CN110153651A - Big L/D ratio planar metal microneedle array, preparation method and its clamping are pierced into auxiliary device - Google Patents
Big L/D ratio planar metal microneedle array, preparation method and its clamping are pierced into auxiliary device Download PDFInfo
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- CN110153651A CN110153651A CN201910391947.2A CN201910391947A CN110153651A CN 110153651 A CN110153651 A CN 110153651A CN 201910391947 A CN201910391947 A CN 201910391947A CN 110153651 A CN110153651 A CN 110153651A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23P—METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS
- B23P15/00—Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
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Abstract
A kind of big L/D ratio planar metal microneedle array, preparation method and its clamping are pierced into auxiliary device, belong to the field of medical instrument technology.Large scale sheet metal is cut to micro metal thin slice；The clamping tooling being made of upper and lower two pieces of metal cover boards is processed, groove is equipped on the inside of tooling upper and lower cover plates, sheet metal is placed in groove, is fastened by bolts；The geometry and size for designing microneedle array, carry out wire cutting to tooling and sheet metal as a whole, obtain the planar metal microneedle array with multiple micropin needle bodies.In addition, the present invention also provides the assembling clamping device of the big L/D ratio planar metal microneedle array and being pierced into auxiliary device, assembled piercing auxiliary device is placed on skin, microneedle array is pierced into skin by auxiliary device.Microneedle array can be in high volume made by simply assembling in the present invention, at low cost high-efficient, can guarantee micropin tip machining accuracy；And the use reliability of big L/D ratio micropin can be improved comprehensively.
Description
Technical field
The invention belongs to the field of medical instrument technology, it is related to a kind of big L/D ratio planar metal microneedle array, preparation method
And its clamping, piercing auxiliary device.
Background technique
Micropin (Microneedle, MN) generally refers to length at tens microns to several millimeters, and tip diameter is at tens microns
Micro needle head below.Keratoderma is punctured using micropin, so that keratoderma biological barrier effect is broken through, in skin table
Layer forms micron-sized medication delivery channel, and experiment shows that drug percutaneous transfer efficiency can be improved in the order of magnitude, simultaneously also
The type and range of percutaneous loading are substantially expanded.Further, since micropin size is small, the wound generated when so puncturing skin
It is all very small with feeling of pain, it will not only cause the significant discomfort of loading patient, but also be beneficial to prevent infection, more favorably
Restore in wound.Exactly because having many advantages, such as above-mentioned, in recent ten years, micropin technology has been closed extensively in percutaneous dosing field
Note.
In addition to for percutaneous loading, micropin is in recent years in biomedical measurement and microsampling analysis field also by more
Carry out more concerns.But it is different only to puncture skin surface tissue from micropin in percutaneous loading technology, samples for biological micro
The micropin of analysis needs to be pierced into certain depth in tissue, so the length of sampling micropin is often in millimeter magnitude.In order to make to sample
Micropin still has the advantages that wound is small, pain is light, samples the lateral dimension of micropin there is still a need for small as far as possible, so that sampling
The draw ratio of micropin is very big, so that the preparation and use to sampling micropin bring difficulty.Firstly, micropin height is higher, difficult processing
Degree and cost are also higher, and the conventional micropin processing technology such as existing photoetching, deep reaction ion etching, x-ray etching is difficult to greatly
The processing of draw ratio micropin；Secondly, the elongated dimension of big L/D ratio micropin is easy to induce the buckling of micropin during being pierced into skin
Or fracture, cause to be pierced into failure.
For the manufacturing issue of big L/D ratio sampling micropin, South Korea scholar once used polymer drawing molding to combine metal electricity
Depositing process is successfully prepared a kind of sampling micropin that length can achieve 2 millimeters, referred to as " Ultra-high aspect
Microneedle ", related ends are also published on authoritative magazine<Advanced Materials>.Briefly, technique benefit
Drawing is carried out to SU-8 glue in a molten state with the drawing head with several micron order microtrabeculaes, SU-8 glue is drawn into column
Shape, it is highly controllable.Metal coating is carried out to column SU-8 glue surface again after cooling and shaping, finally SU-8 glue is dissolved but protected
The coat of metal is stayed, finally obtaining height is that millimetre-sized big L/D ratio metal samples microneedle array.Obviously, the design and manufacture technology
It is ingenious, big L/D ratio metal micro-needle can be successfully prepared, but in contrast manufacturing process is more complex, higher cost, it is difficult to batch
Production.In addition, how to ensure this microneedle array being made of big L/D ratio column micropin without flexing when being pierced into skin
Or fracture solution still not yet in effect.
Summary of the invention
The problem of for big L/D ratio sampling micropin manufacture and use process, the present invention provides a kind of big L/D ratio
Planar metal microneedle array, preparation method and its processing have high-efficient, at low cost, performance with auxiliary device, the invention is pierced into
The advantages that good, suitable for mass production and actual use.
To achieve the above object, the present invention provides the following technical solutions are as follows:
A kind of preparation method of big L/D ratio planar metal microneedle array, comprising the following steps:
Step 1: micropin material is using good biocompatibility, intensity and all good medical stainless steel of toughness or titanium alloy gold
Category sheeting, 20~200 microns of sheet metal thickness.
Step 2: cutting out the sheet metal for sizeable micro metal thin slice 5, recommended size is long 30~50
Millimeter, it is 10~30 millimeters wide.
Step 3: processing dedicated thin slice clamping tooling
Tooling is made of upper and lower two pieces identical metal cover boards 1, and every piece of cover board general thickness is 5~10 millimeters；?
The groove 2 that tooling upper and lower cover plates inwall processing and 5 size of micro metal thin slice match, i.e. groove length and width and aforementioned metal
5 length and width of thin slice are consistent, and for placing sheet metal 5, the depth of upper and lower cover plates groove is 1~5 millimeter；Upper and lower cover plates main body 1
Edge processing is for the through-hole 3 by fastening bolt 4.The clamping tooling material is that electric conductivity is good, intensity is high
The metal materials such as stainless steel, 45# steel.
The micro metal thin slice 5 is placed in the groove 2 of any metal cover board 1 by the 4th step, the metal once placed
5 the piece number of thin slice is adjusted according to sheet thickness and depth of groove, recommends primary placement the piece number 20~200.By another metal
Cover board 1 is placed on the cover board for having placed sheet metal 5, and groove is towards sheet metal 5, consistency from top to bottom；Then by tight
Upper and lower metal cover board 1 is encapsulated and is fastened by fixing bolt 4, compacted metal thin slice 5, with upper and lower cover plates 1 at being integral.
5th step designs the geometry and dimensions of sheet-like plane metal micro-needle
Sheet-like plane metal micro-needle array by for subsequent retained part substrate 6 and big L/D ratio micropin needle body 7 form,
The height of big L/D ratio micropin needle body 7 is 1~5 millimeter, and needle body root width is 50~500 microns, certainly with a thickness of sheet metal 5
Body thickness.For the big L/D ratio micropin needle body 7 and set on 6 top of substrate, every chip base on piece micropin number is 3~50,
0.25~10 millimeter of spacing；6 top two sides of substrate are equipped with a positioning shoulder 8, for be pierced into auxiliary device carry out positioning lead
To；6 lower section middle part of substrate is equipped with a positioning and guiding slot 9, is assembled for successive substrates 6.
The big L/D ratio micropin needle body 7 uses uniform strength design, i.e. big L/D ratio micropin needle body 7 along its length
Change width is necessary to ensure that micropin needle body 7 when tip is acted on by lateral concentrfated load at the maximum stress in bend of each cross-section
Locate equal, it is assumed that 7 root of micropin needle body is x-axis starting point, and x-axis is located at the apical axis of micropin needle body 7, and width direction is assumed to
Y-axis, then uniform strength design requires x, y to meet following relationship:L in formula0For 7 length of micropin needle body, C is comprehensive
Close the constant of reflection material yield strength, micropin thickness, magnitude of load.
Step 6: by the 4th step packaged sheet metal and frock clamping to linear cutting equipment, linear cutting equipment root
Gage travelling path is determined according to the geometry and dimensions of the sheet-like plane metal micro-needle of the 5th step design, to tooling and metal foil
Piece 5 carries out wire cutting as a whole, and sheet metal 5 processes substrate 6 and micropin needle body 7.During wire cutting, to micropin needle body
7 needle point processing is cut using figure of eight path, it is ensured that micropin needle point acuity.In addition, in process, 6 two sides of substrate
Not exclusively cutting, reserved 2~5 millimeters in order to keep part 10 of the clamping tooling integrality without cutting, it is ensured that clamping tooling and
Sheet metal 5 is still integral after processing, has not only prevented added working hour metal micro-needle array from being washed away by coolant liquid, but also be can guarantee and made
Tooling after still has the sufficiently high rigidity of structure, so that tooling is reusable.
Step 7: unloading the fastening bolt 4 in tooling, taking out machined sheet metal 5 and being cleaned, do not cut out
Micropin substrate when cutting.
8th step, the micropin substrate obtained to the 7th step are cut, and are removed the material of 6 two sides reserved area of substrate, are made
Sheet-like plane metal micro-needle is removed from sheet metal 5, obtains the sheet-like plane metal micro-needle array with multiple micropin needle bodies.
A kind of big L/D ratio planar metal microneedle array, sheet-like plane metal micro-needle array is by for subsequent retained part
Substrate 6 and big L/D ratio micropin needle body 7 form, and the height of big L/D ratio micropin needle body 7 is 1~5 millimeter, needle body root width
It is 50~500 microns, with a thickness of 5 thickness of sheet metal.The big L/D ratio micropin needle body 7 is and on substrate 6
Side, every chip base on piece micropin number are 3~50,0.25~10 millimeter of spacing；6 top two sides of substrate are equipped with a positioning shoulder
8, positioning and guiding is carried out for being pierced into auxiliary device；6 lower section middle part of substrate is equipped with a positioning and guiding slot 9, is used for successive substrates 6
It is assembled.The big L/D ratio micropin needle body 7 uses uniform strength design, i.e. big L/D ratio micropin needle body 7 along its length
Change width be necessary to ensure that the maximum stress in bend of each cross-section when tip is acted on by lateral concentrfated load of micropin needle body 7
It is equal everywhere, it is assumed that 7 root of micropin needle body is x-axis starting point, and x-axis is located at the apical axis of micropin needle body 7, and width direction assumes
For y-axis, then uniform strength design requires x, y to meet following relationship:L in formula0For 7 length of micropin needle body, C
For concentrated expression material yield strength, micropin thickness, magnitude of load constant.
A kind of assembling clamping device of big L/D ratio planar metal microneedle array, dedicated micropin thin slice assemble clamping device packet
Main body 11, partition 15 are included, main body 11, partition 15 are prepared using light-weight metal or high molecular material, select aluminium alloy or polytetrafluoro
The materials such as ethylene, but it is not limited to both materials.
The main body 11 is the box-like rectangular body structure of a side opening, and intracavity bottom is equipped with to be oriented to micropin substrate bottom
The sliding rail 12 that slot 9 matches；11 bottom of main body is equipped with the threaded hole 13 for subsequent installation handle；11 side of main body is equipped with
One tapped through hole 14, for being held out against by bolt 16 to partition 15.Big L/D ratio planar metal microneedle array is vertically put
It is placed in assembling clamping device, micropin needle body 7 is upward.The equivalent width of main body 11 housing width and micropin substrate 6；Chamber
Body depth is consistent with 6 outer ledge height of substrate (not including needle body 7 and the height for positioning shoulder), i.e., substrate 6 is put down where positioning shoulder
Face is generally aligned in the same plane with 11 upper surface of main body；Cavity length is according between the micropin substrate the piece number and each substrate of quasi- clamping
Away from determination, it is proposed that 10~40 millimeters of length range.The partition 15 is thin rectangular parallelepiped structure, for fixed when microneedle array assembles
Each micropin substrate in position；15 width of partition is consistent with 11 cavity depth of main body, and length is consistent with the housing width of main body 11, with a thickness of
1-5 millimeters, 15 bottom of partition is equipped with and the matched groove of 6 bottom guide groove of substrate 9.
Big L/D ratio planar metal microneedle array is disposed vertically in the cavity of clamping device main body 11, every substrate it
Between separated by partition 15；Bolt 16 passes through clamping device flank threads through-hole 14, squeezes partition 15, keeps each micropin substrate
Stablize.Micropin substrate is higher than partition 15 and clamping device body upper surface close to micropin needle body side when clamping, is specifically higher by ruler
The very little size by 6 liang of side positioning shoulders 8 of micropin substrate determines, after clamping is good at the bottom thread hole 13 of clamping device main body 11
Hand-held handle 17 is installed, the group clamping of big L/D ratio planar metal microneedle array is completed.
A kind of piercing auxiliary device of big L/D ratio planar metal microneedle array, the piercing auxiliary device includes rectangle
Frame main body 18, grid spacer 20, the small partition 21 of positioning, the rectangle frame main body 18, grid spacer 20 use light-weight metal or height
Molecular material preparation, selects the materials such as aluminium alloy or polytetrafluoroethylene (PTFE), but be not limited to both materials；The small partition 21 of positioning
With the same material of micropin substrate 6.
The rectangle frame main body 18 is the frame-shaped cuboid of upper and lower opening, for being placed on above assembling clamping device.
The inside casing length of rectangle frame main body 18, the cavity length of width and clamping device main body 11, equivalent width, rectangle frame main body 18
Height is consistent with the height of two side positioning shoulder 8 of micropin substrate, and the setting of 18 two sides of rectangle frame main body is for passing through non-cap bolt 22
Tapped through hole 19 is held out against for subsequent.The grid spacer 20 is specific as shown in figure 20, the height and rectangle of grid spacer 20
The height of frame main body 18 is consistent, and 20 length of grid spacer is consistent with 15 length of partition of clamping device, 20 thickness of grid spacer with
The consistency of thickness of clamping device partition 15, grid spacer 20 are slightly polished with micropin needle body corresponding position using fine sandpaper.It is fixed
Position partition 20 is spaced by positioning small partition 21 between any two, and the gap 23 between two grid spacers 20 is used to pass through micropin needle
Body 7.The height and 20 height of partition grid spacer of the small partition 21 of positioning are consistent, and width is more fixed than micropin substrate (6) two sides
The width of position shoulder 8 is 0.1~1 millimeter small, and thickness is consistent with micropin substrate, for ensure between grid spacer 20 gap 23 with it is micro-
Needle substrate thickness is consistent.
The grid spacer 20 is assembled in rectangle frame main body 18, in every 20 both ends placement positioning septulum of grid spacer
Piece 21, makes 20 spacing of grid spacer and micropin consistency of thickness, and grid spacer 20 and micropin needle body contact position are polished, be can ensure that micro-
There is gap between needle needle body and grid spacer 20, to avoid serious scraping collision.Non-cap bolt 22 passes through 18 end of rectangle frame main body
Face side threaded hole for compressing grid spacer 20 and positioning small partition 21, and keeps one-to-one relationship with clamping device.It is right
The skin area for needing to be pierced into carries out disinfection processing, and assembled piercing auxiliary device is placed on skin, then will be assembled
Microneedle array skin is pierced by the gap 23 of each grid spacer 20 in auxiliary device.
Further, it is contemplated that the reliability used reinforces grid spacer using 502 glue at 20 both ends of grid spacer
20, the connection between small partition 21 and rectangle frame main body 18 is positioned.
Compared with prior art, the invention has the benefit that
(1) the plane micropin design of sheet is conducive to simplify processing program, and using flexible, by simply assembling
The three-dimensional microneedle array of different size is made；Metal micro-needle array can be disposably processed in batch, with other micropin processing methods
It is greatly improved compared to efficiency, along with the relatively low cost of linear cutter technology, so micropin battle array provided by the present invention
Column processing method is low in cost.
(2) clamping tooling use later in addition to cutting wire cut away through the material at path other than, other parts are still protected
It holds completely, this aspect, which can protect whole tooling, has sufficiently high rigidity to repeat clamping use for subsequent, on the other hand due to processing road
Tooling material has been removed at diameter, subsequent only to cut sheet metal itself when reusing, so that further increasing can once add
The piece number of the metal micro-needle of work improves efficiency and reduces cost.If carrying out monolithic cutting to sheet metal, very due to thickness
Thin, the lateral force of very little will be such that micropin deforms, and when required processing micropin height is higher, this deformation is bigger, and precision is more difficult
To guarantee, and the compacting of multi-disc sheet metal is integral by clamping tooling, and workpiece stiffness can be improved, because lateral when preventing from cutting
Power leads to dimension deviation, greatly improves precision and processable micropin length, meets the processing needs of big L/D ratio micropin.
(3) in process, " 8 " font machining path is used when micropin tip is cut, it is possible to prevente effectively from directly in point
End carries out crest truncation caused by deflecting, to guarantee micropin tip machining accuracy；Micropin uses equal strength in the width direction
Design, can effectively improve the anti-flexion capabilities of micropin in the width direction, prevent micropin from occurring in the width direction when being pierced into skin
Buckling failure, while and using special piercing auxiliary device that can effectively mention to the additional constraint of micropin offer thickness direction
The anti-flexion capabilities of high micropin through-thickness, buckling failure occurs for through-thickness when micropin being prevented to be pierced into skin, thus entirely
The use reliability of face raising big L/D ratio micropin.
Detailed description of the invention
Fig. 1 is the main view in processing clamping device three-view diagram；
Fig. 2 is the top view in processing clamping device three-view diagram；
Fig. 3 is the side view in processing clamping device three-view diagram；
Fig. 4 is the schematic diagram after metal substrate clamping installation；
Fig. 5 is the sheet-like plane microneedle array schematic diagram with equal strength needle body；
Fig. 6 is linear cutter path schematic diagram；
Fig. 7 is the clamping tooling and microneedle array substrate schematic diagram when cutting is not dismantled after the completion；
Fig. 8 is the overall schematic of the sheet microneedle array and substrate after the completion of cutting；
Fig. 9 is the main view in microneedle array assembling clamping device three-view diagram；
Figure 10 is the top view in microneedle array assembling clamping device three-view diagram；
Figure 11 is the side view in microneedle array assembling clamping device three-view diagram；
Figure 12 is that microneedle array assembles the partition positioned in clamping device for micropin substrate；
Figure 13 is the main view in the schematic diagram after the completion of microneedle array group clamping；
Figure 14 is the top view in the schematic diagram after the completion of microneedle array group clamping；
Figure 15 is the side view in the schematic diagram after the completion of microneedle array group clamping；
Figure 16 is the main view that microneedle array is pierced into auxiliary device three-view diagram；
Figure 17 is the main view that microneedle array is pierced into auxiliary device three-view diagram；
Figure 18 is the main view that microneedle array is pierced into auxiliary device three-view diagram；
Figure 19 is that micropin is pierced into the partition positioned in auxiliary device for micropin partition；
Figure 20 is that microneedle array is pierced into the schematic diagram of auxiliary device after the assembly is completed.
In figure: 1 upper and lower cover plates main body；2 grooves；3 bolt holes；4 fastening bolts；5 be sheet metal；6 substrates；7 micropins
Needle body；8 positioning shoulders；9 guide grooves；10 in order to keep clamping tooling integrality without the part of cutting；11 assembling clamping device masters
Body；12 sliding rails；13 threaded holes；14 tapped through holes；15 partitions；16 bolts；17 hand-held handles；18 rectangle frame main bodys；19 screw threads are logical
Hole；20 grid spacers；The 21 small partitions of positioning；22 non-cap bolts；23 gaps.
Specific embodiment
Below in conjunction with attached drawing, the technical schemes of the invention are described in detail.The present invention disposably processes metal micro-needle battle array in batch
Column are calculated with 2 centimetres of the comparatively ideal total cutting thickness of wire cutting, such as tooling whole 5 millimeters of wall thickness up and down, 2 milli of depth of groove
Rice, every sheet metal with a thickness of 100 microns, then primary cleavable micropin quantity is 140, with other micropin processing sides
Method is greatly improved compared to efficiency, along with the relatively low cost of linear cutter technology, so micropin provided by the present invention
Array-processing method is low in cost.Clamping tooling use later in addition to cutting wire cut away through the material at path other than,
Its part still keeps complete, can be improved efficiency and reduces cost.The compacting of multi-disc sheet metal is integral by clamping tooling, is mentioned
High workpiece stiffness greatly improves precision and processable micropin length because lateral force leads to dimension deviation when preventing from cutting, full
The processing of sufficient big L/D ratio micropin needs." 8 " font machining path is used when micropin tip is cut, and guarantees micropin tip processing essence
Degree.Micropin uses uniform strength design in the width direction, improves the anti-flexion capabilities of micropin in the width direction, micropin is prevented to be pierced into skin
Buckling failure occurs when skin in the width direction, while providing the additional of thickness direction to micropin using special piercing auxiliary device
Constraint improves the use reliability of big L/D ratio micropin comprehensively.Specific embodiment is as follows:
A kind of preparation method of big L/D ratio planar metal microneedle array, comprising the following steps:
Step 1: micropin material is using good biocompatibility, intensity and all good foil material of toughness, the present embodiment
Medical 304 stainless steel thin slice of middle use, it is a length of 1000 millimeters of Thin Stainless Steel chip size, 100 millimeters wide, 80 microns of thickness.
Step 2: sheet metal described in the first step is cut out as sizeable micro metal thin slice 5, it is long in the present embodiment
It is 50 millimeters, 25 millimeters wide, 80 microns of thickness.
Step 3: processing dedicated thin slice clamping tooling, tooling surface structure is as shown in Figure 1, 2, 3；
Clamping tooling is made of identical two pieces of metal cover boards 1 up and down, and clamping tooling upper and lower covers are long in the present embodiment
It is 80 millimeters, 55 millimeters wide, 6 millimeters of plate thickness, the groove 2 that the setting of cover board inner wall matches with small-sized lamina dimensions described in S2, this reality
1.5 millimeters of a concave groove depth is applied, groove is 50 millimeters long, 25 millimeters wide.Tooling material is good using electric conductivity in the present embodiment
Stainless steel good, intensity is high.In clamping tooling two sides, processing is bolted 6 fixed M6 bolt holes 3 for subsequent, hole
Quantity can adjust according to actual needs.
100 micro metal thin slices 5 are placed in the groove 2 of any metal cover board 1, are stacked by the 4th step.
Another metal cover board 1 is placed on the cover board for having placed sheet metal 5, groove is towards sheet metal 5, consistency from top to bottom；
Then upper and lower metal cover board 1 is encapsulated by fastening bolt 4 and is fastened, compacted metal thin slice 5, with upper and lower cover plates 1 at being integral,
It is whole to obtain packaged sheet metal and processing clamping tooling as shown in Figure 4.
5th step designs the geometry and dimensions of sheet-like plane metal micro-needle
Sheet-like plane metal micro-needle array by for subsequent retained part substrate 6 and big L/D ratio micropin needle body 7 form.
Needle body shape is shown in Fig. 5 in sheet microneedle array in the present embodiment, and 7 thickness of micropin needle body is sheet metal thickness,
Needle body is uniform strength design in the width direction, i.e., micropin change width will ensure micropin when tip is acted on by lateral concentrfated load
The maximum stress in bend of each cross-section is equal everywhere, it is assumed that micropin root is x-axis starting point, and x-axis is the vertical symmetrical of micropin
Axis, width direction are assumed to y-axis, then this uniform strength design requires x, y to meet following relationship:L in formula0
For micropin length, C is constant, and 1.5 millimeters of micropin needle level in this embodiment, 150 microns of bottom width, C is according to micropin bottom
It is 0.0612 that portion's width and length, which can be calculated,.Fig. 5 is monolithic microneedle array schematic diagram.8 in Fig. 5 be to stay in subsequent piercing
The positioning shoulder of auxiliary device positioning, 9 be the locating slot for successive substrates assembling in Fig. 5.
Micropin number in the present embodiment in such as single substrate is selected as 7, and 3.5 millimeters of spacing, substrate disregards body sections
Highly 13 millimeters, bottom setting groove 9 as shown in Figure 5,5 millimeters of the present embodiment concave groove height, 5 millimeters of width, micropin base
Piece two sides indwelling at needle body positions shoulder 8 as shown in Figure 5, positions when being pierced into for subsequent microneedle array, the present embodiment
In the portion size be it is 3 millimeters high, it is 3 millimeters wide.
Step 6: by the 4th step packaged sheet metal and frock clamping to linear cutting equipment, linear cutting equipment root
Gage travelling path is determined according to the geometry and dimensions of the sheet-like plane metal micro-needle of the 5th step design, according to shown in fig. 6
Gage travelling path carries out wire cutting to tooling and sheet metal 5 as a whole, and sheet metal 5 processes substrate 6 and micropin needle body 7.
During wire cutting, the needle point processing of micropin needle body 7 is cut using figure of eight path, it is ensured that micropin needle point acuity.Separately
Outside, in process, monolithic micropin substrate two sides stay a little material as shown in appended drawing reference " 10 " in Fig. 6 or Fig. 7 not cut, this
Not 2 millimeters of cut portion height in embodiment, 2 millimeters of width.Showing when sheet metal and tooling after the completion of cutting are not dismantled
It is intended to as shown in Figure 7 (top view).
Step 7: unloading the fastening bolt 4 in tooling, taking out machined sheet metal 5 and being cleaned, obtain such as figure
Micropin substrate when not cut shown in 8.
8th step, the micropin substrate obtained to the 7th step are cut, and are removed the material of 6 two sides reserved area of substrate, are made
Sheet-like plane metal micro-needle is removed from sheet metal 5, obtains sheet-like plane microneedle array as shown in Figure 5.
A kind of assembling clamping device of big L/D ratio planar metal microneedle array, dedicated micropin thin slice assemble clamping device packet
Main body 11, partition 15 are included, main body 11, partition 15 use aluminum alloy materials.A clamping device generally side opening it is box-like
Cuboid, intracavity bottom is equipped with the sliding rail 12 with micropin substrate bottom matching grooves described in S9, such as appended drawing reference in Fig. 9,10,11
Shown in " 12 ", inner cavity is having a size of 25 millimeters long, 20 millimeters wide, 10 millimeters high, and 5 millimeters of wall thickness.In assembly bottom, processing is used for
The threaded hole 13 of hand-held handle is installed, assembly both sides of the face are threaded hole 14, for by bolt 16 to partition 15 into
Row is held out against；Clamping device entirety three-view diagram is as shown in Fig. 9,10,11.Partition uses partition 15 used for positioning in the present embodiment
Aluminum alloy materials, 15 10 millimeters of height of partition, septum plate length need to be consistent with the housing width of main body 11, i.e., and 20 millimeters；Partition 15
Width is set as needed, and 3.5 millimeters is taken in the present embodiment, partition block number is 7 pieces；15 bottom of partition is equipped with and micropin substrate bottom
The consistent groove of portion's groove size.
Sheet-like plane microneedle array and partition 15 as shown in Figure 5 are successively arranged, are placed in clamping device main body 11,
Using any one side end face of bolt clamping device the tapped through hole 14 as shown in Fig. 9,10,11 to micropin substrate and partition into
Row compacting is fixed, and hand-held handle 17 is installed in clamping device bottom thread hole 13, is finally obtained as shown in Figure 13,14,15
Tissue after the completion of microneedle array.
A kind of piercing auxiliary device of big L/D ratio planar metal microneedle array, the piercing auxiliary device includes rectangle
Frame main body 18, grid spacer 20, the small partition 21 of positioning, as shown in Figure 16,17,18.The rectangle frame main body 18, grid spacer
20 use aluminum alloy materials；The small partition 21 of positioning and the same material of micropin substrate 6.
The rectangle frame main body 18 is the frame-shaped cuboid of upper and lower opening, is set to above assembling clamping device.Inside casing is long
Cavity length, the equivalent width of degree, width and clamping device main body 11.18 height of rectangle frame main body need to determine with shown in Fig. 5
Position 8 size of shoulder matches, and the portion size is 3 millimeters high in the present embodiment, and 3 millimeters wide, the height need to be with the micropin substrate
The size for being higher by partition is consistent；The setting of 18 two sides of rectangle frame main body is for the tapped through hole 19 by non-cap bolt 22, after being used for
It is continuous to hold out against.
The grid spacer 20 is specific as shown in figure 19, the height of grid spacer 20 and the height one of rectangle frame main body 18
It causes, is 3 millimeters；20 length of grid spacer is consistent with 15 length of partition of clamping device, is 20 millimeters；20 thickness of grid spacer with
The consistency of thickness of clamping device partition 15, grid spacer 20 are slightly polished with micropin needle body corresponding position using fine sandpaper.It is fixed
Position partition 20 is spaced by positioning small partition 21 between any two, and the gap 23 between two grid spacers 20 is used to pass through micropin needle
Body 7.The height and 20 height of grid spacer of the small partition 21 of positioning are consistent, are 3 millimeters；Septa width should be slightly less than in S9
8 width of positioning shoulder as shown in Figure 5,2.8 millimeters of width in the present embodiment；Thickness is consistent with micropin substrate.It will positioning
Partition described in frame, partition and S24 is assembled, and is finally obtained microneedle array as shown in figure 20 and is pierced into auxiliary device.
The grid spacer 20 is assembled in rectangle frame main body 18, in every 20 both ends placement positioning septulum of grid spacer
Piece 21 makes 20 spacing of grid spacer and micropin consistency of thickness, carries out compression envelope from 18 side of rectangle frame main body using non-cap bolt
Dress compresses grid spacer 20 and positions small partition 21, obtains microneedle array as shown in figure 20 and be pierced into auxiliary device.Positioning every
20 both ends of plate reinforce the connection between grid spacer 20, the small partition 21 of positioning and rectangle frame main body 18 using 502 glue, finally
Piercing auxiliary device after being completed is as shown in figure 20.It carries out disinfection processing to the skin area for needing to apply drug, by group
The piercing auxiliary device as shown in figure 20 installed is placed on skin, then the assembled micropin battle array as shown in Figure 13,14,15
Column are pierced into skin by the gap 23 of each grid spacer 20 in auxiliary device.
The embodiment of the present invention is merely to illustrate and explains technical solution of the present invention rather than limit, although implementing referring to preferable
Example describes the invention in detail, those skilled in the art should understand that, can to the technical solution of invention into
Row modification or equivalent replacement without departing from the spirit and scope of the technical solution of the present invention, should all cover in right of the invention
In claimed range.
Claims (8)
1. a kind of preparation method of big L/D ratio planar metal microneedle array, which comprises the following steps:
Step 1: micropin material uses medical stainless steel or titanium alloy foil material, sheet metal thickness 20~200 is micro-
Rice；
Step 2: the sheet metal is cut out as sizeable micro metal thin slice (5), it is 30~50 millimeters long, wide by 10~
30 millimeters；
Step 3: processing dedicated thin slice clamping tooling
Tooling is made of upper and lower two pieces identical metal cover boards (1), and every piece of cover board general thickness is 5~10 millimeters；In work
Load onto the groove (2) that lower cover plate inwall processing and micro metal thin slice (5) size match, i.e. groove length and width and aforementioned gold
Category thin slice (5) length and width are consistent, and for placing sheet metal (5), the depth of upper and lower cover plates groove is 1~5 millimeter；Upper and lower cover plates
The processing of 1 edge of main body is for the through-hole (3) by fastening bolt (4)；
The micro metal thin slice (5) is placed in the groove (2) of any metal cover board (1), the gold once placed by the 4th step
Belong to thin slice (5) the piece number to be adjusted according to sheet thickness and depth of groove, recommends primary placement the piece number 20~200；It will be another
Metal cover board (1) is placed on the cover board for having placed sheet metal (5), and groove is towards sheet metal (5), consistency from top to bottom；
Then upper and lower metal cover board (1) is encapsulated by fastening bolt (4) and is fastened, compacted metal thin slice (5), with upper and lower metal cover board
(1) at being integral；
5th step designs the geometry and dimensions of sheet-like plane metal micro-needle
Sheet-like plane metal micro-needle array by for subsequent retained part substrate (6) and big L/D ratio micropin needle body (7) form；
The big L/D ratio micropin needle body (7) is set to above substrate (6)；Two sides are equipped with a positioning shoulder above substrate (6)
(8), positioning and guiding is carried out for being pierced into auxiliary device；Middle part is equipped with positioning and guiding slot (9) positioning and guiding below substrate (6)
Slot (9) is assembled for successive substrates (6)；
Step 6: linear cutting equipment is according to by the 4th step packaged sheet metal and frock clamping to linear cutting equipment
The geometry and dimensions of the sheet-like plane metal micro-needle of five steps design determine gage travelling path, to tooling and sheet metal
(5) wire cutting is carried out as a whole, and sheet metal (5) processes substrate (6) and micropin needle body (7)；During wire cutting, to micro-
The needle point processing of needle needle body (7) is cut using figure of eight path, it is ensured that micropin needle point acuity；In addition, in process,
Reserved 2~5 millimeters of substrate (6) two sides are without cutting, it is ensured that clamping tooling and sheet metal (5) are still whole for one after processing
Body；
Step 7: unloading the fastening bolt (4) in tooling, taking out machined sheet metal (5) and being cleaned, do not cut out
Micropin substrate when cutting；
8th step, the micropin substrate obtained to the 7th step are cut, and are removed the material of substrate (6) two sides reserved area, are made piece
Shape planar metal micropin is removed from sheet metal (5), obtains the sheet-like plane metal micro-needle array with multiple micropin needle bodies.
2. a kind of preparation method of big L/D ratio planar metal microneedle array according to claim 1, which is characterized in that institute
The clamping tooling material stated is the stainless steel that electric conductivity is good, intensity is high, 45# steel metal material.
3. the big L/D ratio planar metal microneedle array that any method of claim 1-2 is prepared, which is characterized in that
The sheet-like plane metal micro-needle array is by the substrate (6) and big L/D ratio micropin needle body (7) group for subsequent retained part
At the height of big L/D ratio micropin needle body (7) is 1~5 millimeter, and needle body root width is 50~500 microns, with a thickness of metal foil
Piece (5) thickness；The big L/D ratio micropin needle body (7) is and above substrate (6), every chip base on piece micropin number
It is 3~50,0.25~10 millimeter of spacing；Two sides are equipped with a positioning shoulder (8) above substrate (6), for being pierced into auxiliary dress
Set carry out positioning and guiding；Middle part is equipped with positioning and guiding slot (9) positioning and guiding slot (9) below substrate (6), is used for successive substrates
(6) it is assembled；
The big L/D ratio micropin needle body (7) uses uniform strength design, i.e. big L/D ratio micropin needle body (7) along short transverse
Change width is necessary to ensure that the maximum stress in bend of micropin needle body (7) each cross-section when tip is acted on by lateral concentrfated load
It is equal everywhere, it is assumed that micropin needle body (7) root is x-axis starting point, and x-axis is located at the apical axis of micropin micropin needle body (7), width
Direction is assumed to y-axis, then uniform strength design requires x, y to meet following relationship:L in formula0For micropin needle body
(7) length, C are the constant of concentrated expression material yield strength, micropin thickness, magnitude of load.
4. a kind of assembling clamping device of big L/D ratio planar metal microneedle array as claimed in claim 3, which is characterized in that institute
The assembling clamping device stated includes main body (11), partition (15)；Main body (11), partition (15) material are light-weight metal or macromolecule
Material；
The main body (11) is the box-like rectangular body structure of a side opening, and intracavity bottom is equipped with leads with the positioning of micropin substrate bottom
The sliding rail (12) to match to slot (9)；Main body (11) bottom is equipped with the threaded hole (13) for subsequent installation handle；Main body
(11) side is equipped with a tapped through hole (14), for being held out against by bolt (16) to partition (15)；Big L/D ratio plane
Metal micro-needle array is disposed vertically in assembling clamping device, and micropin needle body (7) is upward；Main body (11) housing width with
The equivalent width of micropin substrate (6)；Cavity depth is consistent with substrate (6) outer ledge height, i.e., flat where substrate (6) positioning shoulder
Face is generally aligned in the same plane with main body (11) upper surface；Between micropin substrate the piece number and each substrate of the cavity length according to quasi- clamping
Spacing determines, it is proposed that 10~40 millimeters of length range；The partition (15) is thin rectangular parallelepiped structure, and microneedle array is used when assembling
In each micropin substrate of positioning；Partition (15) width is consistent with main body (11) cavity depth, the housing width of length and main body (11)
Unanimously, with a thickness of 1-5 millimeters, partition (15) bottom is equipped with and substrate (6) bottom positioning and guiding slot (9) matched groove；
Big L/D ratio planar metal microneedle array is disposed vertically in the cavity of clamping device main body (11), between every substrate
It is separated by partition (15)；Bolt (16) passes through clamping device flank threads through-hole (14), squeezes partition (15), makes each micropin base
Piece keeps stablizing；Micropin substrate is higher than partition (15) and clamping device body upper surface, tool close to micropin needle body side when clamping
Body is higher by size and is determined by the size of (6) two side positioning shoulder (8) of micropin substrate, in clamping device main body (11) after clamping is good
Hand-held handle 17 is installed at bottom thread hole (13), completes the group clamping of big L/D ratio planar metal microneedle array.
5. the assembling clamping device of big L/D ratio planar metal microneedle array according to claim 4, which is characterized in that institute
Main body (11), partition (15) selection aluminium alloy or the polytetrafluoroethylene (PTFE) stated.
6. a kind of piercing auxiliary device of big L/D ratio planar metal microneedle array as claimed in claim 3, which is characterized in that institute
The piercing auxiliary device stated includes rectangle frame main body (18), grid spacer (20), the small partition (21) of positioning, the rectangle frame main body
(18), grid spacer (20) material is light-weight metal or high molecular material；The small partition (21) of positioning and micropin substrate (6) are same
Material；
The rectangle frame main body (18) is the frame-shaped cuboid of upper and lower opening, for being placed on above assembling clamping device；Square
Inside casing length, cavity length, the equivalent width of width and clamping device main body (11) of shape frame main body (18), rectangle frame main body
(18) height is consistent with the height of two side positioning shoulder (8) of micropin substrate, and rectangle frame main body (18) two sides are arranged for passing through nothing
The tapped through hole (19) of cap bolt (22), holds out against for subsequent；The grid spacer (20), the height of grid spacer (20) with
The height of rectangle frame main body (18) is consistent, and grid spacer (20) length is consistent with partition (15) length of clamping device, positioning every
The consistency of thickness of plate (20) thickness and clamping device partition (15), grid spacer (20) and micropin needle body corresponding position are using thin
Sand paper is slightly polished；Grid spacer (20) is spaced by positioning small partition (21) between any two, between two grid spacers (20)
Gap (23) be used for pass through micropin needle body (7)；The height of the small partition of the positioning (21) and partition grid spacer (20) are high
Degree is consistent, and width is 0.1~1 millimeter smaller than the width of (6) two side positioning shoulder (8) of micropin substrate, and thickness is consistent with micropin substrate, uses
In ensuring that gap (23) are consistent with micropin substrate thickness between grid spacer (20)；
The grid spacer (20) is assembled in rectangle frame main body (18), and at every grid spacer (20) both ends, placement positioning is small
Partition (21) makes grid spacer (20) spacing and micropin consistency of thickness, and grid spacer (20) and micropin needle body contact position are polished, energy
Ensure there is gap between micropin needle body and grid spacer (20), to avoid serious scraping collision；Non-cap bolt (22) passes through rectangle
Frame main body (18) end face side threaded hole for compressing grid spacer (20) and positioning small partition (21), and is protected with clamping device
Hold one-to-one relationship；It carries out disinfection processing to the skin area that is pierced into of needs, assembled piercing auxiliary device is placed in
On skin, then assembled microneedle array is pierced into skin by the gap (23) of each grid spacer (20) in auxiliary device.
7. the piercing auxiliary device of big L/D ratio planar metal microneedle array according to claim 6, which is characterized in that institute
State rectangle frame main body (18), grid spacer (20) selects aluminium alloy or polytetrafluoroethylene (PTFE).
8. the piercing auxiliary device of big L/D ratio planar metal microneedle array according to claim 6 or 7, feature exist
In at grid spacer (20) both ends using 502 glue reinforcing grid spacer (20), the small partition (21) of positioning and rectangle frame main body
(18) connection between.
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