Medical gas slow-release patch and application thereof

Abstract

The invention provides a medical gas slow-release patch and application thereof, and belongs to the field of biological medicine. The medical gas slow-release patch comprises a water-blocking and gas-blocking layer A, a reaction layer B, a water-blocking and gas-permeable layer C and a water-absorbing layer D, wherein the reaction layer B comprises a plurality of layers of thin-film solid-gas conversion materials. The application is designed by using a solid gas production material, a semi-closed microenvironment is formed between the application and the skin, the application can react with wound exudate and water vapor in real time, and conversion and release of a solid medical gas source are started. According to the invention, a high-oxygen environment can be locally established to promote local wound healing, and the damage of the prior art (such as an oxygen cabin) is avoided. According to the application provided by the invention, under the condition that high-pressure gas treatment equipment is not used, the concentration of medical gas such as oxygen and hydrogen can be rapidly increased, the medical gas such as oxygen and hydrogen or combined gas can be locally, continuously and stably released, the release rate is close to be constant, and additional equipment is not needed for control.

Description

Technical Field

[0001] The present invention belongs to the field of biomedicine, and in particular relates to a medical gas slow-release dressing and application thereof. Background Art

[0002] Generally speaking, the body's basic energy needs are primarily met by oxygen consumption during aerobic respiration. Activated phagocytes consume oxygen during the respiratory burst, producing reactive oxygen species (ROS), which play a crucial role in the initial inflammatory response following tissue injury. O₂ is directly required for the formation of new blood vessels and connective tissue during wound healing. Phagocyte NADPH oxidase (NOX-2) requires O₂ consumption to enable phagocytes to produce sufficient lactate to activate transcription factors that promote the development of angiogenic factors. The amount of O₂ available also influences connective tissue remodeling, playing a role in collagen maturation and fibroblast proliferation. Furthermore, O₂ consumption supports a robust host immune response to infection, as sufficient O₂ ensures that phagocytes produce the appropriate amount of antimicrobial ROS.

[0003] The oxygen supply to wounds primarily depends on the PO2 in the surrounding tissues and circulating blood. Therefore, edema, impaired microcirculation, and vasoconstriction in damaged tissues can impair adequate oxygen delivery. Furthermore, poor circulation can inhibit oxygen delivery to the wound. Other factors affecting oxygen delivery include diffusion barriers caused by edema and oxygen consumption by bacterial biofilms. Furthermore, it is important to note that the active metabolic activity of healing wounds can also reduce overall tissue oxygen levels.

[0004] Chronic wound infections increase oxygen consumption. Neutrophils, the body's primary phagocytes, experience increased O2 consumption in response to a variety of stimuli, including Gram-negative and Gram-positive bacteria, fungi, and even sterile tissue damage. This increased O2 consumption is primarily due to the activation of NADPH oxidase in phagocytes, which generates large amounts of ROS. The ability of NOX-2 to consume O2 has been demonstrated in multiple studies, even at very low O2 levels.

[0005] If the adsorbed neutrophils successfully clear invading microorganisms and pro-inflammatory debris from the tissue, their work ceases, O2 consumption gradually decreases, and the wound tends to heal. However, bacteria have the ability to resist attacking neutrophils, as demonstrated when bacteria aggregate to form biofilms. Biofilms can attract activated neutrophils, which continuously deplete O2 in the microenvironment to generate ROS but cannot eradicate the bacteria. Similarly, the inability to ameliorate tissue damage and remove tissue debris can lead to the accumulation of neutrophils, further accelerating O2 consumption, and the hypoxic state can delay or even halt wound healing. It can be seen that the presence of oxygen has a significant impact on the wound healing process.

[0006] Chronic wounds (such as diabetic ulcers and pressure sores) heal slowly due to local hypoxia. Medical gases such as oxygen (O2) can promote cell metabolism, collagen synthesis and angiogenesis, which is especially important for chronic hypoxic wounds (such as diabetic foot ulcers). Hydrogen (H2) has antioxidant and anti-inflammatory effects, which can reduce ROS damage and accelerate the healing of infected wounds. Other gases (such as nitric oxide (NO) and carbon dioxide) have the function of regulating inflammation and vasodilation. Chlorine dioxide can kill bacteria on the wound surface, reduce the risk of infection, and promote wound healing. It has obvious advantages in the application of wound repair. However, existing hyperbaric oxygen therapy requires special equipment, is costly, and has poor patient compliance, and may cause symptoms such as oxygen poisoning / barotrauma. Portable oxygen-releasing materials (such as peroxides and liquid oxygen carriers) have problems such as uncontrollable oxygen concentration and poor biocompatibility.

[0007] Therefore, the present invention hopes to provide a medical dressing that is simple to operate, can provide the medical gas required for wound repair, form a semi-closed micro-pressure gas environment at the wound, and perform positive pressure therapy and negative pressure therapy. Summary of the Invention

[0008] The purpose of the present invention is to provide a multifunctional medical dressing with a long-lasting sustained-release function, which can continuously and stably release medical gas on the wound surface.

[0009] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0010] The present invention provides a medical gas sustained-release dressing, which comprises a water-blocking and gas-blocking layer A, a reaction layer B, a water-blocking and gas-permeable layer C, and a water-absorbing layer D;

[0011] The water- and gas-blocking layer A is a material having water- and gas-blocking functions, and the reaction layer B is a solid-gas conversion layer, comprising a multi-layer thin-film solid-gas conversion material.

[0012] Preferably, the material of the water- and gas-blocking layer A includes adhesive tape, PET film, silicone film, PE film, laminated non-woven fabric or HDPE composite film.

[0013] Preferably, the reaction layer B includes a reaction layer B1 and a reaction layer B2;

[0014] Among them, the solid-gas conversion material of the reaction layer B1 is an acidic or metallic material, which is the reaction B1 agent;

[0015] The solid-gas conversion material of the reaction layer B2 is a material that reacts with acid or metal to generate gas, and is the reaction B2 agent.

[0016] Preferably, the multilayer solid-gas conversion material can react with wound exudate or water vapor emitted by the skin to produce medical gas;

[0017] The medical gas is one or more of active oxygen, hypoxia, oxygen, nitric oxide, singlet oxygen, hydrogen peroxide, hydrogen sulfide, nitric oxide, argon and helium.

[0018] Preferably, the reaction B1 agent includes one or more of acid cloth, acid film, aluminum wire cloth or aluminum film;

[0019] The reaction B2 agent is a film material made of one or more of calcium peroxide powder, calcium hydroxide powder, calcium carbonate powder, sodium nitrite powder or sodium chlorite powder.

[0020] The multilayer solid-gas conversion material reacts with the wound exudate or the water vapor emitted by the skin in one or more of the following ways:

[0021] When the medical gas is oxygen, the solid-gas conversion material is an acidic cloth made of citric acid and a calcium peroxide film, and the reaction formula is: C6H8O7+CaO2+H2O→Ca(OH)2+O2↑;

[0022] Or when the medical gases are oxygen and hydrogen, and the solid-gas conversion materials are citric acid mesh, calcium peroxide film, and aluminum film, two reactions occur, and the reaction formula is:

[0023] Primary reaction: C6H8O7+Al+H2O→Ca(OH)2+O2↑;

[0024] Secondary reaction Ca(OH)2+Al+H2O→Ca(Al(OH)4)2+H2↑;

[0025] Or when the medical gases are oxygen and carbon dioxide, the multilayer solid-gas conversion material is a sodium bicarbonate film, an acidic cloth made of citric acid, and a calcium peroxide film, and the reaction formula is: NaHCO3+C3H4(OH)(COOH)3+CaO2+H2O→C3H4(OH)(COONa)3+H2O+CO2↑+Ca(OH)2+O2↑;

[0026] Or when the medical gas is nitric oxide, the multilayer solid-gas conversion material is a sodium nitrite membrane and an acidic cloth made of sulfuric acid, and the reaction formula is: 6NaNO2+3H2SO4→3Na2SO4+2H2O+4NO↑+2HNO3. Preferably, the material of the water-blocking and breathable layer C is a microporous membrane, including PE, PS, PTFA or PDFE.

[0027] Preferably, the material of the water-absorbing layer D is a sponge material, a cellulose material, a fiber material, a cotton material or a highly absorbent polymer.

[0028] The present invention also provides application of the medical gas slow-release dressing in promoting local wound healing.

[0029] Layer A of the medical dressing of the present invention is a water and gas barrier layer with excellent gas barrier capability. It can act as a gas barrier layer to allow the gas generated by the reaction layer B to diffuse unidirectionally toward layer D.

[0030] Layer B of the medical dressing of the present invention is a reaction layer, mainly composed of multiple layers of solid-gas conversion materials. When in use, wound exudate or skin vapor transmitted by layers C / D can react with the solid-gas conversion material to generate gas. In conjunction with layer A, the gas diffuses unidirectionally toward layer D, forming a semi-enclosed micro-pressure gas environment at the wound site, thereby facilitating wound healing, improving wound healing efficiency, and effectively preventing bacterial infection. The solid-gas conversion materials are acidic or metallic material - reaction agent B1 and material that can react with acid or metal to generate gas - reaction agent B2. When these two materials meet with wound exudate or skin vapor, they can complete one or more of the following gas production equations:

[0031] Oxygen: calcium peroxide + citric acid + water (water vapor) → oxygen ↑ + calcium hydroxide;

[0032] Hydrogen: calcium hydroxide + metallic aluminum + water (water vapor) → hydrogen ↑ + calcium aluminate;

[0033] Carbon dioxide: sodium bicarbonate + citric acid + calcium peroxide + water (water vapor) → calcium citrate + carbon dioxide↑;

[0034] Nitric oxide: sodium nitrite + sulfuric acid + water (water vapor) → sodium sulfate + nitric oxide↑ + nitric acid;

[0035] Chlorine dioxide: sodium chlorite + citric acid + water (water vapor) → chlorine dioxide↑ + sodium chloride + sodium citrate;

[0036] This layer can generate medical gases through the above reaction formula, such as oxygen and hydrogen for tissue repair, which can help wound recovery. Oxygen (O2 / O-), hydrogen (H2 / H- / H+), carbon dioxide (CO2), nitric oxide (NO) and other gases are absorbed through the skin surface through the skin at a nearly constant rate and enter the systemic circulation, producing systemic or local therapeutic effects.

[0037] Layer C of the medical dressing described in this invention is a water-blocking, breathable layer. This layer boasts excellent, uniform air permeability, effectively isolating moisture and discharging heat and moisture. It also offers an excellent hand feel, making the product softer and more comfortable. It exhibits excellent tensile and elongation properties, is corrosion-resistant, easily printed, and is sun-resistant and high-temperature resistant. It is also waterproof, liquid-proof, breathable, environmentally friendly, and high-strength. It can be used to block water and secretions, but is permeable to water vapor, with its moisture permeability adjustable depending on the design. Gas generated by layer B can permeate through this layer in a unidirectional manner toward direction D.

[0038] The D layer of the medical dressing of the present invention is a water-absorbing layer, which is in direct contact with the skin and is used to absorb wound exudate and water vapor.

[0039] The present invention utilizes a solid gas-generating material to design a patch, which forms a semi-enclosed microenvironment with the skin and can react with wound exudate, water vapor and local carbon dioxide in real time to initiate the conversion and release of a solid medical gas source. The present invention can establish a high-oxygen environment locally to promote local wound healing and avoid the damage of existing technologies (oxygen chambers, etc.). The patch provided by the present invention can rapidly increase the local oxygen and hydrogen concentrations without the use of hyperbaric oxygen equipment, and can continuously and stably release mixed medical gases such as hydrogen and oxygen on the wound surface for a long time (<72hrs), with a release rate close to constant, and no additional equipment is required for control.

[0040] The present invention can achieve the following multiple benefits:

[0041] 1. Promote wound healing and epithelial regeneration;

[0042] 2. Reduce scar formation;

[0043] 3. Suppress the risk of local infection;

[0044] This invention can be applied to wound care across a wide range of disciplines, including chronic wounds (such as diabetic foot and pressure ulcers), postoperative wounds, burns, and skin grafts. Compared to traditional hyperbaric oxygen therapy, this dressing offers clinical advantages such as ease of use, low cost, reduced risk, and increased flexibility, demonstrating significant commercial potential and clinical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 This is a schematic diagram of the structure of a medical gas sustained-release dressing;

[0046] Figure 2 Measure concentration changes over time for H2 and O2 in sealed and vacuum vessels. DETAILED DESCRIPTION

[0047] The technical solutions provided by the present invention are described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0048] Example 1

[0049] A medical gas sustained-release dressing, comprising a water-blocking and gas-blocking layer A, a reaction layer B, a water-blocking and gas-permeable layer C and a water-absorbing layer D, has a structure as follows: Figure 1 As shown;

[0050] The water- and gas-blocking layer A is located at the end away from the skin, forming a gas barrier layer to prevent the release of gas generated by the reaction layer B and to allow the reaction gas to diffuse in one direction. The material is a laminated non-woven fabric.

[0051] Reaction layer B is a reaction gas-producing layer, which is a multi-layer structure composed of multiple layers of solid-gas conversion materials. The solid-gas conversion material is laid on a substrate (non-woven fabric) on the side close to the skin. It has two layers, namely reaction layer B1 and reaction layer B2. Among them, reaction layer B1 is citric acid cloth (a saturated citric acid solution is prepared, and cotton gauze is soaked in the solution for 5 minutes. After complete infiltration, the acidic layer can be obtained) and aluminum wire cloth. Reaction layer B2 is a thin film layer made of calcium peroxide powder. When used, it can react with wound exudate or water vapor emitted by the skin to produce gas (primary reaction: C6H8O7+Al+H2O→Ca(OH)2+O2↑; secondary reaction Ca(OH)2+Al+H2O→Ca(Al(OH)4)2+H2↑), generating medical gases (oxygen and hydrogen) and permeating toward the C / D layer;

[0052] The water-blocking and breathable layer C is used to block water and secretions, but is permeable to water vapor. The permeated water vapor reacts with the gas-generating reactant in the reaction layer B to produce a predetermined gas, which then penetrates this layer and penetrates deeper into the D layer. The material is PE (polyethylene).

[0053] The water-absorbing layer D is a skin-friendly layer that can absorb wound exudate and is permeable to water vapor. Its material is polyester.

[0054] Example 2

[0055] A medical gas sustained-release patch, which differs from Example 1 in that the material of reaction layer B1 in reaction layer B is citric acid cloth (prepared by the same method as in Example 1), and the material of reaction layer B2 is sodium bicarbonate film and calcium peroxide film. The gas reaction is as follows:

[0056] NaHCO3+C3H4(OH)(COOH)3+CaO2+H2O→C3H4(OH)(COONa)3+H2O+C

[0057] O2↑+Ca(OH)2+O2↑.

[0058] Example 3

[0059] A medical gas sustained-release dressing, which differs from Example 1 in that: reaction layer B1 in reaction layer B is sulfuric acid cloth (prepared by preparing a sulfuric acid solution (pH 2.0-3.0), soaking cotton gauze in the solution until completely soaked, and then drying), and reaction layer B2 is a sodium nitrite film made of sodium nitrite powder, and the reaction formula is: 6NaNO2+3H2SO4→3Na2SO4+2H2O+4NO↑+2HNO3.

[0060] Example 4

[0061] A medical gas sustained-release dressing, which differs from Example 1 in that: reaction layer B1 in reaction layer B is citric acid cloth (preparation method is the same as Example 1), reaction layer B2 is calcium peroxide film, and the reaction formula is: C6H8O7+CaO2+H2O→Ca(OH)2+O2↑.

[0062] Test example

[0063] The reaction B1 agent and the reaction B2 agent used in Example 1 were placed in a sealed container. Immediately after adding water, the concentration changes of H2 and O2 in the sealed and vacuum containers over time were measured. The results are as follows: Figure 2 As shown by Figure 2 It can be seen that the solid-gas conversion material used in layer B of this embodiment has a stable hydrogen generation rate of 0.23 ppm / min and an oxygen release rate of 68.3 ppm / min, which lasts for 12 hours.

[0064] It can be seen that the medical gas sustained-release dressing provided by the present invention can quickly increase the local oxygen and hydrogen concentrations without using high-pressure oxygen equipment, and continuously and stably release mixed medical gases such as hydrogen and oxygen at the wound, which is beneficial to wound healing and epithelial regeneration.

[0065] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A medical gas sustained-release dressing, characterized in that: The medical gas sustained-release dressing comprises a water-blocking and gas-blocking layer A, a reaction layer B, a water-blocking and gas-permeable layer C, and a water-absorbing layer D; The water- and gas-blocking layer A is a material having water- and gas-blocking functions, and the reaction layer B is a solid-gas conversion layer, comprising a multi-layer thin-film solid-gas conversion material.

2. The medical gas sustained-release dressing according to claim 1, characterized in that: The material of the water- and gas-blocking layer A includes adhesive tape, PET film, silicone film, PE film, coated non-woven fabric or HDPE composite film.

3. The medical gas sustained-release dressing according to claim 2, characterized in that: The reaction layer B includes a reaction layer B1 and a reaction layer B2; Among them, the solid-gas conversion material of the reaction layer B1 is an acidic or metallic material, which is the reaction B1 agent; The solid-gas conversion material of the reaction layer B2 is a material that reacts with acid or metal to generate gas, and is the reaction B2 agent.

4. The medical gas sustained-release dressing according to claim 3, characterized in that: The multilayer solid-gas conversion material of the reaction layer B can react with the exudate from the wound or water vapor emitted by the skin to produce medical gas; the medical gas is one or more of active oxygen, hypoxia, oxygen, nitric oxide, singlet oxygen, hydrogen peroxide, hydrogen sulfide, nitric oxide, argon, and helium.

5. The medical gas sustained-release dressing according to claim 4, characterized in that: The reaction B1 agent includes one or more of acid cloth, acid film, aluminum wire cloth or aluminum film.

6. The medical gas sustained-release dressing according to claim 5, characterized in that: The reaction B2 agent is a film made of one or more of calcium peroxide powder, calcium hydroxide powder, calcium carbonate powder, sodium nitrite powder or sodium chlorite powder.

7. The medical gas sustained-release dressing according to claim 6, characterized in that: The multilayer solid-gas conversion material reacts with the wound exudate or the water vapor emitted by the skin in one or more of the following ways: When the medical gas is oxygen, the solid-gas conversion material is an acidic cloth made of citric acid and a calcium peroxide film, and the reaction formula is: C6H8O7+CaO2+H2O→Ca(OH)2+O2↑; Or when the medical gases are oxygen and hydrogen, and the solid-gas conversion materials are citric acid mesh, calcium peroxide film, and aluminum film, two reactions occur, and the reaction formula is: Primary reaction: C6H8O7+Al+H2O→Ca(OH)2+O2↑; Secondary reaction: Ca(OH)2+Al+H2O→Ca(Al(OH)4)2+H2↑; Or when the medical gases are oxygen and carbon dioxide, the multilayer solid-gas conversion material is a sodium bicarbonate film, an acidic cloth made of citric acid, and a calcium peroxide film, and the reaction formula is: NaHCO3+C3H4(OH)(COOH)3+CaO2+H2O→C3H4(OH)(COONa)3+H2O+CO2↑+Ca(OH)2+O2↑; Or when the medical gas is nitric oxide, the multilayer solid-gas conversion material is a sodium nitrite film and an acid cloth made of sulfuric acid, and the reaction formula is: 6NaNO2+3H2SO4→3Na2SO4+2H2O+4NO↑+2HNO3.

8. The medical gas sustained-release dressing according to claim 7, characterized in that: The material of the water-blocking and breathable layer C is a microporous membrane, including PE, PS, PTFA or PDFE.

9. The medical gas sustained-release dressing according to claim 8, characterized in that: The material of the water-absorbing layer D is a sponge material, a cellulose material, a fiber material, a cotton material or a highly absorbent polymer.

10. Use of the medical gas sustained-release dressing according to any one of claims 1 to 9 in promoting local wound healing.

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