WO2023103753A1 - 外科手术用辅助工具 - Google Patents

外科手术用辅助工具 Download PDF

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Publication number
WO2023103753A1
WO2023103753A1 PCT/CN2022/132973 CN2022132973W WO2023103753A1 WO 2023103753 A1 WO2023103753 A1 WO 2023103753A1 CN 2022132973 W CN2022132973 W CN 2022132973W WO 2023103753 A1 WO2023103753 A1 WO 2023103753A1
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WO
WIPO (PCT)
Prior art keywords
sleeve
tearable
tearable sleeve
electrode
tear line
Prior art date
Application number
PCT/CN2022/132973
Other languages
English (en)
French (fr)
Inventor
姜传江
章海涛
宁益华
Original Assignee
苏州景昱医疗器械有限公司
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Application filed by 苏州景昱医疗器械有限公司 filed Critical 苏州景昱医疗器械有限公司
Publication of WO2023103753A1 publication Critical patent/WO2023103753A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators

Definitions

  • the present application relates to the technical field of surgical operation auxiliary instruments, for example, to an auxiliary surgical operation tool.
  • the metal needle is first connected to the metal sleeve, and the metal sleeve is placed in the cranial hole as a tunnel. , and then insert the electrode into the designated position in the skull along the tunnel, and finally take out the metal sleeve along the electrode wire, and finally fix the electrode in the skull hole through the electrode lock.
  • the metal sleeve in this fixing mechanism is not compatible with MRI (magnetic resonance imaging), and because the sleeve needs to be taken out along the electrode wire, the electrode wire needs to be reserved at least twice the length of the metal sleeve, and the practicability needs to be improved.
  • the present application provides an auxiliary tool for surgical operations that solves the above-mentioned problems.
  • a surgical aid for installing electrodes on the brain comprising: a tearable sleeve and a guide;
  • the tearable sleeve is used to cooperate with the guide to pass through the cranial hole of the skull and insert into the brain, and after the guide is pulled away, the electrode is inserted, and the insertion end of the tearable sleeve is used to insert into the brain.
  • the rear end of the tearable sleeve away from the insertion end is provided with a tear portion, and the tearable sleeve is provided with one or more tear lines extending along the length direction of the tearable sleeve.
  • the part is used to tear the tearable sleeve into multiple parts along the tear line after the electrode is inserted into the tearable sleeve;
  • the guide is used for inserting into the tearable sleeve and guiding the tearable sleeve to pass through the cranial hole of the skull and then insert into the brain.
  • the tear line is a plurality of point-like structures, and the plurality of point-like structures extend along the length direction of the tearable sleeve, and multiple parts of the tearable sleeve pass through multiple points structure connection.
  • the thickness of the tear line is smaller than the thickness of the pipe wall of the part of the tearable sleeve except the tear line, and the multiple parts of the tearable sleeve are connected by the tear line .
  • the inside of the guide is provided with a core that prevents the guide from breaking and extends along the length of the guide.
  • the material of the guide is ceramic.
  • the thickness of the wall of the tearable sleeve except for the tear line is uniform, and the insertion end of the tearable sleeve is open.
  • the beneficial effect of the solution is that when the tear line of the tearable sleeve is connected in a point shape, the hand feeling of the medical staff when tearing the sleeve can be improved, and the length and distance during tearing can be controlled conveniently.
  • An auxiliary tool for surgical operation used for installing electrodes in the brain, comprising: a tearable sleeve;
  • the tearable sleeve is used to pass through the cranial hole of the skull and insert into the brain for electrode insertion.
  • the tearable sleeve is a hard sleeve, and the insertion end of the tearable sleeve is used to insert into the brain. part, the rear end of the tearable sleeve away from the insertion end is provided with a tearing portion, the tearable sleeve is provided with one or more tear lines extending along the length direction of the tearable sleeve, the The tearing part is used for tearing the tearable sleeve into multiple parts along the tear line after the electrode is inserted into the tearable sleeve.
  • the tear line is a plurality of point-like structures, and the plurality of point-like structures extend along the length direction of the tearable sleeve, and multiple parts of the tearable sleeve pass through multiple points
  • the thickness of the tearable sleeve is not uniform, the thickness of the tear line of the tearable sleeve is smaller than the thickness of the pipe wall, and the tear line is arranged on the pipe wall of the tearable sleeve along the axis direction.
  • the beneficial effect of this solution is that, when the medical personnel tear the tearable sleeve, they can smoothly tear the sleeve along the tearing part by applying force evenly.
  • the thickness of the tear line is smaller than the thickness of the pipe wall of the part of the tearable sleeve except the tear line, and the multiple parts of the tearable sleeve are connected by the tear line .
  • the thickness of the pipe wall of the part of the tearable sleeve except the tear line is uniform.
  • the insertion end of the tearable sleeve is open.
  • the tearable sleeve is made of PTFE or FEP.
  • the surgical auxiliary tool provided by the application has at least the following advantages: Compared with the related art, the beneficial effects of the application include at least:
  • the tearable sleeve serves as a tunnel to guide the electrode to the designated position to stimulate the cerebral cortex. After the electrode is inserted into the designated position, the tearable sleeve is directly torn along the tear line and taken out. After the removal is completed, it can be The tear sleeve is torn into two or more parts and separated from the electrode to facilitate the removal of the sleeve. At the same time, there is no need to reserve a certain length of the electrode wire for removing the metal sleeve.
  • This tearable The sleeve is MRI compatible when in use.
  • Fig. 1 is a schematic structural view of a tearable sleeve according to the first embodiment of the present application
  • Fig. 2 is a schematic structural view of another tearable sleeve according to the first embodiment of the present application
  • Fig. 3 is a structural schematic diagram of the first step of using the auxiliary tool for surgical operation according to the embodiment of the present application;
  • Fig. 4 is a schematic structural diagram of the second step of using the surgical auxiliary tool according to the embodiment of the present application.
  • Fig. 5 is a structural schematic diagram of the third step of using the surgical auxiliary tool according to the embodiment of the present application.
  • Fig. 6 is a schematic structural diagram of an electrode lock according to an embodiment of the present application.
  • At least one means one or more, and “multiple” means two or more.
  • “And/or” describes the association relationship of associated objects, indicating that there may be three types of relationships, for example, A and/or B, which can mean: A exists alone, A and B exist at the same time, and B exists alone, where A, B can be singular or plural.
  • the character “/” generally indicates that the contextual objects are an “or” relationship.
  • “At least one of the following" or similar expressions refer to any combination of these items, including any combination of single or plural items.
  • At least one item (piece) of a, b or c can represent: a, b, c, a and b, a and c, b and c or a and b and c, wherein a, b and c can be It can be single or multiple. It is worth noting that "at least one item (item)" can also be interpreted as “one item (item) or multiple items (item)”.
  • An implantable neurostimulation system (an implantable medical system) mainly includes a stimulator implanted in a patient (ie, an implantable stimulator) and a program-controlled device installed outside the patient's body.
  • the related neuromodulation technology mainly uses stereotaxic surgery to implant electrodes 5 in specific structures (i.e., target points) in the body, and the stimulator implanted in the patient sends electrical pulses to the target points through the electrodes 5 to regulate the corresponding neural structures and networks. electrical activity and its function, thereby improving symptoms and relieving pain.
  • the stimulator can be an implantable electrical nerve stimulation device, an implantable cardiac electrical stimulation system (also known as a cardiac pacemaker), an implantable drug infusion device (Implantable Drug Delivery System, referred to as IDDS) and a wire. Any one of the switching devices.
  • Implantable electrical nerve stimulation devices are, for example, Deep Brain Stimulation (DBS), Implantable Cortical Nerve Stimulation (CNS), Implantable Spinal Cord Stimulation , referred to as SCS), implanted sacral nerve stimulation system (Sacral Nerve Stimulation, referred to as SNS), implanted vagus nerve stimulation system (Vagus Nerve Stimulation, referred to as VNS), etc.
  • the stimulator can include IPG, extension wires and electrode wires.
  • IPG implantable pulse generator, implantable pulse generator
  • IPG implantable pulse generator
  • the electrical stimulation energy through the implanted extension lead and electrode lead, delivers one or two controllable specific electrical stimulations to specific areas of tissues in the body.
  • the extension wire is used in conjunction with the IPG as a transmission medium for the electrical stimulation signal, and transmits the electrical stimulation signal generated by the IPG to the electrode wire.
  • Electrode leads deliver electrical stimulation to specific areas of tissue in the body through multiple electrode contacts.
  • the stimulator is provided with one or more electrode wires on one side or both sides, and a plurality of electrode contacts are arranged on the electrode wires, and the electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode wires.
  • the electrode contacts may be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode wire.
  • Electrode contacts may include stimulation electrode contacts and/or collection electrode contacts.
  • the electrode contacts can be in the shape of, for example, a sheet, a ring, or a dot.
  • the stimulated body tissue may be the patient's brain tissue, and the stimulated site may be a specific part of the brain tissue.
  • the stimulated site is generally different, the number of stimulation contacts (single source or multi-source) used, one or more channels (single-channel or multi-channel) specific electrical stimulation signals
  • the application and stimulus parameter data are also different.
  • the embodiment of the present application does not limit the applicable disease types, which may be the applicable disease types for deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation.
  • disorders for which DBS can be used for treatment or management include, but are not limited to: spasticity disorders (e.g., epilepsy), pain, migraine, psychiatric disorders (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, Post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder (OCD), conduct disorder, mood disorder, memory disorder, mental status disorder, mobility disorder (eg, essential tremor or Parkinson's disease), Huntington's disease, Al Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric conditions and impairments.
  • spasticity disorders e.g., epilepsy
  • pain migraine
  • psychiatric disorders e.g., major depressive disorder (MDD)
  • bipolar disorder e.g., anxiety disorders, Post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder (OCD)
  • OCD obsessive-compulsive disorder
  • conduct disorder e.g
  • the program-controlled device when the program-controlled device and the stimulator establish a program-controlled connection, can be used to adjust the stimulation parameters of the stimulator (different stimulation parameters correspond to different electrical stimulation signals), and the stimulator can also be used to sense the deep brain of the patient.
  • the bioelectric activity of the stimulator can be used to collect the electrophysiological signal, and the stimulation parameters of the electrical stimulation signal of the stimulator can be adjusted continuously through the collected electrophysiological signal.
  • Stimulation parameters can include at least one of the following: frequency (for example, the number of electrical stimulation pulse signals per unit time 1s, the unit is Hz), pulse width (the duration of each pulse, the unit is ⁇ s), amplitude (generally used Voltage expression, that is, the intensity of each pulse, the unit is V), timing (for example, it can be continuous or triggered), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cycle stimulation mode) , The upper and lower limits of the doctor's control (the range that can be adjusted by the doctor) and the upper and lower limits of the patient's control (the range that can be adjusted by the patient).
  • frequency for example, the number of electrical stimulation pulse signals per unit time 1s, the unit is Hz
  • pulse width the duration of each pulse, the unit is ⁇ s
  • amplitude generally used Voltage expression, that is, the intensity of each pulse, the unit is V
  • timing for example, it can be continuous or triggered
  • stimulation mode including one or more of current mode, voltage mode, time
  • various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.
  • the program-controlled device may be a doctor-programmed device (ie, a program-controlled device used by a doctor) or a patient-programmed device (ie, a program-controlled device used by a patient).
  • the doctor's program-controlled device can be, for example, a tablet computer, a notebook computer, a desktop computer, a mobile phone and other smart terminal devices equipped with program-controlled software.
  • the patient program-controlled device can be, for example, smart terminal devices such as tablet computers, notebook computers, desktop computers, and mobile phones equipped with program-controlled software, and the patient program-controlled device can also be other electronic devices with program-controlled functions (such as chargers with program-controlled functions, data collection device).
  • the embodiment of the present application does not limit the data interaction between the doctor's program-controlled device and the stimulator.
  • the doctor's program-controlled device can perform data interaction with the stimulator through the server and the patient's program-controlled device.
  • the doctor’s program-controlled device can interact with the stimulator through the patient’s program-controlled device, and the doctor’s program-controlled device can also directly interact with the stimulator.
  • the patient program-controlled device may include a host (communicating with the server) and a slave (communicating with the stimulator), and the host and slave are communicably connected.
  • the doctor's program-controlled equipment can exchange data with the server through the 3G/4G/5G network
  • the server can exchange data with the host through the 3G/4G/5G network
  • the host can exchange data with the slave through the Bluetooth protocol/WIFI protocol/USB protocol.
  • the sub-machine can exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band, and the doctor's program-controlled equipment can directly exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band interact.
  • the present embodiment provides a surgical auxiliary tool for installing an electrode 5 on the brain, including: a tearable sleeve 1 and a guide 2 .
  • the tearable sleeve 1 is used to cooperate with the guide 2 to pass through the cranial hole 41 of the skull 4 and insert into the brain, and after the guide 2 is pulled away, the electrode 5 is inserted.
  • the tearable sleeve 1 has The two opposite ends, one end is the rear end, and the other end is the insertion end, the insertion end of the tearable sleeve 1 is used for inserting into the brain, and the rear end of the tearable sleeve 1 away from the insertion end is provided with a tear part 11, the tearable sleeve 1 is provided with one or more tear lines 12 extending along the length direction of the tearable sleeve 1, and the tearing part 11 is used to insert the tearable tube into the electrode 5 After covering 1, the tearable sleeve 1 is torn into multiple parts along the tear line 12 .
  • the guide 2 is used to insert into the tearable sleeve 1 and guide the tearable sleeve 1 to pass through the cranial hole 41 of the skull 4 and then insert into the brain.
  • the hardness of the guide 2 is greater than that of the tearable sleeve 1 , insert the tearable sleeve 1 into the cranial hole 41 of the brain by interspersing inside the tearable sleeve 1, and insert the electrode 5 into the tunnel behind the brain.
  • the guide member 2 is used for inserting into the tearable sleeve 1 and guiding the tearable sleeve 1 to pass through the cranial hole 41 of the skull 4 and then insert into the brain.
  • the material of the tearable sheath 1 is preferably a soft material or a biocompatible material, so as to reduce damage to the brain during the insertion process.
  • the tear line 12 is a plurality of point-like structures extending along the length direction of the tearable sleeve 1, and multiple parts of the tearable sleeve 1 pass through multiple The two point-like structures are connected, and a plurality of tear lines 12 are connected at the insertion end of the tearable sleeve 1.
  • the bottom insertion end of the tearable sleeve 1 can be designed as a seal, and the seal is intersected by the tearable line 12.
  • the medical staff controls the uniform force applied to the tearable sleeve 1 to move the multiple parts of the tearable sleeve 1 along the tear line. 12 are separated one by one, and feel through the arm whether the multiple parts of the tearable sleeve 1 have been completely torn apart, so as to facilitate the control of the tearing progress of the tearable sleeve 1.
  • the thickness of the tear line 12 is less than the thickness of the pipe wall of the part except the tear line 12 of the tearable sleeve 1, and multiple parts of the tearable sleeve 1 pass through the tear line 12, and a plurality of tear lines 12 meet at the insertion end of the tearable sleeve 1.
  • the tearing line 12 that is smaller than the thickness of the tube wall of the tearable sleeve 1, in actual use, when the medical staff tears the tube wall, the tearing line 12 of uniform thickness is convenient for the medical staff to quickly and smoothly tear the tube wall.
  • the multiple parts of the tear sleeve 1 are separated.
  • the guide member 2 is a ceramic needle
  • the inside of the ceramic needle is provided with a core that prevents the ceramic needle from breaking and extends along the length of the ceramic needle.
  • the core inside the ceramic needle will connect the remaining parts of the broken ceramic needle in the form of a lotus-broken wire connection, so as to prevent the broken ceramic needle from falling into the skull 4 .
  • the ceramic needle is compatible with MRI.
  • the insertion end of the tearable sleeve 1 can be open, and when the guide 2 penetrates into the tearable sleeve 1, the tearable sleeve will be torn under the friction of the guide 2 and the tearable sleeve 1.
  • the split sleeve 1 is vertically inserted into the designated brain, and during the pulling out process, the medical staff controls the outer end of the tearable sleeve 1 with one hand, and slowly pulls out the guide 2 with the other hand.
  • the guide member 2 is a ceramic needle, and when the ceramic needle penetrates into the tearable sleeve 1 , there is a small gap between the tearable sleeve 1 and the ceramic needle.
  • described electrode 5 is connected the output terminal of external nerve stimulator by wire, and external nerve stimulator transmits pulse electrical signal to electrode 5 by wire, and the contact point that is provided with on electrode 5 transmits pulse electrical signal. Signals release stimuli on the corresponding cerebral cortex.
  • the peripheral side of the extension end of the skull 4 of the tearable sleeve 1 is provided with a limiting part, and the main function of the limiting part is to prevent the insertion depth of the tearable sleeve 1 from being too deep during the insertion process, resulting in The tearable sleeve 1 does not reserve a tear portion 11, which is inconvenient for tearing.
  • the limiting part is a set of matched electrode locks 3, and the material of the electrode locks 3 is an insulating elastic material.
  • This embodiment provides an auxiliary tool for surgical operation, which is used to install electrodes 5 on the brain, including:
  • Tearable sleeve 1 the tearable sleeve 1 is used to pass through the cranial hole 41 of the skull 4 and insert into the brain for insertion of the electrode 5, the tearable sleeve 1 is a hard sleeve, so The tearable sleeve 1 has opposite two ends, one end is the rear end, and the other end is the insertion end, the insertion end of the tearable sleeve 1 is used for inserting into the brain, and the tearable sleeve 1 is away from The rear end of the insertion end is provided with a tear portion 11, and the tearable sleeve 1 is provided with one or more tear lines 12 extending along the length direction of the tearable sleeve 1, and the tear portion 11 is used for After the electrode 5 is inserted into the tearable sleeve 1, the tearable sleeve 1 is torn into multiple parts along the tear line 12 .
  • the tearable sleeve 1 can be inserted into a designated position first, then the electrode 5 can be inserted into the tearable sleeve 1, and then the Part 11, tear the tearable sleeve 1 along the tear line 12 into multiple parts.
  • the tear line 12 is a plurality of point-like structures extending along the length direction of the tearable sleeve 1 , and multiple parts of the tearable sleeve 1 are connected by the multiple point-like structures.
  • the thickness of the tear line 12 is smaller than the thickness of the pipe wall of the part of the tearable sleeve 1 other than the tear line 12, and multiple parts of the tearable sleeve 1 pass through the tear line. 12 connections.
  • the implementation and technical effects of the multiple point-shaped tear lines 12 and the thin-thick tear lines 12 are similar to those of the first embodiment, and will not be repeated here.
  • the bottom end of the tearable sleeve 1 may be open, and more preferably, the insertion end of the tearable sleeve 1 has a smooth end surface, so as to reduce damage to the brain during the insertion process.
  • the medical staff will insert the tearable sleeve 1 into the cranial hole 41 of the patient in the vertical direction until it is inserted into the designated position, and then insert the electrode 5 into the inside of the tearable sleeve 1.
  • the medical staff When preparing to tear the tearable sleeve 1 along the tear line 12, the medical staff hold the top extension end of the electrode 5 with one hand to prevent the electrode 5 from falling off, and the other medical staff slowly pull the tearable sleeve 1 with both hands.
  • the sleeve 1 is torn gradually along the tear line 12, and during the tearing process, it can be torn apart and pulled up at the same time until it falls off completely. Finally, the two sides of the electrode 5 are sequentially snapped together with the electrode lock 3, Finish fixing the electrode 5 and get final product.
  • the material of the tearable sleeve 1 is polytetrafluoroethylene or fluorinated ethylene propylene copolymer, and the thickness of the wall of the tearable sleeve 1 except the tear line 12 is uniform.
  • the medical personnel manually insert the tearable sheath 1 into the point to be stimulated in the cranial hole 41, hold the tearable sheath 1 with one hand, and insert the electrode 5 along the tearable sheath 1 to the point to be stimulated, then tear the tear part 11 of the tearable sleeve 1 along the tear line 12 extending along the length direction of the tearable sleeve 1, and lift up the separated
  • the sheath 1 can be torn until it is completely torn and separated from the electrode 5 .
  • other medical staff are required to assist the electrode 5 to be fixed to prevent the electrode 5 from being pulled out of the brain following the tearable sleeve 1.
  • the rubber semi-circular rings of the electrode lock 3 are respectively surrounded on both sides of the electrode 5, and Elastically buckle the outer side of the rubber semi-circle of the electrode lock 3 inside the cranial hole 41, start the nerve stimulator to send a pulse electrical signal through the wire, and the pulse electrical signal is transmitted to the contact of the electrode 5 through the wire, and finally stimulate the brain designated location for treatment.
  • nuclear magnetic resonance imaging can be performed simultaneously.

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Abstract

一种外科手术用辅助工具，包括：可撕裂管套（1）和导向件（2）；可撕裂管套（1）用于与导向件（2）配合穿过颅骨（4）的颅孔（41）后插入脑部，并在抽离导向件（2）后供电极（5）插入，可撕裂管套（1）的插入端用于插入脑部，可撕裂管套（1）远离插入端的后端设置有撕裂部（11），可撕裂管套（1）上设有一条或多条沿可撕裂管套（1）轴向延伸的撕裂线（12），撕裂部（11）用于在电极（5）插入可撕裂管套（1）后将可撕裂管套（1）沿撕裂线（12）撕裂为多个部分。可撕裂管套（1）在使用时，可以兼容核磁共振成像。

Description

外科手术用辅助工具
本申请要求于2021年12月9日提交的申请号为202123088733.X的中国专利的优先权，上述中国专利通过全文引用的形式并入。
技术领域
本申请涉及外科手术辅助器械技术领域，例如涉及一种外科手术用辅助工具。
背景技术
随着植入式的神经电刺激疗法的技术水平逐渐提高，病人需要在脑部植入脉冲电极时，首先将金属针串上金属管套，并将金属管套对应放置在颅孔内作为隧道，然后将电极顺着隧道插入到颅骨内指定的位置，最后将金属管套沿着电极导线向上取出，最后将电极通过电极锁固定在颅骨孔内。此种固定机构中的金属管套不兼容MRI(核磁共振成像)，同时由于需要将管套沿着电极导线取出，电极导线需要预留大于等于金属管套二倍的长度，实用性有待改进。
发明内容
本申请提供了解决上述问题的外科手术用辅助工具。
本申请的目的采用以下技术方案实现：
一种外科手术用辅助工具，用于在脑部安装电极，包括：可撕裂管套和导向件；
所述可撕裂管套用于与导向件配合穿过颅骨的颅孔后插入脑部，并在抽离导向件后供电极插入，所述可撕裂管套的插入端用于插入脑部，所述可撕裂管套远离插入端的后端设置有撕裂部，所述可撕裂管套上设有一条或多条沿可撕裂管套长度方向延伸的撕裂线，所述撕裂部用于在电极插入可撕裂管套后将所述可撕裂管套沿撕裂线撕裂为多个部分；
所述导向件用于插入可撕裂管套内并引导可撕裂管套穿过颅骨的颅孔后插入脑部。
在一些可能的方式中，所述撕裂线为多个点状结构，多个点状结构沿可撕裂管套的长度方向延伸，所述可撕裂管套的多个部分通过多个点状结构连接。
在一些可能的方式中，所述撕裂线的厚度小于可撕裂管套的除撕裂线以外的部分的管壁的厚度，所述可撕裂管套的多个部分通过撕裂线连接。
在一些可能的方式中，所述导向件的内部设有防止导向件断裂并沿导向件长度方向延伸的芯。
在一些可能的方式中，所述导向件的材料是陶瓷。
在一些可能的方式中，所述可撕裂管套的除撕裂线以外的部分的管壁的厚度均匀，所述可撕裂管套的插入端为开口状。
该方案的有益效果在于，可撕裂管套的撕裂线为点状连接时，可以提高医护人员在撕裂管套时的手感，便于控制撕裂时的长度和距离。
一种外科手术用辅助工具，用于在脑部安装电极，包括：可撕裂管套；
所述可撕裂管套用于穿过颅骨的颅孔后插入脑部并供电极插入，所述可撕裂管套为硬质管套，所述可撕裂管套的插入端用于插入脑部，所述可撕裂管套远离插入端的后端设置有撕裂部，所述可撕裂管套上设有一条或多条沿可撕裂管套长度方向延伸的撕裂线，所述撕裂部用于在电极插入可撕裂管套后将所述可撕裂管套沿撕裂线撕裂为多个部分。
在一些可能的方式中，所述撕裂线为多个点状结构，多个点状结构沿可撕裂管套的长度方向延伸，所述可撕裂管套的多个部分通过多个点状结构连接，可撕裂管套厚度不均匀时，可撕裂管套的撕裂线厚度小于管壁的厚度，且撕裂线沿轴线方向设置在可撕裂管套的管壁上。
该方案的有益效果在于，医护人员在撕开可撕裂管套时，通过均匀的施力即可将管套沿着撕裂部顺畅的撕开。
在一些可能的方式中，所述撕裂线的厚度小于可撕裂管套的除撕裂线以外的部分的管壁的厚度，所述可撕裂管套的多个部分通过撕裂线连接。
在一些可能的方式中，所述可撕裂管套的除撕裂线以外的部分的管壁的厚度均匀。所述可撕裂管套的插入端为开口状。
在一些可能的方式中，所述可撕裂管套的材质为PTFE或FEP。
本申请提供的外科手术用辅助工具，至少具有以下优点：与相关技术相比，本申请的有益效果至少包括：
可撕裂管套作为隧道将电极导向指定的位置处刺激大脑皮层，在将电极插入 到指定的位置后，直接将可撕裂管套沿着撕裂线撕开取出，当取出完毕后，可撕裂管套被撕开成两个或多个部分，从电极上分开，方便将管套取下，同时不需要将电极导线预留一定的长度用于取出金属管套，这种可撕裂管套在使用时，可以兼容核磁共振成像。
附图说明
下面结合附图和实施例对本申请进一步说明。
图1是本申请第一实施例的一种可撕裂管套的结构示意图；
图2是本申请第一实施例的另一种可撕裂管套的结构示意图；
图3是本申请实施例使用外科手术用辅助工具的第一步骤的结构示意图；
图4是本申请实施例使用外科手术用辅助工具的第二步骤的结构示意图；
图5是本申请实施例使用外科手术用辅助工具的第三步骤的结构示意图；
图6是本申请实施例的电极锁的结构示意图。
图中：1、可撕裂管套；11、撕裂部；12、撕裂线；2、导向件；3、电极锁；4、颅骨；41、颅孔；5、电极。
具体实施方式
下面，结合附图以及具体实施方式，对本申请做进一步描述，需要说明的是，在不相冲突的前提下，以下描述的各实施例之间或各技术特征之间可以任意组合形成新的实施例。
在本申请中，“至少一个”是指一个或者多个，“多个”是指两个或两个以上。“和/或”，描述关联对象的关联关系，表示可以存在三种关系，例如，A和/或B，可以表示：单独存在A，同时存在A和B，单独存在B的情况，其中A，B可以是单数或者复数。字符“/”一般表示前后关联对象是一种“或”的关系。“以下至少一项(个)”或其类似表达，是指的这些项中的任意组合，包括单项(个)或复数项(个)的任意组合。例如，a，b或c中的至少一项(个)，可以表示：a，b，c，a和b，a和c，b和c或a和b和c，其中a、b和c可以是单个，也可以是多个。值得注意的是，“至少一项(个)”还可以解释成“一项(个)或多项(个)”。
下面，首先对本申请实施例的其中一个应用领域(即可植入医疗设备)进行简单说明。
植入式神经刺激系统(一种植入式医疗系统)主要包括植入患者体内的刺激器(即植入式刺激器)以及设置于患者体外的程控设备。相关的神经调控技术主要是通过立体定向手术在体内特定结构(即靶点)植入电极5，并由植入患者体内的刺激器经电极5向靶点发放电脉冲，调控相应神经结构和网络的电活动及其功能，从而改善症状、缓解病痛。其中，刺激器可以是植入式神经电刺激装置、植入式心脏电刺激系统(又称心脏起搏器)、植入式药物输注装置(Implantable Dr ug Delivery System，简称I DDS)和导线转接装置中的任意一种。植入式神经电刺激装置例如是脑深部电刺激系统(Deep Brain Stimulation，简称DBS)、植入式脑皮层刺激系统(Cortical Nerve Stimulation，简称CNS)、植入式脊髓电刺激系统(Spinal Cord Stimulation，简称SCS)、植入式骶神经电刺激系统(S acral Nerve Stimulation，简称SNS)、植入式迷走神经电刺激系统(Vagus Ner ve Stimulation，简称VNS)等。
刺激器可以包括IPG、延伸导线和电极导线，IPG(implantable pulse gener ator，植入式脉冲发生器)设置于患者体内，接收程控设备发送的程控指令，依靠密封电池和电路向体内组织提供可控制的电刺激能量，通过植入的延伸导线和电极导线，为体内组织的特定区域递送一路或两路可控制的特定电刺激。延伸导线配合IPG使用，作为电刺激信号的传递媒体，将IPG产生的电刺激信号，传递给电极导线。电极导线通过多个电极触点，向体内组织的特定区域递送电刺激。刺激器设置有单侧或双侧的一路或多路电极导线，电极导线上设置有多个电极触点，电极触点可以均匀排列或者非均匀排列在电极导线的周向上。作为一个示例，电极触点可以以4行3列的阵列(共计12个电极触点)排列在电极导线的周向上。电极触点可以包括刺激电极触点和/或采集电极触点。电极触点例如可以采用片状、环状、点状等形状。
在一些可能的实施方式中，受刺激的体内组织可以是患者的脑组织，受刺激的部位可以是脑组织的特定部位。当患者的疾病类型不同时，受刺激的部位一般来说是不同的，所使用的刺激触点(单源或多源)的数量、一路或多路(单通道或多通道)特定电刺激信号的运用以及刺激参数数据也是不同的。本申请实施例对适用的疾病类型不做限定，其可以是脑深部刺激(DBS)、脊髓刺激(SCS)、骨盆刺激、胃刺激、外周神经刺激、功能性电刺激所适用的疾病类型。其中，DBS 可以用于治疗或管理的疾病类型包括但不限于：痉挛疾病(例如，癫痫)、疼痛、偏头痛、精神疾病(例如，重度抑郁症(MDD))、躁郁症、焦虑症、创伤后压力心理障碍症、轻郁症、强迫症(OCD)、行为障碍、情绪障碍、记忆障碍、心理状态障碍、移动障碍(例如，特发性震颤或帕金森氏病)、亨廷顿病、阿尔茨海默症、药物成瘾症、孤独症或其他神经学或精神科疾病和损害。
本申请实施例中，程控设备和刺激器建立程控连接时，可以利用程控设备调整刺激器的刺激参数(不同的刺激参数所对应的电刺激信号不同)，也可以通过刺激器感测患者脑深部的生物电活动以采集得到电生理信号，并可以通过所采集到的电生理信号来继续调节刺激器的电刺激信号的刺激参数。
刺激参数可以包括以下至少一种：频率(例如是单位时间1s内的电刺激脉冲信号个数，单位为Hz)、脉宽(每个脉冲的持续时间，单位为μs)、幅值(一般用电压表述，即每个脉冲的强度，单位为V)、时序(例如可以是连续或者触发)、刺激模式(包括电流模式、电压模式、定时刺激模式和循环刺激模式中的一种或多种)、医生控制上限及下限(医生可调节的范围)和患者控制上限及下限(患者可自主调节的范围)。
在一个具体应用场景中，可以在电流模式或者电压模式下对刺激器的各刺激参数进行调节。
程控设备可以是医生程控设备(即医生使用的程控设备)或者患者程控设备(即患者使用的程控设备)。医生程控设备例如可以是搭载有程控软件的平板电脑、笔记本电脑、台式计算机、手机等智能终端设备。患者程控设备例如可以是搭载有程控软件的平板电脑、笔记本电脑、台式计算机、手机等智能终端设备，患者程控设备还可以是其他具有程控功能的电子设备(例如是具有程控功能的充电器、数据采集设备)。
本申请实施例对医生程控设备和刺激器的数据交互不进行限制，当医生远程程控时，医生程控设备可以通过服务器、患者程控设备与刺激器进行数据交互。当医生线下和患者面对面进行程控时，医生程控设备可以通过患者程控设备与刺激器进行数据交互，医生程控设备还可以直接与刺激器进行数据交互。
在一种可能的实现方式中，患者程控设备可以包括(与服务器通信的)主机和(与刺激器通信的)子机，主机和子机可通信的连接。其中，医生程控设备可 以通过3G/4G/5G网络与服务器进行数据交互，服务器可以通过3G/4G/5G网络与主机进行数据交互，主机可以通过蓝牙协议/WIFI协议/USB协议与子机进行数据交互，子机可以通过401MHz-406MHz工作频段/2.4GHz-2.48GHz工作频段与刺激器进行数据交互，医生程控设备可以通过401MHz-406MHz工作频段/2.4GHz-2.48GHz工作频段与刺激器直接进行数据交互。
第一实施例：
参照图1-6，本实施例提供了外科手术用辅助工具，用于在脑部安装电极5，包括：可撕裂管套1和导向件2。
所述可撕裂管套1用于与导向件2配合穿过颅骨4的颅孔41后插入脑部，并在抽离导向件2后供电极5插入，所述可撕裂管套1具有相对的两端，一端为后端，另一端为插入端，所述可撕裂管套1的插入端用于插入脑部，所述可撕裂管套1远离插入端的后端设置有撕裂部11，所述可撕裂管套1上设有一条或多条沿可撕裂管套1长度方向延伸的撕裂线12，所述撕裂部11用于在电极5插入可撕裂管套1后将所述可撕裂管套1沿撕裂线12撕裂为多个部分。所述导向件2用于插入可撕裂管套1内并引导可撕裂管套1穿过颅骨4的颅孔41后插入脑部，导向件2的硬度大于可撕裂管套1的硬度，通过穿插在可撕裂管套1内部的形式，将可撕裂管套1插入到大脑的颅孔41内，作为电极5插入大脑后的隧道。
所述导向件2用于插入可撕裂管套1内并引导可撕裂管套1穿过颅骨4的颅孔41后插入脑部。可撕裂管套1的材料优选为软质材料或生物相容性材料，以减少插入过程对脑部的损伤。颅骨4上通过工具开设的颅孔41，且颅孔41的形状例如为圆形，可撕裂管套1的内部经过导向件2穿插，并在导向件2的作用下，可撕裂管套1最终插入在颅骨4内，接着将导向件2取出，并将电极5沿着可撕裂管套1插入在指定的位置处，最后将可撕裂管套1的顶部端沿着撕裂线12撕开，直至将可撕裂管套1完全取出或抽出。
参照图1-2，所述撕裂线12为多个点状结构，多个点状结构沿可撕裂管套1的长度方向延伸，所述可撕裂管套1的多个部分通过多个点状结构连接，且多条撕裂线12在所述可撕裂管套1的插入端相接。可撕裂管套1的底部插入端可以设计成封口状，且封口通过可撕裂线12相交在一起，当导向件2穿入在可撕裂 管套1的内，导向件2的插入端抵住可撕裂管套1的插入端，缓慢将可撕裂管套1插入到指定的位置即可。通过将多条撕裂线12设计成在所述可撕裂管套1的插入端相接，在将可撕裂管套1的多个部分撕开时，多个部分在撕裂到可撕裂管套1的插入端时，容易分离或分开，方便可撕裂管套1的多个部分成为独立的部分，并被抽离。
优选的，点状连接的可撕裂管套1在撕裂分开时，医护人员通过控制可撕裂管套1均匀的施力大小，将可撕裂管套1的多个部分沿撕裂线12逐个分开，并且在分开时通过手臂感受到可撕裂管套1的多个部分是否已被完全撕开，方便控制可撕裂管套1的撕裂进度。
参照图2，所述撕裂线12的厚度小于可撕裂管套1的除撕裂线12以外的部分的管壁的厚度，所述可撕裂管套1的多个部分通过撕裂线12连接，且多条撕裂线12在所述可撕裂管套1的插入端相接。
优选的，小于可撕裂管套1的管壁厚度的撕裂线12，在实际使用时，医护人员在撕裂管壁时，均匀厚度的撕裂线12，方便医护人员快速流畅的将可撕裂管套1的多个部分分离。
优选的，导向件2是陶瓷针，且陶瓷针的内部设有防止陶瓷针断裂并沿陶瓷针长度方向延伸的芯，陶瓷针插入在可撕裂管套1内并一同进入颅孔41内部时，如果出现陶瓷针断裂的情况，陶瓷针内部的芯将会通过藕断丝连的形式连接断裂后的陶瓷针其余部分，防止断裂的陶瓷针掉落到颅骨4内。同时陶瓷针兼容核磁共振。
可撕裂管套1的插入端可以是开口状，当导向件2穿入在可撕裂管套1的内部时，通过导向件2和可撕裂管套1的摩擦力作用下将可撕裂管套1竖直插入到指定的大脑内，并在拔出的过程中，医护人员一手控制住可撕裂管套1的外部端，另一只手缓慢将导向件2拔出即可，优选的，导向件2是陶瓷针，当陶瓷针穿入在可撕裂管套1的内部时，可撕裂管套1和陶瓷针之间存在较小的间隙。
参照图3-5，所述电极5通过导线连接外部的神经刺激器的输出端，外部的神经刺激器通过导线将脉冲电信号传输到电极5上，电极5上设有的触点将脉冲电信号释放刺激在对应的大脑皮层上。所述可撕裂管套1的颅骨4外的伸出端周侧设有限位部，限位部的主要作用是防止可撕裂管套1在插入的过程中，插入的 深度过深，导致可撕裂管套1没有预留撕裂部11，不方便撕开的作用。
参照图6，限位部是一组配合的电极锁3，电极锁3的材料为绝缘弹性材料。当可撕裂管套1完全从颅骨4内部取出，并从导线上分离后，随即依次将两个电极锁3的半圆内壁对应抵住在电极5的外侧，并将电极锁3对应扣合固定在颅孔41内部，电极5即可固定在颅孔41的内部。
第二实施例：
本实施例提供一种外科手术用辅助工具，用于在脑部安装电极5，包括：
可撕裂管套1，所述可撕裂管套1用于穿过颅骨4的颅孔41后插入脑部并供电极5插入，所述可撕裂管套1为硬质管套，所述可撕裂管套1具有相对的两端，一端为后端，另一端为插入端，所述可撕裂管套1的插入端用于插入脑部，所述可撕裂管套1远离插入端的后端设置有撕裂部11，所述可撕裂管套1上设有一条或多条沿可撕裂管套1长度方向延伸的撕裂线12，所述撕裂部11用于在电极5插入可撕裂管套1后将所述可撕裂管套1沿撕裂线12撕裂为多个部分。
由此，通过设置硬质管套结构的可撕裂管套1，可以先将可撕裂管套1插入到指定位置，接着将电极5插入到可撕裂管套1内，再通过撕裂部11，沿撕裂线12将可撕裂管套1沿撕裂线12撕裂为多个部分。
所述撕裂线12为多个点状结构，多个点状结构沿可撕裂管套1的长度方向延伸，所述可撕裂管套1的多个部分通过多个点状结构连接。作为替换方式，所述撕裂线12的厚度小于可撕裂管套1的除撕裂线12以外的部分的管壁的厚度，所述可撕裂管套1的多个部分通过撕裂线12连接。上述多个点状结构的撕裂线12和厚度小的撕裂线12的实施方式和技术效果与第一实施例类似，在此不予赘述。
可撕裂管套1的底部端可以是开口状，更优选地，可撕裂管套1的插入端更优选具有圆滑端面，以减少插入过程对脑部的损伤。在使用时，医护人员将可撕裂管套1沿着竖直方向插入到患者的颅孔41内，直至插入到指定位置处，然后将电极5插入到可撕裂管套1的内部，在准备沿着撕裂线12将可撕裂管套1撕开时，医护人员一手扶着电极5的顶部伸出端，防止电极5脱落，另外的医护人员，通过双手缓慢的将可撕裂管套1沿着撕裂线12逐渐撕开，并在撕开的过程中，可以一边撕开，一边上拉，直至完全脱落即可，最后将电极5的两侧依次卡 合电极锁3组合，完成电极5固定即可。
所述可撕裂管套1的材质为聚四氟乙烯或氟化乙烯丙烯共聚物，所述可撕裂管套1的除撕裂线12以外的部分的管壁的厚度均匀。
在一具体实施方式中，医护人员手动将可撕裂管套1插入在颅孔41内待刺激点，一手扶着可撕裂管套1，并将电极5沿着可撕裂管套1插入到待刺激点，然后将可撕裂管套1的撕裂部11沿着沿可撕裂管套1长度方向延伸的撕裂线12依次撕开，并在撕开的同时向上提出分开后的可撕裂管套1，直至完全撕开，并从电极5脱离。在此过程中，需要其他医护人员辅助电极5固定，防止电极5跟随可撕裂管套1拔出脑部，最后将电极锁3的橡胶半圆环分别对应在电极5的两侧包围，并将电极锁3的橡胶半圆环外侧弹性扣合在颅孔41的内部，启动神经刺激器通过导线发出脉冲电信号，脉冲电信号通过导线对应传输到电极5的触点上，最后刺激大脑上的指定位置，进行治疗。在插入可撕裂管套1插入和取出可撕裂管并固定电极5的整个过程中，可以同时进行核磁共振成像。
尽管上面已经示出和描述了本申请的实施例，可以理解的是，上述实施例是示例性的，不能理解为对本申请的限制，本领域的普通技术人员在不脱离本申请的原理和宗旨的情况下，在申请的范围内可以对上述实施例进行变化、修改、替换和变型，所有的这些改变都应该属于本申请权利要求的保护范围之内。

Claims (11)

  1. 一种外科手术用辅助工具，用于在脑部安装电极(5)，包括：可撕裂管套(1)和导向件(2)；
    所述可撕裂管套(1)用于与导向件(2)配合穿过颅骨(4)的颅孔(41)后插入脑部，并在抽离导向件(2)后供电极(5)插入，所述可撕裂管套(1)的插入端用于插入脑部，所述可撕裂管套(1)远离插入端的后端设置有撕裂部，所述可撕裂管套(1)上设有一条或多条沿可撕裂管套(1)长度方向延伸的撕裂线，所述撕裂部用于在电极(5)插入可撕裂管套(1)后将所述可撕裂管套(1)沿撕裂线撕裂为多个部分；
    所述导向件(2)用于插入可撕裂管套(1)内并引导可撕裂管套(1)穿过颅骨(4)的颅孔(41)后插入脑部。
  2. 根据权利要求1所述的外科手术用辅助工具，其中，所述撕裂线为多个点状结构，多个点状结构沿可撕裂管套(1)的长度方向延伸，所述可撕裂管套(1)的多个部分通过多个点状结构连接。
  3. 根据权利要求1所述的外科手术用辅助工具，其中，所述撕裂线的厚度小于可撕裂管套(1)的除撕裂线以外的部分的管壁的厚度，所述可撕裂管套(1)的多个部分通过撕裂线连接。
  4. 根据权利要求1所述的外科手术用辅助工具，其中，所述导向件的内部设有防止导向件断裂并沿导向件长度方向延伸的芯。
  5. 根据权利要求4所述的外科手术用辅助工具，其中，所述导向件的材料是陶瓷。
  6. 根据权利要求2或3所述的外科手术用辅助工具，其中，所述可撕裂管套(1)的除撕裂线以外的部分的管壁的厚度均匀，所述可撕裂管套的插入端为开口状。
  7. 一种外科手术用辅助工具，用于在脑部安装电极(5)，其中，包括：可撕裂管套(1)；
    所述可撕裂管套(1)用于穿过颅骨(4)的颅孔(41)后插入脑部并供电极 (5)插入，所述可撕裂管套(1)为硬质管套，所述可撕裂管套(1)的插入端用于插入脑部，所述可撕裂管套(1)远离插入端的后端设置有撕裂部，所述可撕裂管套(1)上设有一条或多条沿可撕裂管套(1)长度方向延伸的撕裂线，所述撕裂部用于在电极(5)插入可撕裂管套(1)后将所述可撕裂管套(1)沿撕裂线撕裂为多个部分。
  8. 根据权利要求7所述的外科手术用辅助工具，其中，所述撕裂线为多个点状结构，多个点状结构沿可撕裂管套(1)的长度方向延伸，所述可撕裂管套(1)的多个部分通过多个点状结构连接。
  9. 根据权利要求7所述的外科手术用辅助工具，其中，所述撕裂线的厚度小于可撕裂管套(1)的除撕裂线以外的部分的管壁的厚度，所述可撕裂管套(1)的多个部分通过撕裂线连接。
  10. 根据权利要求7所述的外科手术用辅助工具，其中，所述可撕裂管套(1)的除撕裂线以外的部分的管壁的厚度均匀，所述可撕裂管套的插入端为开口状。
  11. 根据权利要求10所述的外科手术用辅助工具，其中，所述可撕裂管套(1)的材质为PTFE或FEP。
PCT/CN2022/132973 2021-12-09 2022-11-18 外科手术用辅助工具 WO2023103753A1 (zh)

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