WO2024040733A1 - 一种复合微针结构 - Google Patents

一种复合微针结构 Download PDF

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Publication number
WO2024040733A1
WO2024040733A1 PCT/CN2022/127288 CN2022127288W WO2024040733A1 WO 2024040733 A1 WO2024040733 A1 WO 2024040733A1 CN 2022127288 W CN2022127288 W CN 2022127288W WO 2024040733 A1 WO2024040733 A1 WO 2024040733A1
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Prior art keywords
needle
soft
hard
soft needle
positioning opening
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PCT/CN2022/127288
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English (en)
French (fr)
Inventor
黄立
黄晟
童贝
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武汉衷华脑机融合科技发展有限公司
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Publication of WO2024040733A1 publication Critical patent/WO2024040733A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/262—Needle electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
    • A61B5/293—Invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A61B5/37—Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A61B5/386—Accessories or supplementary instruments therefor

Definitions

  • the invention belongs to the technical field of brain-computer interface neural microelectrodes, and specifically relates to a composite microneedle structure.
  • brain signals are collected through electrodes.
  • the electrodes include invasive and non-invasive forms.
  • the brain signals collected by invasive electrodes are more accurate and reliable.
  • most invasive microneedle structures are single-type electrodes, such as Michigan electrodes and Utah electrodes with hard needle structures, and polyimide electrodes with soft needle structures.
  • hard needles rigid needles
  • soft needle structures are prone to deformation during implantation and require the assistance of external equipment. Implantation has problems such as complex structure and low efficiency.
  • the purpose of the present invention is to provide a composite microneedle structure that can at least solve some of the defects existing in the prior art.
  • a composite microneedle structure includes hard needles and soft needles.
  • the soft needles are placed on the upper surface of the hard needles.
  • At least one soft needle fixing member is spaced along the length direction of the hard needles on the upper surface.
  • the soft needles are The needle is provided with a positioning opening, and the soft needle fixing member fixes the soft needle to the hard needle at the positioning opening.
  • the positioning opening of the soft needle is provided with a positioning opening that allows the soft needle fixing member to exit its position when the hard needle is pulled. Open fixed structure exit piece.
  • the soft needle fixation component includes a first part and a second part, and both ends of the second part are respectively connected to the first part and the hard needle surface, and the first part is parallel to the hard needle surface, And the soft needle is located between the first part and the hard needle surface, and the second part and the hard needle surface form a preset angle.
  • the upper surface of the hard needle has a plurality of soft needle fixing parts, the first part and the second part of the soft needle fixing part and the surface of the hard needle form a slot, and the slot faces the tip of the hard needle,
  • the fixing structure exit piece is located on the side of the positioning opening away from the tip of the soft needle.
  • the preset angle between the second part of the soft needle fixing member and the hard needle surface is an acute angle.
  • the fixing structure exit part is a dehooking part extending from the edge of the positioning opening into the positioning opening, the distance between the decoupling parts is less than the width of the second part of the soft needle fixation part, and the decoupling part is relative to the positioning opening. They are arranged symmetrically along the axis, and there is a gap between the side edges of the dehooking portion and the side edges of the corresponding positioning openings.
  • one end of the two dehooking parts close to the soft needle fixing member is in the shape of a figure eight.
  • the tail of the hard needle is provided with at least one latch structure at intervals along its width direction
  • the tail of the soft needle is provided with a latch hole corresponding to the latch structure, and is arranged outward along the edge of the latch hole on the tail of the soft needle.
  • a centrally symmetrical figure, the projection of the latch structure and the centrally symmetrical figure of the soft needle on the surface of the hard needle is at least partially coincident.
  • the latch structure is composed of two coaxial cylinders, one larger at the top and smaller at the bottom, and the diameter of the upper cylinder of the latch structure is larger than the diameter of the latch hole.
  • center point of the centrally symmetrical figure coincides with the center point of the latch hole.
  • the bottom surface of the second part is in contact with the hard needle surface
  • the top surface of the second part is in contact with the bottom surface of the first part
  • the bottom surface of the second part is larger than the second part. part of the top surface.
  • the composite microneedle structure provided by the present invention uses hard needles to drive soft needles to be implanted into tissues together.
  • the soft needle fixing parts can drive the soft needles to be implanted; It can well fix hard needles and soft needles, prevent them from moving, and reduce the risk of soft needles warping.
  • the hard needle can be pulled out, and the soft needle can follow the blood vessels. Adaptable deformation due to expansion and contraction avoids the shortcomings of using a single hard needle or soft needle.
  • Figure 1 is a schematic structural diagram of the composite microneedle of the present invention.
  • FIG. 2 is an enlarged schematic diagram of part I in Figure 1;
  • Figure 3 is a schematic cross-sectional view of the fixing parts of hard needles and soft needles in the present invention.
  • Figure 4 is a schematic structural diagram of the soft needle fixing member on the hard needle in the present invention.
  • Figure 5 is a schematic structural diagram of the patterned dehooking part on the soft needle of the present invention.
  • Figure 6 is an enlarged schematic diagram of part M in Figure 1;
  • Figure 7 is a schematic structural diagram of the latch on the tail of the hard needle in the present invention.
  • Figure 8 is a schematic structural diagram of the petal portion on the tail of the soft needle in the present invention.
  • connection should be understood in a broad sense.
  • it can be a fixed connection or a detachable connection.
  • the connection can also be a conflicting connection or an integral connection; for those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood in specific situations; in the description of the present invention, unless otherwise stated, “multiple "One” and “several” mean two or more.
  • this embodiment provides a composite microneedle structure, including a hard needle 1 and a soft needle 2.
  • the soft needle 2 is placed on the upper surface of the hard needle 1.
  • the upper surface of the hard needle 1 is along the At least one soft needle fixing part 3 is provided at intervals in the length direction.
  • the soft needle 2 is provided with a positioning opening 4.
  • the soft needle fixing part fixes the soft needle 2 to the hard needle 1 at the positioning opening 4.
  • the positioning opening 4 of the soft needle 2 is provided with a fixing structure exiting part that can make the soft needle fixing part 3 exit the positioning opening 4 when the hard needle is pulled.
  • the hard needle 1 has a certain degree of rigidity and can be implanted into the soft tissue of the human body or an animal.
  • the hard needle 1 can be made of silicon material; the soft needle 2 needs to have a certain degree of flexibility, such as silicon nitride or polysilicon.
  • Soft needles 2 are made from materials such as silicon carbide and silicon carbide.
  • the soft needle 2 since the hard needle 1 has a certain rigidity, the soft needle 2 is laid flat on the upper surface of the hard needle 1, and the soft needle fixing member 3 is grown on the hard needle 1, so that the soft needle 2 and the hard needle 1 can be fixed. , so that the hard needle 1 can drive the soft needle 2 to be implanted into the soft tissue of the human body or animal; when the soft needle 2 is implanted in the tissue, the hard needle 1 is pulled, and the soft needle fixing member 3 on the hard needle 1 is in contact with the soft needle 2
  • the fixing structure withdrawal piece cooperates, so that the soft needle fixing piece 3 withdraws from the positioning opening 4 on the soft needle 2, thereby releasing the fixing effect on the soft needle 2, the hard needle 1 and the soft needle 2 separate, the hard needle 1 is pulled out, and the soft needle 2 2 remains in the implanted tissue, the soft needle 2 has a certain degree of flexibility and can adaptively deform as the blood vessels expand and contract in the implanted tissue, thus avoiding the problem of traditional rigid microneedle causing damage to the
  • the soft needle fixation member 3 includes a first part and a second part, and both ends of the second part are respectively connected with the first part and the second part.
  • the surface of the hard needle 1 is connected, the first part is parallel to the surface of the hard needle 1, and the soft needle 2 is located between the first part and the surface of the hard needle 1, and the second part is connected to the surface of the hard needle 1.
  • the surface of needle 1 is at a preset angle.
  • the upper surface of the hard needle 1 is designed with multiple soft needle fixing parts 3.
  • a soft needle fixing part 3 is provided at the front end and the middle position of the hard needle 1.
  • the soft needle fixing part 3 is The first part, the second part and the surface of the hard needle 1 form a groove, and the groove faces the needle tip of the hard needle 1.
  • the fixed structure exit piece is located on the side of the positioning opening 4 away from the needle tip of the soft needle 2.
  • the hard needle 1 After reaching the implantation site, the hard needle 1 is pulled backward, and the soft needle fixing part 3 on the hard needle 1 comes into contact with After the fixing structure at the rear end of the positioning opening 4 is withdrawn, the fixing structure is withdrawn so that the soft needle fixing part 3 is separated from the soft needle 2, and the fixation between the soft needle 2 and the hard needle is released, so that the hard needle 1 can be pulled out while the soft needle 2 remains. Purpose within the organization.
  • the fixed structure exit piece is two decoupling parts 5 extending from the edge of the positioning opening 4 into the positioning opening 4.
  • the two decoupling parts 5 are symmetrically arranged with respect to the axis of the positioning opening 4.
  • There is a spacing between the dehooking parts 5 of the two pieces which is smaller than the width of the soft needle fixing part 3.
  • the dehooking part 5 is made by patterning on the soft needle 2, that is, the dehooking part 5 and the soft needle 2 are an integrated structure, so that when the two decoupling parts 5 are opened upward, the soft needle fixing part 3
  • the second part squeezes the decoupling part 5, causing the decoupling part 5 to tilt upward along the retracting direction of the hard needle 1, expanding the area of the positioning opening 4, the soft needle fixing part 3 is separated from the soft needle 1 from the positioning opening 4, and the soft needle 2
  • the unhooking part 5 is made of elastic material. After the hard needle 1 and the soft needle 2 are separated, the erected part of the unhooking part 5 descends and returns to its original shape.
  • the first part and the second part of the soft needle fixation part 3 are integrally formed.
  • the bottom surface of the second part is designed to be in contact with the hard needle surface, and the top surface of the second part is in contact with the bottom surface of the first part, and the bottom surface of the second part is larger than the top surface of the second part.
  • two pieces of the dehooking part 5 can be designed to have a figure-eight shape at one end close to the soft needle fixing part 3.
  • This structural design can make the dehooking part 5 more conveniently tilt upward when the soft needle fixing part 3 contacts the dehooking part 5. to expand the area of the positioning opening 4.
  • the angle between the second part of the soft needle fixing member 3 and the surface of the hard needle 1 is set to an acute angle, that is, to avoid moving away from the hard needle. 1.
  • the first part of the soft needle fixing member 3 exceeds the end of the second part in the direction of the tip, which is conducive to the second part of the soft needle fixing member 3 squeezing the decoupling part 5 and causing the dehooking part 5 to tilt upward.
  • At least one latch structure 6 can also be provided at the tail end of the hard needle 1 along its width direction, and the tail end of the soft needle 2 There is a latch hole 8 corresponding to the latch structure 6, and a number of centrally symmetrical graphics 7 are set outward along the edge of the latch hole 8 on the tail of the soft needle 2.
  • the centrally symmetrical graphics 7 at the graphics can be similar to a petal structure.
  • the projection of the centrally symmetrical figure 7 of the soft needle 2 on the surface of the hard needle 1 at least partially overlaps with the latch structure 6; specifically, the latch structure 6 is composed of two coaxial cylinders with a larger upper and smaller one, and the latch The diameter of the upper cylinder of the structure 6 is larger than the diameter of the latch hole 8 .
  • a pin hole 8 is opened on the tail of the soft needle 2, and a centrally symmetrical figure 7 is patterned, and then a pin structure 6 is grown at the pin hole 8. Due to the pin structure The diameter of the upper cylinder of 6 is larger than the diameter of the latch hole 8.
  • the upper cylinder will press part of the soft needle 2 structure on the edge of the latch hole 8, thereby fixing the soft needle 2 and further ensuring that there will be no displacement between the hard needle 1 and the soft needle 2. ;
  • the hard needle 1 drives the soft needle 2 to be implanted into the tissue together, by pulling the hard needle 1 downward, the upper cylinder of the latch structure 6 will exert a certain downward force on the soft needle 2, and the central symmetrical figure 7 on the soft needle 2 A certain degree of bending and deformation will occur until the latch structure 6 is completely withdrawn, and then the hard needle 1 is continued to be pulled backward to withdraw the soft needle fixing member 3 on the hard needle 1, so that the hard needle 1 and the soft needle 2 are completely separated and pulled out Hard needle 1, keep soft needle 2 in the tissue.
  • the center point of the centrally symmetrical figure 7 coincides with the center point of the latch hole 8 .
  • the composite microneedle structure provided by the present invention uses the hard needle to drive the soft needle to be implanted into the tissue.
  • the soft needle fixing part can drive the soft needle.
  • Implantation on the other hand, can well fix the hard needle and the soft needle, prevent them from moving between them, and reduce the risk of warping of the soft needle.
  • the hard needle can be pulled out and the soft needle can be pulled out.
  • the needle can adapt to the deformation as the blood vessel expands and contracts, avoiding the disadvantages of using a single hard needle or soft needle.

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Abstract

一种复合微针结构，包括硬针(1)和软针(2)，软针(2)置于硬针(1)上表面，硬针(1)上表面沿其长度方向间隔设有至少一个软针固定件(3)，软针(2)上设有定位开口(4)，软针固定件(3)在定位开口(4)处将软针(2)固定于硬针(1)上，软针(2)的定位开口(4)处设有拉动硬针(1)时可使软针固定件(3)退出定位开口(4)的固定结构退出件。该复合微针结构通过硬针(1)带动软针(2)一同植入组织，同时通过沿硬针(1)长度方向设置软针固定件(3)，一方面能够通过软针固定件(3)带动软针(2)植入，另一方面能够很好的固定硬针(1)和软针(2)，防止它们之间发生移动，减小软针(2)发生翘曲的风险，并且在微针植入组织后，硬针(1)可拔出，软针(2)可随着血管伸缩而进行适应性形变，避免了采用单一硬针(1)或软针(2)的缺陷。

Description

一种复合微针结构 技术领域
本发明属于脑机接口神经微电极技术领域，具体涉及一种复合微针结构。
背景技术
在神经接口中，通过电极采集脑信号，其中电极包括侵入式和非侵入式等形式，侵入式电极采集的脑信号更为准确、可靠性更高。目前侵入式微针结构多数为单一类型电极，如硬针结构的密西根电极、犹他电极，软针结构的聚酰亚胺电极。然而，对于硬针(刚性针)在植入时无法随着血管伸缩而进行适应性形变，可能会对组织造成一定的损伤；而软针结构在植入时易发生变形，需借助外部设备辅助植入，存在结构复杂，效率低下等问题。
发明内容
本发明的目的是提供一种复合微针结构，至少可以解决现有技术中存在的部分缺陷。
为实现上述目的，本发明采用如下技术方案：
一种复合微针结构，包括硬针和软针，所述软针置于所述硬针上表面，所述硬针上表面沿其长度方向间隔设有至少一个软针固定件，所述软针上设有定位开口，所述软针固定件在定位开口处将所述软针固定于硬针上，所述软针的定位开口处设有拉动硬针时可使软针固定件退出定位开口的固定结构退出件。
进一步的，所述软针固定件包括第一部分和第二部分，所述第二部分两端分别与所述第一部分和所述硬针表面连接，所述第一部分与所述硬针表面平行，且所述软针位于所述第一部分与所述硬针表面之间，所述第二 部分与所述硬针表面呈预设角度。
进一步的，所述硬针上表面有多个软针固定件，所述软针固定件的第一部分、第二部分和所述硬针表面组成开槽，所述开槽朝向硬针的针尖，所述固定结构退出件位于定位开口上远离软针针尖的一侧。
进一步的，所述软针固定件的第二部分与所述硬针表面之间预设角度为锐角。
进一步的，所述固定结构退出件为由定位开口边缘向定位开口内延伸的脱钩部，所述脱钩部之间的间距小于软针固定件的第二部分的宽度，且脱钩部关于定位开口的轴线对称布置，所述脱钩部侧边与对应定位开口侧边沿之间具有间隙。
进一步的，两片所述脱钩部靠近软针固定件一端呈八字形。
进一步的，所述硬针的尾部沿其宽度方向间隔设有至少一个插销结构，所述软针的尾部对应插销结构处开设有插销孔，且在软针的尾部上沿插销孔边缘向外设置中心对称图形，所述插销结构与软针的所述中心对称图形在硬针表面的投影至少存在部分重合。
进一步的，所述插销结构由上大下小的两个同轴圆柱构成，且插销结构的上圆柱直径大于所述插销孔直径。
进一步的，所述中心对称图形的中心点与所述插销孔的中心点重合。
进一步的，所述第二部分的底面与所述硬针表面抵接，所述第二部分的顶面与所述第一部分的底面抵接，而且所述第二部分的底面大于所述第二部分的顶面。
与现有技术相比，本发明的有益效果：
本发明提供的这种复合微针结构通过硬针带动软针一同植入组织，同时通过沿硬针长度方向设置软针固定件，一方面能够通过软针固定件带动软针植入，另一方面能够很好的固定硬针和软针，防止它们之间发生移动，减小软针发生翘曲的风险，并且在微针植入组织后，硬针可拔出，软针可 随着血管伸缩而进行适应性形变，避免了采用单一硬针或软针的缺陷。
以下将结合附图对本发明做进一步详细说明。
附图说明
图1是本发明复合微针结构示意图；
图2是图1中I部的放大示意图；
图3是本发明中硬针和软针固定部位的截面示意图；
图4是本发明中硬针上软针固定件的结构示意图；
图5是本发明中软针上图形化的脱钩部结构示意图；
图6是图1中M部的放大示意图；
图7是本发明中硬针尾部上插销结构示意图；
图8是是本发明中软针尾部上花瓣部结构示意图。
附图标记说明：1、硬针；2、软针；3、软针固定件；4、定位开口；5、脱钩部；6、插销结构；7、中心对称图形；8、插销孔。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其它实施例，都属于本发明保护的范围。
在本发明的描述中，需要理解的是，术语“中心”、“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。
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”应做广义理解，例如，可以是固定连接，也可以 是可拆卸连接，还可以是抵触连接或一体地连接；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；在本发明的描述中，除非另有说明，“多个”、“若干”的含义是两个或两个以上。
如图1所述，本实施例提供了一种复合微针结构，包括硬针1和软针2，所述软针2置于所述硬针1上表面，所述硬针1上表面沿其长度方向间隔设有至少一个软针固定件3，所述软针2上设有定位开口4，所述软针固定件在定位开口4处将所述软针2固定于硬针1上，所述软针2的定位开口4处设有拉动硬针时可使软针固定件3退出定位开口4的固定结构退出件。其中，硬针1具有一定刚性，其可以被植入人体或者动物的软组织内，例如可采用硅材料制得硬针1；所述软针2需要具有一定柔性，例如可采用氮化硅、多晶硅、碳化硅等材料制得软针2。
在本实施例中，由于硬针1具有一定刚性，将软针2平铺于硬针1上表面，同时在硬针1生长软针固定件3，可将软针2与硬针1进行固定，这样硬针1可以带动软针2一同植入人体或动物的软组织内；当软针2植入组织后，再拉动硬针1，硬针1上的软针固定件3与软针2上的固定结构退出件配合，使得软针固定件3退出软针2上的定位开口4，从而解除对软针2的固定作用，硬针1与软针2分离，硬针1拔出，软针2留在植入的组织中，软针2具有一定柔性，在植入的组织内可随着血管伸缩而进行适应性形变，从而避免了传统刚性微针对人体或动物的软组织造成损伤的问题。
在可选的实施方式中，如图2、图3和图4所示，所述软针固定件3包括第一部分和第二部分，所述第二部分两端分别与所述第一部分和所述硬针1表面连接，所述第一部分与所述硬针1表面平行，且所述软针2位于所述第一部分与所述硬针1表面之间，所述第二部分与所述硬针1表面呈预设角度。具体的，所述硬针1上表面设计有多个软针固定件3，本实施例中在硬针1的前端和中部位置各设一个软针固定件3，所述软针固定件3的第一部分、第二部分和所述硬针1表面组成开槽，所述开槽朝向硬针1的 针尖，所述固定结构退出件位于定位开口4上远离软针2针尖的一侧。当硬针1植入组织时，通过该软针固定件3带动软针2一同植入，在到达植入地点后，向后拉动硬针1，硬针1上的软针固定件3接触到定位开口4后端的固定结构退出件后，固定结构退出件使得软针固定件3与软针2脱离，软针2与硬针之间的固定解除，实现硬针1拔出而软针2留在组织内的目的。
可选的，如图5所示，所述固定结构退出件为由定位开口4边缘向定位开口4内延伸的两片脱钩部5，两片脱钩部5关于定位开口4的轴线对称布置，两片所述脱钩部5之间具有间距，该间距小于软针固定件3的宽度，两片所述脱钩部5侧边与对应定位开口4侧边沿之间具有间隙，以便脱钩部5能向上翻起以及向两侧方向挤压。拔出硬针1时，向后拉动硬针1，软针固定件3接触该脱钩部5后，脱钩部5将会慢慢向上翘起，从而使得软针固定件3向下退出定位开口4。具体的，该脱钩部5通过在软针2上图形化制得，即该脱钩部5与软针2为一体化结构，这样两片脱钩部5在向上打开过程中，软针固定件3的第二部分挤压脱钩部5，使得脱钩部5沿硬针1回退的方向向上翘起，扩大定位开口4的区域，软针固定件3从定位开口4中脱离软针1，软针2和脱钩部5为弹性材料，在硬针1与软针2脱离后，脱钩部5竖起的部分下降，恢复至原形。
可选的，如图2至图4所示，为了提高软针固定件3的强度，软针固定件3的第一部分和第二部分一体成型。在硬针1和软针2分离的过程中，为了便于软针固定件3从定位开口4中脱离，以及在软针固定件3挤压脱钩部5的过程中避免第一部分对脱钩部5造成影响，本实施例中设计第二部分的底面与硬针表面抵接，第二部分的顶面与第一部分的底面抵接，而且第二部分的底面大于第二部分的顶面。
优化的，可设计两片所述脱钩部5靠近软针固定件3一端呈八字形，这种结构设计可使得软针固定件3在接触脱钩部5时，脱钩部5能更方便 的向上翘起，以便扩大定位开口4的区域。
如图3所示，为了便于硬针1脱离软针2，本实施例中，将软针固定件3的第二部分与硬针1表面之间的角度设置为锐角，即避免在远离硬针1尖端的方向上软针固定件3的第一部分超出第二部分的端部，同时有利于软针固定件3的第二部分挤压脱钩部5而使脱钩部5向上翘起。
在可选的实施方式中，如图6、图7和图8所示，还可在所述硬针1的尾部沿其宽度方向间隔设有至少一个插销结构6，所述软针2的尾部对应插销结构6处开设有插销孔8，且在软针2的尾部上沿插销孔8边缘向外设置若干中心对称图形7，如本实施例中图形处的中心对称图形7可以为类似花瓣结构，所述插销结构6与软针2的中心对称图形7在硬针1表面的投影至少存在部分重合；具体的，所述插销结构6由上大下小的两个同轴圆柱构成，且插销结构6的上圆柱直径大于所述插销孔8直径。制备微针时，在硬针1上生长软针2后，在软针2尾部上开设插销孔8，并图形化出中心对称图形7，再在插销孔8处生长插销结构6，由于插销结构6的上圆柱直径大于所述插销孔8直径，上圆柱会压住插销孔8边缘的部分软针2结构，从而固定软针2，进一步保证硬针1和软针2之间不会发生位移；当硬针1带动软针2一同植入组织后，通过向下拉动硬针1，插销结构6的上圆柱会对软针2产生一定向下作用力，软针2上的中心对称图形7会发生一定程度弯曲变形，直至插销结构6完全退出，然后继续向后拉动硬针1，使硬针1上的软针固定件3退出，从而使硬针1和软针2完全脱离，拔出硬针1，保留软针2在组织内。
上述复合微针结构在制备时，先在硬针1表面生长一定厚度的牺牲层，再在牺牲层的表面生长软针2，在软针2的前部和尾部分别开设定位开口4和插销孔8，并在软针2上图形化出脱钩部5和中心对称图形7，然后在定位开口4处再生长软针固定件3的竖直段和水平段，使得定位开口4边缘的软针1部分压入至软针固定件3内，在插销孔8处再生长插销结构6，使 插销结构6的上圆柱边缘覆盖插销孔8边缘的部分软针2，然后释放硬针1与软针2之间的牺牲层即可。
本实施例中，中心对称图形7的中心点与插销孔8的中心点重合。
综上所述，本发明提供的这种复合微针结构通过硬针带动软针一同植入组织，同时通过沿硬针长度方向设置软针固定件，一方面能够通过软针固定件带动软针植入，另一方面能够很好的固定硬针和软针，防止它们之间发生移动，减小软针发生翘曲的风险，并且在微针植入组织后，硬针可拔出，软针可随着血管伸缩而进行适应性形变，避免了采用单一硬针或软针的缺陷。
以上例举仅仅是对本发明的举例说明，并不构成对本发明的保护范围的限制，凡是与本发明相同或相似的设计均属于本发明的保护范围之内。

Claims (10)

  1. 一种复合微针结构，其特征在于：包括硬针和软针，所述软针置于所述硬针上表面，所述硬针上表面沿其长度方向间隔设有至少一个软针固定件，所述软针上设有定位开口，所述软针固定件在定位开口处将所述软针固定于硬针上，所述软针的定位开口处设有拉动硬针时可使软针固定件退出定位开口的固定结构退出件。
  2. 如权利要求1所述的复合微针结构，其特征在于：所述软针固定件包括第一部分和第二部分，所述第二部分两端分别与所述第一部分和所述硬针表面连接，所述第一部分与所述硬针表面平行，且所述软针位于所述第一部分与所述硬针表面之间，所述第二部分与所述硬针表面呈预设角度。
  3. 如权利要求2所述的复合微针结构，其特征在于：所述硬针上表面有多个软针固定件，所述软针固定件的第一部分、第二部分和所述硬针表面组成开槽，所述开槽朝向硬针的针尖，所述固定结构退出件位于定位开口上远离软针针尖的一侧。
  4. 如权利要求2所述的复合微针结构，其特征在于：所述软针固定件的第二部分与所述硬针表面之间预设角度为锐角。
  5. 如权利要求2所述的复合微针结构，其特征在于：所述固定结构退出件为由定位开口边缘向定位开口内延伸的脱钩部，所述脱钩部之间的间距小于软针固定件的第二部分的宽度，且脱钩部关于定位开口的轴线对称布置，所述脱钩部侧边与对应定位开口侧边沿之间具有间隙。
  6. 如权利要求5所述的复合微针结构，其特征在于：两片所述脱钩部靠近软针固定件一端呈八字形。
  7. 如权利要求1所述的复合微针结构，其特征在于：所述硬针的尾部沿其宽度方向间隔设有至少一个插销结构，所述软针的尾部对应插销结构处开设有插销孔，且在软针的尾部上沿插销孔边缘向外设置中心对称图形，所述插销结构与软针的所述中心对称图形在硬针表面的投影至少存在部分重合。
  8. 如权利要求7所述的复合微针结构，其特征在于：所述插销结构由上大下小的两个同轴圆柱构成，且插销结构的上圆柱直径大于所述插销孔直径。
  9. 如权利要求7所述的复合微针结构，其特征在于：所述中心对称图形的中心点与所述插销孔的中心点重合。
  10. 如权利要求2所述的复合微针结构，其特征在于：所述第二部分的底面与所述硬针表面抵接，所述第二部分的顶面与所述第一部分的底面抵接，而且所述第二部分的底面大于所述第二部分的顶面。
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