WO2020233389A1

WO2020233389A1 - Light-shielding gel eye protectin patch

Info

Publication number: WO2020233389A1
Application number: PCT/CN2020/088332
Authority: WO
Inventors: 舒朝锋; 俞瑞珺; 田复波
Original assignee: 杭州炬九生物科技有限公司
Priority date: 2019-05-20
Filing date: 2020-04-30
Publication date: 2020-11-26
Also published as: ZA202108311B; CN111000681A

Abstract

A light-shielding gel eye protection patch consists of an application layer (I), a light-shielding layer (II), a thermal insulation layer (III) ), an isolation layer 1 (5) and an isolation layer 2 (4), wherein the application layer (I) is a silicone gel layer, the light shielding layer (II) is an aluminum foil (2.2) combined with non-woven fabric (2.4) or cotton cloth, the thermal insulation layer (III) is a hydrogel (3), the isolation layer 1 (5) or the isolation layer 2 (4) may be one of a pearl film, a release paper or a PE film, and has a shape that conforms to the structural and physiological characteristics of eyes, and is raindrop-shaped, spectacle frame-shaped, bean sprout-shaped, oval, or dolphin-shaped. The patch can prevent harmful light, including blue light during phototherapy of neonatal jaundice, and laser or IPL during laser or IPL treatment, from harming human eyes, and is safe, effective and comfortable.

Description

Gel shading eye protector

Technical field

The invention relates to a gel shading eye protection sticker, in particular to a protective product that can block light (laser/IPL/blue light, etc.) from harming eyes.

Background technique

When performing photon/laser surgery, the surgical site is especially on the face, the high-energy light is very easy to cause damage to the eyes. According to data, the amount of radiation that causes damage to the fundus macula is 10mw/cm2, and the irradiation time is only picoseconds, while the energy density of general intense pulsed light/laser is between 100mw-200mw/cm2. Therefore, during photon/laser surgery, both doctors and patients need to wear professional protective facilities to avoid medical accidents.

At present, the main protective equipment for patients during photon/laser surgery is laser protective eye mask and laser protective eye patch. Laser eye masks are generally made of flexible medical plastics and fixed on the back of the head with a fixed rope; laser protective eye patches are fixed by adhesive sticking. The laser protective goggles have the following defects: 1. After the laser goggles are worn on the eyes, there may be a gap between the edge and the skin, and the light may damage the eyes through the gap; 2. The laser goggles, the goggles when the patient is in the supine position during the operation The fixed rope will come into contact with the pillow or the operating table, and a slight movement of the head may cause the eye mask to move or fall off, and the eyes may be exposed to protection and be damaged by strong light. Laser protective eye patch, as mentioned in JP 2007-160023A, the product consists of a substrate, a first adhesive layer, a non-woven fabric and a second adhesive layer, and an isolation film. The product of this design has the following problems: 1. Laser or IPL are all high-energy rays. They shine on the protective eye patch. Although they can block the light from directly harming the eyes, the high-energy heat generated can easily cause eye skin burns (Europe has new regulations, laser protection The product must be able to prevent skin burning); 2. It is fixed on the second adhesive layer of the skin. If the viscosity is not strong enough, it is easy to fall off and cause eye damage. If the viscosity is too strong, it is easy to stick to the eyelashes or eyebrows. Patent 201310073280.4 is a hydrogel laser eye protection patch, which is composed of a three-layer structure of a support layer, a hydrogel layer and an isolation layer. The hydrogel layer is in contact with the skin. The viscosity of the hydrogel is softer than that of the eyelashes. Eyebrows, but their adhesion to the skin is too weak, in the process of clinical use, can not be firmly fixed on the eyelid skin, easy to fall off, resulting in photon/laser surgery is an increased risk of eye damage.

Neonatal jaundice is a very common disease in newborns. Excessive blood bilirubin will affect the brain development of children. Normally, bilirubin treatment is required. Among them, blue light (wavelength main peak 425～475 nanometers) is the most One of the common treatments for neonatal jaundice. However, blue light damages children’s eyes, retina, and genitals in the morning and needs to be protected. China Patent No. 201120028280.9 discloses a new type of blue-ray eye mask. Its technical solution is: including eye mask, elastic elastic band and Velcro. Both ends of the eye mask are provided with elastic elastic bands, which are connected by Velcro. The shortcomings of this blue eye mask are: 1. It is difficult to control the elasticity of the elastic elastic band during use. Too tight will easily compress the eyes, and too loose will easily fall off; 2. During the phototherapy, the child cries and turns the head, which is prone to up and down of the eye mask. And left and right displacements, causing the eyes to be exposed to blue light. In China Patent No. 200620071206.4, a newborn protective eye mask with a cover structure is disclosed. The technical solution is: a newborn protective eye mask, comprising a cover body and a light-shielding belt, and the cover body is a mesh structure with a closed top , The shading band is arranged at the port part of the cover body and fixedly connected with the cover body, and an eye pad is arranged on the inner surface of the shading band. The cover adopts medical elastic bandage material. The defects of this kind of newborn eye mask are: 1. When the elastic cover body fixes the shading band, it is difficult to choose the size of the mask body. If it is too large, the shading band is not firmly fixed in the eyes of the child, and it is easy to move and fall off; The head and eyes of the child are under too much pressure, which oppresses the eyeball, and affects the local blood supply and comfort around the eye. The child does not cooperate with phototherapy. 2. After the cover body covers the entire head, it can effectively avoid the up and down displacement of the shading belt; but when the cover body is in contact with the phototherapy bed or pillow, when the child's head rotates, it will usually cause a gap between the cover body and the head. Rotation will cause the shading belt to move left and right, exposing the child’s eyes to blue light. 3. The material of the shading goggles is mainly cotton or gauze. The material is relatively rough. The skin of the child is relatively delicate and rubs against the skin, which will cause damage to the skin of the child. At the same time, the child’s eyes cannot be kept completely closed. Easily enter the eyes, irritate the cornea or cause damage to the cornea. The current fixing methods of blue light protective goggles for newborns are basically the above-mentioned two fixing methods: binding type and hood type. No matter how improved these two methods are, due to their design defects, it is difficult to avoid the difficulty of tightness and control during use. Moving left and right, up and down leads to a defect that exposes the eyes.

In order to overcome the above shortcomings, patent 201920064674.6 (shading dressing for newborns), patent 201910029426.2 (a shading dressing for newborns and its preparation method), etc., through various methods such as increasing the thickness of the hydrogel and increasing the adhesion of the hydrogel. To achieve the purpose of firm fixation, the effect is not ideal. In the clinical trial process, 12 cases of blue light treatment of children, using the patented product for eye protection, during the treatment, 4 cases fell off, the fall off rate was 33.3%; 3 cases of eye protection patch displacement greater than 2mm, accounting for 25%; Five cases of clinical verification were completed, with a completion rate of 41.7%. The displacement of the eye patch is greater than 2mm, the stability of the product is poor, and it is easy to cause blue light damage to the eyes of children. The shedding rate of the product and the proportion of displacement greater than 2mm are as high as 58.3%, and the eye safety of children with phototherapy cannot be fully protected.

Therefore, it is the starting point of the present invention to develop a light-shielding product that can more effectively prevent strong light or blue light from harming the eyes of patients with less light pollution, convenient use, good compatibility, firm and safe fixation, and more comfortable patient experience.

Summary of the invention

The purpose of the present invention is to overcome the shortcomings of the prior art and the problems generated during clinical application, such as 1. The product is not firmly fixed on the eyelid skin and is easy to fall off; 2. The temperature of the product rises when high-energy light such as laser irradiates the surface of the product Causes eyelid skin burns; 3. The product should not cause damage to the skin and its accessory organs (brows and eyelashes) during use; provide a safe, effective and comfortable gel shading eye protection patch for clinical use. The purpose of the present invention is achieved through the following technical solutions:

The gel shading eye protection patch is composed of an external application layer, a shading layer, a heat insulation layer, an isolation layer 1, and an isolation layer 2.

The adhesive layer is composed of a three-layer structure of PE film/TPU film/adhesive, and the adhesive layer can be one of silicone gel or pressure sensitive adhesive. Among them, the TPU film must have the function of air permeability and water impermeability in providing the adhesion layer of the viscose. In theory, any film with the function of air permeability and water impermeability can replace the TPU film, such as PU film with a thickness of 10μm-50μm, the preferred solution It is 20μm-30μm. Since TPU is thin and soft, it is inconvenient to use. It is necessary to attach a layer of PE film on its surface with a thickness of 20 μm-60 μm, and the preferred solution is 30-40 μm. The applied adhesive material can theoretically be any medical adhesive with good compatibility, such as the current medical pressure-sensitive adhesive, medical silicone gel, etc., but the preferred solution is medical silicone gel, usually medical silicone The gel is made of a mixture of A and B components. By adjusting the different ratios of AB components, medical silicone gel products with different adhesion forces can be obtained. Usually the ratio of A/B components is 1:1 to 1 :2.

The light-shielding layer is composed of a four-layer structure of white or black PE film/aluminum foil/PE adhesive/non-woven fabric. The outer layer of the light-shielding layer is a PE film. The color of the PE film can be white or black. The preferred solution is white. The diffuse reflection of the white dye particles reduces the laser energy absorption of the product, which can protect the eyes well and is a product The temperature is not too high to avoid burning the skin; the white material can be titanium dioxide, magnesium carbonate, magnesium oxide, aluminum oxide, titanium oxide, calcium hydroxide, magnesium hydroxide, aluminum hydroxide, magnesium sulfate, barium sulfate, talc Powder, etc., the preferred solution is titanium dioxide. The aluminum foil can be an aluminum vapor deposition film (a material that deposits aluminum vapor on an organic film) and a metal aluminum foil. The preferred solution is metal aluminum foil. The thickness of the aluminum foil layer is 4-50um, and the preferred solution is 7-10um. The aluminum foil is a barrier. The main functional layer that the laser penetrates is too thin, and its ability to block the laser is too low, and too thick causes the product to be rigid and inconvenient to use. Non-woven fabrics and aluminum foils directly need adhesives to be combined together. All well-known, safe and non-toxic adhesives can be used, such as polyethylene (PE), polyurethane (PU), thermoplastic polyurethane (TPU), polyester ( PET), polypropylene (PP), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), ethylene-vinyl acetate (EVA), silicone rubber, polyimide (PI), etc. The preferred solutions are Polyethylene (PE). The thickness of the non-woven fabric can be 30-60 g/square meter, and the preferred solution is 30-35 g/square meter.

The light-shielding layer can be composed of three layers of blue cotton/sponge/black cotton. This structure can be used to protect the eyes from blue light damage during the blue light irradiation treatment of newborns. It cannot be used as eye protection during laser surgery. The previous structure can be used for both laser surgery and neonatal blue light therapy.

The heat-insulating layer is hydrogel or foam glue or a sponge filled with hydrogel in voids. During laser surgery, if the laser is irradiated on the surface of the product, although the light-shielding layer material of the product can block the laser's damage to the eyes, the high energy of the laser is converted into heat and transferred to the product, which will cause burns on the patient's eyelid skin. The thermal insulation layer is a hydrogel or foam glue or a sponge with a gap filled with a hydrogel. The preferred solution is a hydrogel. The structure and process of the hydrogel can refer to another patent of our company 201010217910.7, using hydrogel The advantage is that it has suitable adhesion performance, does not stick to the eyelashes, and can provide a large amount of water (the water content can reach more than 70%). The specific heat of water in common substances is the largest, and absorbs the same heat. Compared with other substances, the temperature rises less, which helps protect the eyelid skin from burns. Since this product is designed with an application layer to participate in the fixation, the thickness of the hydrogel layer should not be too thick, it is recommended to be between 0.5mm and 4mm, and the preferred solution is 1-1.5mm.

Because the blue light ability of neonatal jaundice treatment is relatively low, and the thermal effect is relatively small, when used in the blue light treatment of neonatal jaundice, the heat insulation layer can be removed without affecting the light blocking prevention effect of the product. If the heat insulation layer is removed, it can be Reducing the thickness of the product and increasing the compliance of the product are conducive to the application and fixation of the product. If the insulation layer remains, it also has its advantages. In a drier environment than the incubator, it can provide suitable moisture to the eye skin, which is beneficial to increase the comfort of the child and can be more coordinated with the treatment. If the insulation layer is removed, At the same time, the isolation layer 2 is also omitted.

The material of the isolation layer 1 and the isolation layer 2 is one of pearl film, release paper or PE film. The preferred version of the isolation layer 1 is a pearl film, and the preferred version of the isolation layer 2 is a PE film.

The isolation layer 1 is directly in contact with the adhesive of the application layer, and the middle part of the isolation layer 1 and the part with the same size and shape of the light-shielding layer are removed, so that the PE film of the light-shielding layer is directly fixed on the adhesive of the application layer , The isolation layer 2 is in direct contact with the insulation layer; it is also possible to cover the isolation layer 1 on the surface of the adhesive layer and the insulation layer at the same time, and the adhesive surface of the application layer and the hydrogel of the insulation layer are protected by the isolation layer 1 at the same time On the surface, the isolation layer 2 is omitted. Just remove the isolation layer 1 during use, which is convenient for customers to use. At the same time, the water of the hydrogel can nourish the eyes and the skin around the eyes; the third type of isolation layer 1 and the isolation layer 2 are heat insulation There is an isolation layer 2 on the surface of the layer, and the isolation layer 1 covers the surface of the application layer and the isolation layer 2 at the same time. In these three cases, the preferred solution is the first one, that is, the isolation layer 1 is in direct contact with the adhesive of the application layer, and the middle part of the isolation layer 1 and the part with the same size and shape of the shading layer are removed, so that the PE film of the shading layer It is directly fixed on the adhesive of the adhesive layer, and the isolation layer 2 directly contacts the heat insulation layer. This solution can achieve good product fixation, and at the same time, it can well block the thermal effect of the laser, avoid burning the skin, and will not stick off Eyelashes, while the hydrogel moisture can nourish the eyes and the skin around the eyes, easy to use.

The shape of the gel shading eye protector conforms to the structural and physiological characteristics of the eye, and is raindrop shape, spectacle frame shape, bean sprout shape, oval shape, dolphin shape, but is not limited to these shapes. The shape here refers to the shape of the application layer and the shape of the corresponding isolation layer 1, as well as the shape of the light shielding layer, the heat insulation layer and the isolation layer 2. The final product can be a combination of these types; The size of the sticking layer and the isolation layer 1 is 4-15mm larger than the light-shielding layer, the heat insulation layer and the isolation layer 2, so that the sticking layer can play a proper role in fixing.

Adopting the above scheme: the present invention has good adhesion, air permeability, good biocompatibility, and at the same time has the characteristics of keeping the local environment moist, comfortable for patients, convenient for doctors, etc., and is suitable for neonatal hyperbilirubinemia phototherapy eye protection It can also be used for laser or IPL surgery to protect the eyes of patients. It can be stored for a long time after radiation sterilization.

The beneficial effects of the present invention are:

1. It can effectively prevent the damage of blue light to the eyes in the process of neonatal phototherapy.

2. The present invention is convenient to use, can be peeled off and pasted many times, so that doctors can observe the eyes of patients and observe the degree of jaundice in children.

3. It can effectively prevent the eye damage of patients with light during laser or IPL surgery.

4. The present invention uses silicone gel to assist the fixation, has suitable adhesion, is firm and does not fall off, and can ensure the safety of the patient's eyes during the treatment process; at the same time, it avoids the patient's eyebrows and eyelashes from tearing off.

5. The hydrogel layer of the present invention can maintain the moisture of the local environment around the eyes, which is beneficial to the protection of the eyes and the skin around the eyes.

6. The shape of the present invention is designed according to the principle of ergonomics, conforms to the various physiological bending of the eye, and has a good adhesion effect.

Description of the drawings

Figure 1 is a cross-sectional view of the present invention:

Ⅰ is the adhesive layer, 1.1 is the PE film, 1.2 is the TPU film, and 1.3 is the viscose; Ⅱ is the light-shielding layer, 2.1 is the PE film, 2.2 is the aluminum foil, 2.3 is the PE adhesive, and 2.4 is non-woven fabric; Ⅲ is the spacer Thermal layer, 3 is hydrogel; 4 is isolation layer 2; 5 is isolation layer 1.

Fig. 2 is a top view of the first embodiment of the present invention.

Fig. 3 is a top view of the second embodiment of the present invention.

Fig. 4 is a top view of a third embodiment of the present invention.

Fig. 5 is a plan view of a fourth embodiment of the present invention.

Fig. 6 is a plan view of a fifth embodiment of the present invention.

Detailed ways

In the following, the present invention will be further described in conjunction with the embodiments:

Example 1

As shown in Figure 1, a gel shading eye protection patch is composed of an adhesive layer, a light-shielding layer, a heat insulation layer, an isolation layer 1, an isolation layer 2. The adhesive layer is composed of PE film/TPU/silicone gel, Its shape is dolphin-shaped; the light-shielding layer is composed of white PE film/aluminum foil/PE adhesive/non-woven fabric, the heat-insulating layer is hydrogel, the isolation layer 2 is PE film, the light-shielding layer, the heat-insulation layer and the isolation layer 2 The shape is spectacle-like; the isolation layer 1 is a pearl film, and there is a spectacle-shaped void in the middle of the isolation layer 1 with the same size and shape as the light-shielding layer, and the light-shielding layer is adhered and fixed to the silicone gel of the application layer on the gap. The size of the application layer and the isolation layer 1 is larger than the size of the light shielding layer, the heat insulation layer and the isolation layer 2 by about 4 mm. The details are shown in Figure 2.

Example 2

On the basis of Example 1, the silicone gel of the sticking layer was replaced with pressure-sensitive adhesive, the light-shielding layer was replaced with three layers of blue cotton/sponge/black cotton, the heat insulation layer and the isolation layer 2 were omitted, and the isolation layer 1 is a release paper, the sticking layer and the light-shielding layer are both frame-shaped, and the size of the sticking layer and the isolation layer 1 is about 15mm larger than the size of the light-shielding layer. As shown in Figure 3.

Example 3

On the basis of Example 1, replace the thermal insulation layer with foam glue. The surface of the thermal insulation layer foam glue has an isolation layer 2. The isolation layer 1 simultaneously covers the adhesive layer and the isolation layer 2. The shape of layer 1 is bean sprout shape, the shape of shading layer, heat insulation layer and isolation layer 2 is oval shape, isolation layer 1 is made of PE film, isolation layer 2 is release paper; the shape of bean sprout shape is 8mm larger than the oval shape, As shown in Figure 4.

Example 4

On the basis of Example 1, the heat insulation layer was replaced with a sponge containing water-containing gel. There is no insulation layer 2 on the surface of the foam rubber of the insulation layer. The insulation layer 1 simultaneously covers the adhesive layer and the insulation layer. The insulation layer 1 The material is PE film. The shape of the application layer and isolation layer 1 is a large oval shape, and the shape of the shading layer, heat insulation layer and isolation layer 2 is a small oval shape. The size of the large oval shape is 10mm larger than the small oval shape, as shown in Figure 5. Show.

Example 5

On the basis of Example 1, the shape of the present invention is designed to be raindrop-shaped, and the size of the application layer and the isolation layer 1 is larger than the size of the light shielding layer, the heat insulation layer and the isolation layer 2 by about 12 mm, as shown in FIG. 6.

Claims

A gel light-shielding eye protection patch is characterized in that it is composed of an adhesive layer, a light-shielding layer, a heat insulation layer, an isolation layer 1, and an isolation layer 2 from the outside to the inside.
The gel shading eye protection patch according to claim 1, wherein the application layer is composed of a three-layer structure of PE film/TPU film/adhesive, and the adhesive may be one of silicone gel or pressure sensitive adhesive.
The gel shading eye protector according to claim 1, wherein the shading layer is composed of a four-layer structure of white or blue PE film/aluminum foil/PE adhesive/non-woven fabric.
The gel shading eye protector according to claim 1, wherein the shading layer is composed of three layers of blue cotton/sponge/black cotton.
The gel shading eye protection patch according to claim 1, wherein the heat insulation layer is a hydrogel or foam glue or a sponge filled with hydrogel in voids.
The gel light-shielding eye protector according to claim 1, characterized in that when the gel light-shielding eye protector is used to shield blue light, the heat insulation layer and the isolation layer 2 can be omitted.
The gel shading eye protector according to claim 1, wherein the material of the isolation layer 1 and the isolation layer 2 is one of pearl film, release paper or PE film, and the preferred version of the isolation layer 1 is a pearl film. The preferred solution of the isolation layer 2 is a PE film.
The gel shading eye protector according to claim 1, characterized in that the isolation layer 1 is in direct contact with the adhesive of the application layer, and the middle part of the isolation layer 1 and the part with the same size and shape of the shading layer are removed, so that the shading layer It is directly fixed on the application layer, and the isolation layer 2 directly contacts the thermal insulation layer.
The gel shading eye protection patch according to claim 1, wherein the isolation layer 1 simultaneously covers the surface of the sticking layer and the heat insulation layer.
The gel shading eye protection patch according to claim 1, characterized in that there is an isolation layer 2 on the surface of the heat insulation layer, and the isolation layer 1 covers the surface of the application layer and the isolation layer 2 at the same time.
The gel shading eye protection patch according to claim 1, characterized in that its shape and shading layer conform to the structure and physiological characteristics of the eye, and can be raindrop-shaped, spectacle frame-shaped, bean sprout-shaped, oval, dolphin-shaped, and The size of the application layer and the isolation layer 1 is 4-15 mm larger than the light-shielding layer, the heat insulation layer and the isolation layer 2.