WO2020024642A1 - 一种神经探测装置 - Google Patents

一种神经探测装置 Download PDF

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Publication number
WO2020024642A1
WO2020024642A1 PCT/CN2019/086104 CN2019086104W WO2020024642A1 WO 2020024642 A1 WO2020024642 A1 WO 2020024642A1 CN 2019086104 W CN2019086104 W CN 2019086104W WO 2020024642 A1 WO2020024642 A1 WO 2020024642A1
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WO
WIPO (PCT)
Prior art keywords
probe
nerve
detection device
current
elastic member
Prior art date
Application number
PCT/CN2019/086104
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English (en)
French (fr)
Inventor
史志刚
李健聪
Original Assignee
江苏百宁盈创医疗科技有限公司
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Publication date
Application filed by 江苏百宁盈创医疗科技有限公司 filed Critical 江苏百宁盈创医疗科技有限公司
Priority to PCT/CN2019/115537 priority Critical patent/WO2020134584A1/zh
Priority to US16/699,847 priority patent/US20200100691A1/en
Publication of WO2020024642A1 publication Critical patent/WO2020024642A1/zh
Priority to US17/342,712 priority patent/US20210290144A1/en
Priority to US17/805,858 priority patent/US20220296156A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
    • A61B5/0053—Detecting, measuring or recording by applying mechanical forces or stimuli by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6885—Monitoring or controlling sensor contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/7475—User input or interface means, e.g. keyboard, pointing device, joystick
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin

Definitions

  • the present application relates to the field of medical equipment, and in particular, to a nerve detection device.
  • Nerve probes are often used. Nerve probes are usually connected to a nerve detection monitor. Surgeons use nerve probes to locate and identify nerves at risk in the surgical area, thereby protecting the nerves from damage during surgery.
  • the existing nerve probes have problems such as inconvenience in operation, difficulty in controlling the intensity, and the magnitude of the stimulation current. Therefore, it is necessary to provide an improved neural detection device.
  • This application provides a nerve detection device, which includes a probe, a handle, and an elasticity prompting piece; the probe is connected to the handle; the probe includes a probe, an elastic piece, and an elasticity measuring piece; the probe and The elastic member is connected; the elastic force measuring member is connected to the elastic member, and is used to measure the elastic force value of the elastic member and convert the elastic force value into an electric signal; the elastic force prompting member and the elastic force measuring member
  • the electrical connection is configured to receive the electrical signal and generate prompt information about the elastic force value according to the electrical signal.
  • the elastic reminder is disposed on the handle.
  • the spring force reminder is used to display the spring force value.
  • the nerve detection device further includes an elasticity adjusting member, and the elasticity adjusting member is used to adjust a maximum elasticity value of the elastic member.
  • the elastic member is made of a conductive material.
  • a current regulating member is provided on the handle to adjust the magnitude of the nerve stimulation current.
  • the nerve detection device further includes a monitor, the monitor includes: a host, configured to receive a current adjustment signal sent by the current adjustment member, to generate a current control signal; and a current output unit, configured to receive The current control signal generated by the host outputs a current of a corresponding magnitude to the probe.
  • the current control signal includes a pulse width modulated wave control signal.
  • the current regulator includes at least one button.
  • the current regulator is further configured to: within a first current value range, adjust the magnitude of the nerve stimulation current by a first adjustment step; within a second current value range, by a second adjustment step Regulate the magnitude of nerve stimulation current.
  • the handle is provided with a current display member for displaying the magnitude of the nerve stimulation current.
  • the nerve detection device further includes a probe monitoring member for monitoring the use status of the probe to generate probe monitoring information; wherein the use status of the probe includes cumulative use of the probe Time and / or elasticity of the elastic member.
  • the probe further includes a sleeve, the elastic member is installed in the sleeve, and one end of the probe is inserted into the first end of the sleeve to connect with the elastic member; the sleeve The second end of the tube is connected to the handle.
  • an end of the probe inserted into the sleeve is provided with a non-slip out step, and an inner wall of the sleeve is provided with a limit step matching the non-slip out step.
  • the sleeve surface is provided with an insulating layer.
  • one end of the probe where the probe meets the human body is a ball head structure.
  • FIG. 1 is a schematic cross-sectional view of a nerve detection device according to some embodiments of the present application.
  • FIG. 2 is a schematic structural diagram of a nerve detection device according to some embodiments of the present application.
  • FIG. 3 is a schematic structural diagram of a connection between a probe and a sleeve according to some embodiments of the present application.
  • a flowchart is used in the present application to explain the operations performed by the system according to the embodiments of the present application. It should be understood that the preceding or following operations are not necessarily performed precisely in sequence. Instead, the various steps can be processed in reverse order or simultaneously. At the same time, you can add other operations to these processes, or remove a step or steps from these processes.
  • FIG. 1 is a schematic cross-sectional view of a nerve detection device according to some embodiments of the present application.
  • FIG. 2 is a schematic structural diagram of a nerve detection device according to some embodiments of the present application.
  • the nerve detection device includes a handle 4, a probe 7, and a spring force prompting member 10.
  • the probe 7 is connected to the handle 4.
  • the probe 7 includes a probe 1, an elastic member 8, and an elastic force measuring member 11.
  • the probe 1 is connected to an elastic member 8.
  • the probe 1 When in use, the probe 1 will contact the human body (such as nerves, tissues, etc.) and receive pressure from the human body.
  • the probe 1 transmits the pressure to the elastic member 8, and the elastic member 8 undergoes elastic deformation, so that the probe 1 moves.
  • the probe 1 Due to the elastic deformation of the elastic member, the probe 1 can be extended and contracted, so that the human body can be reliably contacted continuously.
  • the user can feel the resilience when using the nerve detection device of the present application, so as to sense the pressure exerted by the probe 7 on the human body, so that the user can control the force of using the nerve detection device, and ensure that the probe and nerves or tissues Reliable contact.
  • the elastic force measuring member 11 is connected to the elastic member 8 and is used to measure the elastic force value of the elastic member 8 and convert the elastic force value into an electrical signal.
  • the elasticity prompting piece 10 is connected to the elasticity measuring piece 11 and is configured to receive an electrical signal about the elasticity value of the elastic piece generated by the elasticity measuring piece 11 and generate prompt information about the elasticity value of the elastic piece according to the electrical signal.
  • the elasticity prompting member 11 may indicate the elasticity value of the elastic member in various forms, including but not limited to text, image, voice, and the like.
  • the elastic reminder 11 can be disposed on the handle 4.
  • the spring force reminder 11 may include a display screen for displaying a spring force value.
  • the spring force reminder 11 may issue a warning, such as displaying a warning image, issuing a warning sound, etc., to remind the user to control the operation strength.
  • the set threshold may be a fixed value or may be determined according to different kinds of nerves to be detected.
  • the threshold may be set lower, such as 0.8N; for the laryngeal nerve, the threshold may be set to 1.2N; for the face, hands, and feet For nerves at the knees, the threshold can be set to 3N.
  • the nerve detection device of the present application further includes a monitor (not shown).
  • a monitor (not shown).
  • one end of the lead 5 is connected to the probe 7, and the other end is connected to the monitor through the socket 6.
  • the elastic reminder 11 may be provided in the monitor.
  • the monitor may receive an electrical signal about the elastic force value of the elastic member generated by the elasticity measuring member 11 and generate prompt information about the elastic force value of the elastic member.
  • the monitor has a display through which the spring value can be displayed. In addition to text display, the monitor can also indicate the elasticity value by means of images and voice.
  • the user (such as a doctor) can easily know the amount of pressure applied to the patient when using the nerve detection device of the present application, so that the force can be controlled, and the contact between the probe and the nerve or tissue is guaranteed It also protects the patient's nerves or tissues from damage.
  • different models of neural detection devices may have different maximum spring force values.
  • elastic members with different elastic coefficients can be selected to achieve the difference in the maximum elastic force value. Specifically, according to Hooke's law:
  • F is the elastic force value of the elastic member
  • k is the elastic coefficient of the elastic member
  • X is the elastic deformation amount of the elastic member.
  • a nerve detection device with a maximum elasticity value of 0.8N can be selected; for the laryngeal nerve, a nerve detection device with a maximum elasticity value of 1.2N can be selected; You can choose a neural detection device with a maximum elastic force of 3N.
  • neural detection devices with different maximum elasticity values may also be selected. For example, for patients with higher sensitivity, a nerve detection device with a smaller maximum elasticity value can be selected; for patients with lower sensitivity, a nerve detection device with a higher maximum elasticity value can be selected.
  • the elastic force measuring member 11 can convert the elastic force value of the elastic member 8 into an electrical signal.
  • the elasticity measuring member 11 includes an adjustable resistor connected to the elastic member 8. A change in the expansion and contraction length of the elastic member 8 can change the resistance of the adjustable resistor, so as to convert the elastic force value into an electrical signal.
  • the elastic force value may have a positive correlation with the resistance value; or the elastic force value may have a negative correlation with the resistance value.
  • the elastic force measuring member 11 includes a pressure sensor, and the pressure sensor can measure the elastic force value of the elastic member 8.
  • the elastic member 8 when the nerve detecting device is in use, when the probe 1 comes into contact with the human body and receives pressure from the human body, the elastic member 8 will compress and deform, apply pressure to the pressure sensor, and obtain elasticity according to the pressure value measured by the pressure sensor. Elastic value of piece 8.
  • the elastic member 8 is further connected with an elasticity adjusting member (not shown) for adjusting the maximum elastic force value of the elastic member 8.
  • the maximum elastic force value can be adjusted by limiting the retractable length of the elastic member 8 to change the elastic force.
  • the maximum elastic force value of the elastic member 8 can be adjusted to match the maximum elastic force value of the surgery of this type by the elasticity adjusting member.
  • the maximum elastic force value of the elastic member 8 can be adjusted to 0.8N; for the laryngeal nerve, the maximum elastic force value can be adjusted to 1.2N; for the nerves on the face, hands, feet, and knees, the maximum The spring force value is adjusted to 3N.
  • the elastic member 8 is made of a conductive material.
  • the conductive material may include one or more of any combination of metal, conductive rubber, conductive non-metal, conductive alloy, and the like.
  • the maximum elastic force value of the elastic member 8 can also be adjusted for different individuals. For example, for patients with high sensitivity, the maximum elastic force value can be reduced; for patients with low sensitivity, the maximum elastic force value can be increased.
  • the handle 4 is further provided with a current adjusting member 9 for adjusting the magnitude of the nerve stimulation current.
  • the current regulating member 9 is electrically connected to the monitor through a wire, and the monitor controls the magnitude of the stimulation current output after receiving the current regulating signal sent by the current regulating member 9.
  • the monitor includes a host and a current output unit. The host is used to receive the current adjustment signal sent by the current regulator 9 and generate a current control signal according to the current adjustment signal and send it to the current output unit. The current output unit is based on the received current control signal. Output corresponding current.
  • the current output section may include a voltage / current conversion integrated circuit that converts an input voltage into a current output.
  • the micro controller unit (MCU) of the host can control the input voltage in the voltage / current conversion integrated circuit by controlling the Pulse Width Modulation (PWM) wave. Size, the voltage / current conversion of the integrated circuit can output a current of an appropriate size.
  • PWM Pulse Width Modulation
  • different types of nerves can be adjusted to obtain stimulation currents of different sizes.
  • the stimulation current can be adjusted to 0 to 0.5 mA; for the throat nerve, the stimulation current can be adjusted to 0.5 mA to 10 mA; for the nerves on the face, hands, feet, and knees, the stimulation current can be adjusted It is 10 mA to 30 mA.
  • different sizes of stimulation currents can be obtained for different individuals. For example, for patients with high sensitivity, the stimulation current can be turned down; for patients with low sensitivity, the stimulation current can be turned up.
  • a maximum current threshold may be set, and the stimulation current is limited to not exceed the maximum current threshold to ensure the safety of detecting nerves or tissues.
  • the maximum current threshold may be 40 mA, 35 mA, 30 mA, 25 mA, 20 mA, and so on.
  • different maximum current thresholds may be set for different types of nerves. For example, for the brain nerve, the maximum current threshold can be set to 0.5 mA; for the throat nerve, the maximum current threshold can be set to 10 mA; for the nerves on the face, hands, feet, and knees, the maximum current threshold can be set to 30 mA.
  • different maximum current thresholds may be set for different individuals. For example, for patients with high sensitivity, the maximum current threshold can be set lower; for patients with low sensitivity, the maximum current threshold can be set higher.
  • the current adjusting member 9 may be in various forms, including but not limited to keys, knobs, touch keys, and the like. In some embodiments, as shown in FIG. 1 and FIG. 2, the current adjusting member 9 may be two buttons for increasing and decreasing the current, respectively.
  • the adjustment step size can be a fixed value or a variable value. In some embodiments, different adjustment step sizes may be set for different stimulation current ranges. It can be understood that for smaller stimulation currents, it requires higher adjustment accuracy. Setting smaller adjustment steps can achieve high-precision adjustment, and for larger stimulation currents, the requirements for adjustment accuracy are relatively low. Setting a larger step size allows quick adjustments.
  • the adjustment step size can be 0.01 mA; in the range of 0.5 mA to 1 mA, the adjustment step size can be 0.1 mA; in the range of 1 mA to 10 mA, the adjustment step size can be 0.5 mA; In the range of 10mA to 30mA, the adjustment step size can be 1mA.
  • the two keys shown in FIG. 1 and FIG. 2 are merely examples of the current adjusting member, and are not used to limit the present application. In some embodiments, other forms of current adjusting members may be provided. For example, four keys can be set, two of which are used to thicken (up or down) the stimulation current in the first step, and the other two buttons are used to fine-tune the stimulation current in the second step. The second step length is smaller than the first step length.
  • the nerve probe device of the present application further includes a stimulation current prompting member for prompting the magnitude of the stimulation current.
  • the magnitude of the stimulation current can be prompted in various forms, including but not limited to text, images, speech, and the like.
  • the stimulation current reminder may be provided on the handle 4.
  • a display screen may be provided on the handle 4 to display the magnitude of the stimulation current.
  • the stimulation current prompting device and the elasticity value prompting device described above may be integrated into the same component; alternatively, the two may also be independent components.
  • the stimulation current reminder can also be provided on the monitor.
  • the monitor's display can show the magnitude of the stimulation current.
  • the probe 7 further comprises a cannula 2.
  • FIG. 3 is a schematic structural diagram of a connection between a probe 1 and a sleeve 2 according to some embodiments of the present application.
  • the elastic member 8 is installed in the sleeve 2, and one end of the probe 7 is inserted into the first end of the sleeve 2 and connected to the elastic member 8.
  • the second end of the sleeve 2 is connected to the handle 4.
  • the sleeve 2 is made of a conductive material, and the lead 5 can be electrically connected to the sleeve 2 so as to achieve the electrical connection between the lead 5 and the probe 7.
  • the surface of the sleeve 2 is further provided with an insulation layer 3, and the insulation layer may be a structure such as a heat-shrinkable sleeve or an insulation coating.
  • the probe 1 has a spherical head structure.
  • one end of the sleeve 2 in order to prevent the probe 1 from slipping out of the sleeve 2, in addition to welding the probe 1 and the elastic member 8 by welding, one end of the sleeve 2 can be provided with a non-slip step. 2 Matching limit steps are provided on the inner wall.
  • the probe 1 is inserted into the sleeve 2 from the other end of the sleeve 2, and after the step end of the probe and the inner step of the sleeve are offset, the head of the probe 1 is subjected to spherical surface upsetting.
  • the end of the probe with a stepped body can be inserted into the sleeve 2 tube, and the end of the sleeve is turned inward to form a non-retreating inner step.
  • the nerve detection device of the present application further includes a probe monitoring member (not shown), which is used to monitor the use status of the probe 7 and generate probe monitoring information.
  • the probe monitor can monitor the cumulative usage time of the probe.
  • the probe monitoring device can read / write the accumulated usage time of the probe through an electrically erasable programmable read-write memory (Electrically Programmable Read Only Memory).
  • the probe monitoring member can monitor the elasticity of the elastic member in the probe.
  • the probe monitoring device may issue a prompt.
  • the probe monitoring member will issue an alarm to prompt the user to replace it in time.
  • the probe monitoring member may be provided on the handle 4. In other embodiments, the probe monitor may be integrated into the monitor.
  • the beneficial effects that may be brought by the embodiments of the present application include, but are not limited to: (1) the elastic probe is provided to make the probe expandable and contractible to ensure reliable contact between the probe and nerves or tissues; (2) the elastic member also allows the user to feel The feedback force, combined with the elasticity reminder that can indicate the elasticity value, allows the user to know the pressure on the patient during the use of the probe in time to adjust the strength in time to further ensure that the probe is in reliable contact with the nerve or tissue and protect the targeted nerve or tissue Not to be damaged; (3) For different types of nerves or tissues, or for individuals with different sensitivities, you can choose nerve detection devices with different maximum elasticity values, or adjust to obtain a suitable maximum elasticity value to ensure the detection effect while ensuring Nerves or tissues are not damaged due to excessive pressure applied by the probe; (4) For different types of nerves or tissues, or for individuals with different sensitivities, the magnitude of the stimulation current can be adjusted to achieve better detection results. It should be noted that different embodiments may have different beneficial effects. In different embodiments,

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Abstract

一种神经探测装置，包括探针（7）、手柄（4）和弹力提示件（10）；探针（7）与手柄（4）连接；探针（7）包括探头（1）、弹性件（8）和弹力测量件（11）；探头（1）与弹性件（8）连接；弹力测量件（11）与弹性件（8）连接，用于测量弹性件（8）的弹力值并将弹力值转换为电信号；弹力提示件（10）与弹力测量件（11）电气连接，用于接收电信号，根据电信号生成关于弹力值的提示信息。

Description

一种神经探测装置
交叉引用
本申请要求2018年8月1日递交的申请号为201810863181.9、标题为“一种能感知接触状态的神经探测针”的中国专利申请的优先权，其内容以引用方式并入本申请。
技术领域
本申请涉及医疗器械领域，尤其涉及一种神经探测装置。
背景技术
在手术中，经常会使用到神经探测针。神经探测针通常与神经探测监护仪相连，外科医师使用神经探测针定位和识别外科手术区内处于危险之中的神经，从而在手术过程中保护神经不受损伤。现有的神经探测针存在操作不便、难以控制力度和刺激电流大小等问题。因此，有必要提供一种改进的神经探测装置。
发明内容
本申请提供了一种神经探测装置，该装置包括探针、手柄和弹力提示件；所述探针与所述手柄连接；所述探针包括探头、弹性件和弹力测量件；所述探头与所述弹性件连接；所述弹力测量件与所述弹性件连接，用于测量所述弹性件的弹力值并将所述弹力值转换为电信号；所述弹力提示件与所述弹力测量件电气连接，用于接收所述电信号，根据所述电信号生成关于所述弹力值的提示信息。
在一些实施例中，所述弹力提示件设置在所述手柄上。
在一些实施例中，所述弹力提示件用于显示所述弹力值。
在一些实施例中，所述神经探测装置还包括弹力调节件，所述弹力调节件用于调节所述弹性件的最大弹力值。
在一些实施例中，所述弹性件由导电材料制成。
在一些实施例中，所述手柄上设有电流调节件，用于调节神经刺激电流的大小。
在一些实施例中，所述神经探测装置还包括监护仪，所述监护仪包括：主机，用于接收所述电流调节件发送的电流调节信号，生成电流控制信号；电流输出部，用于接收所述主机生成的所述电流控制信号，向所述探针输出相应大小的电流。
在一些实施例中，所述电流控制信号包括脉冲宽度调制波控制信号。
在一些实施例中，所述电流调节件包括至少一个按键。
在一些实施例中，所述电流调节件还用于：在第一电流值范围内，以第一调节步长调节神经刺激电流的大小；在第二电流值范围内，以第二调节步长调节神经刺激电流的大小。
在一些实施例中，所述手柄上设有电流显示件，用于显示神经刺激电流的大小。
在一些实施例中，所述神经探测装置还包括探针监测件，用于监测所述探针的使用状况，生成探针监测信息；其中，所述探针的使用状况包括探针的累计使用时间和/或弹性件的弹性状况。
在一些实施例中，所述探针还包括套管，所述弹性件安装在所述套管内，所述探头的一端插入所述套管的第一端与所述弹性件连接；所述套管的第二端与所述手柄连接。
在一些实施例中，所述探头插入所述套管的一端设有防滑出台阶，所述套管内壁上设有与所述防滑出台阶相匹配的限位台阶。
在一些实施例中，所述套管表面设有绝缘层。
在一些实施例中，所述探头与人体相接处的一端呈球头结构。
附图说明
本申请将以示例性实施例的方式进一步说明，这些示例性实施例将通过附图进行详细描述。这些实施例并非限制性的，在这些实施例中，相同的编号表示相同的结构，其中：
图1为根据本申请一些实施例所示的神经探测装置的剖面示意图；
图2为根据本申请一些实施例所示的神经探测装置的结构示意图；
图3为根据本申请一些实施例所示的探头与套管连接结构示意图。
具体实施方式
为了更清楚地说明本申请的实施例的技术方案，下面将对实施例描述中所需要使用的附图作简单的介绍。显而易见地，下面描述中的附图仅仅是本申请的一些示例或实施例，对于本领域的普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图将本申请应用于其它类似情景。除非从语言环境中显而易见或另做说明，图中相同标号代表相同结构或操作。
如本申请和权利要求书中所示，除非上下文明确提示例外情形，“一”、“一个”、“一种”和/或“该”等词并非特指单数，也可包括复数。一般说来，术语“包括”与“包含”仅提示包括已明确标识的步骤和元素，而这些步骤和元素不构成一个排它性的罗列，方法或者设备也可能包含其它的步骤或元素。
虽然本申请对根据本申请的实施例的系统中的某些模块或单元做出了各种引用，然而，任何数量的不同模块或单元可以被使用并运行在客户端和/或服务器上。所述模块仅是说明性的，并且所述系统和方法的不同方面可以使用不同模块。
本申请中使用了流程图用来说明根据本申请的实施例的系统所执行的操作。应当理解的是，前面或下面操作不一定按照顺序来精确地执行。相反，可以按照倒序或同时处理各种步骤。同时，也可以将其他操作添加到这些过程中，或从这些过程移除某一步或数步操作。
为了更清楚地说明本申请实施例的技术方案，下面将对实施例描述中所需要使用的附图作简单的介绍。显而易见地，下面描述中的附图仅仅是本申请的一些示例或实施例，对于本领域的普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图将本申请应用于其他类似情景。除非从语言环境中显而易见或另做说明，图中相同标号代表相同结构或操作。
图1为根据本申请一些实施例所示的神经探测装置的剖面示意图。图2为根据本申请一些实施例所示的神经探测装置的结构示意图。该神经探测装置包括手柄4、探针7和弹力提示件10。探针7与手柄4连接。探针7包括探头1、弹性件8和弹力测量件11。探头1与弹性件8连接。在使用时，探头1会与人体(如神经、组织等)接触，受到人体给予的压力，探头1将该压力传递给弹性件8，弹性件8发生弹性形变，使得探头1发生移动。由于弹性件的弹性形变，探头1可伸缩，故可以持续地人体可靠接触。另外，使用者在使用本申请的神经探测装置时，可以感受到回弹力，从而感知探针7向人体施加的压力，以便使用者控制使用神经探测装置的力度，保证了探针与神经或组织的接触可靠。弹力测量件11与弹性件8连接，用来测量弹性件8的弹力值并将该弹力值转换为电信号。弹力提示件10与弹力测量件11连接，用于接收弹力测量件11生成的关于弹性件弹力值的电信号，并根据该电信号生成关于弹性件弹力值的提示信息。弹力提示件11可以以各种形式提示弹性件的弹力值，提示形式包括但不限于文字、图像、语音等。
如图2所示，弹力提示件11可以设置于手柄4上。在一些实施例中，弹力提示件11可以包括显示屏，用于显示弹力值。在一些实施例中，当弹力值超过设定阈值时，弹力提示件11可以发出警示，如显示警示图像、发出警示音等，以提醒用户控制操作力度。所述设定阈值可以为固定数值，也可以根据要探测的不同种类的神经确定。仅作为示例，对于脑神经，由于脑神经较为敏感，可将所述阈值设定得较低，如设为0.8N；对于喉管神经，可将阈值设为1.2N；对于面部、手、脚、膝盖处的神经，可将阈值设为3N。
在一些实施例中，本申请的神经探测装置还包括监护仪(未图示)。在一些实施例中， 导线5的一端连接探针7，另一端通过插座6与监护仪连接。在一些实施例中，弹力提示件11可以设于监护仪中。具体地，监护仪可以接收弹力测量件11生成的关于弹性件弹力值的电信号，并生成关于弹性件弹力值的提示信息。例如，监护仪具有显示屏，可通过该显示屏显示弹力值。除文字显示外，监护仪也可以通过图像、语音等方式提示弹力值。由于采用了弹力提示件，使用者(如医生)在使用本申请神经探测装置时，可以方便地知道向患者施加的压力大小，从而能控制使用力度，保证了探针与神经或者组织的接触可靠，同时也保护患者的神经或组织不被损伤。
在一些实施例中，不同型号的神经探测装置可具有不同的最大弹力值。例如，可以选用弹性系数不同的弹性件来实现最大弹力值的差异化。具体地，根据胡克定律：
F＝k×X        (1)
其中，F为弹性件的弹力值，k为弹性件的弹性系数，X为弹性件的弹性形变量。由公式(1)可知，对于弹性系数k不同的弹性件，在发生相同弹性形变X时，产生的弹力不同。相应地，在固定最大弹性形变的情况下，通过选用弹性系数不同的弹性件，可以实现不同的最大弹力值。在一些实施例中，针对不同类型的手术，可以选用最大弹力值不同的神经探测装置。例如，对于敏感度较高的神经，可以选用最大弹力值较小的神经探测装置；对于敏感度较低的神经，可以选用最大弹力值较高的神经探测装置。仅作为示例，对于脑神经，可以选用最大弹力值为0.8N的神经探测装置；对于喉管神经，可以选择最大弹力值为1.2N的神经探测装置；对于面部、手、脚、膝盖处的神经，可以选用最大弹力值为3N的神经探测装置。在一些实施例中，针对不同的个体，也可以选用最大弹力值不同的神经探测装置。例如，对于敏感度较高的患者，可以选用最大弹力值较小的神经探测装置；对于敏感度较低的患者，可以选用最大弹力值较高的神经探测装置。
弹力测量件11可以将弹性件8的弹力值转换为电信号。在一些实施例中，弹力测量件11包括与弹性件8连接的可调电阻，弹性件8伸缩长度的变化可以改变该可调电阻的阻值，从而实现弹力值向电信号的转换。例如，弹力值可以与电阻值呈正相关的关系；或者，弹力值可以与电阻值呈负相关的关系。在一些实施例中，弹力测量件11包括压力传感器，压力传感器可以测量弹性件8的弹力值。具体地，神经探测装置在使用中时，当探头1与人体接触并受到人体给予的压力时，弹性件8会发生压缩形变，对压力传感器施加压力，根据压力传感器测得的压力值可以得到弹性件8的弹力值。
在一些实施例中，弹性件8还连接有弹力调节件(未图示)，用于调节弹性件8的最大弹力值。例如，可以通过限制弹性件8的可伸缩长度调节其最大弹力值，改变其弹力大小。 针对不同类别的手术，可以通过弹力调节件将弹性件8的最大弹力值调节到匹配该类别手术的最大弹力值。例如，对于脑神经，可以将弹性件8的最大弹力值调为0.8N；对于喉管神经，可将最大弹力值调为1.2N；对于面部、手、脚、膝盖处的神经，可将最大弹力值调为3N。
在一些实施例中，弹性件8由导电材料制成。导电材料可以包括金属、导电橡胶、导电非金属、导电合金等中的一种或以上任意组合。在一些实施例中，针对不同的个体，也可以对弹性件8的最大弹力值进行调节。例如，对于敏感度高的患者，可以将最大弹力值调小；对于敏感度低的患者，可以将最大弹力值调大。
在一些实施例中，手柄4上还设有电流调节件9，用于调节神经刺激电流的大小。在一些实施例中，电流调节件9通过导线与监护仪电气连接，监护仪接收电流调节件9发送的电流调节信号后控制输出的刺激电流的大小。例如，监护仪包括主机和电流输出部，主机用于接收电流调节件9发送的电流调节信号，并根据电流调节信号生成电流控制信号发送给电流输出部，电流输出部根据接收到的电流控制信号输出相应大小的电流。在一些实施例中，电流输出部可以包括电压/电流转换集成电路，该集成电路可将输入的电压转换为电流输出。具体地，监控仪的主机接收到电流调节信号后，主机的微控制单元(Microcontroller Unit，MCU)可以通过控制脉冲宽度调制(Pulse Width Modulation，PWM)波控制电压/电流转换集成电路中输入电压的大小，经过该集成电路的电压/电流转换可以输出适当大小的电流。
在一些实施例中，针对不同类型的神经，可以调节得到大小不同的刺激电流。例如，对于脑神经，可以将刺激电流调节为0～0.5mA；对于喉管神经，可将刺激电流调节为0.5mA～10mA；对于面部、手、脚、膝盖处的神经，可将刺激电流调节为10mA～30mA。在一些实施例中，由于不同个体敏感度的差异，针对不同的个体，可以调节得到大小不同的刺激电流。例如，对于敏感度高的患者，可以将刺激电流调小；对于敏感度低的患者，可以将刺激电流调大。
在一些实施例中，可以设置最大电流阈值，限制刺激电流不得超过该最大电流阈值，以保证探测神经或组织的安全。例如，最大电流阈值可以为40mA、35mA、30mA、25mA、20mA等。在一些实施例中，针对不同类型的神经，可以设置不同的最大电流阈值。例如，对于脑神经，可以设置最大电流阈值为0.5mA；对于喉管神经，可设置最大电流阈值为10mA；对于面部、手、脚、膝盖处的神经，可设置最大电流阈值为30mA。在一些实施例中，针对不同的个体，可以设置不同的最大电流阈值。例如，针对敏感度高的患者，可以将最大电流阈值设置得较低；对于敏感度较低的患者，可以将最大电流阈值设置得较高。
电流调节件9可以为各种形式，包括但不限于按键、旋钮、触摸键等。在一些实施例 中，如图1和图2所示，电流调节件9可以为两个按键，分别用来调大和调小电流。调节的步长可以为固定值，也可以为变化值。在一些实施例中，对于不同的刺激电流范围，可以设置不同的调节步长。可以理解，对于较小的刺激电流，其对调节精度要求较高，设置较小的调节步长可以实现高精度的调节，而对于较大的刺激电流，其对调节精度的要求相对较低，设置较大的步长可以实现快速调节。例如，在0至0.5mA范围内，调节步长可以为0.01mA；在0.5mA至1mA范围内，调节步长可以为0.1mA；在1mA至10mA范围内，调节步长可以为0.5mA；在10mA至30mA范围内，调节步长可以为1mA。需要注意的是，图1和图2中所示的两个按键作为电流调节件仅为示例，并不用于限制本申请，在一些实施例中，还可以设置其他形式的电流调节件。例如可设置四个按键，其中两个按键用来以第一步长对刺激电流进行粗条(调大或调小)，另两个按键用来以第二步长对刺激电流进行精调，其中所述第二步长小于所述第一步长。
在一些实施例中，本申请的神经探测针装置还包括刺激电流提示件，用于提示刺激电流的大小。可以以各种形式提示刺激电流的大小，包括但不限于文字、图像、语音等。在一些实施例中，该刺激电流提示件可以设在手柄4上。例如，可以在手柄4上设一个显示屏，用来显示刺激电流的大小。在一些实施例中，刺激电流提示件与前文所述的弹力值提示件可以集成为同一部件；或者，两者也可以为独立部件。在一些实施例中，该刺激电流提示件也可以设在监护仪上。例如，监护仪的显示屏可显示刺激电流的大小。
在一些实施例中，探针7还包括套管2。图3为根据本申请一些实施例所示的探头1与套管2连接结构示意图。如图1和图3所示，弹性件8安装在套管2内，探头7的一端插入套管2的第一端与弹性件8相连。套管2的第二端与手柄4相连。在一些实施例中，套管2由导电材料制成，导线5可以与套管2电气连接，从而实现导线5与探针7的电气连接。在一些实施例中，套管2的表面还设有绝缘层3，绝缘层可以为热缩套管或者绝缘涂层等结构。在一些实施例中，探头1呈球头状结构。在一些实施例中，为了防止探头1从套管2中滑出，除了使探头1与弹性件8焊接相连的方式外，还可使插入套管2的一端设有防滑出台阶，在套管2内壁上设有相匹配的限位台阶。安装时，将探头1从套管2另一端插入套管2中，待探头台阶端与套管内台阶相抵后，再对探头1的头部进行球面化镦粗加工。此外还可将探头设有台阶体的一端插入套2管后，将套管端部内翻形成止退内台阶。
在一些实施例中，本申请的神经探测装置还包括探针监测件(未图示)，用来监测探针7的使用状况，生成探针监测信息。例如，探针监测件可以监测探针的累计使用时间。仅作为示例，探针监测件可以通过带电可擦可编程读写存储器(Electrically Erasable  Programmable Read Only Memory，EEPROM)读取/写入探针的累计使用时间。又例如，探针监测件可以监测探针中弹性件的弹性状况。在一些实施例中，响应于探针监测信息满足设定条件，探针监测件可以发出提示。例如，当累计使用时间超过一定时长，或者弹性件的弹性状况衰减到一定程度，探针监测件会发出警报，以提示用户及时更换。在一些实施例中，探针监测件可设于手柄4上。在另一些实施例中，探针监测件可以集成在监护仪中。
本申请实施例可能带来的有益效果包括但不限于：(1)通过设置弹性件，使得探头可伸缩，保证探头与神经或组织的可靠接触；(2)弹性件还能让使用者感受到反馈力，结合能够提示弹力值的弹力提示件，使用者可及时知晓使用过程中探头对患者施加的压力，从而及时调整力度，进一步确保探头与神经或组织可靠地接触，保护针对的神经或组织不被损伤；(3)针对不同类型的神经或组织，或针对敏感度不同的个体，可以选用最大弹力值不同的神经探测装置，或调节得到合适的最大弹力值，在保证探测效果的同时确保神经或组织不因探针施加的压力过大而损伤；(4)针对不同类型的神经或组织，或针对敏感度不同的个体，可以调节刺激电流的大小，实现较好的探测效果。需要说明的是，不同实施例可能产生的有益效果不同，在不同的实施例里，可能产生的有益效果可以是以上任意一种或几种的组合，也可以是其他任何可能获得的有益效果。
上文已对基本概念做了描述，显然，对于本领域技术人员来说，上述详细披露仅仅作为示例，而并不构成对本申请的限定。虽然此处并没有明确说明，本领域技术人员可能会对本申请进行各种修改、改进和修正。该类修改、改进和修正在本申请中被建议，所以该类修改、改进、修正仍属于本申请示范实施例的精神和范围。
同时，本申请使用了特定词语来描述本申请的实施例。如“一个实施例”、“一实施例”、和/或“一些实施例”意指与本申请至少一个实施例相关的某一特征、结构或特点。因此，应强调并注意的是，本说明书中在不同位置两次或多次提及的“一实施例”或“一个实施例”或“一替代性实施例”并不一定是指同一实施例。此外，本申请的一个或多个实施例中的某些特征、结构或特点可以进行适当的组合。
此外，除非权利要求中明确说明，本申请所述处理元素和序列的顺序、数字字母的使用、或其他名称的使用，并非用于限定本申请流程和方法的顺序。尽管上述披露中通过各种示例讨论了一些目前认为有用的实施例，但应当理解的是，该类细节仅起到说明的目的，附加的权利要求并不仅限于披露的实施例，相反，权利要求旨在覆盖所有符合本申请实施例实质和范围的修正和等价组合。
同理，应当注意的是，为了简化本申请披露的表述，从而帮助对一个或多个实施例的 理解，前文对本申请实施例的描述中，有时会将多种特征归并至一个实施例、附图或对其的描述中。但是，这种披露方法并不意味着本申请对象所需要的特征比权利要求中提及的特征多。实际上，实施例的特征要少于上述披露的单个实施例的全部特征。

Claims (24)

  1. 一种神经探测装置，其特征在于，包括探针、手柄和弹力提示件；
    所述探针与所述手柄连接；
    所述探针包括探头、弹性件和弹力测量件；所述探头与所述弹性件连接；所述弹力测量件与所述弹性件连接，用于测量所述弹性件的弹力值并将所述弹力值转换为电信号；
    所述弹力提示件与所述弹力测量件电气连接，用于接收所述电信号，根据所述电信号生成关于所述弹力值的提示信息。
  2. 根据权利要求1所述的神经探测装置，其特征在于，所述弹力提示件设置在所述手柄上。
  3. 根据权利要求1所述的神经探测装置，其特征在于，所述弹力提示件用于显示所述弹力值。
  4. 根据权利要求1所述的神经探测装置，其特征在于，所述神经探测装置还包括弹力调节件，所述弹力调节件用于调节所述弹性件的最大弹力值。
  5. 根据权利要求1所述的神经探测装置，其特征在于，所述弹性件由导电材料制成。
  6. 根据权利要求1所述的神经探测装置，其特征在于，所述手柄上设有电流调节件，用于调节神经刺激电流的大小。
  7. 根据权利要求6所述的神经探测装置，其特征在于，所述神经探测装置还包括监护仪，所述监护仪包括：
    主机，用于接收所述电流调节件发送的电流调节信号，生成电流控制信号；
    电流输出部，用于接收所述主机生成的所述电流控制信号，向所述探针输出相应大小的 电流。
  8. 根据权利要求7所述的神经探测装置，其特征在于，所述电流控制信号包括脉冲宽度调制波控制信号。
  9. 根据权利要求6所述的神经探测装置，其特征在于，所述电流调节件包括至少一个按键。
  10. 根据权利要求6所述的神经探测装置，其特征在于，所述电流调节件还用于：
    在第一电流值范围内，以第一调节步长调节神经刺激电流的大小；
    在第二电流值范围内，以第二调节步长调节神经刺激电流的大小。
  11. 根据权利要求1所述的神经探测装置，其特征在于，所述手柄上设有电流显示件，用于显示神经刺激电流的大小。
  12. 根据权利要求1所述的神经探测装置，其特征在于，所述神经探测装置还包括探针监测件，用于监测所述探针的使用状况，生成探针监测信息；其中，所述探针的使用状况包括探针的累计使用时间和/或弹性件的弹性状况。
  13. 根据权利要求1所述的神经探测装置，其特征在于，所述探针还包括套管，所述弹性件安装在所述套管内，所述探头的一端插入所述套管的第一端与所述弹性件连接；所述套管的第二端与所述手柄连接。
  14. 根据权利要求13所述的神经探测装置，其特征在于，所述探头插入所述套管的一端设有防滑出台阶，所述套管内壁上设有与所述防滑出台阶相匹配的限位台阶。
  15. 根据权利要求13所述的神经探测装置，其特征在于，所述套管表面设有绝缘层。
  16. 根据权利要求1所述的神经探测装置，其特征在于，所述探头与人体相接处的一端呈球头结构。
  17. 一种能感知接触状态的神经探测针，它包括手柄(4)、导线(5)和探针(7)，其特征是所述的探针(7)由套管(2)、探头(1)和弹性件(8)组成，所述的探头(1)的一端插装在套管(2)中并与安装在套管(2)中的弹性件(8)的保持电气连接，弹性件定位在套管(2)中并与之电气连接，弹性件(8)使探头(1)产生一个能使使用者感知的反弹力；手柄(4)安装在套管(2)未安装探头的另一端上，导线(5)的一端与套管(2)电气连接，另一端与神经监护仪相连。
  18. 根据权利要求17所述的能感知接触状态的神经探测针，其特征是所述的弹性件(8)为导电弹性件。
  19. 根据权利要求17或18所述的能感知接触状态的神经探测针，其特征是所述的弹性件(8)为金属弹簧、导电橡胶件、导电非金属弹簧或导电合金弹簧。
  20. 根据权利要求19所述的能感知接触状态的神经探测针，其特征是所述的弹性件(8)的弹力可调。
  21. 根据权利要求17所述的能感知接触状态的神经探测针，其特征是所述的套管(2)表面设有绝缘层(3)。
  22. 根据权利要求17所述的能感知接触状态的神经探测针，其特征是所述的手柄(4) 上设有调节神经刺激电流调整开关(9)。
  23. 根据权利要求17所述的能感知接触状态的神经探测针，其特征是所述的探头(1)插入套管(2)的一端设有防滑出台阶，在套管内壁上设有相匹配的限位台阶。
  24. 根据权利要求17所述的能感知接触状态的神经探测针，其特征是所述的探头(1)与人体相接触的一端呈球头结构。
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