CN114515152A - Auxiliary device for implanted microneedle and microneedle implantation system - Google Patents
Auxiliary device for implanted microneedle and microneedle implantation system Download PDFInfo
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- CN114515152A CN114515152A CN202111683371.0A CN202111683371A CN114515152A CN 114515152 A CN114515152 A CN 114515152A CN 202111683371 A CN202111683371 A CN 202111683371A CN 114515152 A CN114515152 A CN 114515152A
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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
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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
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
- A61B5/293—Invasive
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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
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/369—Electroencephalography [EEG]
- A61B5/386—Accessories or supplementary instruments therefor
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Abstract
The invention provides an implanted microneedle auxiliary device and a microneedle implantation system. According to the invention, the functional area to be implanted is accurately positioned through the partition plate, and meanwhile, the microneedle implantation depth and the microneedle removal are controlled through the cooperation of the partition plate and the partition plate frame, so that the microneedle position deviation and secondary damage caused by manual operation or brain tissue movement can be effectively avoided.
Description
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to an implanted microneedle auxiliary device and a microneedle implantation system.
Background
The neural interface provides a path for connecting the nerve cells with external equipment, and can stimulate the nerve cells to generate action potentials through the external equipment and also record the action potentials generated by the nerve cells so as to realize the bidirectional communication between the nerve cells and the external equipment. Therefore, neural interfaces are widely used in research and treatment of various neurological diseases, such as parkinson's disease, epilepsy, depression, essential tremor, and the like.
At present, an invasive micro-needle for a nerve interface is implanted in an artificial manual mode or directly nailed into nerve tissues by an air hammer, no related micro-needle implantation auxiliary equipment exists, the precision is poor and blood vessels are easily punctured during implantation, and the follow-up micro-needle is difficult to insert and pull.
Disclosure of Invention
The invention aims to provide an implanted microneedle auxiliary device and a microneedle implantation system, which can at least solve part of defects in the prior art.
In order to achieve the purpose, the invention adopts the following technical scheme: providing an implanted microneedle auxiliary device, which comprises a clapboard frame and a clapboard, wherein the bottom of the clapboard frame is provided with a supporting part, and the upper part of the clapboard frame is provided with a limiting part which is matched with the edge of a target position for positioning;
the edge of the bottom surface of the partition plate is supported on the supporting part of the partition plate frame, and the partition plate is provided with at least one micro-needle hole for the micro-needle to pass through.
Preferably, the spacer bracket includes an adjustment mechanism for adjusting the spacing portion to a predetermined position.
Preferably, the partition plate frame comprises a connecting plate, a supporting plate and a limiting plate, one end of the connecting plate is connected with the limiting plate, and the other end of the connecting plate is connected with the supporting plate;
the limiting plate is used as a limiting part of the clapboard frame, and the supporting plate is used as a supporting part of the clapboard frame.
Preferably, the connecting plate is provided with a mark for indicating a change in position of the supporting plate.
Preferably, there are at least two of said spacer brackets.
Preferably, the partition is made of a biocompatible material.
Preferably, the separator is made of at least one degradable material.
In order to achieve the purpose, the invention adopts the following technical scheme: providing a microneedle implantation system comprising a microneedle, and an assistive device described herein; the micro-needle comprises at least one body electrode, and the body electrodes are arranged in one-to-one correspondence with the micro-needle holes in the partition plate.
Preferably, the microneedle comprises at least one microneedle assembly, the microneedle assembly comprises a microneedle body and an integrated circuit chip, the integrated circuit chip is arranged on the microneedle body, and the microneedle body comprises at least one body electrode.
Preferably, the microneedle comprises: a restraining device for unitizing at least two microneedle assemblies.
Compared with the prior art, the invention has the beneficial effects that:
(1) according to the auxiliary device for the implanted microneedle, the functional area to be implanted is accurately positioned through the partition plate, and the depth of the implanted microneedle and the removal of the microneedle are controlled through the cooperation of the partition plate and the partition plate frame, so that the position deviation and secondary damage of the microneedle caused by manual operation or movement of nervous tissues can be effectively avoided.
(2) The micro-needle in the micro-needle implantation system provided by the invention is provided with a multi-contact area array, and brain wave signals can be recorded through the multi-electrode contact, so that the spatial resolution and the signal accuracy are improved; meanwhile, the micro needle body is combined with an integrated circuit chip (namely, a metal oxide semiconductor), so that the input and output functions of signals can be realized, and the problem that the existing invasive micro needle can only realize a single brain wave signal acquisition function is effectively solved.
The present invention will be described in further detail below with reference to the accompanying drawings.
Drawings
Fig. 1 is a schematic structural diagram of an auxiliary device of an implantable microneedle according to the present invention;
FIG. 2 is a schematic view of the auxiliary device of the present invention mounted on the opening of the skull;
FIG. 3 is a schematic view of the auxiliary device mounted to the opening of the skull in an embodiment of the present invention;
fig. 4 is a schematic structural view of a microneedle body in an embodiment of the present invention.
Description of reference numerals: 1. a partition plate frame; 2. a limiting plate; 3. a support plate; 4. a connecting plate; 5. a partition plate; 6. micro-pinholes; 7. microneedles; 8. a micro needle body; 9. an integrated circuit chip; 10. a connecting rod; 11. the skull; 12. a bulk electrode; 13. a body electrode point; 14. a microneedle body tail; 15. an indium column; 16. and a through hole.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In the description of the present invention, it is to be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplicity of description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention.
The terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature; in the description of the present invention, "a plurality" means two or more unless otherwise specified.
Example 1:
the embodiment provides an auxiliary device for an implantable microneedle, which comprises a clapboard frame and a clapboard, wherein the bottom of the clapboard frame is provided with a supporting part, and the upper part of the clapboard frame is provided with a limiting part which is matched with the edge of a target position for positioning; the edge of the bottom surface of the partition plate is supported on the supporting part of the partition plate frame, and the partition plate is provided with at least one micro-needle hole for the micro-needle to pass through.
In this embodiment, the septum housing includes an adjustment mechanism for adjusting the stop portion to a predetermined position. Wherein the adjustment mechanism comprises an adjustment knob.
The partition plate frame comprises a connecting plate, a supporting plate and a limiting plate, wherein one end of the connecting plate is connected with the limiting plate, the other end of the connecting plate is connected with the supporting plate, and the supporting plate and the limiting plate are positioned on two sides of the connecting plate; the limiting plate is used as a limiting part of the clapboard frame, and the supporting plate is used as a supporting part of the clapboard frame.
In addition, the connecting plate is provided with a mark for indicating the change of the position of the supporting plate.
For the specific structure and usage of the auxiliary device, please refer to the following embodiments.
Example 2:
as shown in fig. 1, 2 and 3, the present embodiment provides an implantable microneedle auxiliary device, which includes a septum bracket 1 and a septum 5, wherein the bottom of the septum bracket 1 has a supporting portion, and the upper portion of the septum bracket 1 has a position-limiting portion that is positioned in cooperation with an edge of a target location, wherein the target location may be an opening on a skull 11, the edge of the bottom surface of the septum 5 is supported on the supporting portion of the septum bracket 1, and the septum 5 is provided with at least one microneedle hole 6 for a microneedle to pass through.
In the embodiment, the target position can be an opening on a skull 11 as an example for explanation, firstly, the skull 11 is opened with an opening of a certain area through a craniotomy so as to be used for implanting a subsequent microneedle, then, the partition plate frame 1 is placed at the opening of the skull 11, one end of the supporting part of the partition plate frame 1 extends into the opening of the skull 11, the limiting part of the partition plate frame 1 is positioned outside the opening of the skull 11, the partition plate frame 1 is matched with the edge of the opening of the skull 11 through the limiting part for limiting and fixing, then, the partition plate 5 is placed on the supporting part of the partition plate frame 1, the partition plate 5 is limited through the partition plate frame 1, the partition plate 5 is prevented from moving, and a brain functional area to be implanted with the microneedle is accurately positioned through the partition plate 5; when carrying out the micropin and plant, can implant micropin 7 with the every degree of depth of 50um with the help of high definition camera and brain stereotaxic appearance, micropin 7's micropin one-to-one passes micropin hole 6 on the baffle 5, through the position of micropin hole 6 injecture micropin, can effectively prevent because the skew of manual operation or the activity of brain tissue make the micropin position, avoid secondary damage.
In this embodiment, the partition shelf includes a limiting plate 2, a connecting plate 4 and a supporting plate 3, one end of the connecting plate 4 is connected to the limiting plate 2, the other end of the connecting plate 4 is connected to the supporting plate 3, and the supporting plate 3 and the limiting plate 2 are located at two sides of the connecting plate 4; the limiting plate 2 is used as a limiting part of the partition rack, and the supporting plate 3 is used as a supporting part of the partition rack.
In order to ensure that the partition can be positioned, the support plate 3 is perpendicular to the connecting plate 4; the position relationship between the limiting plate 2 and the connecting plate 4 may be determined according to actual conditions, and the limiting plate 2 is perpendicular to the connecting plate 4, or the limiting plate 2 is not perpendicular to the connecting plate 4.
In a specific embodiment, as shown in fig. 1, the partition frame 1 is composed of a limiting plate 2, a connecting plate 4 and a supporting plate 3, the limiting plate 2 is arranged perpendicular to the upper part of the connecting plate 4 as the limiting part of the partition frame 1, the supporting plate 3 is arranged perpendicular to the lower part of the connecting plate 4 as the supporting part of the partition frame 1, the bottom surface of the supporting plate 3 is flush with the bottom surface of the connecting plate 4, and the limiting plate 2 and the supporting plate 3 are respectively located on two sides of the connecting plate 4. When the device works, the supporting plate 3 extends into an opening of a skull 11, the connecting plate 4 is tightly attached to the side wall of the opening of the skull 11, the limiting plate 2 is arranged on the outer surface of the opening edge of the skull 11, and the depth of the clapboard frame 1 extending into the opening of the skull 11 can be controlled by designing the height of the connecting plate 4 and the installation position of the limiting plate 2 relative to the connecting plate 4; then, the partition board 5 is arranged on the supporting part in the opening of the skull 11, the side wall of the partition board 5 is abutted against the connecting board 4 around the opening of the skull 11, and the partition board 5 is limited through the connecting board 4 so as to avoid the movement of the partition board 5. Optimized, in order to guarantee the stability of installing of baffle frame 1 at skull 11 opening part, can design the extension length of limiting plate 2 is greater than the extension length of backup pad 3, simultaneously in order to guarantee that backup pad 3 can effectively support baffle 5 and do not influence the implantation of micropin 7, the extension length of backup pad 3 chooses for use 1 ~ 2mm in this embodiment.
In a preferred embodiment, the septum housing includes an adjustment mechanism for adjusting the stop portion to a predetermined position. The adjusting mechanism is connected with the connecting plate and used for adjusting the position of the connecting plate so as to adjust the position of the limiting part. For example, the angle between the connecting plate and the limiting plate is adjusted through the adjusting mechanism, and the horizontal distance or the vertical distance of the connecting plate relative to the limiting plate can be adjusted through the adjusting mechanism, so that the limiting part can be adjusted in the three-dimensional direction, and the application range of the auxiliary device is widened.
In this embodiment, at least two of the partition frames, for example, two of the partition frames, are disposed oppositely, in this way, the two ends of the supporting portion of the partition frame are respectively provided with the positioning plate, so that the partition can be prevented from generating relative displacement along the supporting portion; the intracranial baffle plate fixing device can also comprise four baffle plates, every two intracranial baffle plates are oppositely arranged, in addition, the supporting plate 3 can be designed into an arc shape, and in this case, three baffle plates can be arranged.
In one embodiment, four partition racks 1 are adopted and are respectively arranged at equal intervals along the circumferential direction of the partition 5; meanwhile, the clapboard frame 1 needs to be placed in the opening of the skull 11, so that the clapboard frame 1 is made of titanium-tungsten alloy or bone cement and other materials in order to avoid the damage of the clapboard frame 1 to the skull 11 and the influence on the micro-needle acquisition of brain wave signals.
Optionally, the micropin 6 on the baffle 5 is corresponding with the micropin of micropin 7, and micropin 6 is the array distribution in the middle of baffle 5 to the size of micropin 6 and the micropin diameter phase-match of micropin 7 guarantee that the micropin can pass micropin 6, and be difficult for producing relative movement, and is concrete, and 100 ~ 200um can be chooseed for use in the aperture of micropin 6. Similarly, in order to avoid the damage of the partition plate 5 to the skull 11 and the influence on the micro-needle collection of brain wave signals, the partition plate frame is made of PDMS or silicon or polyimide and the like, and the thickness of the partition plate 5 is about 1mm, for example, 0.5mm to 1.5 mm.
In a preferred embodiment, the spacer 5 is made of a biocompatible material, and the spacer 5 can also be made of a degradable material.
In addition, the present embodiment further provides a microneedle implantation system, as shown in fig. 1 and fig. 4, including a microneedle 7 and the above auxiliary device, where the microneedle 7 includes at least one body electrode 12, the body electrode 12 has a plurality of body electrode points 13, and the body electrode 12 and the micro-needle holes 6 on the partition 5 are arranged in a one-to-one correspondence manner. When the micro-needle is implanted, the micro-needle 7 is implanted at the depth of 50um each time by means of a high-definition camera and a brain stereotaxic apparatus, so that the body electrode 12 of the micro-needle 7 penetrates through the micro-needle hole 6, the blood vessel puncture is avoided as far as possible, and the micro-needle can be pulled out in time if the micro-needle cannot be avoided.
In an optimized embodiment, as shown in fig. 1 and 4, the microneedle 7 includes at least one microneedle assembly, the microneedle assembly includes a microneedle body 8 and an integrated circuit chip 9, the microneedle body 8 includes a microneedle body tail 14 and at least one body electrode 12 disposed on the microneedle body tail 14, the integrated circuit chip 9 is mounted on the microneedle body tail 14 of the microneedle body 8, and the body electrode 8 has a plurality of body electrode points 13 thereon, which can record brain wave signals. Specifically, the micro needle body tail 14 has a plurality of first welding points thereon; for each of the micro-needles 8, each of the body electrode points 13 is electrically connected to the integrated circuit chip 9 through the corresponding first bonding pad. Wherein, a plurality of body electrodes 12 are arranged on the micro needle body 8, and for each micro needle body 8, each body electrode 12 is arranged along the extending direction of the micro needle body tail 14.
In the embodiment, a plurality of micro needles 8 are assembled into micro needles with an array structure, and a plurality of body electrode points 13 are arranged on a single body electrode 12, so that the body electrode 12 forms a three-dimensional micro needle electrode with a multi-contact area array, and brain wave signals can be recorded by a plurality of electrode contacts, thereby improving the spatial resolution and the signal accuracy; meanwhile, the integrated circuit chip 9 is assembled on the tail 14 of the micro needle body 8, and the brain wave signal acquisition and reading circuit of the micro needle body 8 is integrated, so that the input and output functions of signals can be realized, the brain wave signal can be acquired, the electrical stimulation can be realized, the lost function of the brain can be recovered, and the problem that the existing invasive micro needle can only realize the single brain wave signal acquisition function is effectively solved.
In this embodiment, the microneedles further comprise a binding device, and the microneedles adjacent to the microneedle assembly are assembled together by the binding device to form an array structure.
In an alternative embodiment, the restraining means is made of a material having adhesive properties.
In another optional embodiment, the binding device includes a fixing member, the fixing member is provided with a plurality of first engaging portions, the tail portion of the microneedle body is provided with a second engaging portion, the first engaging portion and the second engaging portion engage with each other to fix at least two microneedle assemblies on the fixing member, for example, the second engaging portion may be provided in a direction away from the needle point of the microneedle body.
In yet another alternative embodiment, the two ends of the tail of the micro needle body are provided with through holes, and the binding device comprises a connecting rod which penetrates through the through holes on the same side. Specifically, the micro-needles 8 are arranged in parallel, the micro-needles 8 are connected into a whole through the connecting rod 10, and the distance between two adjacent micro-needles 8 can be adjusted according to actual requirements. In one embodiment, through holes 16 are provided at two ends of the microneedle body tail 14, an axis of each through hole 16 is perpendicular to a length direction of the body electrode 12, the through hole 16 is located outside the most lateral body electrode 12 at the corresponding side, and the connecting rod 10 penetrates through the through hole 16 at the same side of the microneedle body tail 14 of each microneedle body 8, wherein an axis of each through hole 16 passes through a center of the through hole 16 and is perpendicular to a plane where the microneedle body tail 14 is located.
In a practical application scenario, the through holes 16 on the tail portions of the micro needles 8 are at the same position, so that the connecting rod 10 can sequentially penetrate through the through holes 16 on the micro needles 8. In addition, the size of the through hole 16 is matched with the diameter of the connecting rod 10, so that the connecting rod 10 can pass through the through hole 16 and is not easy to move relatively.
In this embodiment, two ends of the tail 14 of the microneedle body of each microneedle body are respectively connected in series by two connecting rods 10, so that a plurality of microneedle bodies 8 are connected into a whole to assemble the microneedle 7, and the assembly is convenient and the controllability is high.
In one embodiment, each micro needle body 8 comprises a plurality of body electrodes 12, and after the micro needle bodies 8 are respectively connected in series into micro needles through the connecting rods 103, the body electrodes 12 of two adjacent rows of micro needle bodies 8 are in the same position.
In practical application scenarios, the brain wave signals of adjacent areas may not be greatly different, and in order to acquire more brain wave signals, in another alternative embodiment, the body electrodes 12 of two adjacent rows of micro-needles 8 are arranged in a staggered manner, for example, the first row of micro-needles includes a first body electrode a, a second body electrode b, and a third body electrode c; the second row of micro-needle bodies comprises a first body electrode d and a second body electrode e; the projection of the first body electrode d on the first row of micro-needles is located between the first body electrode a and the second body electrode b.
For the integration mode of the micro-needle body 8 and the integrated circuit chip 9, optionally, indium columns 15 are arranged on the connection surfaces of the integrated circuit chip 9 and the micro-needle body tail 14, the integrated circuit chip 9 and the micro-needle body tail 14 are connected by bonding corresponding indium columns 15, brain wave signals are transmitted to the indium column 15 end through body electrode points 13 on the body electrodes 12, the indium columns 15 bonded on the integrated circuit chip 9 in one-to-one correspondence are connected with internal circuits of the integrated circuit chip 9, and the signals are transmitted to an ASIC signal processing end through metal wires, so that the output of the signals is realized; the input transmission process of the signal is opposite to the input transmission process of the signal.
In this embodiment, the tail of the micro pin body has at least one first solder joint, each of the first solder joints is provided with a conductive material, the integrated circuit chip has at least one second solder joint, each of the second solder joints is provided with a conductive material, and the first solder joints are electrically connected to the second solder joints. The micro needle body further comprises at least one body electrode, and at least one body electrode point is arranged on the body electrode. The body electrode point is connected with the first welding point through a connecting line. Wherein the conductive material comprises indium, gold, or pt.
In an optional embodiment, each body electrode point 13 is connected to the corresponding first solder joint through a metal wire, the first solder joint is provided with a first indium column, the integrated circuit chip 2 is provided with a plurality of second solder joints, each second solder joint is provided with a second indium column, and the first indium column is connected to the corresponding second indium column, so that the integrated circuit chip 9 and the corresponding micro-needle body tail 14 are connected by bonding through the corresponding indium column 15.
(1) The micro needle comprises a micro needle body, wherein the micro needle body is provided with at least one body electrode regardless of whether an integrated circuit chip is arranged or not;
(2) the micro needle comprises a micro needle body, wherein the micro needle body is provided with at least three body electrodes, and at least two body electrodes are distributed in one row or multiple rows regardless of whether an integrated circuit chip is arranged or not;
(3) the microneedle comprises a microneedle assembly, the microneedle assembly comprises the microneedle body and the integrated circuit chip, and the integrated circuit chip is bonded with the microneedle body to form the microneedle assembly;
(4) the microneedle comprises at least two microneedle assemblies, the at least two microneedle assemblies are assembled together, and the at least two microneedle assemblies are distributed in one or more rows.
The above examples are merely illustrative of the present invention and should not be construed as limiting the scope of the invention, which is intended to be covered by the claims and any design similar or equivalent to the scope of the invention.
Claims (10)
1. An implanted microneedle assist device, comprising: the partition board comprises a partition board frame and a partition board, wherein the bottom of the partition board frame is provided with a supporting part, and the upper part of the partition board frame is provided with a limiting part which is matched and positioned with the edge of a target position;
the bottom surface edge of the partition plate is supported on the supporting part, and the partition plate is provided with at least one micro-needle hole for the micro-needle to penetrate through.
2. An implantable microneedle assistance device according to claim 1, in which: the spacer bracket includes an adjustment mechanism for adjusting the spacing portion to a predetermined position.
3. An implantable microneedle assistance device according to claim 2, in which: the partition plate frame comprises a connecting plate, a supporting plate and a limiting plate, one end of the connecting plate is connected with the limiting plate, and the other end of the connecting plate is connected with the supporting plate;
the limiting plate is used as a limiting part of the partition rack, and the supporting plate is used as a supporting part of the partition rack.
4. An implantable microneedle assistance device according to claim 3, in which: the connecting plate is provided with a mark for indicating the change of the position of the supporting plate.
5. An implantable microneedle assistance device according to claim 1, in which: the number of the clapboard bracket is at least two.
6. An implantable microneedle assistance device according to claim 1, in which: the partition plate is made of biocompatible materials.
7. An implantable microneedle assistance device according to claim 1, in which: the partition plate is made of degradable materials.
8. A microneedle implantation system, characterized by: comprising a microneedle and an accessory device according to any one of claims 1 to 7; the micro-needle comprises at least one body electrode, and the body electrodes are arranged in one-to-one correspondence with the micro-needle holes in the partition plate.
9. A microneedle implantation system according to claim 8, wherein: the micro-needle comprises at least one micro-needle component, the micro-needle component comprises a micro-needle body and an integrated circuit chip, the integrated circuit chip is arranged on the micro-needle body, and the micro-needle body comprises at least one body electrode.
10. A microneedle implantation system according to claim 9, wherein: the microneedle further comprises: a restraining device for unitizing at least two microneedle assemblies.
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