Manufacturing method and manufacturing device of special-shaped microneedle patch and special-shaped microneedle patch

Abstract

The invention provides a manufacturing method and a manufacturing device of a special-shaped microneedle patch and the special-shaped microneedle patch, and the manufacturing method of the special-shaped microneedle patch comprises the following steps: configuring a microneedle material; the microneedle material is suspended above the boss; heating the temperature of the microneedle material and the boss to a first temperature, wherein part of the microneedle material flows into the boss; cooling the microneedle material and the boss; inverting the cooled microneedle material and the boss; fixing the microneedle material; heating the microneedle material and the boss to a first temperature; enabling the boss to approach the microneedle material along the first direction; the boss is made to be far away from the microneedle material in the first direction, the temperature of the microneedle material and the boss is reduced till the microneedle material is separated from the boss, the special-shaped microneedle patch is formed, the manufacturing cost of the microneedle is greatly reduced through the method, and the microneedle can be produced in batches.

Description

Technical Field

[0001] The invention belongs to the field of medical treatment and cosmetology, and particularly relates to a method for manufacturing a special-shaped microneedle patch, a manufacturing device and 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 high top. Due to their shape, they are easily squeezed out of the skin tissue after being applied to the skin and cannot be stably maintained in the skin. Some microneedles have been equipped with multi-level structures, barbs, swelling structures, etc., which can effectively prevent the microneedles from sliding out after they penetrate the skin. However, they require complex and expensive processes such as photolithography and 4D printing, and do not require manufacturing solutions such as multi-step curing that are prone to repeatability errors, nor do they require specific magnetic materials, which limits their mass production 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 manufacturing device for the special-shaped microneedle patch have become technical problems that need to be solved urgently. Summary of the invention

[0004] An embodiment of the present invention provides a method for manufacturing a special-shaped microneedle patch.

[0005] The embodiment of the present invention provides a device for manufacturing a special-shaped microneedle patch.

[0006] An embodiment of the present invention provides a special-shaped microneedle patch.

[0007] In view of this, the first aspect of the present application provides a method for manufacturing a special-shaped microneedle patch, comprising: configuring a microneedle material; suspending the microneedle material above a boss; heating the temperature of the microneedle material and the boss to a first temperature, and allowing part of the microneedle material to flow into the boss; cooling the microneedle material and the boss; inverting the cooled microneedle material and the boss; fixing the microneedle material; heating the microneedle material and the boss to a first temperature; moving the boss closer to the microneedle material along a first direction; moving the boss away from the microneedle material along a first direction, and lowering the temperature of the microneedle material and the boss until the microneedle material and the boss are separated to form a special-shaped microneedle patch.

[0008] In some technical solutions, the microneedle material includes one or more of hyaluronic acid, polyglycolic acid and maltose.

[0009] In some technical solutions, the first temperature is greater than or equal to the glass transition temperature of the microneedle material, and less than or equal to the melting point temperature of the microneedle material.

[0010] According to a second aspect of the present invention, a manufacturing device for a special-shaped microneedle patch is provided, which is used to implement the manufacturing method of the special-shaped microneedle patch as in the first aspect. The manufacturing device for the special-shaped microneedle patch comprises: a first heating plate, on which a plurality of bosses are arranged, and the plurality of bosses are distributed at intervals; a second heating plate, which 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.

[0011] In some technical solutions, a groove is arranged 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.

[0012] 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.

[0013] In some technical schemes, the manufacturing 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.

[0014] The third aspect of the present invention provides a special-shaped microneedle patch, which is manufactured using the manufacturing method of the special-shaped microneedle patch as in the first aspect. The special-shaped microneedle patch includes: 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.

[0015] In some technical solutions, the base sheet, the first needle segment and the second needle segment are an integrated structure.

[0016] 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.

[0017] In some technical solutions, the diameter of the fourth end is less than or equal to 500 μm.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] The beneficial effects brought by the present invention are as follows: the raw material is fixed on the second heating plate; the first heating plate and the second heating plate are heated so that the temperature of the raw material is between the glass transition temperature and the melting point temperature, 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 reduce the temperature of the first heating plate and the second heating plate, so that the temperature of the raw material is lower than the glass transition temperature. The first heating plate, the raw material and the second heating plate are turned 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 then the first heating plate is moved upward to form the first needle segment, and then cooled, so that the shape of the special-shaped microneedle is stable. That is, the special-shaped microneedle patch disclosed in this application does not require complex and expensive processes such as lithography and 4D printing, does not require multi-step curing and other manufacturing schemes that are prone to repeatability errors, does not require specific magnetic materials, etc., only the corresponding thermoplastic stretching boss needs to be manufactured, which greatly reduces the manufacturing cost of the microneedle, so that the microneedle can be produced in batches, and at the same time, the special-shaped microneedle in this application has the largest area at the junction of the first needle segment and the second needle segment, which can prevent the microneedle from slipping out in the skin tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A schematic diagram showing a process of manufacturing a special-shaped microneedle patch according to an embodiment of the present invention; Figure 2 A schematic diagram showing the structure of a special-shaped microneedle patch according to an embodiment of the present invention; Figure 3 One of the structural schematic diagrams showing a manufacturing device for a special-shaped microneedle patch according to an embodiment of the present invention; Figure 4 A second structural schematic diagram showing a device for manufacturing a special-shaped microneedle patch according to an embodiment of the present invention; Figure 5 A third structural schematic diagram showing a device for manufacturing a special-shaped microneedle patch according to an embodiment of the present invention; Figure 6 A fourth structural schematic diagram of a device for manufacturing a special-shaped microneedle patch according to an embodiment of the present invention.

[0024] in, Figures 2 to 6 The corresponding relationship between the reference numerals and component names is as follows: 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

[0025] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution in the embodiment of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiment of the present invention. Obviously, the described embodiment is a part of the embodiment of the present invention, not all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0026] The present invention provides a method for manufacturing a special-shaped microneedle patch, such as Figure 1 As shown, including: S101: preparing microneedle materials; S102: suspending the microneedle material above the boss; S103: heating the microneedle material and the boss to a first temperature, so that part of the microneedle material flows into the boss; S104: cooling the microneedle material and the boss, and inverting the cooled microneedle material and the boss; S105: fixing the microneedle material, and heating the microneedle material and the boss to a first temperature; S106: moving the boss closer to the microneedle material along the first direction; S107: moving the boss away from the microneedle material along a first direction, and lowering the temperature of the microneedle material and the boss until the microneedle material and the boss are separated to form a special-shaped microneedle patch.

[0027] In this embodiment, the microneedle material includes: one or more of hyaluronic acid, polyglycolic acid and maltose. Relevant drugs can be mixed in the microneedle material so that the drugs can act directly on the skin.

[0028] In this embodiment, the first temperature is greater than or equal to the glass transition temperature of the microneedle material and less than or equal to the melting point of the microneedle material, so that the microneedle material has a certain fluidity although it is not melted, and part of the microneedle material will flow onto the boss under the action of gravity and attraction.

[0029] According to a second aspect of the present invention, a device for manufacturing a special-shaped microneedle patch is provided, such as Figures 2 to 6 As shown, it is used to implement the manufacturing method of the special-shaped microneedle patch according to the first aspect. The manufacturing device of the special-shaped microneedle patch includes: a first heating plate 3, on which a plurality of bosses 31 are arranged, 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.

[0030] In this embodiment, the manufacturing device of the special-shaped microneedle patch includes: a first heating plate 3, on which a plurality of bosses 31 are arranged, 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. The first heating plate 3 and the second heating plate 4 are heated 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 adjusted, so that the glassy raw materials are thermoplastically stretched and deformed, thereby forming a special-shaped microneedle patch.

[0031] In some embodiments, a groove 32 is disposed 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 .

[0032] 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.

[0033] 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 .

[0034] 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 improvement, 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.

[0035] In some embodiments, the manufacturing device of the special-shaped microneedle patch also includes: a distance adjustment device 5, on which the first heating plate 3 and the second heating plate 4 are fixed, 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, on which the distance adjustment device 5 is arranged, 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.

[0036] The third aspect of the present invention provides a special-shaped microneedle patch, which is manufactured by the manufacturing method of the special-shaped microneedle patch of the first aspect, such as Figures 2 to 6As 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.

[0037] 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 with thin ends and a thick middle. When the needle body 2 penetrates the skin, the first segment structure can penetrate smoothly, and the second segment structure can provide effective restraining force to prevent the microneedle from slipping out during use, thereby improving the efficiency and stability of drug delivery.

[0038] In some embodiments, the substrate 1 , the first needle segment 21 and the second needle segment 22 are an integrated structure.

[0039] 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.

[0040] In this embodiment, the substrate 1, the first needle segment 21 and the second needle segment 22 are formed by a thermoplastic stretching process, that is, the substrate 1, the first needle segment 21 and the second needle segment 22 in the present application are formed by thermoplastic stretching of a raw material. The thermoplastic stretching process reduces the difficulty of producing special-shaped microneedles and improves the production output of special-shaped microneedles.

[0041] In some embodiments, the diameter of the fourth end 222 is less than or equal to 500 μm.

[0042] 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, while if the diameter of the fourth end 222 is too large, it is not easy for the skin to recover.

[0043] 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.

[0044] 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 into 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 penetrate the skin surface, resulting in the inability of the drug to penetrate into the skin.

[0045] 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.

[0046] 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 the first needle segment 21 is formed by a thermoplastic stretching process in the present application, the height of the first needle segment 21 will not be shorter than the height of the second needle segment 22. If the height of the first needle segment 21 is shorter than that of the second needle segment 22, the first needle segment 21 may not have the ability to pierce the skin. Therefore, the height of the first needle segment 21 should 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 absorption performance of the drug. The second needle segment 22 should be long enough to ensure that the third end can smoothly penetrate the skin.

[0047] In some embodiments, the 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.

[0048] 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.

[0049] In this embodiment, the shape is defined by defining 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 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 the preparation and penetration of the skin.

[0050] The steps of manufacturing the special-shaped microneedle patch by the above-mentioned special-shaped microneedle patch manufacturing device are as follows: Figure 3 As shown, first, a second heating plate 4 made of metal and a first heating plate 3 with a column array with inwardly concave ends are manufactured through precision machining. At high temperature, a polymer material such as hyaluronic acid, polyglycolic acid or maltose loaded with drugs is scraped and coated on the second heating plate, and cooled and solidified, so that the raw materials are spread flat and adhered to the second bottom plate.

[0051] Step 1, such as Figure 4As 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 depression in the 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.

[0052] In this step, the temperature of the heating plate can be accurately controlled between the glass transition temperature and the melting point of the material to ensure that the material is in a suitable flow state, thereby ensuring that the desired microneedle column structure is formed during the pulling process. The slow pulling speed of the bottom plate can ensure that the material is uniformly deformed during the stretching process, forming a stable column with a concave middle.

[0053] Step 2, such as Figure 5 As shown, the whole 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, so that the material forms a protruding structure at the middle part of the segment, and the protruding structure at the segment has the required shape and size.

[0054] Step three, such as Figure 6 As shown, the bottom plate is finally pulled upward to form the tip structure of the microneedle. As the pulling process proceeds, the temperature is gradually lowered to room temperature, so that the microneedle is separated from the heating plate, and finally a special-shaped microneedle with a two-stage "Christmas tree" structure is formed.

[0055] The flipping process in this step can ensure the stability of the overall structure. The reheating of the first heating plate 3 and the second heating plate 4 makes the material enter a plastic state again, ensuring that a sharp needle tip can be formed in the subsequent pulling process. The operation of slowly pulling and lowering the temperature at the same time can gradually solidify the microneedles during the formation process and finally separate from the heating plate.

[0056] This flip-lift manufacturing method is not only simple in process but also highly flexible. During the manufacturing process, the boss 31 always keeps in 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 manufactured to meet different application requirements. The length, width and proportion 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 manufacturing 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.

[0057] In addition, this special-shaped microneedle with a two-stage "Christmas tree" structure has significant advantages in actual use. When the microneedle penetrates the skin, the first section of the structure can ensure that the microneedle penetrates smoothly, while the second section of the structure can provide effective restraint after penetrating the skin to prevent the microneedle from slipping out during use, thereby improving the efficiency and stability of drug delivery. This structural design not only improves the functionality of the microneedle, but also increases the safety and reliability of use, further promoting the development and application of microneedle technology.

[0058] The above are preferred embodiments 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 within the scope of protection of the present invention.

Claims

1. A method for manufacturing a special-shaped microneedle patch, characterized in that: include: Configure microneedle materials; suspending the microneedle material above the boss; Heating the microneedle material and the boss to a first temperature, so that part of the microneedle material flows into the boss; Cooling the microneedle material and the boss; Inverting the cooled microneedle material and the boss; fixing the microneedle material; heating the microneedle material and the boss to the first temperature; Placing the boss close to the microneedle material along a first direction; The boss is moved away from the microneedle material along a first direction, and the temperature of the microneedle material and the boss is lowered until the microneedle material and the boss are separated to form the special-shaped microneedle patch.

2. The method for manufacturing a special-shaped microneedle patch according to claim 1, characterized in that: The microneedle material includes: one or more of hyaluronic acid, polyglycolic acid and maltose.

3. The method for manufacturing a special-shaped microneedle patch according to claim 1, characterized in that: The first temperature is greater than or equal to the glass transition temperature of the microneedle material and less than or equal to the melting point temperature of the microneedle material.

4. A device for manufacturing a special-shaped microneedle patch, characterized in that: A method for manufacturing a special-shaped microneedle patch according to any one of claims 1 to 3, wherein the manufacturing device of the special-shaped microneedle patch comprises: A first heating plate, wherein a plurality of bosses are arranged on the first heating plate, and the plurality of bosses are distributed at intervals; 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.

5. The manufacturing device of the special-shaped microneedle patch according to claim 4, characterized in that: A groove is arranged on the end surface of one end of the boss, the cross section of the groove is circular and the diameter of the groove gradually decreases from one end of the boss to the other end of the boss.

6. The manufacturing device of the special-shaped microneedle patch according to claim 5, 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.

7. The manufacturing device of the special-shaped microneedle patch according to claim 6, 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; The flipping device, the distance adjusting 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.

8. A special-shaped microneedle patch, characterized in that: The special-shaped microneedle patch is manufactured by the manufacturing method of any one of claims 1 to 3, wherein the special-shaped microneedle patch comprises: 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.

9. The special-shaped microneedle patch according to claim 8, characterized in that: The diameter of the fourth end is less than or equal to 500 μm.

10. The special-shaped microneedle patch according to claim 8 or 9, 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; and / or 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 a height of the second needle segment to a diameter of the third end is less than or equal to 1.

Images