CN114052896A - Ablation catheter effect parameter evaluation method and evaluation device - Google Patents
Ablation catheter effect parameter evaluation method and evaluation device Download PDFInfo
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- CN114052896A CN114052896A CN202111561268.9A CN202111561268A CN114052896A CN 114052896 A CN114052896 A CN 114052896A CN 202111561268 A CN202111561268 A CN 202111561268A CN 114052896 A CN114052896 A CN 114052896A
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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
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical 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
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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
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical 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
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
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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
- A61B2018/00434—Neural system
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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
- A61B2018/00791—Temperature
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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
- A61B2018/00898—Alarms or notifications created in response to an abnormal condition
Abstract
The application relates to the technical field of medical equipment, in particular to an ablation catheter effect parameter evaluation method and an ablation catheter effect parameter evaluation device. The pressure sensor measures the pressure of blood flow, the temperature sensors arranged at the near end and the far end measure the distance D between the blood flow from the near end to the far end, the process of the blood from the near end sensor to the far end sensor measures the time T consumed by the near end temperature sensor to flow to the far end temperature sensor, the pressure sensor measures the pressure of the blood flow, all data are fed back to a personal computer, data calculation and data comparison are carried out through the data, corresponding data are obtained for judgment, the method for confirming the renal nerve ablation point in advance in the relevant technology is solved, accurate ablation targets are provided for doctors, and the technical problem that whether the ablation is effective or not can be evaluated in real time is urgently needed to be found.
Description
Technical Field
The application relates to the technical field of medical equipment, in particular to an ablation catheter effect parameter evaluation method and an ablation catheter effect parameter evaluation device.
Background
Blood pressure is controlled by the complex interaction of signals from a number of systems in the body, including the nervous system, circulatory system and endocrine system. The general activation of sympathetic nerves is an important component of the pathogenesis of hypertension. Clinical studies have shown that Renal Sympathetic Nerve Activity (RSNA) leads to increased tubular sodium reabsorption, resulting in renin release and altered renal vascular resistance, resulting in elevated blood pressure. And the reflex signals of the renal receptors are conducted to the center through the renal sympathetic afferent nerves, and the blood pressure changes are regulated by the renal sympathetic efferent nerves. RSNA is therefore not only a short-term regulation of renal artery vascular tone changes, but is also an important factor in the long-term maintenance of hypertension. Therefore, the renal artery radiofrequency ablation catheter for the renal artery sympathetic nerve ablation of the patient with refractory hypertension is a new hope for treating hypertension, and is a new method for treating hypertension by non-medicine, and the method is safe and effective according to the early-stage clinical test in foreign countries and can be widely used.
However, the renal nerve ablation is currently operated in a "blind" manner, that is, a doctor performing the renal nerve ablation operation does not know the specific position of the distribution of renal sympathetic nerves, does not know whether the currently ablated point is an effective point, and performs ablation only on the whole renal artery; furthermore, the current ablation results are only examined for possible effects after surgery, which can only be fully confirmed by measuring the blood pressure of the patient for at least one month after surgery, in such a way that a delay is used to confirm whether the renal nerve is actually ablated.
Therefore, there is an urgent need for a method for confirming the ablation point of renal nerve in advance in clinic, so as to provide an accurate ablation target for doctors, and at the same time, there is an urgent need for finding out clinically relevant indexes capable of evaluating whether the ablation is effective or not in real time.
Disclosure of Invention
The main purpose of the present application is to provide an ablation catheter effect parameter evaluation method and an ablation catheter effect parameter evaluation device, so as to solve the problem that clinically urgent needs a method capable of confirming the renal nerve ablation point in advance in the related art, so as to provide an accurate ablation target for a doctor, and at the same time, urgently need to find out clinically relevant indexes capable of immediately evaluating whether an ablation procedure is effective.
In order to achieve the above object, in a first aspect, the present application provides an ablation conduit effect evaluation parameter measurement method.
According to the application, the ablation duct effect evaluation parameter measuring method comprises the following steps:
s1, controlling a single electrode to generate radio frequency heat energy by the energy emitter to heat blood;
s2, respectively recording the temperature by the temperature sensors at the near end and the far end;
s3, the processing end records the change curve of the temperature along with the time according to the temperature data of the near end and the far end;
s4, the time T consumed by the blood flow from the near-end temperature sensor to the far-end temperature sensor;
s5, acquiring the relative distance D between the near-end temperature sensor and the far-end temperature sensor;
s6, determining the blood flow velocity V according to the blood flow consumption time and the relative distance;
s7, acquiring the pressure P of a pressure sensor at the front end of the catheter body of the data acquisition catheter;
s8, determining an evaluation parameter R according to the blood flow velocity and the pressure of the far end of the blood vessel;
s9, calculating a series of evaluation parameters, and judging RnAnd Rn+1The numerical value of (c).
Further, the velocity calculation formula in step S6 is: and V is D/T.
Further, the evaluation parameter calculation formula in step S8 is: and R is P/V.
Further, an ablation pipeline effect evaluation device is provided, which comprises a bendable pipe body arranged at any end of the catheter pipe body, wherein the temperature sensor is arranged on the bendable pipe body, and a pressure sensor is arranged on the bendable pipe body.
Furthermore, an electrode is arranged on the bendable pipeline.
Further, a personal computer is arranged at one end, far away from the bendable pipe body, of the pipe body, a sensor interface is arranged on the personal computer and electrically connected with the pressure sensor, and a control end is arranged in the personal computer.
Furthermore, the control end comprises at least one programmable logic controller for storing data by a stack algorithm, and the personal computer and the programmable logic controller are in data synchronization.
Further, the catheter tube is made of an electroactive polymer.
The advantages are that:
1. a method and a device for evaluating the effect parameters of an ablation catheter are disclosed, wherein the head end of the ablation catheter is a bendable catheter body, and the catheter body is made of electroactive polymers and can be bent and deformed under the action of electrical stimulation to form a spiral structure. The deformation degree can be changed along with the voltage, so that the adherence adaptability is better. The tip shape can be switched between helical and linear under both positive and negative electrical stimuli.
2. The ablation catheter effect parameter evaluation method and device has pressure sensor in the catheter head end for accurate monitoring of the real-time pressure change inside blood vessel.
3. An energy generator is matched with an electrode to realize two functions of stimulation and ablation, so that renal artery nerve ablation is more accurate.
4. An ablation catheter effect parameter evaluation method and an ablation catheter effect parameter evaluation device can calculate an effect evaluation parameter so as to evaluate whether ablation is effective or not in real time.
Through the characteristics, the accuracy of renal artery nerve ablation is optimized, the operation effect is improved, the benefit of a patient is increased, an instant feedback mechanism is established, and the curative effect certainty is increased.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this application, serve to provide a further understanding of the application and to enable other features, objects, and advantages of the application to be more apparent. The drawings and their description illustrate the embodiments of the invention and do not limit it. In the drawings:
fig. 1 is a flowchart of an ablation catheter effect parameter evaluation method provided in accordance with an embodiment of the present application;
fig. 2 is a schematic structural diagram of an ablation catheter effect parameter evaluation method and an ablation catheter effect parameter evaluation device according to an embodiment of the application;
fig. 3 is a schematic view of the connection of internal modules of an ablation catheter effect parameter evaluation method and an evaluation device according to an embodiment of the application.
Description of the drawings:
1. a catheter tube body; 11. a bendable pipe body; 12. a temperature sensor; 13. a pressure sensor; 14. An electrode; 2. a personal computer; 21. a sensor interface; 3. a control end; 31. a display component; 32. A programmable logic controller; 33. a logic control unit; 34. a database unit; 35. alarm unit
Detailed Description
In order to make the technical solutions better understood by those skilled in the art, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only partial embodiments of the present application, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
It should be noted that the terms "first," "second," and the like in the description and claims of this application and in the drawings described above are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It should be understood that the data so used may be interchanged under appropriate circumstances such that embodiments of the application described herein may be used. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed, but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.
In this application, the terms "upper", "lower", "left", "right", "front", "rear", "top", "bottom", "inner", "outer", "middle", "vertical", "horizontal", "lateral", "longitudinal", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings. These terms are used primarily to better describe the present application and its embodiments, and are not used to limit the indicated devices, elements or components to a particular orientation or to be constructed and operated in a particular orientation.
Moreover, some of the above terms may be used to indicate other meanings besides the orientation or positional relationship, for example, the term "on" may also be used to indicate some kind of attachment or connection relationship in some cases. The specific meaning of these terms in this application will be understood by those of ordinary skill in the art as appropriate.
In addition, the term "plurality" shall mean two as well as more than two.
It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present application will be described in detail below with reference to the embodiments with reference to the attached drawings.
As shown in fig. 1, an ablation duct effect evaluation device and a parameter measurement method include the following steps:
s1, controlling a single electrode to generate radio frequency heat energy by the energy emitter to heat blood;
s2, respectively recording the temperature by the temperature sensors at the near end and the far end;
s3, the processing end records the change curve of the temperature along with the time according to the temperature data of the near end and the far end;
s4, the time T consumed by the blood flow from the near-end temperature sensor to the far-end temperature sensor;
s5, acquiring the relative distance D between the near-end temperature sensor and the far-end temperature sensor;
s6, determining the blood flow velocity V according to the blood flow consumption time and the relative distance;
by the formula of the blood flow calculation: calculating the blood flow velocity when V is D/T;
s7, acquiring the pressure P of a pressure sensor at the front end of the catheter body of the data acquisition catheter;
s8, determining an evaluation parameter R according to the blood flow velocity and the pressure of the far end of the blood vessel;
the formula is calculated by evaluating the parameters: calculating an evaluation parameter R when R is P/V;
s9, calculating a series of evaluation parameters, and judging RnAnd Rn+1The numerical value of (c).
Calculating to obtain RnThen, with the preceding Rn-1Making a comparison if RnLess than Rn-1The ablation procedure is indicated to be effective. The next stage of ablation is continued. If R isnNot less than Rn-1Then it is indicated that sufficient target points have been ablated to reach the ablation procedure endpoint. The method solves the problems that a method capable of confirming the renal nerve ablation point in advance is urgently needed clinically, so that an accurate ablation target is provided for a doctor, and simultaneously, clinically relevant indexes capable of evaluating whether the ablation operation is effective or not in real time are urgently needed to be found.
As shown in fig. 2, a flexible tube 11 is provided at either end of a catheter tube 1, a temperature sensor 12 is provided on the flexible tube 11, the flexible pipe body 11 is provided with a pressure sensor 13, the pressure sensor 13 measures the pressure of blood flow through the pressure sensor 13 and the temperature sensor 12, by means of the temperature sensors 12 arranged at the proximal and distal ends, the distance D between the blood flow from the proximal end to the distal end is first measured, and then by heating the blood, the time T consumed by the blood flowing from the proximal sensor to the distal sensor 12 is measured, and the blood pressure is measured by means of the pressure sensor 13, all data is fed back to the personal computer 2, and performing data calculation on the data through the personal computer 2 and a calculation formula, and performing data comparison on the calculation result to obtain corresponding data for judgment.
As shown in fig. 2, the flexible tube 11 is provided with electrodes 14, the electrodes 14 are uniformly arranged on the flexible tube 11 at intervals along the length direction of the catheter tip, and the radio frequency energy sent to the motor by the control of the personal computer 2 can be controlled, so that the electrodes 14 only generate low-level electric pulses to stimulate potential renal nerve tissues. Meanwhile, the personal computer 2 may also control the single electrode 14 at the proximal end to generate radio frequency heat energy to directly heat blood, so that the hot blood flows from the proximal end to the distal end along the blood flow direction, and therefore, the temperature curve measured by the temperature sensor 12 at the proximal end may be earlier than the temperature curve measured by the temperature sensor 12 at the distal end by a large amount, and corresponding data is calculated, and by analyzing the two temperature curves, a time difference may be obtained, which is the time T consumed by the blood flow from the proximal end sensor to the distal end temperature sensor 12, and the relative distance D between the proximal end temperature sensor 12 and the distal end temperature sensor 12 is pre-designed and fixed.
In another embodiment, as shown in fig. 2, cold saline is injected into the renal artery, and the cold saline flows from the proximal end to the distal end of the renal artery, so that the temperature curve measured by the temperature sensor 12 at the proximal end is much earlier than the temperature curve measured by the temperature sensor 12 at the distal end, and after the corresponding data is counted and calculated by the personal computer 2, the time difference, i.e. the time T taken for the blood flow to flow from the proximal end sensor to the distal end temperature sensor 12, can be obtained by analyzing the two temperature curves, and the relative distance D between the proximal end temperature sensor 12 and the distal end temperature sensor 12 is pre-designed and fixed.
As shown in fig. 2, a personal computer 2 is arranged at one end of the catheter tube 1 far from the bendable tube 11, a sensor interface 21 is arranged on the personal computer 2, the sensor interface 21 is electrically connected with the pressure sensor 13, a control end 3 is arranged in the personal computer 2, data statistics and data calculation are carried out through the personal computer 2, the data are analyzed and sorted through the personal computer 2, firstly, relevant data such as time T, distance D, blood pressure P and the like are acquired, and then, through a calculation formula: v is D/T; r is P/V; and sequentially calculating data of the numerical values of Rn and Rn +1, and judging the data of the corresponding data.
As shown in fig. 3, the control terminal 3 includes at least one programmable logic controller 32 that uses a stack algorithm to store data, and the programmable logic controller 32 is in communication connection with the personal computer 2 to implement data synchronization, so that a worker can control and manufacture the programmable logic controller 32 through the personal computer 2. The amount of data stored in the programmable logic controller 32 is small, a stack algorithm is adopted to temporarily store the data, the personal computer 2 adopts a hard disk to store the data, the amount of the data stored in the hard disk is large, the programmable logic controller 32 receives new preset information and then synchronizes the new preset information to the personal computer 2 to store the new preset information, so that the data is prevented from being lost, and meanwhile, the programmable logic controller realizes repeated coverage of the data, namely, if the latest data arrives, the latest data can be covered and replaced by the old data, so that iteration of the data is realized.
As shown in fig. 3, the plc 32 includes a logic control unit 33, a database unit and an alarm unit 35, and the data unit 34 and the alarm unit 35 are connected to the logic control unit 33. The sensor feeds back the detected index real-time data to the programmable logic controller 32, the logic control unit 33 searches corresponding index target data from the database unit according to the feedback information of the digital sensor and sends the index target data to the logic control unit 33 for comparison and judgment, and finally whether the renal artery ablation is effective is evaluated according to the judgment result and displayed to a worker through the display component 31.
As shown in fig. 2, the catheter tube 1 is made of electroactive polymer, and bound charges appear at both ends of the polarized electroactive polymer sheet, and a layer of free charges from the outside is adsorbed on the surface of the electrode. When an external pressure F is applied to the electroactive polymer sheet, a discharge occurs at both ends of the sheet. Charging occurs on the contrary when a pulling force is applied. The phenomenon of converting the mechanical effect into the electrical effect belongs to the positive voltage effect. Electroactive polymers have the property of spontaneous polarization, which can be transformed by an external electric field. Thus, when an external electric field is applied to a dielectric having piezoelectricity, the electroactive polymer may be deformed. However, the electroactive polymer is deformed because the external electric field, which is similar to spontaneous polarization, is applied to the polymer to increase the polarization intensity. The increase in the polarization causes the electroactive polymer sheet to elongate in the direction of polarization. Conversely, if a reverse electric field is applied, the electroactive polymer sheet shortens in the direction of polarization. This phenomenon, which is converted into a mechanical effect due to an electrical effect, is an inverse piezoelectric effect.
As shown in fig. 2, an insulating coating is disposed between the electrodes 14, so that a ceramic coating with high volume resistivity and capable of withstanding a strong electric field without breakdown is formed between the electrodes, and the coating has high mechanical strength and chemical stability, and is resistant to aging, water and chemical corrosion; meanwhile, the material has internal mechanical shock and thermal shock performance and can continuously work at corresponding working temperature.
The working principle is as follows: firstly, the distance D between the blood flow from the near end to the far end is measured, then the time T consumed by the blood flowing from the near end temperature sensor 12 to the far end temperature sensor 12 is measured through the process that the blood is heated and the blood flows from the near end sensor to the far end sensor, then the blood flow pressure is measured through the pressure sensor 13, all data are fed back to the personal computer 2, the data are subjected to data calculation through the personal computer 2 and a calculation formula, the calculation results are subjected to data comparison, and the corresponding data are obtained for judgment.
The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.
Claims (9)
1. An ablation catheter effect parameter evaluation method and an ablation catheter effect parameter evaluation device are characterized by comprising the following steps:
s1, controlling a single electrode to generate radio frequency heat energy by the energy emitter to heat blood;
s2, respectively recording the temperature by the temperature sensors at the near end and the far end;
s3, the processing end records the change curve of the temperature along with the time according to the temperature data of the near end and the far end;
s4, the time T consumed by the blood flow from the near-end temperature sensor to the far-end temperature sensor;
s5, acquiring the relative distance D between the near-end temperature sensor and the far-end temperature sensor;
s6, determining the blood flow velocity V according to the blood flow consumption time and the relative distance;
s7, acquiring the pressure P of a pressure sensor at the front end of the catheter body of the data acquisition catheter;
s8, determining an evaluation parameter R according to the blood flow velocity and the pressure of the far end of the blood vessel;
s9, calculating a series of evaluation parameters, and judging RnAnd Rn+1The numerical value of (c).
2. The ablation catheter effect parameter evaluation method and evaluation device according to claim 1,
the velocity calculation formula in step S6 is: and V is D/T.
3. The ablation catheter effect parameter evaluation method and evaluation device according to claim 1,
the evaluation parameter calculation formula in step S8 is: and R is P/V.
4. The ablation catheter effect evaluation device according to claims 1-3, wherein a flexible tube (11) is provided at any end of the catheter tube (1), the temperature sensor (12) is located on the flexible tube (11), and a pressure sensor (13) is provided on the flexible tube (11).
5. The ablation catheter effect evaluation device according to claim 4, wherein the flexible tube (11) is provided with a plurality of electrodes (14).
6. The ablation catheter effect evaluation device according to claim 4, wherein a personal computer (2) is disposed at an end of the catheter tube (1) away from the bendable tube (11), a sensor interface (21) is disposed on the personal computer (2), the sensor interface (21) is electrically connected to the pressure sensor (13), and a control end (3) is disposed in the personal computer (2).
7. The ablation catheter effect evaluation device according to claim 6, wherein the control terminal (3) comprises at least one programmable logic controller (32) with a stack algorithm for data storage, and the personal computer (2) and the programmable logic controller (32) are synchronized.
8. The ablation catheter effect evaluation device according to claim 4, wherein the catheter tube (1) is made of an electroactive polymer.
9. The ablation catheter effect evaluation device according to claim 4, wherein an insulating coating is provided between a plurality of said electrodes (14).
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111561268.9A CN114052896A (en) | 2021-12-17 | 2021-12-17 | Ablation catheter effect parameter evaluation method and evaluation device |
| PCT/CN2022/073459 WO2023108861A1 (en) | 2021-12-17 | 2022-01-24 | Ablation catheter effect parameter evaluation method and device |
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| CN202111561268.9A CN114052896A (en) | 2021-12-17 | 2021-12-17 | Ablation catheter effect parameter evaluation method and evaluation device |
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| WO (1) | WO2023108861A1 (en) |
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| EP4311483A3 (en) * | 2022-07-29 | 2024-03-20 | Medtronic Ireland Manufacturing Unlimited Company | Systems and methods for measuring pulse wave velocity |
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| CN108601616A (en) * | 2015-12-01 | 2018-09-28 | 苏州信迈医疗器械有限公司 | The system and method for arterial wall functional nerve are dominated for mapping and can realize the 3D mappings method and conduit of identical function |
| CN108601534A (en) * | 2016-02-01 | 2018-09-28 | 美敦力阿迪安卢森堡有限公司 | System and method for monitoring and assessing neuromodulation therapy |
| CN112638301A (en) * | 2018-08-13 | 2021-04-09 | 悉尼大学 | Catheter ablation device with impedance monitoring |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| EP4311483A3 (en) * | 2022-07-29 | 2024-03-20 | Medtronic Ireland Manufacturing Unlimited Company | Systems and methods for measuring pulse wave velocity |
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| WO2023108861A1 (en) | 2023-06-22 |
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