the added components. The method also comprises the step of detecting the abutting condition by using a high-frequency signal detection circuit, namely outputting a weak high-frequency signal to tissues, detecting the amplitude of the high-frequency signal through rectification and filtering, so as to detect the impedance.
Disclosure of Invention
The present invention is directed to a pulse ablation system, which solves at least one of the problems of the prior art or related art.
In order to achieve the above object, in a first aspect, the present invention provides a pulse ablation system, which includes an energy supply module, a high voltage pulse generation module, an impedance detection module, a pulse ablation catheter and a control module; wherein, the liquid crystal display device comprises a liquid crystal display device,
the energy supply module is electrically connected with the high-voltage pulse generation module and is configured to supply energy to the high-voltage pulse generation module;
the high-voltage pulse generation module is electrically connected with the pulse ablation catheter and the impedance detection module and is configured to send a high-voltage pulse signal to the pulse ablation catheter;
the pulse ablation catheter comprises a catheter shaft and an electrode section arranged at the distal end of the catheter shaft, wherein the electrode section comprises an electrode assembly, the electrode assembly comprises at least one electrode carrier and a plurality of ablation electrodes positioned on the electrode carrier, the ablation electrodes comprise an outer electrode and an inner electrode, in an initial state, the acting surface of the outer electrode faces away from the catheter shaft, the acting surface of the inner electrode faces towards the catheter shaft, and at least part of the ablation electrodes are configured to receive the high-voltage pulse signals and perform ablation treatment on target tissues;
The impedance detection module is electrically connected with the pulse ablation catheter and the control module, and is configured to select paired ablation electrodes and detect impedance values between the paired ablation electrodes under the control of the control module, wherein at least one of the paired ablation electrodes is the working electrode;
the control module is configured to receive the impedance value detected by the impedance detection module and evaluate the contact degree of the working electrode and the target tissue.
Optionally, at least one of the paired ablation electrodes is the outer electrode.
Optionally, the outer electrode is disposed near a distal end of the electrode carrier, the inner electrode is disposed near a proximal end of the electrode carrier, and the paired ablation electrode is an inner electrode and/or an outer electrode.
Optionally, the electrode segment further comprises an end electrode disposed at a distal end of the catheter shaft, one of the paired ablation electrodes being the end electrode and the other being the outer electrode.
Optionally, the outer electrodes on the same electrode carrier are divided into an outer electrode group, and the end electrodes are paired with the outer electrode group in turn to detect the impedance value between the end electrodes and the outer electrodes.
Optionally, the proximal end and the distal end of the electrode carrier are respectively connected with the catheter shaft and can relatively move on the catheter shaft, so that the electrode segments can be switched between a contracted state and an expanded state, and in the expanded state, ablation electrodes in the same outer diameter range are divided into electrode groups by taking the distal end of the catheter shaft as a circle center, and the paired ablation electrodes in each electrode group are paired alternately at fixed intervals.
Optionally, the expanded state includes a basket state or a petal state, in which the paired ablation electrode is an outer electrode; in the petal state, the paired ablation electrodes are an inner electrode disposed proximate to a proximal end of the electrode carrier and the outer electrode disposed proximate to a distal end of the electrode carrier.
Optionally, the proximal and distal ends of the electrode carrier are respectively connected to and relatively movable on the catheter shaft to switch the electrode segments between a contracted state and an expanded state, the expanded state comprising a petal state; in the petal state, taking the distal end of the catheter shaft as a circle center, dividing the outer electrodes positioned in the same outer diameter range into outer electrode groups, dividing the inner electrodes positioned in the same outer diameter range into inner electrode groups, alternately pairing the paired ablation electrodes in each outer electrode group at fixed intervals, and alternately pairing the paired ablation electrodes in each inner electrode group at fixed intervals; and/or the number of the groups of groups,
And in the petal state, dividing the outer electrodes on the same electrode carrier into an outer electrode group, dividing the inner electrodes on the same electrode carrier into an inner electrode group, alternately pairing the paired ablation electrodes in each outer electrode group at fixed intervals, and alternately pairing the paired ablation electrodes in each inner electrode group at fixed intervals.
Optionally, the impedance detection module detects an initial impedance value when the ablation electrode contacts blood, and the paired ablation electrode for detecting the initial impedance value is an inner electrode disposed near the proximal end of the electrode carrier.
Optionally, the initial impedance value is detected before the working electrode is against the target tissue.
Optionally, the impedance detection module further includes a first multi-path selection switch, where the first multi-path selection switch includes a plurality of first selection switches that are in one-to-one correspondence with the ablation electrodes and are electrically connected, and the first selection switches are configured to be selectively opened or closed under the control of the control module, so that the impedance detection module is in electrical communication with the corresponding paired ablation electrodes.
Optionally, the pulse ablation system further comprises a mapping module electrically connected with the pulse ablation catheter and the control module, the mapping module being configured to select at least part of the ablation electrodes as mapping electrodes under the control of the control module to detect the electrocardiograph signals of the target tissue.
In a second aspect, the invention also provides another pulse ablation system, which comprises an energy supply module, a high-voltage pulse generation module, a mapping module, a pulse ablation catheter, a control module and an interlocking module; wherein, the liquid crystal display device comprises a liquid crystal display device,
the energy supply module is electrically connected with the high-voltage pulse generation module and is configured to supply energy to the high-voltage pulse generation module;
the high-voltage pulse generation module is electrically connected with the pulse ablation catheter and the mapping module and is configured to send a high-voltage pulse signal to the pulse ablation catheter;
the pulse ablation catheter comprises a plurality of ablation electrodes, at least part of which is configured as a working electrode for receiving the high-voltage pulse signal and performing ablation treatment on target tissues;
the mapping module is electrically connected with the pulse ablation catheter and the control module and is configured to select at least part of the ablation electrodes as mapping electrodes under the control of the control module so as to detect electrocardiosignals of the target tissue;
The interlocking module is electrically connected with the control module and the high-voltage pulse generation module, the mapping module sends a cutting-off signal to the control module during mapping, and the control module controls the interlocking module to cut off the high-voltage pulse signal output of the high-voltage pulse generation module, receives the electrocardiosignal detected by the mapping module and evaluates the treatment effect.
In a third aspect, the present invention further provides a pulse ablation system, including an energy supply module, a high voltage pulse generation module, an acquisition module, a diagnosis module, a pulse ablation catheter, and a control module; wherein, the liquid crystal display device comprises a liquid crystal display device,
the energy supply module is electrically connected with the high-voltage pulse generation module and is configured to supply energy to the high-voltage pulse generation module;
the high-voltage pulse generation module is electrically connected with the pulse ablation catheter and is configured to send a high-voltage pulse signal to the pulse ablation catheter;
the pulse ablation catheter comprises a plurality of ablation electrodes, at least part of which is configured as a working electrode for receiving the high-voltage pulse signal and performing ablation treatment on target tissues;
the control module is configured to control the high-voltage pulse generation module to perform pre-discharge according to a discharge mode, and the working voltage provided by the energy supply module during pre-discharge is smaller than the working voltage provided by the energy supply module during ablation treatment;
The acquisition module is electrically connected with the pulse ablation catheter and is configured to acquire current and voltage data of the working electrode during pre-discharge;
the diagnosis module is electrically connected with the acquisition module and the control module, and is configured to judge whether the discharge of the working electrode is normal according to the acquired current and voltage data and feed back to the control module.
Optionally, the pulse ablation system further comprises a man-machine interaction interface electrically connected with the control module, and the control module is further configured to establish a three-dimensional model of the pulse ablation catheter based on the impedance value according to the electrode morphology in the treatment mode and display the three-dimensional model through the man-machine interaction interface.
Optionally, the pulse ablation system further includes an electrode switching module, where the electrode switching module is electrically connected to the high-voltage pulse generating module, the pulse ablation catheter and the control module, and the electrode switching module is configured to receive the high-voltage pulse signal sent by the high-voltage pulse generating module under the control of the control module, and perform selection of the working electrode and positive-negative electrode switching.
Optionally, the electrode switching module includes a first layer combination switch, a second layer combination switch and a third layer combination switch; wherein, the liquid crystal display device comprises a liquid crystal display device,
The input end of the first layer combination switch is respectively and electrically connected with the positive electrode and the negative electrode of the high-voltage pulse signal output;
the input ends of the second combination switches are respectively and correspondingly connected with the output ends of the first combination switches in a switchable manner, and the second combination switches are configured to commutate the anode and the cathode under the control of the control module;
the third layer combination switch comprises a plurality of ablation selection switches which are in one-to-one correspondence with the ablation electrodes, the input ends of the ablation selection switches are electrically connected with the second layer combination switch, the output ends of the ablation selection switches are electrically connected with the corresponding ablation electrodes, and the third layer combination switch is configured to select working electrodes and positive and negative of each working electrode under the control of the control module.
Optionally, the mapping module further includes a second multiple-way selection switch, where the second multiple-way selection switch includes a plurality of second selection switches electrically connected to the ablation electrodes in a one-to-one correspondence, and the second selection switches are configured to be selectively opened or closed under the control of the control module, perform mapping electrode selection, and detect the electrocardiographic signals of the target tissue through the mapping electrode.
Optionally, the pulse ablation system further includes an interlock module, the interlock module is electrically connected with the control module and the high-voltage pulse generation module, the mapping module sends a cutting-off signal to the control module when the mapping and/or the impedance detection module detects, the control module controls the interlock module to cut off the high-voltage pulse signal output of the high-voltage pulse generation module, and the control module is further configured to receive the electrocardiosignal detected by the mapping module and evaluate the treatment effect and/or receive the impedance value detected by the impedance detection module and evaluate the contact degree of the working electrode and the target tissue.
Optionally, the control module is further configured to control the high voltage pulse generation module to perform pre-discharge according to a discharge mode, and the pulse ablation system further includes:
the acquisition module is electrically connected with the pulse ablation catheter and is configured to acquire current and voltage data of the working electrode during pre-discharge;
the diagnosis module is electrically connected with the acquisition module and the control module, and is configured to judge whether the discharge of the working electrode is normal according to the acquired current and voltage data and feed back to the control module.
In a fourth aspect, the invention also provides a pulse ablation system, which comprises an energy supply module, a high-voltage pulse generation module, an electrode switching module, a pulse ablation catheter and a control module; wherein, the liquid crystal display device comprises a liquid crystal display device,
the energy supply module is electrically connected with the high-voltage pulse generation module and is configured to supply energy to the high-voltage pulse generation module;
the high-voltage pulse generation module is electrically connected with the pulse ablation catheter and is configured to send a high-voltage pulse signal to the pulse ablation catheter;
the pulse ablation catheter comprises a plurality of ablation electrodes, at least part of which is configured as a working electrode for receiving the high-voltage pulse signal and performing ablation treatment on target tissues;
the electrode switching module is electrically connected with the high-voltage pulse generation module, the pulse ablation catheter and the control module, and is configured to receive a high-voltage pulse signal sent by the high-voltage pulse generation module under the control of the control module, and select the working electrode and switch the anode and the cathode;
the electrode switching module comprises a first layer combination switch, a second layer combination switch and a third layer combination switch; wherein, the liquid crystal display device comprises a liquid crystal display device,
The input end of the first layer combination switch is respectively and electrically connected with the positive electrode and the negative electrode of the high-voltage pulse signal output;
the input ends of the second combination switches are respectively and correspondingly connected with the output ends of the first combination switches in a switchable manner, and the second combination switches are configured to commutate the anode and the cathode under the control of the control module;
the third layer combination switch comprises a plurality of ablation selection switches which are in one-to-one correspondence with the ablation electrodes, the input ends of the ablation selection switches are electrically connected with the second layer combination switch, the output ends of the ablation selection switches are electrically connected with the corresponding ablation electrodes, and the third layer combination switch is configured to select working electrodes and positive and negative of each working electrode under the control of the control module.
In the pulse ablation system provided by the invention, at least one of the following beneficial effects is achieved:
1) The method has the advantages that electrodes and sensors are not required to be additionally arranged, an impedance detection module is additionally arranged on the basis of hardware of an existing pulse ablation system, the degree of adhesion between a working electrode and a target tissue can be obtained by detecting impedance values between the matched ablation electrodes comprising the working electrode, and the method is high in detection speed and accuracy and real-time;
2) The system is characterized in that a mapping module is additionally arranged, and the electrocardiographic signal of the target tissue region can be detected through the mapping module and is used for evaluating a treatment object and a treatment effect;
3) By arranging the interlocking module, high-voltage pulse can be ensured not to be transmitted to the mapping module and the impedance detection module during ablation treatment, and electrocardiosignal detection or impedance detection is performed, so that the high-voltage pulse generation module can not output high-voltage pulse signals, and independent work of each functional module is realized;
4) The control module is also configured to control the high-voltage pulse generation module to perform pre-discharge according to a discharge mode, rapidly evaluate the current discharge condition of the system through lower voltage discharge, detect the integrity of a discharge loop, and further guarantee the discharge safety of ablation treatment.
Drawings
Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention. Wherein:
FIG. 1 is a block diagram of a pulse ablation system according to an embodiment of the present invention;
FIG. 2 is a schematic view of an electrode segment according to an embodiment of the present invention in a contracted state;
FIG. 3 is a schematic view of an electrode segment according to an embodiment of the present invention in a basket state;
FIG. 4 is a schematic view of an electrode segment according to an embodiment of the present invention in a petal state;
FIG. 5 is a schematic diagram of grouping of outer electrodes according to an embodiment of the present invention;
fig. 6 is a schematic diagram illustrating connection of functional modules in a pulse ablation system according to an embodiment of the present invention.
Wherein:
1-an energy supply module; 2-a high voltage pulse generation module; 3-an impedance detection module; 4-pulse ablation catheter; 5-a control module; 6-a human-computer interaction interface; 7-an electrode switching module; 8-mapping module; 9-an interlocking module; 10-an acquisition module; 11-a diagnostic module;
40-catheter shaft; 41 electrode segments; 31-a first multiplexing switch; a 32-impedance detection unit; 71-a first layer combination switch; 72-a second layer combination switch; 73-third layer combination switch; 80-a second multiplexing switch;
400-an inner shaft; 401-an outer tube; 410-electrode carrier; 411-outer electrode; 412-an inner electrode; 413-end electrodes;
411-1-a first outer electrode; 411-2-second external electrode; 411-3-third outer electrode; 411-4-fourth outer electrode; 411-5-fifth outer electrode; 411-6-sixth outer electrode; 411-7-seventh outer electrode; 411-8-eighth outer electrode; 411-9-ninth outer electrode; 411-10-tenth outer electrode; 411-11-eleventh outer electrode; 411-12-twelfth outside electrode; 411-13-thirteenth outer electrode; 411-14-fourteenth outer electrode; 411-15-fifteenth outer electrode.
Detailed Description
The invention will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for the purpose of facilitating and clearly aiding in the description of embodiments of the invention. For a better understanding of the invention with objects, features and advantages, refer to the drawings. It should be understood that the structures, proportions, sizes, etc. shown in the drawings are shown only in connection with the present disclosure for the understanding and reading of the present disclosure, and are not intended to limit the scope of the invention, which is defined by the appended claims, and any structural modifications, proportional changes, or dimensional adjustments, which may be made by the present disclosure, should fall within the scope of the present disclosure under the same or similar circumstances as the effects and objectives attained by the present invention.
As used in this disclosure, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this disclosure, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. As used in this disclosure, the term "plurality" is generally employed in its sense including "at least one" unless the content clearly dictates otherwise. As used in this disclosure, the term "at least two" is generally employed in its sense including "two or more", unless the content clearly dictates otherwise. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", "a third" may include one or at least two such features, either explicitly or implicitly.
In the description of the present invention, unless explicitly stated and limited otherwise, the terms "mounted," "connected," and "secured" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
Referring to fig. 1, an embodiment of the present invention provides a pulse ablation system for ablating target tissue, including an energy supply module 1, a high-voltage pulse generation module 2, an impedance detection module 3, a pulse ablation catheter 4 and a control module 5; wherein, the liquid crystal display device comprises a liquid crystal display device,
the energy supply module 1 is electrically connected with the high-voltage pulse generation module 2 and is configured to supply energy to the high-voltage pulse generation module 2;
a high-voltage pulse generation module 2 electrically connected with the pulse ablation catheter 4 and the impedance detection module 3 and configured to send a high-voltage pulse signal to the pulse ablation catheter 4;
A pulse ablation catheter 4 comprising 4 a catheter shaft 40 and an electrode section 41 arranged at the distal end of the catheter shaft 40, the electrode section 41 comprising an electrode assembly comprising at least one electrode carrier and a number of ablation electrodes on the electrode carrier 410, the ablation electrodes comprising an outer electrode 411, in an initial state with the active surface of the outer electrode 411 facing away from the catheter shaft 40 and the active surface of the inner electrode 412 facing towards the catheter shaft 40, at least part of the ablation electrodes being configured as working electrodes for receiving high voltage pulse signals and for performing ablation treatment of a target tissue;
an impedance detection module 3 electrically connected to the pulse ablation catheter 4 and the control module 5, configured to select paired ablation electrodes and detect impedance values between the paired ablation electrodes under the control of the control module 5, at least one of the paired ablation electrodes being a working electrode;
and a control module 5 configured to receive the impedance value detected by the impedance detection module 3 and evaluate the degree of abutment of the working electrode with the target tissue.
According to the embodiment of the invention, the electrode and the sensor are not required to be additionally added, the adhesion degree of the working electrode and the target tissue can be obtained by detecting the impedance value between the matched ablation electrodes comprising the working electrode, the detection speed is high, the precision is high, and the real-time performance is realized.
It is to be understood that the definition of "proximal" and "distal" herein is: "proximal" generally refers to the end of the medical device that is closest to the operator during normal operation, and "distal" generally refers to the end of the medical device that first enters the patient during normal operation.
Specifically, referring to fig. 2-4, as a preferred example of the present embodiment, at least one of the ablation electrodes of the pulse ablation catheter participating in the pairing is an outer electrode 411.
As another preferred example in this embodiment, the outer electrode 411 is disposed near the distal end of the electrode carrier 410 and the inner electrode 412 is disposed near the proximal end of the electrode carrier 410, and the ablation electrodes participating in the pairing are the inner electrode 412 and/or the outer electrode 411.
Further, the electrode segment 41 further comprises an end electrode 413, the end electrode 413 being arranged at the distal end of the catheter shaft 40, one of the ablation electrodes participating in the pairing being the end electrode 413 and the other being the outer electrode 411.
In this embodiment, the proximal and distal ends of the electrode carrier 410 are connected to the catheter shaft 40 and are capable of relative movement on the catheter shaft 40, respectively, to switch the electrode segments 41 between a contracted state and an expanded state, the expanded state comprising a basket state and a petal state, the pulse ablation system having a treatment pattern corresponding to the different electrode segment 41 states, and the pulse ablation system having a different ablation treatment pattern depending on the different configurations of the electrode segments 41.
For example, in a contracted state where the electrode carrier 410 is abutted against the outer wall of the catheter shaft 40, the active surface of the outer electrode 411 is facing away from the catheter shaft 40, the active surface of the inner electrode 412 is facing toward the catheter shaft 40, the pulse ablation system has a head end treatment mode corresponding to the contracted state, in a contracted state where the working electrode is the end electrode 413, the end electrode 413 is paired with the inner electrode 412 for ablation treatment, and when impedance detection is performed, the end electrode 413 is paired with the outer electrode 411.
Preferably, in the contracted state, the outer electrodes 411 on the same electrode carrier 410 are divided into one outer electrode group, and the end electrodes 413 are paired with the respective outer electrode groups in turn to detect the impedance value between the end electrodes 413 and the corresponding outer electrodes 411.
In the basket state in which the electrode carrier 410 is in the expanded state and the active surface of the outer electrode 411 is at least partially facing the distal end of the catheter shaft 40, the pulse ablation system has a basket treatment mode corresponding to the basket state in which the working electrode is the outer electrode 411 and/or the end electrode 413, and in which the degree of abutment of the end electrode 413 with the target tissue is reflected by detecting the degree of abutment of the outer electrode 411 with the target tissue, since the end electrode 413 protrudes further from the outer electrode 411.
In the petal state, the electrode carrier 410 is in the expanded state, the acting surfaces of the outer electrode 411 and the inner electrode 412 face the distal end of the catheter shaft 40, the pulse ablation system has a petal treatment mode corresponding to the petal state, the working electrode is the outer electrode 411 and/or the inner electrode 412, when impedance detection is performed, the outer electrode 411 is paired with the outer electrode 411, and the inner electrode 412 is paired with the inner electrode 412, or the outer electrode 411 is paired with the inner electrode 412.
Further, the proximal and distal ends of the electrode carrier 410 are connected to the catheter shaft 40 and are movable relative to each other on the catheter shaft 40 to switch the electrode segments 41 between a contracted state and an expanded state, in which the ablation electrodes located within the same outer diameter range are divided into electrode groups with the distal end of the catheter shaft 40 as the center, and the paired ablation electrodes in each electrode group are alternately paired at fixed intervals. By axially grouping the electrodes, the contact degree of the electrodes can be dynamically mastered in real time according to the change of local impedance.
Specifically, the expanded state includes a basket state or a petal state; in the basket state, the degree of contact between the outer electrode 411 and the target tissue is mainly detected, so that the outer electrode 411 located in the same outer diameter range can be divided into outer electrode groups by taking the distal end of the catheter shaft 40 as the center of a circle, and the paired ablation electrodes in each outer electrode group are paired in turn at fixed intervals.
As shown in fig. 5, it is assumed that the outer electrodes 411 are divided into 3 groups, i.e., a first outer electrode group includes a first outer electrode 411-1, a second outer electrode 411-2, a third outer electrode 411-3, a fourth outer electrode 411-4, and a fifth outer electrode 411-5; the second outer electrode group includes a sixth outer electrode 411-6, a seventh outer electrode 411-7, an eighth outer electrode 411-8, a ninth outer electrode 411-9, and a tenth outer electrode 411-10; the third outer electrode group includes an eleventh outer electrode 411-11, a twelfth outer electrode 411-12, a thirteenth outer electrode 411-13, a fourteenth outer electrode 411-14, and a fifteenth outer electrode 411-15. Each outer electrode group is matched separately and impedance value detection is carried out.
Specifically, for each of the outer electrode groups, every two outer electrodes 411 are paired in turn at a fixed interval, the pairing number is the same as the number of electrodes (i.e., 5 outer electrodes correspond to five pairing numbers), and the impedance value between the paired electrodes is detected, taking the first outer electrode group as an example, if the pairing interval is 0, the paired electrodes are respectively the first outer electrode 411-1 and the second outer electrode 411-2, the second outer electrode 411-2 and the third outer electrode 411-3, the third outer electrode 411-3 and the fourth outer electrode 411-4, the fourth outer electrode 411-4 and the fifth outer electrode 411-5, and the fifth outer electrode 411-5 and the first outer electrode 411-1; if the pairing interval is 1, the paired electrodes are the first outer electrode 411-1 and the third outer electrode 411-3, the second outer electrode 411-2 and the fourth outer electrode 411-4, the third outer electrode 411-3 and the fifth outer electrode 411-5, the fourth outer electrode 411-4 and the first outer electrode 411-1, and the fifth outer electrode 411-5 and the second outer electrode 411-2, respectively. The impedance detection module 3 detects the impedance value of each pair of paired electrodes respectively to determine the degree of abutment of the lateral region where the first outer electrode 411-1 group is located. It is to be understood that the pairing interval may be set according to the number of electrodes, which is not limited by the present application. In theory, the smaller the pairing interval is, the higher the measurement accuracy of the impedance value is, and the more the degree of the contact between the outer electrode and the target tissue is judged.
Alternatively, in the basket state, the outer electrodes 411 on the same electrode carrier 410 are divided into one outer electrode group and paired with the end electrodes 413, respectively, so that it is more accurately determined which outer electrode 412 on which electrode carrier 410 paired with the end electrodes 413 is in contact with the tissue and which outer electrode 412 on which electrode carrier 410 is in the blood, thereby improving reliability of the degree of abutment detection. The outer electrodes 411 on the same electrode carrier 410 may also be paired in turn to improve reliability of the detection of the degree of abutment.
In the petal state, the working electrodes are the outer electrode 411 and the inner electrode 412, and the electrode carrier 410 has the largest expanded outer diameter. The detection of the degree of abutment in the petal state increases the detection of the mating impedance of the inner electrode 412 relative to the basket state described above. Meanwhile, the grouping of the electrodes in the petal state may be performed in a mesh basket state, the outer electrodes 411 in the respective groupings are paired with each other, and the inner electrodes 412 in the respective groupings are paired with each other.
Preferably, in the petal state, the distal end of the catheter shaft 40 is used as a center, the outer electrodes 411 located in the same outer diameter range are divided into outer electrode groups, the inner electrodes 412 located in the same outer diameter range are divided into inner electrode groups, the paired ablation electrodes in each outer electrode group are paired in turn at fixed intervals, and the paired ablation electrodes in each inner electrode group are paired in turn at fixed intervals; and/or the number of the groups of groups,
In the petal state, the outer electrode 411 on the same electrode carrier 410 is divided into an outer electrode group, the inner electrode 412 on the same electrode carrier 410 is divided into an inner electrode group, the paired ablation electrodes in each outer electrode group are paired in turn at fixed intervals, and the paired ablation electrodes in each inner electrode group are paired in turn at fixed intervals; and/or the number of the groups of groups,
in the petal state, the electrodes positioned in the same outer diameter range are divided into a group, namely the inner electrode and the outer electrode in the same outer diameter range are divided into a group, so that the contact condition of the region where the working electrode in the same outer diameter range is positioned can be further known.
Preferably, the catheter shaft 40 comprises, for example, an inner shaft 400 and an outer tube 401, the proximal end of the carrier being disposed on the outer tube 401 and the distal end of the carrier being disposed on the inner shaft 400, the electrode carrier 410 being switched between a contracted state and an expanded state by urging the inner shaft 400 and the outer tube 401 to move relative to each other.
Preferably, the outer tube 401 is sleeved on the inner shaft 400. Preferably, the inner shaft 400 and the outer shaft may be woven from polyurethane, pebax (polyether block polyamide), polyimide, or the like.
Preferably, the impedance detection module 3 is further configured to detect the impedance value between the paired electrodes before and after the working electrode is abutted against the target tissue, respectively, so as to overcome individual differences caused by the patient. The impedance value of the counter electrode is detected before the working electrode is abutted against the tissue, and the initial impedance value of the counter electrode when contacting the blood is obtained, so that initial abutment data of a patient are obtained. Since the more closely the working electrode is abutted against the target tissue, the larger the increase in the impedance value is, the impedance value of the counter electrode can be detected after the working electrode is abutted against the tissue, so that the abutment degree of each electrode can be judged by the change of the impedance value before and after abutment.
In practical applications, before measuring the impedance value of each mating electrode, the initial impedance value of the mating electrode in blood needs to be obtained, but the initial impedance value is different for different patients near different tissues, and during the measurement, the initial impedance value is not measured accurately because the outer electrode 411 may touch other tissues, and the method for obtaining the initial impedance value is provided by measuring the impedance value between the mating inner electrodes 412 based on the characteristic that the inner electrodes 412 are not easy to touch the tissues. First, to obtain a mapping relationship between the impedance values of each of the paired electrodes and the impedance values of the inner electrodes 412, an initial impedance value between the inner electrodes 412, which may be an average value of all the adjacent inner electrodes 412 in the stable electrolyte solution, is measured and recorded at the time of production of the pulse ablation catheter 4, and then the mapping ratio relationship between each other is determined according to the ratio between the initial impedance values of the other paired electrodes and the initial impedance values of the paired inner electrodes 412. Next, when the pulse ablation catheter 4 is introduced into the patient, the impedance value between the paired inner electrodes 412 of the current patient in, for example, a contracted state (or an expanded state) is acquired, and then the impedance values of the other paired electrodes in the blood and the threshold value for abutment judgment are determined according to the corresponding mapping relation.
In this embodiment, referring to fig. 6, the impedance detection module 3 further includes a first multiplexing switch 31, where the first multiplexing switch 31 includes a plurality of first selection switches that are in one-to-one correspondence with the ablation electrodes and are electrically connected, and the first selection switches are configured to be selectively opened or closed under the control of the control module 5, so that the impedance detection module 3 is electrically connected to the paired ablation electrodes. In this embodiment, the impedance detection module 3 includes a plurality of impedance detection units 32, each for detecting an impedance value between each pair of ablation electrodes.
For example, in the contracted state, the end electrode 413 is a working electrode, the control module 5 can control to turn on the first selection switch corresponding to the end electrode 413, and at the same time, the control module 5 also controls the first selection switch corresponding to each outer electrode 411 paired with the end electrode 413, so as to realize pairing of the end electrode 413 and each outer electrode 411, so as to poll and detect the impedance value of the end electrode 413 and the outer electrode 411, and further, more conveniently judge the contact degree of the end electrode 413 and the outer electrode 411 with the target tissue. It should be understood that, since only the end electrode 413 is the working electrode in the contracted state, if only one impedance value indicating that the end electrode 413 is completely abutted against the target tissue is obtained by polling, it can be determined that the end electrode 413 is completely abutted against the target tissue, and different impedance values obtained by the different outer electrode 411 and the end electrode 413 can be used to reflect the abutment condition of the outer electrode 411.
For example, assuming that the impedance value of the end electrode 413 in blood is 500 ohms, if the detected impedance value between the end electrode 413 and the at least one outer electrode 411 is 600 ohms, it is determined that both the end electrode 413 and the outer electrode 411 have been completely abutted to the tissue; if the detected impedance value between the end electrode 413 and the outer electrode 411 is 550, it is judged that the working electrode portion is abutted against the target tissue, that is, the better the abutment, the larger the impedance value will be. If the impedance between the detected end electrode 413 and at least one of the outer electrodes 411 is 600 ohms and at the same time the impedance between the end electrode 413 and a portion of the outer electrodes 411 is detected to be less than 600 ohms, it is indicated that the outer electrodes 411 are partially abutted against the target tissue.
In addition, the control module 5 may further control the first multiplexing switch 31 to batch detect the impedance values of the end electrode 413 and the outer electrode 411, for example, divide the outer electrode 411 into a plurality of outer electrode groups, pair the end electrode 413 with the first outer electrode group first, and send the detected impedance value to the control module 5, then pair with the second outer electrode group, and send the detected impedance value to the control module 5 until the pairing detection with all the outer electrode groups is completed. By detecting in this way, the degree to which the end electrode 413 and each of the outer electrodes 411 are abutted against the target tissue can be determined stereoscopically.
Preferably, the pulse ablation system further comprises a man-machine interaction interface 6 electrically connected with the control module 5, when the impedance detection module 3 detects the impedance value of the paired electrodes and transmits the impedance value to the control module 5, the control module 5 can establish a pulse ablation catheter three-dimensional model based on the impedance value according to the electrode shape in the treatment mode, and the three-dimensional model can display the degree of adhesion between each electrode and the tissue based on the impedance value and can be displayed on the man-machine interaction interface 6 through the transmission of the control module 5.
Further, the control module 5 can combine the real-time image data of the tissue, display the contact degree between the electrode and the tissue on the human-computer interaction interface 6 in real time, and instruct the user how to adjust the electrode segment 41 to improve the contact effect.
In this embodiment, the control module 5 can identify the treatment mode by reading the position of the push-pull member on the operation handle of the pulse ablation catheter 4, or by inputting the human-computer interaction interface 6, or by a combination of both, which is not limited in the present application.
With continued reference to fig. 1, the pulse ablation system further includes an electrode switching module 7, where the electrode switching module 7 is electrically connected to the high-voltage pulse generating module 2, the pulse ablation catheter 4 and the control module 5, and the electrode switching module 7 is configured to receive the high-voltage pulse signal sent by the high-voltage pulse generating module 2 under the control of the control module 5, and perform selection of a working electrode and switching between positive and negative electrodes.
Preferably, referring to fig. 6, the electrode switching module 7 includes a first layer combination switch 71, a second layer combination switch 72, and a third layer combination switch 73; wherein, the liquid crystal display device comprises a liquid crystal display device,
the input end of the first layer combination switch 71 is electrically connected with the positive electrode and the negative electrode of the high-voltage pulse signal output respectively;
the input ends of the second combination switches 72 are respectively and correspondingly connected with the output ends of the first combination switches 71 in a switchable manner, and the second combination switches 72 are configured to perform positive and negative electrode commutation under the control of the control module 5;
the third layer combination switch 73 comprises a plurality of ablation selection switches which are in one-to-one correspondence with the ablation electrodes, the input ends of the ablation selection switches are electrically connected with the second layer combination switches, the output ends of the ablation selection switches are electrically connected with the corresponding ablation electrodes, and the third layer combination switch 73 is configured to select working electrodes and positive and negative of each working electrode under the control of the control module.
In this embodiment, the first combination switch 71 includes two control switches, the input ends of the two control switches are respectively electrically connected with the positive and negative poles of the high-voltage pulse signal output, and the first combination switch 71 can gate the positive and negative poles according to the discharge requirement, so as to ensure the stability of discharge, and simultaneously can cut off the output of the high-voltage pulse signal in time under abnormal conditions. For example, when the second layer combination switch 72 and/or the third layer combination switch 73 need to be turned off for pulse output, but cannot be turned off in time due to adhesion, damage, etc., or when the system fails, the output of the high-voltage pulse signal can be turned off by controlling the turning-off of the first layer combination switch 71, so as to further ensure the safety of treatment; the second combination switch 72 includes two reversing switches, the input ends of the two reversing switches are respectively and switchably connected with the output ends of the two control switches, and the second combination switch 72 is configured to perform positive and negative electrode reversing under the control of the control module 5.
Preferably, referring to fig. 1, the pulse ablation system further includes a mapping module 8, wherein the mapping module 8 is electrically connected to the pulse ablation catheter 4 and the control module 5, and the mapping module 8 is configured to select at least part of the ablation electrodes as mapping electrodes under the control of the control module 5 to detect the electrocardiosignal of the target tissue. The mapping module 8 is capable of detecting the electrocardiosignals of the target tissue region and delivering the electrocardiosignals to a multichannel meter for evaluating the treatment object and the treatment effect.
Further, the mapping module 8 further includes a second multi-path selection switch 80, where the second multi-path selection switch 80 includes a plurality of second selection switches electrically connected to the ablation electrodes in a one-to-one correspondence, and the second selection switches are configured to be selectively opened or closed under the control of the control module 5, perform mapping electrode selection, and detect the electrocardiographic signals of the target tissue through the mapping electrodes.
Referring to fig. 6, the pulse ablation system further includes an interlock module 9, where the interlock module 9 is electrically connected to the impedance detection module 3, the mapping module 8, and the control module 5, and the mapping module 8 sends a cutting signal to the control module 5 when the mapping and/or impedance detection module 3 detects, and the control module 5 controls the interlock module 9 to cut off the high-voltage pulse signal output of the high-voltage pulse generating module 2, and the control module 5 is further configured to receive the electrocardiosignal detected by the mapping module and evaluate the treatment effect and/or receive the impedance value detected by the impedance detection module and evaluate the adhesion degree of the working electrode to the target tissue. The interlocking module 9 is used for ensuring that high-voltage pulse is not transmitted to the mapping module 8 and the impedance detection module 3 during ablation treatment and ensuring that the high-voltage pulse generation module 2 does not output high-voltage pulse signals during electrocardiosignal detection or impedance detection.
In this embodiment, when the pulse ablation system works, the electrode segment 41 is placed in the target tissue region, the treatment mode is selected, the working state (the contracted state, the basket state and the petal state) of the corresponding electrode segment 41 is determined, the control module 5 controls the second multi-way selection switch 80 to electrically connect the mapping module 8 with the selected working electrode according to the treatment mode, at this time, the mapping module 8 sends a mapping interlocking signal to the interlocking module 9, the interlocking module 9 cuts off the high-voltage pulse signal output of the high-voltage pulse generating module 2 after receiving the mapping interlocking signal, and the mapping module 8 detects the electrocardiosignals of the target tissue region and transmits the electrocardiosignals to the control module 5 to confirm the treatment region. The control module 5 can identify the treatment mode by reading the position of the push-pull member on the operation handle of the pulse ablation catheter 4, or by inputting a man-machine interaction interface, or by combining the two. After confirming the treatment area, the control module 5 controls the first multi-path selection switch 31 to electrically connect the impedance detection module 3 with the selected working electrode according to the treatment mode, at this time, the impedance detection module 3 sends an impedance detection interlocking signal to the interlocking module 9, the interlocking module 9 sends a signal to the control module 5 after receiving the impedance detection interlocking signal, the control module 5 controls the second multi-path selection switch 80 to disconnect the electrical connection between the mapping module 8 and the working electrode, the impedance detection module 3 detects the impedance value of the paired electrode and transmits the impedance value to the control module 5, the degree of the adhesion between the working electrode and the target tissue is confirmed, and the adhesion between the working electrode and the target tissue is adjusted according to the detection result. After the working electrode and the target tissue reach the expected contact degree, the control module 5 controls the first multiplexing switch 31 and the second multiplexing switch 80 to disconnect the electrical connection between the mapping module 8 and the impedance detection module 3 and the working electrode, and then controls the high-voltage pulse generating module 2 to output a high-voltage pulse signal to reach the working electrode through the first layer combination switch 71, the second layer combination switch 72 and the third layer combination switch 73 in order to perform ablation treatment on the target tissue. After ablation treatment, the control module 5 controls the second multi-way selection switch 80 to electrically connect the mapping module 8 with the selected working electrode, at this time, the mapping module 8 sends a mapping interlocking signal to the interlocking module 9, the interlocking module 9 cuts off the high-voltage pulse signal output of the high-voltage pulse generating module 2 after receiving the mapping signal, and the mapping module 8 detects the electrocardiosignal and confirms the treatment effect.
Further, the control module 5 is further configured to control the high-voltage pulse generating module 2 to perform pre-discharge according to a discharge mode, rapidly evaluate the current discharge condition of the system through lower voltage discharge, and detect the integrity of the discharge loop, so as to further ensure the discharge safety of the subsequent ablation treatment. The pulse ablation system further comprises:
the acquisition module 10 is electrically connected with the pulse ablation catheter 4 and is configured to acquire current and voltage data of the working electrode during pre-discharge;
the diagnosis module 11 is electrically connected with the acquisition module 10 and the control module 5, and is configured to judge whether the discharge of the working electrode is normal according to the acquired current and voltage data, and feed back to the control module 5.
The difference between the method and the method is that the voltage and the number of energy output pulses adopted by the pre-discharge are different, and the situation of the discharge, such as discharge short circuit, open circuit, pulse number error and the like, is estimated by collecting feedback information of current, voltage and the like of the system during the pre-discharge, so that the surgical interruption caused by the short circuit and the like of certain electrodes of the pulse ablation catheter 4 can be effectively avoided in advance, the surgical ablation efficiency is improved, and the surgical time is shortened.
The flow of pre-discharge is approximately as follows:
s1, after pre-discharge is started, controlling the voltage of the energy supply module 1 to be extremely low (generally not higher than 500V);
S2, pre-discharging according to a normal therapeutic discharging mode. The mode of pre-discharge is the same as that of normal discharge, but the number of pulses can be adjusted to 10 or less, and the discharge interval (interval between each group of pulse groups) is set to a comparatively low interval of 50 ms-200 ms or the like, so that the rapid discharge inspection can be completed;
s3, collecting data such as voltage and current of the working electrode;
s4, judging whether the system discharge is normal or not according to the collected voltage and current data, for example, whether the actual release voltage is a preset voltage or not; the current is not too high or too low (an excessive current indicates an electrode short or other cause, and an insufficient current indicates an electrode combination open circuit currently detected); whether the number of discharge pulses is abnormal.
In addition, the system can shut off two sets of discharge through the control module 5 according to the feedback electrode combination condition if only one or two sets are abnormal, and the other sets of discharge normally, and if the system detects three or more sets of discharge abnormality, the system is not allowed to continue discharging, and the system is prompted to replace the pulse ablation catheter 4 or adjust the state of the pulse ablation catheter 4.
In a second aspect, an embodiment of the present invention provides a pulse ablation system for ablating target tissue, including an energy supply module 1, a high-voltage pulse generation module 2, a mapping module 8, a pulse ablation catheter 4, a control module 5 and an interlocking module 9; wherein, the liquid crystal display device comprises a liquid crystal display device,
The energy supply module 1 is electrically connected with the high-voltage pulse generation module 2 and is configured to supply energy to the high-voltage pulse generation module 2;
a high-voltage pulse generation module 2 electrically connected with the pulse ablation catheter 4 and the mapping module 8 and configured to send a high-voltage pulse signal to the pulse ablation catheter 4;
a pulsed ablation catheter 4 comprising a number of ablation electrodes, at least part of which is configured as a working electrode that receives the high voltage pulse signal and performs an ablation treatment on the target tissue;
a mapping module 8 electrically connected to the pulse ablation catheter 4 and the control module 5, configured to select at least part of the ablation electrodes as mapping electrodes under the control of the control module 5 to detect electrocardiograph signals of the target tissue;
the interlocking module 9 is electrically connected with the control module 5 and the high-voltage pulse generation module 2, the mapping module 8 sends a cutting-off signal to the control module 5 during mapping, and the control module 5 controls the interlocking module 9 to cut off the high-voltage pulse signal output of the high-voltage pulse generation module 2, receives the electrocardiosignal detected by the mapping module 8 and evaluates the treatment effect.
In a third aspect, the present invention provides a pulse ablation system, comprising an energy supply module 1, a high-voltage pulse generation module 2, an acquisition module 10, a diagnosis module 11, a pulse ablation catheter 4 and a control module 5; wherein, the liquid crystal display device comprises a liquid crystal display device,
The energy supply module 1 is electrically connected with the high-voltage pulse generation module 2 and is configured to supply energy to the high-voltage pulse generation module 2;
the high-voltage pulse generation module 2 is electrically connected with the pulse ablation catheter 4 and is configured to send a high-voltage pulse signal to the pulse ablation catheter 4;
the pulse ablation catheter 4 comprises a number of ablation electrodes, at least part of which are working electrodes configured to receive high voltage pulse signals and to perform ablation treatment on target tissue;
the control module 5 is configured to control the high-voltage pulse generation module 2 to perform pre-discharge according to a discharge mode, and the working voltage provided by the energy supply module 1 during pre-discharge is smaller than the working voltage provided by the energy supply module 1 during ablation treatment;
the acquisition module 10 is electrically connected with the pulse ablation catheter 4 and is configured to acquire current and voltage data of the working electrode during pre-discharge;
the diagnosis module 11 is electrically connected with the acquisition module 10 and the control module 5, and is configured to judge whether the discharge of the working electrode is normal according to the acquired current and voltage data, and feed back to the control module 5.
In a fourth aspect, the present invention provides a pulse ablation system, which comprises an energy supply module 1, a high-voltage pulse generation module 2, an electrode switching module 7, a pulse ablation catheter 4 and a control module 5; wherein, the liquid crystal display device comprises a liquid crystal display device,
The energy supply module 1 is electrically connected with the high-voltage pulse generation module 2 and is configured to supply energy to the high-voltage pulse generation module 2;
a high voltage pulse generation module 2 electrically connected to the pulse ablation catheter 4 and configured to send a high voltage pulse signal to the pulse ablation catheter 4;
a pulsed ablation catheter 4 comprising a number of ablation electrodes, at least part of which is configured as a working electrode that receives the high voltage pulse signal and performs an ablation treatment on the target tissue;
the electrode switching module 7 is electrically connected with the high-voltage pulse generation module 2, the pulse ablation catheter 4 and the control module 5, and the electrode switching module 7 is configured to receive the high-voltage pulse signal sent by the high-voltage pulse generation module 2 under the control of the control module 5 and perform selection of working electrodes and positive-negative electrode switching;
the electrode switching module 7 includes a first layer combination switch 71, a second layer combination switch 72, and a third layer combination switch 73; wherein, the liquid crystal display device comprises a liquid crystal display device,
the input end of the first layer combination switch 71 is electrically connected with the positive electrode and the negative electrode of the high-voltage pulse signal output respectively;
the input ends of the second combination switches 72 are respectively and correspondingly connected with the output ends of the first combination switches 71 in a switchable manner, and the second combination switches 72 are configured to perform positive and negative electrode commutation under the control of the control module 5;
The third layer combination switch 73 comprises a plurality of ablation selection switches which are in one-to-one correspondence with the ablation electrodes, the input ends of the ablation selection switches are electrically connected with the second layer combination switch 72, the output ends of the ablation selection switches are electrically connected with the corresponding ablation electrodes, and the third layer combination switch 73 is configured to select working electrodes and positive and negative of each working electrode under the control of the control module 5.
In summary, the invention provides a pulse ablation system, which does not need to additionally increase electrodes and sensors, adds an impedance detection module on the basis of the hardware of the existing pulse ablation system, and can acquire the adhesion degree of a working electrode and a target tissue by detecting the impedance value between the matched electrodes including the working electrode, thereby having high detection speed, high precision and real-time performance.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present invention. It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, the present invention is intended to include such modifications and alterations insofar as they come within the scope of the invention or the equivalents thereof.

Claims (18)

1. The pulse ablation system is characterized by comprising an energy supply module, a high-voltage pulse generation module, an impedance detection module, a pulse ablation catheter and a control module; wherein, the liquid crystal display device comprises a liquid crystal display device,
the energy supply module is electrically connected with the high-voltage pulse generation module and is configured to supply energy to the high-voltage pulse generation module;
the high-voltage pulse generation module is electrically connected with the pulse ablation catheter and the impedance detection module and is configured to send a high-voltage pulse signal to the pulse ablation catheter;
the pulse ablation catheter comprises a catheter shaft and an electrode section arranged at the distal end of the catheter shaft, wherein the electrode section comprises an electrode assembly, the electrode assembly comprises at least one electrode carrier and a plurality of ablation electrodes positioned on the electrode carrier, the ablation electrodes comprise an outer electrode and an inner electrode, in an initial state, the action surface of the outer electrode faces away from the catheter shaft, the action surface of the inner electrode faces towards the catheter shaft, and at least part of the ablation electrodes are configured to receive the high-voltage pulse signals and perform ablation treatment on target tissues;
the impedance detection module is electrically connected with the pulse ablation catheter and the control module, and is configured to select paired ablation electrodes and detect impedance values between the paired ablation electrodes under the control of the control module, wherein at least one of the paired ablation electrodes is the working electrode;
The control module is configured to receive the impedance value detected by the impedance detection module and evaluate the contact degree of the working electrode and the target tissue;
the proximal end and the distal end of the electrode carrier are respectively connected with the catheter shaft and can relatively move on the catheter shaft so as to enable the electrode segments to be switched between a contracted state and an expanded state, and in the expanded state, ablation electrodes positioned in the same outer diameter range are divided into electrode groups by taking the distal end of the catheter shaft as a circle center, and the paired ablation electrodes in each electrode group are paired in turn at fixed intervals.
2. The pulse ablation system is characterized by comprising an energy supply module, a high-voltage pulse generation module, an impedance detection module, a pulse ablation catheter and a control module; wherein, the liquid crystal display device comprises a liquid crystal display device,
the energy supply module is electrically connected with the high-voltage pulse generation module and is configured to supply energy to the high-voltage pulse generation module;
the high-voltage pulse generation module is electrically connected with the pulse ablation catheter and the impedance detection module and is configured to send a high-voltage pulse signal to the pulse ablation catheter;
the pulse ablation catheter comprises a catheter shaft and an electrode section arranged at the distal end of the catheter shaft, wherein the electrode section comprises an electrode assembly, the electrode assembly comprises at least one electrode carrier and a plurality of ablation electrodes positioned on the electrode carrier, the ablation electrodes comprise an outer electrode and an inner electrode, in an initial state, the action surface of the outer electrode faces away from the catheter shaft, the action surface of the inner electrode faces towards the catheter shaft, and at least part of the ablation electrodes are configured to receive the high-voltage pulse signals and perform ablation treatment on target tissues;
The impedance detection module is electrically connected with the pulse ablation catheter and the control module, and is configured to select paired ablation electrodes and detect impedance values between the paired ablation electrodes under the control of the control module, wherein at least one of the paired ablation electrodes is the working electrode;
the control module is configured to receive the impedance value detected by the impedance detection module and evaluate the contact degree of the working electrode and the target tissue;
wherein the proximal and distal ends of the electrode carrier are respectively connected to and relatively movable on the catheter shaft to switch the electrode segments between a contracted state and an expanded state, the expanded state comprising a petal state; in the petal state, taking the distal end of the catheter shaft as a circle center, dividing the outer electrodes positioned in the same outer diameter range into outer electrode groups, dividing the inner electrodes positioned in the same outer diameter range into inner electrode groups, alternately pairing the paired ablation electrodes in each outer electrode group at fixed intervals, and alternately pairing the paired ablation electrodes in each inner electrode group at fixed intervals; and/or the number of the groups of groups,
And in the petal state, dividing the outer electrodes on the same electrode carrier into an outer electrode group, dividing the inner electrodes on the same electrode carrier into an inner electrode group, alternately pairing the paired ablation electrodes in each outer electrode group at fixed intervals, and alternately pairing the paired ablation electrodes in each inner electrode group at fixed intervals.
3. The pulsed ablation system of claim 1, wherein at least one of the paired ablation electrodes is the outer electrode.
4. The pulsed ablation system of claim 1, wherein the outer electrode is disposed proximate a distal end of the electrode carrier, the inner electrode is disposed proximate a proximal end of the electrode carrier, and the mating ablation electrode is an inner electrode and/or an outer electrode.
5. The pulsed ablation system of claim 1 or 2, wherein the electrode segment further comprises an end electrode disposed distally of the catheter shaft, the end electrode and the outer electrode configured as paired ablation electrodes.
6. The pulse ablation system of claim 5, wherein the outer electrodes on the same electrode carrier are divided into an outer electrode set, and the end electrodes are paired with the outer electrode set in turn to detect the impedance value between the end electrodes and the outer electrodes.
7. The pulsed ablation system of claim 1, wherein the expanded state comprises a basket state or a petal state in which the paired ablation electrode is an outside electrode; in the petal state, the paired ablation electrodes are an inner electrode disposed proximate to a proximal end of the electrode carrier and the outer electrode disposed proximate to a distal end of the electrode carrier.
8. The pulsed ablation system of any one of claims 1-4, 6, 7, wherein the impedance detection module detects an initial impedance value when an ablation electrode contacts blood, and a mating ablation electrode for detecting the initial impedance value is an inner electrode disposed proximate a proximal end of the electrode carrier.
9. The pulsed ablation system of claim 8, wherein the initial impedance value is detected before the working electrode is against the target tissue.
10. The pulsed ablation system of any of claims 1-4, 6, 7, 9, wherein the impedance detection module further comprises a first multiplexing switch comprising a plurality of first selection switches in one-to-one and electrically connected with the ablation electrodes, the first selection switches configured to be selectively opened or closed under control of the control module to place the impedance detection module in electrical communication with the respective paired ablation electrodes.
11. The pulse ablation system of any one of claims 1-4, 6, 7, 9, further comprising a mapping module electrically connected to the pulse ablation catheter and the control module, the mapping module configured to select at least a portion of the ablation electrodes as mapping electrodes under control of the control module to detect cardiac electrical signals of the target tissue.
12. The pulse ablation system of any one of claims 1-4, 6, 7, 9, further comprising a human-machine interface electrically connected to the control module, the control module further configured to create an impedance value-based pulse ablation catheter three-dimensional model from electrode morphology in treatment mode and display via the human-machine interface.
13. The pulse ablation system of any of claims 1-4, 6, 7, 9, further comprising an electrode switching module electrically connected to the high voltage pulse generation module, the pulse ablation catheter, and the control module, the electrode switching module configured to receive a high voltage pulse signal sent by the high voltage pulse generation module and to perform selection and anode-cathode switching of the working electrode under control of the control module.
14. The pulse ablation system of claim 13, wherein the electrode switching module comprises a first layer combination switch, a second layer combination switch, and a third layer combination switch; wherein, the liquid crystal display device comprises a liquid crystal display device,
the input end of the first layer combination switch is respectively and electrically connected with the positive electrode and the negative electrode of the high-voltage pulse signal output;
the input ends of the second combination switches are respectively and correspondingly connected with the output ends of the first combination switches in a switchable manner, and the second combination switches are configured to commutate the anode and the cathode under the control of the control module;
the third layer combination switch comprises a plurality of ablation selection switches which are in one-to-one correspondence with the ablation electrodes, the input ends of the ablation selection switches are electrically connected with the second layer combination switch, the output ends of the ablation selection switches are electrically connected with the corresponding ablation electrodes, and the third layer combination switch is configured to select working electrodes and positive and negative of each working electrode under the control of the control module.
15. The pulsed ablation system of claim 11, wherein the mapping module further comprises a second multiplexing switch comprising a plurality of second selection switches electrically connected in one-to-one correspondence with the ablation electrodes, the second selection switches configured to be selectively opened or closed under control of the control module, to perform mapping electrode selection and to detect cardiac signals of the target tissue via the mapping electrodes.
16. The pulse ablation system of claim 11, further comprising an interlock module electrically connected to the control module and the high voltage pulse generation module, the mapping module sending a shut-off signal to the control module upon detection by the mapping and/or impedance detection module, the control module controlling the interlock module to shut off the high voltage pulse signal output of the high voltage pulse generation module, the control module further configured to receive the cardiac signal detected by the mapping module and evaluate the treatment effect and/or to receive the impedance value detected by the impedance detection module and evaluate the degree of abutment of the working electrode with the target tissue.
17. The pulse ablation system of any of claims 1-4, 6, 7, 9, 14, 15, further comprising an interlock module electrically connected to the control module and the high voltage pulse generation module, the impedance detection module sending a shut-off signal to the control module upon detection, the control module controlling the interlock module to shut off the high voltage pulse signal output of the high voltage pulse generation module, the control module further configured to receive the impedance value detected by the impedance detection module and evaluate the degree of abutment of the working electrode with the target tissue.
18. The pulse ablation system of any of claims 1-4, 6, 7, 9, 14-16, wherein the control module is further configured to control the high voltage pulse generation module to pre-discharge in accordance with a discharge pattern, the pulse ablation system further comprising:
the acquisition module is electrically connected with the pulse ablation catheter and is configured to acquire current and voltage data of the working electrode during pre-discharge;
the diagnosis module is electrically connected with the acquisition module and the control module, and is configured to judge whether the discharge of the working electrode is normal according to the acquired current and voltage data and feed back to the control module.
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