WO2023108861A1 - 一种消融导管效果参数测评方法和测评装置 - Google Patents

一种消融导管效果参数测评方法和测评装置 Download PDF

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WO2023108861A1
WO2023108861A1 PCT/CN2022/073459 CN2022073459W WO2023108861A1 WO 2023108861 A1 WO2023108861 A1 WO 2023108861A1 CN 2022073459 W CN2022073459 W CN 2022073459W WO 2023108861 A1 WO2023108861 A1 WO 2023108861A1
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ablation catheter
effect
temperature sensor
evaluation
sensor
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PCT/CN2022/073459
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English (en)
French (fr)
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江挺益
刘广志
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苏州润迈德医疗科技有限公司
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Publication of WO2023108861A1 publication Critical patent/WO2023108861A1/zh

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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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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

Definitions

  • the present application relates to the technical field of medical equipment, in particular, to an evaluation method and evaluation device for an ablation catheter effect parameter.
  • RSNA renal sympathetic nerve activity
  • renal nerve ablation is performed in a "blind" manner, that is, the doctor performing the renal nerve ablation operation does not know the specific location of the distribution of the renal sympathetic nerve, and does not know whether the current ablation point is an effective point , only ablation of the entire renal artery is performed; in addition, the current ablation results can only be tested for its possible effect after the operation, and this effect can only be fully confirmed by measuring the patient's blood pressure at least one month after the operation. way to confirm whether the renal nerves are indeed removed by ablation.
  • the main purpose of this application is to provide an evaluation method and evaluation device for ablation catheter effect parameters, so as to solve the clinical urgent need for a method that can confirm the renal nerve ablation point in advance in related technologies, so as to provide doctors with accurate ablation targets, and it is also urgent There is a need to identify clinically relevant indicators that can immediately assess the effectiveness of ablation.
  • the present application provides a method for measuring parameters for evaluating the effect of an ablation channel.
  • the method includes the following steps:
  • the energy transmitter controls a single electrode to generate radio frequency heat energy to heat the blood
  • the near-end and far-end temperature sensors record the temperature respectively;
  • the processing end records the temperature change curve with time according to the temperature data at the near end and the far end;
  • an ablation tube effect evaluation device comprising a bendable tube body at any end of the catheter tube body, the temperature sensor is located on the bendable tube body, and a pressure sensor is provided on the bendable tube body.
  • the bendable pipe is provided with electrodes.
  • the end of the catheter body away from the bendable body is provided with a personal computer
  • the personal computer is provided with a sensor interface
  • the sensor interface is electrically connected to the pressure sensor
  • a control terminal is provided in the personal computer.
  • control terminal includes at least one programmable controller with a stack algorithm for data storage, and data synchronization between the personal computer and the programmable logic controller.
  • the catheter tube body is made of electroactive polymer.
  • a parameter evaluation method and evaluation device for the effect of an ablation catheter The head end of the catheter itself is a bendable tube body, and the material of the tube body is made of an electroactive polymer, which can be bent and deformed under electrical stimulation to form a helical structure.
  • the degree of deformation can change with the voltage, which makes the adaptability of sticking to the wall better.
  • the tip shape can be switched between helical and linear under positive and negative electrical stimulation.
  • a method and device for evaluating the effect parameters of an ablation catheter There is a pressure sensor at the tip of the catheter, which can accurately monitor real-time changes in intravascular pressure, which is both accurate and real-time.
  • An ablation catheter effect parameter evaluation method and evaluation device.
  • the energy generator cooperates with the electrodes to realize the two functions of stimulation and ablation, making the ablation of renal artery nerves more accurate.
  • An ablation catheter effect parameter evaluation method and evaluation device capable of calculating effect evaluation parameters, so as to immediately evaluate whether the ablation is effective.
  • the accuracy rate of renal artery nerve ablation can be optimized, the operation effect can be improved, the benefit of patients can be increased, and an instant feedback mechanism can be established to increase the certainty of curative effect.
  • Fig. 1 is a flow chart of a method for evaluating parameters of an ablation catheter effect according to an embodiment of the present application
  • Fig. 2 is a schematic structural diagram of an ablation catheter effect parameter evaluation method and evaluation device provided according to an embodiment of the present application
  • Fig. 3 is a schematic diagram of internal module connection of an ablation catheter effect parameter evaluation method and an evaluation device according to an embodiment of the present application.
  • an ablation pipeline effect evaluation device and parameter measurement method include the following steps:
  • the energy transmitter controls a single electrode to generate radio frequency heat energy to heat the blood
  • the near-end and far-end temperature sensors record the temperature respectively;
  • the processing end records the temperature change curve with time according to the temperature data at the near end and the far end;
  • V D/T, calculate the blood flow velocity
  • R n After calculating R n , compare it with the previous R n-1 , if R n is less than R n-1 , it means that the ablation is effective. Proceed to the next stage of ablation. If R n is not less than R n-1 , it means that enough target points have been ablated to reach the end of the ablation operation. It solves the clinical urgent need for a method that can confirm the renal nerve ablation point in advance, so as to provide doctors with accurate ablation targets, and also urgently needs to find out those clinically relevant indicators that can immediately evaluate whether the ablation is effective.
  • a bendable pipe body 11 is provided at any end of the catheter body 1, and a temperature sensor 12 is located on the bendable pipe body 11, and a pressure sensor 13 is arranged on the bendable pipe body 11, and through the pressure sensor 13 and the temperature sensor 12, The pressure sensor 13 measures the pressure of the blood flow.
  • the pressure sensor 13 measures the pressure of the blood flow.
  • electrodes 14 are arranged on the bendable tubular body 11, and the electrodes 14 are arranged in the bendable tubular body 11 at uniform intervals along the length direction of the catheter tip, and the radio frequency energy sent to the motor by the personal computer 2 can be controlled so that Electrodes 14 generate only low level electrical impulses that stimulate the underlying renal nerve tissue.
  • the personal computer 2 can also control the single electrode 14 at the proximal end to generate radio frequency heat energy to directly heat the blood, then the hot blood flows from the proximal end to the distal end along the blood flow direction, so the temperature curve measured by the temperature sensor 12 at the proximal end A large drop in temperature will occur earlier than the temperature sensor 12 at the far end, and the corresponding data will be calculated.
  • This time difference is the consumption of blood flow from the proximal sensor to the remote temperature sensor 12 time T, and the relative distance D between the proximal temperature sensor 12 and the distal temperature sensor 12 is pre-designed and fixed.
  • cold saline is injected into the renal artery, and the cold saline flows from the proximal end of the renal artery to the distal end, so the temperature curve measured by the temperature sensor 12 at the proximal end will be earlier than the temperature at the distal end.
  • the corresponding data is counted and calculated by the personal computer 2, and the time difference can be obtained by analyzing the two temperature curves. This time difference is the time consumed by the blood flow from the proximal sensor to the remote temperature sensor 12.
  • the time T and the relative distance D between the proximal temperature sensor 12 and the distal temperature sensor 12 are pre-designed and fixed.
  • a personal computer 2 is provided at the end of the catheter tube body 1 away from the bendable tube body 11, a sensor interface 21 is provided on the personal computer 2, the sensor interface 21 is electrically connected with the pressure sensor 13, and a control terminal is provided in the personal computer 2 3.
  • the control terminal 3 includes at least one programmable logic controller 32 that uses a stack algorithm for data storage, and the programmable logic controller 32 communicates with the personal computer 2 to realize data synchronization, so that the staff can 2.
  • the programmable logic controller 32 is controlled and manufactured.
  • the storage data volume of PLC 32 is less, and adopts stack algorithm to store data temporarily, and personal computer 2 adopts hard disk to store, and its storage data volume is larger, after PLC 32 accepts new preset information That is, it is synchronized to the personal computer 2 for storage to prevent data loss.
  • PLC 32 realizes the repeated coverage of data, that is, if the latest data arrives, it will cover and replace the old data, so as to realize the iteration of data.
  • the programmable logic controller 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 both connected to the logic control unit 33 .
  • the sensor feeds back and transmits the real-time data of the detected index to the programmable logic controller 32, and the logic control unit 33 searches for the corresponding index target data from the database unit and sends it to the logic control unit 33 according to the feedback information of the digitized sensor. Compare and judge, and finally evaluate whether the renal artery ablation is effective through the judgment result, and display it to the staff through the display component 31 .
  • the catheter tube body 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 electrode surface.
  • an external pressure F is applied to the electroactive polymer sheet, a discharge phenomenon will occur at both ends of the sheet. On the contrary, pulling force will cause charging phenomenon.
  • the phenomenon that this mechanical effect is transformed into an electrical effect belongs to the positive voltage effect.
  • Electroactive polymers have the property of spontaneous polarization, and the spontaneous polarization can be transformed under the action of an external electric field. Therefore, when an external electric field is applied to the piezoelectric dielectric, the electroactive polymer will deform.
  • the reason why the electroactive polymer deforms is that when the same external electric field as the spontaneous polarization is applied, it is equivalent to increasing the polarization strength.
  • the increase in polarization strength elongates the electroactive polymer sheet in the direction of polarization.
  • the electroactive polymer sheet shortens along the polarization direction. This phenomenon in which the electrical effect is transformed into a mechanical effect is the inverse piezoelectric effect.
  • an insulating coating is set between several electrodes 14, so that a layer of ceramic coating with high volume resistivity and capable of withstanding a strong electric field without being broken down is formed between the electrodes, and the coating has higher mechanical properties.
  • Strength and chemical stability aging resistance, water resistance, chemical corrosion resistance; at the same time, it also has internal mechanical shock and thermal shock performance, and can work continuously within the corresponding working temperature.
  • Working principle first measure the distance D between the blood flow from the proximal end to the distal end, and then measure the flow of the proximal temperature sensor 12 to the distal temperature sensor by heating the blood and the process of the blood from the proximal sensor to the distal sensor
  • the time T consumed by 12 is used to measure the blood flow pressure through the pressure sensor 13, and all the data is fed back to the personal computer 2, and the data is calculated by the personal computer 2 and the calculation formula, and the calculated results are compared to the data , get the corresponding data to judge.

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Abstract

一种消融导管效果参数测评方法和测评装置。其中，消融导管管体（1）上设置有压力传感器（13）和温度传感器（12），压力传感器（13）测量血流的压力P，两个温度传感器（12）分别设置在近端和远端，获取近端温度传感器（12）到远端温度传感器（12）之间的距离D，测量血液从近端温度传感器（12）到远端温度传感器（12）所消耗的时间T，将所有数据反馈到个人计算机（2），基于距离D和时间T计算得到血流速度V，基于速度V和压力P计算得到评价参数R。根据评价参数R确定消融术是否有效以及是否已经完成足够的目标点。

Description

一种消融导管效果参数测评方法和测评装置 技术领域
本申请涉及医疗设备技术领域，具体而言，涉及一种消融导管效果参数测评方法和测评装置。
背景技术
血压是通过体内多个系统(包括神经系统，循环系统和内分泌系统)的信号复杂地相互作用来控制的。交感神经的普遍激活是高血压发病机制的重要环节。临床研究表明肾交感神经活动(renal sympathetic nerve activity，RSNA)导致肾小管钠水重吸收增加、引起肾素释放和肾血管阻力改变，从而使血压升高。并且通过肾交感传入神经将肾脏感受器的反射信号传导至中枢，再由肾交感传出神经调节血压变化。所以RSNA不仅能短期调节肾动脉血管张力变化，也是长期维持高血压的重要因素。因此对于难治性高血压患者使用肾动脉射频消融导管进行肾动脉交感神经的消融，是一个治疗高血压的新希望，同时也是非药物治疗高血压的一个新方法，并根据国外前期的临床试验表明该方法是安全有效的，能被广泛使用。
但是，目前肾神经消融术是以“盲目”的方式进行操作的，即进行肾神经消融手术操作的医生并不知道肾交感神经分布的具体位置，并不知道自己当前消融的点是否是有效点，只是在整段肾动脉进行消融；此外，目前的消融结果只有在术后检测其可能的作用，这一效果要在术后至少一个月通过检测患者的血压才能完全确认，用这种滞后的方式去确认肾神经是否确实被消融去除。
因此，临床上迫切需要能够提前确认肾神经消融点的方法，从而为医生提供准确的消融靶标，同时也迫切需要找出那些能够即时评价消融术是否有效的临床相关指标。
发明内容
本申请的主要目的在于提供一种消融导管效果参数测评方法和测评装置，以解决相关技术中临床上迫切需要能够提前确认肾神经消融点的方法，从而为医生提供准确的消融靶标，同时也迫切需要找出那些能够即时评价消融术是否有效的临床相关指标的问题。
为了实现上述目的，第一方面，本申请提供了一种消融管道效果评价参数测量方法。
根据本申请提供的一种消融管道效果评价参数测量方法，包括如下步骤：
S1、能量发射器控制单个电极产生射频热能，加热血液；
S2、近端和远端的温度传感器分别记录温度；
S3、处理端根据近端和远端的温度数据，记录温度随时间的变化曲线；
S4、血流从近端温度传感器流到远端温度传感器所消耗的时间T；
S5、数据采集近端温度传感器与远端温度传感器的相对距离D；
S6、根据血流消耗的时间和相对距离，确定血流速度V；
S7、数据采集导管管体前端压力传感器的压力P；
S8、根据血流速度和血管远端的压力，确定评价参数R；
S9、计算一系列评价参数，判断R n与R n+1的数值大小。
进一步，步骤S6中的速度计算公式为：V＝D/T。
进一步，步骤S8中的评价参数计算公式为：R＝P/V。
进一步，提供一种消融管道效果评价装置，包括所述导管管体任意一端设有可弯曲管体，所述温度传感器位于可弯曲管体上，所述可弯曲管体上设有压力传感器。
进一步，所述可弯曲管道上设有电极。
进一步，所述导管管体远离可弯曲管体的一端设有个人计算机，所述个人计算机上设有传感器接口，所述传感器接口与压力传感器电性连接，所述个人计算机内设有控制端。
进一步，所述控制端包括至少一台堆栈算法进行数据储存的可编程控制器，所述个人计算机与所述可编程逻辑控制器之间进行数据同步。
进一步，所述导管管体由电活性聚合物制成。
优势：
1、一种消融导管效果参数测评方法和测评装置，导管头端本身为可弯曲 管体，管体材质采用电活性聚合物，可以在电刺激下产生弯曲变形，形成螺旋结构。形变程度可以随电压变化，使得贴壁适应性更好。头端形状可以在正向和负向电刺激下，在螺旋形和直线形之间切换。
2、一种消融导管效果参数测评方法和测评装置，导管头端有压力传感器，可以准确监测血管内压力的实时变化，既准确又实时。
3、一种消融导管效果参数测评方法和测评装置，能量发生器配合电极可以实现刺激和消融两种功能，使得肾动脉神经消融更加精准。
4、一种消融导管效果参数测评方法和测评装置，能够计算效果评价参数，从而即时评价消融术是否有效。
通过以上特点，优化肾动脉神经消融术的准确率，提升手术效果，增加患者获益，建立即时反馈机制，增加疗效确定性。
附图说明
构成本申请的一部分的附图用来提供对本申请的进一步理解，使得本申请的其它特征、目的和优点变得更明显。本申请的示意性实施例附图及其说明用于解释本申请，并不构成对本申请的不当限定。在附图中：
图1是根据本申请实施例提供的一种消融导管效果参数测评方法的流程图；
图2是根据本申请实施例提供的一种消融导管效果参数测评方法和测评装置的结构示意图；
图3是根据本申请实施例提供的一种消融导管效果参数测评方法和测评装置的内部模块连接示意图。
附图说明：
1、导管管体；11、可弯曲管体；12、温度传感器；13、压力传感器；14、电极；2、个人计算机；21、传感器接口；3、控制端；31、显示组件；32、可编程逻辑控制器；33、逻辑控制单元；34、数据库单元；35、警报单元
具体实施方式
为了使本技术领域的人员更好地理解本申请方案，下面将结合本申请实施 例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分的实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都应当属于本申请保护的范围。
需要说明的是，本申请的说明书和权利要求书及上述附图中的术语“第一”、“第二”等是用于区别类似的对象，而不必用于描述特定的顺序或先后次序。应该理解这样使用的数据在适当情况下可以互换，以便这里描述的本申请的实施例。此外，术语“包括”和“具有”以及他们的任何变形，意图在于覆盖不排他的包含，例如，包含了一系列步骤或单元的过程、方法、系统、产品或设备不必限于清楚地列出的那些步骤或单元，而是可包括没有清楚地列出的或对于这些过程、方法、产品或设备固有的其它步骤或单元。
在本申请中，术语“上”、“下”、“左”、“右”、“前”、“后”、“顶”、“底”、“内”、“外”、“中”、“竖直”、“水平”、“横向”、“纵向”等指示的方位或位置关系为基于附图所示的方位或位置关系。这些术语主要是为了更好地描述本申请及其实施例，并非用于限定所指示的装置、元件或组成部分必须具有特定方位，或以特定方位进行构造和操作。
并且，上述部分术语除了可以用于表示方位或位置关系以外，还可能用于表示其他含义，例如术语“上”在某些情况下也可能用于表示某种依附关系或连接关系。对于本领域普通技术人员而言，可以根据具体情况理解这些术语在本申请中的具体含义。
另外，术语“多个”的含义应为两个以及两个以上。
需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互组合。下面将参考附图并结合实施例来详细说明本申请。
如图1所示，一种消融管道效果评价装置和参数测量方法，包括如下步骤：
S1、能量发射器控制单个电极产生射频热能，加热血液；
S2、近端和远端的温度传感器分别记录温度；
S3、处理端根据近端和远端的温度数据，记录温度随时间的变化曲线；
S4、血流从近端温度传感器流到远端温度传感器所消耗的时间T；
S5、数据采集近端温度传感器与远端温度传感器的相对距离D；
S6、根据血流消耗的时间和相对距离，确定血流速度V；
通过血流计算公式：V＝D/T，计算出血流速度；
S7、数据采集导管管体前端压力传感器的压力P；
S8、根据血流速度和血管远端的压力，确定评价参数R；
通过评价参数计算公式：R＝P/V，计算出评价参数R；
S9、计算一系列评价参数，判断R n与R n+1的数值大小。
计算得到R n之后，与之前的R n-1进行比较，如果R n小于R n-1,则说明消融术是有效的。继续进行下一阶段的消融。如果R n不小于R n-1，则说明已经消融足够的目标点，到达消融手术终点。解决了临床上迫切需要能够提前确认肾神经消融点的方法，从而为医生提供准确的消融靶标，同时也迫切需要找出那些能够即时评价消融术是否有效的临床相关指标的问题。
如图2所示，导管管体1任意一端设置可弯曲管体11，温度传感器12位于可弯曲管体11上，可弯曲管体11上设置压力传感器13，通过压力传感器13和温度传感器12，压力传感器13测量血流的压力，通过在近端和远端设置的温度传感器12，首先测量血流从近端到远端的之间的距D，随后通过加热血液，血液从近端传感器到远端传感器的过程，测量出近端温度传感器12流到远端温度传感器12的所消耗的时间T，再通过压力传感器13将测量血流压力，将所有数据反馈到个人计算机2，通过个人计算机2和计算公式，将数据进行数据计算，并对计算结果，进行数据比较，得到相对应的数据进行判断。
如图2所示，可弯曲管体11上设置电极14，电极14沿导管头端的长度方向，均匀间隔排列在可弯曲管体11，个人计算机2控制发送到电机的射频能量可以被控制，使得电极14只产生低水平电脉冲，刺激潜在的肾神经组织。同时，个人计算机2还可以控制近端的单个电极14产生射频热能，直接加热血液，那么热的血液沿着血流方向从近端流向远端，因此近端的温度传感器12测得的温度曲线会早于远端的温度传感器12发生温度的大幅下降，计算相应的数据，通过分析两根温度曲线，可以得到时间差，这个时间差也就是血流从近端传感器流到远端温度传感器12所消耗的时间T，且近端温度传感器12 和远端温度传感器12的相对距离D是预先设计，固定不变。
另一种实施例中，如图2所示，在肾动脉注射冷盐水，冷盐水从肾动脉近端流向远端，因此近端的温度传感器12测得的温度曲线会早于远端的温度传感器12发生温度的大幅上升，在通过个人计算机2统计和计算相应数据，通过分析两根温度曲线，可以得到时间差，这个时间差也就是血流从近端传感器流到远端温度传感器12所消耗的时间T，且近端温度传感器12和远端温度传感器12的相对距离D是预先设计，固定不变。
如图2所示，导管管体1远离可弯曲管体11的一端设置个人计算机2，个人计算机2上设置传感器接口21，传感器接口21与压力传感器13电性连接，个人计算机2内设置控制端3，通过个人计算机2进行数据统计和数据计算，通过个人计算机2对数据的分析和整理，首先通过采集时间T、距离D、血流压力P等相关数据，随后通过计算公式：V＝D/T；R＝P/V；依次计算出Rn与Rn+1的数值的数据，并对相应数据进行数据判断。
如图3所示，控制端3包括至少一台采用堆栈算法进行数据存储的可编程逻辑控制器32，可编程逻辑控制器32与个人计算机2通信连接实现数据同步，使工作人员可通过个人计算机2对可编程逻辑控制器32进行控制制造。而且可编程逻辑控制器32的储存数据量较小，且采用堆栈算法临时存储数据，而个人计算机2采用硬盘存储，其存储数据量较大，可编程逻辑控制器32接受新的预设信息后即同步至个人计算机2进行存储，以防止数据丢失，同时其自身实现了数据的重复覆盖，即最近的数据若有心的数据到来将覆盖替换旧数据，以实现数据的迭代。
如图3所示，可编程逻辑控制器32包括逻辑控制单元33、数据库单元及警报单元35，其数据单元34以及警报单元35均连接与逻辑控制单元33。传感器将检测到的指标实时数据反馈传输至可编程逻辑控制器32中，逻辑控制单元33根据数字化传感器的反馈信息，通过从数据库单元中寻找对应的指标目标数据并发送至逻辑控制单元33来进行比对判断，最后通过判断结果来评价肾动脉消融术是否有效，并通过显示组件31，显示给工作人员。
如图2所示，导管管体1由电活性聚合物制成，经过极化的电活性聚合物片的两端会出现束缚电荷，在电极表面吸附了一层来自外界的自由电荷。当给电活性聚合物片施加一外界压力F时，片的两端会出现放电现象。相反加以拉力会出现充电现象。这种机械效应转变成电效应的现象属于正电压效应。电活性聚合物具有自发化的性质，而自发极化可以在外电场的作用下发生转变。因此当给具有压电性的电介质加上外电场时，电活性聚合物会有变形。然而，电活性聚合物之所以会有变形，是因为当加上与自发极化形同的外电场时，相当于增加了极化强度。极化强度的增大使电活性聚合物片沿极化方向伸长。相反，如果加反向电场，则电活性聚合物片沿极化方向缩短。这种由于电效应转变成机械效应的现象是逆压电效应。
图2所示，若干电极14之间设置绝缘涂层，使得电极之间形成一层具有高体积电阻率，能承受较强电场而不被击穿的陶瓷涂层，涂层具有较高的机械强度和化学稳定性，能耐老化、耐水、耐化学腐蚀；同时还具有内机械冲击和热冲击性能，在相应的工作温度内连续工作。
工作原理：首先测量血流从近端到远端的之间的距D，随后通过加热血液，血液从近端传感器到远端传感器的过程，测量出近端温度传感器12流到远端温度传感器12的所消耗的时间T，再通过压力传感器13将测量血流压力，将所有数据反馈到个人计算机2，通过个人计算机2和计算公式，将数据进行数据计算，并对计算结果，进行数据比较，得到相对应的数据进行判断。
以上所述仅为本申请的优选实施例而已，并不用于限制本申请，对于本领域的技术人员来说，本申请可以有各种更改和变化。凡在本申请的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本申请的保护范围之内。

Claims (9)

  1. 一种消融导管效果参数测评方法和测评装置，其特征在于，包括如下步骤：
    S1、能量发射器控制单个电极产生射频热能，加热血液；
    S2、近端和远端的温度传感器分别记录温度；
    S3、处理端根据近端和远端的温度数据，记录温度随时间的变化曲线；
    S4、血流从近端温度传感器流到远端温度传感器所消耗的时间T；
    S5、数据采集近端温度传感器与远端温度传感器的相对距离D；
    S6、根据血流消耗的时间和相对距离，确定血流速度V；
    S7、数据采集导管管体前端压力传感器的压力P；
    S8、根据血流速度和血管远端的压力，确定评价参数R；
    S9、计算一系列评价参数，判断R n与R n+1的数值大小。
  2. 如权利要求1所述的一种消融导管效果参数测评方法和测评装置，其特征在于，
    步骤S6中的速度计算公式为：V＝D/T。
  3. 如权利要求1所述的一种消融导管效果参数测评方法和测评装置，其特征在于，
    步骤S8中的评价参数计算公式为：R＝P/V。
  4. 如权利要求1-3所述的一种消融导管效果测评装置，其特征在于，所述导管管体(1)任意一端设有可弯曲管体(11)，所述温度传感器(12)位于可弯曲管体(11)上，所述可弯曲管体(11)上设有压力传感器(13)。
  5. 如权利要求4所述的一种消融导管效果测评装置，其特征在于，所述可弯曲管体(11)上设有若干电极(14)。
  6. 如权利要求4所述的一种消融导管效果测评装置，其特征在于，所述导管管体(1)远离可弯曲管体(11)的一端设有个人计算机(2)，所述个人计算机(2)上设有传感器接口(21)，所述传感器接口(21)与压力传感器(13)电性连接，所述个人计算机(2)内设有控制端(3)。
  7. 如权利要求6所述的一种消融导管效果测评装置，其特征在于，所述控制端(3)包括至少一台堆栈算法进行数据储存的可编程控制器(32)，所述个人计算机(2)与所述可编程逻辑控制器(32)之间进行数据同步。
  8. 如权利要求4所述的一种消融导管效果测评装置，其特征在于，所述导管管体(1)由电活性聚合物制成。
  9. 如权利要求4所述的一种消融导管效果测评装置，其特征在于，若干所述电极(14)之间设有绝缘涂层。
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