WO2023245704A1 - 引导装置、用于制造引导装置的方法及使用引导装置的方法 - Google Patents

引导装置、用于制造引导装置的方法及使用引导装置的方法 Download PDF

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Publication number
WO2023245704A1
WO2023245704A1 PCT/CN2022/102317 CN2022102317W WO2023245704A1 WO 2023245704 A1 WO2023245704 A1 WO 2023245704A1 CN 2022102317 W CN2022102317 W CN 2022102317W WO 2023245704 A1 WO2023245704 A1 WO 2023245704A1
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Prior art keywords
section
guide device
electrode wire
sub
electrode
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PCT/CN2022/102317
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English (en)
French (fr)
Inventor
赵郑拓
李雪
包宇
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中国科学院脑科学与智能技术卓越创新中心
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Publication of WO2023245704A1 publication Critical patent/WO2023245704A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/291Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
    • A61B5/293Invasive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/294Bioelectric electrodes therefor specially adapted for particular uses for nerve conduction study [NCS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/369Electroencephalography [EEG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation

Definitions

  • the present disclosure relates to a guide device, a method for making a guide device, a method of guiding a wire electrode, a method of using a guide device, and a method of guiding a wire electrode with a guide device.
  • Electrophysiological recordings from implanted neural electrodes are crucial in neuroscience and offer unique prospects for human neuroprosthetics.
  • conventional micromachined silicon probes suffer from significant mechanical mismatches with their neural tissue hosts, resulting in short- and long-term interface instability.
  • Extensive efforts have been made to reduce the size and mechanical stiffness of neural probes, thus improving biocompatibility and recording reliability.
  • there is an inherent conflict in the requirements for probe stiffness between minimal invasiveness and easy insertion into the brain with minimal surgical trauma.
  • the method, the method of guiding the electrode wire, the method of using the guiding device and the method of guiding the electrode wire with the guiding device can overcome at least one defect in the prior art.
  • a guide device for implanting an electrode wire is provided.
  • the electrode wire is provided with a through hole.
  • the guide device includes along its length direction: a first part located at the end; The largest outer diameter dimension is smaller than the size of the through hole; and a second part adjacent to the first part, the smallest outer diameter dimension of the second part is larger than the size of the through hole, wherein the second part is connected to the first part via a step structure .
  • a guiding device for an electrode wire the guiding device being configured to pass through a joint portion of the electrode wire so as to engage with the joint portion so as to guide the electrode wire, the guiding device
  • the implant section configured to at least partially enter the target object, wherein the implant section has a first portion at a front end, a second portion adjacent to a rear portion of the first portion, and a second portion for receiving the first portion and the second portion.
  • a two-part transition part wherein the first part is configured to be able to pass through the joint part, and the second part is configured to be unable to pass through the joint part, so that the joint part of the electrode wire can be stopped at the transition part.
  • a method for manufacturing a guide device comprising: immersing a first section of an etchable blank in an etchant, subjecting the first section to a first electrochemical process. Chemically etching to obtain a semi-finished part with a step structure; and immersing the first sub-section at the end of the first section into the etchant, and performing a second electrochemical process on the first sub-section.
  • Etching to obtain a guide device with a two-step structure wherein an implanted section of the guide device is obtained on the first section, said implanted section having a first portion corresponding to the first sub-section and a second portion corresponding to the remainder of the first section except the first sub-section, the first section being thinner than the second section.
  • a method for manufacturing a guide device comprising: immersing a distal first sub-section of a first section of an etchable blank into an etchant , perform a first electrochemical etching on the first sub-section, thereby obtaining a semi-finished component with a step structure; and immerse the first section into an etchant, and perform a second electrochemical etching on the first section.
  • Etching to obtain a guide device with a two-step structure wherein an implanted section of the guide device is obtained on the first section, said implanted section having a first portion corresponding to the first sub-section and a second portion corresponding to the remainder of the first section except the first sub-section, the first section being thinner than the second section.
  • a method for guiding an electrode wire including: placing the electrode wire at a first position, with a through hole provided at an end of the electrode wire; aligning the guiding device with the through hole, wherein , the guide device includes a first part located at the front end and a second part adjacent to the first part along its length direction, the largest outer diameter of the first part is smaller than the size of the through hole and the smallest outer diameter of the second part is larger than the size of the through hole , wherein the second part and the first part are connected via a step structure; the forward movement guide device allows the first part to pass through the through hole and the end of the electrode wire is stopped at the step structure due to the pressure from the step structure; and a motion guiding device to guide at least the end of the electrode wire from the first position to the second position.
  • a method of using a guiding device including: bringing the guiding device close to a joint portion of an electrode wire, wherein the guiding device includes a thinner first portion located at a front end, and a rear portion of the first portion. A thicker second part adjacent to the first part and a transition part for receiving the first part and the second part, wherein the first part is configured to be able to pass through the joint part, and the second part is configured not to pass through the joint part; the third part is configured to be able to pass through the joint part; A part passes through the joint part of the electrode wire, so that the joint part of the electrode wire stops at the transition part; and the guide device is used to guide the electrode wire.
  • a method of guiding an electrode wire using a guiding device including a thinner first part at the front end, a thicker second part adjacent to the rear of the first part, and A transition portion for receiving the first portion and the second portion, wherein the first portion is configured to be able to pass through the joint portion, and the second portion is configured to be unable to pass through the joint portion, and the first end of the electrode wire is configured with the joint portion
  • the method includes: passing the first part through the joint part and causing the joint part of the electrode wire to stop at the transition part; further moving the guide device to guide the first end of the electrode wire A pulling force is applied to at least partially separate the wire electrode from the wire fixing device; and the guiding device is used to guide the wire electrode to a target position.
  • Figure 1A is a schematic diagram of a guiding device according to an embodiment of the present disclosure.
  • Figure IB is a schematic diagram of a portion of an example wire electrode that may be used with a guide device according to embodiments of the present disclosure.
  • 1C-IF are schematic diagrams of a guide device engaged with an example electrode wire according to embodiments of the present disclosure.
  • 1G is a schematic diagram of a guide device engaged with an example electrode wire according to an embodiment of the present disclosure.
  • 1H is a partial enlarged view of a guiding device according to an embodiment of the present disclosure.
  • FIGS. 1I and 1J are schematic diagrams of a guide device engaged with an example electrode wire according to embodiments of the present disclosure.
  • FIGS. 2 to 6 are schematic flow diagrams of a method for guiding an electrode wire according to an embodiment of the present disclosure.
  • FIGS. 7 to 10 are flow diagrams of another embodiment of a method for guiding an electrode wire according to an embodiment of the present disclosure.
  • 11A to 11C are schematic diagrams at various steps in a process of implementing a method for manufacturing a guide device according to an embodiment of the present disclosure.
  • 11D is a schematic diagram at one step during implementation of a method for manufacturing a guide device according to an embodiment of the present disclosure.
  • 11E and 11F are schematic diagrams of using an insulating material in implementing a method for manufacturing a guide device according to an embodiment of the present disclosure.
  • FIG. 12A is a schematic diagram of conventional etching of an object to be etched with an etchant solution.
  • Figure 12B is a schematic diagram of a method for manufacturing a guide device according to an embodiment of the present disclosure.
  • 12C to 12E are schematic diagrams of forming an insulating material into a flat surface in a method for manufacturing a guide device according to an embodiment of the present disclosure.
  • FIGS. 13A and 13B are schematic diagrams of at least part of a guiding device according to embodiments of the present disclosure.
  • an element is referred to as being “on,” “attached to,” “connected to,” “coupled to” or “contacting” another element.
  • the element can be directly on, attached to, connected to, coupled to, or contacting another element, or intervening elements may be present.
  • one element is said to be “directly on”, “directly attached to”, “directly connected to”, “directly coupled to” another element or, or “directly coupled” to another element.
  • a feature being arranged “adjacent” to another feature may mean that one feature has a portion that overlaps the adjacent feature or a portion that is above or below the adjacent feature.
  • Coupled means that one element/node/feature can be directly or indirectly mechanically, electrically, logically, or otherwise connected to another element/node/feature to permit each other. effect, even though the two characteristics may not be directly connected. That is, “coupled” is intended to encompass both direct and indirect connections of elements or other features, including connections via one or more intervening elements.
  • spatial relationship terms such as “up”, “down”, “left”, “right”, “front”, “back”, “high”, “low”, etc. can explain the relationship between one feature and another feature. Relationships in the attached figure. It will be understood that the spatially relative terms encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if the device in the figures is turned over, features described as “below” other features would now be described as “above” other features. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the relative spatial relationships will be interpreted accordingly.
  • a or B includes “A and B” as well as “A or B” and does not exclusively include only “A” or only “B” unless specifically stated otherwise.
  • exemplary means “serving as an example, instance, or illustration” rather than as a “model” that will be accurately reproduced. Any implementation illustratively described herein is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, the disclosure is not bound by any expressed or implied theory presented in the above technical field, background, brief summary or detailed description.
  • the term “substantially” is meant to include any minor variations resulting from design or manufacturing defects, device or component tolerances, environmental effects, and/or other factors.
  • the term “substantially” also allows for differences from the perfect or ideal situation due to parasitics, noise, and other practical considerations that may be present in actual implementations.
  • first,” “second,” and similar terms may also be used herein for reference purposes only and are therefore not intended to be limiting.
  • the words “first,” “second,” and other such numerical terms referring to structures or elements do not imply a sequence or order unless clearly indicated by the context.
  • Figure 1A is a schematic diagram of a guiding device 1 according to the present disclosure.
  • 1B is a schematic diagram of a portion of an exemplary electrode wire 2 that may be used with a guiding device 1 according to an embodiment of the present disclosure, illustrating a front-end engaging portion 21 and an adjacent engaging portion 21 of the electrode wire 2 from a plan view perspective Section 22.
  • 1C to 1F are schematic diagrams of exemplary engagement of the guiding device 1 with an exemplary electrode wire 2 according to an embodiment of the present disclosure.
  • 1C and 1D show this example from a perspective view
  • FIGS. 1E and 1F show this example from a side view perspective.
  • FIGS. 1C to 1F show only the portion near the front end of the implantation section 110 of the guiding device 1 in FIG. 1A is shown in FIGS. 1C to 1F.
  • the guiding device 1 for implanting the wire electrode 2 includes an implantation section 110 that at least partially enters the target object when the wire electrode 2 is implanted.
  • the implantation section 110 includes along its length direction: a first part 111 located at the end or front end; and a second part 112 adjacent to or connected to the rear part of the first part 111 .
  • the transition portion 113 has a step structure.
  • the guiding device 1 may be configured to pass through the joint portion 21 of the wire electrode 2 so as to engage with the joint portion 21 so as to guide the wire electrode 2 .
  • FIG. 1B shows a specific example of the wire electrode 2 in which the joint portion 21 of the wire electrode 2 is configured as a through hole.
  • the largest radial dimension of the first portion 111 may be smaller than the size of the through hole, and the smallest radial dimension of the second portion 112 may be larger than the size of the through hole.
  • the first portion 111 may be configured to pass through the through hole, while the second portion 112 may be configured not to pass through the through hole.
  • the joint portion 21 with the through hole of the electrode wire 2 can be stopped at the transition portion 113, as shown in Figure 1E.
  • the section of the electrode wire 2 adjacent to the joint portion 21 (refer to the section 221 in FIGS. 1G, 1I and 1J) abuts against the transition portion. 113 on.
  • the shape of the first part 111 and the second part 112 may be generally columnar. In one embodiment, the first portion 111 and the second portion 112 are generally cylindrical in shape. In other embodiments, the shape of the first part 111 and/or the second part 112 may also be other shapes, such as polygonal prisms, such as triangular prisms, four prisms, or pentagonal prisms, and so on. In more embodiments, the shape of the first part 111 and/or the second part 112 may also be substantially conical, truncated cone, etc.
  • first portion 111 and/or the second portion 112 are depicted as columnar in some of the drawings of this disclosure.
  • the outer diameter of the first part 111 or the second part 112 mentioned in this disclosure refers to the diameter of a circle when the cross-section of the cylindrical part is substantially circular, and refers to a polygonal shape when the cross-section of the cylindrical part is polygonal. The diameter of the circumscribed circle.
  • the outer diameter of the first part 111 may be between 5 ⁇ m and 15 ⁇ m, preferably between 7 ⁇ m and 8 ⁇ m, and the outer diameter of the second part 112 may be between 40 ⁇ m and 70 ⁇ m, preferably between 40 ⁇ m and 50 ⁇ m. between.
  • the length of the first portion 111 may be between 0.05 mm and 0.3 mm, preferably between 0.2 mm and 0.3 mm.
  • the total length of the first part 111 and the second part 112 is not less than 3mm, preferably between 3mm and 4mm.
  • the first part 111 and the second part 112 may be integrally formed.
  • the first part 111 and the second part 112 may be integrally formed of tungsten or stainless steel through an etching process.
  • the implant section 110 may be formed of tungsten or stainless steel through an etching process.
  • implant section 110 may be made of metal, alloy, carbon fiber, or diamond with a Young's modulus greater than 20 GPa.
  • the transition portion 113 with a stepped structure is configured in a platform shape, as shown in FIGS. 1C and 1G .
  • the platform-like transition portion 113 has a plane substantially perpendicular to the longitudinal direction of the guide device 1 , such as the lower surface of the transition portion 113 in FIGS. 1C and 1G .
  • a plane substantially perpendicular to the longitudinal direction of the guide device 1 , such as the lower surface of the transition portion 113 in FIGS. 1C and 1G .
  • the lower surface of the transition portion 113 has ridges and depressions, but is also referred to as a “flat surface” in this disclosure.
  • the size of the lower surface of the transition part 113 is larger than the size of the through hole of the joint part 21 , which enables the joint part 21 to be formed by the lower surface of the transition part 113 after the first part 111 of the guiding device 1 passes through the joint part 21 of the electrode wire 2 .
  • the pressure of the surface in the longitudinal direction of the guide device 1 stops at the lower surface of the transition portion 113 . Furthermore, when the joint part 21 stops at the lower surface of the transition part 113 , the section 221 of the electrode wire 2 adjacent to the joint part 21 rests against the transition part 113 .
  • the transition portion 113 with a stepped structure is configured in a slope shape, as shown in FIGS. 1I and 1J .
  • the ramp-like transition 113 may not have a plane perpendicular to the longitudinal direction of the guide device 1 , but may be configured with an outer diameter that increases in the direction from the first part 111 towards the second part 112 .
  • the transition 113 is configured as a reduction.
  • the transition The slope of the portion 113 has a smaller slope, in other words, a gentler slope.
  • the section of the transition portion 113 close to the second portion 112 has a gentler slope.
  • the slope here refers to the degree to which the straight line of the slope or the tangent line of the curve is inclined with respect to the abscissa axis (the coordinate axis perpendicular to the longitudinal direction of the guide device 1).
  • Such a structure enables the outer periphery of the transition portion 113 at a specific position to apply pressure along the longitudinal direction of the guide device 1 to the joint portion 21 of the electrode wire 2 , thereby enabling the joint portion 21 to stop at a specific position of the transition portion 113 , and the section 221 of the electrode wire 2 adjacent to the joint part 21 is in contact with the transition part 113 .
  • the electrode wire 2 By making the outer diameter of the first part 111 of the guide device 1 smaller than the size of the through hole and the outer diameter of the second part 112 larger than the size of the through hole, on the one hand, when the guide device 1 is used to implant the electrode wire 2, the electrode wire 2 2.
  • the through hole can be stopped at the transition portion 113 of the first part 111 and the second part 112 without positional deviation along the longitudinal direction of the guide device 1, thereby achieving a more accurate and repeatable implantation position. position.
  • the head end of the guide device 1 has a step structure. After the first part 111 of the guide device 1 passes through the through hole of the joint portion 21, the joint portion 21 can be formed by the step structure along the guide device 1. The pressure in the longitudinal direction stops at the step structure, rather than being locked on the guide device 1 due to the friction between the joint portion 21 and the guide device 1 . Therefore, when the guiding device 1 is withdrawn from the implanted object, the electrode wire 2 will not be taken out of the implanted object or the position of the positioned electrode wire 2 will be shifted again.
  • the guide device 1 can also comprise a preferably cylindrical fastening section 120 for fastening the guide device 1 to a movement device for implantation (not shown), wherein the fastening section 120 can be fastened to the implantation section 110 .
  • the fastening section 120 can be adjacent to the implant section 110 , in particular the second part 112 , wherein the fastening section 120 can be formed in one piece with the implant section 110 or connected in a materially bonded manner, such as by welding or adhesive bonding. Connected piecewise.
  • the fastening section 120 can also be designed separately from the implant section 110 and be connected non-positively or positively lockingly.
  • the fastening section 120 can clamp the implant section 110 .
  • the fastening section 120 can be designed to be hollow, and the second part 112 of the implant section 110 can be received and fixed, for example clamped, in the hollow structure of the fastening section 120 .
  • the outer diameter dimension of the fixing section 120 may be larger than the outer diameter dimension of the second portion 112 .
  • the outer diameter size of the fixing section 120 may be between 100 ⁇ m and 200 ⁇ m.
  • the fixation section 120 can also be constructed separately from the implant section 110
  • the fixation section 120 and the implant section 110 can each be constructed from different materials
  • the fixation section 120 can be made of stainless steel
  • the implant section 110 can be made of different materials.
  • Segment 110 may be composed of tungsten, thereby enabling a more flexible choice of material.
  • the material of the fixation section 120 may be stiffer than the material of the implant section 110 .
  • the fixation section 120 thus has, in addition to a greater structural stiffness due to the larger outer diameter dimension, a greater material stiffness than the implant section 110 compared to the implant section 110 . Therefore, it is not easy to deform, and the required stiffness requirements are ensured when being fixed on the sports device and when supporting the implanted section 110 .
  • the implant section 110 when the size of the implant section 110 adopts the dimensions defined by the present disclosure and the material of the implant section 110 is tungsten, on the one hand, the implant area can be ensured during implantation.
  • the segment 110 has an appropriate stiffness that can support the penetration force when passing through the tissue surface to be implanted; on the other hand, due to the smaller radial size and larger axial size of the implanted segment 110 , that is, the implanted section 110 is in the shape of an elongated needle as a whole, so even if unexpected deformation occurs during the implantation process, it will not break easily and leave part of the implanted section 110 remaining in the brain.
  • the material of the implant section 110 may also be stainless steel. Since stainless steel is less rigid than tungsten, the implant segment 110 made of stainless steel needs to be thicker if it is to achieve a comparable mechanical strength to the implant segment 110 made of tungsten in order to penetrate the surface of the object to be implanted.
  • the blank is first cut to an appropriate length of 1.5cm to 2.0cm, as shown in Figure 11A, and can be mounted on a fixing table using copper tape and conductive glue, such as silver glue. Then the first section of the blank that can be etched (for example, the right section of the blank shown in Figure 11A, section L in Figure 11F) can be immersed in the etchant, and the first section is subjected to a first Electrochemical etching is performed to obtain a semi-finished part with a step structure, as shown in Figure 11B.
  • the etchant may be an alkaline solution, such as potassium hydroxide solution.
  • the first electrochemical etching can be carried out at a voltage between 20 V and 40 V, in particular 29 V, wherein the voltage is applied to the blank via the graphite.
  • the length of the immersed first section corresponds to the length of the finally obtained implant section 110 , ie not less than 3 mm, for example 3 mm to 4 mm.
  • the first electrochemical etching may be stopped.
  • the first target diameter may correspond to the outer diameter of the second portion 112 of the implant section 110 .
  • the first sub-section located at the end of the first section (for example, the right end of the semi-finished product shown in Figure 11B, section L1 in Figure 11F) can be immersed in the etchant, and the first sub-section The segment is subjected to a second electrochemical etching, thereby obtaining a guide device 1 with a two-step structure, as shown in Figure 11C.
  • the length of the first sub-section corresponds to the length of the first part 111 of the implantation section 110, for example 0.05 mm to 0.3 mm.
  • the first sub-section and the part of the rear end of the blank that is connected to the conductive glue can be kept exposed, and the third section of the first section that is not subject to electrochemical etching can be protected by the insulating material 6 .
  • the two sub-sections cover and optionally also the remaining part of the blank, so that during the second electrochemical etching only the first sub-section is in contact with the etchant.
  • only the second sub-section L2 of the first section L adjacent to the first sub-section L1 can be covered with the insulating material 6 , and the first sub-section L1 and the first sub-section L1 can be separated.
  • the insulating material 6 may be silicone adhesive. After the silicone adhesive dries, a second electrochemical etching is performed on the first sub-section using a voltage between 0.5V and 5V, especially 2V, to achieve the final target diameter. The final target diameter may correspond to the outer diameter of the first portion 111 of the implant section 110 . Finally, an implanted section 110 of the guiding device 1 is obtained on the first section.
  • the implanted section 110 has a first part 111 corresponding to the first sub-section and a first part 111 corresponding to the first sub-section. The remainder of the segment corresponds to the second portion 112 .
  • a schematic illustration of the implantation section 110 of the exemplary guide device 1 may be shown in Figures 13A and 13B.
  • the second part 112 of the implant section 110 is formed first, and then the first part 111 of the implant section 110 is formed.
  • the semi-finished product of the first part 111 of the implant section 110 may also be formed first, and then the entire implant section 110, that is, the first part 111 and the second part 112, may be formed.
  • the first sub-section at the end of the first section of the blank that can be etched (for example, the right end of the blank shown in Figure 11A) can be first immersed in the etchant, and the first sub-section is immersed in the etchant.
  • the sub-section is subjected to first electrochemical etching, thereby obtaining a semi-finished part with a step structure, as shown in Figure 11D.
  • the length of the immersed first sub-section corresponds to the length of the finally obtained first part 111 of the implanted section 110 , for example 0.05 mm to 0.3 mm.
  • the first electrochemical etching may be stopped.
  • the target value may correspond to the difference between the outer diameter of the second portion 112 of the implant section 110 and the outer diameter of the first portion 111 .
  • the first section (for example, the right section of the semi-finished product shown in Figure 11D) can then be immersed in the etchant and subjected to a second electrochemical etching to obtain a guide with a two-step structure.
  • the first electrochemical etching can be performed at a lower voltage
  • the second electrochemical etching can be performed at a higher voltage.
  • the transition portion 113 of the guide device 1 has a step structure, which is configured to have a planar platform shape that is substantially perpendicular to the longitudinal direction of the guide device 1, or has a smaller slope. slope shape. Therefore, in the above method for manufacturing a guide device, it is desired to etch a step structure as flat as possible. However, due to the effect of liquid surface tension, as shown in Figure 12A, the surface of the etchant solution will arch at the part to be etched that is immersed in it, and adhere to the outside of the part to be etched above the level of the solution. wall, thereby making it difficult for the etched object to be etched into a step structure with the required gentleness.
  • FIG. 12B it is necessary to form a substantially flat surface at one end of the insulating material 6 close to the first sub-section L1 , that is, in the view direction shown in FIG. 12B , the lower surface of the insulating material 6 is a substantially flat surface.
  • the generally flat surface is as perpendicular to the longitudinal direction of the etched object as possible.
  • the angle between the generally flat surface and the longitudinal direction of the second sub-section L2 (refer to the angle ⁇ in Figure 11F) is not Less than a threshold angle, such as 60 degrees.
  • FIG. 12C to 12E illustrate a method that enables the insulating material 6 to form the above-mentioned substantially flat surface.
  • the blank to be etched is placed vertically with the first sub-section L1 located above the second sub-section L2, as shown in Figure 12C.
  • a container 7 for containing insulating material is placed outside the second sub-section L2, with the opening of the container 7 pointing upward, as shown in Figure 12D.
  • the container 7 is conical.
  • the container 7 can be of any shape with an upward opening and can be sleeved outside the blank to contain the insulating material.
  • the first section L1 of the blank can be vertically immersed in the etchant.
  • the blank shown in Figure 12E is turned upside down and the first section L1 (which can be along with the second section At least the portion of L2 close to the first section L1 is vertically immersed in the etchant.
  • the etching state of the first section of the blank can be observed from the side with the aid of an observation device.
  • the first section L1 of the blank can also be immersed laterally (eg obliquely, or transversely) in the etchant, enabling the electrochemical etching for viewing the first section L1
  • the etching state observation device observes the electrochemical etching state of the first section L1 from top to bottom.
  • the above-mentioned inclination means that the angle between the longitudinal direction of the blank and the surface of the etchant solution is less than 90 degrees
  • the above-mentioned transverse direction means that the longitudinal direction of the blank is basically parallel to the surface of the etchant solution, for example, from the side of a container containing the etchant.
  • the wall is immersed in the etchant.
  • the observation device can vertically observe the electrochemical etching state of the first section L1 from top to bottom.
  • the observation device can be designed as an optical microscope. Therefore, in the embodiment in which the first section L1 of the blank is immersed laterally in the etchant, there is no need to rely on a lateral microscope, but instead a universal microscope with a top-down viewing direction can be used.
  • the blanks can be electrochemically etched individually.
  • electrochemical etching can also be performed on multiple blanks at the same time, and the electrochemical etching process of each blank can be individually controlled.
  • each blank before performing the first electrochemical etching, can be connected in series with an individual switching element, and the corresponding sub-circuit including the corresponding blank and the corresponding switching element can be connected in parallel to the main circuit.
  • each blank is connected in series with an independent switch, and then all the series-connected lines are connected in parallel to the main line, and then the first section of the blank is electrochemically etched.
  • FIGS. 2 to 6 are flow diagrams of a method for guiding the electrode wire 2 according to an embodiment of the present disclosure.
  • the fixing section 120 of the guiding device 1 can be received and fixed in the guiding device receiving tube 4 , while the implanting section 110 is at least partially exposed for guiding the electrode wire 2 .
  • the electrode wire 2 is first placed at the first position.
  • the end of the electrode wire 2 is provided with a through hole (refer to Figure 1B).
  • the electrode wire 2 is adhered to the first position. on substrate 3.
  • the guide device 1 is then aligned with said through-hole, wherein the guide device 1 is shown in Figures 2 to 6 as the implantation section 110 and the guide device receiving tube 4.
  • the guiding device 1 is moved forward or brought close to the through hole of the electrode wire 2 , so that the first part 111 (refer to FIG. 1D ) of the implantation section 110 passes through the through hole and the end of the electrode wire 2
  • the stop is at the transition portion 113 of the first portion 111 and the second portion 112 (refer to FIG. 1E ).
  • the movement guiding device 1 is used to guide at least the end portion of the electrode wire 2 from the first position to the second position, wherein at least the end portion of the electrode wire 2 is guided from the first position to the second position. During this period, at least part of the electrode wire 2 is peeled off from the substrate 3 .
  • the liquid 5 can be sprayed onto the electrode wire 2 so that at least the first section of the electrode wire 2 adheres to the guide.
  • a schematic diagram of the transition portion 113 and/or the second portion 112 of the device 1 after attachment refer to Figure 1F.
  • the wire electrode 2 can be fastened to the transition and/or to the second part 112 without additional holding devices.
  • the transition portion 113 and/or the second portion 112 can be configured with a smooth surface, thus facilitating the attachment of the first section of the electrode wire 2 .
  • the guiding device 1 and the fixing plane of the electrode wire 2 on the fixing device can be made vertically, that is, at an angle of 90 degrees, away from the fixing plane. Move in a plane direction to exert tensile force on the first end of the electrode wire 2 .
  • FIGS. 7 to 10 are flow diagrams of another embodiment of a method for guiding the electrode wire 2 according to an embodiment of the present disclosure.
  • the difference between the embodiment shown in Figs. 7 to 10 and the embodiment shown in Figs. 2 to 6 is that in the embodiment shown in Figs.
  • the direction is at a non-vertical angle, such as a 60-degree angle.
  • other aspects of the embodiment shown in FIGS. 7 to 10 may refer to the description of FIGS. 2 to 6 .
  • the fixing plane on the fixing device and the guiding direction of the guiding device 1 can also form other angles other than 60 degrees and 90 degrees, as long as the guiding device and the electrode wire are located. It is sufficient for the fixed plane on the fixture to move at an angle in order to exert a pulling force on the end of the electrode wire.

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Abstract

一种用于植入电极丝(2)的引导装置(1),电极丝(2)上设置有通孔,引导装置(1)沿其长度方向包括:位于末端的第一部分(111),第一部分(111)的最大的外径尺寸小于通孔的尺寸;以及与第一部分(111)连接的第二部分(112),第二部分(112)的最小的外径尺寸大于通孔的尺寸,其中,第二部分(112)与第一部分(111)经由台阶结构连接。

Description

引导装置、用于制造引导装置的方法及使用引导装置的方法 技术领域
本公开涉及引导装置、用于制造引导装置的方法、引导电极丝的方法、使用引导装置的方法和用引导装置引导电极丝的方法。
背景技术
植入神经电极的电生理记录在神经科学中至关重要,并为人类神经修复术带来了独特的前景。尽管取得了巨大的成功和潜力,但传统的微加工硅探针,与神经组织宿主存在明显的机械失配,从而导致短期和长期界面不稳定。目前已经作出广泛的努力,以减少神经探针的尺寸和机械刚度,从而改善生物相容性和记录可靠性。然而,对于探针硬度的要求存在着内在的冲突,在最小的侵入性和以最小的外科损伤轻松插入大脑之间存在冲突。为了消除慢性组织反应降低神经探针的刚性,使探针的变形力与神经组织中的细胞力相当是必要的。
因而,柔性电极被开发出来。但柔性电极因为自身的“柔性”特点,使得它的植入成为难题。由于柔性电极在其宽度和厚度方向上具有较小的尺寸,而在其长度方向上具有远大于其宽度和厚度的尺寸,因此,在本公开中将柔性电极依其形状特点称为“电极丝”。
发明内容
本公开的目的在于提供引导装置、用于制造引导装置的方法、引导电极丝的方法、使用引导装置的方法以及用引导装置引导电极丝的方法,所述引导装置、所述用于制造引导装置的方法、所述引导电极丝的方法、所述使用引导装置的方法以及所述用引导装置引导电极丝的方法能够克服现有技术中的至少一个缺陷。
根据本公开的第一方面,提供了一种用于植入电极丝的引导装置,所述电极丝上设置有通孔,所述引导装置沿其长度方向包括:位于末端的第一部分,第一部分的最大的外径尺寸小于通孔的尺寸;以及与第一部分相邻的第二部分,第二部分的最小的外径尺寸大于通孔的尺寸,其中,第二部分与第一部分经由台阶结构连接。
根据本公开的第二方面,提供一种用于电极丝的引导装置,所述引导装置构造为能够穿过电极丝的接合部从而与所述接合部相接合以便引导电极丝,所述引导装置具 有被构造为至少部分进入目标物的植入区段,其中,所述植入区段具有位于前端的第一部分、与第一部分的后部邻接的第二部分、以及用于承接第一部分和第二部分的过渡部,其中,第一部分构造为能够穿过接合部,而第二部分构造为无法穿过接合部,从而使得电极丝的所述接合部能够止挡在过渡部处。
根据本公开的第三方面,提供一种用于制造引导装置的方法,包括:将可被刻蚀的坯件的第一区段浸入到刻蚀剂中,对第一区段进行第一电化学刻蚀,从而得到带有一个台阶结构的半成件;以及将第一区段中的位于末端的第一子区段浸入到刻蚀剂中,对第一子区段进行第二电化学刻蚀,从而得到带有两个台阶结构的引导装置,其中,在第一区段上得到引导装置的植入区段,所述植入区段具有与第一子区段相对应的第一部分和与第一区段的除第一子区段的其余部分对应的第二部分,第一部分比第二部分更细。
根据本公开的第四方面,提供一种用于制造引导装置的方法,包括:将可被刻蚀的坯件的第一区段中的位于末端的第一子区段浸入到刻蚀剂中,对第一子区段进行第一电化学刻蚀,从而得到带有一个台阶结构的半成件;以及将第一区段浸入到刻蚀剂中,对第一区段进行第二电化学刻蚀,从而得到带有两个台阶结构的引导装置,其中,在第一区段上得到引导装置的植入区段,所述植入区段具有与第一子区段相对应的第一部分和与第一区段的除第一子区段的其余部分对应的第二部分,第一部分比第二部分更细。
根据本公开的第五方面,提供一种引导电极丝的方法,包括:将电极丝放置在第一位置处,电极丝的端部设置有通孔;将引导装置对准所述通孔,其中,引导装置沿其长度方向包括位于前端的第一部分和与第一部分相邻的第二部分,第一部分最大的外径尺寸小于通孔的尺寸并且第二部分最小的外径尺寸大于通孔的尺寸,其中,第二部分与第一部分经由台阶结构连接;向前运动引导装置,以使第一部分穿过所述通孔并且电极丝的端部由于来自台阶结构的压力而止挡在台阶结构处;以及运动引导装置,以将电极丝的至少端部从第一位置处引导到第二位置处。
根据本公开的第六方面,提供一种使用引导装置的方法,包括:将引导装置靠近电极丝的接合部,其中,所述引导装置包括位于前端的较细的第一部分、与第一部分的后部邻接的较粗的第二部分、以及用于承接第一部分和第二部分的过渡部,其中,第一部分构造为能够穿过接合部,而第二部分构造为无法穿过接合部;将第一部分穿过所述电极丝的接合部,并使得所述电极丝的接合部止挡在过渡部处;以及用所述引 导装置来引导所述电极丝。
根据本公开的第七方面,提供一种用引导装置引导电极丝的方法,所述引导装置包括位于前端的较细的第一部分、与第一部分的后部邻接的较粗的第二部分、以及用于承接第一部分和第二部分的过渡部,其中,第一部分构造为能够穿过接合部,而第二部分构造为无法穿过接合部,所述电极丝的第一端部构造有接合部,所述方法包括:将第一部分穿过所述接合部,并使得所述电极丝的所述接合部止挡在过渡部处;使引导装置进一步运动以对所述电极丝的第一端部施加拉力,从而将所述电极丝至少部分地从所述电极丝的固定装置上分离;用所述引导装置将所述电极丝引导到目标位置。
通过以下参照附图对本公开的示例性实施例的详细描述,本公开的其它特征及其优点将会变得清楚。
附图说明
构成说明书的一部分的附图描述了本公开的实施例,并且连同说明书一起用于解释本公开的原理。
图1A是根据本公开实施例的引导装置的示意图。
图1B是可以与根据本公开实施例的引导装置配合使用的示例电极丝的部分的示意图。
图1C至图1F是根据本公开实施例的引导装置与示例电极丝接合的示意图。
图1G是根据本公开实施例的引导装置与示例电极丝接合的示意图。
图1H是根据本公开实施例的引导装置的局部放大图。
图1I和图1J是根据本公开实施例的引导装置与示例电极丝接合的示意图。
图2至图6是根据本公开实施例的引导电极丝的方法的一种实施例的流程示意图。
图7至图10是根据本公开实施例的引导电极丝的方法的另一种实施例的流程示意图。
图11A至图11C是实施根据本公开实施例的用于制造引导装置的方法的过程中在各个步骤处的示意图。
图11D是实施根据本公开实施例的用于制造引导装置的方法的过程中在一个步骤处的示意图。
图11E和图11F是实施根据本公开实施例的用于制造引导装置的方法中使用隔绝材料的示意图。
图12A是常规的对被刻蚀件进行刻蚀剂溶液刻蚀的示意图。
图12B是根据本公开实施例的用于制造引导装置的方法的示意图。
图12C至图12E是实施根据本公开实施例的用于制造引导装置的方法中使隔绝材料形成平整表面的示意图。
图13A和图13B是根据本公开实施例的引导装置的至少部分的示意图。
注意,在以下说明的实施方式中,有时在不同的附图之间共同使用同一附图标记来表示相同部分或具有相同功能的部分,而省略其重复说明。在一些情况中,使用相似的标号和字母表示类似项,因此,一旦某一项在一个附图中被定义,则在随后的附图中不需要对其进行进一步讨论。
为了便于理解,在附图等中所示的各结构的位置、尺寸及范围等有时不表示实际的位置、尺寸及范围等。因此,本公开并不限于附图等所公开的位置、尺寸及范围等。
具体实施方式
以下将参照附图描述本公开,其中的附图示出了本公开的若干实施例。然而应当理解的是,本公开可以以多种不同的方式呈现出来,并不局限于下文描述的实施例;事实上,下文描述的实施例旨在使本公开的公开更为完整,并向本领域技术人员充分说明本公开的保护范围。还应当理解的是,本文公开的实施例能够以各种方式进行组合,从而提供更多额外的实施例。
应当理解的是,本文中的用语仅用于描述特定的实施例,并不旨在限定本公开的范围。本文使用的所有术语(包括技术术语和科学术语)除非另外定义,均具有本领域技术人员通常理解的含义。为简明和/或清楚起见,公知的功能或结构可以不再详细说明。
在本文中,称一个元件位于另一元件“上”、“附接”至另一元件、“连接”至另一元件、“耦合”至另一元件、或“接触”另一元件等时,该元件可以直接位于另一元件上、附接至另一元件、连接至另一元件、联接至另一元件或接触另一元件,或者可以存在中间元件。相对照的是,称一个元件“直接”位于另一元件“上”、“直接附接”至另一元件、“直接连接”至另一元件、“直接耦合”至另一元件或、或“直接接触”另一元件时,将不存在中间元件。在本文中,一个特征布置成与另一特征“相邻”,可以指一个特征具有与相邻特征重叠的部分或者位于相邻特征上方或下方的部分。
在本文中,可能提及了被“耦接”在一起的元件或节点或特征。除非另外明确说明, “耦接”意指一个元件/节点/特征可以与另一元件/节点/特征以直接的或间接的方式在机械上、电学上、逻辑上或以其它方式连结以允许相互作用,即使这两个特征可能并没有直接连接也是如此。也就是说,“耦接”意图包含元件或其它特征的直接连结和间接连结,包括利用一个或多个中间元件的连接。
在本文中,诸如“上”、“下”、“左”、“右”、“前”、“后”、“高”、“低”等的空间关系用语可以说明一个特征与另一特征在附图中的关系。应当理解的是,空间关系用语除了包含附图所示的方位之外,还包含装置在使用或操作中的不同方位。例如,在附图中的装置倒转时,原先描述为在其它特征“下方”的特征,此时可以描述为在其它特征的“上方”。装置还可以以其它方式定向(旋转90度或在其它方位),此时将相应地解释相对空间关系。
在本文中,用语“A或B”包括“A和B”以及“A或B”,而不是排他地仅包括“A”或者仅包括“B”,除非另有特别说明。
在本文中,用语“示例性的”意指“用作示例、实例或说明”,而不是作为将被精确复制的“模型”。在此示例性描述的任意实现方式并不一定要被解释为比其它实现方式优选的或有利的。而且,本公开不受在上述技术领域、背景技术、发明内容或具体实施方式中所给出的任何所表述的或所暗示的理论所限定。
在本文中,用语“基本上”意指包含由设计或制造的缺陷、器件或元件的容差、环境影响和/或其它因素所致的任意微小的变化。用语“基本上”还允许由寄生效应、噪声以及可能存在于实际的实现方式中的其它实际考虑因素所致的与完美的或理想的情形之间的差异。
另外,仅仅为了参考的目的,还可以在本文中使用“第一”、“第二”等类似术语,并且因而并非意图限定。例如,除非上下文明确指出,否则涉及结构或元件的词语“第一”、“第二”和其它此类数字词语并没有暗示顺序或次序。
还应理解,“包括/包含”一词在本文中使用时,说明存在所指出的特征、步骤、操作、单元和/或组件,但是并不排除存在或增加一个或多个其它特征、步骤、操作、单元和/或组件以及/或者它们的组合。
图1A是根据本公开的引导装置1的示意图。图1B是可以与根据本公开实施例的引导装置1配合使用的示例性电极丝2的部分的示意图,其以平面图的视角示出了电极丝2的位于前端的接合部21和邻近接合部21的区段22。图1C至图1F是根据本公开实施例的引导装置1与示例电极丝2示例性接合的示意图。其中,图1C和图1D 以立体图的视角、以及图1E和图1F以侧视图的视角分别示出了该示例。为简便起见,图1C至图1F中仅示出了图1A中的引导装置1的植入区段110的靠近前端的部分。
如图所示,根据本公开的用于植入电极丝2的引导装置1包括在植入电极丝2时至少部分进入目标物的植入区段110。植入区段110沿其长度方向包括:位于末端或者说前端的第一部分111;以及与第一部分111的后部邻接、或连接的第二部分112。在第一部分111与第二部分112之间可以存在有用于承接第一部分111与第二部分112的过渡部113,以使得第一部分111与第二部分112之间经由过渡部113相连接。在根据本公开各实施例的引导装置1中,过渡部113具有台阶结构。
引导装置1可以构造为能够穿过电极丝2的接合部21从而与接合部21相接合以便引导电极丝2。图1B示出了电极丝2的一个具体示例,在该示例中,电极丝2的接合部21构造为通孔。第一部分111的最大的径向尺寸可以小于通孔的尺寸,并且第二部分112的最小的径向尺寸可以大于通孔的尺寸。换言之,第一部分111可以构造为能够穿过通孔,而第二部分112可以构造为无法穿过通孔。由此,当引导装置1对准电极丝2的通孔沿纵向朝向通孔运动时,即以图1C和图1D的视图方向向下运动,在引导装置1的第一部分111穿过通孔后,电极丝2的具有通孔的接合部21能够止挡在过渡部113处,如图1E所示。此外,在电极丝2的接合部21止挡在过渡部113处时,电极丝2的邻近接合部21的区段(可参考图1G、1I和1J中的区段221)贴靠在过渡部113上。
第一部分111和第二部分112的形状可以为大致的柱状。在一个实施例中,第一部分111和第二部分112的形状为大致的圆柱形。在其他实施例中,第一部分111和/或第二部分112的形状也可以是其他形状,例如多棱柱,如三棱柱、四棱柱或五棱柱等等。在更多的实施例中,第一部分111和/或第二部分112的形状也可以是大致的圆锥形、圆台形等。由于第一部分111和/或第二部分112的轴向尺寸远大于径向尺寸,因此在本公开的部分附图中将第一部分111和/或第二部分112描绘为柱状。本公开提及的第一部分111或第二部分112的外径,在柱状部分的横截面为大致圆形时指的是圆形的直径,在柱状部分的横截面为多边形时指的是多边形的外接圆的直径。第一部分111的外径尺寸可以介于5μm至15μm之间,优选介于7μm至8μm之间,而第二部分112的外径尺寸可以介于40μm至70μm之间,优选介于40μm至50μm之间。第一部分111的长度可以介于0.05mm至0.3mm之间、优选介于0.2mm至0.3mm之间。第一部分111与第二部分112的总长度不小于3mm,优选介于3mm至4mm之 间。第一部分111与第二部分112可以一体形成。在一些实施例中,第一部分111与第二部分112可以一体地由钨或不锈钢通过刻蚀工艺形成。换言之,植入区段110可以由钨或不锈钢通过刻蚀工艺形成。在一些实施例中,植入区段110可以由杨氏模量大于20GPa的金属、合金、碳纤维或金刚石制成。
在一些实施例中,具有台阶结构的过渡部113被构造为平台状,如图1C和图1G所示。在这些实施例中,平台状的过渡部113具有基本上垂直于引导装置1的纵向方向的平面,例如图1C和图1G中过渡部113的下表面。需要说明的是,除特别强调光滑或平滑的表面之外,本公开当提及“平面”时,均不在于强调其为平滑的表面,而旨在说明其延伸方向可以被大致看成平面。例如在图1H所示的示例中,过渡部113的下表面,虽具有隆起和凹陷,但在本公开中也被称为“平面”。过渡部113的下表面的尺寸大于接合部21的通孔的尺寸,这使得在引导装置1的第一部分111穿过电极丝2的接合部21之后,接合部21能够因来自过渡部113的下表面的沿引导装置1的纵向方向的压力而止挡在过渡部113的下表面处。此外,在接合部21止挡在过渡部113的下表面处时,电极丝2的邻近接合部21的区段221贴靠在过渡部113上。
在一些实施例中,具有台阶结构的过渡部113被构造为斜坡状,如图1I和图1J所示。在这些实施例中,斜坡状的过渡部113可以不具有垂直于引导装置1的纵向方向的平面,而是被构造为沿从第一部分111指向第二部分112的方向具有变大的外径。换言之,在这些实施例中,过渡部113被构造为变径部。由于第一部分111的外径尺寸明显小于第二部分112的外径尺寸、并且过渡部113的轴向尺寸较小(即过渡部113沿引导装置1的纵向方向延伸的长度受限),因此过渡部113的斜坡具有较小的斜率,换言之,即较为平缓的斜坡。例如在图1I所示的示例中,过渡部113接近于第二部分112的区段具有较为平缓的斜坡。需要说明的是,此处斜率指的是斜坡的直线、或曲线的切线关于横坐标轴(垂直于引导装置1的纵向方向的坐标轴)倾斜的程度。这样的构造能够使得过渡部113的特定位置处的外周缘向电极丝2的接合部21施加沿引导装置1的纵向方向的压力,从而使得接合部21能够止挡在过渡部113的特定位置处,并且电极丝2的邻近接合部21的区段221贴靠在过渡部113上。
通过使引导装置1的第一部分111的外径尺寸小于通孔的尺寸并且第二部分112的外径尺寸大于通孔的尺寸,一方面,在利用引导装置1植入电极丝2时,电极丝2在通孔处可以止挡在第一部分111和第二部分112的过渡部113处而不会沿引导装置1的纵向方向发生位置偏移,从而实现植入位置的更准确的且可重复的定位。
另一方面,在现有技术中已知具有渐进式头端部(例如尺寸渐变的锥状的头端部)的引导装置,其渐进式头端部的一部分可以穿过电极丝的通孔来引导电极丝。在渐进式头端部引导电极丝以进入目标物时,电极丝由于在植入过程中承受的阻力而从渐进式头端部的较细的区段向着较粗的区段滑移,从而导致电极丝的通孔因和头端部之间的摩擦力而紧卡在渐进式头端部上。因此,在将渐进式头端部取出时,存在使电极丝发生不期望的位移或将电极丝带出目标物的风险。而根据本公开实施例的引导装置1的头端部具有台阶结构,在引导装置1的第一部分111穿过接合部21的通孔之后,接合部21能够因来自台阶结构的沿引导装置1的纵向方向的压力而止挡在台阶结构处,而不是因接合部21与引导装置1之间的摩擦力而锁紧在引导装置1上。因此,在将引导装置1从植入目标物中回撤时,不会将电极丝2从植入目标物中带出或使定位后的电极丝2再发生位置偏移。
除了植入区段110以外,引导装置1还可以包括将引导装置1固定在用于植入的运动装置(未示出)的优选柱状的固定区段120,其中,该固定区段120可以固定在如图2至图6所示的引导装置接纳管4中。固定区段120可以与植入区段110、尤其是第二部分112相邻,其中,固定区段120可以与植入区段110一体形成,或材料锁合地连接、如焊接或粘接一件式地连接。在一些实施例中,固定区段120也可以与植入区段110分开构造并且力锁合地或形锁合地连接。在力锁合连接的情况下,固定区段120可以夹紧植入区段110。固定区段120可以构造为中空的,植入区段110的第二部分112能够接纳和固定、例如夹紧在固定区段120的中空结构中。固定区段120的外径尺寸可以大于第二部分112的外径尺寸。固定区段120的外径尺寸可以介于100μm至200μm之间。
在固定区段120也可以与植入区段110分开构造的情况下,固定区段120和植入区段110可以分别由不同的材料构造,例如固定区段120可以由不锈钢构成,而植入区段110可以由钨构成,由此可以实现材料的更灵活的选择。固定区段120的材料的刚度可以高于植入区段110的材料的刚度。由此,固定区段120与植入区段110相比,除了由于更大的外径尺寸而产生的更大的结构刚度以外,还具有与植入区段110相比更大的材料刚度,从而不容易发生变形,保证了固定在运动装置上时以及支撑植入区段110时所需的刚度要求。对于植入区段110而言,在植入区段110的尺寸采用本公开所限定的尺寸并且植入区段110的材料为钨的情况下,一方面在进行植入时可以确保植入区段110具有适当的刚度,该适当的刚度可以支撑在穿过待植入的组织表面时 的穿透力;另一方面,由于植入区段110的径向尺寸较小而轴向尺寸较大,即植入区段110整体为细长的针状,因此在植入过程中即使发生不期望的形变,也不会轻易断裂而使部分植入区段110残留在脑部中。此外,植入区段110的材料还可以为不锈钢。由于不锈钢的刚度小于钨,因此如果要达到与钨制成的植入区段110相当的机械强度以穿透待植入目标物的表面,不锈钢制成的植入区段110需要更粗一些。
下面结合图11A至图11F描述用于制造根据本公开的引导装置1的方法的一种实施例。首先将坯件切割成1.5cm至2.0cm的适当长度,如图11A所示,并且可以利用铜胶带和导电胶、例如银胶安装在固定台上。然后可以将可被刻蚀的坯件的第一区段(例如图11A所示坯件的右段、图11F中的区段L)浸入到刻蚀剂中,对第一区段进行第一电化学刻蚀,从而得到带有一个台阶结构的半成件,如图11B所示。刻蚀剂可以为碱溶液、例如氢氧化钾溶液。该第一电化学刻蚀可以在介于20V至40V之间、尤其是29V的电压下进行,其中,通过石墨将电压施加到坯件上。浸入的第一区段的长度相应于最终获得的植入区段110的长度,即不小于3mm,例如为3mm至4mm。在达到第一目标直径之后,可以停止第一电化学刻蚀。该第一目标直径可以相应于植入区段110的第二部分112的外径。接着可以将第一区段中的位于末端的第一子区段(例如图11B所示半成件的右端部、图11F中的区段L1)浸入到刻蚀剂中,对第一子区段进行第二电化学刻蚀,从而得到带有两个台阶结构的引导装置1,如图11C所示。第一子区段的长度相应于植入区段110的第一部分111的长度,例如为0.05mm至0.3mm。
在进行第二电化学刻蚀之前,可以使第一子区段以及坯件后端与导电胶连通的部分保持暴露,并且借助隔绝材料6将第一区段的不用进行电化学刻蚀的第二子区段覆盖以及可选地将坯件的其余部分也覆盖,从而在第二电化学刻蚀时在第一区段中仅第一子区段与刻蚀剂接触。可替换地,参考图11E和图11F,可以借助隔绝材料6只覆盖第一区段L的邻接于第一子区段L1的第二子区段L2,并将第一子区段L1和第二子区段L2的至少部分浸入刻蚀剂溶液,以使得第二子区段L2在第二电化学刻蚀时不与刻蚀剂接触。隔绝材料6可以为硅胶粘合剂。待硅胶粘合剂干燥后,利用0.5V至5V之间、尤其是2V的电压对第一子区段进行第二电化学刻蚀,以达到最终目标直径。该最终目标直径可以相应于植入区段110的第一部分111的外径。最终,在第一区段上得到引导装置1的植入区段110,所述植入区段110具有与第一子区段相对应的第一部分111和与第一区段的除第一子区段的其余部分对应的第二部分112。示例性引 导装置1的植入区段110的示意图可以如图13A和图13B所示。
在上述实施例中,首先成型出植入区段110的第二部分112,然后成型出植入区段110的第一部分111。在另一种实施例中,也可以首先成型出植入区段110的第一部分111的半成品,然后成型出整个植入区段110,即第一部分111和第二部分112。在此,可以首先将可被刻蚀的坯件的第一区段中的位于末端的第一子区段(例如图11A所示坯件的右端部)浸入到刻蚀剂中,对第一子区段进行第一电化学刻蚀,从而得到带有一个台阶结构的半成件,如图11D所示。浸入的第一子区段的长度相应于最终获得的植入区段110的第一部分111的长度,例如为0.05mm至0.3mm。在被刻蚀部分的直径与坯件的直径之差达到目标值之后,可以停止第一电化学刻蚀。该目标值可以相应于植入区段110的第二部分112的外径与第一部分111的外径之差。然后可以将第一区段(例如图11D所示半成件的右段)浸入到刻蚀剂中,对第一区段进行第二电化学刻蚀,从而得到带有两个台阶结构的引导装置1,如图11C所示。其中,第一电化学刻蚀可以在较低的电压下进行,第二电化学刻蚀可以在较高的电压下进行。
如上所述,根据本公开各实施例的引导装置1的过渡部113具有台阶结构,该台阶结构被构造为具有基本上垂直于引导装置1的纵向方向的平面平台状、或具有较小的斜率的斜坡状。因此,在上述用于制造引导装置的方法中,希望能够刻蚀出尽量平的台阶结构。然而,由于液体表面张力的作用,如图12A所示,刻蚀剂溶液的表面会在浸入其中的被刻蚀件处拱起,并在高于溶液水平表面处附着于被刻蚀件的外侧壁,从而使得被刻蚀件难以被刻蚀出具有需要的平缓程度的台阶结构。例如,只能得到如图12A所示的渐进式头端部。因此,如图12B所示,需要使得隔绝材料6的接近第一子区段L1的一端形成大致平整的表面,即以图12B所示的视图方向为隔绝材料6的下表面为大致平整的表面。此外,还需要这个大致平整的表面尽量垂直于被刻蚀件的纵向方向,例如,大致平整的表面与第二子区段L2的纵向方向的夹角(参考图11F中的夹角α)不小于阈值角度,例如60度。
图12C至图12E示出了能够使得隔绝材料6形成上述大致平整的表面的方法。将待刻蚀的坯件竖直放置并使第一子区段L1位于第二子区段L2上方,如图12C所示。在第二子区段L2的外部套设一个用于盛装隔绝材料的容器7,并使容器7的开口向上,如图12D所示。在该具体的示例中,容器7为圆锥形。本领域技术人员应理解,在其他实施例中,容器7可以为任何具有向上的开口并且可以套设在坯件外以盛装隔绝材料的形状。向容器7中灌入可流动的隔绝材料6,可流动的隔绝材料6的上表面61在 重力的作用下会形成大致平整的表面,如图12E所示。需要说明的是,在图12C至图12E所示的示例中,将待刻蚀的坯件上未显示出具有台阶结构。本领域技术人员应理解,附图中的示例仅为简便,图12C至图12E中的待刻蚀的坯件可以为如图11A所示的状态、也可以为如图11B所示的状态。
在一些实施例中,坯件的第一区段L1可以垂直地浸入到刻蚀剂中,例如将图12E中所示的坯件上下翻转后将第一区段L1(可以连同第二区段L2的至少靠近第一区段L1的部分一起)垂直地浸入到刻蚀剂中。其中,可以借助观察装置从侧向对坯件的第一区段的刻蚀状态进行观察。在一些实施例中,坯件的第一区段L1也可以侧向地(例如倾斜地、或横向地)浸入到刻蚀剂中,使得能够借助用于观测第一区段L1的电化学刻蚀状态的观测装置从上向下观测第一区段L1的电化学刻蚀状态。上述倾斜是指坯件的纵向与刻蚀剂溶液的表面的夹角小于90度,上述横向是指坯件的纵向与刻蚀剂溶液的表面基本平行,例如从盛装刻蚀剂的容器的侧壁浸入到刻蚀剂中。所述观测装置可以从上向下垂直地观测第一区段L1的电化学刻蚀状态。观测装置可以构造为光学显微镜。因此,在坯件的第一区段L1侧向地浸入到刻蚀剂中的实施例中,不需要依赖侧向显微镜,而是能使用通用的具有从上向下的观测方向的显微镜。
坯件可以分别单个地进行电化学刻蚀。在一些实施例中,也可以同时对多个坯件进行电化学刻蚀,并分别对各个坯件的电化学刻蚀过程进行单独控制。在此,在进行第一电化学刻蚀之前,可以将各个坯件分别串联单独的开关元件,并且将包括相应的坯件和相应的开关元件的相应的子线路并联到主线路。具体而言,将每个坯件串联一个独立开关,然后所有串联后的线路并联到主线路,接着对坯件的第一区段进行电化学刻蚀,此时在显微镜下观察,哪一个坯件的第一区段完成了电化学刻蚀过程就先把该坯件所对应的那条线路关断(此时坯件依然浸泡在刻蚀剂中,但因为线路被关断而无电流流过,因此不会继续腐蚀),同时其他坯件继续腐蚀,直至所有坯件都完成腐蚀,然后将所有最终得到的引导装置1一起取出。
图2至图6是根据本公开实施例的引导电极丝2的方法的一种实施例的流程示意图。在图2至图6的实施例中,引导装置1的固定区段120可以接纳并且固定在引导装置接纳管4中,而植入区段110则至少部分露出,以用于引导电极丝2。
如图2至图4所示,首先将电极丝2放置在第一位置处,电极丝2的端部设置有通孔(可参考图1B),电极丝2粘附在位于第一位置处的基板3上。然后将引导装置1对准所述通孔,其中,引导装置1在图2至图6中示出为植入区段110和引导装置 接纳管4。然后向前运动引导装置1或者说使引导装置1靠近电极丝2的通孔,以使植入区段110的第一部分111(可参考图1D)穿过所述通孔并且电极丝2的端部止挡在第一部分111与第二部分112的过渡部113处(可参考图1E)。接着,运动引导装置1,以将电极丝2的至少端部从第一位置处引导到第二位置处,其中,在将电极丝2的至少端部从第一位置处引导到第二位置处期间,使电极丝2的至少部分地从基板3上剥离。
如图5和图6所示,在用引导装置1引导电极丝2之前,可以对所述电极丝2喷射液体5,使得所述电极丝2的至少所述第一段贴附在所述引导装置1的过渡部113和/或第二部分112上,贴附后的示意图可参考图1F。由此,无需附加的保持装置便可以将电极丝2固定在过渡部和/或第二部分112上。为此,过渡部113和/或第二部分112可以被构造为具有平滑的表面,从而有助于电极丝2的第一段的贴附。
在图2至图6所示的实施例中,为了剥离电极丝2,可以使引导装置1与电极丝2在固定装置上的固定平面垂直地、即成90度夹角地朝着远离该固定平面的方向运动,以对所述电极丝2的第一端部施加拉力。
图7至图10是根据本公开实施例的引导电极丝2的方法的另一种实施例的流程示意图。图7至图10所示的实施例与图2至图6所示的实施例的区别在于,在图7至图10所示的实施例中,固定装置上的固定平面与引导装置1的引导方向成非垂直的夹角,例如60度夹角。为避免重复描述,图7至图10所示的实施例的其他方面可以参考对于图2至图6的描述。本领域技术人员应理解,在其他实施例中,固定装置上的固定平面与引导装置1的引导方向也可以成除了60度和90度以外的其他夹角,只要使得引导装置与电极丝所在的固定装置上的固定平面成角度地运动即可,以便对电极丝的端部施加拉力。
虽然已经通过示例对本公开的一些特定实施例进行了详细说明,但是本领域的技术人员应该理解,以上示例仅是为了进行说明,而不是为了限制本公开的范围。在此公开的各实施例可以任意组合,而不脱离本公开的精神和范围。本领域的技术人员还应理解,可以对实施例进行多种修改而不脱离本公开的范围和精神。本公开的范围由所附权利要求来限定。

Claims (49)

  1. 一种用于植入电极丝的引导装置,所述电极丝上设置有通孔,所述引导装置沿其长度方向包括:
    位于末端的第一部分,第一部分的最大的外径尺寸小于通孔的尺寸;以及
    与第一部分连接的第二部分,第二部分的最小的外径尺寸大于通孔的尺寸,
    其中,第二部分与第一部分经由台阶结构连接。
  2. 根据权利要求1所述的引导装置,其中,所述台阶结构被构造为平台状和/或斜坡状。
  3. 根据权利要求1所述的引导装置,其中,第一部分的外径尺寸介于5μm至15μm之间。
  4. 根据权利要求1所述的引导装置,其中,第一部分的外径尺寸介于7μm至8μm之间。
  5. 根据权利要求1所述的引导装置,其中,第二部分的外径尺寸介于40μm至70μm之间。
  6. 根据权利要求1所述的引导装置,其中,第二部分的外径尺寸介于40μm至50μm之间。
  7. 根据权利要求1至6中任一项所述的引导装置,其中,第一部分的长度介于0.05mm至0.3mm之间,第一部分与第二部分的总长度不小于3mm。
  8. 根据权利要求1至6中任一项所述的引导装置,其中,第一部分与第二部分一体形成。
  9. 根据权利要求1至6中任一项所述的引导装置,其中,第一部分与第二部分一体地由大致柱状的钨或不锈钢通过刻蚀工艺形成。
  10. 根据权利要求1至6中任一项所述的引导装置,还包括用于将引导装置固定在用于植入的运动装置的大致柱状的固定区段,固定区段与第二部分连接并且固定区段的外径尺寸大于第二部分的外径尺寸。
  11. 根据权利要求10所述的引导装置,其中,固定区段的外径尺寸介于100μm至200μm之间。
  12. 根据权利要求10所述的引导装置,其中,所述引导装置的总长度介于1.5cm至2.0cm之间。
  13. 根据权利要求10所述的引导装置,其中,所述引导装置一体形成。
  14. 根据权利要求10所述的引导装置,其中,所述引导装置一体地由大致柱状的钨或不锈钢通过刻蚀工艺形成。
  15. 一种用于电极丝的引导装置,所述引导装置构造为能够穿过电极丝的接合部从而与所述接合部相接合以便引导电极丝,所述引导装置具有被构造为至少部分进入目标物的植入区段,其中,所述植入区段具有位于前端的第一部分、与第一部分的后部邻接的第二部分、以及用于承接第一部分和第二部分的过渡部,其中,第一部分构造为能够穿过接合部,而第二部分构造为无法穿过接合部,从而使得电极丝的所述接合部能够止挡在过渡部处。
  16. 根据权利要求15所述的引导装置,其中,在电极丝的所述接合部止挡在过渡部处时,电极丝的邻近所述接合部的第一段贴靠在过渡部上。
  17. 根据权利要求15所述的引导装置,其中,所述过渡部被构造为具有基本上垂直于引导装置的纵向方向的平面,所述平面的尺寸使其无法穿过接合部,从而使得电极丝的所述接合部能够止挡在过渡部的所述平面处。
  18. 根据权利要求15所述的引导装置,其中,所述过渡部被构造为沿从第一部分至第二部分的方向具有变大的外径,以使得过渡部的特定位置处的外周缘向电极丝的所述接合部施加沿引导装置的纵向方向的压力,从而使得电极丝的所述接合部能够止挡在过渡部的所述特定位置处。
  19. 根据权利要求15所述的引导装置,其中,所述引导装置还具有用于将引导装置固定在用于使引导装置运动的驱动装置上的固定区段,所述固定区段位于引导装置的后端。
  20. 根据权利要求19所述的引导装置,其中,所述固定区段与植入区段一体式构造。
  21. 根据权利要求19所述的引导装置,其中,所述固定区段构造为中空的,植入区段的第二部分能够接纳和固定在固定区段的中空结构中。
  22. 根据权利要求21所述的引导装置,其中,所述固定区段的材料的刚度高于植入区段的材料的刚度。
  23. 根据权利要求15所述的引导装置,其中,所述接合部构造有通孔,并且所述第一部分的尺寸小于通孔的尺寸,而所述第二部分的尺寸大于通孔的尺寸。
  24. 根据权利要求15所述的引导装置,其中,至少所述植入区段由杨氏模量大于 20 GPa的金属、合金、碳纤维或金刚石制成。
  25. 根据权利要求15所述的引导装置,其中,至少所述植入区段由钨或不锈钢通过刻蚀制成。
  26. 根据权利要求15所述的引导装置,其中,第一部分构造为直径介于5μm至15μm之间的柱状,和/或,第二部分构造为直径介于40μm至70μm之间的柱状。
  27. 根据权利要求19所述的引导装置,其中,所述固定区段构造为直径介于100μm至200μm之间的柱状。
  28. 一种用于制造引导装置的方法,包括:
    将可被刻蚀的坯件的第一区段浸入到刻蚀剂中,对第一区段进行第一电化学刻蚀,从而得到带有一个台阶结构的半成件;以及
    将第一区段中的位于末端的第一子区段浸入到刻蚀剂中,对第一子区段进行第二电化学刻蚀,从而得到带有两个台阶结构的引导装置,
    其中,在第一区段上得到引导装置的植入区段,所述植入区段具有与第一子区段相对应的第一部分和与第一区段的除第一子区段的其余部分对应的第二部分,第一部分比第二部分更细。
  29. 根据权利要求28所述的方法,其中,所述刻蚀剂为碱溶液。
  30. 根据权利要求28所述的方法,其中,所述刻蚀剂为氢氧化钾溶液。
  31. 根据权利要求28所述的方法,其中,将可被刻蚀的坯件的第一区段浸入到刻蚀剂中包括:
    将坯件的第一区段侧向地浸入到刻蚀剂中,使得能够借助用于观测第一区段的电化学刻蚀状态的观测装置从上向下观测第一区段的电化学刻蚀状态。
  32. 根据权利要求31所述的方法,其中,所述观测装置从上向下垂直地观测第一区段的电化学刻蚀状态。
  33. 根据权利要求31所述的方法,其中,所述观测装置构造为光学显微镜。
  34. 根据权利要求28所述的方法,还包括:在对第一区段的第一子区段进行第二电化学刻蚀之前,借助隔绝材料至少覆盖第一区段的邻接于第一子区段的第二子区段,以使得第二子区段在第二电化学刻蚀时不与刻蚀剂接触。
  35. 根据权利要求34所述的方法,其中,所述隔绝材料为硅胶粘合剂。
  36. 根据权利要求34所述的方法,其中,借助隔绝材料覆盖第二子区段包括:使隔绝材料的接近第一子区段的一端形成大致平整的表面,所述大致平整的表面与第二 子区段的纵向方向的夹角不小于阈值角度。
  37. 根据权利要求36所述的方法,还包括:将坯件竖直放置并使第一子区段位于第二子区段上方,在套设在第二子区段外部并且开口向上的容器中灌入可流动的隔绝材料,以使得灌入的隔绝材料的上表面在重力的作用下形成所述大致平整的表面。
  38. 根据权利要求28所述的方法,还包括:
    同时对多个坯件进行电化学刻蚀,并分别对各个坯件的电化学刻蚀过程进行单独控制。
  39. 根据权利要求38所述的方法,其中,在进行第一电化学刻蚀之前,将各个坯件分别串联单独的开关元件,并且将包括相应的坯件和相应的开关元件的相应的子线路并联到主线路。
  40. 根据权利要求28所述的方法,其中,第二电化学刻蚀的刻蚀速度小于第一电化学刻蚀的刻蚀速度。
  41. 一种用于制造引导装置的方法,包括:
    将可被刻蚀的坯件的第一区段中的位于末端的第一子区段浸入到刻蚀剂中,对第一子区段进行第一电化学刻蚀,从而得到带有一个台阶结构的半成件;以及
    将第一区段浸入到刻蚀剂中,对第一区段进行第二电化学刻蚀,从而得到带有两个台阶结构的引导装置,
    其中,在第一区段上得到引导装置的植入区段,所述植入区段具有与第一子区段相对应的第一部分和与第一区段的除第一子区段的其余部分对应的第二部分,第一部分比第二部分更细。
  42. 一种引导电极丝的方法,包括:
    将电极丝放置在第一位置处,电极丝的端部设置有通孔;
    将引导装置对准所述通孔,其中,引导装置沿其长度方向包括位于前端的第一部分和与第一部分连接的第二部分,第一部分最大的外径尺寸小于通孔的尺寸并且第二部分最小的外径尺寸大于通孔的尺寸,其中,第二部分与第一部分经由台阶结构连接;
    向前运动引导装置,以使第一部分穿过所述通孔并且电极丝的端部由于来自台阶结构的沿引导装置的纵向方向的压力而止挡在台阶结构处;以及
    运动引导装置,以将电极丝的至少端部从第一位置处引导到第二位置处。
  43. 根据权利要求42所述的方法,其中,通过将电极丝粘附在位于第一位置处的基板上从而将电极丝放置在第一位置处,所述方法还包括:
    通过运动引导装置将电极丝的至少部分地从基板上剥离,以便将电极丝的至少端部从第一位置处引导到第二位置处。
  44. 一种使用引导装置的方法,包括:
    将引导装置靠近电极丝的接合部,其中,所述引导装置包括位于前端的较细的第一部分、与第一部分的后部邻接的较粗的第二部分、以及用于承接第一部分和第二部分的过渡部,其中,第一部分构造为能够穿过接合部,而第二部分构造为无法穿过接合部;
    将第一部分穿过所述电极丝的接合部,并使得所述电极丝的接合部止挡在过渡部处;以及
    用所述引导装置来引导所述电极丝。
  45. 根据权利要求44所述的方法,还包括:
    在用所述引导装置来引导所述电极丝之前,对所述电极丝喷射液体,使得所述电极丝的至少所述第一段贴附在所述引导装置的过渡部和/或第二部分上。
  46. 根据权利要求44所述的方法,其中,所述接合部构造有通孔,并且所述第一部分的外径小于通孔的内径,所述第二部分的外径大于通孔的内径。
  47. 一种用引导装置引导电极丝的方法,所述引导装置包括位于前端的较细的第一部分、与第一部分的后部邻接的较粗的第二部分、以及用于承接第一部分和第二部分的过渡部,其中,第一部分构造为能够穿过接合部,而第二部分构造为无法穿过接合部,所述电极丝的第一端部构造有接合部,所述方法包括:
    将第一部分穿过所述接合部,并使得所述电极丝的所述接合部止挡在过渡部处;
    使引导装置进一步运动以对所述电极丝的第一端部施加拉力,从而将所述电极丝至少部分地从所述电极丝的固定装置上分离;
    用所述引导装置将所述电极丝引导到目标位置。
  48. 根据权利要求47所述的方法,其中,使引导装置进一步运动以对所述电极丝的第一端部施加拉力包括:
    使引导装置与所述电极丝在固定装置上的固定平面成角度地朝着目标位置运动,以对所述电极丝的第一端部施加拉力。
  49. 根据权利要求47所述的方法,其中,所述接合部构造为通孔,并且所述第一部分的外径小于通孔的内径,而所述第二部分的外径大于通孔的内径。
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