WO2020233389A1 - 凝胶遮光眼保护贴 - Google Patents

凝胶遮光眼保护贴 Download PDF

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Publication number
WO2020233389A1
WO2020233389A1 PCT/CN2020/088332 CN2020088332W WO2020233389A1 WO 2020233389 A1 WO2020233389 A1 WO 2020233389A1 CN 2020088332 W CN2020088332 W CN 2020088332W WO 2020233389 A1 WO2020233389 A1 WO 2020233389A1
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Prior art keywords
layer
isolation layer
light
gel
shading
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PCT/CN2020/088332
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English (en)
French (fr)
Inventor
舒朝锋
俞瑞珺
田复波
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杭州炬九生物科技有限公司
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Application filed by 杭州炬九生物科技有限公司 filed Critical 杭州炬九生物科技有限公司
Publication of WO2020233389A1 publication Critical patent/WO2020233389A1/zh
Priority to ZA2021/08311A priority Critical patent/ZA202108311B/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/04—Eye-masks ; Devices to be worn on the face, not intended for looking through; Eye-pads for sunbathing
    • A61F9/045—Eye-shades or visors; Shields beside, between or below the eyes

Definitions

  • 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.
  • the surgical site 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.
  • laser protective eye mask and laser protective eye patch 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.
  • a newborn protective eye mask with a cover structure 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.
  • 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.
  • 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.
  • 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.
  • the child’s eyes cannot be kept completely closed. Almost 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.
  • patent 201920064674.6 shade dressing for newborns
  • patent 201910029426.2 a shading dressing for newborns and its preparation method
  • various methods such as increasing the thickness of the hydrogel and increasing the adhesion of the hydrogel.
  • the effect is not ideal.
  • 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.
  • 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.
  • the TPU film must have the function of air permeability and water impermeability in providing the adhesion layer of the viscose.
  • any film with the function of air permeability and water impermeability can replace the TPU film, such as PU film with a thickness of 10 ⁇ m-50 ⁇ m, the preferred solution It is 20 ⁇ m-30 ⁇ m. 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 ⁇ m-60 ⁇ m, and the preferred solution is 30-40 ⁇ m.
  • 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.
  • A/B components By adjusting the different ratios of AB components, medical silicone gel products with different adhesion forces can be obtained.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Example 1 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 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 1 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.
  • 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.

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Abstract

一种凝胶遮光眼保护贴，由贴敷层（I）、遮光层（II）、隔热层（III）、隔离层1（5）、隔离层2（4）组成，贴敷层（I）为硅凝胶层、遮光层（II）为铝箔（2.2）复合无纺布（2.4）或复合棉布，隔热层（III）为水凝胶（3），隔离层1（5）或隔离层2（4）可以是珠光膜、离型纸或PE膜中的一种，其外形符合眼部的结构和生理特征，为雨滴状、眼镜框状、豆芽状，椭圆形、海豚状。能避免有害光线对人体眼睛的伤害，包括新生儿黄疸光疗时保护眼睛免受蓝光伤害，以及激光或IPL治疗时预防激光或IPL对眼睛的伤害，安全、有效、舒适。

Description

凝胶遮光眼保护贴 技术领域
本发明涉及一种凝胶遮光眼保护贴，具体的说是一种能阻挡光线(激光/IPL/蓝光等)对眼睛伤害的防护产品。
背景技术
进行光子/激光手术时，手术部位特别是在颜面部时，高能量的光线非常容易对眼睛造成伤害。据资料显示，引起眼底黄斑的损伤的辐照量为10mw/cm 2，照射时间仅为皮秒级，而一般强脉冲光/激光的能量密度均在100mw-200mw/cm 2之间。因此，光子/激光手术时，医生和患者均需要配带专业的防护设施，以免出现医疗事故。
目前光子/激光手术时，患者主要防护用品有激光防护眼罩和激光防护眼贴。激光眼罩一般采用柔性的医用塑料制作而成，采用固定绳固定在脑后；激光防护眼贴采用粘胶贴敷式固定。激光防护眼罩存在以下缺陷：1、激光眼罩戴在眼睛上后，其边缘和皮肤之间可能会留有间隙，光线可能通过间隙伤害到眼睛；2、手术时患者处于仰卧位时激光眼罩，眼罩固定绳会和枕头或手术台接触，头部稍有移动，可能会使眼罩发生移动或脱落，眼睛可能会暴露在保护之外，受到强光损伤。激光防护眼贴，如JP特开2007-160023A提到的，产品由基板、第一粘胶层、无纺布和第二粘胶层、隔离膜组成，该设计的产品存在以下问题：1、激光或IPL等均是高能光线，它们照射到防护眼贴上，虽然可以阻挡光直接 对眼睛伤害，但是其高能产生的热量，容易导致眼部皮肤灼烧(欧洲已经新的法规规定，激光防护产品必须能防止皮肤灼烧功能)；2、固定在皮肤第二粘胶层，如果粘性不够强，容易发生脱落导致，眼睛受到伤害，如果粘性太强，容易发生粘脱睫毛或眉毛。专利201310073280.4一种水凝胶激光眼保护贴，由支持层、水凝胶层和隔离层三层结构组成，其水凝胶层和皮肤接触，水凝胶粘性比柔和，不会粘脱睫毛或眉毛，但是其和皮肤的粘附性能太弱，在临床使用过程中，无法牢固的固定在眼睑皮肤上，容易脱落，导致光子/激光手术是眼睛伤害风险增加。
新生儿黄疸是新生儿非常常见的疾病，血胆红素过高，将影响患儿的脑部发育，通常需要做降胆红素处理，其中蓝光(波长主峰425～475毫微米)照射是最常见的治疗新生儿黄疸方法之一。但是蓝光早上对患儿的眼睛、视网膜以及生殖器有伤害，需要对其进行保护。中国201120028280.9号专利，公开了一种新型蓝光眼罩，其技术方案是：包含眼罩、弹力松紧带和魔术贴，眼罩的两端设有弹性松紧带，弹性松紧带通过魔术贴相连。这种蓝光眼罩的缺陷是：1、使用时弹力松紧带松紧控制比较困难，太紧容易压迫眼睛，太松容易脱落；2、光疗过程中患儿哭闹，和头部转动，容易发生眼罩的上下和左右位移，导致眼睛暴露在蓝光下。在中国200620071206.4号专利中，公开了一种罩装结构的新生儿保护眼罩，其技术方案是：一种新生儿保护眼罩，包含罩体和遮光带，所述罩体为顶端封闭的网状结构，遮光带设在罩体的端口部，并与罩体固定连接，在遮光带的内表面设有眼垫。罩体采用医用弹力绷带材料。这种新生儿眼罩的缺陷是：1、弹力罩体固定遮光带时，选用罩体的大小比较困难，选用太大，遮光带在患儿眼睛固定不牢固，容易移 动和脱落；选用太小，患儿头部和眼睛受到压力太大，压迫眼球，并影响眼周局部血运，和舒适性，患儿不配合光疗。2、罩体将整个头部罩住后，可以有效避免遮光带的上下位移；但是使用时罩体和光疗床或枕头接触，患儿头部转动时，通常会导致罩体和头部之间发生转动，会导致遮光带发生左右移动，使患儿的眼睛暴露在蓝光下。3、遮光眼罩的材质，主要为棉布或纱布，其材质比较粗糙，患儿的皮肤比较娇嫩，与皮肤发生摩擦，会导致患儿皮肤受到伤害；同时由于患儿眼睛不能保持完全闭合状态，棉纱容易进入眼睛，刺激角膜或导致角膜受损。目前的新生儿蓝光防护眼罩的固定方式基本上是上述的两种固定方式：捆绑式和头罩式，这两种方式不管如何改进，由于其设计的缺陷，很难避免使用时松紧控制困难和左右、上下移动导致眼睛暴露的缺陷。
为了克服上述缺陷，专利201920064674.6(新生儿遮光敷料)，专利201910029426.2(一种新生儿遮光敷料及其制备方法)等，通过增加水凝胶厚度，增加水凝胶粘附性等各种方法，以期达到牢固固定的目，效果不理想。在临床试验过程中，12例蓝光治疗患儿，采用该专利产品进行眼睛保护，治疗过程中，有4例脱落，脱落率为33.3％；眼保护贴位移大于2mm者3例，占25％；完成临床验证5例，完成率41.7％。眼贴位移大于2mm，产品固定的稳定性差，容易导致患儿眼睛受到蓝光伤害。该产品脱落率和位移大于2mm的比例高达58.3％，患儿光疗过程的眼睛安全不能得到充分的保护。
因此，开发一种能更有效的预防强光或蓝光对患者眼睛伤害，光污染少，使用方便，相容性好，固定牢固安全，患者体验更加舒适的遮光 产品，成为本发明的出发点。
发明内容
本发明的目的在于克服现有技术的不足和临床应用过程中产生的问题，如1、产品在眼睑皮肤上固定不牢固，容易脱落；2、激光等高能光线照射产品表面时，产品温度升高导致眼睑皮肤灼伤；3、产品使用过程中，不能对皮肤及其附属器官(眉毛和睫毛)产生伤害；为临床提供一种安全、有效、舒适的凝胶遮光眼保护贴。本发明的目的是通过以下技术方案实现的：
所述的凝胶遮光眼保护贴，由外贴敷层、遮光层、隔热层、隔离层1、隔离层2组成。
所述的贴敷层由PE膜/TPU膜/粘胶三层结构组成，粘胶层可以是硅凝胶或压敏胶中的一种。其中TPU膜在提供粘胶的附着层，必须具有透气不透水的功效，理论上讲，任何具有透气不透水功能的薄膜均可替换TPU膜，如PU膜，其厚度在10μm-50μm，优选方案为20μm-30μm。由于TPU薄且柔软，使用不方便，需要在其表面附上一层PE膜，其厚度在20μm-60μm，优选方案为30-40μm。贴敷成的粘胶材质，理论上可以是任何具有良好相容性的医用胶均可，如目前医用压敏胶、医用硅凝胶等，但其优选方案为医用硅凝胶，通常医用硅凝胶由A、B两种组分混合而成，通过调节AB组分的不同比例，可以得到不同粘附力的医用硅凝胶产品，通常A/B组分的比例为1:1～1:2。
所述的遮光层由白色或黑色PE膜/铝箔/PE粘合剂/无纺布四层结构 组成。遮光层的外侧层为PE膜，PE膜颜色可以是白色或黑色，其优选方案是白色，通过白色染料颗粒的漫反射，降低产品的激光的能量吸收，能很好的保护眼睛，并且是产品的温度不会太高，避免灼烧皮肤；白色材质可以是二氧化钛、碳酸镁、氧化镁、氧化铝、钛氧化物、氢氧化钙、氢氧化镁、氢氧化铝、硫酸镁、硫酸钡、滑石粉等，其优选方案是二氧化钛。铝箔可以是铝蒸汽沉积薄膜(将铝蒸汽沉积在有机薄膜上的一种材质)和金属铝箔，其优选方案为金属铝箔，铝箔层厚度为4～50um，优选方案为7-10um，铝箔是阻挡激光穿透的主要功能层，太薄，其阻挡激光的能力太低，太厚导致产品僵硬，使用不方便。无纺布和铝箔直接需要粘合剂才能复合在一起，一切公知的、安全无毒的粘合剂均可，如聚乙烯(PE)、聚氨酯(PU)、热塑性聚氨酯(TPU)、聚酯(PET)、聚丙烯(PP)、聚氯乙烯(PVC)、聚偏二氯乙烯(PVDC)乙烯－醋酸乙烯聚物(EVA)、硅橡胶、聚酰亚胺(PI)等，其优选方案为聚乙烯(PE)。无纺布的厚度可以是30-60g/平方米，优选方案为30-35g/平方米。
所述的遮光层可以由蓝色棉布/海绵/黑色棉布三层组成，该种结构可以用于新生儿蓝光照射治疗时，保护眼睛避免被蓝光损伤所用，不能作为激光手术时眼睛保护用，而前面一种结构可以用于激光手术和新生儿蓝光治疗时两种情况。
所述的隔热层为水凝胶或泡棉胶或含有空隙中充满水凝胶的海绵。在激光手术过程中，如果激光照射到产品表面，虽然可以通过产品的遮光层材料阻挡激光对眼睛的伤害，但是激光的高能量转化为热能传到产品的上，会导致患者眼睑皮肤的灼伤。隔热层为水凝胶或泡棉胶或含有 空隙中充满水凝胶的海绵，其优选方案是水凝胶，该水凝胶结构和工艺可以参照本公司另外一个专利201010217910.7，采用水凝胶的优势在于具有合适的粘附性能，又不会粘脱睫毛，同时可以提供大量的水分(水的含量可以达到70％以上)，常见物质中水的比热是最大的，吸收同样的热量，比其它物质温度上升的少，有利于保护眼睑皮肤不被灼伤。由于本产品设计有贴敷层参与固定，因此水凝胶层的厚度不宜太厚，建议在0.5mm到4mm之间，其优选方案为1-1.5mm。
由于新生儿黄疸治疗的蓝光能力比较低，产生的热效应比较少，因此在用于新生儿黄疸蓝光治疗时，隔热层可以去除，不影响产品的阻挡光线预防效果，如果隔热层去除，可以减少产品的厚度，增加产品的顺应性，有利于产品的贴敷固定。如果隔热层存留，也有其优势，在恒温箱比干燥的环境中，可以为眼部皮肤提供适宜的水分，有利于增加患儿的舒适性，从而能更加配合治疗，如果隔热层去除，同时隔离层2也省略不用。
所述的隔离层1和隔离层2的材质是珠光膜、离型纸或PE膜中的一种，隔离层1优选方案为珠光膜，隔离层2优选方案为PE膜。
所述的隔离层1直接和贴敷层的粘胶接触，隔离层1中间部分和遮光层大小、外形相同的部分被去除，以便遮光层的PE膜直接被固定在贴敷层的粘胶上，隔离层2直接和隔热层接触；也可以将隔离层1同时覆盖在贴敷层和隔热层表面，由隔离层1同时保护贴敷层的粘胶面和隔热层的水凝胶面，隔离层2被省略不用，使用时去除隔离层1即可，方便客户使用，同时水凝胶水分可以滋养眼睛及眼睛周围皮肤；第三种隔 离层1和隔离层2的关系是隔热层表面有隔离层2，隔离层1同时覆盖在贴敷层和隔离层2表面。这三种情况，其优选方案是第一种，即隔离层1直接和贴敷层的粘胶接触，隔离层1中间部分和遮光层大小、外形相同的部分被去除，以便遮光层的PE膜直接被固定在贴敷层的粘胶上，隔离层2直接和隔热层接触,该方案可以起到良好产品固定，同时可以良好的阻隔激光的热效应，避免灼烧皮肤，又不会粘脱睫毛，同时水凝胶水分可以滋养眼睛及眼睛周围皮肤，使用方便。
所述的凝胶遮光眼保护贴的外形符合眼部的结构和生理特征，为雨滴状、眼镜框状、豆芽状，椭圆形、海豚状，但不限于这几种外形。该处的外形指的是贴敷层的外形和与之相对应的隔离层1的外形，同时也指遮光层、隔热层和隔离层2的外形，最终产品可以是这几种的组合；贴敷层和隔离层1的尺寸比遮光层、隔热层和隔离层2要大4～15mm，以便贴敷层起到应有的固定作用。
采用以上方案：本发明具有良好粘附性、透气性、生物相容性好，同时具有保持局部环境湿润，患者舒适，医生使用方便等特点，适用于新生儿高胆红素血症光疗眼睛保护，同时也可以用于激光或IPL手术是患者眼睛的保护，经过辐射灭菌，可以长期存储；。
本发明的有益效果是：
1、可以有效的预防新生儿光疗过程中，蓝光对眼睛的伤害。
2、本发明使用方便，可以多次揭、贴，方便医生观察患者眼睛，观察患儿黄疸的程度。
3、可以有效的预防激光或IPL手术时，光线患者眼睛的伤害。
4、本发明采用硅凝胶辅助固定，粘附力适宜，固定牢固、不脱落，可确保患者治疗过程中的眼睛安全；同时又避免患者眉毛和睫毛撕脱。
5、本发明的水凝胶层，可维持眼睛周围局部环境的湿润，有利于眼睛及眼周皮肤的保护。
6、本发明的外形按人体工程学原理设计，符合眼睛局部的各种生理弯曲，粘附的效果好。
附图说明
图1是本发明截面图：
Ⅰ为贴敷层，1.1为PE膜，1.2为TPU膜，1.3为粘胶；Ⅱ为遮光层，2.1为PE膜，2.2为铝箔，2.3为PE粘合剂，2.4无纺布；Ⅲ为隔热层，3为水凝胶；4为隔离层2；5为隔离层1。
图2是本发明的第一实施例的俯视图。
图3是本发明的第二实施例的俯视图。
图4是本发明的第三实施例的俯视图。
图5是本发明的第四实施例的俯视图。
图6是本发明的第五实施例的俯视图。
具体实施方式
下面结合实施例对本发明进一步说明：
实施例1
如图1所示，一种凝胶遮光眼保护贴，由贴敷层、遮光层、隔热层、隔离层1、隔离层2组成，贴敷层由PE膜/TPU/硅凝胶组成，其外形为海豚状；遮光层由白色PE膜/铝箔/PE粘合剂/无纺布组成，隔热层为水凝胶，隔离层2为PE膜，遮光层、隔热层和隔离层2的外形为眼镜状；隔离层1为珠光膜，隔离层1中间有大小和形状均与遮光层相同的眼镜状空缺，遮光层在该空缺上和贴敷层的硅凝胶粘附、固定。贴敷层和隔离层1的尺寸大于遮光层、隔热层和隔离层2的尺寸约4mm。具体如图2所示。
实施例2
在实施例1的基础上，将贴敷层的硅凝胶更换为压敏胶，遮光层更换为由蓝色棉布/海绵/黑色棉布三层组成，隔热层、隔离层2省略、隔离层1为离型纸，贴敷层及遮光层均为眼镜框状，贴敷层和隔离层1的尺寸大于遮光层的尺寸约15mm。如图3所示。
实施例3
在实施例1的基础上，将隔热层更换为泡棉胶，隔热层泡棉胶表面有隔离层2，隔离层1同时覆盖贴敷层粘胶和隔离层2，贴敷层、隔离层1外形为豆芽状，遮光层、隔热层和隔离层2的外形为椭圆形，隔离 层1材质为PE膜，隔离层2为离型纸；豆芽状外形尺寸比椭圆形打大8mm，如图4所示。
实施例4
在实施例1的基础上，将隔热层更换为含水凝胶的海绵，隔热层泡棉胶表面没有隔离层2，隔离层1同时覆盖贴敷层粘胶和隔热层，隔离层1材质为PE膜，贴敷层、隔离层1外形为大椭圆形，遮光层、隔热层和隔离层2的外形为小椭圆形，大椭圆形尺寸比小椭圆形大10mm，如图5所示。
实施例5
在实施例1的基础上，将本发明的外形设计为雨滴状，贴敷层和隔离层1的尺寸大于遮光层、隔热层和隔离层2的尺寸约12mm，如图6所示。

Claims (11)

  1. 一种凝胶遮光眼保护贴，其特征在于由外向内分别由贴敷层、遮光层、隔热层、隔离层1、隔离层2组成。
  2. 根据权利要求1所述的凝胶遮光眼保护贴，其特征在于贴敷层由PE膜/TPU膜/粘胶三层结构组成，粘胶可以是硅凝胶或压敏胶中的一种。
  3. 根据权利要求1所述的凝胶遮光眼保护贴，其特征在于遮光层由白色或蓝色PE膜/铝箔/PE粘合剂/无纺布四层结构组成。
  4. 根据权利要求1所述的凝胶遮光眼保护贴，其特征在于遮光层由蓝色棉布/海绵/黑色棉布三层组成。
  5. 根据权利要求1所述的凝胶遮光眼保护贴，其特征在于隔热层为水凝胶或泡棉胶或含有空隙中充满水凝胶的海绵。
  6. 根据权利要求1所述的凝胶遮光眼保护贴，其特征在于当凝胶遮光眼保护贴作为遮挡蓝光使用，隔热层、隔离层2可以省略。
  7. 根据权利要求1所述的凝胶遮光眼保护贴，其特征在于隔离层1和隔离层2的材质是珠光膜、离型纸或PE膜中的一种，隔离层1优选方案为珠光膜，隔离层2优选方案为PE膜。
  8. 根据权利要求1所述的凝胶遮光眼保护贴，其特征在于隔离层1直接和贴敷层的粘胶接触，隔离层1中间部分和遮光层大小、外形相同的部分被去除，以便遮光层直接被固定在贴敷层上，隔离层2直接和隔热层接触。
  9. 根据权利要求1所述的凝胶遮光眼保护贴，其特征在于隔离层1同时 覆盖在贴敷层和隔热层表面。
  10. 根据权利要求1所述的凝胶遮光眼保护贴，其特征在于隔热层表面有隔离层2，隔离层1同时覆盖在贴敷层和隔离层2表面。
  11. 根据权利要求1所述的凝胶遮光眼保护贴，其特征在于其外形和遮光层符合眼部的结构和生理特征，可以为雨滴状、眼镜框状、豆芽状，椭圆形、海豚状，并且贴敷层和隔离层1的尺寸比遮光层、隔热层和隔离层2要大4～15mm。
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