Adhesive patch for skin surface fixation of small devices

Abstract

This invention relates to the field of medical dressings and skin device fixation technology, and in particular to a dressing tape for fixing small devices on the skin surface. It comprises, from the inside out, a contact layer, a support layer, a fixation layer, and a functional modification layer. The contact layer is in direct contact with the skin, and the fixation layer is used to bond and fix the small device to the surface. The layers are bonded together using a gradient bonding process, where the bonding strength increases progressively from the contact layer to the fixation layer. The contact layer of this invention uses a silicone-hydrocolloid blend modified material, combining the ultra-low allergenicity of silicone with the skin-friendly and exudation-absorbing properties of hydrocolloids. It is further enhanced with a medical-grade toughening agent to improve extensibility. Biocompatibility testing shows no allergenicity or cytotoxicity, exhibiting ultra-low allergenicity and high skin-friendliness, making it suitable for all populations, including the general population, people with sensitive skin, and children. Removal causes no skin damage.

Description

Technical Field

[0001] This invention relates to the field of medical dressings and skin device fixation technology, and in particular to a dressing tape for fixing small devices on the skin surface. Background Technology

[0002] In medical and health monitoring fields, it is often necessary to fix small devices such as blood glucose sensors, monitoring electrodes, and microcatheters onto the surface of human skin. Adhesive tape is a core component for achieving this fixation function. Currently, the materials used for fixing small devices on the skin surface mainly include single materials or simple composite materials such as polyurethane film, hydrocolloid, silicone, and non-woven fabric. While each has its advantages, several technical shortcomings remain. Allergy issues: Traditional acrylic adhesives are highly adhesive but irritate the skin. While silicone is hypoallergenic, it lacks stability. Hydrocolloids are only suitable for mild leakage scenarios. Sensitive skin, children, and other special groups may experience skin redness, swelling, and allergies when using them. Breathability and fixation are difficult to balance: porous non-woven fabrics have good breathability, but their stickiness drops sharply after absorbing moisture and they are prone to curling at the edges; polyurethane films have good waterproof properties, but their microporous structure is simple, and long-term application can easily lead to stuffiness and sweating of the skin, thus affecting the fixation effect. Poor scene adaptability: Most existing patches are designed with a single function, and functions such as waterproof, antibacterial and moisture-wicking cannot be adjusted as needed. They also lack anti-pull and anti-displacement designs for sports people, and their adhesive retention is insufficient for long-term fixed scenarios. Low ease of use: The existing patches have no special edge treatment, which makes them prone to lifting. There is no special tearing structure when removing them, which can easily cause skin damage. In addition, the device contact end has no fitting structure, which can easily cause the device to shift or fall off. Defects of composite process: Traditional composite dressings have uniform adhesion strength in each layer, which can easily lead to problems such as the contact layer being too tightly bonded to the skin or the fixation layer being too loosely bonded to the device, resulting in a high risk of delamination.

[0003] With the development of medical monitoring technology, small instruments on the skin surface are becoming increasingly miniaturized, intelligent, and designed for long-term use. This places higher demands on the hypoallergenicity, breathability, fixation, adaptability to various scenarios, and ease of use of adhesive dressings. Currently, no adhesive dressing can simultaneously achieve all of these properties. Therefore, developing a composite adhesive dressing that is compatible with various small instruments and application scenarios, and possesses ultra-low hypoallergenicity, high breathability, strong fixation, and ease of use, has become an urgent technical challenge. Summary of the Invention

[0004] The technical problem to be solved by the present invention is that there is no adhesive tape in the prior art that can take into account low allergenicity, breathability, fixation, adaptability to multiple scenarios and ease of use.

[0005] The technical solution adopted by the present invention to solve its technical problem is: an adhesive tape for fixing small instruments on the skin surface, comprising a contact layer, a support layer, a fixing layer and a functional modification layer sequentially compounded from the inside out. The contact layer is in direct contact with the skin, the fixing layer is used to bond and fix to the surface of the small instrument, and the layers are compounded together by a gradient bonding process, wherein the bonding strength is set to increase in a gradient from the contact layer to the fixing layer.

[0006] The contact layer is a silicone-hydrocolloid blend modified layer, which is made by blending and calendering medical-grade silicone particles, carboxymethyl cellulose hydrophilic particles and medical-grade toughening agent in a mass ratio of 6:3:1. The contact layer thickness is 0.05-0.1mm, and the surface is provided with micron-level breathable micropores with a pore size of 5-10μm and a porosity of 30%-40%. It retains the ultra-low allergenicity of silicone and the skin-friendly and exudation-absorbing properties of hydrocolloid, while improving the material's ductility through toughening agent. The micron-level breathable micropores ensure the skin's basic breathability needs.

[0007] The support layer is a porous structured polyurethane film layer with a thickness of 0.1-0.2mm. It has interconnected three-dimensional mesh-like breathable channels with a pore size of 20-50μm and an elongation of 150%-200%. The surface is also modified with hydrophilicity. The three-dimensional mesh-like breathable channels achieve efficient air and moisture permeability in the multi-layer structure, avoiding stuffiness on the skin. The hydrophilic modification improves the adhesion stability with the contact layer and fixing layer. The high elongation adapts to the movement curve of human skin and reduces edge curling.

[0008] The fixing layer is a gradient tack acrylic adhesive layer. The tack is 8-10N / 25mm on the side near the support layer and 15-20N / 25mm on the side away from the support layer. The thickness is 0.08-0.12mm, and the surface is provided with instrument adaptation grooves. The shape of the grooves matches the contact end of small instruments. The gradient tack design ensures stable adhesion to the support layer and improves the fixing strength to small instruments. The instrument adaptation grooves enable precise positioning of instruments and prevent displacement or detachment.

[0009] The functional modification layer is a replaceable coating structure, including one or more of the following: antibacterial modification layer, waterproof modification layer, and moisture-permeable enhancement layer. The thickness is 0.03-0.05mm. It is applied to the surface of the fixation layer by electrostatic spraying. The coating type can be flexibly selected according to different usage scenarios such as postoperative antibacterial, sports waterproof, and long-term moisture permeability, so as to achieve multi-scenario adaptation of the dressing.

[0010] The antibacterial modified layer is a silver ion-loaded polyurethane coating with a silver ion loading of 0.5%-1%; the waterproof modified layer is a fluorocarbon resin coating with a water contact angle ≥110°; the moisture-permeable reinforcing layer is a polyethylene glycol-modified acrylate coating with a moisture permeability ≥8000g / (m³). 2 •24h).

[0011] The adhesive tape features an elastic edging made of spandex elastic fabric, wrapped around the perimeter of each layer, with a width of 0.3-0.5cm. Its elasticity matches the support layer, effectively preventing edge curling and improving overall tensile strength, making it suitable for the activities of athletes. One side of the elastic edging features an easy-tear tab made of adhesive-free non-woven fabric, heat-pressed to the elastic edging. This tab is 1-2cm long and 0.5-1cm wide, with a non-slip textured surface for easy removal. The adhesive-free design prevents skin damage during removal, and the non-slip texture enhances ease of use.

[0012] One side of the elastic edging is provided with an easy-tear tab. The easy-tear tab is made of non-woven fabric without adhesive and is heat-pressed and bonded to the elastic edging. The length of the easy-tear tab is 1-2cm and the width is 0.5-1cm. The surface is provided with anti-slip texture.

[0013] A release protective layer, which is silicone release paper or release film, is provided on the side of the contact layer away from the support layer. It is bonded to the contact layer and its area is larger than the main area of ​​the adhesive tape, effectively protecting the adhesion and integrity of the contact layer. It can be easily peeled off during use.

[0014] The overall thickness of the adhesive tape of this invention is 0.31-0.49mm, and the overall extensibility is 120%-180%. It has passed the ISO10993 biocompatibility test and has no skin sensitization or cytotoxicity. In an environment of 37℃ and 90% humidity, the adhesion retention rate is ≥90%. Depending on the different settings of the functional modification layer, the continuous use time can reach 1-14 days, which can be adapted to different fixation needs in the short, medium and long term.

[0015] The beneficial effects of this invention are: (1) The contact layer of the present invention is made of silicone-hydrocolloid blend modified material, which combines the ultra-low allergenicity of silicone and the skin-friendly and exudation absorption properties of hydrocolloid. It is combined with medical-grade toughening agent to improve extensibility. It has been tested for biocompatibility and has no allergenicity or cytotoxicity. It has ultra-low allergenicity and high skin-friendliness, and is suitable for all people, including the general population, sensitive skin population, and children. It does not cause skin damage when removed. (2) The micron-level breathable micropores of the contact layer and the three-dimensional mesh breathable channels of the support layer form a double-layer breathable structure with significant moisture permeability and breathability, avoiding skin stuffiness and sweating caused by long-term application; the gradient bonding process and gradient adhesive fixation layer realize the gradient increase of the bonding strength from the skin to the device, which not only ensures skin affinity, but also improves the fixation strength of the device. The adhesion retention rate is ≥90% in high humidity environment, taking into account both breathability and fixation. (3) The functional modification layer is a replaceable coating structure. Antibacterial, waterproof and breathable coatings can be selected according to needs. The elastic edge wrapping improves the tensile strength and is suitable for various scenarios such as postoperative, sports, daily monitoring and long-term care. The continuous use time can reach 1-14 days, covering all fixed needs in the short, medium and long term, and flexibly adapting to multiple scenarios. (4) The device fitting groove enables precise positioning of small devices, avoiding displacement and detachment; the elastic edge wrapping solves the problem of edge lifting of traditional dressings and improves overall stability; the easy-tear ear piece facilitates dressing removal, and the glue-free design avoids skin damage; the release protective layer effectively protects the adhesiveness of the contact layer, making it simple to operate and greatly improving the convenience and stability of use. (5) The layered composite structure has clear functions and synergistic effects. The gradient bonding process avoids the layer from falling off. The overall thickness is thin and has good extensibility. It can closely fit the curve of the human skin without foreign body sensation, improving wearing comfort. The structural design is scientific and reasonable. Attached Figure Description

[0016] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0017] Figure 1 This is a schematic diagram of the structure of the present invention.

[0018] In the diagram: 1. Contact layer, 11. Breathable micropores, 2. Support layer, 21. Three-dimensional mesh breathable channel, 3. Fixing layer, 31. Instrument fitting groove, 4. Functional modification layer, 5. Elastic edging, 6. Easy-tear ear, 61. Anti-slip texture, 7. Release protective layer. Detailed Implementation

[0019] The present invention will now be described in further detail with reference to the accompanying drawings. These drawings are simplified schematic diagrams, illustrating only the basic structure of the invention, and therefore only show the components relevant to the invention.

[0020] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0021] like Figure 1As shown, the adhesive tape for fixing small devices on the skin surface in this embodiment includes a contact layer 1, a support layer 2, a fixing layer 3, and a functional modification layer 4, which are sequentially laminated from the inside out. The contact layer 1 is in direct contact with human skin, and the fixing layer 3 is used to bond and fix to the surface of small devices such as blood glucose sensors and monitoring electrodes. The layers are laminated together by a gradient bonding process. The gradient bonding process is set so that the bonding strength increases in a gradient from the contact layer 1 to the fixing layer 3, so as to avoid the contact layer 1 being too tightly bonded to the skin or the fixing layer 3 being too loosely bonded to the device, and at the same time prevent the layers from delaminating and falling off.

[0022] Contact layer 1 is a silicone-hydrocolloid blend modified layer, made by blending and calendering medical-grade silicone particles, carboxymethyl cellulose hydrophilic particles, and medical-grade toughening agent (polycaprolactone) in a mass ratio of 6:3:1. The thickness of contact layer 1 is 0.08 mm, and the surface is provided with micron-sized breathable micropores 11, with a pore size of 8 μm and a porosity of 35%. Medical-grade silicone particles ensure ultra-low allergenicity of contact layer 1, carboxymethyl cellulose hydrophilic particles allow for the absorption of a small amount of skin exudate to maintain a moist skin environment, polycaprolactone toughening agent improves the extensibility and tear resistance of contact layer 1, and micron-sized breathable micropores 11 enable basic gas exchange between the skin and the external environment, preventing skin stuffiness.

[0023] The support layer 2 is a porous structured polyurethane film layer with a thickness of 0.15 mm. It contains interconnected three-dimensional mesh-like breathable channels 21 with a pore size of 35 μm. The support layer 2 has a stretchability of 180%, and its surface is treated with plasma to achieve hydrophilicity modification. The three-dimensional mesh-like breathable channels 21 are interconnected with the breathable micropores 11 of the contact layer 1, forming a double-layer breathable structure. This significantly improves the breathability and moisture permeability of the patch. The hydrophilic modification treatment enhances the adhesion compatibility and stability between the support layer 2, the contact layer 1, and the fixing layer 3. The high stretchability of 180% allows for close conformity to curved areas such as joints and limbs, reducing edge lifting caused by skin movement.

[0024] The fixing layer 3 is a gradient adhesive acrylate layer, prepared using microphase separation technology. The adhesive strength of the fixing layer 3 is 9 N / 25 mm on the side closer to the support layer 2 and 18 N / 25 mm on the side farther from the support layer 2. The thickness of the fixing layer 3 is 0.1 mm, and its surface is provided with a device adapter groove 31. The shape of the device adapter groove 31 matches the contact end of the dynamic blood glucose sensor, and its depth is 0.05 mm. The gradient adhesive design ensures stable adhesion between the fixing layer 3 and the support layer 2, and also improves the fixing strength with small devices, preventing device displacement. The device adapter groove 31 enables precise positioning of small devices, further improving fixing stability and preventing the device from sliding on the skin surface.

[0025] The functional modification layer 4 is an antibacterial-waterproof composite modification layer with a thickness of 0.04 mm. It is laminated onto the surface of the fixing layer 3 using an electrostatic spraying process. The antibacterial-waterproof composite modification layer is composed of a silver ion-loaded polyurethane coating and a fluorocarbon resin coating in a 1:1 mass ratio, with a silver ion loading of 0.8% and a water contact angle ≥115°. The silver ion-loaded polyurethane coating provides a continuous antibacterial effect, inhibiting bacterial growth on the skin surface, and is suitable for antibacterial applications such as postoperative instrument fixation. The fluorocarbon resin coating provides highly efficient waterproofing, preventing a decrease in adhesiveness due to washing or sweating, and is suitable for athletes or daily washing scenarios. In other embodiments, the functional modification layer 4 can be set as a single moisture-permeable enhancement layer, which is a polyethylene glycol-modified acrylate coating with a moisture permeability ≥8500 g / (m²). 2 •24h), suitable for long-term fixed moisture permeability requirements.

[0026] The adhesive tape has an elastic edging 5 at its edge. The elastic edging 5 is a spandex elastic fabric layer that wraps around the outer periphery of the contact layer 1, support layer 2, fixing layer 3, and functional modified layer 4. The elastic edging 5 is 0.4 cm wide and has an elongation of 180%, matching the elongation of the support layer 2. The elastic edging 5 is connected to the outer periphery of each layer using a hot-press bonding process, effectively wrapping the tape edge and solving the technical problem of traditional tape edges easily lifting. It also improves the overall tensile strength of the tape, ensuring stability and preventing it from falling off even during vigorous human activity.

[0027] One side of the elastic edging 5 is equipped with an easy-tear ear piece 6. The easy-tear ear piece 6 is made of adhesive-free polyester non-woven fabric and is heat-pressed together with the elastic edging 5. The easy-tear ear piece 6 is 1.5cm long and 0.8cm wide, and its surface is decorated with a diamond-shaped anti-slip texture 61. The easy-tear ear piece 6 is adhesive-free to avoid sticking to the skin. When using it, simply pinch the easy-tear ear piece 6 and gently tear it off to remove the patch from the skin surface without causing skin damage. The diamond-shaped anti-slip texture 61 increases the friction between the hand and the patch during tearing, improving ease of use.

[0028] A release layer 7 is provided on the side of the contact layer 1 away from the support layer 2. In this embodiment, the release layer 7 is double-sided silicone release paper, which is tightly adhered to the contact layer 1. The area of ​​the release layer 7 is 0.2 cm larger than the main body area of ​​the adhesive tape. The edge of the release layer 7 is provided with a tear notch for easy removal during use. In other embodiments, the release layer 7 can be made of PET release film to suit different usage and storage requirements.

[0029] The adhesive tape of this embodiment, after preparation, has an overall thickness of 0.42 mm and an overall extensibility of 150%. It passed the ISO10993 biocompatibility test, showing no skin sensitization or cytotoxicity, with a skin irritation rating of 0. In a simulated human body environment of 37°C and 90% humidity, after 14 days of continuous placement, the adhesive retention rate was 95%, with no curling, delamination, or detachment. When the dynamic blood glucose sensor was fixed to the skin of the arm using this adhesive tape, the sensor did not shift during daily activities and washing. After 7 days of continuous use, there was no stuffiness, redness, swelling, or allergic reaction on the skin, and no skin damage occurred upon removal, demonstrating good sensor fixation stability.

[0030] In another embodiment, for small electrode pads for short-term temporary fixation (1-3 days), the functional modification layer 4 is set as a single moisture-permeable enhancement layer, the contact layer 1 has a thickness of 0.05 mm, the support layer 2 has a thickness of 0.1 mm, the fixation layer 3 has a thickness of 0.08 mm, the functional modification layer 4 has a thickness of 0.03 mm, the elastic edging 5 has a width of 0.3 cm, the easy-tear ear piece 6 has a length of 1 cm and a width of 0.5 cm, the overall thickness of the application is 0.31 mm, the overall extensibility is 120%, and the adhesion retention rate is 92% under simulated conditions. It is suitable for the fixation needs of short-term, lightweight devices, and is thinner and more comfortable.

[0031] In another embodiment, for postoperative microcatheters with long-term fixation (10-14 days), the functional modification layer 4 is configured as an antibacterial-moisture-permeable composite modification layer. The contact layer 1 has a thickness of 0.1 mm, the support layer 2 has a thickness of 0.2 mm, the fixation layer 3 has a thickness of 0.12 mm, the functional modification layer 4 has a thickness of 0.05 mm, the elastic edging 5 has a width of 0.5 cm, the easy-tear ear piece 6 has a length of 2 cm and a width of 1 cm, the overall thickness of the dressing is 0.49 mm, the overall extensibility is 180%, the adhesion retention rate is 90% under simulated conditions, the antibacterial rate is ≥99%, and the moisture permeability is ≥8000 g / (m²). 2 • 24h) can achieve long-term stable fixation of the microcatheter after surgery, while taking into account the needs of antibacterial and skin breathability.

[0032] Based on the above-described preferred embodiments of the present invention, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the inventive concept. The technical scope of this invention is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. A dressing tape for fixing small instruments on the skin surface, characterized in that, It includes a contact layer (1), a support layer (2), a fixation layer (3) and a functional modification layer (4) that are sequentially composited from the inside out. The contact layer (1) is in direct contact with the skin, and the fixation layer (3) is used to bond and fix to the surface of a small instrument. The layers are composited together by a gradient bonding process, in which the bonding strength increases in a gradient from the contact layer (1) to the fixation layer (3).

2. The adhesive tape for fixing small instruments on the skin surface according to claim 1, characterized in that, The contact layer (1) is a silicone-hydrocolloid blend modified layer, which is made by blending and calendering medical silicone particles, carboxymethyl cellulose hydrophilic particles and medical-grade toughening agent in a mass ratio of 6:3:

1. The thickness of the contact layer (1) is 0.05-0.1 mm, and the surface is provided with micron-sized breathable micropores (11). The pore size of the breathable micropores (11) is 5-10 μm, and the porosity is 30%-40%.

3. The adhesive tape for fixing small instruments on the skin surface according to claim 1, characterized in that, The support layer (2) is a porous structured polyurethane film layer with a thickness of 0.1-0.2 mm. It has interconnected three-dimensional mesh ventilation channels (21) with a pore size of 20-50 μm. The support layer (2) has an elongation of 150%-200% and its surface is hydrophilic modified.

4. The adhesive tape for fixing small instruments on the skin surface according to claim 1, characterized in that, The fixing layer (3) is a gradient tack acrylic adhesive layer. The tack of the fixing layer (3) near the support layer (2) is 8-10 N / 25 mm, and the tack of the side away from the support layer (2) is 15-20 N / 25 mm. The thickness of the fixing layer (3) is 0.08-0.12 mm, and the surface is provided with an instrument adapter groove (31). The shape of the instrument adapter groove (31) matches the contact end of the small instrument.

5. The adhesive tape for fixing small instruments on the skin surface according to claim 1, characterized in that, The functional modification layer (4) is a replaceable coating structure, including one or more of the following: antibacterial modification layer, waterproof modification layer and moisture-permeable enhancement layer. The thickness of the functional modification layer (4) is 0.03-0.05 mm, and it is composited onto the surface of the fixed layer (3) by electrostatic spraying.

6. The adhesive tape for fixing small instruments on the skin surface according to claim 5, characterized in that, The antibacterial modified layer is a silver ion-loaded polyurethane coating with a silver ion loading of 0.5%-1%; the waterproof modified layer is a fluorocarbon resin coating with a water contact angle ≥110°; the moisture-permeable reinforcing layer is a polyethylene glycol-modified acrylate coating with a moisture permeability ≥8000g / (m³). 2 •24h).

7. The adhesive tape for fixing small instruments on the skin surface according to claim 1, characterized in that, The edge of the adhesive tape is provided with an elastic edging (5). The elastic edging (5) is a spandex elastic fabric layer that wraps around the outer periphery of the contact layer (1), support layer (2), fixing layer (3) and functional modification layer (4). The width of the elastic edging (5) is 0.3-0.5cm, and its extensibility matches that of the support layer (2).

8. The adhesive tape for fixing small instruments on the skin surface according to claim 7, characterized in that, One side of the elastic edging (5) is provided with an easy-tear ear piece (6). The easy-tear ear piece (6) is made of non-woven fabric without glue and is heat-pressed and bonded to the elastic edging (5). The length of the easy-tear ear piece (6) is 1-2cm and the width is 0.5-1cm. The surface is provided with anti-slip texture (61).

9. The adhesive tape for fixing small instruments on the skin surface according to claim 1, characterized in that, A release protective layer (7) is provided on the side of the contact layer (1) away from the support layer (2). The release protective layer (7) is a silicone release paper or release film, which is attached to the contact layer (1), and the area of ​​the release protective layer (7) is larger than the main area of ​​the adhesive tape.

10. The adhesive tape for fixing small instruments on the skin surface according to any one of claims 1-9, characterized in that, The overall thickness of the adhesive tape is 0.31-0.49mm, and the overall extensibility is 120%-180%. It has passed the ISO10993 biocompatibility test and is non-allergenic and non-cytotoxic. In an environment of 37℃ and 90% humidity, the adhesion retention rate is ≥90%, and the continuous use time can reach 1-14 days.

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