WO2017173671A1 - 脑深部刺激电极、其制作方法及刺激系统 - Google Patents

脑深部刺激电极、其制作方法及刺激系统 Download PDF

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Publication number
WO2017173671A1
WO2017173671A1 PCT/CN2016/079617 CN2016079617W WO2017173671A1 WO 2017173671 A1 WO2017173671 A1 WO 2017173671A1 CN 2016079617 W CN2016079617 W CN 2016079617W WO 2017173671 A1 WO2017173671 A1 WO 2017173671A1
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electrode
deep brain
stimulation
brain stimulation
contacts
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PCT/CN2016/079617
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English (en)
French (fr)
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豆美娟
朱为然
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苏州景昱医疗器械有限公司
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Publication of WO2017173671A1 publication Critical patent/WO2017173671A1/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
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0534—Electrodes for deep brain stimulation

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  • the invention relates to the technical field of implantable medical devices, in particular to a deep brain stimulation electrode, a manufacturing method thereof and a stimulation system.
  • Implantable nerve electrical stimulation plays an important role in the treatment of neurological dysfunction and the recovery of nerve injury.
  • the implantable nerve electrical stimulation system releases high-frequency electrical stimulation by implanting electrodes in specific nerves of the human body such as motor nerves and sensory nerves to stimulate specific nerves, thereby restoring the human body function to a normal working state.
  • implantable neurostimulation systems include implantable deep brain stimulation (DBS), implantable cortical stimulation (CNS), implantable spinal cord electrical stimulation (SCS), and implantable radial nerve stimulation.
  • DBS implantable deep brain stimulation
  • CNS implantable cortical stimulation
  • SCS implantable spinal cord electrical stimulation
  • VNS implantable vagal nerve stimulation system
  • Implantable deep brain stimulation and other related procedures involving the implantation of electrodes and catheters into the brain are increasingly used to treat conditions like Parkinson's disease, dystonia, essential tremors, epilepsy, obesity, Depression, motor control disorders, and other debilitating diseases.
  • electrodes or other medical devices are strategically placed at the target site of the brain. Positioning the electrode at the "best" or optimal location of deep brain stimulation can be a laborious process.
  • An object of the present invention is to provide a deep brain stimulation electrode, a method for producing the same, and a stimulation system.
  • an embodiment of the present invention provides a deep brain stimulation electrode, the electrode including an electrode body having a proximal end and a distal end, the electrode body having a longitudinal direction and a width direction perpendicular to each other.
  • the electrode further includes a plurality of electrode contacts at the distal end, and the spacing between adjacent two electrode contacts is 1.0 ⁇ 0.1 mm in the length direction.
  • the spacing between adjacent two electrode contacts is 1.0 mm.
  • the width of each of the electrode contacts along the length direction is 1.5 mm.
  • the plurality of electrode contacts are arranged in four rows along the width direction, and a spacing between adjacent two rows is maintained as 1.0 mm.
  • the electrode body has a circular cross section along the width direction.
  • each of the electrode contacts is an annular electrode contact extending in a circumferential direction of the electrode body.
  • an embodiment of the present invention provides a deep brain stimulation electrode, the electrode including a cylindrical electrode body having a proximal end and a distal end, the electrode body having a longitudinal direction, and the electrode further includes A plurality of annular electrode contacts have a spacing between adjacent two annular electrode contacts of 1.0 ⁇ 0.1 mm in the length direction.
  • the spacing between adjacent two annular electrode contacts is 1.0 mm.
  • each of the annular electrode contacts has a width of 1.5 mm along the length direction.
  • the electrode is evenly distributed with four of the annular electrode contacts along the length direction.
  • an embodiment of the present invention provides a deep brain stimulation system comprising the deep brain stimulation electrode as described above.
  • an embodiment of the present invention provides a method for manufacturing a deep brain stimulation electrode, comprising:
  • An electrode body is provided, the electrode body has a proximal end and a distal end, and the electrode body has a length direction;
  • a plurality of electrode contacts are formed at a distal end of the electrode body, and a distance between adjacent two electrode contacts is 1.0 ⁇ 0.1 mm in the length direction.
  • the invention has the beneficial effects that the spacing between adjacent two electrode contacts of the invention is 1.0 ⁇ 0.1 mm, and the spacing design can effectively consider the magnetic resonance deviation and the electrode drift.
  • the deviation of the position of the brain deep stimulating electrode insertion into the nucleus caused by the error condition such as brain collapse and surgical head frame can greatly improve the effective stimulation area of the electrode contact located in the nucleus, thus improving the patient's
  • the stimulating effect reduces the side effects caused by the stimulation when the insertion is performed, and prolongs the battery life in the deep brain electrical stimulation system.
  • FIG. 1 is a schematic view showing the structure of a deep brain stimulation electrode according to an embodiment of the present invention
  • FIG. 2a is a front view and a cross-sectional view of a deep brain stimulation electrode according to an example of the present invention
  • Figure 2b is a front elevational view and a cross-sectional view of a deep brain stimulation electrode of another example of the present invention.
  • FIG. 3 is a front view and an unfolded plan view of a deep brain stimulation electrode according to an example of the present invention
  • FIG. 4 is a schematic view showing the structure of a three-pitch deep brain stimulation electrode insertion nucleus according to an embodiment of the present invention
  • FIG. 5 is a schematic view showing the structure of a deep brain stimulation electrode inserted and an uninserted nuclei according to an embodiment of the present invention
  • 6a-6i are effective stimulation curves of three kinds of deep brain deep stimulation electrodes inserted at respective points of a nucleus according to an embodiment of the present invention
  • Fig. 9 is a flow chart showing a method of producing a deep brain stimulation electrode according to an embodiment of the present invention.
  • the terms “upper”, “upper”, “lower”, “lower”, and the like, as used herein, are used to refer to the relative position of the space for the purpose of description. The relationship to another unit or feature. Terms of spatial relative position may be intended to include different orientations of the device in use or operation other than the orientation shown in the figures. For example, elements that are described as “below” or “beneath” other elements or features are “above” other elements or features. Thus, the exemplary term “lower” can encompass both the above and the The device may be oriented (rotated 90 degrees or other orientation) in other ways and the spatially related descriptors used herein interpreted accordingly.
  • the brain deep stimulation electrode 100 of the present embodiment includes an electrode body 10 having a proximal end and a distal end, and the electrode body 10 has perpendicular to each other.
  • the electrode 100 further includes a plurality of electrode contacts 11 at the distal end.
  • the spacing L between adjacent two electrode contacts 11 is 1.0 ⁇ 0.1 mm.
  • the pitch P between two adjacent electrode contacts 11 may have a certain error range due to manufacturing process or other errors.
  • the longitudinal direction A herein is defined as the extending direction of the electrode body 10.
  • the pitch L design of the present embodiment can effectively take into account the deviation of the position of the deep brain stimulation electrode 100 inserted into the nucleus 200 due to errors such as magnetic resonance deviation, electrode drift, brain collapse, and head frame.
  • the effective stimulation area of the electrode contact 11 located in the nuclear group is greatly improved, thereby improving the stimulation effect on the patient, reducing the side effects caused by the stimulation when the insertion is performed, and prolonging the battery use in the deep brain stimulation system. life.
  • the electrode body 10 can be in various forms, as shown in FIGS. 2a-2b, which are schematic views of various forms of the electrode body 10, including a front view of the electrode body 10 and a cross section along the width direction B.
  • Figure. As shown in Figure 2a As shown, the electrode body 10 is a cylindrical electrode body 10a, and the cylindrical electrode body 10a has a circular cross section in the width direction B at this time. As shown in FIG. 2b, the electrode body 10 is a flat electrode body 10b, and the cross section of the flat electrode body 10b in the width direction B is rectangular in shape.
  • the electrode body 10 can also be in other forms, and is not limited to the above examples.
  • the electrode contact 11 located at the distal end of the electrode body 10 can also be in various forms.
  • the electrode body 10 is a cylindrical electrode body 10a and the spacing L between the electrode contacts 11 is 1.0 mm.
  • a front view and a developed tile view of the cylindrical electrode body 10a which is defined as a tile pattern in which the longitudinal direction A is a dividing line and spreads in the width direction B, is included.
  • the electrode contact 11 is an annular electrode contact 11a extending in the circumferential direction of the cylindrical electrode body 10, and the annular electrode contact 11a is connected end to end.
  • a plurality of annular electrode contacts 11a are arranged in four rows along the width direction B, and the spacing L between adjacent rows is maintained at 1.0 mm.
  • the width of each of the electrode contacts 11 along the length direction A is 1.5 mm, but not limited thereto.
  • the deep brain stimulation electrode of the present invention will be described in detail below with a specific example.
  • This example is exemplified by a cylindrical electrode body 10a having four annular electrode contacts 11a, and four annular electrode contacts 11a are evenly distributed on the cylindrical electrode body 10a.
  • the brain deep stimulation electrode of the present example is a schematic diagram for realizing an effective stimulation area.
  • the brain deep stimulating electrode 100 having the pitch between the adjacent annular electrode contacts 11a of 0.5 mm, 1.0 mm, and 1.5 mm, respectively, is accurately projected into the center of the nucleus 200 as an example.
  • the deep brain stimulating electrode 100 has the best stimulating effect on the patient, that is, the deep brain stimulating electrode 100 protrudes into the nucleus 200.
  • the higher the probability that the effective stimulation area is the two annular electrode contacts 11a the better the stimulation effect of the deep brain stimulation electrode 100 on the patient.
  • FIG. 4 is a state diagram in which the doctor extends the deep brain stimulation electrode 100 into the nucleus 200 according to the MRI (magnetic resonance) detection result, and it can be seen that the deep brain is 0.5 mm, 1.0 mm, and 1.5 mm apart.
  • the stimulating electrode 100 ensures that two annular electrode contacts 11a are located in the nucleus 200, and it is considered that the deep brain stimulating electrode 100 is at the optimum position considered by the doctor.
  • the actual situation is that the relative position of the deep brain stimulation electrode 100 and the nucleus 200 changes due to the above-mentioned error condition, as shown in the schematic diagram in the right frame in FIG.
  • the schematic diagram in the right frame is also Schematic diagram of the actual stimulation process, the deep brain stimulation electrode 100 relative to the left frame
  • the internal schematic diagram has been moved downward.
  • the deep brain stimulation electrodes 100 having a pitch of 0.5 mm and 1.5 mm have only one annular electrode contact 11a located in the nuclear group 200.
  • the deep brain stimulating electrode 100 having a pitch of 1.0 mm still has two annular electrode contacts 11a located in the nucleus, that is, the effective stimulation area of the deep brain stimulating electrode 100 with a pitch of 1.0 mm extending into the nucleus 200.
  • the probability of being two annular electrode contacts 11a is high.
  • the probability that the effective stimulation area of the deep brain stimulation electrode 100 extending into the nucleus 200 with the interval of 1.0 mm is two annular electrode contacts 11a is high, and on the one hand, the stimulation effect of the deep brain stimulation electrode 100 can be maintained at all times.
  • the deep brain stimulation electrode 100 since the deep brain stimulation electrode 100 always maintains a large stimulation area, the service life of the power supply battery in the deep brain stimulation system can be greatly prolonged.
  • the deep brain stimulation electrode 100 further includes a plurality of wires (not labeled) connected to the plurality of annular electrode contacts 11a, in order to prevent the insulation effectiveness between the wires from being fixed, in order to prevent more effectively Short-circuiting between adjacent annular electrode contacts 11a, preferably increasing the spacing between adjacent annular electrode contacts 11a, as shown by the deep brain stimulation electrode 100 with a pitch of 1.5 mm as in the present example;
  • the adjacent ring-shaped electrode contacts 11a are minimized.
  • the spacing between the electrodes is shown as a deep brain stimulation electrode 100 with a spacing of 0.5 mm as in the present example.
  • the deep brain stimulation electrode 100 with a pitch of 0.5 mm and 1.5 mm is also the commonly used deep brain stimulation electrode 100, and the deep brain stimulation electrode 100 with a spacing of 1.0 mm proposed by the present invention can avoid the adjacent annular electrode touch.
  • the short circuit between the points 11a can also increase the effective stimulation area of the annular electrode contact 11a in a nucleus 200, and more importantly, the deep brain stimulating electrode 100 having a pitch of 1.0 mm can be considered in various errors.
  • the probability that the effective stimulation area is two annular electrode contacts 11a is greatly improved, and the deep brain stimulation electrode 100 having a pitch of 1.0 mm is superior to the deep brain stimulation electrode 100 having a pitch of 0.5 mm and 1.5 mm.
  • the deep brain stimulation electrode 100 of the present example having a pitch of 1.0 mm is also advantageous in that the side effect to the patient caused by the stimulation of the deep brain stimulation electrode 100 can be reduced.
  • FIG. 5 is a schematic structural view of the deep brain stimulation electrode 100 not inserted and inserted into the nuclei 200
  • FIGS. 6a-6i are different depths of the brain deep stimulation electrode 100 in each of the nuclei 200.
  • the ring electrode contact 11a at the time of position insertion is an effective stimulation graph.
  • a representative nine points (a point, b point, c point, d point, e point, f point, g point, h point, and o point) are exemplified on the nuclei 200, wherein
  • the o point is the center point of the nuclear group 200, and is also the point where the theoretical stimulation effect is the best.
  • the other points a to h can be regarded as the point deviating from the center point of the nuclear group 200, that is, when the deep brain stimulation electrode 100 When inserted to any point from point a to point h, the deep brain stimulation electrode 100 is determined to be in an insertion state.
  • the abscissa of the effective stimulation curve of the annular electrode contact 11a is defined as the depth of the inserted nucleus of the deep brain stimulation electrode 100, and the ordinate is defined as the effective stimulation length of the annular electrode contact 11a (i.e., along the edge) Longitudinal direction A, the total length of the annular electrode contact 11a which is actually provided with the stimulation pulse in the nuclear group 200), and then the deep brain stimulation electrodes 100 having the intervals of 0.5 mm, 1.0 mm and 1.5 mm are respectively taken in the nuclei 200.
  • the effective stimulation length change curve when the depth of the inserted nuclei is increased, and the area formed by the curve and the abscissa can indicate the effective stimulation area of the annular electrode contact 11a. It can be seen that the effective stimulation area of the deep brain stimulation electrode 100 with a pitch of 1.0 mm is always kept the maximum, whether at the insertion position (point a to point h) or at the center point o point, that is, when some errors When the situation occurs and the relative position of the deep brain stimulation electrode 100 and the nuclei 200 changes or the deep brain stimulation electrode 100 is inserted, the stimulation effect of the deep brain stimulation electrode 100 with a pitch of 1.0 mm is always optimal.
  • the 1.0 mm deep brain stimulation electrode 100 can reduce the side effects caused by the stimulation of the deep brain stimulation electrode 100.
  • the probability that the effective stimulation area of the deep brain stimulation electrode 100 extending into the nucleus 200 with the interval of 1.0 mm is the two annular electrode contacts 11a is the highest.
  • the effective thickness of the nuclei 200 is H
  • the upper end of the nuclei 200 is C point
  • the lower end of the nuclei 200 is D point
  • H DC
  • the effective thickness H is defined as the deep brain stimulation electrode 100.
  • the electrode contact 11 includes four annular electrode contacts 11a having a width of 1.5 mm in the longitudinal direction A, and three annular electrode contacts 11a include three pitches each having a length of ⁇ mm, and the deep brain stimulation electrode 100
  • the available stimulation length is (6+3 ⁇ ) mm, where ⁇ [0, 2], the lower edge of the annular electrode contact 11a of the deep brain stimulation electrode 100 is the actual coordinate point x;
  • the target of the deep brain stimulation electrode 100 is D point, and the allowable error range of implantation is ⁇ 5 mm, then x ⁇ [D-5, D+5], when the ring electrode contact 11a having at least m length is in the core
  • the effective thickness H of the nuclei 200 is typically in the 4-6 mm range (varies from person to person).
  • the present invention also provides a deep brain stimulation device comprising the deep brain stimulation electrode 100 as described above, a control device for connecting electrodes, and the like.
  • An embodiment of the present invention further provides a method for manufacturing a deep brain stimulation electrode. As shown in FIG. 9, the method includes the following steps:
  • An electrode body 10 is provided, the electrode body 10 has a proximal end and a distal end, and the electrode body 10 has a length direction A;
  • a plurality of electrode contacts 11 are formed at the distal end of the electrode body 10. In the longitudinal direction A, the spacing between adjacent two electrode contacts 11 is 1.0 ⁇ 0.1 mm.
  • the pitch P design of the present embodiment can effectively take into account the deviation of the position of the deep brain stimulation electrode 100 inserted into the nucleus 200 due to the presence of errors such as magnetic resonance deviation, electrode drift, brain collapse, and surgical head frame, and thus can greatly Increasing the effective stimulation area of the electrode contact 11 located in the nuclear group, thereby improving the stimulation effect on the patient, reducing the side effects caused by the stimulation when the insertion is performed, and prolonging the battery life in the deep brain electrical stimulation system.

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Abstract

一种脑深部刺激电极（100）、其制作方法及刺激系统，所述电极（100）包括具有近端及远端的电极本体（10、10a），所述电极本体（10、10a）具有相互垂直的长度方向（A）及宽度方向（B），所述电极（100）还包括位于远端的若干电极触点（11、11a），于所述长度方向（A）上，相邻两个电极触点（11、11a）之间的间距（L）为1.0±0.1毫米。如此的间距设计，可以有效考虑到因磁共振偏差、电极漂移、脑部塌陷、手术头架等误差情况存在而引起的脑深部刺激电极（100）插入核团（200）的位置的偏差，从而可以大大提高位于核团（200）内的电极触点（11、11a）有效刺激面积，如此，提高了对患者的刺激效果，减少了插偏时刺激所带来的副作用，且延长了脑深部电刺激系统中的电池使用寿命。

Description

脑深部刺激电极、其制作方法及刺激系统
本申请要求了申请日为2016年04月07日，申请号为201610213488.5，发明名称为“脑深部刺激电极、其制作方法及刺激系统”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本发明涉及植入式医疗器械技术领域，尤其涉及一种脑深部刺激电极、其制作方法及刺激系统。
背景技术
神经电刺激在神经功能失调治疗和神经损伤康复中具有重要的作用。植入式神经电刺激系统通过在人体内诸如运动神经、感觉神经的特定神经处植入电极，来释放高频电刺激，以对于特定神经进行刺激，从而使人体机能恢复到正常运作的状态。目前，植入式神经电刺激系统主要包括植入式脑深部电刺激(DBS)，植入式脑皮层刺激(CNS)，植入式脊髓电刺激系统(SCS)，植入式骶神经电刺激系统(SNS)，植入式迷走神经电刺激系统(VNS)等等。
植入式脑深部电刺激(DBS)以及其他涉及向脑部植入电极和导管的有关手术越来越多地用来治疗像帕金森症、肌张力障碍、特发性震颤、癫痫、肥胖、抑郁、运动控制障碍及其他使人衰弱的疾病。在这些手术中，策略地把电极或其他医疗器件放置在脑部的目标部位。将电极定位在脑深部刺激的“最佳”或最优部位可能是辛苦的过程。
现有技术中，植入式脑深部电刺激系统中的电极植入患者脑部核团时，在医生手术误差等于零的情况下，因为存在磁共振偏差、电极漂移、脑部塌陷、手术头架等产生误差的情况，所以往往电极不会维持在医生希望的核团最佳位置，包括在核团的上下左右都会存在这样的不确定误差问题，如此，电极上提供刺激脉冲的电极触点有效刺激面积就会减少，对医生手术操作的成功率及患者使用效果都有很大的影响。
发明内容
本发明的目的在于提供一种脑深部刺激电极、其制作方法及刺激系统。
为实现上述发明目的之一，本发明一实施方式提供一种脑深部刺激电极，所述电极包括具有近端及远端的电极本体，所述电极本体具有相互垂直的长度方向及宽度方向，所述电极还包括位于远端的若干电极触点，于所述长度方向上，相邻两个电极触点之间的间距为1.0±0.1毫米。
作为本发明一实施方式的进一步改进，相邻两个电极触点之间的间距为1.0毫米。
作为本发明一实施方式的进一步改进，每一所述电极触点沿所述长度方向的宽度为 1.5毫米。
作为本发明一实施方式的进一步改进，当所述电极本体处于展开平铺状态时，所述若干电极触点沿所述宽度方向呈四排排布，且相邻两排之间的间距保持为1.0毫米。
作为本发明一实施方式的进一步改进，所述电极本体沿所述宽度方向的截面为圆形。
作为本发明一实施方式的进一步改进，每一所述电极触点为沿所述电极本体圆周方向延伸的环状电极触点。
为实现上述发明目的之一，本发明一实施方式提供一种脑深部刺激电极，所述电极包括具有近端及远端的圆柱状电极本体，所述电极本体具有长度方向，所述电极还包括若干环状电极触点，于所述长度方向上，相邻两个环状电极触点之间的间距为1.0±0.1毫米。
作为本发明一实施方式的进一步改进，相邻两个环状电极触点之间的间距为1.0毫米。
作为本发明一实施方式的进一步改进，每一所述环状电极触点沿所述长度方向的宽度为1.5毫米。
作为本发明一实施方式的进一步改进，所述电极沿所述长度方向均匀分布有四个所述环状电极触点。
为实现上述发明目的之一，本发明一实施方式提供一种脑深部刺激系统，包括如上所述的脑深部刺激电极。
为实现上述发明目的之一，本发明一实施方式提供一种脑深部刺激电极制作方法，包括：
提供一电极本体，所述电极本体具有近端及远端，且所述电极本体具有长度方向；
于所述电极本体的远端形成若干电极触点，于所述长度方向上，相邻两个电极触点之间的间距为1.0±0.1毫米。
与现有技术相比，本发明的有益效果在于：本发明的相邻两个电极触点之间的间距为1.0±0.1毫米，如此的间距设计，可以有效考虑到因磁共振偏差、电极漂移、脑部塌陷、手术头架等误差情况存在而引起的脑深部刺激电极插入核团的位置的偏差，从而可以大大提高位于核团内的电极触点有效刺激面积，如此，提高了对患者的刺激效果，减少了插偏时刺激所带来的副作用，且延长了脑深部电刺激系统中的电池使用寿命。
附图说明
图1是本发明一实施方式的脑深部刺激电极结构示意图；
图2a是本发明一示例的脑深部刺激电极主视图及横截面图；
图2b是本发明另一示例的脑深部刺激电极主视图及横截面图；
图3是本发明一示例的脑深部刺激电极主视图及展开平铺图；
图4是本发明一实施方式的三种间距的脑深部刺激电极插入核团的结构示意图；
图5是本发明一实施方式的脑深部刺激电极插入及未插入核团的结构示意图；
图6a-6i本发明一实施方式的三种间距的脑深部刺激电极于核团各个点插入时的有效刺激曲线图；
图7-8是本发明一实施方式的数学依据推导示意图；
图9是本发明一实施方式的脑深部刺激电极制作方法步骤图。
具体实施方式
以下将结合附图所示的具体实施方式对本发明进行详细描述。但这些实施方式并不限制本发明，本领域的普通技术人员根据这些实施方式所做出的结构、方法、或功能上的变换均包含在本发明的保护范围内。
为清楚地表达本申请内所描述的位置与方向，以器械操作者作为参照，靠近操作者的一端为近端，远离操作者的一端为远端。另外，本申请使用的例如“上”、“上方”、“下”、“下方”等表示空间相对位置的术语是出于便于说明的目的来描述如附图中所示的一个单元或特征相对于另一个单元或特征的关系。空间相对位置的术语可以旨在包括设备在使用或工作中除了图中所示方位以外的不同方位。例如，如果将图中的设备翻转，则被描述为位于其他单元或特征“下方”或“之下”的单元将位于其他单元或特征“上方”。因此，示例性术语“下方”可以囊括上方和下方这两种方位。设备可以以其他方式被定向(旋转90度或其他朝向)，并相应地解释本文使用的与空间相关的描述语。
如图1所示，为本发明一实施方式的脑深部刺激电极结构示意图，本实施方式的脑深部刺激电极100包括具有近端及远端的电极本体10，所述电极本体10具有相互垂直的长度方向A及宽度方向B，所述电极100还包括位于远端的若干电极触点11，于所述长度方向A上，相邻两个电极触点11之间的间距L为1.0±0.1毫米。需要说明的是，由于制作工艺或其他方面的误差，相邻两个电极触点11之间的间距P可具有一定的误差范围。另外，这里的长度方向A定义为电极本体10的延伸方向。
本实施方式的间距L设计，可以有效考虑到因磁共振偏差、电极漂移、脑部塌陷、手术头架等误差情况存在而引起的脑深部刺激电极100插入核团200的位置的偏差，从而可以大大提高位于核团内的电极触点11的有效刺激面积，如此，提高了对患者的刺激效果，减少了插偏时刺激所带来的副作用，且延长了脑深部电刺激系统中的电池使用寿命。
在本实施方式中，所述电极本体10可为多种形态，如图2a-2b所示，为电极本体10多种形态的示意图，包括电极本体10的正视图及沿宽度方向B的横截面图。如图2a 所示，电极本体10为圆柱状电极本体10a，此时圆柱状电极本体10a沿宽度方向B的横截面呈圆形。如图2b所示，电极本体10为扁平状电极本体10b，此时扁平状电极本体10b沿宽度方向B的横截面呈类矩形。当然，电极本体10还可为其他形态，并不以上述举例为限。
在本实施方式中，位于电极本体10远端的电极触点11也可为多种形态，这里，以电极本体10为圆柱状电极本体10a且电极触点11之间的间距L为1.0毫米为例，包括圆柱状电极本体10a的正视图及展开平铺图，所述展开平铺图定义为以长度方向A为分割线且沿宽度方向B展开的平铺图。如图3所示，所述电极触点11为沿所述圆柱状电极本体10圆周方向延伸的环状电极触点11a，环状电极触点11a首尾相连，当圆柱状电极本体10a展开时，若干环状电极触点11a沿所述宽度方向B呈四排排布，且相邻两排之间的间距L保持为1.0毫米。
在本实施方式中，每一所述电极触点11沿所述长度方向A的宽度为1.5毫米，但不以此为限。
下面以一具体示例来详细介绍本发明的脑深部刺激电极。本示例以具有四个环状电极触点11a的圆柱状电极本体10a为例，四个环状电极触点11a均匀分布在圆柱状电极本体10a上。
如图4所示，为本示例的脑深部刺激电极实现提高有效刺激面积的示意图。这里，分别以相邻环状电极触点11a之间的间距为0.5毫米、1.0毫米及1.5毫米的脑深部刺激电极100准确伸入核团200中心为例。在实际运用中，当有两个环状电极触点11a位于核团200内时，脑深部刺激电极100对患者的刺激效果最佳，也就是说，脑深部刺激电极100伸入核团200的有效刺激面积为两个环状电极触点11a的概率越高，脑深部刺激电极100对患者的刺激效果越好。
在实际运用中，因为存在磁共振偏差、电极漂移、脑部塌陷、手术头架等产生误差的情况，例如，MRI(磁共振)检测结果本身有偏差、开颅后颅内压发生变化而导致与开颅前的MRI检测结果有差异、脑部塌陷导致脑深部刺激电极100与核团200的相对位置发生偏差等等，脑深部刺激电极100于核团200的位置并不能很好地维持在医生认为的最佳位置处。假设图4中的左框内为医生根据MRI(磁共振)检测结果将脑深部刺激电极100伸入核团200的状态图，可以看到，间距为0.5毫米、1.0毫米及1.5毫米的脑深部刺激电极100均保证有两个环状电极触点11a位于核团200内，此时可以认为脑深部刺激电极100处于医生认为的最佳位置。但实际情况是，由于上述提到的误差情况的存在，脑深部刺激电极100与核团200的相对位置会发生变化，如图4中的右框内的示意图所示，右框内的示意图也是实际刺激过程的示意图，脑深部刺激电极100相对左框 内的示意图发生了下移，此时，可以看到，考虑到上述误差情况后，间距为0.5毫米及1.5毫米的脑深部刺激电极100均仅有一个环状电极触点11a位于核团200内，而间距为1.0毫米的脑深部刺激电极100仍有两个环状电极触点11a位于核团内，也就是说，间距为1.0毫米的脑深部刺激电极100伸入核团200的有效刺激面积为两个环状电极触点11a的概率较高。
这里，间距为1.0毫米的脑深部刺激电极100伸入核团200的有效刺激面积为两个环状电极触点11a的概率较高，一方面，可以使得脑深部刺激电极100的刺激效果始终保持较佳，另一方面，由于脑深部刺激电极100始终保持较大的刺激面积，可以大大延长脑深部刺激系统中供电电池的使用寿命。
在实际运用中，一方面，脑深部刺激电极100还包括与若干环状电极触点11a相连的若干导线(未标示)，在导线之间的绝缘有效性固定的情况下，为了更有效地防止相邻环状电极触点11a之间短路，较佳的做法是加大相邻环状电极触点11a之间的间距，如本示例间距为1.5毫米的脑深部刺激电极100所示；而另一方面，为了增大环状电极触点11a在一个核团200内的有效刺激面积，且不至于每个环状电极触点11a面积过大，会尽量降低相邻环状电极触点11a之间的间距，如本示例间距为0.5毫米的脑深部刺激电极100所示。间距为0.5毫米及1.5毫米的脑深部刺激电极100恰好也是目前比较常用的脑深部刺激电极100，而本发明提出的间距为1.0毫米的脑深部刺激电极100，不仅可以避免相邻环状电极触点11a之间短路，还可以增大环状电极触点11a在一个核团200内的有效刺激面积，更重要的是，间距为1.0毫米的脑深部刺激电极100可以在考虑各种误差的情况下大大提高有效刺激面积为两个环状电极触点11a的概率，相较于间距为0.5毫米及1.5毫米的脑深部刺激电极100，间距为1.0毫米的脑深部刺激电极100的优势明显。
另外，本示例间距为1.0毫米的脑深部刺激电极100的优势还在于可以减少脑深部刺激电极100插偏时刺激所带来的对患者的副作用。具体的，如图5至图6i所示，图5为脑深部刺激电极100未插入及插入核团200的结构示意图，图6a-6i分别为不同间距的脑深部刺激电极100在核团200各个位置插入时的环状电极触点11a有效刺激曲线图。
参图5，在核团200上例举了具有代表性的9个点(a点、b点、c点、d点、e点、f点、g点、h点及o点)，其中，o点是核团200的中心点，也是理论上刺激效果最佳的点，其余的a点至h点均可认为是偏离核团200中心点的点，也就是说，当脑深部刺激电极100插入至a点至h点中任意一点时，脑深部刺激电极100认定为处于插偏状态。
参图6a-图6i，环状电极触点11a有效刺激曲线图的横坐标定义为脑深部刺激电极100的插入核团深度，纵坐标定义为环状电极触点11a的有效刺激长度(即沿长度方向 A上，位于核团200内的实际提供刺激脉冲的环状电极触点11a的总长)，而后分别获取间距为0.5毫米、1.0毫米及1.5毫米的脑深部刺激电极100在核团200内随着插入核团深度加大时的有效刺激长度变化曲线，曲线与横坐标所围设形成的面积便可示意环状电极触点11a的有效刺激面积。可以看到，无论是在插偏位置(a点至h点)，还是在中心位置o点，间距为1.0毫米的脑深部刺激电极100的有效刺激面积始终保持最大，也就是说，当一些误差情况发生而导致脑深部刺激电极100与核团200的相对位置发生变化或脑深部刺激电极100插入时便插偏时，间距为1.0毫米的脑深部刺激电极100的刺激效果始终保持最佳，间距为1.0毫米的脑深部刺激电极100可以减少脑深部刺激电极100插偏时刺激所带来的对患者的副作用。
在本发明中，还提供了间距为1.0毫米的脑深部刺激电极100伸入核团200的有效刺激面积为两个环状电极触点11a的概率最高的数学依据。
如图7及图8所示，假设核团200的有效厚度为H，核团200上端为C点，核团200下端为D点，则H＝D-C，有效厚度H定义为脑深部刺激电极100插入核团200中心点时脑深部刺激电极100位于核团200内的长度。电极触点11包括四个长度方向A的宽度为1.5mm的环状电极触点11a，且四个环状电极触点11a之间包括三个长度均为Δmm的间距，脑深部刺激电极100总的可使用刺激长度为(6+3Δ)mm，其中Δ∈[0,2]，脑深部刺激电极100最下方的环状电极触点11a的下边沿实际坐标点为x；
脑深部刺激电极100的植入目标为D点，植入可允许误差范围为±5mm，则x∈[D-5,D+5]，当至少有m长的环状电极触点11a在核团200内时，x∈[x1,x2]；其中x1＝D-Y,0≤Y≤5；x2＝D+Z,0≤Z≤5。
参图8，
当0.0≤m≤1.5mm时，x1＝D-(H-m)；x2＝D+(6+3Δ-m)；
当1.5＜m≤3.0mm时，x1＝D-(H-m-Δ)；x2＝D+(6+2Δ-m)；
当3.0＜m≤4.5mm时，x1＝D-(H-m-2Δ)；x2＝D+(6+Δ-m)；
当4.5＜m≤6.0mm时，x1＝D-(H-m-3Δ)；x2＝D+(6-m)；
如果植入位置服从均匀分布，即x～U[D-5,D+5],则至少有m长的环状电极触点11a在核团200内的概率P＝(x2-x1)/10。
在植入式脑深部电刺激手术应用中，核团200的有效厚度H通常在4～6mm区间(因人而异)。
假设m＝3.0，此时：
当Δ≤1，且4≤H≤6时，x1＝D-(H-3-Δ)；x2＝D+(3+2Δ)；P＝(x2-x1)/10＝(H+Δ)/10，也就是说，若H一定，则当Δ＝1时，概率P最大；
当Δ＞1，且4≤H≤6时x1＝D-(H-3-Δ)；x2＝D+5；P＝(x2-x1)/10＝(H+2-Δ)/10，也就是说，若H一定，则Δ趋近于1时，概率P趋近于最大。
综上可知，当相邻环状电极触点11a之间的间隙Δ＝1mm时，可以使得有3.0mm及以上的环状电极触点11a处于核团200内的概率最大，此时概率P＝(H+1)/10。且当H处于4～6mm区间内时，P∈[0.5，0.7]，即核团200内环状电极触点11a长度不低于3.0mm的几率超过50％。根据上述数学依据，可以进一步证明间距为1.0毫米的脑深部刺激电极100伸入核团200的有效刺激面积为两个环状电极触点11a的概率最高。
本发明还提供一种脑深部刺激装置，包括如上所述的脑深部刺激电极100、连接电极的控制装置等等。
本发明一实施方式还提供一种脑深部刺激电极制作方法，如图9所示，所述方法包括步骤：
提供一电极本体10，所述电极本体10具有近端及远端，且所述电极本体10具有长度方向A；
于所述电极本体10的远端形成若干电极触点11，于所述长度方向A上，相邻两个电极触点11之间的间距为1.0±0.1毫米。
本实施方式的间距P设计，可以有效考虑到因磁共振偏差、电极漂移、脑部塌陷、手术头架等误差情况存在而引起的脑深部刺激电极100插入核团200的位置的偏差从而可以大大提高位于核团内的电极触点11有效刺激面积，如此，提高了对患者的刺激效果，减少了插偏时刺激所带来的副作用，且延长了脑深部电刺激系统中的电池使用寿命。
本实施方式的脑深部刺激电极制作方法的其他说明可以参考上述脑深部刺激电极100结构的说明，在此不再赘述。
应当理解，虽然本说明书按照实施方式加以描述，但并非每个实施方式仅包含一个独立的技术方案，说明书的这种叙述方式仅仅是为清楚起见，本领域技术人员应当将说明书作为一个整体，各实施方式中的技术方案也可以经适当组合，形成本领域技术人员可以理解的其他实施方式。
上文所列出的一系列的详细说明仅仅是针对本发明的可行性实施方式的具体说明，它们并非用以限制本发明的保护范围，凡未脱离本发明技艺精神所作的等效实施方式或变更均应包含在本发明的保护范围之内。

Claims (12)

  1. 一种脑深部刺激电极，所述电极包括具有近端及远端的电极本体，所述电极本体具有相互垂直的长度方向及宽度方向，其特征在于所述电极还包括位于远端的若干电极触点，于所述长度方向上，相邻两个电极触点之间的间距为1.0±0.1毫米。
  2. 根据权利要求1所述的脑深部刺激电极，其特征在于，相邻两个电极触点之间的间距为1.0毫米。
  3. 根据权利要求1所述的脑深部刺激电极，其特征在于，每一所述电极触点沿所述长度方向的宽度为1.5毫米。
  4. 根据权利要求1所述的脑深部刺激电极，其特征在于，当所述电极本体处于展开平铺状态时，所述若干电极触点沿所述宽度方向呈四排排布，且相邻两排之间的间距保持为1.0毫米。
  5. 根据权利要求1所述的脑深部刺激电极，其特征在于，所述电极本体沿所述宽度方向的截面为圆形。
  6. 根据权利要求5所述的脑深部刺激电极，其特征在于，每一所述电极触点为沿所述电极本体圆周方向延伸的环状电极触点。
  7. 一种脑深部刺激电极，所述电极包括具有近端及远端的圆柱状电极本体，所述电极本体具有长度方向，其特征在于所述电极还包括若干环状电极触点，于所述长度方向上，相邻两个环状电极触点之间的间距为1.0±0.1毫米。
  8. 根据权利要求7所述的脑深部刺激电极，其特征在于，相邻两个环状电极触点之间的间距为1.0毫米。
  9. 根据权利要求7所述的脑深部刺激电极，其特征在于，每一所述环状电极触点沿所述长度方向的宽度为1.5毫米。
  10. 根据权利要求8所述的脑深部刺激电极，其特征在于，所述电极沿所述长度方向均匀分布有四个所述环状电极触点。
  11. 一种脑深部刺激系统，其特征在于包括如权利要求1-10中任意一项所述的脑深部刺激电极。
  12. 一种脑深部刺激电极制作方法，其特征在于包括：
    提供一电极本体，所述电极本体具有近端及远端，且所述电极本体具有长度方向；
    于所述电极本体的远端形成若干电极触点，于所述长度方向上，相邻两个电极触点之间的间距为1.0±0.1毫米。
PCT/CN2016/079617 2016-04-07 2016-04-19 脑深部刺激电极、其制作方法及刺激系统 WO2017173671A1 (zh)

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