A medical adhesive material for a continuous glucose monitoring device and its preparation method

Abstract

This invention relates to a medical adhesive material for continuous glucose monitoring devices. The medical adhesive material is a single patch formed from medical pressure-sensitive adhesive tape through a die-cutting process, comprising: a support layer having opposing first and second surfaces; a first medical pressure-sensitive adhesive layer formed on the first surface of the support layer; and a second medical pressure-sensitive adhesive layer formed on the second surface of the support layer, for direct contact with the skin. The medical adhesive material of this invention employs a double-layer medical pressure-sensitive adhesive structure. The first adhesive layer has strong anchoring force with the support layer and forms a stable bond with the sensor base; the second adhesive layer has moderate initial tack and holding power to the skin. The two layers work together to ensure the overall structural integrity of the continuous glucose monitoring device during a 7-14 day wearing period, preventing the sensor base from loosening or shifting.

Description

Technical Field

[0001] This invention belongs to the field of blood glucose monitoring technology, specifically relating to a medical adhesive material for a continuous blood glucose monitoring device and its preparation method. Background Technology

[0002] In continuous blood glucose monitoring, sensors are usually attached to the surface of human skin to enable long-term, continuous monitoring of interstitial fluid glucose levels. To ensure that the sensor works stably for several days or even longer, the way it is fixed to the skin usually depends on the attachment material. These attachment materials are generally of a homogeneous structure and are mostly made of the same viscoelastic material.

[0003] However, in practical applications, the adhesive material needs to have sufficient initial adhesion and holding power. If the viscosity is too low, the fixing strength will be insufficient, and the sensor may fall off accidentally, resulting in monitoring interruption or data loss. Conversely, if the fixing effect is enhanced by increasing the overall viscosity of the adhesive layer, although the sensor can be stably installed, the high viscosity adhesive layer will exert a strong shearing and peeling effect on the stratum corneum of the skin after a long period of application.

[0004] Specifically, when users move, turn over, or remove the patch, the adhesive layer will generate significant resistance due to skin deformation, making it easy to pull, twist, or even tear the skin, causing obvious stinging and itching. It often leaves adhesive residue after removal, and in severe cases, it can cause skin redness, allergies, or damage to the stratum corneum, significantly reducing user compliance.

[0005] Furthermore, most adhesive layers of the bonding materials are designed to be completely continuous within the bonding area, lacking buffer space. Specifically, human skin is not a rigid plane, but a dynamic tissue with high flexibility, elasticity, and irregular curvature. When users perform actions such as bending their elbows, clenching their fists, or twisting their forearms, the skin undergoes significant stretching, compression, and wrinkling. The continuous solid adhesive layer acts like a rigid "shackle," hindering the natural deformation of the skin. This results in significant stress concentration at the edges of the adhesive layer and at the connection between the sensor base and the adhesive layer. During repeated skin deformation, this accelerates the tendency of the adhesive layer edges to lift off the skin, thus triggering local failure at the point of highest stress. This leads to the sensor becoming loose or detaching prematurely, making it unable to support long-term stable blood glucose monitoring.

[0006] Therefore, there is a need to design a medical adhesive material that can effectively disperse stress, reduce skin discomfort, and provide long-term, stable fixation support for sensors while ensuring sufficient adhesion strength. Summary of the Invention

[0007] To achieve the above objectives, the present invention provides a medical patch material for a continuous glucose monitoring device. The medical patch material is a single patch formed from medical pressure-sensitive adhesive tape through a die-cutting process, comprising:

[0008] A support layer having opposing first and second surfaces;

[0009] A first medical pressure-sensitive adhesive layer is formed on the first surface of the support layer;

[0010] A second medical pressure-sensitive adhesive layer is formed on the second surface of the support layer for direct contact with the skin;

[0011] The adhesive material has at least one local structural region that penetrates or partially penetrates at least one adhesive layer.

[0012] The local structural region corresponds to the sensor needle location, the edge region of the adhesive material, or a combination thereof, and the coverage of the first medical pressure-sensitive adhesive layer and / or the second medical pressure-sensitive adhesive layer in the local structural region is lower than that in other regions.

[0013] Preferably, the first medical pressure-sensitive adhesive layer is a conventional medical acrylic pressure-sensitive adhesive layer or an acrylic hot-melt medical pressure-sensitive adhesive layer; the second medical pressure-sensitive adhesive layer is a conventional medical acrylic pressure-sensitive adhesive layer.

[0014] Preferably, the support layer is an elastic polyurethane nonwoven fabric with a basis weight range of 50~100 g / m².

[0015] Preferably, the local structural regions are distributed in any one of the following ways in the planar direction of the attached material: ring-shaped, arc-shaped, island-shaped, strip-shaped, or hollow-out.

[0016] Preferably, in the local structural region, the support layer is exposed to the external environment or in direct contact with the release layer, or the thickness of the first and / or second medical pressure-sensitive adhesive layer is reduced.

[0017] Preferably, the thickness of the first and / or second medical pressure-sensitive adhesive contained in the local structural region is less than the average thickness of the corresponding adhesive layer.

[0018] Preferably, the local structural region is configured to reduce the direct contact area between the adhesive material and the skin around the sensor needle site, or to reduce the adhesion stress between the edge of the adhesive material and the skin.

[0019] Another aspect of the present invention provides a method for preparing a medical adhesive material, characterized by comprising the following steps:

[0020] S01 provides an elastic nonwoven fabric as a support layer, the support layer having opposing first and second surfaces;

[0021] S02 A first medical pressure-sensitive adhesive layer is formed on the first surface of the support layer;

[0022] S03 A second medical pressure-sensitive adhesive layer is formed on the second surface of the support layer;

[0023] S04 composite release layer;

[0024] S05 At least one local structural region is formed on the adhesive material such that the coverage of the first and / or second medical pressure-sensitive adhesive layer in the region is lower than that in other regions.

[0025] Compared with the prior art, the beneficial effects of the present invention are:

[0026] The medical adhesive material in this invention adopts a double-layer medical pressure-sensitive adhesive structure. The first layer of adhesive has strong anchoring force with the support layer and forms a stable bond with the sensor base. The second layer of adhesive has moderate initial adhesion and holding force to the skin. The two layers work together to ensure that the overall structure of the continuous blood glucose monitoring device remains intact during the 7-14 day wearing period, and the sensor base does not loosen or shift.

[0027] This invention uses medical-grade acrylic pressure-sensitive adhesive with extremely low monomer residue, combined with a solvent-free coating process, so that the adhesive material has no obvious irritating odor when the packaging is opened and during use, which significantly improves the patient's acceptance and comfort.

[0028] The adhesive material of this invention has a local structural area at the edge, so that the edge adhesion is lower than that of the central area. When the skin deforms due to limb movement, the low-adhesion edge can adapt to the stretching of the skin without generating excessive tensile stress, thus avoiding edge lifting, blistering or tension blisters caused by stress concentration.

[0029] The elastic nonwoven support layer of this invention can adapt to the stretching and contraction of the skin, reducing deformation and discomfort. At the same time, it can controllably reduce the coverage of the adhesive layer in the needle hole area through local structural regions, thereby reducing the average peel stress actually borne by the skin by 30% to 50%, achieving the effect of "firm but not damaging the skin". Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the structure of the traditional Chinese medicine adhesive material of the present invention;

[0031] Figure 2 This is a cross-sectional schematic diagram showing the application state of the traditional Chinese medicine patch material of the present invention;

[0032] Figure 3 This is a flowchart illustrating the preparation process of the traditional Chinese medicine adhesive material of the present invention.

[0033] The numbers in the diagram are: 1-support layer, 101-first surface, 102-second surface, 2-first medical pressure-sensitive adhesive layer, 3-second medical pressure-sensitive adhesive layer, 4-local structural area, 5-release layer. Detailed Implementation

[0034] 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.

[0035] Example 1

[0036] like Figures 1 to 2 The illustrated medical adhesive material for a continuous glucose monitoring device is a single patch formed from medical pressure-sensitive adhesive tape using a die-cutting process. It includes: a support layer 1 having opposing first and second surfaces 101 and 102; a first medical pressure-sensitive adhesive layer 2 formed on the first surface 101 of the support layer 1; and a second medical pressure-sensitive adhesive layer 3 formed on the second surface 102 of the support layer 1 for direct contact with the skin. The adhesive material has at least one local structural region 4 that penetrates or partially penetrates at least one adhesive layer. The local structural region 4 corresponds to the sensor needle location, the edge region of the adhesive material, or a combination thereof. The coverage of the first medical pressure-sensitive adhesive layer 2 and / or the second medical pressure-sensitive adhesive layer 3 within the local structural region 4 is lower than in other regions. The first medical pressure-sensitive adhesive layer 2 is a conventional medical acrylic pressure-sensitive adhesive layer or an acrylic hot-melt medical pressure-sensitive adhesive layer. The second medical pressure-sensitive adhesive layer 3 is a conventional medical acrylic pressure-sensitive adhesive layer. The support layer 1 is an elastic polyurethane nonwoven fabric with a basis weight range of 50-100%. g / m²; the local structural region 4 is distributed in any one of the following shapes in the planar direction of the adhesive material: ring-shaped, arc-shaped, island-shaped, strip-shaped, or hollow-out; in the local structural region 4, the support layer 1 is exposed to the external environment or in direct contact with the release layer 5, or the thickness of the first and / or second medical pressure-sensitive adhesive layer is reduced; the thickness of the first and / or second medical pressure-sensitive adhesive contained in the local structural region 4 is less than the average thickness of the corresponding adhesive layer; the local structural region 4 is configured to reduce the direct contact area between the adhesive material and the skin around the sensor needle site, or to reduce the adhesion stress between the edge of the adhesive material and the skin.

[0037] like Figure 3 The method for preparing a medical adhesive material, as shown, is characterized by comprising the following steps:

[0038] S01 provides an elastic nonwoven fabric as a support layer 1, the support layer 1 having a first surface 101 and a second surface 102 opposite to each other;

[0039] S02 A first medical pressure-sensitive adhesive layer 2 is formed on the first surface 101 of the support layer 1;

[0040] S03 A second medical pressure-sensitive adhesive layer 3 is formed on the second surface 102 of the support layer 1;

[0041] S04 Composite Release Layer 5;

[0042] S05 At least one local structural region 4 is formed on the adhesive material such that the coverage of the first and / or second medical pressure-sensitive adhesive layer 3 in the region is lower than that in other regions.

[0043] The medical adhesive material of this invention adopts a double-layer medical pressure-sensitive adhesive structure. The first layer of adhesive has strong anchoring force with the support layer 1 and forms a stable bond with the sensor base. The second layer of adhesive has moderate initial tack and holding force to the skin. The two layers work together to ensure the overall structural integrity of the continuous blood glucose monitoring device during the 7-14 day wearing period, and that the sensor base does not loosen or shift. This invention uses medical-grade acrylic pressure-sensitive adhesive with extremely low monomer residue, combined with a solvent-free coating process, so that the adhesive material has no obvious irritating odor when opened and during use, significantly improving patient acceptance and comfort. Adaptability; The edge of the adhesive material in this invention is provided with a local structural region 4, so that the edge adhesion force is lower than that of the central region. When the skin deforms due to limb movement, the low-adhesion edge can adapt to the skin stretching without generating excessive tensile stress, avoiding edge lifting, blistering or tension blisters caused by stress concentration; The elastic non-woven fabric support layer 1 of this invention can adapt to skin stretching and contraction, reducing deformation discomfort. At the same time, the adhesive layer coverage in the needle hole area can be controlled to be reduced through the local structural region 4, so that the average peel stress actually borne by the skin is reduced by 30% to 50%, achieving the effect of "firm but not damaging the skin".

[0044] Example 2

[0045] like Figures 1 to 2 The above describes a medical adhesive material for a continuous blood glucose monitoring device. The medical adhesive material is formed into a single patch by die-cutting medical pressure-sensitive tape. It has a single-use independent patch structure and can be directly used with the sensor base of the continuous blood glucose monitoring device.

[0046] Medical adhesive materials include:

[0047] The support layer 1 has a first surface 101 and a second surface 102. The support layer 1 is an elastic polyurethane nonwoven fabric with a basis weight range of 50~100 g / m², which makes it have sufficient mechanical strength while also having good elasticity, flexibility and moisture permeability. It can adapt to the stretching and contraction of the skin under different body activity states and reduce peeling or discomfort caused by inconsistent deformation between the attached material and the skin.

[0048] The first medical pressure-sensitive adhesive layer 2 is formed on the first surface 101 of the support layer 1. It is mainly used to connect the support layer 1 with the sensor base or fixing ring of the continuous blood glucose monitoring device, so as to ensure that the sensor component is stably attached to the adhesive material and avoid relative displacement during use.

[0049] The second medical pressure-sensitive adhesive layer 3 is formed on the second surface 102 of the support layer 1 and is used for direct contact with the skin. The second medical pressure-sensitive adhesive is a medical pressure-sensitive adhesive that is hypoallergenic to the skin and can be gently peeled off, ensuring that it can still be removed painlessly after wearing for a long time without leaving any adhesive residue.

[0050] Furthermore, the adhesive material has at least one local structural region 4 that penetrates or partially penetrates at least one adhesive layer; the local structural region 4 corresponds to one or more of the following locations: the sensor needle port location, the edge area of ​​the adhesive material, or a combination of the above. Within the local structural region 4, the coverage of the first medical pressure-sensitive adhesive layer 2 and / or the second medical pressure-sensitive adhesive layer 3 is lower than that of other areas; here, "coverage" specifically refers to the proportion of adhesive present in the adhesive layer per unit area, and its reduction can be manifested as the complete absence of the adhesive layer in a specific area, or as a reduction in the thickness of the adhesive layer.

[0051] Specifically, if the local structural region 4 is in the form of a through hole, then one or two adhesive layers in this region are completely missing, exposing the support layer 1 or forming a through hole; if it is in the form of a partial through hole, then the thickness of the adhesive layer is reduced or it is distributed in a discontinuous dot or grid pattern, which significantly reduces the coating amount per unit area of ​​the adhesive layer in this region.

[0052] Furthermore, the local structural region 4 corresponding to the sensor needle location is a through-hole penetrating the entire layer of the adhesive material. That is, local structural region 4 simultaneously penetrates the first adhesive layer, the support layer 1, and the second adhesive layer, allowing the sensor needle to pass through without contact. This prevents the adhesive from coming into contact with the needle or wound exudate, reducing the risk of infection and minimizing the adhesive's obstruction of needle movement. Conversely, the local structural region 4 corresponding to the edge area of ​​the adhesive material is a reduced-adhesion area that only reduces the coverage of the second adhesive layer. This reduced-adhesion area is distributed in a ring-shaped pattern along the outer periphery of the adhesive material, with a width of 1–5 mm. This design weakens the adhesive force at the edges, reducing skin pulling sensation caused by excessive edge adhesion, and creating a breathable channel. It also facilitates removal from the edge after use.

[0053] The medical adhesive material also includes a composite release layer 5 covering the lower surface of the second medical pressure-sensitive adhesive layer 3 and the lower opening of the local structural area 4. The composite release layer 5 can be a single-layer or double-layer structure, such as release paper or release film, and has protrusions or indentations at the corresponding local structural area 4 to protect the adhesive layer from contamination before use.

[0054] Example 3

[0055] like Figures 1 to 2 The medical adhesive material shown is for a continuous blood glucose monitoring device. The first medical pressure-sensitive adhesive layer 2 is a conventional medical acrylic pressure-sensitive adhesive layer or an acrylic hot-melt medical pressure-sensitive adhesive layer. Specific optional materials include, but are not limited to: synthetic rubber platform, solvent-free acrylic platform, or 100% solids adhesive.

[0056] The second medical pressure-sensitive adhesive layer 3 is a conventional medical acrylic pressure-sensitive adhesive layer. Specific materials that can be selected include, but are not limited to, solvent-free acrylic adhesives or 100% solid adhesives.

[0057] Using the specific materials described above, the specific components of the medical adhesive material, from top to bottom, are as follows:

[0058] First medical pressure-sensitive adhesive layer 2: Coating amount is 15-40 g / m²;

[0059] Support layer 1: Elastic polyurethane nonwoven fabric, basis weight 50-100 g / m²;

[0060] Second medical pressure-sensitive adhesive layer 3: Coating amount is 20-50 g / m²;

[0061] Composite release layer 5: Covers the lower surface of the second medical pressure-sensitive adhesive layer 3.

[0062] In summary, both the conventional and hot-melt types of the first layer of acrylic pressure-sensitive adhesive provide excellent anchoring force to the polyurethane nonwoven fabric support layer 1 and form a strong bond with the sensor base material. The second layer of acrylic pressure-sensitive adhesive provides moderate initial tack and long-lasting retention to the stratum corneum of the skin. The two layers work together to ensure the overall structural integrity of the continuous blood glucose monitoring device during the 7-14 day wearing period, and that the sensor base does not loosen or shift.

[0063] Furthermore, synthetic rubber platforms, solvent-free acrylic platforms, or 100% solids adhesives do not use organic solvents during the coating process, thus avoiding the strong, irritating odor caused by organic solvent residues.

[0064] Following the previous point, the first layer only needs to ensure adhesion strength to the sensor base and does not directly contact the skin. Therefore, the requirements for the sensitization of the adhesive are relatively relaxed, and an acrylic formula with stronger cohesion can be selected. The second layer comes into direct contact with the skin and uses a conventional medical-grade acrylic pressure-sensitive adhesive that has been verified through skin irritation testing. Its pH value is close to that of the skin, and the monomer residue is extremely low. Long-term application is unlikely to cause erythema, itching, or contact dermatitis. At the same time, the inherent moisture-permeable and breathable properties of the acrylic pressure-sensitive adhesive system will not significantly seal the skin, which helps to reduce maceration and folliculitis. In addition, it has high compatibility with existing medical tape production lines and does not require additional equipment modifications. It is particularly suitable for the long-term wear requirements of continuous blood glucose monitoring devices.

[0065] Example 4

[0066] like Figures 1 to 2 The illustrated medical adhesive material for a continuous blood glucose monitoring device has a local structural region 4 distributed in any of the following shapes in the planar direction of the adhesive material: ring-shaped, arc-shaped, island-shaped, strip-shaped, or hollowed-out. The local structural region 4 can be formed by a die-cutting process, specifically using a circular die-cutting or a flat die-cutting method. Using die-cutting blades of different depths and shapes, corresponding portions of the first medical pressure-sensitive adhesive layer 2 and / or the second medical pressure-sensitive adhesive layer 3 are selectively removed, while the support layer 1 remains intact or is partially cut through. In this region, the support layer 1 is exposed to the external environment or in direct contact with the release layer 5. That is, in this local structural region 4: if it is a single-sided adhesive removal, one side of the support layer 1 is exposed to the air or in contact with the sensor base, while the other side has no adhesive layer; if it is a double-sided adhesive removal, neither side of the support layer 1 is covered with adhesive layer, and the support layer 1 itself is directly exposed or in contact with the composite release layer 5 before use.

[0067] The thickness of the first and / or second medical pressure-sensitive adhesive contained in the local structural region 4 is less than the average thickness of the corresponding adhesive layer, so as to ensure that the local structural region 4 retains a low adhesive force rather than being completely non-adhesive; the thickness reduction can be achieved by one or more of the following methods: local thinning coating, partial removal after die cutting, or forming a thickness gradient region by using transfer printing.

[0068] Specifically, the local structural region 4 is configured to reduce the direct contact area between the adhesive material and the skin around the sensor needle site, or to reduce the adhesion stress between the edge of the adhesive material and the skin.

[0069] In the local structural area 4 corresponding to the sensor needle site, if the second medical pressure-sensitive adhesive layer 3 is partially or completely missing, in order to significantly reduce the adhesion area between the adhesive material and the skin around the needle site, this area can adopt the following distribution forms: a ring distribution of continuous or intermittent adhesive-reducing strips around the needle site, an island-like distribution forming multiple isolated non-adhesive areas, and a hollow distribution of grid-like or dot-matrix-like non-adhesive areas inside the adhesive material; the above design can avoid the adhesive directly contacting the micro-damaged skin at the edge of the puncture point, reduce the risk of local maceration and infection caused by the reaction of exudate and colloid, and reduce the pain when removing the needle, while providing a micro-permeable environment for the needle site and promoting wound healing.

[0070] If the thickness of the second medical pressure-sensitive adhesive layer 3 is reduced or discontinuous in the local structural region 4 at the edge of the adhesive material, so that the adhesion force at the edge is lower than that in the central region, the region can adopt the following distribution forms: a strip-shaped distribution with a breathable channel set along a certain edge or diagonal direction of the adhesive material; an arc-shaped distribution set in a local area at the edge of the adhesive material; or a ring-shaped distribution with a continuous or discontinuous adhesive-reducing strip set around the sensor needle position.

[0071] Furthermore, when the user's skin deforms due to limb movement, the low-adhesion edge can adapt to the skin stretching without generating excessive tensile stress, avoiding edge lifting, blistering, or tension blisters caused by stress concentration; after the wearing period ends, the operator can easily peel off from this low-adhesion edge and gradually separate the adhesive material, reducing sudden tearing damage to the skin.

[0072] In summary, this embodiment, based on high-strength adhesion, controls the coverage of the adhesive layer in the needle hole and edge areas by reducing the actual average peel stress on the skin by 30% to 50% through local structural region 4, thereby avoiding tension blisters and avulsion injuries, and achieving the technical effect of "firm but not damaging the skin".

[0073] Example 5

[0074] like Figure 3 The method for preparing the medical adhesive material shown includes the following steps:

[0075] S01 provides an elastic nonwoven fabric as a support layer 1, the support layer 1 having a first surface 101 and a second surface 102 opposite to each other;

[0076] S02 A first medical pressure-sensitive adhesive layer 2 is formed on the first surface 101 of the support layer 1;

[0077] S03 A second medical pressure-sensitive adhesive layer 3 is formed on the second surface 102 of the support layer 1;

[0078] S04 Composite Release Layer 5;

[0079] S05 At least one local structural region 4 is formed on the adhesive material such that the coverage of the first and / or second medical pressure-sensitive adhesive layer in the region is lower than that in other regions.

[0080] Specifically, the elastic nonwoven fabric is preferably an elastic polyurethane nonwoven fabric with a basis weight range of 50 to 100 g / m². The support layer 1 needs to be cleaned and pretreated before use to enhance the anchoring force between the subsequent pressure-sensitive adhesive layer and the surface of the nonwoven fabric.

[0081] A first pressure-sensitive adhesive composition is applied to the first surface 101 of the support layer 1 using a coating process. The first medical pressure-sensitive adhesive adhesion layer 2 is a conventional medical acrylic pressure-sensitive adhesive layer or an acrylic hot-melt medical pressure-sensitive adhesive layer. After coating, it is dried or cooled and cured to form a uniform adhesive layer. The coating amount is 15-40 g / m². When using an acrylic hot-melt pressure-sensitive adhesive, the coating temperature is controlled at 120-180℃. After coating, it is immediately cooled and shaped. Then, using the same or different coating process as SO2, a second pressure-sensitive adhesive composition is applied to the second surface 102 of the support layer 1. The second medical pressure-sensitive adhesive adhesion layer 3 is a conventional medical acrylic pressure-sensitive adhesive layer. After coating, it is dried and cured to form a uniform adhesive layer. The coating amount is 20-50 g / m².

[0082] To ensure that the first and second adhesive layers do not interfere with each other, S02 and S03 can be performed sequentially. In the step-by-step coating process, the coated surface must be fully dried or cooled before the coating operation on the other side can be carried out to prevent the adhesive layer from transferring or sticking; or a double-sided synchronous coating equipment can be used to complete the process in one step.

[0083] Release layer 5 is selected from release paper or release film, with a release force of 5 to 30 g / in, and the release surface faces the second pressure-sensitive adhesive layer. The lamination method adopts pressure roller bonding, and the bonding pressure is 0.2 to 0.8 MPa to ensure that there are no air bubbles or wrinkles between release layer 5 and adhesive layer. If release layer 5 also needs to be attached to the exposed surface of the first medical pressure-sensitive adhesive layer 2, the release force of the selected release paper or release film should be lower than that of the second side release layer 5 to facilitate the peeling and use of each layer during the production process.

[0084] Subsequently, at least one local structural region 4 is formed on the adhesive material through a die-cutting process, such that the coverage of the first and / or second medical pressure-sensitive adhesive layer 3 in this region is lower than that in other regions; wherein the die-cutting process includes one or more of full cut, half cut, gap cut or punching, to achieve selective removal or thinning of the adhesive layer in the local structural region 4.

[0085] Full cut refers to the cutting tool completely penetrating all layers of the adhesive material, separating the adhesive material into independent single pieces, and removing the complete material at the corresponding position of the local structural area 4 to form a through hole; half cut refers to penetrating only part of the layers to form a local structural area 4 where the adhesive layer is removed on one side; gap cut uses a die-cutting tool with a discontinuous cutting edge to form dotted, dotted, or grid-like cutting marks on the adhesive material, thereby selectively removing the discontinuous parts of the adhesive layer, making the adhesive layer in the local structural area 4 discontinuously distributed; and punching uses an independent punching die to punch one or more circular, elliptical, or other shaped through holes or blind holes at the position corresponding to the sensor needle.

[0086] In practical applications, the center of the material can be punched to form a sensor needle clearance hole, and then a ring-shaped adhesive reduction zone can be formed at the edge of the material by half-cutting. After die-cutting, the excess material cut off in the local structural area 4 is removed by a waste removal device, so that the support layer 1 is exposed to the external environment or in direct contact with the release layer 5. After die-cutting and waste removal, a single patch-shaped medical adhesive material is obtained, which is then inspected, packaged and sterilized.

[0087] The medical adhesive material obtained by the above preparation method has a first and / or second medical pressure-sensitive adhesive layer 3 in the local structural region 4 with a thickness less than the average thickness of the corresponding adhesive layer. The local structural region 4 is distributed in any one of the following shapes in the planar direction of the adhesive material: ring-shaped, arc-shaped, island-shaped, strip-shaped, or hollow-out. It is configured to reduce the direct contact area between the adhesive material and the skin around the sensor needle site, or to reduce the adhesion stress between the edge of the adhesive material and the skin.

[0088] Example 6

[0089] In practical use, medical adhesive material is used to fix the sensor body to the skin surface, and the local structural area 4 at least partially covers the sensor needle site.

[0090] I. The following is a comparison of the effects of post-die-cutting irradiation sterilization process on adhesion.

[0091] Test samples: Three types of elastic nonwoven CGM tape, namely SYD-W7OTA-CGM, SYD-W7OTA-CGM-H and SYD-W6OTA-CGM, were used as test samples.

[0092] Test method: The test samples were sterilized by electron beam irradiation (dose 20-30 kGy). The change in 180° peel strength of SUS plates before and after sterilization was compared, and the adhesion retention rate was calculated.

[0093] Test results: As shown in the table below, the adhesion retention rate of SYD-W7OTA-CGM (corresponding to the first pressure-sensitive adhesive layer) after 30 kGy irradiation is 72.9% to 75.0%; the adhesion retention rate of SYD-W7OTA-CGM-H (corresponding to the second pressure-sensitive adhesive layer) after 30 kGy irradiation is 78.8%; SYD-W6OTA-CGM also maintains high adhesion.

[0094] All three adhesive layers maintain high adhesion after irradiation sterilization, meeting the requirements for CGM sensor wear.

[0095] sample Before sterilization (gf / 25mm) Sterilization at 30 kGy (gf / 25 mm) Retention rate SYD-W7OTA-CGM 1200 875~900 72.9%～75.0% SYD-W7OTA-CGM-H 1650 1300 78.8% SYD-W6OTA-CGM - - ≥70%

[0096] Conclusion: This medical adhesive material (models: SYD-W7OTA-CGM, SYD-W7OTA-CGM-H, SYD-W6OTA-CGM) can be sterilized by 20-30 kGy electron beam irradiation. After sterilization, the adhesive retention rate is ≥70%, which can meet the sterilization requirements of sterile medical devices and ensure sufficient adhesive strength during the wearing period.

[0097] Second, a long-term skin adaptability test of the sensor was conducted to ensure that the overall structure of the sensor remained intact during the 7-14 day wearing period and that prolonged application was unlikely to cause adverse skin reactions.

[0098] Test samples: The three types of medical adhesive materials mentioned above and AR products from the United States were used.

[0099] Experimental method: The test sample was applied to the skin of the subject, who maintained normal daily life and applied the sample continuously for 2 weeks (14 days); the skin condition was observed during the application period and after removal, and the occurrence of adverse reactions such as erythema, maceration, and folliculitis was assessed.

[0100] Test results: As shown in the table below, during the 14-day normal life application process, none of the three types of adhesive materials experienced unexpected detachment, and no adverse reactions such as obvious erythema, maceration, or folliculitis were observed on the skin; after removing the adhesive materials, there was no residual adhesive on the skin and no tearing damage.

[0101] American AR products This product Substrate / Elastic nonwoven fabric Coating amount / 30-35g / ㎡ Release paper / Commercially available release paper Drying conditions / 100℃-120s Ripening conditions / RT 7 days Adhesion 14.5 22.2FF

[0102] Conclusion: This medical patch material (model: SYD-W7OTA-CGM, SYD-W7OTA-CGM-H, SYD-W6OTA-CGM) can meet the wearing requirements of CGM sensors for up to 14 days. During the wearing period, the skin condition is good, and there is no residue or damage after removal.

[0103] Example 7

[0104] In another feasible technical solution, a local functional component is also included, which is disposed in the local structural region 4 or its adjacent region. The local functional component includes a surface-fixed anti-inflammatory component, an anti-allergic component, or a combination thereof. The above components are microencapsulated or directly coated / impregnated on the surface of the prefabricated substrate. They work together to slowly release through contact with the skin during wear, reducing skin redness, pain and the release of inflammatory mediators, and alleviating acute inflammation and delayed-type hypersensitivity reactions.

[0105] Local functional components are configured as prefabricated ring-shaped, arc-shaped, or island-shaped components and are located in the area around the sensor needle, the high-stress area at the edge, or a combination thereof, to locally improve the inflammatory response, skin discomfort, and long-term wear tolerance of the attachment interface.

[0106] Specifically, when the local functional component is placed in the area around the sensor needle site, the local functional component is located directly between the skin and the adhesive material, or embedded in the local structural area 4, to alleviate local inflammatory reactions caused by puncture, adhesive irritation, and sweat accumulation; when the local functional component is placed in the high-stress area at the edge, the local functional component is located at the interface between the edge of the adhesive material and the skin, to reduce edge erythema, itching, or tension blisters caused by skin stretching and shear stress concentration; when the local functional component is placed in the combined area, multiple identical or different types of local functional components can coexist in different positions on the same adhesive material, each playing an optimizing role.

[0107] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0108] The above description is only used to illustrate the technical solution of the present invention and is not intended to limit it. Any other modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention, as long as they do not depart from the spirit and scope of the technical solution of the present invention, should be covered within the scope of the claims of the present invention.

Claims

1. A medical adhesive material for a continuous glucose monitoring device, wherein the medical adhesive material is formed from medical pressure-sensitive adhesive tape in the form of a single patch through a die-cutting process, characterized in that, include: A support layer having opposing first and second surfaces; A first medical pressure-sensitive adhesive layer is formed on the first surface of the support layer; A second medical pressure-sensitive adhesive layer is formed on the second surface of the support layer for direct contact with the skin; The adhesive material has at least one local structural region that penetrates or partially penetrates at least one adhesive layer. The local structural region corresponds to the sensor needle location, the edge region of the adhesive material, or a combination thereof, and the coverage of the first medical pressure-sensitive adhesive layer and / or the second medical pressure-sensitive adhesive layer in the local structural region is lower than that in other regions.

2. The medical adhesive material for a continuous blood glucose monitoring device according to claim 1, characterized in that, The first medical pressure-sensitive adhesive layer is a conventional medical acrylic pressure-sensitive adhesive layer or an acrylic hot-melt medical pressure-sensitive adhesive layer; the second medical pressure-sensitive adhesive layer is a conventional medical acrylic pressure-sensitive adhesive layer.

3. The medical adhesive material for a continuous blood glucose monitoring device according to claim 1, characterized in that, The support layer is an elastic polyurethane nonwoven fabric with a basis weight range of 50~100 g / m².

4. The medical adhesive material for a continuous blood glucose monitoring device according to claim 1, characterized in that, The local structural regions are distributed in any one of the following ways along the plane of the attached material: ring-shaped, arc-shaped, island-shaped, strip-shaped, or hollow-out.

5. A medical adhesive material for a continuous blood glucose monitoring device according to claim 4, characterized in that, In the local structural region, the support layer is exposed to the external environment or in direct contact with the release layer, or the thickness of the first and / or second medical pressure-sensitive adhesive layer is reduced.

6. The medical adhesive material for a continuous blood glucose monitoring device according to claim 5, characterized in that, The thickness of the first and / or second medical pressure-sensitive adhesive contained in the local structural region is less than the average thickness of the corresponding adhesive layer.

7. A medical adhesive material for a continuous blood glucose monitoring device according to claim 6, characterized in that, The local structural region is configured to reduce the direct contact area between the adhesive material and the skin around the sensor needle site, or to reduce the adhesion stress between the edge of the adhesive material and the skin.

8. A method for preparing the medical adhesive material according to any one of claims 1 to 7, characterized in that, Includes the following steps: S01 provides an elastic nonwoven fabric as a support layer, the support layer having opposing first and second surfaces; S02 A first medical pressure-sensitive adhesive layer is formed on the first surface of the support layer; S03 A second medical pressure-sensitive adhesive layer is formed on the second surface of the support layer; S04 composite release layer; S05 At least one local structural region is formed on the adhesive material such that the coverage of the first and / or second medical pressure-sensitive adhesive layer in the region is lower than that in other regions.

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