WO2023070796A1 - 一种带针道消融功能的有源活检装置及其系统和方法 - Google Patents

一种带针道消融功能的有源活检装置及其系统和方法 Download PDF

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WO2023070796A1
WO2023070796A1 PCT/CN2021/132669 CN2021132669W WO2023070796A1 WO 2023070796 A1 WO2023070796 A1 WO 2023070796A1 CN 2021132669 W CN2021132669 W CN 2021132669W WO 2023070796 A1 WO2023070796 A1 WO 2023070796A1
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biopsy
ablation
radio frequency
needle
frequency generator
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PCT/CN2021/132669
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English (en)
French (fr)
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唐淑君
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上海美微达医疗科技有限公司
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Priority to US18/704,943 priority Critical patent/US20240325002A1/en
Publication of WO2023070796A1 publication Critical patent/WO2023070796A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/06—Biopsy forceps, e.g. with cup-shaped jaws
    • 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
    • A61B18/1206—Generators therefor
    • 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
    • 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
    • A61B18/1477—Needle-like probes
    • 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
    • A61B18/148—Probes or electrodes therefor having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
    • 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
    • A61B18/1482—Probes or electrodes therefor having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A61B2010/045—Needles
    • 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
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • 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
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • 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
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle

Definitions

  • the invention relates to the technical field of medical devices, in particular to an active biopsy device and system with a function of needle tract ablation and an implementation method thereof.
  • Tissue biopsy is the most important technique for tumor diagnosis. The most common and serious complication of the damage is bleeding, which can lead to death in severe cases.
  • Existing radiofrequency ablation systems are often used for tumor ablation, and the commonly used power output is relatively large, and the ablation range is relatively large.
  • the existing biopsy tools are all passive devices. Passive devices do not have the function of needle tract ablation. In the process of needle withdrawal, it is easy to cause needle track bleeding and needle track planting, which will bring complications and seriously affect the recovery of patients.
  • Chinese utility model patent discloses a portable needle tract ablation system, including a bipolar needle body and a connecting handle.
  • the bipolar needle body is composed of a needle tube part and a needle core part. Needle interface, the function of the needle tube part in this system is equivalent to the trocar.
  • the biopsy cannula is established. After the biopsy is completed, the needle core part is inserted into the needle tube part to form the whole ablation motor.
  • this utility model emphasizes the portable function, and the ablation is performed in a battery-powered device without external power supply, which makes the ablation process more convenient.
  • the present invention adopts the method of improving the traditional biopsy device and adding a new low-power ablation function to solve the problems of needle tract planting and bleeding caused by the biopsy operation. radiofrequency ablation.
  • the present invention combines an active radiofrequency ablation system, which includes two parts, a low-power radiofrequency host and a radiofrequency electrode needle, and a disposable biopsy tool with a channel, and invents a radiofrequency ablation system for ablation
  • the biopsy tool with needle tract ablation under the skin, laparoscope or bronchoscope and other channels and the system composition effectively solve the problems of needle tract bleeding and needle tract planting of traditional passive biopsy tools.
  • the present invention also provides a method for realizing an active biopsy system with a needle track ablation function.
  • an active biopsy device with a function of needle tract ablation including a 400-500KHz radio frequency generator, a biopsy sleeve (which can simultaneously function as a radio frequency ablation electrode) and a biopsy tool,
  • the biopsy sleeve is an active device, which is connected to the radio frequency generator through a connection line; the wall of the biopsy sleeve is provided with a radio frequency ablation electrode, and the biopsy tool is movably arranged in the biopsy sleeve.
  • the above-mentioned active biopsy device with needle tract ablation function also includes an ablation electrode middle pole, the ablation electrode middle pole is an electrode needle, and the electrode needle is movably arranged in the biopsy sleeve, and the electrode needle An insulating layer is provided between the inner wall and the outer wall of the biopsy sleeve to electrically isolate the two parts, and the tail of the electrode needle is connected to the radio frequency port of the radio frequency generator through a connecting line.
  • the front end of the outer wall of the biopsy cannula is provided with a temperature measuring probe.
  • the biopsy tool in the biopsy cannula is taken out, and the outer cannula of the biopsy cannula with a connecting line is connected to the radio frequency output port of the host, and activated by the host.
  • the ablation function can realize needle tract ablation.
  • the above-mentioned active biopsy device with needle tract ablation function also includes a radio-frequency negative plate (usually attached to the surface of the human body), the radio-frequency negative plate is an electrode belt, and the radio-frequency generator includes two radio-frequency ports, respectively connected to the The biopsy sleeve and the electrode belt are connected to the two radio frequency ports of the radio frequency generator through connecting wires.
  • the front end of the outer wall of the biopsy sleeve is provided with a temperature measuring probe, which measures the ablation temperature in real time after the ablation electrode is turned on for ablation, and uploads it to the radio frequency generator.
  • the biopsy tool is a disposable biopsy brush or a disposable biopsy forceps.
  • an active biopsy system with needle track ablation function including the above-mentioned active biopsy device with needle track ablation function
  • the radio frequency generator is provided with a host system, so
  • the host system includes a temperature monitoring module and a radiofrequency ablation module.
  • the maximum RF output power of the RF generator is 100W. After the upper limit of the set temperature of the RF generator is reached, it will work according to the predetermined holding time. The usual ablation holding time is 3-8s. After ablation according to the temperature and time of the system, the system will automatically shut down the ablation function.
  • a method for realizing an active biopsy system with needle track ablation function includes the following steps:
  • Step 1 use the biopsy sleeve together with the biopsy tool, and place it on the target lesion for biopsy sampling. At this time, the biopsy sleeve does not need to be connected to the radio frequency generator;
  • Step 2 withdrawing the biopsy tool from the biopsy sleeve to obtain a biopsy sample
  • Step 3 then the biopsy sleeve is connected to the radio frequency generator through the connecting wire;
  • Step 4 operate the radio frequency generator to start the ablation mode, the temperature measuring probe starts to work, and feed back the ablation temperature to the system in real time;
  • Step 5 after the ablation is completed, withdraw the needle.
  • step 4 of the implementation method of the above-mentioned active biopsy system with needle tract ablation function when the temperature measured by the temperature measuring probe exceeds 50°C, the temperature monitoring module in the system feeds back the signal to the radio frequency ablation module, and the radio frequency The ablation module starts to calculate the ablation time. After the ablation time reaches the system setting value, the system will automatically stop the ablation, and the ablation is over.
  • the present invention has the following beneficial effects:
  • the present invention adopts the method of improving the traditional biopsy device and adding low-power ablation function to solve the problems of needle track planting and bleeding caused by the biopsy operation.
  • Power of radiofrequency ablation This device adopts low-power radio frequency function, does not use water cooling system, and belongs to the ablation device only used for needle tract ablation function.
  • the present invention improves the design of commonly used biopsy tools, so that the improved biopsy tools have the function of taking biopsies, and the improved biopsy tools are compatible with radio frequency ablation systems and have the function of needle tract ablation.
  • the invention effectively solves the problems of needle track bleeding and needle track planting of traditional passive biopsy tools, and reduces the complications of biopsy operations.
  • Fig. 1 is the structural representation of embodiment 1 of the present invention.
  • Fig. 2 is the structural representation of embodiment 2 of the present invention.
  • Fig. 3 is a schematic diagram of the use state of Embodiment 2 of the present invention.
  • Biopsy sleeve 1 biopsy tool 2, electrode needle 3, temperature measuring probe 4, connecting wire 5, radio frequency generator 6, radio frequency port 61, electrode belt 7.
  • an active biopsy device with needle tract ablation function includes a biopsy cannula 1, a temperature measuring probe 4 is arranged on the outer wall of the biopsy cannula 1 near the front end, and the biopsy cannula 1 can pass through the connection system
  • the host is used as a radiofrequency ablation electrode, and the electrode needle 3 can also be inserted into the hollow channel of the biopsy sleeve 1 to be used as an ablation electrode.
  • the biopsy sleeve 1 is an active device, and is connected to a radio frequency generator through a connection line 5 , and the electrode needle 3 is connected to the radio frequency generator through a connection line 5 .
  • the biopsy tool is a disposable electrode forceps or a disposable biopsy brush, which is placed in the biopsy sleeve 1 for use.
  • the device is used as follows:
  • the biopsy cannula 1 is used as one pole of the radiofrequency electrode for needle tract ablation, and does not need to be connected to the radiofrequency generator 6 at the beginning of the operation. It is used as a passive device during the biopsy operation and is used in conjunction with the biopsy tool for biopsy. After the biopsy operation is completed, the biopsy tool is withdrawn from the biopsy sleeve 1, and the biopsy sample is properly preserved. At this time, the biopsy sleeve 1 remains still, the electrode needle 3 is placed in the biopsy sleeve 1, and the biopsy sleeve 1 and the electrode needle 3 are respectively connected to the radio frequency port 61 provided on the radio frequency generator 6 through the connection line 5, Turn on RF generator 6.
  • the operator performs system settings on the radio frequency generator 6, and activates the ablation mode with one key to perform needle tract ablation.
  • the temperature measuring probe 4 on the outer wall of the biopsy cannula 1 starts to work, measures the ablation temperature of the biopsy cannula 1 in real time and uploads the temperature data to the system.
  • the ablation temperature reaches 50°C
  • the system will start to calculate the ablation time, keep the ablation time for 2-3s, and the system will automatically shut down the ablation function.
  • the radio frequency generator 6 is turned off, and the needle can be withdrawn.
  • an active biopsy device with needle tract ablation function includes a biopsy sleeve 1 and a radio frequency generator 6, the tube wall of the biopsy sleeve 1 is connected to the ablation host through a connecting line, and the radio frequency
  • the ablation electrode part works, and the electrode belt 7 is a radio frequency negative plate (usually attached to the surface of the human body).
  • the biopsy tool 2 is a disposable biopsy forceps, which is placed in the biopsy sleeve 1 .
  • the radio frequency generator 6 is provided with two radio frequency ports 61 , the electrode belt 7 is connected to one radio frequency port 61 through the connection line 5 , and the tail of the biopsy sleeve 1 is connected to the other radio frequency port 61 through the connection line 5 .
  • the device is used as follows:
  • the biopsy sleeve 1 Bind the two electrode belts 7 on the two thighs of the patient respectively, and the biopsy sleeve 1 is used as one pole of the radiofrequency electrode for needle tract ablation.
  • the biopsy sleeve 1 does not need to be connected to the radio frequency generator 6.
  • the biopsy operation it is only used as a passive device, and it cooperates with the biopsy tool 2 to perform the biopsy operation.
  • the biopsy tool 2 is withdrawn from the biopsy sleeve 1, and the biopsy sample is properly preserved.
  • the biopsy sleeve 1 remains still, and the electrode belt 7 is connected to the radio frequency port 61 of the radio frequency generator 6 through the connection line 5, and the connection line 5 of the biopsy sleeve 1 is connected to the radio frequency port 61 of the radio frequency generator 6 .
  • the ablation operation is performed, the radio frequency generator 6 is turned on, the operator operates the radio frequency generator 6 to set the system, and starts the ablation mode.
  • the temperature measuring probe 4 on the outer wall of the biopsy sleeve 1 starts to work.
  • the temperature measuring probe 4 is located at the front end of the biopsy sleeve 1 and is in the ablation area.
  • the system can measure the ablation temperature of the biopsy sleeve 1 in real time and upload the temperature data to the system.
  • the ablation temperature reaches 50°C
  • the system starts to calculate the ablation time, and when it reaches the set temperature range value, the ablation time is maintained for 3-8s.
  • the specific retention time depends on the application, and the system automatically shuts down the ablation function. Since only the needle tract needs to be ablated to meet the functions of hemostasis and anti-plantation, the ablation power and ablation time do not need to be too long.
  • the operator can turn off the radio frequency generator 6 to withdraw the needle safely. At this time, in the process of withdrawing the needle, there will be no more needle track planting.
  • the present invention develops the radio frequency ablation technology. Through system optimization, the output power of the radio frequency generator is more accurate, and the ablation is realized through low power output. Since the maximum output power of the generator is 100W, it usually does not exceed 50W in actual use, so this device does not need to be equipped with a separate cooling system, and a hollow system design without water cooling is chosen.
  • the present invention combines the traditional passive puncture tool with the active ablation electrode technology, adds the local ablation function in the conventional biopsy process, and controls the ablation temperature, which can completely solve the needle tract bleeding and ablation caused by the puncture needle.
  • the problem of needle tract planting The present invention improves the existing biopsy puncture device, adds a needle track ablation function to the biopsy tool, makes the biopsy device capable of ablation and hemostasis in addition to the biopsy function, and uses a set of devices to complete multiple functions.

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Abstract

一种带针道消融功能的有源活检装置，包括射频发生器（6）、活检套管（1）和活检工具（2），活检套管（1）为有源器件，通过连接线（5）与射频发生器（6）相连接；活检套管（1）管壁设置有射频消融电极，活检工具（2）可移动的设置于活检套管（1）内。一种带针道消融功能的有源活检系统，射频发生器（6）内设置有主机系统，主机系统包括温度监测模块和射频消融模块。通过在射频发生器（6）内设置系统，该射频消融系统兼容可穿刺活检工具（2），使无源穿刺活检工具（2）成为有源系统的一部分，可用于防止针道出血和针道种植，避免并发症的出现。

Description

一种带针道消融功能的有源活检装置及其系统和方法 技术领域
本发明涉及医疗器械技术领域，具体涉及一种带针道消融功能的有源活检装置及系统及其实现方法。
背景技术
组织活检是肿瘤诊断最重要的技术手段，带来的损伤最常见和最严重的并发症是出血，严重时可导致死亡。目前市面上已有的活检工具，不论是带活检套管的还是不带活检套管，都为无源器件，目前都不具有止血的功能。现有两种临床中常用的工具，一种是有源射频消融系统，一种是一次性活检工具。现有的射频消融系统，常用于肿瘤消融，常用的功率输出较大，消融范围较大，并且，现有取活检的工具都为无源器械，无源器械因其不具有针道消融功能，在退针过程中，容易造成针道出血，以及针道种植，带来并发症，严重影响患者的康复。
中国实用新型专利(授权公告号CN210582634U)公开了一种便携式针道消融系统，包括双极针体和连接手柄，双极针体由针管部件和针芯部件组成，针体通过连接电缆插入双极针接口，该系统中针管部件作用等同于套管针，建立活检套管，完成活检后将针芯部件插入针管部件，组成消融电机整体，主机采用电池供电，一键操作，便于携带。该实用新型与本发明的不同之处在于，该实用新型着重强调便携式功能，在装置中采取电池供电，无需外接电源的方式进行消融，使消融过程更加便捷。本发明采用对传统的活检装置改进新增低功率消融功能的方式，解决活检手术带来的针道种植和出血问题，采用将活检装置设计成有源的方式，增加测温装置，进行低功率的射频消融。
发明内容
有鉴于现有技术的上述缺陷，本发明结合了有源射频消融系统，该系统包含低功率的射频主机和射频电极针两部分，以及带通道的一次性活检工具，发明了一种用于经皮，腹腔镜或支气管镜等通道下的带针道消融的活检工具以及系统组成，有效的解决了传统无源活检工具针道出血，以及针道种植的问题。为此，本发明还提供一种带针道消融功能的有源活检系统的实现方法。
为解决上述技术问题，本发明采用如下技术方案：
在本发明的第一方面，提供一种带针道消融功能的有源活检装置，包括 400-500KHz的射频发生器、活检套管(同时可兼具射频消融电极的功能)和活检工具，所述活检套管为有源器件，通过连接线与所述射频发生器相连接；所述活检套管管壁设置有射频消融电极，所述活检工具可移动的设置于所述活检套管内。
上述的一种带针道消融功能的有源活检装置，还包括消融电极中间极，所述消融电极中间极为电极针，所述电极针可移动的设置于所述活检套管内，所述电极针内壁与所述活检套管外壁之间设有绝缘层，将两部件电隔离，所述电极针尾部通过连接线与所述射频发生器的射频端口相连接。所述活检套管外壁的前端设置有测温探头，在需要使用消融功能时，将活检套管内的活检工具取出，将带连接线的活检套管外套管接主机射频输出口，并通过主机激活消融功能，即可实现针道消融。
或者，上述的一种带针道消融功能的有源活检装置，还包括射频负极板(通常贴人体表面)，该射频负极板为电极带，所述射频发生器包括两个射频端口，分别与活检套管、电极带通过连接线连接至射频发生器的两个射频端口。所述活检套管外壁的前端设置有测温探头，在消融电极开启消融后实时测量消融温度，并上传至射频发生器。
上述的一种带针道消融功能的有源活检装置，所述活检工具为一次性活检刷或一次性活检钳。
在本发明的第二方面，提供一种带针道消融功能的有源活检系统，包括上述的一种带针道消融功能的有源活检装置，所述射频发生器内设置有主机系统，所述主机系统包括温度监测模块和射频消融模块。所述射频发生器的最大射频输出功率为100W。所述射频发生器设定温度上限达到后，按预定的保持时间工作，通常的消融保持时间为3-8s，按系统的温度和时间消融后，系统自动关停消融功能。
在本发明的第三方面，提供一种带针道消融功能的有源活检系统的实现方法，该方法包括如下步骤：
步骤1，将活检套管与活检工具配合使用，放置于目标病灶进行活检取样，此时活检套管不需与射频发生器连接；
步骤2，将活检工具退出活检套管，取得活检样品；
步骤3，然后将活检套管通过连接线连接至射频发生器；
步骤4，操作射频发生器开启消融模式，测温探头开始工作，将消融温度实时反馈至系统；
步骤5，消融结束后，退针。
上述的一种带针道消融功能的有源活检系统的实现方法所述步骤4中，所述测温探头测得温度超过50℃时，系统内温度监测模块将信号反馈至射频消融模块，射频消融模块开始计算消融时间。消融时间达到系统设定值后，系统自动停止消融，消融即为结束。
与现有技术相比，本发明具备如下有益效果：
本发明采用对传统的活检装置改进，新增低功率消融功能的方式，解决活检手术带来的针道种植和出血问题，采用将活检装置设计成有源的方式，增加测温装置，进行低功率的射频消融。本装置采用低功率射频功能，不采用水冷系统，属于仅用于针道消融功能的消融装置。本发明基于已有的射频消融系统原理，将常用的活检工具设计改进，使得改进的活检工具具有取活检的功能，将其改进后兼容射频消融系统，具有针道消融功能。本发明有效的解决了传统无源活检工具针道出血，以及针道种植的问题，降低了活检操作的并发症。
以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明，以充分地了解本发明的目的、特征和效果。
附图说明
图1是本发明实施例1的结构示意图；
图2是本发明实施例2的结构示意图；
图3是本发明实施例2的使用状态示意图。
其中，附图标记如下：
活检套管1，活检工具2，电极针3，测温探头4，连接线5，射频发生器6，射频端口61，电极带7。
具体实施方式
为了使发明实现的技术手段、创造特征、达成目的和功效易于明白了解，下结合具体图示，进一步阐述本发明。但本发明不仅限于以下实施的案例。
须知，本说明书所附图式所绘示的结构、比例、大小等，均仅用以配合说明书所揭示的内容，以供熟悉此技术的人士了解与阅读，并非用以限定本发明可实施的限定条件，故不具技术上的实质意义，任何结构的修饰、比例关系的改变或大小的调整，在不影响本发明所能产生的功效及所能达成的目的下，均应仍落在本发明所揭示的技术内容得能涵盖的范围内。
实施例1
如图1所示，一种带针道消融功能的有源活检装置，包括活检套管1，活检套管1的外壁上靠近前端处设置有测温探头4，活检套管1可通过连接系统主机做为射频消融电极使用，也可以将电极针3插入做为消融电极使用，可拆卸的设置于活检套管1的中空通道中。活检套管1为有源器件，通过连接线5与射频发生器相连接，电极针3通过连接线5与射频发生器相连接。活检工具为一次性电极钳或一次性活检刷，置于活检套管1中使用。
该装置的使用方法如下：
活检套管1作为针道消融射频电极的其中一极，在刚开始操作时不需接入射频发生器6，在活检操作中作为无源器件使用，配合活检工具进行活检。在活检操作完成后，将活检工具从活检套管1中退出，妥善保存活检样本。此时活检套管1保持不动，将电极针3放置于活检套管1中，将活检套管1和电极针3分别通过连接线5与射频发生器6上设置的射频端口61相连接，开启射频发生器6。操作者对射频发生器6进行系统设置，一键开启消融模式，进行针道消融。此时活检套管1外壁上的测温探头4开始工作，实时测量活检套管1的消融温度并将温度数据上传至系统。当消融温度达到50℃时，系统内开始计算消融时间，保持2-3s的消融时间，系统自动关停消融功能。消融完成后，关闭射频发生器6，可以退针。
实施例2
如图2及图3所示，一种带针道消融功能的有源活检装置，包括活检套管1，射频发生器6，活检套管1的管壁通过连接线接上消融主机，以射频消融电极部件工作，电极带7为射频负极板(通常贴人体表面)，电极带7有两条，在使用过程中能够分别绑定在患者两条大腿上。活检工具2为一次性活检钳，放置于活检套管1中。射频发生器6设置有两个射频端口61，电极带7通过连接线5与一个射频端口61相连接，活检套管1尾部通过连接线5，与另一个射频端口61相连接。
该装置的使用方法如下：
将两条电极带7分别绑定在患者的两条大腿上，活检套管1作为针道消融射频电极的其中一极，在活检步骤中活检套管1不需接入射频发生器6，在活检操作中仅作为无源器件使用，配合活检工具2进行活检操作。在活检操作完成后，将活检工具2从活检套管1中退出，妥善保存活检样本。此时活检套管1保持不动，将电极带7通过连接线5与射频发生器6的射频端口61相连接，将活检套管1的连接线5与射频发生器6的射频端口61相连接。此时进行消融操作，开启射频发生器6，操作者操作射频发生器6设定系统，开启消融模式。此时活检套管1外壁上的测温探头4开始工作，测温探头4位于活检套管1的前端，处于消融区域，能够实时测量活检套管1的消融温度并将温度数据上传至系统。当消融温度达到50℃时，系统内开始计算消融时间，当到达设定的温度范围值后，保持3-8s的消融时间，具体保持时间，根据实现应用而定，系统自动关停消融功能。由于仅需要对针道进行消融，满足止血和防种植的功能，因此消融功率和消融时间不必过长。待消融完成后，操作者可以关闭射频发生器6，安全退针。此时在退针过程中，不会再有针道种植情况发生。
本发明将射频消融技术进行了发展，通过系统优化，使射频发生器的输出功 率更加精准，通过小功率输出实现消融。由于发生器输出功率最大输出功率为100W，通常在实际使用过程中不超过50W，所以本装置不需要设有单独的冷却系统，选择采用中空的不带水冷的系统设计。本发明将传统的无源穿刺工具与有源的消融电极技术相结合，在常规的活检流程当中增加了局部消融功能，并且对消融温度进行控制，能够彻底解决穿刺针带来的针道出血和针道种植的问题。本发明将现有的活检穿刺器进行改进，在活检工具上增加了针道消融功能，使得活检装置除了活检功能还能够消融止血，采用一套装置完成多项功能。
以上详细描述了本发明的较佳具体实施例。应当理解，本领域的普通技术无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此，凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案，皆应在由权利要求书所确定的保护范围内。

Claims (10)

  1. 一种带针道消融功能的有源活检装置，其特征在于，包括射频发生器、活检套管和活检工具，所述活检套管为有源器件，通过连接线与所述射频发生器相连接；所述活检套管管壁设置有射频消融电极，所述活检工具可移动的设置于所述活检套管内。
  2. 如权利要求1所述的装置，其特征在于，所述活检套管外壁的前端设置有测温探头。
  3. 如权利要求2所述的装置，其特征在于，所述装置还包括消融电极中间极，该消融电极中间极为电极针，所述电极针可移动的设置于所述活检套管内，所述电极针内壁与所述活检套管外壁之间设有绝缘层，所述电极针尾部通过连接线与所述射频发生器的射频端口相连接。
  4. 如权利要求2所述的装置，其特征在于，所述装置还包括射频负极板，该射频负极板为电极带，所述射频发生器包括两个射频端口，分别与活检套管、电极带通过连接线相连接。
  5. 如权利要求1-4任一项所述的装置，其特征在于，所述活检工具为一次性活检刷或一次性活检钳。
  6. 一种带针道消融功能的有源活检系统，其特征在于，包括如权利要求5所述的一种带针道消融功能的有源活检装置，所述射频发生器内设置有主机系统，所述主机系统包括温度监测模块和射频消融模块。
  7. 如权利要求6所述的系统，其特征在于，所述射频发生器的最大射频输出功率为100W。
  8. 如权利要求7所述的系统，其特征在于，所述射频发生器设定的消融时间为3-8s。
  9. 一种如权利要求6-8任一项所述的带针道消融功能的有源活检系统的实现方法，其特征在于，该方法包括如下步骤：
    步骤1，将活检套管与活检工具配合使用，放置于目标病灶进行活检取样，此时活检套管不需与射频发生器连接；
    步骤2，将活检工具退出活检套管，取得活检样品；
    步骤3，将活检套管通过连接线连接至射频发生器；
    步骤4，操作射频发生器开启消融模式，测温探头开始工作，将消融温度实时反馈至系统；
    步骤5，消融结束后，退针。
  10. 如权利要求9所述的方法，其特征在于，所述步骤4中，所述测温探头测得温度超过50℃时，系统内温度监测模块将信号反馈至射频消融模块，射频消融 模块开始计算消融时间。
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