MICRO NEEDLE PRODUCTION MOLD AND METHOD OF PRODUCING MICRO NEEDLES USING THE MOLD

Abstract

The invention relates to a mold (1) used in the production of hollow microneedles which can be used for subcutaneous injection and collection of liquid samples, and a microneedle production method (100) carried out using the mold (1).

Description

1 TARIFF MICRO NEEDLE PRODUCTION MOLD AND MICRO NEEDLE PRODUCTION USING THE MOLD. METHOD Technical Area 5 The invention is for the purpose of subcutaneous injection and collection of fluid samples. a mold and die used in the production of hollow microneedles that can be used It relates to the microneedle production method carried out using [method name]. Previous Technique Microneedles available on the market are generally metallic and solid in structure. Stainless steel, titanium, and nickel are most commonly used in their production. However, Stainless steel can cause adverse effects in the body due to its high corrosion rate. This can open the door. Although titanium alloys are preferred in this case, their costs are quite high. The levels are high. Nickel, however, can cause allergic reactions in some people. Metal microneedles are commonly used in direct metal laser sintering, laser cutting, and laser applications. ablation, etching, electroplating, hot embossing, and metal injection They are produced using methods such as molding. However, these methods are multi-stage and take 20 years. It requires high device dependency. Polymer materials, on the other hand, have superior properties. Thanks to its economic advantages, it is attracting increasing interest in the production of microneedles. And when evaluated from a safety perspective, polymers are more suitable for large-scale production. It is suitable and offers advantages such as low cost and ease of processing. Solid The most common manufacturing method for polymeric microneedles is micromolding. 25 Although it is almost a single-step process, this method can be used to create hollow micro-structures. A needle structure cannot be formed, and additional centrifugation or vacuuming steps are required. This requires. In current techniques, hollow polymeric microneedles are generally used. They are produced using photolithography methods (e.g., UV photolithography, etching). However, these methods involve long, complex processes and costly facilities like cleanrooms. This requires facilities. Alternatively, simpler methods such as solvent casting can also be used. 2 is used; however, in these methods, the tip or base of the needles is usually It becomes closed. Additional processes such as laser cutting or sanding can be used to open the closed sections. Processes are applied, which can damage the structure of the needles and the production process. It prolongs it. For these reasons, a new production method is needed to address the shortcomings of existing methods. A pattern and method are needed. 5 United States Regulation US20130116523A1, which is included in the known state of the art. The production method described in the patent document involves a viscous material being formed. starting with surface coating, followed by metal plating, microstructure formation, by emptying this structure, a hollow microstructure is obtained and in the final stage, a micro-needle 10 A multi-stage process is described, culminating in production. Throughout the process... coating thickness, frame diameter, temperature, removal rate, and coating thickness, etc. The parameters can be adjusted. In contrast, the proposed method only allows for adjustment of the parameters. The coating process involves applying polymer material; any metal coating, There is no microneedle production or microstructure removal step. Coating 15 After that, the mold is simply removed. Brief Description of the Invention The purpose of this invention is to enable subcutaneous injection and fluid sample collection. 20 a mold used in the production of hollow microneedles that can be used for this purpose and microneedle production method carried out using a mold to accomplish. Another aim of this invention is to improve the traditional methods in the micro-needle production process. By eliminating its long, costly, and multi-stage structure, it becomes a single-step, fast, and efficient process. The aim is to offer a low-cost production option. 3 Detailed Description of the Invention The "Micro Needle Production Mold" was developed to achieve the purpose of this invention. The "Method of Producing Microneedles by Molding" is shown in the attached figure; this figure is: Figure 1. This is an exploded view of the mold that is the subject of the invention. Figure 2. A view of the mold that is the subject of the invention. Figure 3. A schematic view of the procedural steps involved in the invention. 1. Mold 10 2. Bottom part 3. Needle sequence 4. Upper part 15 for subcutaneous injection and fluid sample collection. The invention concerns a mold used in the production of hollow microneedles that can be used. (1); - at least one lower part in the shape of a cylinder with a cylindrical cavity in the center (2), - suitable shape and size to be placed in the gap in the center of the lower part (2) having, on it, vertically positioned polymeric hollow micro 20 at least one row of needles (3) and -placed on the lower part (2), with the lower part (2) having in its center at least in a cylindrical structure having a cavity with a diameter larger than the diameter of the cavity It includes an upper part (4). The subject of the invention is the lower part (2), upper part (4) and needle series (3) located in the mold (1) It acts as a support element that keeps it together, The series of needles (3) placed in the central gap with a tight fit in the vertical position It makes it stop. 4 The needle array (3) in the mold (1) which is the subject of the invention, on which is made of metal or titanium The product is a structure in which polymeric hollow microneedles are circularly aligned, It fits snugly into the gap (2) in the lower part. The upper part (4) in the mold (1) which is the subject of the invention, is placed on the lower part (2) 5 The bottom is secured with a clamp to keep it in place and ensure a watertight seal. The upper part (4) is fixed to the part (2). The upper part (4) holds the micro needles (3) in the needle array. It serves as a liquid reservoir for the solution that will come into contact with its outer surfaces. The upper part (4) is the same as or smaller than the diameter of the lower part (2), needle array (3) It has a larger diameter than its original diameter. 10 Method 100 The invention is a micro needle production method carried out using a mold (1). (100); 15 - After sterilizing the lower part (2) and the upper part (4), the lower part (4) of the upper part Placed on part (2) and centered on lower part (2) needle string (3) placement (101), - Preparation of polymer or monomer solution to be used for microneedles (102), 20 -the prepared solution, channels between the microneedles (3) in the needle array applied to the center in a controlled manner using a drip method and applied The solution spreads radially from the center outwards due to surface tension and capillarity. by wetting the surfaces of the micro-needles in the needle array (3) capillary effect / meniscus effect by holding the needles upwards (103), 25 -then, the total of the same solution was poured into the area located on the outer part of the needle array (3). The amount should not exceed the height of the micro-needle, meaning it will remain below the needle tips. microscopically, thanks to its application by drip or continuous pouring method the needle shafts are surrounded by the solution without the tips of the needles being closed (104), 30 -the solution surrounding the microneedle body is removed by thermal or chemical methods solidification (105) and - mechanical damage to the mold (1) of solidified polymeric hollow microneedles It includes the steps of leaving without seeing (106). The invention concerns the method to be used for polymer or microneedles (100) In step (102) of preparing the monomer solution, polycaprolactone (PCL), poly(lactic-co-glycolic acid) (PLGA), polyglycolic acid (PGA), poly(methyl methacrylate (PMMA), polystyrene (PS), polycarbonate (PC) and their derivatives or any of its copolymers; dichloromethane (DCM), chloroform, acetone, 10 volatile compounds such as tetrahydrofuran (THF), ethyl acetate, or mixtures thereof. A homogeneous polymer solution will be obtained in any of the solvents. It is dissolved in the concentration range of 5–25% (w / v) and then processed into a polymer or A monomer solution is obtained. In another application of the invention, polyethylene glycol diacrylate (PEGDA), 2-hydroxyethyl methacrylate (HEMA) and suitable acrylate 15 or methacrylate-based photopolymerizable liquid systems and these systems one of the suitable LAP, TPO or Irgacure series photoinitiators or any of them polymer or monomer by mixing any of these combinations a solution is obtained. The invention method involves the thermal or thermal treatment of the solution surrounding the (100) microneedle body. In the step of solidifying the outer surface of the micro needle by chemical methods (105), The surrounding rising solution is heated in a controlled oven at a temperature of 20–40°C. and / or solidification of the polymer and solvent by evaporation under light vacuum. The evaporation method is applied. In another application of the invention, micro 25 The solution around the needle is exposed to UV or visible light in the wavelength range of 365–405 nm. is exposed and the polymer undergoes free radical photopolymerization. solidification and in-situ formation of hollow micro-needle structure is provided. 6 Industrial Application of the Invention The invention relates to metal plating or high-technology production equipment. without the need for, only a polymer or monomer-based solution and low Obtaining hollow microneedles by using a costly mold (1) 5 This reduces production time and significantly lowers costs. Furthermore, because it contains no metal, the risk of allergic reactions or corrosion is eliminated. This provides a biocompatible, safe, and economical production method. The invention allows for the controlled operation of surface tension and 10 without the need for centrifugal force. It is based on the diffusion principle. The drop of solution deposited into the inner space of the needle array (3), It moves outwards with a radial vector from the point of impact. Mold (1) Positioning of the upper part (4) and the needle array (3) inside the solution simultaneously fills the spaces / channels between the needles through gravity and capillary effects. It ensures that it fills. The area outside the needle array (3) controls the overflow of the liquid. 15 by preserving structural integrity. The subject of the meeting was “Micro Needle Production Mold (1) and around these basic concepts. A wide variety of applications for the "Mold (1) Micro Needle Production Method (100)". It is possible to develop it further, and the invention cannot be limited to the examples described here. 20 It is essentially as stated in the requests. 30

Claims

7 REQUESTS 1. For the purpose of administering subcutaneous injections and collecting fluid samples. used in the production of hollow microneedles that can be used; -a cylindrical base with a cylindrical cavity in the center. part (2), - a shape suitable for placement in the gap in the center of the lower part (2) and having dimensions, with a vertically positioned polymeric inner core at least one needle array (3) containing empty microneedles and -placed on the lower part (2), in the center of which the lower part (2) has 10 in a cylindrical structure having a cavity with a diameter larger than the diameter of the cavity a mold (1) characterized by containing at least one upper part (4).

2. Support that holds the upper part (4) and the needle string (3) together. He serves as a member and fits tightly into the gap in the center, 15 lower part that ensures the inserted needle array (3) remains in an upright position A pattern like the one in Claim 1 characterized by (2) (1).

3. Containing hollow polymeric microneedles made of metal or titanium. It is a structure in which it is circularly aligned and fits tightly into the gap (2) in the lower part 20 Characterized by the sequence of needles (3) that sits with the interlocking in Claim 1 or 2 a pattern like (1).

4. The lower part (2) must remain fixed in the position on which it is placed and 25 fixed to the bottom part (2) with the help of a clamp to ensure a seal. any of the above claims characterized by the upper part (4) a pattern like one of them (1).

5. Solution that will contact the outer surfaces of the (3) microneedles in the needle array. 30 characterized by the upper part (4) which serves as a liquid reservoir. a pattern like any of the above requests (1). 8 6. The diameter of the needle string (3) is the same as or smaller than the diameter of the lower part (2). the above is characterized by having a larger diameter upper part (4) a pattern like in any of the requests (1).

7. Performed using the mold (1); - After sterilizing the lower part (2) and the upper part (4), the upper part (4) The lower part (2) is placed on top of the lower part (2) and the needle string (3) is placed in the center of the lower part (2) placement (101), -10 of the polymer or monomer solution to be used for microneedles preparation (102), -the prepared solution between the microneedles (3) in the needle array by dripping into the center of the channels in a controlled manner application and radial distribution of the applied solution from the center outwards. spreading and thanks to surface tension and capillarity, the 15 located in the needle array (3) By wetting the surfaces of micro-needles, via capillary action / meniscus action holding upwards along the needles (103), -then, the same solution was applied to the area on the outside of the needle array (3) The total amount will not exceed the height of a micro-needle, i.e., the needle tips. by drip or continuous pouring in an amount that will remain below 20 Thanks to this application, the tips of the micro-needles remain open, leaving only the needle itself intact. the body being surrounded by solution (104), -the solution surrounding the microneedle body is removed by thermal or chemical methods solidification (105) and -the solidified polymeric hollow microneedles mechanically removed from the mold (1) 25 characterized by including the steps of leaving without damage (106) a micro needle production method (100).

8. Polymer or monomer solution to be used for microneedles. In the preparation step (102), polycaprolactone (PCL), poly(lactic-co-30 glycolic acid) (PLGA), polyglycolic acid (PGA), poly(methyl methacrylate) 9 (PMMA), polystyrene (PS), polycarbonate (PC) and their derivatives or any of its copolymers; dichloromethane (DCM), chloroform, acetone, tetrahydrofuran (THF), ethyl acetate or mixtures thereof a homogeneous polymer solution in any of the volatile solvents 5 to be obtained in the concentration range of 5–25% (w / v). a method like the one in Claim 7 characterized by its dissolution (100).

9. Polymer or monomer solution to be used for microneedles. In the preparation step (102), polyethylene glycol diacrylate (PEGDA), 2- Hydroxyethyl methacrylate (HEMA) and suitable acrylate or methacrylate-based 10 Photopolymerizable liquid systems and LAP (Light Anti-Corrosion) compatible with these systems, One of the TPO or Irgacure series photo initiators or these characterized by mixing any of its combinations A method like the one in claim 7 (100).

10. The solution surrounding the microneedle body is removed by thermal or chemical methods. in the solidification step (105) by surrounding the outer surface of the micro needle the rising solution is kept at a temperature of 20–40°C under controlled oven conditions and / or Solidification of the polymer and solvent by evaporation under slight vacuum. 20 as in Claim 7, characterized by the application of the evaporation method. a method (100).

11. The solution surrounding the microneedle body is removed by thermal or chemical methods. In the solidification step (105), the solution around the micro needle is 365–405 nm exposed to UV or visible light within the wavelength range and free 25 Solidification of the polymer by radical photopolymerization and hollow microneedle Claim 7, characterized by the in-situ creation of the structure such a method (100).

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