Medical silica gel dressing fixing adhesive tape and fixing method thereof

Abstract

The invention belongs to the field of medical instruments, and discloses a medical silica gel dressing fixing adhesive tape which comprises an adhesive tape body, and the adhesive tape body sequentially comprises a carrier layer, a silica gel adhesive layer and a stripping liner from outside to inside; the carrier layer is made of an elastic breathable material, and the silica gel adhesive layer is made of medical-grade organic silica gel; a plurality of first microcapsules are dispersed in the silica gel adhesive layer, the first microcapsules are drug-loaded microcapsules, and wall materials of the drug-loaded microcapsules are made of materials responding to the pH value, enzyme concentration or temperature change of a wound environment. Enzyme or ions are released after the second microcapsule is broken, the wall material of the first microcapsule is actively degraded, cascade response of'exudate increase-developing prompt-drug accelerated release 'is realized, a large amount of drugs are quickly released when the exudate appears, and infection or inflammation is effectively controlled.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically, to medical silicone dressing fixation tape and its fixation method. Background Technology

[0002] In clinical wound care, adhesive tape is commonly used to secure medical dressings (such as gauze, foam dressings, and hydrocolloid dressings) to the patient's skin. Traditional pressure-sensitive tapes (such as acrylic tapes) suffer from problems such as painful peeling, high sensitization, and easy damage to newly formed skin tissue. In recent years, medical-grade silicone gel has been widely used as the adhesive layer of medical tapes due to its advantages such as good biocompatibility, low sensitization, painless peeling, and reusability.

[0003] However, existing silicone dressing fixation tapes still have the following shortcomings:

[0004] 1. Lack of wound condition indication function: Medical staff or patients cannot intuitively judge whether there is excessive wound exudate or whether infection has occurred. They often need to remove the dressing to check, which can easily cause secondary contamination.

[0005] 2. Passive and delayed drug release: Although there have been attempts to add drug-loaded microcapsules to silicone adhesives, drug release usually depends on slow changes in the wound environment (pH, temperature, etc.), resulting in a slow response and difficulty in releasing sufficient amounts of drug in time when exudate suddenly increases or infection occurs. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art by proposing a medical silicone dressing fixation tape and its fixation method.

[0007] To solve the above problems, the present invention adopts the following technical solution:

[0008] Medical silicone dressing fixation tape includes a tape body, which comprises, from the outside to the inside, a carrier layer, a silicone adhesive layer, and a release liner; the carrier layer is an elastic and breathable material, and the silicone adhesive layer is made of medical-grade silicone gel;

[0009] The silicone adhesive layer contains a plurality of first microcapsules, which are drug-loaded microcapsules. The wall material of the drug-loaded microcapsules is made of a material that responds to changes in the pH value, enzyme concentration, or temperature of the wound environment.

[0010] A color-developing film is disposed between the carrier layer and the silicone adhesive layer. A second microcapsule is uniformly distributed in the color-developing film. The second microcapsule contains a substance that ruptures and releases the color-developing agent due to the absorption of moisture or volatile substances in wound exudate.

[0011] Furthermore, the colorimetric agent or accompanying auxiliary substance released after the second microcapsule ruptures contains an enzyme or ion that can degrade the wall material of the first microcapsule, thereby accelerating the release of the drug from the first microcapsule after color development.

[0012] As a further aspect of the present invention: the carrier layer is a spunlace nonwoven fabric, which is opaque in a dry state and becomes translucent or transparent when wet after absorbing wound exudate, so as to allow the color change of the color developing film to be observed through the carrier layer; this design greatly improves the convenience and accuracy of color change recognition.

[0013] As a further aspect of the invention: the first microcapsule comprises at least two independent types of microcapsules, wherein the wall material of the first type of microcapsule degrades at pH 6.5–7.0, releasing an anti-inflammatory drug; and the wall material of the second type of microcapsule degrades at pH > 7.2, releasing an antibacterial drug. This zoned response design enables precise, stepwise drug therapy.

[0014] As a further aspect of the present invention, the drug in the first microcapsule includes one or more of an antibacterial agent, growth factor, analgesic, or anti-inflammatory agent.

[0015] As a further aspect of the present invention: the polymer film material of the color-developing film is one of polyurethane, polyvinyl alcohol, or polyacrylate; the wall material of the second microcapsule is made of gelatin, gum arabic, or polyelectrolyte material; the color-developing agent is one of pH indicator, thermochromic dye, or moisture-sensitive dye. For example, the pH indicator can be bromocresol green (which turns blue at pH > 7.2) to indicate the risk of infection.

[0016] As a further aspect of the present invention, the auxiliary substance released after the second microcapsule ruptures is lipase, protease, or calcium ions. For example, if the wall material of the first microcapsule is a polyester-based pH-sensitive material, the auxiliary substance can be lipase to accelerate its degradation; if the wall material is calcium alginate, the auxiliary substance can be a calcium ion chelating agent or release calcium ions to change the osmotic pressure.

[0017] As a further aspect of the present invention: the main body of the tape is wound onto a spool, and the spool and the main body of the tape are stored in a storage box; the storage box is provided with a tape outlet, and the tape outlet is provided with an elastically deformable sealing lip, which closes naturally when the tape is not pulled out to prevent external moisture from entering the storage box.

[0018] As a further aspect of the invention: the storage box includes a box body and a lid. A protruding post is located at the center of the box body for housing the reel. A slot is formed at the center of the protruding post. A corresponding insert post is located at the center of the lid, and a fastening bolt is provided on the lid, penetrating the insert post. A threaded hole corresponding to the fastening bolt is formed in the slot. This structure ensures smooth rotation of the reel and a secure connection between the lid and the box body.

[0019] As a further aspect of the present invention: the wireless identification tag is pre-stored with information, including the tape production batch number, sterilization date, recommended replacement time, or data related to the patient's wound care plan.

[0020] A method for fixing a dressing using the above-mentioned medical silicone dressing fixation tape includes the following steps:

[0021] S1: Pull the tape body out from the tape outlet of the storage box and cut it with the tape cutting blade to obtain the required length of tape; during the pulling process, the circuit of the destructible RFID tag is physically broken, recording that the tape has been used;

[0022] S2: Remove the release liner from the tape body to expose the silicone adhesive layer;

[0023] S3: Cover the wound with a medical dressing;

[0024] S4: Apply the exposed silicone adhesive layer to the skin, so that the main body of the tape fixes and covers the edge and part of the peripheral skin of the medical dressing;

[0025] S5: When wound exudate increases, moisture permeates the silicone adhesive layer, causing the second microcapsule to rupture and release the chromogenic agent. At the same time, the carrier layer is wetted and becomes translucent, showing a color change. The released chromogenic agent or auxiliary substance accelerates the drug release from the first microcapsule.

[0026] S6: When it is necessary to verify product information or record care data, the information and usage status records pre-stored in the wireless identification tag are read through an external reading and writing device.

[0027] Compared with the prior art, the advantages of this invention are:

[0028] 1. By setting up a second microcapsule (color development) to release enzymes or ions after rupture, the wall material of the first microcapsule (drug-loaded) is actively degraded, realizing a cascade response of "increased exudate → color development indication → accelerated drug release". When exudate appears, the drug is released rapidly and in large quantities, effectively controlling infection or inflammation.

[0029] Second, the second microcapsule in the color-developing film ruptures to release the color-developing agent, while the carrier layer (spunlace nonwoven fabric) becomes transparent when wet, making the color change clearly visible. Medical staff or patients can assess wound exudation without removing the dressing, allowing for timely dressing changes or intervention.

[0030] Third, by setting different pH response thresholds for the first microcapsule (releasing anti-inflammatory drugs at pH 6.5-7.0 and antibacterial drugs at pH >7.2), it is possible to dynamically match the changes in the microenvironment at different stages of wound healing and achieve precise treatment.

[0031] IV. Information Management: The built-in wireless identification tags enable digital management of medical devices, simplify the traceability process, improve the accuracy and efficiency of medical services, and help build a smart hospital system. Attached Figure Description

[0032] Figure 1 This is a schematic diagram of the cross-sectional layered structure of the tape body of the present invention;

[0033] Figure 2 This is a schematic diagram showing the distribution of the first microcapsules within the silicone adhesive layer of the present invention;

[0034] Figure 3 This is a schematic diagram of the overall structure of the medical silicone dressing fixing tape of the present invention stored in a box;

[0035] Figure 4 This is a schematic diagram of the opening structure of the storage box of the present invention;

[0036] Figure 5 This is a schematic diagram of the structure of the wireless identification tag of the present invention.

[0037] Explanation of the labels in the diagram:

[0038] 1. Adhesive tape body; 11. Carrier layer; 12. Silicone adhesive layer; 121. First microcapsule; 13. Release liner; 14. Color developing film; 141. Second microcapsule; 15. Wireless identification tag;

[0039] 2. Roll;

[0040] 3. Storage box; 30. Box body; 31. Tape outlet; 311. Sealing lip; 32. Lid; 33. Protrusion; 34. Slot; 35. Insert post; 36. Fastening bolt; 37. Threaded hole;

[0041] 4. Tape cutter. Detailed Implementation

[0042] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0043] Example 1

[0044] Please refer to Figure 1 , 2 This embodiment provides a medical silicone dressing fixation tape, the core of which is the tape body 1. The tape body 1 has a multi-layer composite structure, which consists of the following layers from the outside to the inside (i.e., from the side away from the skin to the side in contact with the skin): carrier layer 11, color developing film 14, silicone adhesive layer 12, and release liner 13.

[0045] The carrier layer 11 is made of highly elastic spunlace nonwoven fabric, specifically a spunlace fabric composed of polyester and viscose fibers. In its dry state, the spunlace nonwoven fabric is white and opaque, possessing good flexibility and tensile strength. When it absorbs wound exudate and becomes wet, the refractive index of the fibers approaches that of water, thus becoming translucent or even transparent, allowing the color changes of the color-developing film 14 to be observed through the carrier layer 11.

[0046] The silicone adhesive layer 12 is made of medical-grade silicone gel, such as a two-component addition-type medical-grade liquid silicone rubber, coated and cured, with a thickness of 50-150 micrometers. This silicone layer has high skin affinity, is non-cytotoxic, and can be repeatedly applied. Before the silicone is cured, a pre-prepared first microcapsule 121 is uniformly mixed into it using microfluidic technology or mechanical stirring dispersion. The first microcapsule 121 is a drug-loaded microcapsule, and the wall material of the drug-loaded microcapsule is made of a material that responds to changes in the pH, enzyme concentration, or temperature of the wound environment. Further, the first microcapsule 121 includes at least two independent types of microcapsules, wherein the wall material of the first type of microcapsule degrades at pH 6.5–7.0, releasing an anti-inflammatory drug; and the wall material of the second type of microcapsule degrades at pH > 7.2, releasing an antibacterial drug. The drug within the first microcapsule 121 includes one or more of antibacterial agents, growth factors, analgesics, or anti-inflammatory drugs.

[0047] In this embodiment, the first microcapsule 121 is divided into two types:

[0048] Category 1: The wall material is made of polymethyl methacrylate copolymer (such as Eudragit L100), which is soluble in the pH range of 6.5-7.0. It contains anti-inflammatory drugs (such as ibuprofen or dexamethasone).

[0049] The second type: The wall material is made of polyacrylic resin (such as Eudragit S100), which dissolves at pH > 7.2 and contains broad-spectrum antibacterial drugs (such as nano-silver particles or mupirocin).

[0050] The color-developing film 14 is located between the carrier layer 11 and the silicone adhesive layer 12, and can be an independent film formed by lamination or coating processes. The polymer film material of the color-developing film 14 is one of polyurethane, polyvinyl alcohol, or polyacrylate.

[0051] In the color-developing film 14, a second microcapsule 141 is uniformly dispersed. The second microcapsule 141 encapsulates a substance that, upon absorbing moisture or volatile substances from wound exudate, ruptures and releases a color-developing agent. Furthermore, the color-developing agent released after the second microcapsule 141 ruptures, or the accompanying auxiliary substances, contains an enzyme or ion that can degrade the wall material of the first microcapsule 121, thereby accelerating the drug release from the first microcapsule 121 after color development. Further, the wall material of the second microcapsule 141 is made of gelatin, gum arabic, or a polyelectrolyte material; the color-developing agent is one of a pH indicator, a thermochromic dye, or a moisture-sensitive dye.

[0052] In this embodiment, the wall material of the second microcapsule 141 is prepared by a gelatin-gum arabic composite coagulation method, and its core contains: bromothymol blue (a pH indicator that changes from yellow to blue at pH > 7.2) and trace amounts of lipase. This lipase, as an auxiliary substance, can accelerate the degradation of the polymethacrylate wall material of the first microcapsule 121.

[0053] The release liner 13 is made of a double-sided release PET film, with light release on one side and heavy release on the other, which facilitates separation from the silicone adhesive layer 12.

[0054] Working principle: When the tape is used normally, both the first microcapsule 121 and the second microcapsule 141 remain intact. Once the wound becomes infected, exudate increases, and the pH rises above 7.2. Moisture and volatile substances permeate the porous structure of the silicone adhesive layer 12 and first come into contact with the second microcapsule 141. The gelatin-gum arabic wall material absorbs water and ruptures, releasing bromothymol blue (blue in color) and lipase. Simultaneously, the carrier layer 11 (spunlace nonwoven fabric) becomes translucent due to absorbing exudate, making the blue color clearly visible and indicating to healthcare personnel that replacement or intervention is needed. At the same time, the released lipase begins to degrade the polymethacrylate wall material in the first microcapsule 121, accelerating the release of antibacterial drugs, thereby enhancing treatment against the infection. In mild inflammation (pH 6.5-7.0), the second microcapsule 141 does not rupture (or ruptures slowly), and the first type of microcapsule slowly releases anti-inflammatory drugs in response to pH, achieving preventative treatment.

[0055] Example 2

[0056] Please refer to Figure 3-4 Based on Example 1, this example provides a complete packaging and intelligent management system.

[0057] The tape body 1 is wound onto a paper or plastic roll 2 and stored entirely inside a storage box 3. The storage box 3 includes a box body 30 and a cover 32. A protrusion 33 is provided at the center of the box body 30, and the roll 2 is fitted onto the protrusion 33. The insert 35 of the cover 32 is inserted into the slot 34 of the protrusion 33 and locked in place by a fastening bolt 36 and a threaded hole 37 to ensure stable rotation of the roll 2.

[0058] The box body 30 has a tape outlet 31 on its side, with a silicone sealing lip 311 at the outlet. The lip thickness is approximately 0.5mm, and the two lips are naturally closed. In the natural state, the two lips of the sealing lip 311 are tightly closed to prevent external moisture from entering. When the tape is pulled out, the tape body 1 opens the sealing lip 311, and the elasticity of the lip keeps it lightly touching the surface of the tape, which is both moisture-proof and ensures low resistance.

[0059] A metal toothed tape cutter 4 is also installed on the outside of the outlet of the box 30 to facilitate cutting the tape.

[0060] In addition, such as Figure 5 As shown, a wireless identification tag 15 is encapsulated within the carrier layer 11 at the end of each roll of tape. The wireless identification tag 15 is an UHF RFID tag. The wireless identification tag 15 is pre-stored with information, including the tape production batch number, sterilization date, recommended replacement time, or data related to the patient's wound care plan. When using the tag, nurses can scan it with a handheld PDA in the ward, and the information is automatically entered into the hospital information system and linked to the specific patient's electronic medical record, achieving paperless and precise nursing management.

[0061] Example 3

[0062] Based on the above embodiments, the present invention also provides a method for fixing the medical silicone dressing with the adhesive tape, comprising the following steps:

[0063] S1: Pull the tape body 1 out from the tape outlet 31 of the storage box 3 and cut it with the tape cutting blade 4 to obtain the required length of tape; during the pulling process, the circuit of the destructible RFID tag is physically broken, recording that the tape has been used;

[0064] S2: Remove the release liner 13 on the tape body 1 to expose the silicone adhesive layer 12;

[0065] S3: Cover the wound with a medical dressing;

[0066] S4: Attach the exposed silicone adhesive layer 12 to the skin, so that the tape body 1 fixes and covers the edge and part of the peripheral skin of the medical dressing;

[0067] S5: When wound exudate increases, moisture permeates through the silicone adhesive layer 12, causing the second microcapsule 141 to rupture and release the color developer. At the same time, the carrier layer 11 is wetted and becomes translucent, showing a color change. The released color developer or auxiliary substance accelerates the drug release from the first microcapsule 121.

[0068] S6: When it is necessary to verify product information or record care data, the information and usage status records pre-stored in the wireless identification tag 15 are read through an external reading and writing device.

[0069] The above description is merely a preferred embodiment of the present invention; however, the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and its improved concepts, should be covered within the scope of protection of the present invention.

Claims

1. A medical silicone dressing fixation tape, comprising a tape body (1), wherein the tape body (1) comprises, from the outside to the inside, a carrier layer (11), a silicone adhesive layer (12), and a release liner (13); wherein the carrier layer (11) is an elastic and breathable material, and the silicone adhesive layer (12) is made of medical-grade silicone gel; Its features are: The silicone adhesive layer (12) contains a plurality of first microcapsules (121), the first microcapsules (121) being drug-loaded microcapsules, the wall material of the drug-loaded microcapsules being made of a material that responds to changes in the pH value, enzyme concentration or temperature of the wound environment; A color-developing film (14) is disposed between the carrier layer (11) and the silicone adhesive layer (12). A second microcapsule (141) is uniformly distributed in the color-developing film (14). The second microcapsule (141) contains a substance that will rupture and release the color-developing agent due to the absorption of moisture or volatile substances in wound exudate. Furthermore, the colorimetric agent or accompanying auxiliary substance released after the second microcapsule (141) ruptures contains an enzyme or ion that can degrade the wall material of the first microcapsule (121), thereby accelerating the release of the drug from the first microcapsule (121) after color development.

2. The medical silicone dressing fixation tape according to claim 1, characterized in that: The carrier layer (11) is a spunlace nonwoven fabric. The spunlace nonwoven fabric is opaque in a dry state and becomes translucent or transparent in a wet state after absorbing wound exudate, so as to allow the color change of the color developing film (14) to be observed through the carrier layer (11).

3. The medical silicone dressing fixation tape according to claim 1, characterized in that: The first microcapsule (121) comprises at least two independent types of microcapsules, wherein the wall material of the first type of microcapsule degrades at pH 6.5–7.0, releasing an anti-inflammatory drug; and the wall material of the second type of microcapsule degrades at pH > 7.2, releasing an antibacterial drug.

4. The medical silicone dressing fixation tape according to claim 1, characterized in that: The drug contained in the first microcapsule (121) includes one or more of an antibacterial agent, growth factor, analgesic or anti-inflammatory agent.

5. The medical silicone dressing fixation tape according to claim 1, characterized in that: The polymer film material of the color developing film (14) is one of polyurethane, polyvinyl alcohol or polyacrylate; The wall material of the second microcapsule (141) is made of gelatin, gum arabic, or polyelectrolyte material; The color-developing agent is one of a pH indicator, a thermochromic dye, or a moisture-sensitive dye.

6. The medical silicone dressing fixation tape according to claim 1, characterized in that: The auxiliary substances released after the second microcapsule (141) ruptures are lipase, protease or calcium ions.

7. The medical silicone dressing fixation tape according to claim 1, characterized in that: The tape body (1) is wound on a roll (2), and the roll (2) and the tape body (1) are stored in a storage box (3). The storage box (3) is provided with a tape outlet (31), and a flexible sealing lip (311) is provided at the tape outlet (31). When the tape is not pulled out, the sealing lip (311) closes naturally to prevent external moisture from entering the storage box (3).

8. The medical silicone dressing fixation tape according to claim 7, characterized in that: The storage box (3) includes a box body (30) and a cover (32). A protruding post (33) is provided at the center of the box body (30). The protruding post (33) is used to fit the roll (2). A slot (34) is provided at the center of the protruding post (33). A plug (35) that matches the slot (34) is provided at the center of the cover (32). A fastening bolt (36) is provided on the cover (32). The fastening bolt (36) passes through the plug (35). A threaded hole (37) that matches the fastening bolt (36) is provided in the slot (34).

9. The medical silicone dressing fixation tape according to claim 1, characterized in that: The wireless identification tag (15) is pre-stored with information including the tape production batch number, sterilization date, recommended replacement time, or data related to the patient's wound care plan.

10. A method for fixing a dressing using medical silicone dressing fixation tape as described in any one of claims 1-9, characterized in that, Includes the following steps: S1: Pull out the tape body (1) from the tape outlet (31) of the storage box (3) and cut it with the tape cutting blade (4) to obtain the required length of tape; during the pulling process, the circuit of the destructible RFID tag is physically broken, recording that the tape has been used; S2: Remove the release liner (13) on the tape body (1) to expose the silicone adhesive layer (12). S3: Cover the wound with a medical dressing; S4: Attach the exposed silicone adhesive layer (12) to the skin so that the tape body (1) is fixedly covering the edge and part of the peripheral skin of the medical dressing; S5: When the wound exudate increases, moisture permeates through the silicone adhesive layer (12) to cause the second microcapsule (141) to rupture and release the color developer. At the same time, the carrier layer (11) is wetted and becomes translucent, showing a color change. The released color developer or auxiliary substance accelerates the drug release of the first microcapsule (121). S6: When it is necessary to verify product information or record nursing data, the information and usage status records stored in the wireless identification tag (15) are read through an external reading and writing device.

Images