CN116807594A - Intelligent control system for pulse electric field ablation signals - Google Patents
Intelligent control system for pulse electric field ablation signals Download PDFInfo
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- CN116807594A CN116807594A CN202310815882.6A CN202310815882A CN116807594A CN 116807594 A CN116807594 A CN 116807594A CN 202310815882 A CN202310815882 A CN 202310815882A CN 116807594 A CN116807594 A CN 116807594A
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- 238000002679 ablation Methods 0.000 title claims abstract description 79
- 230000005684 electric field Effects 0.000 title claims abstract description 47
- 230000000694 effects Effects 0.000 claims abstract description 16
- 238000012360 testing method Methods 0.000 claims abstract description 8
- 239000008280 blood Substances 0.000 claims description 8
- 210000004369 blood Anatomy 0.000 claims description 8
- 230000000638 stimulation Effects 0.000 claims description 3
- 230000000747 cardiac effect Effects 0.000 claims 2
- 230000001746 atrial effect Effects 0.000 claims 1
- 238000005259 measurement Methods 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 4
- 206010003658 Atrial Fibrillation Diseases 0.000 description 4
- 210000000170 cell membrane Anatomy 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 238000004520 electroporation Methods 0.000 description 3
- 230000002427 irreversible effect Effects 0.000 description 3
- 230000002107 myocardial effect Effects 0.000 description 3
- 230000006907 apoptotic process Effects 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 210000005246 left atrium Anatomy 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 230000003680 myocardial damage Effects 0.000 description 2
- 208000005189 Embolism Diseases 0.000 description 1
- 206010051814 Eschar Diseases 0.000 description 1
- 206010028851 Necrosis Diseases 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 238000013153 catheter ablation Methods 0.000 description 1
- 230000034994 death Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 231100000333 eschar Toxicity 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000003211 malignant effect Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 208000010125 myocardial infarction Diseases 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 238000007674 radiofrequency ablation Methods 0.000 description 1
- 230000001052 transient effect Effects 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00875—Resistance or impedance
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
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- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Abstract
The invention discloses an intelligent control system for a pulse electric field ablation signal, which relates to the technical field of pulse electric field ablation, wherein the system tests an intracavity electrocardiosignal or impedance of each channel, judges the abutting effect and the ablation effect of the pulse electric field according to a test result, and controls the opening or closing of the pulse electric field ablation signal; the system employs a switch mode or a relay mode. The invention can intelligently control the pulse electric field ablation signal of each channel according to clinical application requirements, can reduce the occurrence frequency and frequency of ineffective ablation, improves the ablation efficiency in the operation process, and ensures safer operation.
Description
Technical Field
The invention relates to the technical field of pulsed electric field ablation, in particular to an intelligent control system for pulsed electric field ablation signals.
Background
Atrial fibrillation (atrial fibrillation) is the most common arrhythmia with a prevalence of about 2% and progressively increasing prevalence with age. The most serious complication of atrial fibrillation is thromboembolism, which can lead to stroke, myocardial infarction, etc., with stroke being the most common complication of atrial fibrillation death.
In recent years, the application of pulsed electric field ablation in the field of cardiac ablation has been explored at home and abroad, and favorable results have been obtained. Unlike conventional energy, pulsed electric field energy forms irreversible micropores on cell membranes by transient discharge, causing apoptosis, achieving the purpose of non-thermal ablation, also known as irreversible electroporation. Electroporation ablation has been used as an effective means of destroying malignant tissue. Pulsed electric field ablation can theoretically damage myocardial cells without heating the tissue, and has cell/tissue selectivity, protecting critical structures around the ablated tissue.
Pulse ablation is based on the principle that a short dc high voltage pulse can create an electric field of several hundred volts in the range of several centimeters, which can cause damage to the cell membrane to form perforations. If the electric field formed at the cell membrane is greater than a threshold, the electroporation that is formed is irreversible, maintaining the stomata open. Resulting in necrosis or apoptosis. Thus, pulsed ablation is a non-thermal biological ablation, as opposed to radio frequency, cryo, microwave, ultrasound. Can effectively avoid the damage of blood vessels, nerves and esophagus.
Recent studies have shown that although pulse electric field ablation does not rely on catheter abutment force to cause extensive myocardial damage, the depth of the pulse electric field abutment degree ablation is closely related, and foreign related studies have shown that myocardial damage can occur even without electrodes in direct contact with tissue. However, if the distance between the electrode generating the pulsed electric field and the myocardial tissue increases, the ablation depth decreases significantly, and a linear relationship is shown in fig. 1. Therefore, the previous catheter for radio frequency ablation is designed as a single electrode large head, and the single electrode head can be preloaded with a pressure sensor for judging the tissue abutting force. However, most catheters ablated by the pulsed electric field are arranged by multiple electrodes, so that the cost is obviously increased when the pressure sensor is arranged by the multiple electrodes, and the leaning direction is uncontrollable. Meanwhile, during ablation, the impedance between the electrodes of the partial pulse ablation channel is low, the electrodes are not abutted against the tissue, and the electrodes are in contact with blood, so that the ablation is ineffective.
Therefore, those skilled in the art have been working to develop an intelligent control system for pulsed electric field ablation signals that can determine the abutment between the pulsed ablation catheter and the myocardial tissue, reducing the number and frequency of ineffective ablations.
Disclosure of Invention
In view of the above-mentioned drawbacks of the prior art, the present invention is to solve the technical problem of how to intelligently control the pulse electric field ablation signal of each channel according to the clinical application requirement.
In order to achieve the above purpose, the invention provides an intelligent control system for a pulsed electric field ablation signal, which tests an intracavity electrocardiosignal or impedance of each channel, judges the abutting effect and the ablation effect of the pulsed electric field according to a test result, and controls the opening or closing of the pulsed electric field ablation signal; the system employs a switch mode or a relay mode.
Further, when the system is in a switch mode, a physical switch is arranged on each channel of the device and the catheter which send out the pulse electric field ablation signal, and the physical switch is manually controlled to be opened and closed.
Further, when the system is in a relay mode, a relay is arranged on each channel of the device and the catheter which send out the pulse electric field ablation signal for relay, and the relay is controlled through a PCB.
Further, the switch mode monitors impedance between the catheter electrodes, traverses impedance values between every two adjacent catheter electrodes when the measuring catheter is attached to tissue and calculates an average value to obtain a first impedance average value, traverses impedance values between every two adjacent catheter electrodes when the measuring catheter is attached to the tissue in blood of a left atrium of a heart and calculates an average value to obtain a second impedance average value; and comparing the impedance values between every two adjacent catheter electrodes with the first impedance average value and the second impedance average value respectively when the catheters are attached to the tissues, and judging the attaching effect of the catheter electrodes on the tissues.
Further, the relay mode monitors intra-cavity electrocardiosignals between the catheter electrodes, and judges the leaning effect of the catheter electrodes on tissues according to the amplitude values of the intra-cavity electrocardiosignals.
Further, the impedance value between the electrodes is larger than 200% of the average value of the first impedance, the electrode is prompted to be broken, and the catheter is inspected;
the impedance value between the electrodes is greater than 150% of the average value of the first impedance and less than 200% of the average value of the first impedance, a catheter is inspected, and an electrode pulse discharge switch is closed;
the inter-electrode impedance value is greater than 80% of the first impedance average value and less than 150% of the first impedance average value, and is greater than the second impedance average value, and an electrode pulse discharge switch is opened for pulse ablation;
the inter-electrode impedance value is greater than 50% of the first impedance average value and less than 80% of the first impedance average value, or is close to the second impedance average value, so that an operator is reminded of adjusting electrode leaning, or an electrode pulse discharge switch is closed;
the inter-electrode impedance value is less than 50% of the first impedance average value and less than the second impedance average value, and the catheter is inspected or the electrode pulse discharge switch is turned off.
Further, the electrocardiosignals in the cavity are obvious and not lower than 0.3mV, and the potential of the electrocardiosignals is not far field, and an electrode pulse discharge switch is automatically turned on to perform pulse ablation;
the electrocardiosignals in the cavity are obvious and not lower than 0.3mV, but are far-field potential, and an electrode pulse discharge switch is automatically turned off to perform pacing stimulation judgment;
the weaker electrocardiosignal in the cavity is not more than 0.2mV, and the electrode pulse discharge switch is automatically turned off, or the combined impedance is prompted to judge whether the ablation needs to be continued or not.
Further, the first impedance average value is calculated by taking data with an impedance value of 30-500 ohms.
Further, the first impedance average value is calculated by taking data with an impedance value of 50-400 ohms.
Further, the first impedance average value takes data with an impedance value of 100-300 ohms for average calculation.
Compared with the prior art, the invention has at least the following beneficial technical effects:
the invention can intelligently control the pulse electric field ablation signals of each channel according to clinical application requirements, control the opening and closing of the pulse electric field ablation signals of each channel, reduce the frequency and the frequency of invalid ablation, improve the ablation efficiency in the operation process and ensure safer operation.
The conception, specific structure, and technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, features, and effects of the present invention.
Drawings
FIG. 1 is a schematic diagram of the relationship between the abutment distance and the ablation width in the prior art;
FIG. 2 is a schematic diagram of a switch mode of a preferred embodiment of the present invention;
fig. 3 is a schematic view of a relay mode according to a preferred embodiment of the present invention.
Detailed Description
The following description of the preferred embodiments of the present invention refers to the accompanying drawings, which make the technical contents thereof more clear and easy to understand. The present invention may be embodied in many different forms of embodiments and the scope of the present invention is not limited to only the embodiments described herein.
In the drawings, like structural elements are referred to by like reference numerals and components having similar structure or function are referred to by like reference numerals. The dimensions and thickness of each component shown in the drawings are arbitrarily shown, and the present invention is not limited to the dimensions and thickness of each component. The thickness of the components is exaggerated in some places in the drawings for clarity of illustration.
The invention provides an intelligent control system for a pulse electric field ablation signal, which adopts a working mode or a relay mode, and tests an intracavitary electrocardiosignal or impedance and the like of each channel, and intelligently judges the contact condition or the ablation effect and the like according to a test result so as to intelligently control the opening and closing of the pulse electric field ablation signal. The pulse signal of each channel can be opened or closed manually through a physical switch, and can also be opened or closed through the programming control of a relay switch.
Example 1:
as shown in fig. 1, the ablation signal of each channel is connected or disconnected by a physical way such as a switch, for example, a physical switch is arranged on each channel of the catheter and the equipment sending out the pulsed electric field ablation signal, and when in use, the physical switch is manually controlled to be turned on and off.
Monitoring impedance between the catheter electrodes, traversing to measure impedance between every two adjacent catheter electrodes and calculating an average value, taking data with impedance value between 30-500 ohms to perform average calculation to obtain a first impedance average value between catheter tissues, traversing to measure impedance value between every two adjacent catheter electrodes in blood of left atrium of heart and calculating an average value to obtain a second impedance average value; comparing the impedance value between every two adjacent catheter electrodes with the first impedance average value and the second impedance average value when the catheters are attached to the tissue, and judging the attaching effect of the catheter electrodes on the tissue:
the impedance value between the electrodes is obviously more than 200% of the average value of the first impedance, the impedance between the electrodes is obviously higher, the electrodes are prompted to be broken, and the catheter is inspected;
the impedance value between the electrodes is in the range of 150-200% of the average value of the first impedance, the impedance between the electrodes is increased, the electrode is suggested to possibly generate eschar, the catheter is inspected, and the electrode pulse discharge switch is closed;
the impedance value between the electrodes is in the range of 80-150% of the average value of the first impedance and is higher than the average value of the impedance 2 of the electrodes in blood, the electrodes are well attached to tissues, and an electrode pulse discharge switch is turned on to perform pulse ablation;
the impedance value between the electrodes is in the interval of 50-80% of the average value of the first impedance, or is close to the average value of the impedance 2 of the electrodes in blood, the impedance between the electrodes is smaller, the electrodes are possibly not attached to tissues and are positioned in the blood, and an operator is reminded to adjust the attachment of the electrodes, or an electrode pulse discharge switch is turned off;
the impedance value of the electrode is far lower than 50% of the average value 1 of impedance between tissues of the catheter and is lower than the average value 2 of impedance of the electrode in blood, short circuit risks exist between the electrodes, and the catheter is inspected or an electrode pulse discharge switch is closed.
The pulse ablation device can allow the clinical use process to quickly set the opening and closing of pulse ablation signals of different channels according to the treatment requirement, for example, only two channels of signals are required to be reserved for ablation in the clinical treatment process, and the signals of other channels can be manually closed, so that a doctor can conveniently and quickly control the opening and closing of pulse electric field signals.
Example 2:
as shown in fig. 2, the ablation signal of each channel is connected or interrupted by a relay or the like, for example, a relay is arranged on each channel of the device and the catheter for sending out the pulsed electric field ablation signal for relay, and the relay can be controlled by a PCB circuit board.
Monitoring an intra-cavity electrocardiosignal between catheter electrodes, and judging the adhesion effect of the catheter electrodes on tissues according to the amplitude of the intra-cavity electrocardiosignal:
the signal in the electrode cavity is obvious and is not lower than 0.3mV, the electrode is well attached to the tissue, and the electrode pulse discharge switch is automatically turned on to perform pulse ablation;
the signal in the electrode cavity is obvious and not lower than 0.3mV, but is far-field potential, the electrode is well attached to the tissue, and the electrode pulse discharge switch is automatically turned off to perform pacing stimulation judgment;
the signal in the electrode cavity is weaker and not more than 0.2mV, so that the electrode is not possibly attached to the tissue, or the area is ablated, an electrode pulse discharge switch is automatically turned off, or the combined impedance is prompted to judge whether the ablation needs to be continued or not.
The control of the PCB can also realize multi-mode continuous combined programming ablation; for example, for pulse electric field ablation with 7 channels of electrodes, the first mode can be set to generate pulses for ablation in 1, 2, 3, 4, 5, 6 and 7 channels, the second mode is set to generate pulse signals for ablation in 1, 3, 5 and 7 channels, the third mode is set to generate pulse signals for ablation in 1, 2, 3 and 4 channels, the fourth mode is set to generate pulse signals for ablation in 5, 6 and 7 channels, and the fifth mode is set to generate pulse signals for ablation in 6 and 7 channels, so that different channels can be selected for combination for ablation in clinical treatment.
The foregoing describes in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be made in accordance with the concepts of the invention without requiring creative effort by one of ordinary skill in the art. Therefore, all technical solutions which can be obtained by logic analysis, reasoning or limited experiments based on the prior art by the person skilled in the art according to the inventive concept shall be within the scope of protection defined by the claims.
Claims (10)
1. The intelligent control system for the pulse electric field ablation signals is characterized in that the system tests the intracavitary electrocardiosignals or impedance of each channel, judges the abutting effect and the ablation effect of the pulse electric field according to the test result, and controls the opening or closing of the pulse electric field ablation signals; the system employs a switch mode or a relay mode.
2. The intelligent control system for pulsed electric field ablation signals of claim 1, wherein when the system is in a switching mode, a physical switch is provided on each channel of the catheter and the device emitting the pulsed electric field ablation signal, and the physical switch is manually controlled to be turned on and off.
3. The intelligent control system for pulsed electric field ablation signals according to claim 1, wherein when the system is in a relay mode, a relay is provided on each channel of the catheter and the device emitting the pulsed electric field ablation signals for relay, and control is performed by the PCB.
4. The intelligent control system for pulsed electric field ablation signals of claim 2, wherein the switch mode monitors impedance between catheter electrodes, traverses impedance values between adjacent catheter electrodes when the measurement catheter is abutted against tissue and calculates an average value to obtain a first impedance average value, traverses impedance values between adjacent catheter electrodes in left atrial blood of the heart and calculates an average value to obtain a second impedance average value; and comparing the impedance values between every two adjacent catheter electrodes with the first impedance average value and the second impedance average value respectively when the catheters are attached to the tissues, and judging the attaching effect of the catheter electrodes on the tissues.
5. The intelligent control system for pulsed electric field ablation signals of claim 3, wherein the relay mode monitors intra-luminal cardiac signals between catheter electrodes and determines an effect of catheter electrodes against tissue based on an amplitude of the intra-luminal cardiac signals.
6. The intelligent control system for pulsed electric field ablation signals of claim 4, wherein the inter-electrode impedance is greater than 200% of the average value of the first impedance, prompting electrode disconnection, and inspecting a catheter;
the impedance value between the electrodes is greater than 150% of the average value of the first impedance and less than 200% of the average value of the first impedance, a catheter is inspected, and an electrode pulse discharge switch is closed;
the inter-electrode impedance value is greater than 80% of the first impedance average value and less than 150% of the first impedance average value, and is greater than the second impedance average value, and an electrode pulse discharge switch is opened for pulse ablation;
the inter-electrode impedance value is greater than 50% of the first impedance average value and less than 80% of the first impedance average value, or does not exceed 20% of the second impedance average value, so as to remind a worker to adjust electrode leaning, or close an electrode pulse discharge switch;
the inter-electrode impedance value is less than 50% of the first impedance average value and less than the second impedance average value, and the catheter is inspected or the electrode pulse discharge switch is turned off.
7. The intelligent control system of the pulsed electric field ablation signal according to claim 5, wherein the intracavitary electrocardiosignal is obvious and not lower than 0.3mV, and is not far-field potential, and an electrode pulse discharge switch is automatically opened for pulse ablation;
the electrocardiosignals in the cavity are obvious and not lower than 0.3mV, but are far-field potential, and an electrode pulse discharge switch is automatically turned off to perform pacing stimulation judgment;
the weaker electrocardiosignal in the cavity is not more than 0.2mV, and the electrode pulse discharge switch is automatically turned off, or the combined impedance is prompted to judge whether the ablation needs to be continued or not.
8. The intelligent control system for pulsed electric field ablation signals of claim 4, wherein the first impedance average value averages data between 30-500 ohms.
9. The intelligent control system for pulsed electric field ablation signals of claim 4, wherein the first impedance average value averages data between 50-400 ohms.
10. The intelligent control system for pulsed electric field ablation signals of claim 4, wherein the first impedance average value averages data between 100-300 ohms.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202310815882.6A CN116807594A (en) | 2023-07-04 | 2023-07-04 | Intelligent control system for pulse electric field ablation signals |
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| CN202310815882.6A CN116807594A (en) | 2023-07-04 | 2023-07-04 | Intelligent control system for pulse electric field ablation signals |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117838284A (en) * | 2024-03-07 | 2024-04-09 | 上海微创电生理医疗科技股份有限公司 | Control method of pulse ablation catheter and pulse ablation catheter |
| CN117838284B (en) * | 2024-03-07 | 2024-05-28 | 上海微创电生理医疗科技股份有限公司 | Control method of pulse ablation catheter and pulse ablation catheter |
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2023
- 2023-07-04 CN CN202310815882.6A patent/CN116807594A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117838284A (en) * | 2024-03-07 | 2024-04-09 | 上海微创电生理医疗科技股份有限公司 | Control method of pulse ablation catheter and pulse ablation catheter |
| CN117838284B (en) * | 2024-03-07 | 2024-05-28 | 上海微创电生理医疗科技股份有限公司 | Control method of pulse ablation catheter and pulse ablation catheter |
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