CN114344699B - Preparation method of hollow microneedle patch, hollow microneedle patch and injection device - Google Patents
Preparation method of hollow microneedle patch, hollow microneedle patch and injection device Download PDFInfo
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Abstract
The invention provides a preparation method of a hollow microneedle patch, the hollow microneedle patch and an injection device. Firstly, drawing a hollow microneedle array graph and a bottom plate graph, wherein the hollow microneedle array graph comprises a plurality of circular exposure areas, the areas outside the circular exposure areas are first non-exposure areas, and the center of each circular exposure area is provided with a circular second non-exposure area; the bottom plate picture is provided with a plurality of circular non-exposure areas distributed in an array mode, the rest part is the bottom plate exposure area, and the diameter of the circular non-exposure area is smaller than or equal to that of the circular exposure area and larger than that of the second non-exposure area. The hollow microneedle array pattern and the floor pattern are then directed to a digital light processing (Digital Light Processing, DLP) system that first forms the hollow microneedles from the hollow microneedle array pattern and then forms the floor from the floor pattern. The invention can rapidly prepare large-size and high-quality hollow microneedle patches and finely regulate and control the structures of the hollow microneedle patches.
Description
Technical Field
The invention relates to the technical field of microneedle preparation, in particular to a rapid preparation method of a hollow microneedle patch.
Background
Hollow microneedles are micron-sized length needles with an elongated through-hole structure inside, useful for minimally invasive, painless transdermal drug delivery. The plurality of hollow microneedles are arranged on a substrate corresponding to the through-holes to form hollow microneedle patches for accurate transdermal drug delivery when connected to the drug delivery device. Currently, hollow microneedle patches have been used in a number of fields for transdermal delivery of insulin, vaccines, local anesthetic drugs, and the like. However, since the microneedle patch bottom plate has a larger size and the needle tip has a very fine structure, the efficient preparation of the high-quality hollow microneedle patch has a great technical difficulty, and development of a new preparation method is needed.
The preparation method of the hollow microneedle patch is a Micro-Electro-Mechanical System (MEMS) technology, but the preparation process is complicated, time-consuming and expensive, and is difficult to be used for large-scale manufacturing of the hollow microneedle patch. The 3D printing technology is a novel manufacturing technology which emerges in recent years, and has good application prospect in the preparation of hollow microneedle patches. Laser Stereolithography (SLA) and two-photon polymerization (TPP) techniques have been used in the manufacture of hollow microneedle patches. However, both SLA and TPP are dot-by-dot printing techniques, and it is difficult to meet the requirements of printing speed and precision at the same time.
The applicant filed patent application with application number 201711084057.4 and named microneedle preparation method on the 7 th 11 th 2017, and aims to provide a microneedle preparation method, and the invention is conceived to utilize a digital light processing (Digital Light Processing, DLP) technology, namely, after a printing light beam is projected into a printing material layer, the light intensity of the printing light beam gradually decreases from the center to the periphery on the same cross section, and the light intensity gradually decreases from the light source end to the light source end far away from the same longitudinal section (a section parallel to the light beam propagation direction), so that a conical microneedle structure can be directly formed in the printing material layer by controlling the exposure time of the printing light beam. However, the solid micro-needle is prepared by the method, compared with the solid micro-needle, the needle point structure of the hollow micro-needle is finer and more complex, the bottom plate is required to be aligned with the through hole of the hollow micro-needle, and the preparation of the high-quality hollow micro-needle patch still cannot be supported according to the prior art method.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a preparation method of a hollow microneedle patch, which can rapidly prepare a hollow microneedle patch with large size and high quality and can finely regulate and control the structure of the hollow microneedle patch.
The invention solves the problems by adopting the following technical scheme: a method for preparing hollow microneedle patch comprises
Drawing a hollow microneedle array graph and a bottom plate graph, wherein the hollow microneedle array graph comprises a plurality of circular exposure areas distributed in an array mode, the areas outside the circular exposure areas are first non-exposure areas, and the inside of each circular exposure area is provided with a circular second non-exposure area; the bottom plate diagram is provided with a plurality of circular non-exposure areas distributed in an array mode, the rest part is a bottom plate exposure area, the diameter of the circular non-exposure area is smaller than or equal to that of the circular exposure area and larger than that of the second non-exposure area, and after the bottom plate diagram is overlapped with the hollow microneedle array diagram, each circular non-exposure area covers the second non-exposure area of the circular exposure area;
the hollow microneedle array pattern and the base plate pattern are led into a DLP system, and the DLP system firstly forms the hollow microneedles according to the hollow microneedle array pattern and then forms the base plate according to the base plate pattern.
Further, the DLP system comprises a light source, a digital micromirror device, a micro-mirror and a liquid trough;
when printing, the photosensitive material is placed in a liquid trough, a light source emits light, a digital micro-mirror device adjusts the light into first digital light, after the first digital light is adjusted by a micro-mirror, the irradiation range is consistent with a circular exposure area on a hollow micro-needle array chart, the digital light is injected into the photosensitive material, and the photosensitive material is polymerized to form hollow micro-needles;
after the hollow micro needle is formed, the digital micro mirror device adjusts the light into second digital light, after the second digital light is adjusted by the micro mirror, the irradiation range is consistent with the exposure area of the base plate on the base plate graph, the digital light is injected into the photosensitive material, and the photosensitive material is polymerized to form the base plate.
Further, the liquid surface of the photosensitive material is provided with a transparent bearing plate, the bottom plate is attached to the bearing plate after being formed, and the bottom plate can be taken out after the bearing plate is taken out.
Further, various light-curable materials satisfying the requirements, such as a light-sensitive resin, a light-curable hydrogel, a light-curable silicone material, or a light-curable liquid crystal material, are used as the light-sensitive material.
Further, the second non-exposure area is positioned between the center and the edge of the circular exposure area.
The hollow microneedle patch comprises a bottom plate and hollow microneedles distributed in an array manner, and is prepared by the method.
The injection device comprises a body, wherein one end of the body is provided with a hollow microneedle patch, the hollow microneedle patch comprises a bottom plate and hollow microneedles distributed in an array manner, and the hollow microneedle patch is prepared by adopting the method.
Further, the hollow microneedle patch is connected with the body through a conversion head.
Further, the bottom plate is embedded into one end of the conversion head, and the other end of the conversion head is connected with the body in an inserting mode or in a threaded mode.
The beneficial effects of the invention are as follows: 1. according to the invention, the hollow microneedle array diagram and the bottom plate diagram are designed, so that the hollow microneedle bottom plate with a fine structure and a large size can be rapidly prepared.
2. The key point of the invention is that the conical and hollow microneedle structure can be directly formed in the printing material layer by controlling the exposure time of the printing light beam by utilizing the scattering and refracting effects generated after the hollow printing light beam (digital light) is projected into the photosensitive material layer. Because the hollow microneedle patch is formed by one-time exposure, layer-by-layer printing is not needed, interlayer stepped patterns caused by the existing layer-by-layer printing are avoided, and the quality of the hollow microneedle patch is improved.
3. The size and the structure of the micro needle can be changed by changing the parameters and the processing technology of the micro needle patch, the mould does not need to be redesigned and manufactured, the implementation cost is reduced, the preparation technology is simplified, and the hollow micro needle patch in various forms is beneficial to customization.
4. The exposure range of the printing light beam is changed immediately after the hollow micro-needle is formed, so that the bottom plate is formed, the bottom plate is automatically polymerized with the hollow micro-needle in the forming process, the preparation process is not interrupted, the hollow micro-needle and the bottom plate are rapidly formed, the forming efficiency of the whole micro-needle patch is improved, the high efficiency of production is ensured, and the batch production can be realized.
Drawings
FIG. 1 is a diagram of a hollow microneedle array;
FIG. 2 is a bottom plate diagram;
FIG. 3 is a schematic representation of the preparation of a hollow microneedle patch of the present invention;
FIG. 4 is a schematic illustration of hollow microneedles after being formed;
FIG. 5 is a schematic view of the base plate after formation;
FIG. 6 is a schematic illustration of a hollow microneedle patch made according to the present invention;
FIG. 7 is a schematic view of an injection device of the present invention;
FIG. 8 is a schematic view of another hollow microneedle that can be made according to the present invention;
reference numerals: 1-a hollow microneedle array pattern; 11-a circular exposure field; 12-a first non-exposed area; 13-a second non-exposed area; 2-a bottom plate diagram; 21-circular non-exposed areas; 22-a floor exposure area; 31-a light source; 32-a digital micromirror device; 33—a micromirror; 34-a liquid trough; 35-a carrier plate; 41-a body; 42-a conversion head; 10-hollow microneedles; 20-a bottom plate.
Detailed Description
The invention will be further described with reference to the drawings and examples.
The invention relates to a preparation method of a hollow microneedle patch, the hollow microneedle patch and an injection device, which comprise
Drawing a hollow microneedle array figure 1 and a bottom plate figure 2, wherein the hollow microneedle array figure 1 and the bottom plate figure 2 are respectively provided with an exposure area and a non-exposure area, the exposure area is an area for receiving illumination, and digital light is injected into the exposure area, so that photosensitive materials can be polymerized to form solids in the exposure area, and a part with a certain shape is obtained.
Specifically, the hollow microneedle array fig. 1 is used for forming the hollow microneedles 10, as shown in fig. 1, the hollow microneedle array fig. 1 includes a plurality of circular exposure areas 11 distributed in an array, the circular exposure areas 11 are areas for forming the hollow microneedles 10, the diameter of each circular exposure area 11 is equal to the outer diameter of the root of each hollow microneedle 10, in order to form a liquid suction channel inside the hollow microneedles 10, a circular second non-exposure area 13 is arranged inside each circular exposure area 11, and the diameter of each second non-exposure area 13 is the diameter of the liquid suction channel of the hollow microneedles 10. The through hole inside the existing hollow microneedle 10 is located at the center of the hollow microneedle 10, so that the second non-exposure area 13 is located at the center of the circular exposure area 11 according to the conventional design concept, so that the formed liquid suction channel is located at the center of the hollow microneedle 10, as shown in fig. 6, but the tip of the hollow microneedle 10 obtained in this way is relatively blunt, which is not beneficial to penetrating into the skin of a human body quickly and laborsaving. Therefore, as a more preferred embodiment, the second non-exposure area 13 may also deviate from the center of the circular exposure area 11, and preferably the second non-exposure area 13 is located between the center and the edge of the circular exposure area 11, so that the formed liquid suction channel deviates from the center of the hollow microneedle 10, as shown in fig. 8, and the hollow microneedle 10 thus obtained has a sharp tip, and can quickly penetrate into human skin in use, thereby improving efficiency and reducing the damage area to skin. The dimensions of the circular exposure field 11 and the second non-exposure field 13, the array pattern, etc. are determined according to the design requirements of the microneedle array. The area outside the circular exposure area 11 is the first non-exposure area 12.
The bottom plate fig. 2 is used for forming the bottom plate 20, as shown in fig. 2, a plurality of circular non-exposure areas 21 distributed in an array form are arranged on the bottom plate fig. 2, the rest is a bottom plate exposure area 22, the purpose of arranging the circular non-exposure areas 21 is to form through holes on the bottom plate 20, the through holes are connected with the liquid suction channels of the hollow micro-needles 10, the liquid suction channels of the hollow micro-needles 10 are prevented from being blocked by the bottom plate 20, and the normal use of the hollow micro-needles 10 can be ensured, so that the diameter of the circular non-exposure areas 21 is larger than that of the second non-exposure areas 13. In addition, to ensure that the root of the hollow microneedle 10 is connected to the base plate 20, so that the hollow microneedle 10 and the base plate 20 can be formed quickly, the diameter of the circular non-exposure region 21 cannot be larger than the diameter of the circular exposure region 11, i.e., the diameter of the circular non-exposure region 21 is smaller than or equal to the diameter of the circular exposure region 11.
The circular exposure area 11 may have various array modes, such as rectangular array, circular array, etc., and may be drawn according to design requirements.
In order for the hollow microneedles 10 to be accurately distributed on the base plate 20 according to design requirements, the overall size and shape of the base plate fig. 2 should be identical to those of the hollow microneedle array fig. 1, while each circular non-exposure area 21 covers the second non-exposure area 13 of the circular exposure area 11 and the center of the circular non-exposure area 21 coincides with the center of the corresponding circular exposure area 11 when the base plate fig. 2 is overlapped with the hollow microneedle array fig. 1.
After the hollow microneedle array pattern 1 and the base plate pattern 2 are drawn, the hollow microneedle array pattern 1 and the base plate pattern 2 are introduced into a DLP system, which forms the hollow microneedles 10 according to the hollow microneedle array pattern 1 and then forms the base plate 20 according to the base plate pattern 2.
Specifically, as shown in fig. 3, the DLP system includes a light source 31, a digital micromirror device 32, a micromirror 33, and a liquid trough 34. The light source 31 is used for emitting printing light beams, the digital micro mirror device 32 is used for converting the light beams into digital light, and the digital micro mirror device is matched with the micro mirror 33, so that the shapes and the sizes of the light beams can be adjusted according to the shapes and the sizes of the exposure areas and the non-exposure areas on the hollow micro needle array chart 1 and the bottom plate chart 2, and the printing light beams can be exposed in the exposure areas required by the hollow micro needle array chart 1 and the bottom plate chart 2. The digital light is adjusted by the micromirror 33 to improve printing accuracy.
When printing, the photosensitive material is placed in the liquid tank 34, the photosensitive material can be any existing photo-curing material meeting the requirements, such as photosensitive resin, photo-curing hydrogel, photo-curing organic silicon material or photo-curing liquid crystal material, the light source 31 emits light, the light irradiates the digital micro-mirror device 32, the digital micro-mirror device 32 adjusts the light into first digital light, the irradiation range of the first digital light is consistent with that of the circular exposure area 11 (the circular exposure area 11 does not comprise the second non-exposure area 13) in the hollow micro-needle array figure 1 after the first digital light is adjusted by the micro-mirror 33, the digital light is injected into the photosensitive material, and the photosensitive material is polymerized in the circular exposure area 11 to form the hollow micro-needles 10 distributed in the array, as shown in figure 4.
The light intensity of each printing light beam is gradually weakened from the center to the periphery on the same cross section, the light intensity on the same longitudinal section (the section parallel to the light beam propagation direction) is gradually weakened from the light source end to the light source end, and the printing light beam is set as a hollow light beam, so that the hollow microneedle structure with conical tip shape and hollow shape (shown in fig. 4 to 6) can be directly formed in the printing material layer by controlling the exposure time of the printing light beam. Because the hollow micro needle is formed by one-time exposure and does not need to be printed layer by layer, the obtained hollow micro needle has a flat and smooth surface structure, interlayer stepped patterns caused by the existing layer by layer printing are avoided, and the strength of the hollow micro needle 10 is improved.
Immediately after the hollow microneedle 10 is formed, the digital micromirror device 32 modulates the light into a second digital light, the second digital light is modulated by the micromirror 33, the irradiation range is consistent with the floor exposure area 22 on the floor fig. 2, the digital light is injected into the photosensitive material, and the photosensitive material is polymerized in the floor exposure area 22 to form the floor 20, as shown in fig. 5.
Since the bottom plate 20 is formed immediately after the hollow microneedle 10 is formed, the preparation process is not interrupted, the high efficiency of production is ensured, and mass production can be realized. In addition, the hollow microneedles 10 and the bottom plate 20 can be rapidly formed in a short time, ensuring production efficiency. Because the invention does not need to adopt a mould, when the parameters of the hollow microneedle patch need to be changed, the hollow microneedle array diagram and the bottom plate diagram are directly modified, and the mould does not need to be redesigned and manufactured, thereby reducing the implementation cost, simplifying the preparation process and being beneficial to customizing hollow microneedle patches in various forms. Therefore, the invention can realize mass and rapid production of hollow microneedle patches.
In order to facilitate the taking out of the formed hollow microneedle patch, the liquid surface of the photosensitive material is provided with a bearing plate 35, the bearing plate 35 is made of a light-transmitting material, such as glass, and the like, the passing of digital light is not affected, the bottom plate 20 is attached to the bearing plate 35 after being formed, the bottom plate 20 can be taken out by taking out the bearing plate 35 from the liquid trough 34, and then a new bearing plate is put into the liquid trough 34 for production again. The base plate 20 can be quickly removed from the carrier plate 35.
As shown in fig. 6, the hollow microneedle patch prepared by the invention comprises a bottom plate 20 and hollow microneedles 10 distributed in an array manner, as the light intensity of printing beams on the same cross section is gradually weakened from the center to the periphery, the light intensity on the same longitudinal section (the section parallel to the beam propagation direction) is gradually weakened from the end close to the light source to the end far away from the light source, and photosensitive materials are polymerized at the position with larger light intensity, the outer diameter of the obtained hollow microneedles 10 is gradually reduced from the root to the tip, the hollow microneedles 10 are integrally conical, and the tip is automatically formed, so that the skin of a human body can be rapidly pierced during use.
The injection device, as shown in fig. 7, comprises a body 41, wherein the body 41 can adopt any existing injection device structure, one end of the body 41 is provided with a hollow microneedle patch, and the hollow microneedle patch comprises a bottom plate 20 and hollow microneedles 10 distributed in an array manner.
To facilitate mounting of the hollow microneedle patch to the body 41, the base plate 20 of the hollow microneedle patch is connected to the body 41 by a transfer head 42. The base plate 20 is embedded into one end of the conversion head 42, and the other end of the conversion head 42 is inserted into or screwed with the body 41. The conversion head 42 comprises a cylindrical connecting cylinder and a connector at one end of the connecting cylinder, the bottom plate 20 is embedded into the connector, and the connecting cylinder is spliced or screwed with the body 41, so that the hollow microneedle patch can be quickly assembled and disassembled.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. A preparation method of a hollow microneedle patch is characterized by comprising the following steps: comprising
Drawing a hollow microneedle array graph (1) and a bottom plate graph (2), wherein the hollow microneedle array graph (1) comprises a plurality of circular exposure areas (11) distributed in an array mode, the area outside the circular exposure areas (11) is a first non-exposure area (12), and a circular second non-exposure area (13) is arranged inside each circular exposure area (11); a plurality of circular non-exposure areas (21) distributed in an array mode are arranged on the bottom plate diagram (2), the rest is a bottom plate exposure area (22), the diameter of the circular non-exposure area (21) is smaller than or equal to that of the circular exposure area (11) and larger than that of the second non-exposure area (13), and after the bottom plate diagram (2) is overlapped with the hollow microneedle array diagram (1), each circular non-exposure area (21) covers the second non-exposure area (13) of the circular exposure area (11);
introducing the hollow microneedle array pattern (1) and the base plate pattern (2) into a DLP system, wherein the DLP system firstly forms hollow microneedles (10) according to the hollow microneedle array pattern (1) and then forms a base plate (20) according to the base plate pattern (2);
the DLP system comprises a light source (31), a digital micro-mirror device (32), a micro-mirror (33) and a liquid trough (34);
when printing, a photosensitive material is placed into a liquid trough (34), a light source (31) emits light, a digital micro-mirror device (32) adjusts the light into first digital light, the first digital light is adjusted by a micro-mirror (33), the irradiation range is consistent with a circular exposure area (11) on a hollow micro-needle array chart (1), the digital light is injected into the photosensitive material, and the photosensitive material is polymerized to form hollow micro-needles (10);
after the hollow micro needle (10) is formed, the digital micro mirror device (32) adjusts the light into second digital light, the irradiation range of the second digital light is consistent with the exposure area (22) of the base plate on the base plate graph (2) after the second digital light is adjusted by the micro mirror (33), the digital light is injected into the photosensitive material, and the photosensitive material is polymerized to form the base plate (20);
the second non-exposure area (13) is positioned between the center and the edge of the circular exposure area (11);
each printing beam is scattered and refracted after being projected into the printing material layer, the light intensity of the printing beam is gradually weakened from the center to the periphery on the same cross section, the light intensity on the same longitudinal section is gradually weakened from the end close to the light source to the end far away from the light source, the longitudinal section is a section parallel to the light beam propagation direction, the printing beam is set as a hollow beam, and the conical hollow microneedle structure is directly formed in the printing material layer by controlling the exposure time of the printing beam.
2. The method for preparing the hollow microneedle patch according to claim 1, wherein: the liquid level of the photosensitive material is provided with a bearing plate (35), the bottom plate (20) is attached to the bearing plate (35) after being formed, and the bottom plate (20) can be taken down after the bearing plate (35) is taken out.
3. The method for preparing the hollow microneedle patch according to claim 1, wherein: the photosensitive material adopts photosensitive resin.
4. The method for preparing the hollow microneedle patch according to claim 1, wherein: the photosensitive material adopts photo-curing hydrogel.
5. The method for preparing the hollow microneedle patch according to claim 1, wherein: the photosensitive material is a photo-curing organic silicon material.
6. The method for preparing the hollow microneedle patch according to claim 1, wherein: the photosensitive material is a photo-curing liquid crystal material.
7. Hollow microneedle paster, including bottom plate (20) and be hollow microneedle (10) that array distributes, its characterized in that: a method according to any one of claims 1 to 6.
8. Injection device, including body (41), the one end of body (41) is provided with hollow microneedle paster, hollow microneedle paster includes bottom plate (20) and is hollow microneedle (10) that array distributed, its characterized in that: the hollow microneedle patch is prepared by the method of any one of claims 1 to 6.
9. The injection device of claim 8, wherein: the bottom plate (20) of the hollow microneedle patch is connected with the body (41) through a conversion head (42).
10. The injection device of claim 9, wherein: the base plate (20) is embedded into one end of the conversion head (42), and the other end of the conversion head (42) is connected with the body (41) in an inserting or threaded mode.
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| WO2019136133A1 (en) * | 2018-01-03 | 2019-07-11 | The Trustees Of Columbia University In The City Of New York | Microneedle for local delivery of therapeutic agent |
| CN109125912B (en) * | 2018-08-09 | 2020-09-08 | 武汉大学 | 3D printing microneedle patch for intelligent blood sugar regulation and preparation method thereof |
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| CN110693855B (en) * | 2019-10-10 | 2021-01-26 | 武汉大学 | Preparation method and application of 3D printing microneedle patch |
| CN112316292A (en) * | 2020-07-26 | 2021-02-05 | 浙江工业大学 | Bionic microneedle patch for transdermal drug delivery |
| CN112587790A (en) * | 2020-11-25 | 2021-04-02 | 中山大学 | Transdermal drug pressing/ion electrophoresis controlled release device based on 3D printing hollow microneedle array |
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