WO2021243593A1

WO2021243593A1 - Phototherapy system and use method thereof

Info

Publication number: WO2021243593A1
Application number: PCT/CN2020/094084
Authority: WO
Inventors: 王芷尧; 朱业修
Original assignee: 王芷尧
Priority date: 2020-06-03
Filing date: 2020-06-03
Publication date: 2021-12-09

Abstract

The present invention relates to a phototherapy system, comprising a phototherapy apparatus and a transparent or translucent hydrogel dressing. A use method of the phototherapy system comprises covering the surface of a wound of an individual with a transparent or translucent hydrogel dressing, and using an phototherapy apparatus to irradiate the transparent or translucent hydrogel dressing and the wound to accelerate wound repair.

Description

A phototherapy system and its use method

Technical field

The present invention relates to a phototherapy system and a method of use thereof. The phototherapy system comprises a phototherapy device and a hydrogel dressing, the hydrogel dressing is covered on the wound, and the hydrogel is irradiated by the phototherapy device Dressing and the wound to promote wound healing.

Background technique

Wound repair is a series of complex processes that the body initiates when it is injured. In the first stage, the "inflammatory period" blood needs to flow to the wound area to deliver the factors, proteins and blood coagulation components needed for healing, while the immune system resists and swallows bacteria and debris in the wound. In the second stage, the "proliferative period", the wound area proliferates new capillaries to deliver more collagen. The proliferative granulation tissue is deposited on the wound surface to provide the basic structure. Epidermal cells move and proliferate from the periphery of the wound to the inside to close the wound. The third stage "mature/remodeling period" after wound healing, the excess capillaries degenerate and atrophy, the collagen tissue is elongated and arranged neatly, and the scar becomes flat and light.

In the past, keeping the wound dry was the main care principle. However, the dry wound environment delayed wound healing. In recent years, related studies have proved that keeping the wound moist helps the movement and proliferation of epidermal cells and promotes wound healing. Therefore, various wet dressings have been produced. , Such as hydrocolloid (Hydrocolloid) and hydrogel (Hydrogel) dressings. However, hydrocolloid dressings are mainly composed of carboxymethyl cellulose, which can easily be decomposed by bacteria in the infected wound to produce peculiar smell and breed pathogens. Furthermore, the material itself does not contain water, and its moisture absorption and moisturizing ability is lower than the physiological requirement of 60~ 80% water content, moisture retention is only slightly better than dry gauze dressing.

Although wet dressings can keep the wound moist, it cannot effectively promote blood circulation around the wound. At present, negative pressure wound treatment (NPWT) is often used in difficult-to-heal wounds. Negative pressure wound treatment uses simple negative pressure. Source, forming a negative pressure environment in the wound, extracting wound pus and infectious substances, attracting healthy tissue fluid to maintain a moist healing environment, and promoting blood microcirculation around the wound, transporting nutrients and oxygen required for wound healing, and stimulating wound granulation tissue Formation and movement and proliferation of healthy tissues to achieve the effect of accelerating healing.

Existing negative pressure wound treatment systems can be divided into two systems: exudate collection bottle type and absorption type dressing. US Patent Application Publication No. US2011/0213287 discloses a negative pressure therapy system, which connects a collection bottle between a negative pressure source and a dressing to collect tissue fluid drawn by negative pressure; however, this type of negative pressure therapy system is required The additional configuration of the collection bottle and the connected pipelines and stents requires more space during use, and the patients using this treatment system cannot easily move. Chinese Patent Application Publication No. CN102046119 discloses a multi-layer negative pressure dressing for a negative pressure treatment system, which includes an absorbent layer and a gas-permeable and water-blocking layer. The tissue fluid attracted by the negative pressure is contained through the gas-permeable and water-blocking layer. In the absorbent layer, it will not enter the negative pressure source due to the suction of negative pressure; however, when the absorbent layer absorbs too much tissue fluid, the voids in the absorbent layer will be used to contain the tissue fluid, which will affect the suction of the negative pressure source efficient.

According to research related to negative pressure therapy, when using negative pressure therapy, the original dressing must be removed and replaced with a special negative pressure dressing, which not only easily pulls the wound, but also increases the risk of infection; the joints of the components of the negative pressure therapy system are also prone to incomplete sealing. Insufficient negative pressure affects the effect; or even excessive negative pressure leads to wound pain and excessive bleeding.

Phototherapy, also known as Heliotherapy, is the use of light energy to contact the organism and convert it into bioenergy, accelerate the metabolism of the organism’s cells, promote immune regulation and the expression of inflammatory factors, so as to treat diseases and restore health. Purpose. Specifically, the light waves of light therapy can improve the oxygenation capacity of cell mitochondria, enhance enzymatic reactions, promote ATP synthesis and decomposition, increase DNA and RNA synthesis, promote cell tissue regeneration, and accelerate the therapeutic effect of wound healing. Moreover, the care operation of the phototherapy device only needs to operate the control device, unlike the care operation of the negative pressure device, which requires a complete connection between the wound, dressing and the device to maintain an effective negative pressure value during operation, and then operate the control device. The nursing homework is cumbersome.

At present, the treatment of difficult-to-heal wounds is mainly negative pressure wound treatment. Light therapy is an auxiliary therapy, and most of the wounds are directly exposed to the light therapy device, which easily increases the risk of infection. Although Taiwan Patent No. I564293, No. I670098 and U.S. Patent No. US20160236007 use phototherapy combined with dressing care to avoid the increased risk of infection caused by opening the wound during phototherapy, the dressing used is hydrocolloid or transparent film. ), the dressing material itself does not contain water and has poor moisture absorption and moisturizing ability, which cannot maintain the moisture balance of the physiological state required for wound repair; in addition, the translucent hydrocolloid dressing can only provide a slightly moist wound environment after absorbing tissue fluid. However, it becomes opaque milky white and hinders the irradiation of phototherapy. In addition, although the Chinese patent application number: 201811337174.15 discloses that hydrogels are combined with antibacterial ingredients to treat infected wounds, they are based on opaque carbon nanoparticle hydrogels and photothermal therapy (PTT) that generates heat. Combining antibacterial substances to treat infected wounds in the inflammatory phase at the superficial part of the wound. The above-mentioned patent uses light or heat to improve blood circulation or infection treatment of wounds to promote general wound healing. However, for patients with difficult wounds, they may not be able to effectively produce nutrients or ingredients required for wound healing and promote granulation. Organization formation.

Therefore, in order to accelerate the healing of chronic or large-area wounds, in addition to keeping the wound moist and improving blood circulation, it is also necessary to supplement the wound healing compound. For example, U.S. Patent Publication Nos. 5,489,304 and 5,716,411 patents mix collagen-glycosaminoglycan (glycosaminoglycan) on the wound surface, and then coat a layer of cultured animal or human epidermal cells to promote Skin regeneration. U.S. Patent No. 5,977,088 discloses a pharmaceutical composition containing an agent for treating or promoting alleviation of skin diseases and hyaluronic acid. The pharmaceutical composition uses hyaluronic acid to promote or cause the delivery of the agent to the skin of the wounded. It can accumulate and prolong the stay of the medicine at the site. However, the above-mentioned therapeutic compounds need to be applied to the skin and then covered with a protective covering layer in two steps. The care process is cumbersome and easy to be infected. Moreover, if the therapeutic compounds are applied excessively, it is not only wasteful but also easy to protect. The adhesion of the covering layer to the skin is not good. Although Taiwan Patent No. 1264306 discloses that a collagen-hyaluronic acid mixture is applied to a gauze dressing, it is a composite material of dry gauze that is unfavorable for wound healing.

Although Taiwan Patent No. I589316 applies the therapeutic or beauty composition to the skin in the form of a gel, cream or ointment, or covers it on the skin with a gel pad or hydrogel pad to protect the above-mentioned coating. Dressings, together with light, ultrasonic or electric devices, are used to promote the penetration of the therapeutic or cosmetic composition through the skin epidermal barrier. However, the above-mentioned therapeutic compounds need to be applied to the skin and then covered with a hydrogel pad in two steps, which is cumbersome. Furthermore, they belong to the category of "PATCH", which uses physical devices to promote the penetration of the drug through the skin. The epidermal layer is used for delivery to the skin. It does not discuss whether drugs or compounds with physical devices can assist the absorption of drugs in the human body or accelerate their loss.

Generally, therapeutic chemical components or compounds need to be protected from light and heat to avoid deterioration of the components. In addition to the physical and chemical properties of light that affect the chemical composition or the properties of the compound itself, it also has different effects on the human body (for example: mitochondrial oxygenation, enzymatic reaction, melanin spots or DNA damage), and therapeutic ingredients in the human body The performance and characteristics of power absorption, distribution and metabolism, and whether the compound that promotes wound healing is combined with phototherapy can still promote wound repair or slow down is a problem that needs to be solved.

Therefore, to effectively accelerate wound repair, it is necessary to combine (1) the moisture balance of the wound, (2) promote blood circulation, and (3) provide the ingredients required for wound healing, which are the problems that need to be solved at present. Furthermore, providing convenience and comfort for wound care and reducing the risk of infection are also problems that need to be solved.

Summary of the invention

Therefore, the present invention provides a phototherapy system, which includes a transparent or translucent hydrogel dressing and a phototherapy device. The phototherapy device directly irradiates the hydrogel dressing covering the wound for treatment and accelerates the repair of wounded skin. The hydrogel dressing can provide a moist and balanced microenvironment for the wound, and supplement compounds that promote wound healing, and the phototherapy device can promote blood circulation and metabolism. Therefore, a hydrogel dressing containing a compound that promotes wound healing is used together with a phototherapy device without changing or opening the dressing, which can avoid the risk of infection, reduce the labor of medical staff, and has the convenience of nursing, reducing the risk of bleeding and speeding up wound repair.

The term "a" or "an" in this text is used to describe the components and ingredients of the present invention. This term is only for convenience of description and to give the basic idea of the present invention. This description should be understood to include one or at least one, and unless clearly indicated otherwise, the singular number also includes the plural number. When used with the word "comprise" in the scope of the patent application, the term "a" can mean one or more than one.

The term "or" in this document means the same as "and/or".

The present invention provides a phototherapy system, which includes: a phototherapy device, which includes a light source and a control device, wherein the control device is connected to the light source to control the light source's irradiation mode; and a hydrogel dressing, which includes a hydrogel, and the The hydrogel contains a compound that promotes wound healing, the compound that promotes wound healing contains collagen, hyaluronic acid or a combination thereof, wherein the hydrogel dressing presents a transparent or translucent state, and the light transmittance of the hydrogel dressing More than 60%, and the water content of the hydrogel is greater than 40%; wherein the hydrogel dressing is used to cover the wound of an individual, and the phototherapy device is used to irradiate the hydrogel dressing and the wound to promote the wound Repair.

"Hydrogel" in this article is a hydrophilic solid polymer with a three-dimensional network structure, with a water content of more than 40%. It can absorb water and swell from water, and maintain a large amount of water in a swollen state without dissolving in water. . Through the water absorption, water retention, and moisturizing properties of the hydrogel, it can replenish dry wound moisture or absorb excess wound exudate. Therefore, the hydrogel dressing can maintain a certain moisture balance of the wound, promote the movement and proliferation of epidermal cells, or use its properties The absorbent hydrophilic group adsorbs antibacterial, collagen, or hyaluronic acid and other therapeutic or wound healing compounds into the three-dimensional network structure inside the hydrogel to become a medicinal dressing. When in use, the hydrogel dressing is applied to the wound, and the hydrogel dressing can release compounds that promote wound healing and further accelerate the repair of the wound.

In a specific embodiment, the water content of the hydrogel is greater than 50%. In a preferred embodiment, the water content of the hydrogel is greater than 60%.

In another specific embodiment, the hydrogel is a polymerization product, wherein the components of the polymerization product include a hydrophilic monomer, a crosslinking agent, and/or a polymerization initiator. The hydrogel will eventually form a water-insoluble solid hydrophilic polymer. The solid hydrophilic polymer will have a three-dimensional network structure, and further utilize the adsorption properties of the hydrophilic group of the hydrogel itself to promote The wound healing compound is adsorbed in the solid hydrophilic polymer.

The hydrophilic monomer herein is hygroscopic. In a specific embodiment, the hydrophilic monomer comprises acrylic acid or its derivatives with unsaturated double bonds, acrylamide or its derivatives, polyethylene glycol or its derivatives, or a combination thereof.

The crosslinking agent herein is not particularly limited, as long as it can react with the functional groups of the hydrophilic polymer to initiate crosslinking, and includes but is not limited to compounds having at least two ethylenically unsaturated groups.

The polymerization initiator herein is not particularly limited, and an effective amount is used to initiate the polymerization reaction between the monomer of the hydrophilic polymer and the crosslinking agent. The polymerization of the hydrophilic polymer can be initiated by appropriate selection of heat, visible light, ultraviolet light or other means, depending on the polymerization initiator used. Alternatively, it can be initiated without an initiator, for example using an electron beam (e-beam).

The above-mentioned hydrogel itself has a hydrophilic group, and the compound that promotes wound healing can be adsorbed to the three-dimensional network structure inside the hydrogel before, during or after polymerization to form a hydrogel medical dressing. The three-dimensional network The free water inside the structure can be replaced with an aqueous solution of a compound that promotes wound healing, and the compound that promotes wound healing can be freely distributed in the hydrogel polymer. Therefore, when the hydrogel medicinal dressing is attached to the wound, the compound that promotes wound healing is released from the hydrogel medicinal dressing into the wound skin, which can enhance the healing ability of the wound.

The "compounds that promote wound healing" herein include, but are not limited to, compounds that have the effect of promoting wound healing. In a specific embodiment, the compound that promotes wound healing includes a water-soluble compound that promotes wound healing. In a preferred embodiment, the wound healing promoting compound contains a wound healing promoting factor. In a more preferred embodiment, the compound for promoting wound healing comprises ceramide, alginate, silver ion, chitosan, vitamin, or derivatives of the foregoing components or a combination thereof.

In a specific embodiment, the compound that promotes wound healing accounts for 0.01% to 20% of the total weight of the hydrogel. In a preferred embodiment, the compound that promotes wound healing accounts for 0.05% to 18% of the total weight of the hydrogel. In a more preferred embodiment, the compound that promotes wound healing accounts for 0.1% to 12% of the total weight of the hydrogel.

In another specific embodiment, the phototherapy system promotes the proliferation of cells and collagen in the skin covered by the hydrogel dressing. In a preferred embodiment, the phototherapy system promotes the proliferation of cells and collagen in the wound. In a more preferred embodiment, the phototherapy system promotes collagen proliferation at the wound.

In a specific embodiment, the hydrogel dressing is a thin sheet with a thickness of 0.1 to 5 mm. In a preferred embodiment, the hydrogel dressing is a thin sheet with a thickness of 0.3 to 3 mm.

In another specific embodiment, the individual is an animal, preferably a mammal, more preferably a human.

In a specific embodiment, the light source includes one or more light-emitting components. In a preferred embodiment, the light-emitting component is an LED or an OLED. Since the general halogen light source or white flag light source is too hot, it is easy to cause skin burns; therefore, the present invention adopts cold light source LED or OLED for phototherapy.

In another specific embodiment, the light source includes a near-infrared light source, a red light source, a yellow light source, a blue light source, or a combination thereof. Therefore, the light source of the phototherapy device is used to emit light in a variety of different wavelength ranges, and some or all of the light-emitting components are turned on according to actual application needs.

The introduction and effect of the light source are as follows:

The wavelength of the light emitted by the near-infrared light source is 630 to 830nm. Near-infrared light penetrates the human skin the deepest, can penetrate 1 to 3mm under the skin, and induce the mitochondrial chromophore in the skin cell to absorb photons and trigger electron transmission. It releases ATP (adenosine triphosphate) and NO (nitric oxide), the human body's smallest energy units, to promote blood circulation and ROS (reactive oxygen species) content, and help ATP production through different physiological signals;

The wavelength of the light emitted by the red light source is 600 to 650nm, such as 630nm. Red light can increase cell activity, promote cell metabolism and synthesis, make the skin secrete collagen and fibrous tissue to fill itself, accelerate blood circulation, and increase skin elasticity ；

The wavelength of light emitted by the yellow light source is 550 to 600nm, such as 592nm. Yellow light has the active effect of accelerating blood circulation, activating cells, and stimulating cell excitability. It can promote collagen synthesis and strengthen the collagen fibers and elastic fibers of the skin. Calm the nerves and enhance the immune function of the skin; and

The wavelength of light emitted by the blue light source is 400 to 500nm, such as 415nm and 470nm. The blue light matches the light absorption peak of the bacilli metabolite porphyrin. After the porphyrin is excited, the chemical de-excitation process produces a large amount of singlet active oxygen, which produces a high Oxidize the environment, leading to the death of bacteria.

In a specific embodiment, the power of the light source is 5 to 4000 mW. In a preferred embodiment, the power of the light source is 100 to 500 mW.

The light-emitting components of the light source described in this article, in addition to emitting light of different wavelengths, also include a drive circuit and a control circuit. The drive circuit is used to drive the light-emitting component to emit light, and the control circuit is used to control the drive circuit according to the user's instructions. Output grid signal and data signal.

In a specific embodiment, the control device includes a power supply module, wherein the power supply module is connected to the light source, and is used to provide power and control the light source according to received instructions. For example, the control device can switch between light sources of different luminous colors according to received instructions, or switch between different numbers of light sources. The instruction can be a manual input by a worker, or a detection device or a remote instruction signal received by the control device.

In another embodiment, the phototherapy device further includes a detection device.

In a specific embodiment, the detection device includes a sensor, an infrared monitor, and a data transmission module. The sensor and the infrared monitor are used to detect the temperature of the skin surface or depth during phototherapy, so as to protect the patient from skin burns and protect the patient from skin burns. The information collected by the sensor and the infrared monitor is transmitted to the control device through the data transmission module to adjust the working time and dose of the light source, and/or external equipment is used to communicate with medical personnel.

In a specific embodiment, the light source of the phototherapy device has a cover to prevent the light emitted by the light source from irradiating everywhere, so that the light from the light source can be irradiated in a specific direction. There are no specific restrictions on the shape and material of the cover. In actual applications, it can be determined according to specific needs. For example, the cover can be set to be square, rectangular, round, arc, spherical, etc., regular or irregular Shape, use aluminum alloy profiles, plastic connectors or other lightweight, waterproof materials and brackets to make and so on.

The present invention also provides a method for promoting wound healing, which comprises: (1) covering an individual's wound with a hydrogel dressing; (2) irradiating the hydrogel dressing and the wound with a phototherapy device to promote the wound The repair; wherein, the hydrogel dressing contains a hydrogel, and the hydrogel contains a compound that promotes wound healing, and the compound that promotes wound healing contains collagen, hyaluronic acid or a combination thereof, wherein the hydrogel dressing In a transparent or translucent state, the light transmittance of the hydrogel dressing is greater than 60%, and the water content of the hydrogel is greater than 40%; wherein the phototherapy device includes a light source and a control device, wherein the control device is connected to the light source To control the way the light source illuminates.

In a specific embodiment, the light transmittance of the hydrogel dressing is greater than 70%. In a preferred embodiment, the light transmittance of the hydrogel dressing is greater than 80%. In a more preferred embodiment, the light transmittance of the hydrogel dressing is greater than 90%.

In another specific embodiment, the water content of the hydrogel is greater than 50%. In a preferred embodiment, the water content of the hydrogel is greater than 60%.

In another specific embodiment, the compound that promotes wound healing comprises a water-soluble compound that promotes wound healing. In a preferred embodiment, the wound healing promoting compound contains a wound healing promoting factor. In a more preferred embodiment, the compound for promoting wound healing comprises ceramide, alginate, silver ion, chitosan, vitamin, or derivatives of the foregoing components or a combination thereof.

In a specific embodiment, the light source includes one or more light-emitting components. In a preferred embodiment, the light-emitting component is an LED or an OLED. In a more preferred embodiment, the light source is an LED or an OLED.

In another specific embodiment, the light source includes a near-infrared light source, a red light source, a yellow light source, a blue light source, or a combination thereof.

In a specific embodiment, the light therapy device is irradiated with near-infrared light for 15 minutes, then converted to blue light for 10 minutes, then converted to yellow light for 10 minutes, and irradiated twice a day. In another specific embodiment, the irradiation mode of the phototherapy device includes irradiation with red light for 35 minutes, irradiation twice a day.

In another specific embodiment, the power of the light source is 5 mW to 4000 mW. In a preferred embodiment, the power of the light source is 100 mW to 500 mW.

In a specific embodiment, the control device includes a power supply module, wherein the power supply module is connected to the light source, and is used to provide power and control the light source according to received instructions.

In a specific embodiment, the detection device includes a sensor, an infrared monitor, and a data transmission module. The sensor and the infrared monitor are used to detect the temperature of the wound surface or depth of the individual during phototherapy, and combine the sensor and the The information collected by the infrared monitor is transmitted to the control device through the data transmission module to control the irradiation time and dose of the phototherapy device.

In another specific embodiment, the method further promotes the proliferation of cells and collagen of the skin covered by the hydrogel dressing. In a preferred embodiment, the method further promotes the proliferation of cells and collagen in the wound. In a more preferred embodiment, the method further promotes the proliferation of collagen in the wound.

The present invention further provides the use of a composition for preparing a pharmaceutical composition for treating wounds irradiated by a phototherapy device, wherein the composition comprises a hydrogel, the hydrogel comprises a wound healing compound, which promotes wound healing The compound of contains collagen, hyaluronic acid or a combination thereof, and the water content of the hydrogel is greater than 40%; wherein the pharmaceutical composition contains a hydrogel dressing, and the hydrogel dressing is in a transparent or translucent state, The light transmittance of the hydrogel dressing is greater than 60%; wherein the hydrogel dressing covers the wound of the individual, and the phototherapy device is used to irradiate the hydrogel dressing and the wound to promote the repair of the wound; wherein, The phototherapy device includes a light source and a control device, wherein the control device is connected to the light source to control the light source's irradiation mode.

In another specific embodiment, the composition further promotes the proliferation of cells and collagen of the skin covered by the hydrogel dressing. In a preferred embodiment, the composition further promotes the proliferation of cells and collagen in the wound. In a more preferred embodiment, the composition further promotes the proliferation of collagen at the wound.

Therefore, the main purpose of the present invention is to provide a transparent or translucent hydrogel dressing to provide a moist and balanced microenvironment for the wound, and to further promote the effective absorption of the healing-promoting compound contained in the hydrogel, and then directly irradiate the phototherapy device to cover The (semi-)transparent hydrogel dressing on the wound can promote blood circulation, metabolism and sterilization and anti-inflammatory effects around the wound to accelerate wound healing. The combined use of the hydrogel dressing and the phototherapy device can Play complementary effects in a synergistic manner to accelerate the repair of wounded skin.

Another object of the present invention is that the hydrogel dressing is used in conjunction with the phototherapy device without changing or opening the dressing, which can avoid the risk of infection, reduce the labor of medical staff, and have the convenience of nursing, and provide acne skin and patchy skin. , Repair of burned skin or wounded skin.

Description of the drawings

Figure 1 is a graph showing whether 4 groups of collagen, hyaluronic acid, epidermal growth factor and the control group are added to the cell proliferation with or without light.

Figure 2 is a graph showing the effects of collagen, hyaluronic acid, epidermal growth factor and the control group on the proliferation of collagen in the cells with or without light.

Fig. 3 is a schematic diagram of the structure of the phototherapy system of the present invention acting on a wound.

Symbol Description

10 wound

20 Hydrogel dressing

30 Phototherapy device

31 Light source

32 Control device

33 Detection device

34 Infrared monitor

35 Sensor

detailed description

Several examples are listed for the implementation of this application, and are described in conjunction with the illustration below for review and reference. For the convenience of description, the scale and position of the illustrations in the present invention are not necessarily drawn according to actual scales, and the scales and positions in the icons are not used to limit the protection scope defined by the claims of the present invention.

The following examples are non-limiting and only represent several aspects and characteristics of the present invention.

Example 1: Evaluation of light safety of compounds that promote wound healing

In Vitro Cell Bioassay Experiment

Human Dermal Fibroblasts (Human Dermal Fibroblasts) were used as an in vitro experimental model, and they were inoculated on a 10cm tissue culture dish to grow adherently, and a culture medium containing 200mM glucose (Glucose-DMEM, G-DMEM) was used as an in vitro hyperglycemic diabetes model Culture, change the culture dish every 3 to 4 days/passage. After the cells in the culture dish are centrifuged, 1*10 ⁶ cells are retained in 5ml culture medium. Take a 6-well flat plate culture dish (6-well chamber), add 1*10 ⁴ cells (50μl) and culture medium to each well, and place it in a 37°C, 5% CO ₂ incubator for culture. After the cells are attached , Add 1ml of the compounds in Table 1 and G-DMEM to different wells, and irradiate it with near-infrared light (wavelength 630nm) every day with a power of 150mW to 200mW for 15 minutes or without light, as shown in Table 1 below:

Table 1. The added components of each group and the experimental design with or without light

Bioassay analysis

A. Cell proliferation: CyQuant is used to measure cell proliferation. The collagen, epidermal growth factor and their corresponding light-emitting groups in Table 1 have an overall effect on cell proliferation that is significantly higher than that of the control group without light (Figure 1). Although hyaluronic acid has no obvious effect on cell proliferation, none of them Inhibiting cell proliferation, the results of this experiment show that the above-mentioned compounds in Table 1 and their dosages are not toxic to human skin fibroblasts. And light has the effect of promoting cell proliferation on collagen and hyaluronic acid; but the effect of illuminated epidermal growth factor on cell proliferation is lower than that of the non-illuminated group, and light reduces the effect of epidermal growth factor on cell proliferation.

B. Collagen hyperplasia: The content of type I (type I) collagen in the cell culture fluid was analyzed with a commercially available kit (The Sircol ^{™ collagen assay kit).} Adding the collagen, hyaluronic acid, epidermal growth factor in Table 1 and their corresponding illumination group has an overall effect on cell collagen proliferation that is significantly higher than that of the control group without illumination (Figure 2). And light has the effect of promoting collagen proliferation on collagen and hyaluronic acid; but the effect of illuminated epidermal growth factor on collagen proliferation is lower than that of the non-illuminated group, and light reduces the effect of epidermal growth factor on collagen proliferation. effect.

Example 2: Wound repair experiment

Phototherapy example: phototherapy plus hydrogel dressing (hydrogel dressing) healing test

As shown in Figure 3, after first cleaning the bleeding, dirty or necrotic tissue of the wound 10, a hydrogel dressing 20 (consisting of 1% collagen, 0.2% hyaluronic acid and 0.02% silver ion, the hydrogel The dressing is transparent or translucent) to cover the wound, and the dressing is changed every 1 to 4 days (adjust the frequency of replacement depending on the amount of bleeding and exudation) until the wound is healed; in addition, the light source 31 (LED or OLED light source) of the phototherapy device 30 The quasi-wound 10 is 5 cm away from the dressing on the wound, the control device 32 is turned on, and the initial setting button is pressed (the setting parameter is near-infrared light for 15 minutes, continued to blue light for 10 minutes, and then to yellow light for 10 minutes; The power is 150-200mW), irradiate twice a day for 35 minutes each, and repeat the above steps until the wound is healed. The signal from the infrared monitor 34 inside the detection device 33 connected to the control device 32 synchronously collects the skin temperature where the light is irradiated, and feeds it back to the detection device 33 through the sensor 35; if the skin temperature is higher than 45°C, the detection device 33 Send a signal to the control device 32 immediately to stop the light source 31 to avoid skin burns. Since the preparation of the hydrogel dressing is not the focus of the present invention, it will not be repeated here.

Phototherapy comparison: phototherapy plus hydrocolloid dressing (hydrocolloid dressing) healing test

After clearing the bleeding, dirty or necrotic tissue of the wound 10, cover the wound 10 with a hydrocolloid dressing, and change the dressing every 1 to 3 days (adjust the frequency of replacement depending on the amount of bleeding and exudate) until the wound is healed; The light source 31 of the phototherapy device 30 is aimed at the wound and is 5 cm away from the dressing on the wound, the control device 32 is turned on, and the initial setting button is pressed (the setting parameter is red light for 35 minutes, the power is 150-200 mW), and the irradiation is twice a day Each 35 minutes, and repeat the above steps until the wound healed. The signal from the infrared monitor 34 inside the detection device 33 connected to the control device 32 synchronously collects the skin temperature where the light is irradiated, and feeds it back to the detection device 33 through the sensor 35; if the skin temperature is higher than 45°C, the detection device 33 Send a signal to the control device 32 immediately to stop the light source 21 to avoid skin burns.

Comparison of the above-mentioned phototherapy plus hydrogel dressing (phototherapy example), phototherapy plus hydrocolloid dressing (phototherapy comparison), negative pressure wound treatment NPWT (NPWT comparison), and general wound treatment hydrogel dressing (control group) for wound treatment comparison, NPWT The comparison and control group were implemented according to their routine wound care. Twenty patients selected from type II diabetes or pressure ulcers (5 people in each experiment), with similar wound size, aged 45-65 years, and chronic wound patients who did not heal for more than 7 days.

The pain degree of the patient is expressed by the Numeric Pain Intensity Scale (NPIS) grading method: 0-10 represents different degrees of pain, 0 painless, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain. The patients circle a number according to their own feelings. The average pain sensation of 20 patients at different times is shown in Table 2 below:

Table 2. Pain test results of each experimental group

The curative effect of wound healing is graded as follows: invalid-no improvement in wound; improvement-wound reduction of 30 to 70%; marked effect-wound reduction of more than 70%; recovery-wound healing.

The curative effect of 20 patients at different times is shown in Table 3 below:

Table 3. Wound healing in each experiment

The comparison of Table 2 and Table 3 shows that the hydrogel dressing of the present invention combined with the light therapy treatment examples has both a soothing and analgesic effect. Furthermore, as shown in Table 3, the hydrogel dressing combined with phototherapy of the present invention has a similar degree of healing effect compared with the current negative pressure wound therapy (NPWT) control group commonly used in chronic wounds. It began to get better at 8 days and approached healing at 16 days; while the wounds of the control group and phototherapy were delayed to 12 to 16 days and started to get better. In addition, it is necessary to replace the special negative pressure dressing and tandem equipment during daily negative pressure treatment, which increases the cumbersomeness of nursing care and the risk of infection.

The above-mentioned embodiments are merely illustrative to illustrate the effects of the present invention, and to illustrate the technical features of the present invention, and are not used to limit the protection scope of the present invention. Any changes or arrangements that can be easily made by those skilled in the art without departing from the technical principles and spirit of the present invention fall within the scope of protection claimed by the present invention.

Claims

A method for promoting wound healing, which comprises: (1) covering an individual's wound with a hydrogel dressing; (2) irradiating the hydrogel dressing and the wound with a phototherapy device to promote the healing of the wound Repair; wherein the hydrogel dressing comprises a hydrogel, and the hydrogel comprises a compound that promotes wound healing, and the compound that promotes wound healing comprises collagen, hyaluronic acid or a combination thereof, wherein the water The gel dressing presents a transparent or translucent state, the light transmittance of the hydrogel dressing is greater than 60%, and the water content of the hydrogel is greater than 40%; wherein the phototherapy device includes a light source and a control device, wherein The control device is connected to the light source to control the illumination mode of the light source.
The method of claim 1, wherein the compound that promotes wound healing comprises ceramide, alginate, silver ion, chitosan, vitamin or a combination thereof.
The method of claim 1, wherein the compound that promotes wound healing accounts for 0.01% to 20% of the total weight of the hydrogel.
The method according to claim 1, wherein the hydrogel dressing is a thin sheet with a thickness of 0.1 to 5 mm.
The method of claim 1, wherein the light source comprises a near-infrared light source, a red light source, a yellow light source, a blue light source, or a combination thereof.
The method of claim 1, wherein the light source is an LED or an OLED.
5. The method according to claim 5, wherein the light therapy device is irradiated with near-infrared light for 15 minutes first, then converted to blue light for 10 minutes, then converted to yellow light for 10 minutes, and irradiated twice a day.
The method according to claim 5, wherein the irradiation mode of the phototherapy device comprises irradiation of red light for 35 minutes, irradiation twice a day.
The method of claim 1, wherein the power of the light source is 5 mW to 4000 mW.
The method of claim 1, which further promotes the proliferation of collagen at the wound.
A phototherapy system, comprising: a phototherapy device, which includes a light source and a control device, wherein the control device is connected to the light source to control the irradiation mode of the light source; and a hydrogel dressing, which includes a hydrogel, and The hydrogel comprises a compound that promotes wound healing, the compound that promotes wound healing comprises collagen, hyaluronic acid or a combination thereof, wherein the hydrogel dressing is in a transparent or translucent state, and the hydrogel dressing The light transmittance of is greater than 60%, and the water content of the hydrogel is greater than 40%; wherein the hydrogel dressing is used to cover the wound of an individual, and the light device is used to irradiate the hydrogel dressing And the wound to promote the repair of the wound.
The phototherapy system of claim 11, wherein the compound that promotes wound healing comprises ceramide, alginate, silver ion, chitosan, vitamin or a combination thereof.
The phototherapy system of claim 11, wherein the compound that promotes wound healing accounts for 0.01 to 20% of the total weight of the hydrogel.
The phototherapy system according to claim 11, wherein the hydrogel dressing is a thin sheet with a thickness of 0.1mm to 5mm.
11. The phototherapy system of claim 11, wherein the light source comprises a near-infrared light source, a red light source, a yellow light source, a blue light source, or a combination thereof.
The phototherapy system of claim 11, wherein the light source is an LED or an OLED.
The phototherapy system according to claim 11, which further promotes the proliferation of collagen at the wound.