技术领域technical field
本发明属于植入式医疗仪器制造技术领域，具体涉及一种植入式神经电刺激电极组件及其应用方法。The invention belongs to the technical field of implantable medical instrument manufacturing, and in particular relates to an implantable nerve electrical stimulation electrode assembly and an application method thereof.
背景技术Background technique
植入式神经电刺激系统是一种有源植入式医疗器械。植入式神经电刺激系统通过电刺激的方式来兴奋、抑制或调节神经系统传导，从而达到恢复或改善人体机能运作的治疗效果。植入式神经电刺激疗法已经被证实对二十余种神经功能失调疾病具有确切的疗效。与传统的药物方法和外科手术损毁方法相比较，植入式神经刺激疗法安全可逆，在临床上正越来越多地被使用。植入式神经电刺激系统按照刺激部位的不同，可细分为植入式脑深部电刺激系统、植入式脑皮层刺激系统，植入式脊髓电刺激系统，植入式骶神经电刺激系统，植入式迷走神经电刺激系统等，或称为脑深部刺激器、迷走神经刺激器、脊髓刺激器、骶神经刺激器、外周神经刺激器等。An implantable electrical nerve stimulation system is an active implantable medical device. The implantable nerve electrical stimulation system excites, inhibits or regulates the conduction of the nervous system through electrical stimulation, so as to achieve the therapeutic effect of restoring or improving the function of the human body. Implantable nerve electrical stimulation therapy has been proven to have definite curative effect on more than 20 kinds of neurological dysfunction diseases. Compared with traditional drug methods and surgical damage methods, implantable neurostimulation therapy is safe and reversible, and is being used more and more clinically. Implantable electrical nerve stimulation systems can be subdivided into implantable deep brain electrical stimulation systems, implantable cerebral cortex electrical stimulation systems, implantable spinal cord electrical stimulation systems, and implantable sacral nerve electrical stimulation systems according to different stimulation parts. , Implantable vagus nerve electrical stimulation system, etc., or deep brain stimulator, vagus nerve stimulator, spinal cord stimulator, sacral nerve stimulator, peripheral nerve stimulator, etc.
与广泛使用的心脏起搏器系统类似，植入式神经电刺激系统也由产生刺激信号的脉冲发生器和传递刺激信号的电极导管组成。脉冲发生器产生的信号通过电极导管传递到刺激部位（靶点）产生治疗效果。若要取得长期稳定的治疗效果，必须要保持电极导管上的刺激触点与靶点位置不变。因此，电极导管植入时，应采取有效措施将电极导管与人体组织进行固定。Similar to the widely used cardiac pacemaker system, the implantable electrical nerve stimulation system also consists of a pulse generator that generates stimulation signals and an electrode catheter that transmits stimulation signals. The signal generated by the pulse generator is transmitted to the stimulation site (target) through the electrode catheter to produce therapeutic effect. To achieve long-term and stable therapeutic effect, it is necessary to keep the position of the stimulating contact point and the target point on the electrode catheter unchanged. Therefore, when the electrode catheter is implanted, effective measures should be taken to fix the electrode catheter and human tissue.
目前广泛应用的一类是通过独立的固定夹（或固定套管、固定锚）等装置来实现，例如美国专利申请US20090030492A1、US005484445A中提到的相关装置。One type widely used at present is realized by means of independent fixing clips (or fixing sleeves, fixing anchors), etc., such as the related devices mentioned in US patent applications US20090030492A1 and US005484445A.
该种植入式神经电刺激系统的电极组件植入时分别将固定夹与人体组织固定、固定夹与电极导管相固定，从而实现电极导管与人体组织间的固定，这种植入式神经电刺激电极组件通常需要较大的手术切口，对病人伤害较大。When the electrode assembly of the implantable nerve electrical stimulation system is implanted, the fixing clip is fixed to the human tissue, and the fixing clip is fixed to the electrode catheter, so as to realize the fixation between the electrode catheter and the human tissue. This implantable nerve electrical stimulation electrode Components typically require larger surgical incisions and are more traumatic to the patient.
发明内容Contents of the invention
有鉴于此，确有必要提供一种结构简单、医生易于操作、病人创伤小、成本较低的植入式神经电刺激电极组件及其应用方法。In view of this, it is necessary to provide an implantable nerve electrical stimulation electrode assembly and its application method with simple structure, easy operation by doctors, less trauma to patients, and lower cost.
一种植入式神经电刺激电极组件包括一用于寻找靶点的穿刺针，所述穿刺针上设置有标记刻线；一电极导管，其包括导线、保护套管及固定件，所述导线位于所述保护套管并贯穿整个所述保护套管，所述固定件套设于所述保护套管的预定部位，所述保护套管为一端开口一端闭合的、内空的套管结构体，所述保护套管的、与所述开口相邻的端部设置有包括多个连接触点的连接端部，与所述闭合端相邻的端部设置有包括多个刺激触点的刺激端部，所述保护套管的中间部位、靠近所述刺激端部设置有固定件，所述连接端部与所述固定件之间设置有用于电极导管植入时的对穿刺深度的监视的第一目视标记，所述固定件用于所述电极导管植入后的位置固定；以及，一穿刺管，用于辅助所述电极导管放入靶点，所述穿刺管为管状结构体，所述穿刺管的内径大于所述电极导管及所述穿刺针的外径，所述穿刺管能够套设于所述电极导管及所述穿刺针，所述穿刺管上设置有标记刻线。An implantable electrical nerve stimulation electrode assembly includes a puncture needle for finding a target point, the puncture needle is provided with a marking line; The protective sleeve runs through the entire protective sleeve, the fixing member is sleeved on a predetermined position of the protective sleeve, and the protective sleeve is a hollow sleeve structure with one end open and one end closed, The end of the protective sleeve adjacent to the opening is provided with a connecting end comprising a plurality of connecting contacts, and the end adjacent to the closed end is provided with a stimulating end comprising a plurality of stimulating contacts part, the middle part of the protective sleeve is provided with a fixing piece close to the stimulation end, and a first monitoring device for monitoring the puncture depth when the electrode catheter is implanted is set between the connection end and the fixing piece. A visual mark, the fixing part is used to fix the position of the electrode catheter after implantation; and, a puncture tube is used to assist the electrode catheter to be placed in the target point, the puncture tube is a tubular structure, the The inner diameter of the puncture tube is larger than the outer diameter of the electrode catheter and the puncture needle, the puncture tube can be sleeved on the electrode catheter and the puncture needle, and the puncture tube is provided with marking lines.
所述固定件包括多个固定翼和一固定部，所述多个固定翼和一固定部为一体结构体，所述固定件通过所述固定部套设于所述保护套管，每一固定翼与所述固定部相连，每一固定翼在自由状态下自由端远离所述固定部的方向翘起延伸，受外力可收缩，解除外力弹性恢复自由状态。The fixing part includes a plurality of fixing wings and a fixing part, the plurality of fixing wings and a fixing part are an integral structure, the fixing part is sleeved on the protective sleeve through the fixing part, and each fixing part The wings are connected to the fixed part, and the free end of each fixed wing is tilted and extended in a direction away from the fixed part in a free state, and can be contracted by an external force, and elastically returns to a free state when the external force is released.
所述固定件的材料为聚氨酯、硅橡胶或聚氨酯-硅橡胶共聚物。The material of the fixing part is polyurethane, silicone rubber or polyurethane-silicone rubber copolymer.
所述保护套管的中间部位、进一步设置有一第二目视标记，所述第二目视标记位于所述第一目视标记与所述连接端部之间。The middle part of the protective sleeve is further provided with a second visual mark, and the second visual mark is located between the first visual mark and the connection end.
所述保护套管的中间部位、进一步设置有两个X光显影标记，于所述固定件的起始部位和终止部位各设置一个。The middle part of the protective sleeve is further provided with two X-ray development marks, and one is respectively provided at the starting part and the ending part of the fixing part.
所述导线为带有绝缘层的不锈钢线、钴铬钼合金线、镍钛合金线、铂铱合金线、钨合金线或碳纳米管线。The wire is a stainless steel wire with an insulating layer, a cobalt-chromium-molybdenum alloy wire, a nickel-titanium alloy wire, a platinum-iridium alloy wire, a tungsten alloy wire or a carbon nanotube wire.
所述导线的表面进一步设置有改善润滑性或生物相容性的派拉纶涂层或氟塑料涂层。The surface of the lead is further provided with a paralon coating or a fluoroplastic coating to improve lubricity or biocompatibility.
所述刺激触点为铂或铂铱合金，或者是表面覆盖铂或铂铱合金涂层的环形结构体。The stimulation contact is platinum or platinum-iridium alloy, or a ring-shaped structure covered with platinum or platinum-iridium alloy coating.
一种植入式神经电刺激电极组件的使用方法，包括以下步骤:首先，将穿刺针放入目标组织中寻找靶点，并使的所述穿刺针标记刻线外露于目标组织；当穿刺针的探头寻找到靶点之后，沿着所述穿刺针放置穿刺管于目标组织内，使得所述穿刺管上的标记刻线与所述穿刺针上的标记刻线对齐，并将所述穿刺针拔出；之后，将电极导管通过所述穿刺管的中空空间植入目标组织，待电极导管上的目视标记与穿刺管上的标记刻线对齐；随后从目标组织拔出所述穿刺管，所述电极导管上的固定件的固定翼张开、嵌入到目标组织，实现植入式神经电刺激电极组件的电极导管的固定。A method for using an implantable electrical nerve stimulation electrode assembly, comprising the following steps: first, putting a puncture needle into a target tissue to find a target point, and making the marking line of the puncture needle exposed to the target tissue; when the puncture needle After the probe finds the target point, place the puncture tube in the target tissue along the puncture needle so that the marking line on the puncture tube is aligned with the marking line on the puncture needle, and pull out the puncture needle After that, implant the electrode catheter into the target tissue through the hollow space of the puncture tube, and wait until the visual mark on the electrode catheter is aligned with the marking line on the puncture tube; then pull out the puncture tube from the target tissue, and the The fixing wings of the fixing part on the electrode guide are opened and embedded into the target tissue, so as to realize the fixation of the electrode guide of the implantable nerve electrical stimulation electrode assembly.
相对于现有技术，本发明提供的植入式神经电刺激电极组件具有以下有益效果：电极的植入手术由传统的外科手术变成了简单的穿刺手术，并且，穿刺针、穿刺管以及电极导管均有对应的目视标记，对于医生而言手术操作更加简单、手术用时减少；对于患者而言，可以用局部麻醉代替全身麻醉，麻醉风险大大减小，同时穿刺手术创伤小，伤口愈合快，使得患者更加舒适。故，本发明提供的植入式神经电刺激电极组件结构简单、医生易于操作、病人创伤小、成本较低。Compared with the prior art, the implantable nerve electrical stimulation electrode assembly provided by the present invention has the following beneficial effects: the implantation operation of the electrode is changed from a traditional surgical operation to a simple puncture operation, and the puncture needle, puncture tube and electrode Catheters have corresponding visual marks, which makes the operation easier for doctors and reduces the operation time; for patients, local anesthesia can be used instead of general anesthesia, which greatly reduces the risk of anesthesia, and at the same time, the trauma of puncture surgery is small and the wound heals quickly , making the patient more comfortable. Therefore, the implantable nerve electrical stimulation electrode assembly provided by the present invention has a simple structure, is easy for doctors to operate, has little trauma to the patient, and is low in cost.
附图说明Description of drawings
图1是本发明第一实施例提供的植入式神经电刺激电极组件电极导管的示意图。Fig. 1 is a schematic diagram of an electrode catheter of an implantable nerve electrical stimulation electrode assembly provided by the first embodiment of the present invention.
图2是本发明第一实施例提供的植入式神经电刺激电极组件的应用分解示意图。Fig. 2 is an exploded schematic view of the application of the implantable electrical nerve stimulation electrode assembly provided by the first embodiment of the present invention.
图3是本发明第二实施例提供的植入式神经电刺激电极组件电极导管的示意图。Fig. 3 is a schematic diagram of an electrode catheter of an implantable nerve electrical stimulation electrode assembly provided by a second embodiment of the present invention.
图4是本发明第二实施例提供的植入式神经电刺激电极组件的示意图。Fig. 4 is a schematic diagram of an implantable nerve electrical stimulation electrode assembly provided by a second embodiment of the present invention.
图5是本发明第三实施例提供的植入式神经电刺激电极组件电极导管的示意图。Fig. 5 is a schematic diagram of an electrode catheter of an implantable nerve electrical stimulation electrode assembly provided by a third embodiment of the present invention.
图6是本发明第四实施例提供的植入式神经电刺激电极组件电极导管的示意图。Fig. 6 is a schematic diagram of an electrode catheter of an implantable nerve electrical stimulation electrode assembly provided by a fourth embodiment of the present invention.
主要元件符号说明Explanation of main component symbols
如下具体实施方式将结合上述附图进一步说明本发明。The following specific embodiments will further illustrate the present invention in conjunction with the above-mentioned drawings.
具体实施方式Detailed ways
以下将结合附图详细说明本发明实施例提供的植入式神经电刺激电极组件及其应用方法。所述实施例的示例在附图中示出，其中相同标号表示相同构件、或具有相同或类似功能的构件。下面通过参考附图描述的实施例是示例性的，旨在用于解释本发明，而不能理解为对本发明的限制。The implantable electrical nerve stimulation electrode assembly provided by the embodiment of the present invention and its application method will be described in detail below with reference to the accompanying drawings. Examples of the described embodiments are shown in the drawings, wherein like reference numerals refer to like components, or components having the same or similar functions. The embodiments described below by referring to the figures are exemplary and are intended to explain the present invention and should not be construed as limiting the present invention.
在本发明的描述中，需要理解的是，术语“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。In describing the present invention, it should be understood that the terms "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", The orientation or positional relationship indicated by "horizontal", "top", "bottom", "inner", "outer", etc. are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than Nothing indicating or implying that a referenced device or element must have a particular orientation, be constructed, and operate in a particular orientation should therefore not be construed as limiting the invention.
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体化连接；可以是机械连接，也可以是电磁力连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。In the description of the present invention, it should be noted that unless otherwise specified and limited, the terms "installation", "connection", "connection" and "fixation" should be understood in a broad sense, for example, it can be a fixed connection, or It can be a detachable connection or an integrated connection; it can be a mechanical connection or an electromagnetic force connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention in specific situations.
请参阅图1以及图2，本发明第一实施例提供植入式神经电刺激电极组件。所述植入式神经电刺激电极组件包括电极导管100、穿刺针300及穿刺管400。所述穿刺针300用于寻找目标刺激部位，目标刺激部位医学上也叫做靶点185。所述穿刺管400用于辅助电极导管100放入靶点。本发明的所述植入式神经电刺激电极组件作为整体售卖，植入至神经用作电刺激的元件为所述电极导管100。Please refer to FIG. 1 and FIG. 2 , the first embodiment of the present invention provides an implantable electrical nerve stimulation electrode assembly. The implantable electrical nerve stimulation electrode assembly includes an electrode catheter 100 , a puncture needle 300 and a puncture tube 400 . The puncture needle 300 is used to find the target stimulation site, which is also called the target point 185 in medicine. The puncture tube 400 is used to assist the placement of the electrode catheter 100 into the target point. The implantable nerve electrical stimulation electrode assembly of the present invention is sold as a whole, and the element implanted into the nerve for electrical stimulation is the electrode catheter 100 .
所述电极导管100包括手持元件101、导线(图未标示)、保护套管120及固定件160。所述手持元件101插入保护套管120中，用于增强电极的刚度，方便手术操作。所述导线位于所述保护套管120并贯穿整个所述保护套管120。所述固定件160套设于所述保护套管120的预定部位。手持元件101在电极导管植入后，与电极导管脱离、取出。The electrode catheter 100 includes a hand-held element 101 , a wire (not shown), a protective sleeve 120 and a fixing member 160 . The hand-held element 101 is inserted into the protective sleeve 120 to enhance the rigidity of the electrode and facilitate operation. The wire is located in the protective sleeve 120 and runs through the entire protective sleeve 120 . The fixing member 160 is sheathed on a predetermined position of the protective sleeve 120 . After the electrode catheter is implanted, the hand-held element 101 is separated from the electrode catheter and taken out.
所述导线的材料可为带绝缘层的不锈钢线、钴铬钼合金线、镍钛合金线、铂铱合金线、钨合金线或碳纳米管线等，可为绞线或螺旋线的形式存在，以提高整体的抗疲劳性能。进一步的，可在所述导线的表面制作涂层材料来改善润滑性或生物相容性，例如在表面沉积派拉纶涂层或氟塑料涂层等。The material of the wire can be a stainless steel wire with an insulating layer, a cobalt-chromium-molybdenum alloy wire, a nickel-titanium alloy wire, a platinum-iridium alloy wire, a tungsten alloy wire or a carbon nanotube wire, etc., and can exist in the form of a twisted wire or a helix wire, To improve the overall fatigue resistance. Further, a coating material can be prepared on the surface of the wire to improve lubricity or biocompatibility, for example, depositing a paralon coating or a fluoroplastic coating on the surface.
所述保护套管120为相对的两端为开口121和闭合端122的、内空的套管结构体，所述闭合端122的头部是光滑的曲面，例如半球形。所述保护套管120的、与所述开口121相邻的端部设置有连接端部110，与所述闭合端122相邻的端部设置有刺激端部140。所述保护套管120的中部、靠近所述刺激端部140设置有固定件160，所述连接端部110与所述固定件160之间设置有目视标记150。所述保护套管120的材料可为聚氨酯、硅橡胶或聚氨酯-硅橡胶共聚物等。The protective sleeve 120 is a hollow sleeve structure with an opening 121 and a closed end 122 at opposite ends. The head of the closed end 122 is a smooth curved surface, such as hemispherical. The end of the protective sleeve 120 adjacent to the opening 121 is provided with a connecting end 110 , and the end adjacent to the closed end 122 is provided with a stimulating end 140 . A fixing part 160 is provided in the middle of the protective sleeve 120 near the stimulation end 140 , and a visual mark 150 is provided between the connection end 110 and the fixing part 160 . The material of the protective sleeve 120 can be polyurethane, silicone rubber or polyurethane-silicone rubber copolymer.
所述连接端部110设置有多个连接触点111，所述连接触点111可为环形结构体，由导电的具有生物相容性的材料组成，例如MP35N或不锈钢等。The connection end portion 110 is provided with a plurality of connection contacts 111, and the connection contacts 111 may be annular structures made of conductive biocompatible materials, such as MP35N or stainless steel.
所述刺激端部140设置有多个刺激触点141，所述刺激触点141可为环形结构体，由导电的具有生物相容性的材料组成，例如铂或铂铱合金，或者是表面覆盖铂或铂铱合金涂层的材料，通过电阻点焊或激光点焊的方式与所述导线电连接。本实施例中所述刺激触点141为铂铱合金环。The stimulating end 140 is provided with a plurality of stimulating contacts 141, and the stimulating contacts 141 can be annular structures made of conductive biocompatible materials, such as platinum or platinum-iridium alloy, or surface-covered Platinum or platinum-iridium alloy coated material is electrically connected to the wire by means of resistance spot welding or laser spot welding. In this embodiment, the stimulation contact 141 is a platinum-iridium alloy ring.
所述多个连接触点111用于接收不同的脉冲信号或不同时间段的脉冲信号，所述多个连接触点111接收的脉冲信号通过不同的导线传送至不同的刺激触点141，以实现多个刺激触点141向靶点185输送不同的脉冲信号或不同时间段的脉冲信号等。对应的连接触点111与刺激触点141之间通过对应的导线连接，相邻的所述多个连接触点111或所述多个刺激触点141之间由绝缘体分割，以保持电气隔离。The plurality of connection contacts 111 are used to receive different pulse signals or pulse signals of different time periods, and the pulse signals received by the plurality of connection contacts 111 are transmitted to different stimulation contacts 141 through different wires, so as to realize Multiple stimulation contacts 141 deliver different pulse signals or pulse signals of different time periods to the target point 185 . Corresponding connecting contacts 111 and stimulating contacts 141 are connected by corresponding wires, and the adjacent connecting contacts 111 or stimulating contacts 141 are separated by insulators to maintain electrical isolation.
所述目视标记150用于电极导管植入时的对穿刺深度的监视，可为在所述保护套管120上蚀刻、刷涂、粘贴具有明显区分性的颜色或结构，例如在所述保护套管120上刷涂白色条纹，或在所述保护套管120上粘贴白色条带等。本实施例中，所述目视标记150为用白色硅橡胶薄带粘贴在所述保护套管120上而成的标记带。The visual mark 150 is used for monitoring the puncture depth when the electrode catheter is implanted, and can be etched, brushed, pasted on the protective sleeve 120 with a clearly distinguishable color or structure, for example, on the protective sleeve 120 Paint white stripes on the sleeve 120 , or paste white stripes on the protective sleeve 120 . In this embodiment, the visual mark 150 is a marking tape formed by sticking a thin white silicon rubber tape on the protective sleeve 120 .
本实施例中，所述固定件160的个数为四个，每一固定件160包括四个固定翼161和一固定部162，所述固定件160通过其所述固定部162套设于所述保护套管120，每一固定翼161与所述固定部162相连，每一固定翼161在自由状态下自由端远离所述固定部162的方向翘起延伸。所述固定件160用于所述电极导管100植入后的位置固定。所述固定件160具有单方向收缩性，在所述电极导管100通过所述穿刺管400植入时所述固定翼161收缩，方便穿刺植入，而在植入后所述固定翼161自动张开、嵌入到人体组织中，对电极导管产生固定作用。所述固定件160的材料为聚氨酯、硅橡胶或聚氨酯-硅橡胶共聚物。本实施例中，所述固定件160由硬度为80A的硅橡胶材料制作，所述固定件160的固定部162通过黏合剂粘接在所述保护套管120上。In this embodiment, the number of the fixing parts 160 is four, and each fixing part 160 includes four fixing wings 161 and a fixing part 162, and the fixing part 160 is sheathed on the fixing parts 162 through the fixing parts 162. In the protective sleeve 120, each fixing wing 161 is connected to the fixing portion 162, and the free end of each fixing wing 161 tilts and extends away from the fixing portion 162 in a free state. The fixing member 160 is used for fixing the position of the electrode catheter 100 after implantation. The fixing member 160 has unidirectional shrinkage, and when the electrode catheter 100 is implanted through the puncture tube 400, the fixing wings 161 shrink to facilitate puncture implantation, and the fixing wings 161 automatically expand after implantation. Open and embed into human tissue to fix the electrode catheter. The material of the fixing member 160 is polyurethane, silicone rubber or polyurethane-silicone rubber copolymer. In this embodiment, the fixing member 160 is made of silicone rubber material with a hardness of 80A, and the fixing portion 162 of the fixing member 160 is bonded to the protective sleeve 120 by an adhesive.
所述穿刺针300用于寻找靶点185，所述穿刺针300上设置有标记刻线310，所述穿刺管400用于辅助所述电极导管100的刺激触点141放入靶点185位置。所述穿刺管400的内管径大于所述穿刺针300及电极导管100的外径，以至于使得所述所述穿刺管400顺利套设于所述穿刺针300或电极导管100。所述穿刺管400设置有标记刻线(未标示)。在这里通过图2进一步说明本实施例提供的所述植入式神经电刺激电极组件的使用方法。应用本发明的植入式神经电刺激电极组件时医生先将所述穿刺针300放入人体组织180中寻找到靶点185部位，此时所述穿刺针300的所述标记刻线310外露于人体组织180，然后沿着所述穿刺针300放置所述穿刺管400于人体组织180内，使得所述穿刺管400上的标记刻线与所述穿刺针300上的标记刻线310对齐，随后从人体组织180拔出所述穿刺针300，将电极导管100通过所述穿刺管400的中空空间植入人体组织180，待电极导管100上的目视标记150与穿刺管400上的标记刻线对齐，即已表明电极导管到达预定位置。随后从人体组织180拔出所述穿刺管400，所述电极导管100上的所述固定件160的固定翼161张开、嵌入到人体组织180，实现所述电极导管100的固定。The puncture needle 300 is used to find the target point 185 , the puncture needle 300 is provided with a marking line 310 , and the puncture tube 400 is used to assist the stimulation contact 141 of the electrode catheter 100 to be placed at the target point 185 . The inner diameter of the puncture tube 400 is larger than the outer diameter of the puncture needle 300 and the electrode catheter 100 , so that the puncture tube 400 can be sleeved on the puncture needle 300 or the electrode catheter 100 smoothly. The puncture tube 400 is provided with marking lines (not marked). Here, FIG. 2 is used to further illustrate the usage method of the implantable nerve electrical stimulation electrode assembly provided in this embodiment. When applying the implantable nerve electrical stimulation electrode assembly of the present invention, the doctor first puts the puncture needle 300 into the human tissue 180 to find the target point 185, and at this time, the marking line 310 of the puncture needle 300 is exposed on the human tissue 180, and then place the puncture tube 400 in the human tissue 180 along the puncture needle 300, so that the marked score line on the puncture tube 400 is aligned with the marked score line 310 on the puncture needle 300, and then Pull out the puncture needle 300 from the human tissue 180, implant the electrode catheter 100 into the human tissue 180 through the hollow space of the puncture tube 400, and wait for the visual mark 150 on the electrode catheter 100 to match the marking line on the puncture tube 400 Alignment indicates that the lead is in its intended position. Then the puncture tube 400 is pulled out from the human tissue 180 , and the fixing wings 161 of the fixing member 160 on the electrode catheter 100 are opened and embedded into the human tissue 180 to realize the fixing of the electrode catheter 100 .
请参阅图3及图4，本发明第二实施例提供的植入式神经电刺激电极组件及电极导管100。本实施例的植入式神经电刺激电极组件及电极导管100与上述第一实施例的植入式神经电刺激电极组件及电极导管100基本相同，不同之处在于，所述电极导管100进一步包括一第二目视标记155，该第二目视标记155与所述第一目视标记150间隔一定距离，相对于所述第一目视标记150靠近所述连接端部110设置，故，所述第二目视标记155位于所述第一目视标记150与所述连接端部110之间。Please refer to FIG. 3 and FIG. 4 , the implantable nerve electrical stimulation electrode assembly and the electrode catheter 100 provided by the second embodiment of the present invention. The implantable electrical nerve stimulation electrode assembly and the electrode catheter 100 of this embodiment are basically the same as the implantable electrical nerve stimulation electrode assembly and the electrode catheter 100 of the first embodiment above, the difference is that the electrode catheter 100 further includes A second visual mark 155, the second visual mark 155 is spaced a certain distance from the first visual mark 150, and is arranged near the connecting end 110 relative to the first visual mark 150, so the The second visual mark 155 is located between the first visual mark 150 and the connection end 110 .
应用本实施例的植入式神经电刺激电极组件时医生将电极导管100沿穿刺管400插入人体，当电极导管100的第一目视标记150与穿刺管400的顶面对齐时，电极导管100的刺激端部140已到达预定位置，此时停止电极导管100的插入动作；然后保持电极导管100不动，将穿刺管400向外拔，当穿刺管400的顶面与电极导管100的第二目视标记155对齐时，电极导管100的固定件160已完全伸出穿刺管400。电极导管100的固定件160在穿刺管400中时其固定翼161处于压缩状态，此时电极导管100与穿刺管400之间有较大的摩擦力，在此期间，医生应仔细操作，避免电极导管100或穿刺管400随对方移动。When applying the implantable nerve electrical stimulation electrode assembly of this embodiment, the doctor inserts the electrode catheter 100 into the human body along the puncture tube 400, and when the first visual mark 150 of the electrode catheter 100 is aligned with the top surface of the puncture tube 400, the electrode catheter When the stimulating end 140 of 100 has reached the predetermined position, stop the insertion of the electrode catheter 100; then keep the electrode catheter 100 still, pull the puncture tube 400 outward, When the two visual marks 155 are aligned, the fixing part 160 of the electrode catheter 100 has fully protruded from the puncture tube 400 . When the fixing part 160 of the electrode catheter 100 is in the puncture tube 400, its fixing wings 161 are in a compressed state. At this time, there is a relatively large friction force between the electrode catheter 100 and the puncture tube 400. During this period, the doctor should operate carefully to avoid electrode Catheter 100 or puncture tube 400 moves with each other.
请参阅图5，本发明第三实施例提供的植入式神经电刺激电极组件的电极导管100。本实施例的植入式神经电刺激电极组件的电极导管100与上述第一实施例的植入式神经电刺激电极组件的电极导管100基本相同，不同之处在于，所述电极导管100进一步包括两个X光显影标记170，设置于所述固定件160的起始部位和终止部位各一个。所述X光显影标记170用于电极导管100植入后在X射线下确定固定件160的位置。所述X光显影标记170由对X射线吸收衰减较大的材料制作，例如钽、铂、铂铱合金、铂钨合金或含钡的聚合物等。本实施例中，X光显影标记170由铂铱合金制作。Please refer to FIG. 5 , which shows an electrode catheter 100 of an implantable nerve electrical stimulation electrode assembly according to a third embodiment of the present invention. The electrode catheter 100 of the implantable electrical nerve stimulation electrode assembly of this embodiment is basically the same as the electrode catheter 100 of the implantable electrical nerve stimulation electrode assembly of the first embodiment above, the difference is that the electrode catheter 100 further includes Two X-ray development marks 170 are arranged at the starting position and the ending position of the fixing member 160 respectively. The X-ray imaging mark 170 is used to determine the position of the fixing member 160 under X-ray after the electrode catheter 100 is implanted. The X-ray imaging mark 170 is made of a material that absorbs and attenuates large X-rays, such as tantalum, platinum, platinum-iridium alloy, platinum-tungsten alloy, or barium-containing polymer. In this embodiment, the X-ray imaging mark 170 is made of platinum-iridium alloy.
请参阅图6，本发明第四实施例提供的植入式神经电刺激电极组件的电极导管100。本实施例的植入式神经电刺激电极组件的电极导管100与上述第二实施例的植入式神经电刺激电极组件的电极导管100基本相同不同之处在于，所述电极导管100进一步包括两个X光显影标记170，设置于所述固定件160的起始部位和终止部位各一个。所述X光显影标记170用于电极导管100植入后在X射线下确定固定件160的位置。所述X光显影标记170由对X射线吸收衰减较大的材料制作，例如钽、铂、铂铱合金、铂钨合金或含钡的聚合物等。本实施例中，X光显影标记170由铂铱合金制作。Please refer to FIG. 6 , an electrode catheter 100 of an implantable electrical nerve stimulation electrode assembly provided by a fourth embodiment of the present invention. The electrode catheter 100 of the implantable electrical nerve stimulation electrode assembly of this embodiment is basically the same as the electrode catheter 100 of the implantable electrical nerve stimulation electrode assembly of the second embodiment above, except that the electrode catheter 100 further includes two There are two X-ray developing marks 170 , one at the start and one end of the fixing member 160 . The X-ray imaging mark 170 is used to determine the position of the fixing member 160 under X-ray after the electrode catheter 100 is implanted. The X-ray imaging mark 170 is made of a material that absorbs and attenuates large X-rays, such as tantalum, platinum, platinum-iridium alloy, platinum-tungsten alloy, or barium-containing polymer. In this embodiment, the X-ray imaging mark 170 is made of platinum-iridium alloy.
相对于现有技术，本发明提供的植入式神经电刺激电极组件具有以下有益效果：电极的植入手术由传统的外科手术变成了简单的穿刺手术，并且，穿刺针、穿刺管以及电极导管均有对应的目视标记，对于医生而言手术操作更加简单、手术用时减少；对于患者而言，可以用局部麻醉代替全身麻醉，麻醉风险大大减小，同时穿刺手术创伤小，伤口愈合快，使得患者更加舒适。故，本发明提供的植入式神经电刺激电极组件结构简单、医生易于操作、病人创伤小、成本较低。Compared with the prior art, the implantable nerve electrical stimulation electrode assembly provided by the present invention has the following beneficial effects: the implantation operation of the electrode is changed from a traditional surgical operation to a simple puncture operation, and the puncture needle, puncture tube and electrode Catheters have corresponding visual marks, which makes the operation easier for doctors and reduces the operation time; for patients, local anesthesia can be used instead of general anesthesia, which greatly reduces the risk of anesthesia, and at the same time, the trauma of puncture surgery is small and the wound heals quickly , making the patient more comfortable. Therefore, the implantable nerve electrical stimulation electrode assembly provided by the present invention has a simple structure, is easy for doctors to operate, has little trauma to the patient, and is low in cost.
另外，本领域技术人员还可在本发明精神内做其他变化，当然，这些依据本发明精神所做的变化，都应包含在本发明所要求保护的范围之内。In addition, those skilled in the art can also make other changes within the spirit of the present invention. Of course, these changes made according to the spirit of the present invention should be included within the scope of protection claimed by the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510596458.2ACN105056397B (en) | 2015-09-18 | 2015-09-18 | Implantable neural electrical stimulation electrode assemblie and its application process |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510596458.2ACN105056397B (en) | 2015-09-18 | 2015-09-18 | Implantable neural electrical stimulation electrode assemblie and its application process |
| Publication Number | Publication Date |
|---|---|
| CN105056397Atrue CN105056397A (en) | 2015-11-18 |
| CN105056397B CN105056397B (en) | 2017-07-11 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510596458.2AActiveCN105056397B (en) | 2015-09-18 | 2015-09-18 | Implantable neural electrical stimulation electrode assemblie and its application process |
| Country | Link |
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| CN (1) | CN105056397B (en) |
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| TA01 | Transfer of patent application right | Effective date of registration:20161111 Address after:102200 Beijing city Changping District Nan Shao Zhen Xing Chang Road No. 1 Building 1 layer 5 Applicant after:BEIJING PINS MEDICAL Co.,Ltd. Address before:100084 Beijing Beijing 100084-82 mailbox Applicant before:Tsinghua University Applicant before:BEIJING PINS MEDICAL Co.,Ltd. | |
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| CP03 | Change of name, title or address | Address after:102200 5th floor, building 1, No.1, Xingchang Road, Nanshao Town, Changping District, Beijing Patentee after:Beijing Pinchi Medical Equipment Co.,Ltd. Country or region after:China Address before:102200 5th floor, building 1, No.1, Xingchang Road, Nanshao Town, Changping District, Beijing Patentee before:BEIJING PINS MEDICAL Co.,Ltd. Country or region before:China |