A special-shaped medical adhesive tape and a preparation method thereof

Abstract

The application belongs to the field of medical adhesive tape, and discloses a special-shaped medical adhesive tape and a preparation method thereof, which comprises a special-shaped base material layer, a low-sensitivity adhesive layer and a special-shaped release layer arranged in sequence from bottom to top; the special-shaped base material layer is prepared from the following raw materials: modified polylactic acid-caprolactone blend 50-70 parts, breathable cotton fiber 20-30 parts, nano silicon dioxide 1-3 parts, antibacterial agent solution 5-10 parts and moisturizing agent emulsion 8-15 parts; the low-sensitivity adhesive layer is prepared from the following raw materials: modified hyaluronic acid-chitosan composite adhesive 30-50 parts, acrylate copolymer 15-25 parts, menthol solution 3-5 parts and crosslinking agent 1-2 parts; and the problems of poor adhesion, high risk of sensitization, unbalanced air permeability and moisturizing and process limitation of the traditional adhesive tape are solved.

Description

Technical Field

[0001] This invention relates to the field of medical tape technology, specifically to an irregularly shaped medical tape and its preparation method. Background Technology

[0002] Medical tape is a core consumable used in clinical medicine to fix dressings, catheters, or protect wounds. Traditional medical tapes are mostly flat and have the following technical defects:

[0003] Poor fit: The human body, joints, face and other parts are curved or irregularly shaped, and flat tape is difficult to fit the skin contour completely. It is easy to peel up and bulge, which will lead to fixation failure (such as catheter displacement and dressing fall off). Especially when the joint moves, the relative friction between the tape and the skin will further aggravate the problem of fit failure.

[0004] High risk of allergies: Most existing adhesive tapes use natural rubber or ordinary acrylic esters. Rubber components can easily cause skin allergies, and some adhesives contain formaldehyde releasers. Long-term contact can irritate the skin, causing redness, swelling, and itching.

[0005] Imbalance between breathability and moisture retention: Traditional adhesive tape substrates are mostly made of dense materials such as polyethylene and polypropylene, which have low breathability. Long-term use can easily lead to stuffy and sweaty skin, causing maceration dermatitis. Although some breathable substrates improve breathability, they lack moisturizing function, which can cause the skin around the wound to become dry and cracked, affecting healing.

[0006] Insufficient mechanical properties: Some tapes use low-strength substrates in pursuit of a good fit, which are prone to tearing during joint movement; while high-strength substrates lack elasticity and cannot adapt to the dynamic deformation of the skin, resulting in poor comfort.

[0007] Therefore, in order to solve the above problems, a medical tape with irregular structure adaptation, low sensitivity, breathability and moisture retention, and stable mechanical properties with synergistic optimization is proposed. Summary of the Invention

[0008] To address the problems of poor adhesion, high risk of allergies, imbalance between breathability and moisture retention, and limitations in the manufacturing process of traditional medical tapes, this invention provides a shaped medical tape and its preparation method. By designing a three-layer structure consisting of a shaped substrate layer, a low-allergenic adhesive layer, and a shaped release layer, optimizing the raw material composition of each layer, and combining processes such as 3D calendering and laser finishing, the tape achieves precise adhesion to the curved surfaces of the human body. At the same time, it also possesses low allergenicity, high breathability, long-lasting moisture retention, and stable mechanical properties, meeting the needs of use in complex clinical settings.

[0009] To achieve the above objectives, the present invention provides the following technical solution:

[0010] The technical solution provided by this invention is:

[0011] A shaped adhesive tape includes a shaped substrate layer, a low-sensitivity adhesive layer, and a shaped release layer arranged sequentially from bottom to top;

[0012] The irregularly shaped substrate layer is prepared from the following raw materials: 50-70 parts of modified polylactic acid-caprolactone blend, 20-30 parts of breathable cotton fiber, 1-3 parts of nano-silica, 5-10 parts of antibacterial agent solution (the antibacterial agent solution is prepared by dissolving polyhexamethylene guanidine hydrochloride in deionized water, with a concentration of 50-80 g / L), and 8-15 parts of moisturizing emulsion (the moisturizing emulsion is prepared by dispersing sodium hyaluronate in glycerin, with a concentration of 80-120 g / L).

[0013] The low-sensitivity adhesive layer is prepared from the following raw materials: 30-50 parts of modified hyaluronic acid-chitosan composite adhesive, 15-25 parts of acrylate copolymer, 3-5 parts of menthol solution (menthol solution is prepared by dissolving menthol in ethanol, with a concentration of 30-50 g / L), and 1-2 parts of crosslinking agent (crosslinking agent is prepared by dissolving 1,4-butanediol diglycidyl ether in deionized water, with a concentration of 20-40 g / L).

[0014] The irregularly shaped release layer is a PET film coated with a release agent. The release agent is an organosilicon release agent dissolved in ethyl acetate, with a concentration of 15-25 parts and a coating thickness of 0.5-1 μm.

[0015] The thickness of the irregularly shaped substrate layer is 50-100μm, the thickness of the low-sensitivity adhesive layer is 20-40μm, and the thickness of the irregularly shaped release layer is 15-25μm.

[0016] Furthermore, the preparation method of the modified polylactic acid-caprolactone blend includes: mixing polylactic acid and polycaprolactone at a mass ratio of 3:1-5:1, adding 0.5%-1% of maleic anhydride grafting agent of the total mass of polylactic acid and polycaprolactone, melting and blending at 160-180℃ for 20-30 minutes, cooling and then pulverizing to a particle size of 100-200 mesh.

[0017] Furthermore, the pretreatment method for breathable cotton fibers includes: soaking the cotton fibers in a sodium hydroxide solution for 30-40 minutes (sodium hydroxide solution concentration is 20-30 g / L), rinsing them with deionized water until neutral, then soaking them in a silane coupling agent KH-560 solution for 20-25 minutes (silane coupling agent KH-560 solution concentration is 10-15 g / L), and drying them at 80-90℃ until the moisture content is ≤5%.

[0018] Furthermore, the preparation method of the modified hyaluronic acid-chitosan composite adhesive includes: dissolving hyaluronic acid in deionized water to prepare a hyaluronic acid solution with a concentration of 10-15 parts, dissolving chitosan in acetic acid solution to prepare a chitosan solution with a concentration of 8-12 parts, mixing the two solutions at a volume ratio of 2:1-3:1, adding 1%-2% of propylene oxide by mass of the mixed solution, stirring and reacting at 50-60℃ for 1-1.5 hours, and obtaining the composite adhesive after cooling.

[0019] A method for preparing irregularly shaped adhesive tape includes the following steps:

[0020] S1: Preparation of irregularly shaped substrate layer

[0021] S1-1: Weigh the modified polylactic acid-caprolactone blend, breathable cotton fiber, and nano silica according to the formula, add them to a twin-screw extruder, melt-blend at 150-170℃ for 15-20 minutes, and after extrusion, cast them into a flat film with a thickness of 50-100μm through a casting machine.

[0022] S1-2: Mix the antibacterial agent solution and the moisturizing emulsion evenly, and then spray the mixture evenly onto the surface of the flat film using a spraying device. The spraying amount is 5-8 g / m². 2 Dry at 80-85℃ for 5-10 minutes;

[0023] S1-3: The dried flat film is fed into a 3D irregular calender and calendered according to the preset biomimetic irregular structure. The arc bonding area has a curvature radius of 5-15mm, the elastic transition area has a width of 2-5mm, and the positioning notch depth is 3-8mm, to obtain an irregular substrate layer.

[0024] S2: Preparation of low-sensitivity adhesives

[0025] S2-1: Weigh the modified hyaluronic acid-chitosan composite adhesive and acrylate copolymer according to the formula, add them to a planetary mixer, and stir at 300-400 r / min for 15-20 minutes at 40-50℃.

[0026] S2-2: Add menthol solution and crosslinking agent, and continue stirring for 10-15 minutes to obtain a low-sensitivity adhesive;

[0027] S3: Composite Molding

[0028] S3-1: Use a micro-gravure coating machine to coat the low-sensitivity adhesive onto the non-calendered surface of the irregular substrate layer, with a coating thickness of 20-40μm, and dry at 60-70℃ for 8-12 minutes.

[0029] S3-2: Cut the PET film coated with release agent (release agent concentration 15-25g / L, coating thickness 0.5-1μm) according to the irregular contour to obtain the irregular release layer;

[0030] S3-3: Cover the surface of the low-sensitivity adhesive layer with the irregular release layer, and laminate it under a pressure of 0.1-0.2MPa for 3-5 minutes to obtain the semi-finished irregular tape;

[0031] S4: Finished Product Processing

[0032] S4-1: Use a laser positioning die-cutting machine to refine the outline of the semi-finished product and remove excess edges and corners;

[0033] S4-2: The refined finished product is sterilized using ethylene oxide at a dosage of 400-600 mg / L for 2-3 hours. After cooling, it is packaged to obtain the irregularly shaped adhesive tape.

[0034] Furthermore, the calendering temperature of the 3D irregular calendering machine in S1-3 is 70-80℃, the calendering pressure is 0.3-0.5MPa, the calendering speed is 5-10m / min, and an infrared temperature sensor is used to monitor the flat film temperature in real time during the calendering process, with temperature fluctuation controlled within ±2℃.

[0035] Furthermore, the coating speed of the S3-1 micro-gravure coating machine is 8-15m / min, the depth of the coating roller cells is 30-50μm, and the low-sensitivity adhesive needs to be preheated to 35-40℃ before coating to reduce viscosity fluctuations.

[0036] Furthermore, the laser power of the laser positioning die-cutting machine in S4-1 is 10-15W, the cutting speed is 20-30mm / s, and vacuum adsorption is used to fix the semi-finished product during the die-cutting process to avoid displacement during die-cutting.

[0037] Furthermore, the glass transition temperature of the acrylate copolymer in S2-1 is -20 to -10°C, and when it is dissolved in ethyl acetate to prepare a solution with a concentration of 40-60 g / L, the transmittance of the solution is ≥90%.

[0038] The beneficial effects of this technical solution are:

[0039] (1) The irregular substrate layer is formed by 3D calendering. The arc-shaped bonding area is adapted to the curvature of the human body surface (5-15mm). The elastic transition area can buffer the stress during joint movement. The positioning notch facilitates precise alignment of wounds or catheters, solving the problems of edge lifting and hollowing of traditional flat tape. The fixation stability is significantly improved, especially suitable for complex parts such as the knee joint and face.

[0040] (2) The low-sensitivity adhesive layer is based on modified hyaluronic acid-chitosan composite adhesive, combined with low-irritant acrylate copolymer; menthol solution can relieve skin irritation and avoid redness and itching caused by long-term use, while antibacterial solution inhibits the growth of pathogenic bacteria and reduces the risk of wound infection.

[0041] (3) The porous structure of breathable cotton fiber and the micropores of modified polylactic acid-caprolactone blend work together to make the air permeability of the substrate layer reach 500-800 mm / s, which can quickly expel skin sweat and avoid stuffiness and soaking; the sodium hyaluronate in the moisturizing emulsion forms a moisturizing film with glycerin, locks in skin moisture, prevents the skin around the wound from drying and cracking, and promotes wound healing.

[0042] (4) The modified polylactic acid-caprolactone blend is synergistically reinforced with cotton fiber. The tensile breaking strength of the substrate layer is ≥15MPa and the elongation at break is ≥120%, which can adapt to the dynamic deformation of joint movement. The low-sensitivity adhesive is modified with a crosslinking agent. After being placed in a high-temperature environment of 37℃ for 72 hours, the viscosity change rate is ≤10%, avoiding high-temperature degumming. At the same time, the peel strength is 5-8N / 25mm, taking into account both fixing force and easy peeling. Attached Figure Description

[0043] Figure 1 This is a schematic diagram of the preparation process of an irregularly shaped medical tape and its preparation method proposed in this invention. Detailed Implementation

[0044] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] The specific implementation process is as follows:

[0046] Example 1:

[0047] Please see Figure 1 The present invention provides a technical solution: an irregularly shaped medical tape and its preparation method, comprising the following raw material formula:

[0048] Irregular substrate layer: 300g modified polylactic acid-caprolactone blend, 125g breathable cotton fiber, 10g nano silica, 37.5g antibacterial agent solution, 60g moisturizing emulsion;

[0049] Low-sensitivity adhesive layer: 200g modified hyaluronic acid-chitosan composite adhesive, 100g acrylate copolymer (glass transition temperature -15℃, 92% transmittance of 50g / L ethyl acetate solution), 20g menthol solution, 7.5g crosslinking agent;

[0050] Irregularly shaped release layer: PET film (20μm thick) + release agent (20g / L, coating thickness 0.8μm), cut according to irregular contours;

[0051] Preparation of modified polylactic acid-caprolactone blend: Take 225g of polylactic acid and 75g of polycaprolactone (mass ratio 3:1), add 2g of maleic anhydride grafting agent (0.5% of total mass), specifically polypropylene grafted maleic anhydride (PP-g-MAH), melt-blend at 170℃ for 25 minutes, cool and pulverize to 150 mesh to obtain 300g of modified polylactic acid-caprolactone blend;

[0052] Pretreatment of breathable cotton fibers: Take 125g of cotton fibers (3-5mm in length), soak them in 25g / L sodium hydroxide solution for 35 minutes, rinse with deionized water until pH=7, then soak them in 12g / L silane coupling agent KH-560 solution for 22 minutes, and dry them at 85℃ until the moisture content is 4% to obtain breathable cotton fibers.

[0053] Preparation of modified hyaluronic acid-chitosan composite adhesive: Dissolve 6g of hyaluronic acid in 500mL of deionized water (12g / L) and 5g of chitosan in 500mL of 1% acetic acid solution (10g / L). Mix the two solutions at a volume ratio of 2.5:1, add 2.5g of propylene oxide (total mass of the mixture is 1.5%), stir and react at 55℃ for 1.2 hours, and after cooling, obtain 200g of modified hyaluronic acid-chitosan composite adhesive;

[0054] Preparation of antibacterial agent solution: Dissolve 24.375g of polyhexamethylene guanidine hydrochloride in 375mL of deionized water to prepare a 65g / L antibacterial agent solution, and take 37.5g for later use;

[0055] Preparation of moisturizing emulsion: Disperse 50g of sodium hyaluronate in 500mL of glycerin to prepare a 100g / L moisturizing emulsion, and take 60g for later use;

[0056] Preparation of menthol solution: Dissolve 8g of menthol in 200mL of ethanol to prepare a 40g / L menthol solution, and take 20g for later use;

[0057] Preparation of crosslinking agent: Dissolve 2.25g of 1,4-butanediol diglycidyl ether in 75mL of deionized water to prepare a 30g / L crosslinking agent, and take 7.5g for later use;

[0058] Preparation of release agent: Dissolve 1g of silicone release agent in 50mL of ethyl acetate to obtain 20g / L release agent for later use. The silicone release agent is a solvent-based medical grade polydimethylsiloxane (PDMS) release agent.

[0059] The preparation steps are as follows:

[0060] S1: Preparation of irregularly shaped substrate layer

[0061] S1-1: Add 300g of modified polylactic acid-caprolactone blend, 125g of breathable cotton fiber, and 10g of nano silica to a twin-screw extruder (feeding section 135℃, melting section 160℃, homogenization section 165℃, speed 300r / min), melt blend at 160℃ for 18 minutes, and cast at 165℃ to form a 75μm thick flat film.

[0062] S1-2: Mix 37.5g of antibacterial agent solution with 60g of moisturizing emulsion, and apply under high pressure airless spray (nozzle 0.8mm, pressure 0.25MPa) to the surface of a flat film (spraying amount 6.5g / m²). 2 Dry with hot air at 82℃ for 8 minutes (wind speed 1.5m / s);

[0063] S1-3: The flat film is fed into a 3D irregular calender (temperature 75℃, pressure 0.4MPa, speed 8m / min) and calendered into an irregular structure with an arc-shaped bonding area curvature radius of 10mm, an elastic transition area width of 3.5mm, and a positioning notch depth of 5mm. The temperature is controlled by infrared (75±2℃) to obtain an irregular substrate layer (thickness 75μm).

[0064] S2: Preparation of low-sensitivity adhesives

[0065] S2-1: 200g modified hyaluronic acid-chitosan composite adhesive, 100g acrylate copolymer, planetary mixer (nitrogen flow rate 0.4L / min), 45℃, 350r / min, stir for 18 minutes;

[0066] S2-2: Add 20g of menthol solution and 7.5g of crosslinking agent, and continue stirring for 12 minutes to obtain a low-sensitivity adhesive (viscosity 6500mPa·s at 25℃).

[0067] S3: Composite Molding

[0068] S3-1: Preheat the adhesive to 38°C, apply it to the non-calendered surface of the substrate using a microgravure coating machine (speed 12m / min, cell depth 40μm) to a thickness of 30μm, and dry at 65°C for 10 minutes (wind speed 2m / s).

[0069] S3-2: 20g / L release agent is coated onto a PET film (20μm thick), with a coating thickness of 0.8μm. The film is then dried at 75℃ for 4 minutes and cut into irregularly shaped release layers according to the substrate outline.

[0070] S3-3: The release layer covers the adhesive layer, and the mixture is laminated under a pressure of 0.15MPa for 4 minutes (28℃) to obtain a semi-finished product;

[0071] S4: Finished Product Processing

[0072] S4-1: Laser positioning die-cutting machine (power 12W, speed 25mm / s, suction force -0.07MPa) fine finishing, die-cutting accuracy ±0.08mm;

[0073] S4-2: Ethylene oxide sterilization (dosage 500mg / L, temperature 35℃, RH 50%) for 2.5 hours, 45℃ desorption for 10 hours, vacuum packaging to obtain the finished product;

[0074] This embodiment incorporates the component preparation steps. The modified polylactic acid-caprolactone blend is prepared at a mass ratio of 3:1, and the amount of maleic anhydride grafting agent is precisely controlled at 0.5% to ensure the compatibility of polylactic acid and polycaprolactone. The concentration and soaking time of the cotton fiber pretreatment solution meet the requirements to improve the interfacial bonding force with the blend. The modified hyaluronic acid-chitosan composite adhesive is mixed at a volume ratio of 2.5:1, and the amount of propylene oxide is 1.5%, balancing viscosity and low sensitivity. After multiplying the amount of each component by 5, the process parameters are adjusted accordingly. For example, the twin-screw speed of 300 r / min ensures uniform mixing of high-volume raw materials, and the 3D calendering temperature of 75℃ is adapted to the softening point of the substrate. The final performance indicators all meet clinical requirements.

[0075]

[0076] Test Results

[0077] Example 2:

[0078] Please see Figure 1 The present invention provides a technical solution: an irregularly shaped medical tape and its preparation method, comprising the following raw material formula:

[0079] Irregular substrate layer: 250g modified polylactic acid-caprolactone blend, 150g breathable cotton fiber, 5g nano silica, 25g antibacterial agent solution, 40g moisturizing emulsion;

[0080] Low-sensitivity adhesive layer: 150g modified hyaluronic acid-chitosan composite adhesive, 125g acrylate copolymer, 15g menthol solution, 5g crosslinking agent;

[0081] Shaped release layer: PET film (15μm thick) + release agent (15g / L, coating thickness 0.5μm);

[0082] Preparation of modified polylactic acid-caprolactone blend: Take 190g of polylactic acid and 60g of polycaprolactone (mass ratio 3.2:1), add 1.25g of maleic anhydride grafting agent (0.5% of total mass), melt-blend at 165℃ for 22 minutes, cool and pulverize to 120 mesh to obtain 250g of modified polylactic acid-caprolactone blend;

[0083] Pretreatment of breathable cotton fibers: Take 150g of cotton fibers, soak them in 22g / L sodium hydroxide solution for 32 minutes, rinse with deionized water until pH=7, then soak them in 10g / L silane coupling agent KH-560 solution for 20 minutes, and dry them at 82℃ until the moisture content is 4.5% to obtain breathable cotton fibers.

[0084] Preparation of modified hyaluronic acid-chitosan composite adhesive: Dissolve 3.75g of hyaluronic acid in 312.5mL of deionized water (12g / L), and dissolve 3g of chitosan in 375mL of 1% acetic acid solution (8g / L). Mix the two solutions at a volume ratio of 2:1, add 1.5g of propylene oxide (1% of the total mass of the mixture), stir and react at 52℃ for 1 hour, and after cooling, obtain 150g of modified hyaluronic acid-chitosan composite adhesive;

[0085] Preparation of antibacterial agent solution: Dissolve 12.5g of polyhexamethylene guanidine hydrochloride in 250mL of deionized water to prepare a 50g / L antibacterial agent solution, and take 25g for later use;

[0086] Preparation of moisturizing emulsion: Disperse 32g of sodium hyaluronate in 400mL of glycerin to prepare an 80g / L moisturizing emulsion, and take 40g for later use;

[0087] Preparation of menthol solution: Dissolve 4.5g of menthol in 150mL of ethanol to prepare a 30g / L menthol solution, and take 15g for later use;

[0088] Preparation of crosslinking agent: Dissolve 1g of 1,4-butanediol diglycidyl ether in 50mL of deionized water to prepare a 20g / L crosslinking agent, and take 5g for later use;

[0089] Preparation of release agent: Dissolve 0.375g of organosilicon release agent in 25mL of ethyl acetate to prepare a 15g / L release agent for later use;

[0090] The preparation steps are as follows:

[0091] S1: Preparation of irregularly shaped substrate layer

[0092] S1-1: 250g modified polylactic acid-caprolactone blend, 150g breathable cotton fiber, 5g nano silica, twin-screw extruder (feeding section 130℃, melting section 150℃, homogenization section 160℃, speed 250r / min), blend at 150℃ for 15 minutes, cast at 160℃ to form a 50μm flat film;

[0093] S1-2: Mix 25g of antibacterial agent solution and 40g of moisturizing emulsion, spray at a rate of 5g / m². 2 Dry at 80℃ for 5 minutes;

[0094] S1-3: 3D irregular calender (temperature 70℃, pressure 0.3MPa, speed 5m / min), calenders an irregular structure with a radius of curvature of 5mm in the arc bonding area, a width of 2mm in the elastic transition area, and a positioning notch depth of 3mm, with infrared temperature control (70±2℃), to obtain a 50μm thick substrate layer;

[0095] S2: Preparation of low-sensitivity adhesives

[0096] S2-1: 150g modified hyaluronic acid-chitosan composite adhesive, 125g acrylate copolymer, stirred at 40℃ and 300r / min for 15 minutes;

[0097] S2-2: Add 15g of menthol solution and 5g of crosslinking agent, stir for 10 minutes to obtain a low-sensitivity adhesive (viscosity 5200mPa·s at 25℃).

[0098] S3: Composite Molding

[0099] S3-1: Preheat adhesive to 35℃, coating speed 8m / min, cell depth 30μm, coating thickness 20μm, dry at 60℃ for 8 minutes;

[0100] S3-2: 15g / L release agent is coated onto a PET film (15μm), with a coating thickness of 0.5μm, dried at 70℃ for 3 minutes, and then cut into irregularly shaped release layers;

[0101] S3-3: Compounding at 0.1MPa pressure for 3 minutes (25℃) yields a semi-finished product;

[0102] S4: Finished Product Processing

[0103] S4-1: Laser die-cutting machine (10W power, 20mm / s speed) fine-tuning;

[0104] S4-2: Sterilize with ethylene oxide (dose 400 mg / L, 2 hours), desorb at 40°C for 8 hours, and vacuum pack;

[0105] In this embodiment, the raw material dosage was adjusted to the lower limit of the required range. The modified polylactic acid-caprolactone blend had a mass ratio of 3.2:1 and maleic anhydride grafting agent of 0.5%, balancing rigidity and elasticity. The amount of cotton fiber was 150g, and the sodium hydroxide concentration during pretreatment was 22g / L with a soaking time of 32 minutes to ensure sufficient etching of the fiber surface and improve the air permeability to 780mm / s. The modified hyaluronic acid-chitosan composite adhesive was prepared with a volume ratio of 2:1 and propylene oxide of 1%. Although the dosage was at the lower limit, the viscosity still reached 5.5N / 25mm, meeting the fixation requirements. In terms of process, the twin-screw speed of 250r / min was adapted to the high fiber content to avoid fiber breakage, and the overall performance met the standards.

[0106]

[0107] Test Results

[0108] Example 3:

[0109] Please see Figure 1 The present invention provides a technical solution: an irregularly shaped medical tape and its preparation method, comprising the following raw material formula:

[0110] Irregular substrate layer: 350g modified polylactic acid-caprolactone blend, 100g breathable cotton fiber, 15g nano silica, 50g antibacterial agent solution, 75g moisturizing emulsion.

[0111] Low-sensitivity adhesive layer: 250g modified hyaluronic acid-chitosan composite adhesive, 75g acrylate copolymer, 25g menthol solution, 10g crosslinking agent;

[0112] Shaped release layer: PET film (25μm thick) + release agent (25g / L, coating thickness 1μm);

[0113] Preparation of modified polylactic acid-caprolactone blend: Take 292g of polylactic acid and 58g of polycaprolactone (mass ratio 5:1), add 3.5g of maleic anhydride grafting agent (1% of total mass), melt-blend at 180℃ for 30 minutes, cool and then pulverize to 200 mesh to obtain 350g of modified polylactic acid-caprolactone blend;

[0114] Pretreatment of breathable cotton fibers: Take 100g of cotton fibers, soak them in 30g / L sodium hydroxide solution for 40 minutes, rinse with deionized water until pH=7, then soak them in 15g / L silane coupling agent KH-560 solution for 25 minutes, and dry them at 90℃ until the moisture content is 3% to obtain breathable cotton fibers.

[0115] Preparation of modified hyaluronic acid-chitosan composite adhesive: Dissolve 9.375g of hyaluronic acid in 625mL of deionized water (15g / L) and 6.25g of chitosan in 520mL of 1% acetic acid solution (12g / L). Mix the two solutions at a volume ratio of 3:1, add 5g of propylene oxide (2% of the total mass of the mixture), stir and react at 60℃ for 1.5 hours, and after cooling, obtain 250g of modified hyaluronic acid-chitosan composite adhesive;

[0116] Preparation of antibacterial agent solution: Dissolve 40g of polyhexamethylene guanidine hydrochloride in 500mL of deionized water to prepare an 80g / L antibacterial agent solution, and take 50g for later use;

[0117] Preparation of moisturizing emulsion: Disperse 90g of sodium hyaluronate in 750mL of glycerin to prepare a 120g / L moisturizing emulsion, and take 75g for later use;

[0118] Preparation of menthol solution: Dissolve 12.5g of menthol in 250mL of ethanol to prepare a 50g / L menthol solution, and take 25g for later use;

[0119] Preparation of crosslinking agent: Dissolve 4g of 1,4-butanediol diglycidyl ether in 100mL of deionized water to prepare a 40g / L crosslinking agent, and take 10g for later use;

[0120] Preparation of release agent: Dissolve 1.25g of organosilicon release agent in 50mL of ethyl acetate to prepare a 25g / L release agent for later use;

[0121] The preparation steps are as follows:

[0122] S1: Preparation of irregularly shaped substrate layer

[0123] S1-1: 350g modified polylactic acid-caprolactone blend, 100g breathable cotton fiber, 15g nano silica, twin-screw extruder (feeding section 140℃, melting section 170℃, homogenization section 175℃, speed 350r / min), blend at 170℃ for 20 minutes, cast at 170℃ to form a 100μm flat film.

[0124] S1-2: Mix 50g of antibacterial agent solution and 75g of moisturizing emulsion, spray at a rate of 8g / m². 2 Dry at 85℃ for 10 minutes;

[0125] S1-3: 3D calender (temperature 80℃, pressure 0.5MPa, speed 10m / min), calendering an irregular structure with an arc curvature of 15mm, a transition zone of 5mm, and a notch of 8mm, infrared temperature control (80±2℃), to obtain a 100μm substrate layer;

[0126] S2: Preparation of low-sensitivity adhesives

[0127] S2-1: 250g modified hyaluronic acid-chitosan composite adhesive, 75g acrylate copolymer, stirred at 50℃ and 400r / min for 20 minutes;

[0128] S2-2: Add 25g of menthol solution and 10g of crosslinking agent, stir for 15 minutes to obtain adhesive (viscosity 7800mPa·s at 25℃).

[0129] S3: Composite Molding

[0130] S3-1: Preheat adhesive to 40℃, coating speed 15m / min, cell depth 50μm, coating thickness 40μm, dry at 70℃ for 12 minutes;

[0131] S3-2: 25g / L release agent is coated onto a PET film (25μm), with a coating thickness of 1μm, dried at 80℃ for 5 minutes, and then cut to obtain the release layer;

[0132] S3-3: Compounding at 0.2MPa pressure for 5 minutes (30℃) yields a semi-finished product;

[0133] S4: Finished Product Processing

[0134] S4-1: Laser die-cutting machine (15W power, 30mm / s speed) fine-tuning;

[0135] S4-2: Sterilize with ethylene oxide (600 mg / L, 3 hours), desorb at 50°C for 12 hours, and vacuum pack;

[0136] This embodiment is adjusted to the upper limit. The modified polylactic acid-caprolactone blend has a mass ratio of 5:1 and maleic anhydride grafting agent of 1% to improve rigidity. 15g of nano-silica fills the pores to achieve a tensile strength of 22MPa. 80g / L of antibacterial agent and 120g / L of humectant improve the antibacterial rate to 99.8% and the moisturizing effect to a water content of ≥35% after 72 hours, respectively. The modified hyaluronic acid-chitosan composite adhesive is prepared at a volume ratio of 3:1 and 2% of propylene oxide, with an adhesion of 7.8N / 25mm, suitable for fixing heavy dressings. 25g / L of release agent has a release force of 9.5g / 25mm, which is easy to peel off without residue. The process parameters are adapted to high-volume raw materials.

[0137]

[0138] Test Results

[0139] Example 4:

[0140] Please see Figure 1 The present invention provides a technical solution: an irregularly shaped medical tape and its preparation method, comprising the following raw material formula:

[0141] Irregular substrate layer: 325g modified polylactic acid-caprolactone blend, 110g breathable cotton fiber, 12.5g nano silica, 42.5g antibacterial agent solution, 65g moisturizing emulsion;

[0142] Low-sensitivity adhesive layer: 225g modified hyaluronic acid-chitosan composite adhesive, 90g acrylate copolymer, 22.5g menthol solution, 9g crosslinking agent;

[0143] Shaped release layer: PET film (22μm thick) + release agent (22g / L, coating thickness 0.9μm);

[0144] Preparation of modified polylactic acid-caprolactone blend: Take 244g of polylactic acid and 81g of polycaprolactone (mass ratio 3:1), add 1.63g of maleic anhydride grafting agent (total mass 0.5%), melt-blend at 172℃ for 24 minutes, cool and pulverize to 150 mesh to obtain 325g of modified polylactic acid-caprolactone blend;

[0145] Pretreatment of breathable cotton fibers: Take 110g of cotton fibers, soak them in 26g / L sodium hydroxide solution for 36 minutes, rinse with deionized water until pH=7, then soak them in 13g / L silane coupling agent KH-560 solution for 23 minutes, and dry them at 86℃ until the moisture content is 4% to obtain breathable cotton fibers.

[0146] Preparation of modified hyaluronic acid-chitosan composite adhesive: Dissolve 7.88g of hyaluronic acid in 525mL of deionized water (15g / L) and 5.4g of chitosan in 450mL of 1% acetic acid solution (12g / L). Mix the two solutions at a volume ratio of 2.8:1, add 3.6g of propylene oxide (total mass of the mixture is 1.6%), stir and react at 56℃ for 1.3 hours, and after cooling, obtain 225g of modified hyaluronic acid-chitosan composite adhesive;

[0147] Preparation of antibacterial agent solution: Dissolve 27.6g of polyhexamethylene guanidine hydrochloride in 425mL of deionized water to prepare a 65g / L antibacterial agent solution, and take 42.5g for later use;

[0148] Preparation of moisturizing emulsion: Disperse 65g of sodium hyaluronate in 542mL of glycerin to prepare a 120g / L moisturizing emulsion, and take 65g for later use;

[0149] Preparation of menthol solution: Dissolve 9g of menthol in 225mL of ethanol to obtain a 40g / L menthol solution, and take 22.5g for later use;

[0150] Preparation of crosslinking agent: Dissolve 2.7g of 1,4-butanediol diglycidyl ether in 90mL of deionized water to prepare a 30g / L crosslinking agent, and take 9g for later use;

[0151] Preparation of release agent: Dissolve 0.99g of organosilicon release agent in 45mL of ethyl acetate to prepare 22g / L release agent for later use;

[0152] The preparation steps are as follows:

[0153] S1: Prepare the irregularly shaped substrate layer, the same as in Example 1;

[0154] S1-3: 3D irregular calender temperature 78℃, pressure 0.45MPa, speed 9m / min, infrared temperature control 78±1℃, calender structure curvature 12mm, transition zone 4mm, notch 6mm;

[0155] S2: Prepare a low-sensitivity adhesive, the same as in Example 1;

[0156] The glass transition temperature of the acrylate copolymer is -12℃, the transmittance of the 55g / L ethyl acetate solution is 93%, 225g of modified hyaluronic acid-chitosan composite adhesive and 90g of copolymer are stirred at 48℃ and 380r / min for 19 minutes, 22.5g of menthol and 9g of crosslinking agent are added, and the mixture is stirred for 13 minutes, resulting in a viscosity of 7200mPa・s.

[0157] S3: Composite molding, same as in Example 1;

[0158] S3-1: Preheat adhesive to 39℃, coating speed 14m / min, cell depth 45μm, coating thickness 35μm, dry at 68℃ for 11 minutes;

[0159] S4: Finished product processing, same as in Example 1;

[0160] S4-1: Laser die-cutting machine power 14W, speed 28mm / s, adsorption force -0.075MPa;

[0161] S4-2: Ethylene oxide sterilization (dosage 550 mg / L, temperature 38℃, RH 55%) for 2.8 hours, followed by 48℃ desorption for 11 hours;

[0162] In this embodiment, the melting temperature of the modified polylactic acid-caprolactone blend was 172℃ and the reaction temperature of the composite adhesive was 56℃, both within the required range. The 3D calendering temperature of 78℃ ensured more stable shaping of the irregular structure. The coating speed of 14m / min and the 45μm cell size were matched with the adhesive layer thickness, and the laser die-cutting accuracy reached ±0.06mm. The final peel strength change rate was only 5.6% (less than 10%), and the residual ethylene oxide content was far below the national standard, demonstrating excellent performance stability.

[0163]

[0164] Test Results

[0165] Comparative Example 1:

[0166] Please see Figure 1 The present invention provides a comparative scheme, including a raw material formula:

[0167] Irregular substrate layer: 300g of unmodified polylactic acid-caprolactone blend (without maleic anhydride grafting agent), 125g of breathable cotton fiber, 10g of nano silica, 37.5g of antibacterial agent solution, and 60g of moisturizing emulsion.

[0168] Low-sensitivity adhesive layer and irregularly shaped release layer: Same as in Example 1;

[0169] The ingredients are prepared as follows:

[0170] Preparation of unmodified polylactic acid-caprolactone blend: Take 225g of polylactic acid and 75g of polycaprolactone (mass ratio 3:1), without adding maleic anhydride grafting agent, directly melt and blend at 170℃ for 25 minutes, cool and then pulverize to 150 mesh to obtain 300g of unmodified polylactic acid-caprolactone blend.

[0171] Preparation of other components, such as breathable cotton fiber pretreatment, modified hyaluronic acid-chitosan composite adhesive, and antibacterial agent solution, is exactly the same as in Example 1.

[0172] 4. The preparation steps are the same as in Example 1, except that:

[0173] S1: Unmodified polylactic acid-caprolactone blend with cotton fiber and nano silica was melt-blended, sprayed, and 3D calendered according to the parameters of Example 1;

[0174] S2-S4: Adhesive preparation, composite molding, and finished product processing are the same as in Example 1;

[0175] Maleic anhydride grafting agent is a core component that ensures the compatibility of polylactic acid and polycaprolactone. Without it, the blend exhibits obvious stratification, the mechanical properties and air permeability of the substrate drop sharply, and the bonding stability is severely insufficient, proving the necessity of adding grafting agent.

[0176]

[0177] Test Results

[0178] Comparative Example 2:

[0179] Please see Figure 1 The present invention provides a comparative scheme, including a raw material formula:

[0180] Low-sensitivity adhesive layer: 200g of ordinary hyaluronic acid glue (uncomposite to chitosan, unmodified with propylene oxide), 100g of acrylate copolymer, 20g of menthol solution, and 7.5g of crosslinking agent;

[0181] Irregularly shaped substrate layer and irregularly shaped release layer: Same as in Example 1;

[0182] The preparation of the components is the same as in Example 1, except that:

[0183] Preparation of ordinary hyaluronic acid gel: Dissolve 6g of hyaluronic acid in 500mL of deionized water (12g / L), without adding chitosan solution and propylene oxide, and directly cool to obtain 200g of ordinary hyaluronic acid gel;

[0184] Preparation of the modified polylactic acid-caprolactone blend, cotton fiber pretreatment, antibacterial agent solution, and other components: same as in Example 1;

[0185] 4. The preparation steps are the same as in Example 1.

[0186] S1: Substrate preparation is the same as in Example 1;

[0187] S2: Ordinary hyaluronic acid glue and acrylate copolymer are mixed according to the parameters of Example 1, and menthol solution and crosslinking agent are added;

[0188] S3-S4: Composite molding and finished product processing are the same as in Example 1;

[0189] The chitosan composite and propylene oxide modification of the modified hyaluronic acid-chitosan composite adhesive respectively endow the adhesive with low allergenicity and tack stability, which cannot be replaced by ordinary hyaluronic acid adhesives.

[0190]

[0191] Test Results

[0192] Comparative Example 3:

[0193] Please see Figure 1 The present invention provides a comparative scheme, including a raw material formula:

[0194] Irregularly shaped substrate layer: Same as in Example 1;

[0195] Low-sensitivity adhesive layer and irregularly shaped release layer: Same as in Example 1;

[0196] The ingredients were prepared in the same way as in Example 1:

[0197] The preparation of all components, including the modified polylactic acid-caprolactone blend, cotton fiber pretreatment, and modified hyaluronic acid-chitosan composite adhesive, was the same as in Example 1.

[0198] 4. The preparation steps are the same as in Example 1, except that:

[0199] S1-1: Cast into a 75μm thick flat film as in Example 1;

[0200] S1-2: Apply antibacterial agent and moisturizing agent emulsion as in Example 1 and dry;

[0201] Remove S1-33D irregular calendering: use flat film directly as the substrate layer, without arc-shaped bonding area, elastic transition area and positioning notch;

[0202] S2-S4: Adhesive preparation, composite molding, release layer cutting into rectangles matching the planar substrate, and finished product processing are all the same as in Example 1;

[0203] 3D irregular calendering process is the core of achieving precise adhesion between tape and the curved surface of the human body. Flat substrates cannot be adapted to complex parts such as joints, resulting in rapid adhesion failure, insufficient fixing force and poor comfort.

[0204]

[0205] Test Results

[0206] Examples 1-4, by adjusting the raw material ratios and process parameters, with Example 1 as the baseline and parameters set according to the midpoint of the range, ensured the compatibility of core components such as modified polylactic acid-caprolactone blend (3:1) and modified hyaluronic acid-chitosan composite adhesive (2.5:1), achieving comprehensive performance compliance. Examples 2-3 covered the upper and lower limits of raw material usage, verifying the rationality of the blend ratio (3.2:1 to 5:1) and nano-silica (5-15g) ranges, ensuring that basic performance was still met under extreme conditions. Example 4 optimized process parameters, highlighting the performance-enhancing effects of 3D calendering temperature (78℃) and coating speed (14m / min).

[0207] Comparative Examples 1-3 were used to reverse-verify the necessity of missing key technical features: Comparative Example 1 removed maleic anhydride grafting agent, resulting in delamination of the blend and a 50% decrease in substrate strength; Comparative Example 2 replaced the modified hyaluronic acid-chitosan composite adhesive with ordinary hyaluronic acid adhesive, and the allergy rate increased to 8%, with adhesion attenuation exceeding 40%; Comparative Example 3 eliminated 3D irregular calendering, and the adhesion dropped sharply, with edge curling occurring within 2 hours.

[0208] In summary, the examples demonstrate the effectiveness of the modified polylactic acid-caprolactone blend, the modified hyaluronic acid-chitosan composite adhesive, and the synergistic design of the 3D irregular structure. The comparative examples highlight the irreplaceable nature of each key feature and collectively verify that the technical solution addresses the pain points of traditional tapes, such as poor adhesion, high allergenicity, and insufficient stability.

[0209] The testing steps are as follows:

[0210] I. Substrate Layer Performance Testing

[0211] 1. Breathability test:

[0212] According to GB / T5453-1997 "Textiles - Determination of Air Permeability of Fabrics", a digital air permeability meter was used, the test pressure was 2 kPa, and the sample area was 20 cm². 2 Each sample was tested 5 times, and the average value was taken. The unit is mm / s.

[0213] 2. Tensile breaking strength and elongation test:

[0214] According to GB / T1040.3-2006 "Determination of tensile properties of plastics - Part 3: Test conditions for films and sheets", cut dumbbell-shaped specimens of 150mm×15mm, tensile speed of 300mm / min, clamping distance of 100mm, record the maximum load and elongation at break, calculate the strength (MPa) and elongation (%), and test 5 samples in each group;

[0215] 3. Surface flatness test:

[0216] A surface roughness tester was used, with a test length of 4 mm and a sampling speed of 0.5 mm / s. The Ra value (μm) was recorded. Three different areas were tested for each sample, and the average value was taken.

[0217] II. Adhesive Layer Performance Testing

[0218] 1. Peel strength test:

[0219] According to GB / T2792-2014 "Test Method for 180° Peel Strength of Pressure-Sensitive Adhesive Tape", the tape was pasted onto a stainless steel plate (surface roughness Ra0.8μm), rolled back and forth 3 times with a 2kg roller, and left for 30 minutes. Then, it was peeled at 180° on a tensile testing machine at a speed of 300mm / min. The force value was recorded in N / 25mm. Five samples were tested in each group.

[0220] 2. Viscosity stability test:

[0221] The stainless steel plate with tape was placed in a constant temperature and humidity chamber at 37℃ and 60% relative humidity for 72 hours. After being removed, it was placed in a standard environment (23℃, 50%RH) for 2 hours. The peel strength test was repeated, and the strength retention rate (%) was calculated.

[0222] 3. Viscosity test:

[0223] According to GB / T2794-2013 "Determination of viscosity of adhesives", a rotational viscometer (rotor No. 2) was used. The test temperature was 25℃, the rotation speed was 60r / min, and the reading was taken after stabilizing for 30s. The unit is mPa·s.

[0224] III. Overall Performance Testing

[0225] 1. Fit Test:

[0226] Ten healthy subjects were selected, and the tape was applied to the knee joint (Example 1, 3), face (Example 2), or elbow joint (Example 4). The longest time without lifting or hollowing during continuous activity was recorded, and the average value was taken.

[0227] 2. Release force test:

[0228] Referring to GB / T2792-2014 "Test Method for Peel Strength and Holding Power of Pressure-Sensitive Adhesive Tapes", the release layer was peeled from the adhesive layer at a speed of 300 mm / min, and the average force value was recorded in g / 25 mm.

[0229] 3. Die-cutting accuracy test:

[0230] The actual dimensions of the irregularly shaped tape contour were measured using a vernier caliper with an accuracy of 0.01 mm. The dimensions were compared with the design dimensions, and the deviation value (± mm) was calculated. Ten feature points were tested for each sample.

[0231] IV. Safety and Functional Testing

[0232] 1. Skin sensitization test:

[0233] Referring to GB / T16886.10-2017 "Biological evaluation of medical devices - Part 10: Irritation and skin sensitization test", 100 subjects were selected. 25mm×25mm tape was applied to the inner side of the forearm and removed after 24 hours. Skin reactions were observed at 24 hours, 48 ​​hours and 72 hours, and the allergy rate (%) was calculated.

[0234] 2. Antibacterial rate test:

[0235] According to GB / T20944.2-2007 "Evaluation of antimicrobial properties of textiles - Part 2: Absorption method", the antimicrobial effect against Escherichia coli (ATCC25922) and Staphylococcus aureus (ATCC6538) was tested, and the antimicrobial rate (%) was calculated after 24 h of incubation.

[0236] 3. Moisturizing test:

[0237] Using a skin moisture meter, the moisture content of the stratum corneum of the skin was tested after 72 hours of application and compared with that before application to calculate the moisture retention rate (%).

[0238] All tests were conducted under standard conditions (temperature 23±2℃, relative humidity 50±5%). Each sample was tested in parallel at least three times, and the results were taken as the mean ± standard deviation.

[0239] The above descriptions are merely embodiments of the present invention, and common knowledge regarding specific technical solutions or characteristics is not elaborated upon here. It should be noted that those skilled in the art can make various modifications and improvements without departing from the technical solutions of the present invention, and these should also be considered within the scope of protection of the present invention. These modifications and improvements will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. A shaped adhesive tape, characterized in that, It includes, from bottom to top, an irregularly shaped substrate layer, a low-sensitivity adhesive layer, and an irregularly shaped release layer; The irregularly shaped substrate layer is prepared from the following raw materials: 50-70 parts of modified polylactic acid-caprolactone blend, 20-30 parts of breathable cotton fiber, 1-3 parts of nano silica, 5-10 parts of antibacterial agent solution, and 8-15 parts of moisturizing emulsion. The low-sensitivity adhesive layer is prepared from the following raw materials: 30-50 parts of modified hyaluronic acid-chitosan composite adhesive, 15-25 parts of acrylate copolymer, 3-5 parts of menthol solution, and 1-2 parts of crosslinking agent; The irregularly shaped release layer is a PET film coated with a release agent. The release agent is an organosilicon release agent dissolved in ethyl acetate, with a concentration of 15-25 g / L and a coating thickness of 0.5-1 μm. The thickness of the irregularly shaped substrate layer is 50-100μm, the thickness of the low-sensitivity adhesive layer is 20-40μm, and the thickness of the irregularly shaped release layer is 15-25μm; The preparation method of the modified polylactic acid-caprolactone blend includes: mixing polylactic acid and polycaprolactone at a mass ratio of 3:1-5:1, adding 0.5%-1% of maleic anhydride grafting agent of the total mass of polylactic acid and polycaprolactone, melting and blending at 160-180℃ for 20-30 minutes, cooling and then pulverizing to a particle size of 100-200 mesh; The preparation method of the modified hyaluronic acid-chitosan composite adhesive includes: dissolving hyaluronic acid in deionized water to prepare a hyaluronic acid solution with a concentration of 10-15 g / L, dissolving chitosan in acetic acid solution to prepare a chitosan solution with a concentration of 8-12 g / L, mixing the two solutions at a volume ratio of 2:1-3:1, adding 1%-2% of propylene oxide by mass of the mixed solution, stirring and reacting at 50-60℃ for 1-1.5 hours, and obtaining the composite adhesive after cooling.

2. The irregularly shaped tape according to claim 1, characterized in that, The pretreatment method for the breathable cotton fiber includes: soaking the cotton fiber in sodium hydroxide solution for 30-40 minutes, rinsing it with deionized water until neutral, soaking it in silane coupling agent KH-560 solution for 20-25 minutes, and drying it at 80-90℃ until the moisture content is ≤5%.

3. A method for preparing irregularly shaped adhesive tape as described in any one of claims 1-2, characterized in that, Includes the following steps: S1: Preparation of irregularly shaped substrate layer S1-1: Weigh the modified polylactic acid-caprolactone blend, breathable cotton fiber, and nano silica according to the formula, add them to a twin-screw extruder, melt-blend at 150-170℃ for 15-20 minutes, and after extrusion, cast them into a flat film with a thickness of 50-100μm through a casting machine. S1-2: Mix the antibacterial agent solution and the moisturizing emulsion evenly, and use a spraying equipment to spray the mixture evenly onto the flat film surface. The spraying amount is 5-8g / m², and dry at 80-85℃ for 5-10 minutes. S1-3: The dried flat film is fed into a 3D irregular calender and calendered according to the preset biomimetic irregular structure. The arc bonding area has a curvature radius of 5-15mm, the elastic transition area has a width of 2-5mm, and the positioning notch depth is 3-8mm, to obtain an irregular substrate layer. S2: Preparation of low-sensitivity adhesives S2-1: Weigh the modified hyaluronic acid-chitosan composite adhesive and acrylate copolymer according to the formula, add them to a planetary mixer, and stir at 300-400 r / min for 15-20 minutes at 40-50℃. S2-2: Add menthol solution and crosslinking agent, and continue stirring for 10-15 minutes to obtain a low-sensitivity adhesive; S3: Composite Molding S3-1: Use a micro-gravure coating machine to coat the low-sensitivity adhesive onto the non-calendered surface of the irregular substrate layer, with a coating thickness of 20-40μm, and dry at 60-70℃ for 8-12 minutes. S3-2: Cut the PET film coated with release agent according to the irregular contour to obtain the irregular release layer; S3-3: Cover the surface of the low-sensitivity adhesive layer with the irregular release layer, and laminate it under a pressure of 0.1-0.2MPa for 3-5 minutes to obtain the semi-finished irregular tape; S4: Finished Product Processing S4-1: Use a laser positioning die-cutting machine to refine the outline of the semi-finished product and remove excess edges and corners; S4-2: The refined finished product is sterilized using ethylene oxide at a dosage of 400-600 mg / L for 2-3 hours. After cooling, it is packaged to obtain the irregularly shaped adhesive tape.

4. The preparation method according to claim 3, characterized in that, The calendering temperature of the 3D irregular calendering machine in S1-3 is 70-80℃, the calendering pressure is 0.3-0.5MPa, the calendering speed is 5-10m / min, and an infrared temperature sensor is used to monitor the flat film temperature in real time during the calendering process, with temperature fluctuation controlled within ±2℃.

5. The preparation method according to claim 3, characterized in that, The coating speed of the S3-1 micro-gravure coating machine is 8-15m / min, the depth of the coating roller cells is 30-50μm, and the low-sensitivity adhesive needs to be preheated to 35-40℃ before coating to reduce viscosity fluctuations.

6. The preparation method according to claim 3, characterized in that, The laser power of the S4-1 laser positioning die-cutting machine is 10-15W, the cutting speed is 20-30mm / s, and vacuum adsorption is used to fix the semi-finished product during the die-cutting process to avoid displacement during die-cutting.

7. The preparation method according to claim 3, characterized in that, The glass transition temperature of the acrylate copolymer in S2-1 is -20 to -10℃, and when it is dissolved in ethyl acetate to prepare a solution with a concentration of 40-60 g / L, the transmittance of the solution is ≥90%.

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