Special-shaped microneedle patch and preparation device of special-shaped microneedle patch

Abstract

The utility model provides a special-shaped microneedle patch and a preparation device of the special-shaped microneedle patch, and the special-shaped microneedle patch comprises a substrate; each needle body comprises a first needle section and a second needle section, the first needle section comprises a first end and a second end, the second needle section comprises a third end and a fourth end, the third end is connected with the second end, the cross section of the first needle section is circular, and the diameter of the first needle section is gradually increased from the first end to the second end; the cross section of the second needle section is circular, the diameter of the second needle section is gradually reduced from the third end to the fourth end, the substrate is connected with the fourth end, the microneedle can be prevented from sliding out of skin tissue, meanwhile, only a corresponding thermoplastic stretching mold needs to be prepared, the manufacturing cost of the microneedle is greatly reduced, and the microneedle can be produced in batches.

Description

Technical Field

[0001] The utility model belongs to the field of medical treatment and beauty, and particularly relates to a special-shaped microneedle patch and a preparation device for the special-shaped microneedle patch. Background Art

[0002] Microneedles are an emerging and effective transdermal drug delivery technology. Common microneedles are pyramidal or conical in shape with a wide base and a top. Due to their shape limitations, they are prone to sliding out under the squeezing of skin tissue after being applied to the skin and cannot be stably maintained in the skin. Some work has set up multi-level structures, barbs, swelling structures, etc. on microneedles. When the microneedles penetrate the skin, these structures can effectively prevent the microneedles from sliding out. However, they require complex and expensive processes such as photolithography and 4D printing, and do not require preparation schemes such as multi-step curing that are prone to repeatability errors. They do not require specific magnetic materials, etc., which limits their batch preparation and large-scale application.

[0003] Therefore, a special-shaped microneedle patch that is simple to manufacture and can effectively prevent microneedles from slipping out and a preparation device for the special-shaped microneedle patch have become technical problems that need to be solved urgently. Utility Model Content

[0004] The embodiment of the utility model provides a special-shaped microneedle patch.

[0005] The embodiment of the utility model provides a device for preparing a special-shaped microneedle patch.

[0006] In view of this, the first aspect of the present invention proposes a special-shaped microneedle patch, comprising: a substrate; a plurality of needle bodies, including a first needle segment and a second needle segment, wherein the first needle segment includes a first end and a second end, the second needle segment includes a third end and a fourth end, the third end and the second end are connected, the cross-section of the first needle segment is circular and the diameter gradually increases from the first end to the second end, the cross-section of the second needle segment is circular and the diameter gradually decreases from the third end to the fourth end, and the substrate is connected to the fourth end.

[0007] In some technical solutions, the base sheet, the first needle segment and the second needle segment are an integrated structure.

[0008] In some technical solutions, the first needle segment and the second needle segment are thermoplastic stretched parts formed by a base sheet through a thermoplastic stretching process.

[0009] In some technical solutions, the diameter of the fourth end is less than or equal to 500 μm.

[0010] In some technical solutions, the sum of the heights of the first needle segment and the second needle segment is greater than or equal to 25 μm and less than or equal to 2000 μm.

[0011] In some technical solutions, the ratio of the height of the first needle segment to the height of the second needle segment is greater than or equal to 1 and less than or equal to 10.

[0012] In some technical solutions, the ratio of the height of the first needle segment to the diameter of the third end is greater than or equal to 5.

[0013] In some technical solutions, the ratio of the height of the second needle segment to the diameter of the third end is less than or equal to 1.

[0014] According to a second aspect of the present invention, a device for preparing a special-shaped microneedle patch is provided, for preparing the special-shaped microneedle patch according to the first aspect. The device comprises: a first heating plate having a plurality of bosses disposed thereon, the bosses being spaced apart; and a second heating plate disposed corresponding to the first heating plate and used to secure the raw material for the special-shaped microneedle patch.

[0015] In some technical solutions, a groove is provided on the end surface of one end of the boss, the cross section of the groove is circular and the diameter gradually decreases from one end of the boss to the other end of the boss.

[0016] In some technical solutions, the cross section of the groove is circular, and the diameter of the groove at the end surface of the boss is the same as the diameter of the third end.

[0017] In some technical solutions, the preparation device of the special-shaped microneedle patch also includes: a distance adjustment device, the first heating plate and the second heating plate are fixed on the distance adjustment device, and the distance adjustment device is used to adjust the distance between the first heating plate and the second heating plate; a flipping device, the distance adjustment device is arranged on the flipping device, and the flipping device is used to adjust the upper and lower positions of the first heating plate and the second heating plate.

[0018] The beneficial effects of the present invention are as follows: a raw material is fixed on a second heating plate; a first heating plate and a second heating plate are heated so that the temperature of the raw material is between the glass transition temperature and the melting point, and the raw material flows into the groove of the first heating plate. When the raw material fills the groove, the heating plate is pulled upward to lower the temperature of the first and second heating plates so that the temperature of the raw material is below the glass transition temperature. The first heating plate, the raw material, and the second heating plate are flipped over, the first heating plate is heated so that the raw material is between the glass transition temperature and the melting point, the first heating plate is moved downward, and the first heating plate is moved upward to form the first needle segment, and then cooled, thereby stabilizing the shape of the shaped microneedles. Specifically, the shaped microneedle patch disclosed in this application does not require complex and expensive processes such as photolithography and 4D printing, does not require multi-step curing and other preparation methods that are prone to repeatability errors, and does not require specific magnetic materials. Only the corresponding thermoplastic stretching mold is required, which greatly reduces the manufacturing cost of the microneedles and enables the microneedles to be produced in batches. At the same time, the shaped microneedles in this application have the largest area at the junction of the first needle segment and the second needle segment, which can prevent the microneedles from slipping out of the skin tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 A schematic structural diagram showing a special-shaped microneedle patch according to an embodiment of the present invention;

[0020] Figure 2 One of the structural schematic diagrams showing a device for preparing a special-shaped microneedle patch according to an embodiment of the present invention;

[0021] Figure 3 A second structural schematic diagram showing a device for preparing a special-shaped microneedle patch according to an embodiment of the present invention;

[0022] Figure 4 A third structural diagram showing a device for preparing a special-shaped microneedle patch according to an embodiment of the present invention;

[0023] Figure 5 A schematic diagram of the structure of a device for preparing a special-shaped microneedle patch according to an embodiment of the present invention;

[0024] Figure 6 A schematic diagram showing the difference between the special-shaped microneedle patch provided by an embodiment of the present invention and other microneedles during the formation process.

[0025] in, Figures 1 to 6 The corresponding relationship between the reference numerals and component names is as follows:

[0026] 1 substrate, 2 needle body, 21 first needle segment, 211 first end, 212 second end, 22 second needle segment, 221 third end, 222 fourth end, 3 first heating plate, 31 boss, 32 groove, 4 second heating plate, 5 distance adjustment device, 6 turning device. DETAILED DESCRIPTION

[0027] To make the purpose, technical solutions, and advantages of the present invention more clear, the following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.

[0028] The utility model proposes a special-shaped microneedle patch, such as Figures 1 to 5As shown, the special-shaped microneedle patch includes: a substrate 1; a plurality of needle bodies 2, including a first needle segment 21 and a second needle segment 22, wherein the first needle segment 21 includes a first end 211 and a second end 212, the second needle segment 22 includes a third end 221 and a fourth end 222, the third end 221 and the second end 212 are connected, the cross-section of the first needle segment 21 is circular and the diameter gradually increases from the first end 211 to the second end 212, the cross-section of the second needle segment 22 is circular and the diameter gradually decreases from the third end 221 to the fourth end 222, and the substrate 1 is connected to the fourth end 222.

[0029] In this embodiment, the needle body 2 has a two-end structure, namely a first needle segment 21 and a second needle segment 22, wherein the first needle segment 21 gradually increases from the first end 211 to the second end 212, and the second needle segment 22 gradually decreases from the third end 221 to the fourth end 222, forming a needle body 2 that is thin at both ends and thick in the middle. When the needle body 2 penetrates the skin, the first segment structure can penetrate smoothly, and the second segment structure can provide effective restraint force to prevent the microneedle from slipping out during use, thereby improving the efficiency and stability of drug delivery.

[0030] In some embodiments, the substrate 1 , the first needle segment 21 and the second needle segment 22 are an integral structure.

[0031] In some embodiments, the base sheet 1 , the first needle segment 21 and the second needle segment 22 are an integral structure formed by a thermoplastic stretching process.

[0032] In this embodiment, the substrate 1, the first needle segment 21, and the second needle segment 22 are formed by a thermoplastic stretching process. In other words, the substrate 1, the first needle segment 21, and the second needle segment 22 in this application are formed by thermoplastic stretching of a single raw material. The thermoplastic stretching process reduces the difficulty of producing irregularly shaped microneedles and increases the production yield of irregularly shaped microneedles.

[0033] In some embodiments, the diameter of the fourth end 222 is less than or equal to 500 μm.

[0034] In this embodiment, the diameter of the fourth end 222 is greater than or equal to 50 μm and less than or equal to 500 μm, so as to ensure that the microneedle can be subjected to the pressure applied by the substrate, thereby enabling the microneedle to penetrate the skin. If the diameter of the fourth end 222 is too small, the microneedle may break at the fourth end 222, resulting in the microneedle being unable to penetrate the skin. If the diameter of the fourth end 222 is too large, it is not easy for the skin to recover.

[0035] In some embodiments, the sum of the heights of the first needle segment 21 and the second needle segment 22 is greater than or equal to 25 μm and less than or equal to 2000 μm.

[0036] In this embodiment, the sum of the heights of the first needle segment 21 and the second needle segment 22 can be adjusted as needed. The sum of the heights of the first needle segment 21 and the second needle segment 22 is greater than or equal to 25 μm and less than or equal to 2000 μm. If the sum of the heights of the first needle segment 21 and the second needle segment 22 is too large, the microneedle may penetrate the blood vessels. The microneedles are mainly targeted at the skin, while if the sum of the heights is too small, the microneedle may not be able to pierce the skin surface, resulting in the drug being unable to penetrate the skin.

[0037] In some embodiments, the ratio of the height of the first needle segment 21 to the height of the second needle segment 22 is greater than or equal to 1 and less than or equal to 10.

[0038] In this embodiment, the ratio of the height of the first needle segment 21 to the height of the second needle segment 22 is greater than or equal to 1 and less than or equal to 10. Since the first needle segment 21 is used to pierce the skin, and in this application, the first needle segment 21 is formed through a thermoplastic stretching process, the height of the first needle segment 21 cannot be shorter than the height of the second needle segment 22. If the height of the first needle segment 21 is shorter than the second needle segment 22, the first needle segment 21 may not be able to pierce the skin. Therefore, the height of the first needle segment 21 must be greater than or equal to the height of the second needle segment 22. At the same time, the greater the height of the first needle segment 21, the stronger its ability to pierce the skin and the better the drug absorption performance. The second needle segment 22 should be long enough to ensure that the third end can successfully penetrate the skin.

[0039] In some embodiments, a ratio of the height of the first needle segment 21 to the diameter of the third end 221 is greater than or equal to 5.

[0040] In some embodiments, the ratio of the height of the second needle segment 22 to the diameter of the third end 221 is less than or equal to 1.

[0041] In this embodiment, the shape of the needle is defined by the ratio of the height of the first needle segment 21 and the height of the second needle segment 22 to the diameter of the third end 221. The first needle segment should be long and slender to ensure that it can penetrate the skin, while the second needle segment should be short and thick to ensure that it will not be damaged by pressure during preparation and penetration.

[0042] According to a second aspect of the present invention, a device for preparing a shaped microneedle patch is provided, for preparing the shaped microneedle patch according to the first aspect. The device comprises: a first heating plate 3, on which are provided a plurality of bosses 31 spaced apart; and a second heating plate 4, disposed corresponding to the first heating plate 3 and used to secure the raw materials for the shaped microneedle patch.

[0043] In this embodiment, the preparation device of the special-shaped microneedle patch includes: a first heating plate 3, on which a plurality of bosses 31 are provided, and the plurality of bosses 31 are distributed at intervals; a second heating plate 4, which is arranged corresponding to the first heating plate 3, and the second heating plate 4 is used to fix the raw materials of the special-shaped microneedle patch. Heating is performed by the first heating plate 3 and the second heating plate 4, so that the temperature of the raw materials on the second heating plate 4 exceeds its glass transition temperature and is lower than the melting point, and the material softens but does not melt. The temperature of the first heating plate should be higher than the temperature of the second heating plate to ensure that only the material at the boss has better fluidity and the rest of the raw materials can remain on the second heating plate without falling off. The first heating plate 3 has a boss 31, and the positional relationship between the first heating plate 3 and the second heating plate 4 is such that the glassy raw materials are thermoplastically stretched and deformed, thereby forming the special-shaped microneedle patch of the first aspect of the present application.

[0044] In some embodiments, a groove 32 is provided on an end surface of one end of the boss 31 . The cross section of the groove 32 is circular and the diameter gradually decreases from one end of the boss 31 to the other end of the boss 31 .

[0045] In this technical solution, a groove 32 is provided on the end face of one end of the boss 31. The cross section of the groove 32 is circular and the diameter gradually decreases from one end of the boss 31 to the other end of the boss 31. The glassy raw material will flow into the groove 32, thereby realizing the first shaping process.

[0046] In some embodiments, the cross section of the groove 32 is circular, and the diameter of the groove 32 at the end surface of the boss 31 is the same as the diameter of the third end 221 .

[0047] In this embodiment, the cross-section of the groove 32 is circular, and the diameter of the groove 32 at the end face of the boss 31 is the same as the diameter of the third end 221. Through process improvements, the diameter of the groove 32 at the end face of the boss 31 is the same as the diameter of the third end 221, thereby better controlling the diameter of the third end 221.

[0048] In some embodiments, the preparation device of the special-shaped microneedle patch also includes: a distance adjustment device 5, the first heating plate 3 and the second heating plate 4 are fixed on the distance adjustment device 5, and the distance adjustment device 5 is used to adjust the distance between the first heating plate 3 and the second heating plate 4; a flipping device 6, the distance adjustment device 5 is arranged on the flipping device 6, and the flipping device 6 is used to adjust the upper and lower positions of the first heating plate 3 and the second heating plate 4.

[0049] The steps of preparing the special-shaped microneedle patch by the above-mentioned special-shaped microneedle patch preparation device are as follows: Figure 2As shown, first, a second heating plate 4 made of metal and a first heating plate 3 with an array of pillars with inwardly concave ends are fabricated through precision machining. At high temperature, a drug-loaded polymer material, such as hyaluronic acid, polyglycolic acid, or maltose, is scraped onto the second heating plate and cooled to solidify, spreading the material flat and adhering to the second base plate.

[0050] Step 1, such as Figure 3 As shown, the positions of the first heating plate 3 and the second heating plate 4 are inverted, and the temperatures of the first heating plate 3 and the second heating plate 4 are heated to a temperature range between the glass transition temperature and the melting point of the polymer sheet. The temperature of the first heating plate should be higher than that of the second heating plate to ensure that only the material at the boss has better fluidity and the rest of the raw materials can remain on the second heating plate without falling off. The polymer flows slowly, and after filling the groove 32 under the action of gravity and adsorption force, the second heating plate 4 is slowly pulled vertically upward to form a columnar structure with a small top and a large bottom and an inward concave middle between the bottom plate and the heating plate. After pulling to a certain height, the temperature is lowered to stabilize the initially formed microneedle structure.

[0051] In this step, the heating plate temperature is precisely controlled between the material's glass transition temperature and melting point to ensure the material maintains a suitable flow state, thereby ensuring the desired microneedle column structure is formed during the pulling process. The slow pulling speed of the base plate ensures that the material deforms evenly during the stretching process, forming a stable column with an inward-concave center.

[0052] Step 2, such as Figure 4 As shown, the entire structure is turned over. Only the first heating plate 3 is heated to a suitable temperature range, and the first heating plate 3 is moved downward to form a segmented protruding structure in the middle of the material, ensuring that the segmented protruding structure has the required shape and size.

[0053] Step three, such as Figure 5 As shown, the base plate is then pulled upward to form the microneedle tip. As the pulling process progresses, the temperature is gradually lowered to room temperature, separating the microneedle from the heating plate, ultimately forming a two-stage "Christmas tree" shaped microneedle.

[0054] The flipping process in this step ensures the stability of the overall structure. Reheating the first and second heating plates 3 and 4 re-plasticizes the material, ensuring a sharp tip during subsequent pulling. Slowly pulling and simultaneously lowering the temperature allow the microneedles to gradually solidify during formation, ultimately separating from the heating plates.

[0055] This flip-pull preparation method is not only simple in process but also highly flexible. During the preparation process, the boss 31 always maintains contact with the microneedle, and there is no need for demolding and realignment operations in the middle. It is easy to automate and has a high success rate. By replacing heating plates of different shapes and sizes, various forms of special-shaped microneedles can be prepared to meet different application requirements. The length, width and ratio of the two-stage structure of the microneedle can be precisely controlled by adjusting the parameters of the heating plate and the boss 31. This efficient and convenient preparation method can significantly improve the production efficiency and quality of special-shaped microneedles, giving it broad application prospects in the fields of medicine and beauty.

[0056] like Figure 6 As shown, in Figure 6 The viscosity and vitrification of microneedles at different temperatures are described in a. Figure 6 In b, it is shown that the microneedle structure formed by continuous single drawing at point b is in the shape of a bat. Figure 6 In c, it is shown that the microneedle structure formed by continuous single drawing at point c is cylindrical. Figure 6 d records that the special-shaped microneedles in this application are formed by initial stretching at point b and main stretching at point c.

[0057] Furthermore, this two-stage "Christmas tree" structure of the microneedle offers significant advantages in practical use. Once the microneedle penetrates the skin, the first stage ensures smooth penetration, while the second stage provides effective restraint, preventing the microneedle from slipping out during use, thereby improving the efficiency and stability of drug delivery. This structural design not only enhances the functionality of the microneedle but also increases its safety and reliability, further promoting the development and application of microneedle technology.

[0058] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A special-shaped microneedle patch, characterized in that: include: substrate; A plurality of needle bodies include a first needle segment and a second needle segment, wherein the first needle segment includes a first end and a second end, the second needle segment includes a third end and a fourth end, the third end is connected to the second end, the cross-section of the first needle segment is circular and the diameter gradually increases from the first end to the second end, the cross-section of the second needle segment is circular and the diameter gradually decreases from the third end to the fourth end, and the substrate is connected to the fourth end.

2. The special-shaped microneedle patch according to claim 1, characterized in that The base sheet, the first needle segment and the second needle segment are an integrated structure.

3. The special-shaped microneedle patch according to claim 2, characterized in that: The first needle segment and the second needle segment are thermoplastic stretched parts formed by the base sheet through a thermoplastic stretching process.

4. The special-shaped microneedle patch according to any one of claims 1 to 3, characterized in that: The diameter of the fourth end is less than or equal to 500 μm.

5. The special-shaped microneedle patch according to any one of claims 1 to 3, characterized in that: The sum of the heights of the first needle segment and the second needle segment is greater than or equal to 25 μm and less than or equal to 2000 μm.

6. The special-shaped microneedle patch according to any one of claims 1 to 3, characterized in that: The ratio of the height of the first needle segment to the height of the second needle segment is greater than or equal to 1 and less than or equal to 10; and / or The ratio of the height of the first needle segment to the diameter of the third end is greater than or equal to 5; and / or A ratio of the height of the second needle segment to the diameter of the third end is less than or equal to 1.

7. A device for preparing a special-shaped microneedle patch, characterized in that: For preparing the special-shaped microneedle patch according to any one of claims 1 to 6, the preparation device of the special-shaped microneedle patch comprises: a first heating plate, wherein a plurality of bosses are provided on the first heating plate, and the bosses are spaced apart; The second heating plate is arranged corresponding to the first heating plate, and the second heating plate is used to fix the raw materials of the special-shaped microneedle patch.

8. The device for preparing a special-shaped microneedle patch according to claim 7, characterized in that: A groove is provided on the end surface of one end of the boss. The cross section of the groove is circular and the diameter gradually decreases from one end of the boss to the other end of the boss.

9. The device for preparing a special-shaped microneedle patch according to claim 8, characterized in that: The cross section of the groove is circular, and the diameter of the groove at the end surface of the boss is the same as the diameter of the third end.

10. The device for preparing a special-shaped microneedle patch according to claim 7, characterized in that: Also includes: a distance adjusting device, on which the first heating plate and the second heating plate are fixed, and the distance adjusting device is used to adjust the distance between the first heating plate and the second heating plate; A turning device, wherein the distance adjusting device is arranged on the turning device, and the turning device is used to adjust the upper and lower positions of the first heating plate and the second heating plate.

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