CN112891724A - Micro-needle array with plastic micro-bending and preparation method thereof - Google Patents
Micro-needle array with plastic micro-bending and preparation method thereof Download PDFInfo
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- CN112891724A CN112891724A CN202011579633.4A CN202011579633A CN112891724A CN 112891724 A CN112891724 A CN 112891724A CN 202011579633 A CN202011579633 A CN 202011579633A CN 112891724 A CN112891724 A CN 112891724A
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- microneedle array
- array substrate
- negative angle
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- elastic
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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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- 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
Abstract
A plastic microbend microneedle array and a method of making the same, comprising: the planar microneedle array substrate, the elastic male die and the negative angle female die are arranged, wherein: one end of the planar microneedle array substrate is arranged on the negative angle female die, the other end of the planar microneedle array substrate is matched with the planar microneedle array substrate and arranged in the negative angle female die, and the elastic male die is arranged in the negative angle female die; the planar micro-needle array substrate is a structure formed by arranging a plurality of micro-needle arrays. The planar microneedle array substrate is matched with two ends of the elastic male die at 90 degrees. The negative angle degree of the negative angle female die is the initial rebound angle of the planar microneedle array substrate. The elastic male die comprises: male mold blocks and elastomeric structures. The invention utilizes the characteristics and advantages of plastic micro-forming, the planar micro-needle array substrate can be bent to form a plurality of micro-needles at one time to complete the plastic micro-bending process on the circumference to form the micro-needle array, the micro-needle array can be rapidly, efficiently and accurately produced, and the invention has the advantages of good mechanical property, good biocompatibility, low price and the like, and is suitable for large-scale production.
Description
Technical Field
The invention relates to a technology in the field of microneedle array processing and preparation, in particular to a plastic micro-bent microneedle array and a preparation method thereof.
Background
Microneedle arrays have gained increasing attention as a new form of transdermal drug delivery. The diameter (or thickness) of the micro-needle is about tens of microns, the length of the needle body is 200-800 microns, and the needle body can pierce through the stratum corneum to form a drug delivery channel on the skin.
The microneedle array can be divided into silicon microneedles, metal microneedles, polymer microneedles and the like in terms of material, wherein: the silicon micro-needle can adopt processing technologies such as photoetching, corrosion and the like, but silicon is relatively fragile and has poor biocompatibility; although the polymer micro-needle has rich material types and low price, the strength of the polymer material is difficult to ensure, and the polymer micro-needle is easy to bend and damage when in use; the metal micro-needle is safe and harmless to human bodies, excellent in mechanical property and low in material cost, and is a good application form of the micro-needle array. In summary, how to prepare a material with biocompatibility into a microneedle array is a main direction for future development in the field of microneedle arrays, and the problems of complicated production method and high cost of microneedle arrays are urgently needed to be solved.
Disclosure of Invention
The invention provides a micro-needle array with plasticity and a preparation method thereof, aiming at the defects that a plane micro-needle array prepared by the prior art is limited by linear cutting processing precision, has poor forming precision and is more complex to assemble into a hetero-plane micro-needle array, a plane micro-needle array substrate can be bent to form a plurality of micro-needles at one time to form the micro-needle array, an elastic male die and a negative angle female die are matched to enable the micro-needles of the plane micro-needle array substrate to be bent at a large angle and finally to be perpendicular to the plane micro-needle array substrate at 90 degrees, the micro-needle array substrate can complete the micro-bending process of the micro-needles on the circumference at one time, and the micro-needle array substrate has the advantages of good mechanical property.
The invention is realized by the following technical scheme:
the present invention relates to a plastically microbending microneedle array comprising: the planar microneedle array substrate, the elastic male die and the negative angle female die are arranged, wherein: one end of the planar microneedle array substrate is arranged on the negative angle female die, the other end of the planar microneedle array substrate is matched with the planar microneedle array substrate and arranged in the negative angle female die, and the elastic male die is arranged in the negative angle female die.
The planar microneedle array substrate is a structure formed by arranging a plurality of microneedle arrays.
The planar microneedle array substrate is matched with the two ends of the elastic male die at 90 degrees.
The negative angle degree of the negative angle female die is the initial rebound angle of the planar microneedle array substrate.
The elastic male die comprises: convex mould piece and elastic construction, wherein: the elastic structures are arranged at two ends of the convex module and connected with the planar microneedle array substrate.
The invention relates to a method for preparing the microneedle array, which comprises the steps of cutting a planar microneedle array substrate by laser, determining an original resilience angle as a negative angle degree through a 90-degree micro-bending experiment, placing the original resilience angle in a negative angle female die, pressing the planar microneedle array substrate by a blank holder, extruding the planar microneedle array substrate by an elastic male die to bend the planar microneedle array substrate to form a negative angle, leaving the negative angle female die through an upper chamfer of the elastic male die filled in the negative angle female die after extrusion, and rebounding the bent planar microneedle array substrate to form a 90-degree angle with the horizontal plane.
Technical effects
The invention integrally solves the problems of complex process, high cost and difficult batch production of the existing microneedle array processing technology such as LIGA technology, photoetching technology and the like, the preparation method of the microneedle array used by the invention can solve the pain point, can form a plurality of SUS304 stainless steel microneedles at one time to form the microneedle array, and has the advantages of high processing efficiency, simple process and low process cost.
Compared with the prior art, the method has the advantages that the different-plane microneedle array can be prepared only by laser cutting and micro bending, the plastic micro bending method is processed by depending on a die, the service life is long, the processing efficiency is high, the process is simple, and the process cost is low.
Drawings
FIG. 1 is a schematic structural diagram of a planar microneedle array substrate according to the present invention;
FIG. 2 is a schematic structural view of an elastic male die of the invention;
FIG. 3 is a schematic view of the negative angle female mold of the present invention;
FIG. 4 is a schematic view of the assembly structure of the present invention;
FIG. 5 is a schematic view of the forming process of the present invention;
FIG. 6 is a schematic view showing the end state of forming according to the present invention;
in the figure: the micro-needle array comprises a planar micro-needle array substrate 1, an elastic male die 2, a negative angle female die 3, a male die block 4 and an elastic structure 5.
Detailed Description
As shown in fig. 1, the present embodiment relates to a plastic micro-bending microneedle array, which comprises: the planar microneedle array substrate comprises a planar microneedle array substrate 1, an elastic male die 2 and a negative angle female die 3, wherein: one end of the planar microneedle array substrate 1 is arranged on the negative angle female die 3, the other end of the planar microneedle array substrate is matched with the planar microneedle array substrate 1 and arranged in the negative angle female die 3, and the elastic male die 2 is arranged in the negative angle female die 3.
The planar microneedle array substrate 1 is matched with the two ends of the elastic male die 2 at 90 degrees.
The negative angle degree of the negative angle female die 3 is the initial rebound angle of the planar microneedle array substrate 1, and can float within a certain range according to the properties of the used metal materials.
The planar microneedle array substrate 1 is a structure formed by arranging a plurality of microneedle arrays, is made of SUS304 medical stainless steel and has the thickness of 0.08mm, and the planar microneedle array substrate 1 can also be made of metal with biocompatibility, such as metal titanium and the like.
The length of the planar microneedle array substrate 1 is 800 mu m, the microneedle angle is 20 degrees, and the number of the microneedles is 8.
The elastic male die 2 comprises: male module 4 and elastic structure 5, wherein: the elastic structures 5 are arranged at two ends of the convex module 4 and connected with the planar microneedle array substrate 1, as shown in fig. 2, the elastic convex die 2 is a layer of elastic rubber which is wrapped by the rigid convex module 4 along the axial direction and has a chamfer angle of 45 degrees from top to bottom, and the elastic rubber and the convex module 4 are fixed through concave-convex matching.
As shown in fig. 5, when the elastic male mold 2 descends, the elastic male mold contacts with the planar microneedle array substrate 1 and bends the planar microneedle array substrate towards the inside of the negative angle female mold, and the elastic rubber at the outer side of the elastic male mold 2 elastically deforms and enters the negative angle female mold 3 along with the planar microneedle array substrate 1; due to the elasticity of the rubber of the elastic male die 2, the elastic male die 2 can ensure that the bending deformation end of the planar microneedle array substrate 1 bent into the negative angle female die 3 is tightly attached to the inclined inner wall of the negative angle female die 3, so that the bending deformation end of the planar microneedle array substrate 1 is excessively bent. When the elastic male die 2 starts to move upwards, the micro-bending deformation end of the planar microneedle array substrate 1 can rebound, the rebounded bending deformation end is perpendicular to the horizontal direction, and the elastic rubber belt at the top end of the elastic male die 2 is provided with a chamfer angle of 45 degrees, so that the elastic male die 2 can smoothly exit the negative-angle female die 3.
The embodiment relates to a preparation method of the microneedle array, which comprises the following steps:
preparation: cutting out a planar microneedle array substrate 1 by using laser;
determining a negative angle: carrying out 90-degree micro-bending experiment on the prepared microneedle array substrate 1 to determine an original resilience angle as a negative angle degree;
discharging: putting the planar microneedle array substrate 1 prepared by laser into a negative angle female die 3, and pressing by using a blank holder;
fourthly, deformation: starting a press machine, so that the elastic male die 2 moves downwards, the elastic male die 2 applies extrusion force to the planar microneedle array substrate 1, the elastic male die 2 extrudes into the negative angle female die 3 through elastic rubber of the elastic male die, the planar microneedle array substrate 1 is fully contacted with the negative angle female die 3, and the elastic male die 2 fills the negative angle female die 3 cavity, so that the planar microneedle array substrate 1 bends out of a negative angle:
the fifth step of regressing: the elastic male die 2 ascends, the elastic male die 2 filled in the negative angle female die 3 leaves the negative angle female die 3 through the upper chamfer thereof, and the bent planar microneedle array substrate 1 rebounds to form a 90-degree angle with the horizontal plane.
Through specific practical tests, a 1064 pulse laser of Xinrui laser is used for cutting SUS304 stainless steel to prepare a planar microneedle array substrate; assembling the designed micro-bending die on a Satsu CMT-1203 microcomputer controlled electronic universal testing machine, placing the laser-cut planar microneedle array substrate in the die for 0.001s-1The strain rate of the micro-needle array starts the tester, the male die descends, and after the operation is finished, the micro-needle array which forms an included angle of about 90 degrees with the micro-needle array substrate is obtained.
Compared with the prior art, the device can finish 90-degree bending of a plurality of microneedles by one-step forming of the micro-bending die, so that the hetero-planar microneedle array is formed. The preparation method of the micro-needle array on SUS304 medical stainless steel by using the micro-bending method obtains the micro-needle array with biocompatibility and good mechanical property, and has the advantages of simple and easy process, high processing efficiency and low production cost.
The foregoing embodiments may be modified in many different ways by those skilled in the art without departing from the spirit and scope of the invention, which is defined by the appended claims and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Claims (7)
1. A plastically microbend microneedle array, comprising: the planar microneedle array substrate, the elastic male die and the negative angle female die are arranged, wherein: one end of the planar microneedle array substrate is arranged on the negative angle female die, the other end of the planar microneedle array substrate is matched with the planar microneedle array substrate and arranged in the negative angle female die, and the elastic male die is arranged in the negative angle female die; when the elastic male die descends, the elastic male die is contacted with the planar microneedle array substrate and bends towards the interior of the negative angle female die, elastic rubber on the outer side of the elastic male die elastically deforms and enters the negative angle female die along with the planar microneedle array substrate, and the elastic male die can ensure that the bending deformation end of the planar microneedle array substrate bent into the negative angle female die tightly clings to the inclined inner wall of the negative angle female die and generates excessive bending; when the elastic male die moves upwards, the micro-bending deformation end of the planar microneedle array substrate rebounds and is vertical to the horizontal direction, so that the elastic male die exits from the negative angle female die.
2. The microneedle array of claim 1, wherein the planar microneedle array substrate is mated 90 ° to both ends of the elastic male mold.
3. The microneedle array of claim 1, wherein the negative angle of the negative angle negative mold is the initial spring back angle of the planar microneedle array substrate.
4. A microneedle array as claimed in claim 1, wherein the elastic male mold comprises: convex mould piece and elastic construction, wherein: the elastic structures are arranged at two ends of the convex module and connected with the planar microneedle array substrate.
5. A method of preparing a microneedle array according to any one of the preceding claims, comprising the steps of:
preparation: cutting out a planar microneedle array substrate by using laser;
determining a negative angle: carrying out 90-degree micro-bending experiment on the prepared microneedle array substrate to determine an original resilience angle as a negative angle degree;
discharging: putting the planar microneedle array substrate prepared by laser into a negative-angle concave mould, and pressing by using a blank holder;
deformation: starting a press machine, so that the elastic male die moves downwards, applying extrusion force on the planar microneedle array substrate by the elastic male die, extruding the elastic male die into the negative angle female die through elastic rubber of the elastic male die, fully contacting the planar microneedle array substrate with the negative angle female die, and filling a negative angle female die cavity with the elastic male die to bend the planar microneedle array substrate to form a negative angle:
and (3) degeneration: the elastic male die ascends, the elastic male die filled in the negative angle female die leaves the negative angle female die through the upper chamfer, and the bent planar microneedle array substrate rebounds to form a 90-degree angle with the horizontal plane.
6. The method according to claim 5, wherein the planar microneedle array substrate is made of SUS304 stainless steel for medical use.
7. The manufacturing method according to claim 5 or 6, wherein the length of the planar microneedle array substrate is 800 μm, the angle of the microneedles is 20 °, and the number of the microneedles is 8.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011579633.4A CN112891724A (en) | 2020-12-28 | 2020-12-28 | Micro-needle array with plastic micro-bending and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202011579633.4A CN112891724A (en) | 2020-12-28 | 2020-12-28 | Micro-needle array with plastic micro-bending and preparation method thereof |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003048031A2 (en) * | 2001-11-30 | 2003-06-12 | Alza Corporation | Methods and apparatuses for forming microprojection arrays |
| CN102139138A (en) * | 2011-03-22 | 2011-08-03 | 上海交通大学 | Preparation method of solid metal microneedle array |
| WO2012018486A2 (en) * | 2010-07-26 | 2012-02-09 | Seventh Sense Biosystems, Inc. | Rapid delivery and/or receiving of fluids |
| CN106061546A (en) * | 2014-02-10 | 2016-10-26 | Lts勒曼治疗系统股份公司 | Microneedle system and method for the production thereof |
| CN108367142A (en) * | 2015-12-15 | 2018-08-03 | 久光制药株式会社 | Microneedle sheet |
-
2020
- 2020-12-28 CN CN202011579633.4A patent/CN112891724A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003048031A2 (en) * | 2001-11-30 | 2003-06-12 | Alza Corporation | Methods and apparatuses for forming microprojection arrays |
| WO2012018486A2 (en) * | 2010-07-26 | 2012-02-09 | Seventh Sense Biosystems, Inc. | Rapid delivery and/or receiving of fluids |
| CN102139138A (en) * | 2011-03-22 | 2011-08-03 | 上海交通大学 | Preparation method of solid metal microneedle array |
| CN106061546A (en) * | 2014-02-10 | 2016-10-26 | Lts勒曼治疗系统股份公司 | Microneedle system and method for the production thereof |
| CN108367142A (en) * | 2015-12-15 | 2018-08-03 | 久光制药株式会社 | Microneedle sheet |
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