A method for making barbed medical tension-reducing bandage based on roller microneedles

Abstract

The present invention discloses a method for making a barbed medical tension-reducing bandage based on roller microneedles. The steps include: using roller microneedles to press onto a template substrate at a predetermined inclination angle, using the template substrate with distributed microneedle holes as a microneedle template; dripping liquid medical polymer material onto the surface of the microneedle template so that the liquid medical polymer material evenly covers the surface of the microneedle template; slowly demolding the microneedle patch in the opposite direction to the arrangement of the microneedles through a cell clamp to obtain a microneedle patch with barbs arranged in an orderly manner on the surface; cutting the microneedle patch to obtain microneedle slices, and gluing the microneedle slices to a bandage substrate to obtain a medical tension-reducing bandage. The method for making a barbed medical tension-reducing bandage is simple to operate, efficient and reliable. The prepared medical tension-reducing bandage improves the skin fixation ability and tension-reducing effect through the barbed microneedle structure, has good biocompatibility, and is suitable for fields such as drug delivery, wound management, and real-time monitoring.

Description

Technical Field

[0001] The present invention belongs to the field of microneedles, and in particular relates to a method for producing a barbed medical tension-reducing bandage based on roller microneedles. Background Art

[0002] Microneedle technology is an innovative method for penetrating tissue in a minimally invasive and painless manner. It not only avoids the additional scarring that can occur with traditional methods, but also enables precise drug delivery to the wound site, achieving targeted treatment. Microneedles with specialized structures show broad application prospects for controlled wound treatment. However, several technical challenges remain in the field of microneedle-mediated wound healing. Existing microneedle applications in wound healing fail to fully consider the dynamic tension changes during the wound healing process, making it difficult to meet the differentiated requirements for tension reduction at different stages. Furthermore, existing microneedle designs often utilize an upright needle structure, which in practice limits their ability to securely attach to the skin. The lack of stability between microneedles and the skin surface results in limited tensile strength in response to skin tension, thus limiting their potential for scarless healing. Therefore, developing a microneedle structure with stable fixation and excellent tension reduction is crucial to achieve scarless healing.

[0003] The microneedle roller is a roller-driven microneedle device characterized by the use of densely packed microneedles on the roller's surface, which rapidly and uniformly form standardized microchannel structures on tissue or material surfaces over a short period of time. Compared to traditional microneedle devices, the microneedle roller offers significant advantages in ease of use, efficiency, and channel consistency. This device not only demonstrates superior performance in minimally invasive skin treatments but also provides a highly effective auxiliary tool for the fabrication of microneedle templates. The microneedle roller is highly versatile, with commercially available microneedles of various specifications. Therefore, its simplicity, speed, cost-effectiveness, and high degree of customization make it an ideal choice for developing specialized microneedle structures. Summary of the Invention

[0004] The purpose of the invention is to provide a method for making a barbed medical tension-reducing bandage based on a roller microneedle, which can prepare a medical tension-reducing bandage with excellent skin fixation ability, thereby effectively adapting to the dynamic tension changes during the wound healing process.

[0005] Technical solution: The method for producing a barbed medical tension-reducing bandage based on a roller microneedle according to the present invention comprises the following steps:

[0006] Step 1: Using a roller to press microneedles onto a template substrate at a predetermined inclination angle, thereby forming orderly arranged microneedle holes inclined at a predetermined inclination angle on the surface of the template substrate, and using the template substrate with distributed microneedle holes as a microneedle template;

[0007] Step 2: dripping liquid medical polymer material onto the surface of the microneedle template so that the liquid medical polymer material covers the surface of the microneedle template;

[0008] Step 3: After the liquid medical polymer material solidifies, it is slowly demolded in the direction opposite to the arrangement of the microneedles through a cell clamp to obtain a microneedle patch with barbs arranged in an orderly manner on the surface;

[0009] Step 4: Cut the microneedle patch into the desired shape and size to obtain microneedle slices, and use a medical-grade adhesive to bond the microneedle slices to the bandage substrate to obtain a medical tension-reducing bandage with orderly arranged barbs.

[0010] Furthermore, in step 1, the length of the microneedles on the roller microneedle used is 0.3 mm, 0.5 mm, 1.0 mm or 1.5 mm.

[0011] Furthermore, in step 1, when the roller microneedle is pressed on the template substrate at a predetermined inclination angle, the predetermined inclination angle of the microneedle hole on the microneedle template is controlled by adjusting the pressing angle when the roller microneedle contacts the template substrate, so that the angle range of the predetermined inclination angle is 0° to 90°.

[0012] Furthermore, in step 1, the template substrate is made of an elastic material.

[0013] Furthermore, in step 2, when dripping liquid medical polymer material onto the surface of the microneedle template, one or two liquid medical polymer materials can be used; if one liquid medical polymer material is used, it is evenly dripped onto the surface of the microneedle template to completely cover the surface of the template, and the bubbles under the covered surface are removed; if two liquid medical polymer materials are used, the first liquid medical polymer material is first completely covered on the surface of the microneedle template so that the first liquid medical polymer material fills each microneedle hole, and then the bubbles under the covered surface of the microneedle template are removed, and then the first liquid medical polymer material on the surface of the microneedle template is scraped off, and then the second liquid medical polymer material is completely covered on the surface of the microneedle template, and the bubbles under the covered surface of the microneedle template are removed again.

[0014] Furthermore, in step 2, the amount of liquid medical polymer material uniformly covering the surface of the microneedle template is 0.2 to 0.4 mL per square centimeter.

[0015] Furthermore, in step 2, after the liquid medical polymer material covers the surface of the microneedle template, the microneedle template completely covered with the liquid medical polymer material is placed in a vacuum drying oven, and the pressure of the vacuum drying oven is reduced from normal pressure 0 MPa to -0.1 MPa. After maintaining this pressure state for 1 minute, the atmosphere is slowly introduced until the pressure in the vacuum drying oven returns to normal pressure 0 MPa.

[0016] Furthermore, in step 3, the material of the microneedle patch is silk fibroin, polyurethane or polyethylene glycol diacrylate.

[0017] Furthermore, in step 3, the orderly arrangement of the barbs on the surface of the microneedle patch includes unidirectional arrangement, bidirectional arrangement or staggered arrangement.

[0018] Furthermore, in step 3, the bandage substrate is a medical-grade elastic fabric material, including polyamide fiber, polyester fiber or polypropylene fiber.

[0019] Compared with the prior art, the present invention has the following beneficial effects: the method for producing barbed medical tension-reducing bandages based on roller microneedles disclosed in the present invention adopts roller microneedle technology, and the preparation method is simple and efficient, which not only improves production efficiency but also greatly reduces costs; the specifications, structural configuration and needle body angle (0° to 90°) of the microneedle array on the surface of the medical tension-reducing bandage produced by the method of the present invention can be flexibly adjusted and customized according to actual needs to meet the needs of different application scenarios; the medical tension-reducing bandage produced by the method of the present invention also has excellent skin fixation ability, excellent mechanical properties, and good biocompatibility, thereby providing more ideal tension-reducing support and ensuring the best effect in the wound healing process; the medical tension-reducing bandage produced by the method of the present invention is suitable for fields such as drug delivery, wound management and real-time monitoring. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 Schematic diagram of the process for producing a barbed medical tension-reducing bandage based on roller microneedles of the present invention;

[0021] Figure 2 Schematic diagram of detailed analysis of the interaction between the roller microneedle and the template substrate at different angles of the present invention;

[0022] Figure 3 Schematic diagram showing that the force exerted by the roller microneedle of the present invention when rolling in the horizontal direction is determined by the combined effects of gravity and shear force;

[0023] Figure 4 Figure 3 shows the simulated stress distribution at the initial insertion moment of the roller microneedle of the present invention when it is rolled into templates with different tilt angles (angles of approximately θ = 0°, 30°, 45°, 60°, and 90°) simulated using COMSOL Multiphysics (scale bar: 500 μm).

[0024] Figure 5 The relative flexible motion between the roller microneedle and the template simulated using COMSOL Multiphysics of the present invention was used to form a microneedle mold with tilted microneedles (angles of approximately α = 0°, 30°, 45°, 60°, and 90°) (scale bar: 500 μm);

[0025] Figure 6 A schematic diagram of the triboelectric mechanism of the present invention of a barbed medical tension-reducing bandage made of roller microneedles and applied to triboelectric generation;

[0026] Figure 7 The voltage output curves of the barbed medical tension-reducing bandage made of roller microneedles according to the present invention under (i-iii) soft friction and hard friction conditions and (iv-vi) slow friction and fast friction conditions;

[0027] Figure 8 The voltage output curves of the barbed medical tension-reducing bandage made of roller microneedles of the present invention under multiple friction cycles (i-iii) and friction conditions (iv-vi) with different tilt angles (30°, 60°, 90°) of the microneedles;

[0028] Figure 9 This is a diagram showing the effect of the barbed medical tension-reducing bandage made based on the roller microneedle of the present invention on wound tension-reducing healing in mice (scale: 6 mm);

[0029] Figure 10 Optical images (scale: 500 μm) of the different arrangements of microneedles on the barbed medical tension-reducing bandage based on the roller microneedle of the present invention, including unidirectional (i), bidirectional (ii) or staggered (iii). DETAILED DESCRIPTION

[0030] The present invention will be further illustrated below with reference to the accompanying drawings and specific embodiments. These embodiments are implemented based on the technical solutions of the present invention. It should be understood that these embodiments are only used to illustrate the present invention and are not used to limit the scope of the present invention.

[0031] like Figure 1 As shown, the method disclosed in the present invention for making a barbed medical tension-reducing bandage based on a roller microneedle comprises the following steps:

[0032] Step 1, using a roller microneedle to press on a template substrate at a predetermined inclination angle, the length of the microneedle on the roller microneedle used is 0.3mm, 0.5mm, 1.0mm or 1.5mm, so that the length of the prepared inclined microneedle is roughly consistent with the selected needle length, and the predetermined inclination angle of the microneedle hole on the microneedle template is controlled by adjusting the pressing angle when the roller microneedle contacts the template substrate. The angle range of the predetermined inclination angle is 0° to 90°, that is, gradually shifting from a 0° angle perpendicular to the template substrate to a 90° angle close to parallel to the template substrate, thereby forming each microneedle hole arranged in an orderly manner and inclined at a predetermined inclination angle on the surface of the template substrate. The material of the template substrate is an elastic material, such as PDMS or Ecoflex material, and finally the template substrate with distributed microneedle holes is used as a microneedle template;

[0033] Step 2: dripping liquid medical polymer material onto the surface of the microneedle template so that the liquid medical polymer material evenly covers the surface of the microneedle template, with an amount of 0.2 to 0.4 mL per square centimeter;

[0034] Step 3: After the liquid medical polymer material is solidified, it is slowly demolded in the direction opposite to the arrangement of the microneedles through the cell clamp to obtain a microneedle patch with barbs arranged in an orderly manner on the surface. The material of the microneedle patch is silk fibroin, polyurethane or polyethylene glycol diacrylate, and the orderly arrangement direction of the barbs on the surface of the microneedle patch includes unidirectional arrangement, bidirectional arrangement or staggered arrangement, such as Figure 10 As shown, Figure i is a unidirectional arrangement, Figures ii and iii are combined into a bidirectional arrangement, and Figure iv is a staggered arrangement. In the unidirectional arrangement, the barbs on the surface of the microneedle patch are tilted in one direction; in the bidirectional arrangement, the barbs on the left side of the microneedle patch surface are tilted to the right, and the barbs on the right side are tilted to the left; in the staggered arrangement, two adjacent barbs on the surface of the microneedle patch are a group, and one of the two barbs in a group is tilted to the left and the other is tilted to the right.

[0035] Step 4: Cut the microneedle patch into the desired shape and size to obtain microneedle slices, and use a medical-grade adhesive to bond the microneedle slices to the bandage substrate. The medical-grade adhesive is a polyurethane adhesive, and the bandage substrate is a medical-grade elastic fabric material, including polyamide fiber, polyester fiber or polypropylene fiber, to obtain a medical tension-reducing bandage with orderly arranged barbs.

[0036] Furthermore, in step 1, the predetermined inclination angle ranges from 0° to 90°, and can be adjusted according to the required inclination angle during operation. The inclination angle adjustment can be fine-tuned by holding the mold, or precisely controlled by devices such as fixtures, adjustment knobs or bolts.

[0037] Furthermore, in step 3, the cell clamp is slowly demolded in the direction opposite to the arrangement of the microneedles to gradually release the adhesion and friction between the microneedle template and the microneedles on the microneedle patch, thereby protecting the microneedle structure.

[0038] Furthermore, in step 2, when dripping liquid medical polymer material onto the surface of the microneedle template, one or two liquid medical polymer materials can be used; if one liquid medical polymer material is used, it is evenly dripped onto the surface of the microneedle template to completely cover the surface of the template, and the bubbles under the covered surface are removed; if two liquid medical polymer materials are used, the first liquid medical polymer material is first completely covered on the surface of the microneedle template so that the first liquid medical polymer material fills each microneedle hole, and then the bubbles under the covered surface of the microneedle template are removed, and then the first liquid medical polymer material on the surface of the microneedle template is scraped off, and then the second liquid medical polymer material is completely covered on the surface of the microneedle template, and the bubbles under the covered surface of the microneedle template are removed again.

[0039] Furthermore, in step 2, to ensure that the liquid medical polymer material fills each microneedle pore, the microneedle template, completely covered with the liquid medical polymer material, is placed in a vacuum drying oven. During this process, the pressure in the vacuum drying oven is first reduced from 0 MPa to -0.1 MPa and maintained at this pressure for 1 minute. Subsequently, the air is slowly vented until the pressure in the vacuum drying oven returns to 0 MPa.

[0040] Furthermore, residual bubbles generated under the surface of the microneedle template covered with the liquid medical polymer material after vacuum drying can be removed using a 5 ml plastic dropper, thereby completely removing all bubbles.

[0041] Furthermore, in step 4, the microneedle patch is cut into desired shapes and sizes by laser cutting or a high-precision scalpel.

[0042] Example 1:

[0043] 1) A 10:1 mixture of PDMS (with a curing agent ratio of 17:1) and Ecoflex (A:B = 1:1) was selected as the template substrate. A roller microneedle was used to create the microneedle template. Commercial roller microneedles with a microneedle length of 0.5 mm were used for the production. Before pressing, the template substrate was stretched to 0.4 times its original length using a clamp along both ends to prevent the needles from being too thin. The stretched template substrate was fixed to a workbench, and the tilt angle between the template substrate and the workbench was adjusted (e.g., 0°, 30°, 60°, or 90°). While the template substrate was stretched, the roller microneedle was evenly rolled horizontally from the horizontal end to the tilted end to form the microneedle template.

[0044] The specific details are as follows: On the surface of a template substrate that is stretched and tilted at a certain angle (θ), the roller microneedle rolls horizontally from right to left. Under this condition, the interaction between the roller microneedle and the surface of the template substrate remains in the transition area from the horizontal plane of the template substrate to the tilted area. The tilt angle (θ) of the template substrate surface will affect the insertion path of the roller microneedle, forming a microneedle template with microneedle holes of corresponding tilt angle (α) in the transition area. This rolling process can control the formation morphology of the microneedle holes, ensure that the roller microneedle maintains a stable contact point on the surface of the template substrate, and accurately replicate the tilt angle (θ) of the template substrate, thereby forming a microneedle template with microneedle holes of corresponding tilt angle (α), such as Figure 1 and 2 shown.

[0045] During roller microneedle pressing, the force on the microneedle hole is determined by the combined direction of the normal force (perpendicular to the template substrate surface) and the tangential force (along the rolling direction): F 总 =F 法 +F 切. The larger the inclination angle of the template substrate, the higher the proportion of the tangential force, and the greater the angle at which the microneedle deviates from the vertical direction. Specifically, when the axis of the roller microneedle is at a non-vertical angle to the surface of the template substrate, the pressing direction of the microneedle will deviate from the vertical direction, forming an oblique insertion deformation path. At the same time, the elastic template substrate will undergo asymmetric local deformation under stress. The rolling of the roller microneedle on the template substrate generates a directional pressure gradient, causing the deformation of the template substrate around the microneedle to change toward the rolling direction, further causing the microneedle to tilt, such as Figure 3 shown.

[0046] like Figure 4 As shown in the figure, the simulated stress distribution at the initial insertion moment when the rolling microneedle is rolled into the template substrate with different inclination angles (angles of approximately θ = 0°, 30°, 45°, 60° and 90°) simulated using COMSOL Multiphysics. The simulation explored the effect of the template substrate inclination angle (θ) on the microneedle inclination angle (α) of the microneedle mold. The simulation results at the initial insertion moment between the rolling microneedle and the template substrate showed that at θ = 0°, the stress was concentrated at the puncture site. As θ increased to 30°, 45° and 60°, the stress distribution became wider, indicating that local deformation occurred. It is worth noting that when θ = 90°, the stress distribution is even more uneven, which is not conducive to the production process.

[0047] like Figure 5 As shown, the relative flexible motion between the roller microneedle and the template substrate is simulated using COMSOL Multiphysics to form a microneedle mold with tilted microneedles (angles of approximately α = 0°, 30°, 45°, 60° and 90°). In addition, the results of the relative flexible motion between the roller microneedle and the template substrate show that at an angle of 0°, the stress distribution around the microneedle is symmetrical and is maximum along the vertical axis, which can theoretically increase the penetration depth. As the angle increases to 30°, 45° and 60°, the stress distribution changes and the lateral force vector increases, which can improve the adhesion stability of the microneedle in the tissue. At an angle of 90°, the microneedle is almost parallel to the template substrate, the vertical force is minimal, and the lateral contact area is maximized, making it suitable for applications that require grasping rather than deep penetration. Theoretical modeling shows that the gradual increase in the tilt angle of the microneedle can effectively control the direction of the force, and the tilted structure can evenly distribute stress across the entire surface, reducing local stress concentration.

[0048] 2) A mixture of silk fibroin solution and PU solution in a volume ratio of 7:3 is dripped onto the microneedle template after the above treatment to completely cover the microneedle template to a thickness of 1 mm. Place it in a vacuum drying oven and reduce the pressure to -0.1 MPa. After keeping it for 1 minute, open the atmosphere. The above vacuum drying step is repeated twice to ensure that the silk fibroin solution and the PU mixture fill each microneedle hole. For the residual bubbles generated under the surface of the microneedle template covered with the silk fibroin solution and the PU mixture after vacuum drying, use a 5 ml plastic dropper to remove them. After removing the bubbles, place the microneedle template at room temperature to dry for 12 hours, and then slowly demold it in the opposite direction of the microneedle arrangement through a cell clamp to obtain a transparent microneedle patch with an inclined barb structure.

[0049] 3) A mixed Ecoflex (A:B = 1:1) liquid was applied to the microneedle surface of the microneedle patch and cured at room temperature for 12 hours. A thin copper sheet was then attached to the backing surface of the microneedle patch to serve as an inductive electrode. This was then bonded to a medical-grade elastic fabric (polyamide fiber) using a medical-grade polyurethane adhesive, resulting in a medical tension-reducing bandage with an ordered barbed structure.

[0050] 4) The obtained barbed medical bandage is used to integrate a triboelectric nanogenerator (TENG). When charged objects are periodically in contact, the positive charge on the electrode changes, such as Figure 6 As shown, human skin and the Ecoflex surface of the microneedle patch exhibit triboelectric positive and negative properties, respectively. Upon contact, positive and negative charges are evenly distributed on the skin and microneedle surfaces. When the skin separates from the Ecoflex surface of the microneedle patch, a positive charge is induced, causing electrons to flow to the ground until the induced positive charge balances the negative charge of the Ecoflex surface of the microneedle patch. Conversely, electrons flow from the ground into the microneedle patch, generating an opposite current until equilibrium is reached, maintaining the circuit.

[0051] 5) The open-circuit voltage (Voc) of the TENG under various working conditions was measured using a high-precision oscilloscope to quantitatively evaluate the electrical output performance in energy conversion.

[0052] Specifically, as the friction intensity increases, the voltage amplitude increases significantly. Figure 7 As shown in Figure 2, the voltage output exhibits a stable periodicity with a peak value reaching about 4.5 V. When the friction intensity exceeds a certain threshold, the peak voltage decreases slightly, probably because the surface wear or micro deformation destroys the uniform charge accumulation, as shown in Figure 2. Figure 7 As shown in Figures i to iii in Figure 1, soft friction promotes efficient charge accumulation, while hard friction may reduce the charge accumulation efficiency due to surface damage. In addition, as the friction frequency increases, the voltage waveform responds faster, thereby improving the cycle efficiency per unit time, as shown in Figure 2. Figure 7This phenomenon is shown in Figures iv-vi of Figure 1. This phenomenon indicates that higher friction frequencies shorten the charge recombination interval, thereby improving charge transfer efficiency. These findings further confirm that the TENG exhibits high sensitivity under different friction conditions, responds quickly to changes in friction frequency, and exhibits good dynamic performance.

[0053] In terms of triboelectric stability, the voltage output remains highly consistent over multiple friction cycles, e.g. Figure 8 Even after multiple friction cycles, the voltage waveform remains stable without obvious attenuation, indicating that the above TENG maintains stable electrical performance under cyclic friction loads, as shown in Figure 2. Figure 8 This stability is crucial for long-term wearable applications and ensures durability in actual use. Further investigation of the effect of different microneedle angles on the triboelectric response revealed different results. Throughout the experiment, given the constant mechanical conditions (contact frequency and force), the contact frequency showed relative consistency, as shown in Figures i-iii. Figure 8 As shown in Figures iv to vi in ​​. However, obvious differences in the voltage waveform amplitude were observed. The microneedles with a 30° inclination angle mainly exhibited sliding friction, resulting in unstable charge accumulation, lower voltage and obvious noise. The strong noise may be related to contact instability and random fluctuations generated during the friction process. The microneedles with a 60° inclination angle are located between sliding friction and vertical contact, showing relatively uniform charge accumulation and stable voltage signals. In contrast, due to the larger contact area of ​​the microneedles with a 90° inclination angle, sliding friction is dominant, resulting in more stable charge accumulation, higher voltage amplitude and smoother waveforms with minimal noise. This indicates that the 90° inclination angle microneedles exhibit higher stability, more consistent contact, and a more uniform charge transfer process. Overall, optimizing the microneedle angle can achieve more efficient and stable charge transfer, thereby improving voltage output stability and responsiveness.

[0054] Example 2:

[0055] 1) A 10:1 mixture of PDMS (with a curing agent ratio of 17:1) and Ecoflex (A:B = 1:1) was used as the template substrate, and a roller microneedle was used to produce the microneedle template. Commercial roller microneedles with a microneedle length of 0.5 mm were used for production. Before pressing, the template substrate was stretched to 0.4 times its original length using a clamp along both ends to prevent the needle from being too thin. The stretched template substrate was fixed to a workbench, and the tilt angle between the template substrate and the workbench was adjusted (e.g., 0°, 30°, 60°, or 90°). While the template substrate was stretched, the roller microneedle was evenly rolled horizontally from the horizontal end to the tilted end to form the microneedle template.

[0056] 2) Pour 2 ml of PEGDA solution onto a 5 cm × 1.5 cm microneedle template, then place it in a vacuum drying oven and reduce the pressure to -0.1 MPa. After maintaining for 1 min, vent to the atmosphere. Repeat the above steps twice to ensure that PEGDA fills all microneedle pores. Then, use a surgical blade to gently scrape off the excess PEGDA solution on the surface of the microneedle template. Then, place the microneedle template under ultraviolet light to cure for 2-5 min (depending on the UV light intensity).

[0057] 3) A mixture of a silk fibroin solution and a polyurethane (PU) solution in a volume ratio of 7:3 was dripped onto the treated microneedle template, completely covering the mold surface to a thickness of 1 mm. The template was then dried at room temperature for 12 hours and slowly removed from the mold using a cell clamp in the direction opposite to the microneedle arrangement, yielding a transparent microneedle patch with an inclined barbed structure. This patch was then bonded to a medical-grade elastic fabric material, polyamide fiber, using a medical-grade polyurethane adhesive to produce a medical tension-reducing bandage with an ordered barbed structure.

[0058] 4) The obtained barbed medical tension-reducing bandage was used to reduce the tension of high-tension wounds on the back of mice and the scar-free healing treatment was performed. Figure 9 As shown, the medical tension-reducing bandage has the ability to reduce tension on wounds and achieve scar-free healing.

[0059] Specifically, the experiment was conducted on the back of mice. To ensure comparability of initial wound size across experimental groups, a standardized 2 cm linear excisional wound was created on the back of each mouse using a sterile scalpel under general anesthesia. Initial wound size was recorded immediately after surgery, and digital images were taken on day 0. Wound length was measured with a calibrated ruler to ensure consistency. The tension-relieving and wound-healing abilities of the barbed medical tension-reducing bandage were evaluated by comparing the effects of different treatment groups. The animals were divided into five groups: a control group, a patch without microneedles, a barbed medical tension-reducing bandage loaded with hEGF, a barbed medical tension-reducing bandage combined with a triboelectric nanogenerator, and a barbed medical tension-reducing bandage combined with a triboelectric nanogenerator. The anti-inflammatory and anti-infective properties of hEGF help create a favorable microenvironment around the wound, thereby reducing the risk of infection. hEGF gel was encapsulated in the barbed medical tension-reducing bandage to evaluate its synergistic effect with the barbed medical tension-reducing bandage in reducing tension and accelerating wound healing. The changes in wound width were recorded regularly during the experiment (days 1, 3, 5, 7, 9, 12, and 14). Figure 9The results show that the barbed medical tension-reducing bandage and triboelectric nanogenerator integrated group loaded with hEGF achieved optimal healing results on the 14th day. The combined effects of the barbed medical tension-reducing bandage, hEGF, and triboelectric stimulation significantly reduced tension and accelerated wound healing. Specifically, the control group showed significant inflammation at the wound edge on the first day, and later healing was slow, with obvious scarring. The barbed medical tension-reducing bandage and triboelectric nanogenerator integrated group showed enhanced healing effects on the 7th day, possibly because triboelectric stimulation activated the mechanosensitive pathway, thereby promoting cell adhesion and healing. The barbed medical tension-reducing bandage and triboelectric nanogenerator integrated group loaded with hEGF showed faster wound area contraction starting from the 3rd day, reflecting the synergistic effect of hEGF-induced cell proliferation with the mechanical support provided by the tilted microneedles and microfluidic channels, maintaining optimal wound hydration and nutrient delivery. In addition, triboelectric stimulation can further promote tissue regeneration and wound contraction through local electric fields.

[0060] As described above, although the present invention has been shown and described with reference to specific preferred embodiments, it should not be construed as limiting the present invention itself. Various changes may be made to it in form and detail without departing from the spirit and scope of the present invention as defined in the appended claims.

Claims

1. A method for making a barbed medical tension-reducing bandage based on a roller microneedle, characterized in that: The steps include: Step 1, using a roller microneedle to press on a template substrate at a predetermined inclination angle, and controlling the predetermined inclination angle of the microneedle holes on the microneedle template by adjusting the pressing angle when the roller microneedle contacts the template substrate, thereby forming microneedle holes arranged in an orderly manner and inclined at a predetermined inclination angle on the surface of the template substrate, and using the template substrate with the distributed microneedle holes as a microneedle template. On the surface of the template substrate that is stretched and inclined at a certain angle θ, the roller microneedle rolls horizontally from right to left, and the interaction between the roller microneedle and the surface of the template substrate occurs in the transition area from the horizontal plane of the template substrate to the inclined area, and a microneedle template with microneedle holes of corresponding inclination angle α is formed in the transition area, so that the angle range of the predetermined inclination angle is 0°~90°; Step 2: dripping liquid medical polymer material onto the surface of the microneedle template so that the liquid medical polymer material covers the surface of the microneedle template; Step 3: After the liquid medical polymer material solidifies, it is slowly demolded in the direction opposite to the arrangement of the microneedles through a cell clamp to obtain a microneedle patch with barbs arranged in an orderly manner on the surface; Step 4: Cut the microneedle patch into the desired shape and size to obtain microneedle slices, and use a medical-grade adhesive to bond the microneedle slices to the bandage substrate to obtain a medical tension-reducing bandage with orderly arranged barbs.

2. The method for producing a barbed medical tension-reducing bandage based on roller microneedles according to claim 1, characterized in that: In step 1, the length of the microneedles on the microneedle roller used is 0.3 mm, 0.5 mm, 1.0 mm or 1.5 mm.

3. The method for producing a barbed medical tension-reducing bandage based on roller microneedles according to claim 1, characterized in that: In step 1, the template substrate is made of elastic material.

4. The method for producing a barbed medical tension-reducing bandage based on roller microneedles according to claim 3, characterized in that: In step 2, when dripping liquid medical polymer material onto the surface of the microneedle template, one or two liquid medical polymer materials can be used; if one liquid medical polymer material is used, it is evenly dripped onto the surface of the microneedle template to completely cover the surface of the template, and the bubbles under the covered surface are removed; if two liquid medical polymer materials are used, the first liquid medical polymer material is first completely covered on the surface of the microneedle template so that the first liquid medical polymer material fills each microneedle hole, and then the bubbles under the covered surface of the microneedle template are removed, and then the first liquid medical polymer material on the surface of the microneedle template is scraped off, and then the second liquid medical polymer material is completely covered on the surface of the microneedle template, and the bubbles under the covered surface of the microneedle template are removed again.

5. The method for producing a barbed medical tension-reducing bandage based on roller microneedles according to claim 1, characterized in that: In step 2, the amount of liquid medical polymer material uniformly covering the surface of the microneedle template is 0.2-0.4 mL per square centimeter.

6. The method for producing a barbed medical tension-reducing bandage based on roller microneedles according to claim 1, characterized in that: In step 2, after the liquid medical polymer material covers the surface of the microneedle template, the microneedle template completely covered with the liquid medical polymer material is placed in a vacuum drying oven, and the pressure of the vacuum drying oven is reduced from normal pressure 0 MPa to -0.1 MPa. After maintaining this pressure state for 1 minute, the atmosphere is slowly introduced until the pressure in the vacuum drying oven returns to normal pressure 0 MPa.

7. The method for producing a barbed medical tension-reducing bandage based on roller microneedles according to claim 1, characterized in that: In step 3, the material of the microneedle patch is silk fibroin, polyurethane or polyethylene glycol diacrylate.

8. The method for producing a barbed medical tension-reducing bandage based on roller microneedles according to claim 1, characterized in that: In step 3, the orderly arrangement of the barbs on the surface of the microneedle patch includes unidirectional arrangement, bidirectional arrangement or staggered arrangement.

9. The method for producing a barbed medical tension-reducing bandage based on roller microneedles according to claim 1, characterized in that: In step 3, the bandage substrate is a medical-grade elastic fabric material, including polyamide fiber, polyester fiber or polypropylene fiber.

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