CN111659000A - Hollow metal microneedle, hollow metal microneedle array and preparation method thereof - Google Patents
Hollow metal microneedle, hollow metal microneedle array and preparation method thereof Download PDFInfo
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- CN111659000A CN111659000A CN202010622006.8A CN202010622006A CN111659000A CN 111659000 A CN111659000 A CN 111659000A CN 202010622006 A CN202010622006 A CN 202010622006A CN 111659000 A CN111659000 A CN 111659000A
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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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
- B21D—WORKING OR PROCESSING OF SHEET METAL OR METAL TUBES, RODS OR PROFILES WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
- B21D22/00—Shaping without cutting, by stamping, spinning, or deep-drawing
- B21D22/20—Deep-drawing
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- C—CHEMISTRY; METALLURGY
- C21—METALLURGY OF IRON
- C21D—MODIFYING THE PHYSICAL STRUCTURE OF FERROUS METALS; GENERAL DEVICES FOR HEAT TREATMENT OF FERROUS OR NON-FERROUS METALS OR ALLOYS; MAKING METAL MALLEABLE, e.g. BY DECARBURISATION OR TEMPERING
- C21D9/00—Heat treatment, e.g. annealing, hardening, quenching or tempering, adapted for particular articles; Furnaces therefor
- C21D9/26—Heat treatment, e.g. annealing, hardening, quenching or tempering, adapted for particular articles; Furnaces therefor for needles; for teeth for card-clothing
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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
- A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
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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
- A61M2037/0046—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
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- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Mechanical Engineering (AREA)
- Biomedical Technology (AREA)
- Physics & Mathematics (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Anesthesiology (AREA)
- Thermal Sciences (AREA)
- Medical Informatics (AREA)
- Crystallography & Structural Chemistry (AREA)
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- Metallurgy (AREA)
- Organic Chemistry (AREA)
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Abstract
The invention discloses a hollow metal micro-needle, a hollow metal micro-needle array and a preparation method thereof, wherein the preparation method comprises the following steps: the hollow metal micro-needle and the micro-needle array prepared by the stamping and stretching process are specifically prepared by preparing a metal stamping needle by a grinding or micro-nano processing technology, then preparing a concave membrane structure consisting of a metal film and a substrate, combining the metal stamping needle with the concave membrane structure by the stamping and stretching process to obtain a metal groove, and then controlling stamping equipment by a mechanical stepping mode after the stress removal and polishing annealing treatment process to obtain the metal groove array so as to obtain the hollow metal micro-needle or the metal micro-needle array. The hollow metal microneedle and the microneedle array thereof are obtained based on the stamping and stretching process, the preparation method is simple to operate, short in manufacturing period and high in efficiency, the production cost is reduced, the popularization of the metal microneedle is facilitated, the batch production is realized, and the defects that the hollow metal microneedle in the traditional micro-nano processing mode is difficult to prepare and the preparation method is single are overcome.
Description
Technical Field
The invention relates to the field of biomedical engineering methods, in particular to a hollow metal microneedle, a hollow metal microneedle array and a preparation method thereof.
Background
Currently, most biological therapies and vaccines are administered using hypodermic needle injections. Conventional needle injection, as a low cost, highly effective means of administering drugs, can deliver almost any type of molecule into the body. However, at the same time, it may cause damage such as local skin injury and bleeding to the human body. With the development of microfabrication technology, microneedles have been developed by academic laboratories and pharmaceutical companies as a prospective miniaturized analytical and therapeutic tool. The emerging microneedle drug delivery is used as a relatively efficient minimally invasive means, and has the advantages of high efficiency, small injury, no pain and the like.
Hollow microneedles have a channel that allows for the continuous delivery of both liquid and dry drug formulations into the body due to the unique advantage of their channels. The hollow micro-needle is mostly directly manufactured from a material substrate by utilizing an MEMS technology, and comprises laser micro-processing, deep reactive ion etching of silicon, an integrated lithographic molding technology, deep X-ray lithography, wet chemical etching, micro-processing and the like. Compared to silicon and polymers, metals are inherently hard and not brittle, are good microneedle materials, but receive less attention due to the complex fabrication process.
In the prior art, an effective way is provided for the preparation of hollow metal microneedles by a method of sacrificing a substrate material, but the method has high manufacturing cost and long manufacturing period and is not suitable for production.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a hollow metal microneedle and a microneedle array prepared by a stamping and stretching process. The structure and the preparation method thereof have the advantages of strong operability, short preparation period and low manufacturing cost, and are suitable for large-scale production, popularization and application.
The specific technical scheme for realizing the purpose of the invention is as follows:
a preparation method of a hollow metal microneedle comprises the following specific steps:
step 1: the conical metal needle, the metal film and the polymer substrate are reserved;
step 2: carrying out precision quenching and heat treatment, fillet treatment and polishing treatment on the conical metal needle; bonding the metal film and the polymer substrate together to form a concave die structure;
and step 3: the conical metal needle is used as a punching needle to perform punching and stretching with a concave die structure for 3-5 times to obtain a metal groove with a high depth-to-width ratio, wherein the punching depth is 60-1600um and is controlled by a punching machine;
and 4, step 4: and performing stress relief annealing and polishing treatment on the formed metal groove, and cutting the part of 50-1500um of the depth of the metal groove to obtain the hollow metal microneedle.
A preparation method of a hollow metal microneedle array comprises the following specific steps:
step 1: the conical metal needle, the metal film and the polymer substrate are reserved;
step 2: carrying out precision quenching and heat treatment, fillet treatment and polishing treatment on the conical metal needle; bonding the metal film and the polymer substrate together to form a concave die structure;
and step 3: the conical metal needle is used as a single microneedle template to be punched and stretched 3-5 times with a concave die structure, so as to obtain a single metal groove with a high depth-to-width ratio; controlling the stamping distance through a mechanical stepping motor, and repeating the process of obtaining a single metal groove to obtain a metal groove array; wherein the stamping distance is 100-2000um, the stamping depth is 60-1600um, and the stamping depth is controlled by a stamping machine;
and 4, step 4: performing stress relief annealing and polishing treatment on the formed metal groove array, and then cutting the metal groove array at the position of 50-1500 mu m in depth to obtain the hollow metal microneedle array; wherein:
the conical metal needle is of a conical structure made of steel, copper and iron metal materials, is of a prismatic or circular conical structure, has a height of 500-2000 um and a conical angle of 5-70 degrees;
the metal film material is titanium, platinum or steel, and the thickness is 10-200 um;
the stress relief annealing treatment is to heat the metal groove to 400-1000 ℃ to eliminate residual internal stress;
the polymer substrate is a Polyimide (PI) substrate, a polyethylene terephthalate (PET) substrate or a polylactic acid (PLA) substrate prepared by a liquid drop method, and the thickness of the polymer substrate is 1000-3000 mu m.
A hollow metal microneedle prepared by the method.
A hollow metal microneedle array prepared by the method.
The height of the microneedle is 50-1500um, the thickness of the microneedle metal layer is 10-200um, and the aperture is 10-500 um.
The height of the micro-needle forming the micro-needle array is 50-1500um, the thickness of the metal layer of the micro-needle is 10-200um, the aperture is 10-500 um, and the distance between the micro-needles is 0.1-3 mm.
Compared with the prior art, the preparation method of the hollow metal microneedle array provided by the invention has the advantages that the metal punching needle obtained in the test is used as the punching needle, the punching and stretching treatment is carried out on the metal punching needle and a concave die consisting of a metal film and a polymer substrate to obtain a metal groove, then the punching equipment is controlled to obtain the metal groove array, and finally the bottom of the formed metal groove array is uniformly cut to obtain the hollow metal microneedle array; the manufacturing method has the advantages of simple operation, high repeatability, short manufacturing period and high efficiency, can effectively reduce the production cost of the microneedle, and is beneficial to popularization and use of the microneedle.
Drawings
Fig. 1 is a flowchart of a process for preparing a hollow metallic microneedle according to example 1 of the present invention;
fig. 2 is a flowchart of the preparation of a hollow metal microneedle array according to example 1 of the present invention;
FIG. 3 is a flow chart of the preparation process of forming a hollow metal microneedle array by punching and drawing a solid metal punch needle array according to example 2 of the present invention;
fig. 4 is a top view of fig. 3.
Detailed Description
The following will describe more clearly and completely the preparation steps in the embodiments of the present invention with reference to the attached drawings. For a better description of the embodiments, some parts of the drawings are omitted, enlarged or reduced and do not represent the size of actual physical drawings.
All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
1) In fig. 1, black cones indicate metal punching pins in the present embodiment, hatched portions indicate metal thin films, and colorless portions indicate substrates of polymer materials. The metal film and the polymer material substrate jointly form a sheet-shaped concave die. Although the material of the metal thin film is not limited, it is preferable to use a material that is not easily contaminated and does not harm human body because it is a precursor of the finished product of this embodiment. The invention needs to form the metal groove with high depth-width ratio by a stamping and stretching process, so that the metal film is required to have higher stretchability and ductility. In addition, because the substrate needs to form a deep concave shape along with the metal film and multiple heating treatments can be carried out in the preparation process, a high-temperature-resistant high-molecular polymer material needs to be selected;
2) the metal punching needle is prepared by a micro-nano processing method;
3) specifically, a polymer mold with a deep groove is obtained through a photoetching method, then metal slurry is poured into the mold through a micro-forming method, and finally a conical metal punching needle is obtained through demolding. Although the material is not particularly limited, a metal having high hardness and good workability is suitably used; in addition, the section shape of the metal punch needle is not particularly limited, and a circular shape is suitable (only the requirement of injection is met);
4) the hardness of the metal punching needle can be improved to Hv290-800 by carrying out precise quenching and heat treatment on the metal punching needle, and then the metal punching needle is subjected to grinding, polishing and fillet treatment, so that the hardness of the metal punching needle is not particularly limited, and the punching requirement is met;
5) the metal film and the polymer substrate form a concave die, and for convenience of explanation, the square metal film and the polymer substrate are selected in this embodiment. The specific shape of the metal film is not limited, and can be changed according to the application of the microneedle and injection power equipment;
6) the metal film and the polymer substrate are bonded together through the adhesive to form the concave film structure, the specific bonding mode and the type of the adhesive are not limited, and the required mechanical structure of the concave film structure is met;
7) the thickness of the polymer substrate in the concave die structure is thicker than the height of the formed metal groove, so that the defects that the formed metal groove has cracks and the like due to uneven stress when the metal punching needle penetrates through the concave die are avoided;
8) and cleaning the metal punching needle, and smearing lubricating oil on the surface of the metal punching needle. The type of the lubricating oil is not particularly limited, and may be adjusted according to the shape of the hollow microneedle, the metal material, and the tensile stress. In addition, the metal punching needle and the surface of the metal film can be subjected to surface treatment, such as coating, painting and the like, so as to reduce the friction force between the metal punching needle and the metal film, and the surface treatment is not particularly limited;
9) and carrying out surface heat treatment on the concave die structure, wherein the temperature is lower than the melting temperature of the metal film during the heat treatment, and the polymer substrate below the metal film cannot be damaged irreversibly. The metal thin film is preferably, but not limited to, a temperature around the softening point;
10) obtaining the size of the metal punching needle and the matched metal film and substrate through a pilot punching experiment;
11) the second graph in the flow of fig. 1 shows a structural schematic diagram of a metal punching needle and a female die after three to five times of punching and stretching processes, in the punching and stretching process, a metal groove with a high depth-to-width ratio is obtained through multiple times of stretching, the punching times are not limited, and the metal groove with high quality can be obtained;
12) the height range of the metal groove is about 60um-1600um, and the height of the metal groove is not particularly limited due to the different types of the medicines injected by the micro-needle and the different injection parts;
13) and on the surface of the metal punching needle, the surface of the metal film needs to be regularly and uniformly coated with lubricating oil, and the cleanness of the lubricating part is ensured. This is because the metal punching pin and the surface of the metal film contact each other to generate a large pressure during punching and stretching, and further generate a frictional force. The harmful friction can reduce the deformation degree of stretching, can cause the damage of the surface of a part and can reduce the service life of the metal punching needle;
14) and performing low-temperature stress relief annealing between the stamping and stretching processes to soften the metal structure. This is because the metal is work hardened during the working process, which increases the strength index of the metal and decreases the plasticity index. Meanwhile, residual stress still existing in the stretched material due to uneven plastic deformation can be removed;
15) controlling a punching machine to perform punching and stretching processes on the surface of the female die at equal intervals through a mechanical platform to obtain a metal groove array shown in figure 2;
16) the step density and step distribution of the press are not limited and can be determined according to the purpose. In fig. 2, for convenience, a concave mold for making three microneedles is described as an example;
17) cutting to obtain the hollow metal microneedle array shown in fig. 2, and pickling to remove the lubricant and the oxide skin on the surface of the hollow metal microneedle;
18) polishing the metal micro-needle to remove the defects of folds caused by stretching, unsmooth caused by friction on the surface of the micro-needle and the like;
19) the ratio of the interface diameter of the root of the manufactured hollow metal microneedle to the length is formed to have a section diameter: high aspect ratio cones of length = 1: 1.5 to 1: 6.
Example 2
1) Preparing a solid metal punch pin array shown in figure 3 by a micro-nano processing method;
2) specifically, a polymer array mold with a deep groove is obtained through a photoetching method, then metal slurry is poured into the mold through a micro-forming method, and finally a metal punching needle array is obtained through demolding. The punching needle density can be determined according to the application of the hollow metal micro-needle and the fact that large-area pit-shaped depressions are not generated on the metal film in the punching and stretching process;
3) the solid metal array and the metal film are punched and stretched to obtain a metal groove array;
4) specifically, a metal groove with a sufficiently high aspect ratio is obtained by multiple stamping and stretching;
5) and performing stress relief annealing and polishing treatment on the formed metal groove array, and cutting the metal groove array to form a hollow metal microneedle array.
The protection of the present invention is not limited to the above embodiments. Variations and advantages that may occur to those skilled in the art may be incorporated into the invention without departing from the spirit and scope of the inventive concepts herein set forth and defined by the appended claims.
Claims (6)
1. A preparation method of a hollow metal microneedle is characterized by comprising the following specific steps:
step 1: the conical metal needle, the metal film and the polymer substrate are reserved;
step 2: carrying out precision quenching and heat treatment, fillet treatment and polishing treatment on the conical metal needle; bonding the metal film and the polymer substrate together to form a concave die structure;
and step 3: the conical metal needle is used as a punching needle to perform punching and stretching with a concave die structure for 3-5 times to obtain a metal groove with a high depth-to-width ratio, wherein the punching depth is 60-1600um and is controlled by a punching machine;
and 4, step 4: performing stress relief annealing and polishing treatment on the formed metal groove, and then cutting the metal groove at the position of 50-1500um in depth to obtain the hollow metal microneedle; wherein:
the conical metal needle is of a conical structure made of steel, copper and iron metal materials, the conical structure is prismatic or circular, the height is 500-;
the metal film material is titanium, platinum or steel, and the thickness is 10-200 um;
the stress relief annealing treatment is to heat the metal groove to 400-1000 ℃ to eliminate residual internal stress;
the polymer substrate is a polyimide, poly-p-xylylene-diethyl or polylactic acid substrate prepared by a liquid drop method, and the thickness of the polymer substrate is 1000-3000 mu m.
2. A preparation method of a hollow metal microneedle array is characterized by comprising the following specific steps:
step 1: the conical metal needle, the metal film and the polymer substrate are reserved;
step 2: carrying out precision quenching and heat treatment, fillet treatment and polishing treatment on the conical metal needle; bonding the metal film and the polymer substrate together to form a concave die structure;
and step 3: the conical metal needle is used as a single microneedle template to be punched and stretched 3-5 times with a concave die structure, so as to obtain a single metal groove with a high depth-to-width ratio; controlling the stamping distance through a mechanical stepping motor, and repeating the process of obtaining a single metal groove to obtain a metal groove array; wherein the stamping distance is 100-3000 um, the stamping depth is 60-1600um, and the stamping depth is controlled by a stamping machine;
and 4, step 4: performing stress relief annealing and polishing treatment on the formed metal groove array, and then cutting the metal groove array at the position of 50-1500 mu m in depth to obtain the hollow metal microneedle array; wherein:
the conical metal needle is of a conical structure made of steel, copper and iron metal materials, the conical structure is prismatic or circular, the height is 500-;
the metal film material is titanium, platinum or steel, and the thickness is 10-200 um;
the stress relief annealing treatment is to heat the metal groove to 400-1000 ℃ to eliminate residual internal stress;
the polymer substrate is a polyimide, poly-p-xylylene-diethyl or polylactic acid substrate prepared by a liquid drop method, and the thickness of the polymer substrate is 1000-3000 mu m.
3. A hollow metallic microneedle made according to the method of claim 1.
4. A hollow metallic microneedle array made according to the method of claim 2.
5. The hollow metal microneedle according to claim 3, wherein the height of the microneedle is 50-1500um, the thickness of the microneedle metal layer is 10-200um, and the pore size is 10-500 um.
6. The hollow metal microneedle array according to claim 4, wherein the height of microneedles constituting the microneedle array is 50-1500um, the thickness of the microneedle metal layer is 10-200um, the pore diameter is 10-500 um, and the distance between the microneedles is 0.1-3 mm.
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| CN202010622006.8A CN111659000A (en) | 2020-06-30 | 2020-06-30 | Hollow metal microneedle, hollow metal microneedle array and preparation method thereof |
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| CN202010622006.8A CN111659000A (en) | 2020-06-30 | 2020-06-30 | Hollow metal microneedle, hollow metal microneedle array and preparation method thereof |
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2020
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| CA2591168A1 (en) * | 1999-06-09 | 2000-12-14 | Corium International, Inc. | Method of manufacturing an intracutaneous microneedle array |
| CN101124072A (en) * | 2004-11-26 | 2008-02-13 | 新加坡科技研究局 | Method and device for forming micro-structure |
| CN101148243A (en) * | 2007-09-14 | 2008-03-26 | 大连理工大学 | Method for making three-dimension electric casting micro structure |
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| CN103103583A (en) * | 2013-01-14 | 2013-05-15 | 大连理工大学 | Method for manufacturing multi-layer metal mobile microstructure on metal base |
| CN103924241A (en) * | 2014-04-14 | 2014-07-16 | 北京工业大学 | Method for on-scale preparation of tungsten with micro-nano structure on surface with low surface stress |
| CN106109055A (en) * | 2016-07-21 | 2016-11-16 | 成都嘉宝祥生物科技有限公司 | A kind of blood vessel covered stent manufacture method |
| CN106137483A (en) * | 2016-07-21 | 2016-11-23 | 成都嘉宝祥生物科技有限公司 | A kind of coronary vessel stent manufacture method |
| US20190090811A1 (en) * | 2017-09-28 | 2019-03-28 | Medtronic Minimed, Inc. | Medical devices with microneedle arrays and methods for operating such medical devices |
| CN109078260A (en) * | 2018-07-02 | 2018-12-25 | 华中科技大学 | A method of preparing hollow microneedle arrays |
| CN210231187U (en) * | 2019-06-30 | 2020-04-03 | 烟台众诚新型建材科技有限公司 | Stepping type punching machine |
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Application publication date: 20200915 |
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