CN111317911A - Novel microneedle and manufacturing method thereof - Google Patents
Novel microneedle and manufacturing method thereof Download PDFInfo
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- CN111317911A CN111317911A CN202010126869.6A CN202010126869A CN111317911A CN 111317911 A CN111317911 A CN 111317911A CN 202010126869 A CN202010126869 A CN 202010126869A CN 111317911 A CN111317911 A CN 111317911A
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- 238000000465 moulding Methods 0.000 claims abstract description 8
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Images
Classifications
-
- 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
-
- 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
- A61M2037/0046—Solid microneedles
-
- 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
The invention relates to a novel microneedle and a manufacturing method thereof, wherein the novel microneedle comprises a base and a needle body arrayed on the base, and the needle body comprises a cylindrical part connected with the base and a conical part connected with the cylindrical part; the outer surface of toper portion distributes along the axial has a plurality of standing grooves. The manufacturing method of the novel microneedle comprises the following steps: the method comprises the following steps: the base, the cylindrical part and the conical part of the needle body are produced by reverse molding through a mold; step two: a placing groove is machined on the surface of the tapered portion by laser machining. The microneedle can be loaded with various different treatment factors, the length of the microneedle is controllable, the length of the needle body is longer and can reach 5mm, and the microneedle can penetrate into a diseased position; the manufacturing method has the advantages of simple processing technology, low manufacturing cost, high reusability and good hydrophilic effect, and ensures the roughness of the surface of the microneedle; the die used in the method has good mechanical property, is not easy to damage, and has high strength and long service life.
Description
Technical Field
The present invention relates to the field of microneedles, and more particularly, to a novel microneedle and a method for manufacturing the same.
Background
The micro-needle is a third-generation transdermal drug delivery system and has the advantages of a traditional hypodermic syringe and a transdermal patch. The micro-needle has the advantages of minimally invasive, painless, convenient use, high safety performance, capability of conveying macromolecular medicaments, good transdermal absorption effect of the medicament effect and the like, and can make the medicaments enter the body to play a role by puncturing the stratum corneum which is the outermost layer of the skin.
The polymer microneedle bodies used today are short in length, about 500um, and can only deliver drugs to the superficial layers of flat skin. Is not suitable for delivering drugs to the superficial malignant tumors with rough surfaces and large sizes. In the existing manufacturing method, a metal microneedle is used as a male mold, and a microneedle mold with a high depth-to-width ratio and a microneedle with a length of 1.2mm are prepared by twice die-sinking, so that the depth of drug delivery is effectively increased. However, for a deep, subcutaneous extended body surface malignancy, microneedles are difficult to deliver drugs to the deep affected area. For example, basal cell carcinoma nodularis can extend to 5mm below the skin, but no microneedles are currently available to deliver drugs to the deep afflicted sites of the tumor. And the existing micro-needle can only be mixed and loaded with one drug, and multiple injections are needed if multiple drugs need to be injected, so that the use is inconvenient.
The currently common microneedle manufacturing method is characterized in that a silicon and photoresist composite drug-carrying microneedle mould is prepared by combining a silicon anisotropic etching process and an SU-8 photoresist photoetching process, and a PDMS three-dimensional structure is obtained by casting and copying 2 times of Polydimethylsiloxane (PDMS). The PDMS material is a very soft material, so that the Young modulus of the PDMS material is small, and the PDMS material is easy to press and deform, so that the microneedle mould made of the PDMS material has short service life. In addition, the silicon mold and the glass mold are brittle, are easy to damage in the using process and have short service life. The metal mold prepared by the photoresist exposure technology by using the ultraviolet light source has higher processing cost.
Disclosure of Invention
The invention aims to overcome the problems that the existing microneedle in the prior art can only load one drug and is insufficient in length, and simultaneously aims to overcome the problems that the manufacturing cost of the microneedle is high and the service life of a prepared mould is short, and provides a novel microneedle and a manufacturing method thereof.
In order to solve the technical problems, the invention adopts the technical scheme that: a novel microneedle comprises a base and a needle body arrayed on the base, wherein the needle body comprises a cylindrical part connected with the base and a conical part connected with the cylindrical part; a plurality of placing grooves are distributed on the outer surface of the conical part along the axial direction.
Different medicines are placed in different placing grooves, and different treatment factors can be respectively injected into the affected positions in one injection. The tapered portion is adapted to penetrate the skin of a patient, the taper reducing the resistance to penetration of the skin.
Preferably, the diameter of the conical part is 100-1000 microns, the length is 1000-3000 microns, and the taper is 2-20 degrees; the length of the cylindrical parts is 1000-3000 mu m, and the center distance between the cylindrical parts is 500-1000 mu m. The micro-needle has enough length to directly deliver the therapeutic factor to the affected part in the deep layer of the tumor.
Preferably, the needle body is made of chitosan, hyaluronic acid, gelatin, polylactic acid and polylactic acid-glycolic acid copolymer.
Preferably, the placement groove is inclined in a direction approaching the cylindrical portion. The inclined placing groove can reduce the insertion resistance
Also provided is a method for manufacturing the novel microneedle, which is used for manufacturing the novel microneedle, and comprises the following steps:
the method comprises the following steps: the base, the cylindrical part and the conical part of the needle body are produced by reverse molding through a mold;
step two: a placing groove is machined on the surface of the tapered portion by laser machining.
Preferably, in the first step, the base material of the mold is a metal or alloy material with stable metal properties. The metal or alloy material may be medical titanium and titanium alloy, 316L stainless steel, medical zirconium, medical cobalt-based alloy, gold and gold alloy, silver and silver alloy, platinum and platinum alloy. The die is made of metal materials with stable properties, has long service life, fast heat transfer and easy drying and forming.
Preferably, in the first step, the mold base includes a recess for the back mold base, a cylindrical hole for the back mold cylindrical portion, and a tapered hole for the back mold tapered portion. The processing method of the groove can be turning, milling and grinding, and the depth of the groove can be 20-50% of the height of the base body. The processing method of the cylindrical hole can be mechanical processing, laser processing and electron beam processing, and the mechanical processing method can be drilling, grinding and hole grinding; the machining method of the conical hole can be electron beam machining, laser machining and micro electric spark machining.
Preferably, the surface roughness of the groove is 0.05-0.2 μm. The surface roughness is less, the micro-needle reverse mold forming effect is good, the material loss is less, and the mold is easy to release.
Preferably, in the second step, the laser processing power is 10-40%, the frequency is 10-50 KHz, and the speed is 800-1000 mm/s. The machining efficiency is high in the parameter range, the heat affected zone is small, and the inverted groove type with high quality can be obtained.
Preferably, in the second step, the laser processing is performed while the laser beam is fixed in position, and the placement groove is processed by moving the needle body.
Compared with the prior art, the invention has the beneficial effects that: the microneedle can be loaded with various different treatment factors, the length of the microneedle is controllable, the length of the needle body is longer and can reach 5mm, and the microneedle can penetrate into a diseased position; the manufacturing method has the advantages of simple processing technology, low manufacturing cost, high reusability and good hydrophilic effect, and ensures the roughness of the surface of the microneedle; the die used in the method has good mechanical property, is not easy to damage, and has high strength and long service life.
Drawings
Fig. 1 is a schematic structural view of a novel microneedle of the present invention.
Wherein: 1. a base; 2. a needle body; 201. a cylindrical portion; 202. a tapered portion; 203. and (6) placing the groove.
Detailed Description
The drawings are for illustrative purposes only and are not to be construed as limiting the patent; for the purpose of better illustrating the embodiments, certain features of the drawings may be omitted, enlarged or reduced, and do not represent the size of an actual product; it will be understood by those skilled in the art that certain well-known structures in the drawings and descriptions thereof may be omitted. The positional relationships depicted in the drawings are for illustrative purposes only and are not to be construed as limiting the present patent.
The same or similar reference numerals in the drawings of the embodiments of the present invention correspond to the same or similar components; in the description of the present invention, it should be understood that if there are terms such as "upper", "lower", "left", "right", "long", "short", etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the drawings, it is only for convenience of description and simplicity of description, but does not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and therefore, the terms describing the positional relationships in the drawings are only used for illustrative purposes and are not to be construed as limitations of the present patent, and specific meanings of the terms may be understood by those skilled in the art according to specific situations.
The technical scheme of the invention is further described in detail by the following specific embodiments in combination with the attached drawings:
example 1
Fig. 1 shows an embodiment of a novel microneedle, which includes a base 1 and a needle body 2 arrayed on the base 1, wherein the needle body 2 includes a cylindrical portion 201 connected to the base 1 and a tapered portion 202 connected to the cylindrical portion 201; the outer surface of the conical part 202 is distributed with a plurality of obliquely arranged placing grooves 203 along the axial direction, and the placing grooves 203 are inclined towards the direction close to the cylindrical part.
Specifically, the diameter of the tapered portion 202 is 500 μm, the length is 3000 μm, and the taper is 9.5 °; the length of the cylindrical portions 201 is 2000 μm, and the center-to-center distance between the cylindrical portions 201 is 500 μm. The micro-needle has enough length to directly deliver the therapeutic factor to the affected part in the deep layer of the tumor.
Wherein, the needle body 2 is made of gelatin.
The working principle or working process of the invention is as follows: different medicines are placed in different placing grooves, and different treatment factors can be respectively injected into the affected positions in one injection. The tapered portion is adapted to penetrate the skin of a patient, the taper reducing the resistance to penetration of the skin.
The beneficial effects of this embodiment: the microneedle can be loaded with various different treatment factors, the length of the microneedle is controllable, the length of the needle body is longer and can reach 5mm, and the microneedle can penetrate into a diseased position.
Example 2
This embodiment is different from embodiment 1 in that the tapered portion 202 has a diameter of 1000 μm, a length of 2000 μm, and a taper of 15 °; the length of the cylindrical portions 201 is 3000 μm, and the center-to-center distance between the cylindrical portions 201 is 1000 μm. The remaining features and operating principle correspond to embodiment 1.
Example 3
A method for manufacturing a novel microneedle according to example 1 or example 2, comprising the steps of:
the method comprises the following steps: the base, the cylindrical part and the conical part of the needle body are produced by reverse molding through a mold;
step two: a placing groove is machined on the surface of the tapered portion by laser machining. The laser processing power is 15%, the frequency is 25KHz, and the speed is 800 mm/s.
Specifically, the base material of the mold is a metal or alloy material with stable metal properties, specifically a titanium alloy. The die is made of metal materials with stable properties, has long service life, fast heat transfer and easy drying and forming.
The mold base comprises a groove for the reverse mold base, a cylindrical hole for the reverse mold cylindrical portion and a tapered hole for the reverse mold tapered portion. The groove is processed by grinding and the roughness of the groove surface is processed to 0.05 μm, and the groove depth may be 30% of the height of the base. The processing method of the cylindrical hole is grinding; the machining method of the tapered hole may be electron beam machining. The surface roughness of the groove is small, the micro-needle reverse mold forming effect is good, the material loss is less, and the mold is easy to release.
Specifically, in the second step, during the laser processing, the laser beam is fixed in position, and the placement groove is processed by moving the needle body.
The beneficial effects of this embodiment: the manufacturing method has the advantages of simple processing technology, low manufacturing cost, high reusability and good hydrophilic effect, and ensures the roughness of the surface of the microneedle; the die used in the method has good mechanical property, is not easy to damage, and has high strength and long service life.
Example 4
A method for manufacturing a novel microneedle according to example 1 or example 2, comprising the steps of:
the method comprises the following steps: the base, the cylindrical part and the conical part of the needle body are produced by reverse molding through a mold;
step two: a placing groove is machined on the surface of the tapered portion by laser machining. The laser processing power is 35%, the frequency is 45KHz, and the speed is 1000 mm/s.
Specifically, the base material of the mold is a metal or alloy material with stable metal properties, specifically a titanium alloy.
The mold base comprises a groove for the reverse mold base, a cylindrical hole for the reverse mold cylindrical portion and a tapered hole for the reverse mold tapered portion. The groove is processed by grinding and the roughness of the groove surface is processed to 0.12 μm, and the groove depth may be 40% of the height of the base. The processing method of the cylindrical hole is grinding; the machining method of the tapered hole may be electron beam machining.
Specifically, in the second step, during the laser processing, the laser beam is fixed in position, and the placement groove is processed by moving the needle body.
It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.
Claims (10)
1. A novel microneedle, comprising a base (1) and needle bodies (2) arrayed on the base (1), characterized in that the needle bodies (2) comprise a cylindrical portion (201) connected with the base (1) and a tapered portion (202) connected with the cylindrical portion (201); a plurality of placing grooves (203) are distributed on the outer surface of the conical part (202) along the axial direction.
2. A novel microneedle according to claim 1, wherein said tapered portion (202) has a diameter of 100 to 1000 μm, a length of 1000 to 3000 μm, and a taper of 2 to 20 °; the length of the cylindrical parts (201) is 1000-3000 mu m, and the center distance between the cylindrical parts (201) is 500-1000 mu m.
3. The novel microneedle according to claim 1, wherein the needle body (2) is made of chitosan, hyaluronic acid, gelatin, polylactic acid, or polylactic acid-glycolic acid copolymer.
4. A novel microneedle according to claim 1, wherein said placement groove (203) is inclined in the direction of said cylindrical portion (201).
5. A method for manufacturing a novel microneedle, comprising the steps of:
the method comprises the following steps: the base, the cylindrical part and the conical part of the needle body are produced by reverse molding through a mold;
step two: a placing groove is machined on the surface of the tapered portion by laser machining.
6. A method for manufacturing a novel microneedle according to claim 5, wherein in the first step, the base material of the mold is an alloy material with stable metal properties.
7. A method for manufacturing a novel microneedle according to claim 5, wherein in the first step, the mold base comprises a recess for inverse-molding the base, a cylindrical hole for inverse-molding the cylindrical portion, and a tapered hole for inverse-molding the tapered portion.
8. A novel microneedle manufacturing method according to claim 7, wherein the surface roughness of said grooves is 0.05 to 0.2 μm.
9. The method for manufacturing a novel microneedle according to claim 5, wherein in the second step, the laser processing power is 10-40%, the frequency is 10-50 KHz, and the speed is 800-1000 mm/s.
10. The method of claim 5, wherein in the second step, the laser processing is performed while the laser beam is fixed, and the placement groove is processed by moving the needle body.
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| CN202010126869.6A CN111317911A (en) | 2020-02-28 | 2020-02-28 | Novel microneedle and manufacturing method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112618945A (en) * | 2020-12-14 | 2021-04-09 | 北京航空航天大学 | Hollow closed type microneedle, preparation method thereof and operating device comprising microneedle |
| CN113509636A (en) * | 2021-02-28 | 2021-10-19 | 浙江工业大学 | Percutaneous microneedle with spiral microchannel |
| CN113663208A (en) * | 2021-08-31 | 2021-11-19 | 华中科技大学同济医学院附属协和医院 | Preparation and biological application of lamprey tooth-shaped bionic antibacterial sericin microneedle |
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Application publication date: 20200623 |