CN111000681A

CN111000681A - Gel shading eye protection patch

Info

Publication number: CN111000681A
Application number: CN201910420063.5A
Authority: CN
Inventors: 舒朝锋; 俞瑞珺; 田复波
Original assignee: Hangzhou Jujiu Science & Biotechnology Co ltd
Current assignee: Hangzhou Jujiu Science & Biotechnology Co ltd
Priority date: 2019-05-20
Filing date: 2019-05-20
Publication date: 2020-04-14
Also published as: ZA202108311B; WO2020233389A1

Abstract

The invention relates to a gel shading eye protection patch, in particular to an eye protection patch capable of avoiding harmful light from damaging human eyes, which comprises: the eye protection method has the advantages that the eyes are protected from being damaged by blue light during neonatal jaundice phototherapy, and the laser or IPL is prevented from being damaged by the eyes during laser or IPL treatment. The invention aims to overcome the defects of the prior art and the problems generated in the clinical application process and provide a safe, effective and comfortable gel shading eye protection patch. The purpose of the invention is realized by the following technical scheme: the utility model provides a gel shading eye protection subsides, comprises subsides layer, light shield layer, insulating layer, isolation layer 1, isolation layer 2, and the subsides layer of applying is silica gel layer, and the light shield layer is aluminium foil composite non-woven fabrics or composite cotton, and the insulating layer is aquogel, and isolation layer 1 or isolation layer 2 can be pearly-lustre membrane, from one of type paper or PE membrane, and its appearance accords with the structure and the physiological characteristics of eye, for raindrop form, spectacle-frame form, bean sprouts form, ellipse, dolphin form.

Description

Gel shading eye protection patch

Technical Field

The invention relates to a gel shading eye protection paste, in particular to a protection product capable of blocking light (laser/IPL/blue light and the like) from damaging eyes.

Background

When photon/laser surgery is performed, the high-energy light is very easy to damage eyes at the surgical site, especially on the face. The data show that the irradiation dose causing the damage of the fundus macula lutea is 10mw/cm²The irradiation time is only picosecond, and the energy density of the general intense pulse light/laser is 100mw-200mw/cm²In the meantime. Thus, both the physician and the patient need to be provided with professional protective equipment during photon/laser surgerySo as to avoid medical accidents.

At present, during photon/laser surgery, main protective articles for patients comprise laser protective eye masks and laser protective eye patches. The laser eye mask is generally made of flexible medical plastics and is fixed behind the brain by a fixing rope; the laser protection eye patch is fixed in a viscose applying mode. The laser protective eye mask has the following defects: 1. after the laser eye patch is worn on the eyes, a gap may be left between the edge of the laser eye patch and the skin, and light rays may damage the eyes through the gap; 2. when a patient is in a supine position during operation, the laser eye patch is arranged on the eye patch, the eye patch fixing rope can be contacted with the pillow or the operating table, the head of the patient moves slightly, the eye patch can move or fall off, and eyes can be exposed out of the protection and damaged by strong light. The laser protection eye patch, as mentioned in JP 2007-160023A, is composed of a substrate, a first adhesive layer, a non-woven fabric, a second adhesive layer and an isolating film, and the designed product has the following problems: 1. laser or IPL and the like are high-energy rays which are irradiated on the eye protection paste, although the eye protection paste can prevent light from directly damaging eyes, the eye skin is easily burnt due to heat generated by the high-energy rays (European new regulation provides that a laser protection product has a function of preventing the skin from being burnt); 2. the adhesive is fixed on the second adhesive layer of the skin, and if the adhesiveness is not strong enough, the eye is easily damaged due to falling off, and if the adhesiveness is too strong, the eyelash or eyebrow is easily adhered and fallen off. Patent 201310073280.4 a aquogel laser eye protection subsides comprises supporting layer, aquogel layer and isolation layer three layer construction, and its aquogel layer and skin contact, the aquogel viscidity ratio is soft, can not glue and take off eyelash or eyebrow, but its and the adhesion performance of skin are too weak, in clinical use, can't firm fix on eyelid skin, drop easily, lead to the photon/laser operation to be the eye injury risk increase.

Neonatal jaundice is a very common disease of a neonatal, hyperbilirubinemia affects the brain development of a sick infant, and bilirubin reduction treatment is usually required, wherein blue light (main wavelength peak of 425-475 nanometers) irradiation is one of the most common methods for treating neonatal jaundice. However, the blue light is harmful to the eyes, retina and genitals of the infant patient in the morning and needs to be protected. Chinese patent No. 201120028280.9 discloses a novel blue light eye patch, and its technical scheme is: comprises an eyeshade, elastic bands and magic tapes, wherein the elastic bands are arranged at two ends of the eyeshade and are connected through the magic tapes. The defects of the blue-ray eye patch are as follows: 1. when in use, the elasticity of the elastic band is difficult to control, and the elastic band is too tight and easy to press eyes and is too loose and easy to fall off; 2. during phototherapy, the patient cry and rotate with the head, and the eye mask is easy to move up and down and left and right, so that the eyes are exposed under blue light. In chinese patent No. 200620071206.4, a newborn protective eye mask with a mask structure is disclosed, which has the technical scheme that: a protective eye shield for newborn comprises a shield body and a shading belt, wherein the shield body is of a net structure with a closed top end, the shading belt is arranged at a port part of the shield body and is fixedly connected with the shield body, and an eye pad is arranged on the inner surface of the shading belt. The cover body is made of medical elastic bandage material. The drawbacks of this neonatal eye mask are: 1. when the elastic shade body is used for fixing the shading belt, the size of the shade body is difficult to select, and the shading belt is too large, is not firmly fixed on the eyes of a child patient and is easy to move and fall off; when the size is too small, the head and eyes of the infant patient are too big to press the eyeballs, and the local blood circulation around the eyes and the comfort are affected, and the infant patient is not matched with phototherapy. 2. After the whole head is covered by the cover body, the up-and-down displacement of the shading belt can be effectively avoided; however, when the mask body is in contact with the phototherapy bed or the pillow, the head of the child patient rotates, the mask body and the head of the child patient rotate, the shading belt moves left and right, and the eyes of the child patient are exposed to blue light. 3. The material of the eyeshade is mainly cotton cloth or gauze, the material is rough, the skin of the child patient is delicate, and the skin of the child patient is damaged due to friction with the skin; meanwhile, as the eyes of the children patients cannot keep a complete closed state, cotton yarns easily enter the eyes to stimulate the cornea or cause the cornea to be damaged. The current fixing mode of the blue-light eye shield for the newborn is basically the two fixing modes: the two modes, namely the binding mode and the head cover mode, are improved, and the defects that the tightness control is difficult and eyes are exposed due to the left and right movement and the up and down movement in the use process are difficult to avoid due to the defects of the design of the two modes.

In order to overcome the above defects, patent 201920064674.6 (a newborn light-shielding dressing), patent 201910029426.2 (a newborn light-shielding dressing and a preparation method thereof) and the like aim to achieve firm fixation by various methods such as increasing the thickness of hydrogel, increasing the adhesiveness of hydrogel and the like, and the effect is not ideal. In the clinical test process, 12 cases of blue light treatment children patients adopt the patent product to protect eyes, 4 cases of blue light treatment children fall off in the treatment process, and the falling-off rate is 33.3 percent; the displacement of the eye protection paste is more than 3 cases of 2mm, accounting for 25 percent; the clinical verification is completed by 5 cases, and the completion rate is 41.7%. The displacement of the eye patch is larger than 2mm, the stability of the fixation of the product is poor, and the eyes of the children patients are easily damaged by blue light. The product has a falling rate and displacement of more than 2mm up to 58.3%, and the eye safety of children patients in phototherapy process can not be fully protected.

Therefore, the development of a shading product which can effectively prevent strong light or blue light from damaging eyes of a patient, has less light pollution, convenient use, good compatibility, firm and safe fixation and more comfortable patient experience becomes the starting point of the invention.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and the problems generated in the clinical application process, such as 1, the product is not firmly fixed on the eyelid skin and is easy to fall off; 2. when high-energy rays such as laser and the like irradiate the surface of the product, the temperature of the product is increased to cause eyelid skin burn; 3. the product cannot damage the skin and the accessory organs (eyebrows and eyelashes) thereof in the using process; provides a safe, effective and comfortable gel shading eye protection paste for clinic. The purpose of the invention is realized by the following technical scheme:

the gel shading eye protection patch consists of an outer patch coating layer, a shading layer, a heat insulation layer, an isolation layer 1 and an isolation layer 2.

The pasting layer is composed of a PE film/TPU film/viscose three-layer structure, and the viscose layer can be one of silicone gel or pressure-sensitive adhesive. The TPU film must have the functions of air permeability and water impermeability in order to provide an adhesive layer for the adhesive, and theoretically, any film with the functions of air permeability and water impermeability can replace the TPU film, such as the PU film, and the thickness of the film is 10-50 μm, and the preferable scheme is 20-30 μm. Because TPU is thin and soft and is inconvenient to use, a PE film is required to be attached to the surface of TPU, and the thickness of the PE film is 20-60 mu m, preferably 30-40 mu m. The applied viscose glue material can be any medical glue with good compatibility theoretically, such as the existing medical pressure-sensitive glue, medical silica gel and the like, but the preferred scheme is the medical silica gel, the medical silica gel is generally formed by mixing A, B two components, medical silica gel products with different adhesive force can be obtained by adjusting different proportions of the AB components, and the proportion of the A/B components is generally 1: 1-1: 2.

The shading layer is composed of a white or black PE film/aluminum foil/PE adhesive/non-woven fabric four-layer structure. The outer side layer of the shading layer is a PE film, the color of the PE film can be white or black, the preferred scheme is white, the energy absorption of laser of the product is reduced through the diffuse reflection of white dye particles, eyes can be well protected, the temperature of the product cannot be too high, and the skin is prevented from being burnt; the white material may be titanium dioxide, magnesium carbonate, magnesium oxide, aluminum oxide, titanium oxide, calcium hydroxide, magnesium hydroxide, aluminum hydroxide, magnesium sulfate, barium sulfate, talc powder, etc., and preferably titanium dioxide. The aluminum foil can be an aluminum vapor deposition film (a material for depositing aluminum vapor on an organic film) and a metal aluminum foil, the preferred scheme is the metal aluminum foil, the thickness of the aluminum foil layer is 4-50 um, the preferred scheme is 7-10um, the aluminum foil is a main functional layer for blocking laser penetration, the aluminum foil is too thin, the laser blocking capability of the aluminum foil layer is too low, the aluminum foil layer is too thick, the product is stiff, and the use is inconvenient. The non-woven fabric and the aluminum foil can be compounded together by directly using an adhesive, and all the known, safe and nontoxic 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 copolymer (EVA), silicone rubber, Polyimide (PI) and the like, wherein the preferable scheme is Polyethylene (PE). The thickness of the nonwoven fabric may be 30 to 60 g/m, preferably 30 to 35 g/m.

The light shield layer can constitute by blue cotton cloth/sponge/black cotton cloth three-layer, this kind of structure can be used for when neonate's blue light shines the treatment, protection eyes avoid being used by the blue light damage, eyes protection usefulness when can not regard as laser surgery, and two kinds of circumstances when preceding structure can be used for laser surgery and neonate's blue light treatment.

The heat insulation layer is hydrogel or foam cotton or sponge containing hydrogel filled in gaps. During the laser surgery, if the laser irradiates the surface of the product, although the damage of the laser to eyes can be blocked by the light shading layer material of the product, the high energy of the laser is converted into heat energy which is transmitted to the product, and the skin of the eyelid of a patient can be burnt. The thermal insulation layer is hydrogel or foam cotton or sponge with hydrogel filled in the gaps, the preferred scheme is hydrogel, the structure and the process of the hydrogel can refer to another patent 201010217910.7 of the company, the hydrogel has the advantages that the hydrogel has proper adhesive property, eyelashes cannot be adhered and detached, meanwhile, a large amount of moisture (the content of the water can reach more than 70 percent) can be provided, the specific heat of the water in common substances is maximum, the same heat is absorbed, the temperature rise is less than that of other substances, and the eyelid skin can be protected from being burnt. Because the product is designed with an application layer to participate in fixation, the thickness of the hydrogel layer is not too thick, preferably between 0.5mm and 4mm, and the preferred scheme is 1-1.5 mm.

Because the blue light ability of icterus neonatorum treatment is lower, the heat effect of production is less, consequently when being used for icterus neonatorum blue light treatment, the insulating layer can be got rid of, does not influence the light prevention effect that blocks of product, if the insulating layer is got rid of, can reduce the thickness of product, increases the compliance of product, is favorable to the subsides of product to apply fixedly. If the insulating layer persists, also has its advantage, in the thermostated container than dry environment, can be favorable to increasing infant's travelling comfort for eye skin provides suitable moisture to can cooperate the treatment more, if the insulating layer is got rid of, isolation layer 2 also omits simultaneously and need not.

The isolation layer 1 and the isolation layer 2 are made of pearlized films, release paper or PE films, the preferred scheme of the isolation layer 1 is pearlized films, and the preferred scheme of the isolation layer 2 is PE films.

The isolating layer 1 is directly contacted with the adhesive of the pasting layer, the middle part of the isolating 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 pasting layer, and the isolating layer 2 is directly contacted with the heat insulating layer; the isolating layer 1 can also be covered on the surfaces of the adhesive layer and the thermal insulation layer, the isolating layer 1 can simultaneously protect the adhesive surface of the adhesive layer and the hydrogel surface of the thermal insulation layer, the isolating layer 2 is omitted, the isolating layer 1 is removed when the eye patch is used, the eye patch is convenient for a client to use, and the hydrogel moisture can nourish eyes and skin around the eyes; the third type of isolation layer 1 and isolation layer 2 is that there is isolation layer 2 on the surface of the thermal insulation layer, and isolation layer 1 covers the surface of the coating and isolation layer 2 at the same time. The three conditions are preferably the first one, namely the isolation layer 1 is directly contacted with the viscose of the coating layer, the middle part of the isolation layer 1 and the part of the shading layer with the same size and shape are removed, so that the PE film of the shading layer is directly fixed on the viscose of the coating layer, and the isolation layer 2 is directly contacted with the thermal insulation layer.

The shape of the gel shading eye protection paste conforms to the structure and physiological characteristics of eyes, and is in a raindrop shape, a spectacle frame shape, a bean sprout shape, an oval shape or a dolphin shape, but is not limited to the shapes. The shape of the place refers to the shape of the attaching layer and the shape of the corresponding isolating layer 1, and also refers to the shapes of the light shielding layer, the heat insulating layer and the isolating layer 2, and the final product can be a combination of the shapes; the size of the pasting layer and the isolation layer 1 is 4-15 mm larger than that of the shading layer, the heat insulation layer and the isolation layer 2, so that the pasting layer can play a role in fixing.

The scheme is adopted: the invention has good adhesiveness, air permeability, biocompatibility are good, have keep local environment moist at the same time, patient's comfortable, doctor use characteristic such as being convenient, suitable for the neonatal hyperbilirubinemia phototherapy eyes to protect, can also be used in laser or IPL operation to protect patient's eyes at the same time, through radiating the sterilization, can store for a long time; .

The invention has the beneficial effects that:

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

2. The invention is convenient to use, can be taken off and pasted for multiple times, is convenient for doctors to observe the eyes of patients and observe the degree of jaundice of children patients.

3. Can effectively prevent the damage of the eyes of the patient caused by the light during the laser or IPL operation.

4. The invention adopts silica gel for auxiliary fixation, has proper adhesive force, firm fixation and no falling off, and can ensure the eye safety of patients in the treatment process; meanwhile, the eyebrows and eyelashes of the patient are prevented from being torn off.

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

6. The appearance of the invention is designed according to the principle of human engineering, and conforms to various physiological curvatures of partial eyes, and the adhesion effect is good.

Drawings

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

i is a coating layer, 1.1 is a PE film, 1.2 is a TPU film, and 1.3 is viscose; II is a shading layer, 2.1 is a PE film, 2.2 is an aluminum foil, 2.3 is a PE adhesive and 2.4 is a non-woven fabric; III is a heat insulation layer, and 3 is hydrogel; 4 is an isolating layer 2; 5 is an isolation layer 1.

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

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

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

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

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

Detailed Description

The invention is further illustrated by the following examples:

example 1

As shown in figure 1, a gel shading eye protection patch comprises a pasting layer, a shading layer, a heat insulation layer, an isolation layer 1 and an isolation layer 2, wherein the pasting layer is composed of a PE film/TPU/silicon gel and is in a dolphin shape; the shading layer is composed of a white PE film/aluminum foil/PE adhesive/non-woven fabric, the heat insulation layer is hydrogel, the isolation layer 2 is a PE film, and the shading layer, the heat insulation layer and the isolation layer 2 are in a spectacle shape; the isolation layer 1 is a pearlized film, a glasses-shaped vacancy with the same size and shape as the light shielding layer is arranged in the middle of the isolation layer 1, and the light shielding layer is adhered and fixed with the silica gel of the pasting layer on the vacancy. The size of the pasting layer and the isolation layer 1 is about 4mm larger than that of the shading layer, the heat insulation layer and the isolation layer 2. As shown in particular in fig. 2.

Example 2

On the basis of embodiment 1, the silica gel of pasting the backing layer is changed into pressure sensitive adhesive, and the light shield layer is changed and is become by blue cotton cloth/sponge/black cotton cloth three-layer composition, and insulating layer, isolation layer 2 omit, isolation layer 1 are from type paper, pastes backing layer and light shield layer and is the spectacle-frame form, pastes backing layer and isolation layer 1's size and is greater than about 15mm of light shield layer's size. As shown in fig. 3.

Example 3

On the basis of the embodiment 1, the heat insulation layer is replaced by foam cotton, an isolation layer 2 is arranged on the surface of the foam cotton of the heat insulation layer, the isolation layer 1 covers the adhesive of the pasting layer and the isolation layer 2 at the same time, the pasting layer and the isolation layer 1 are bean sprout-shaped, the light shielding layer, the heat insulation layer and the isolation layer 2 are oval, the isolation layer 1 is made of a PE film, and the isolation layer 2 is made of release paper; the bean sprout-like outer dimension is larger than the oval by 8mm as shown in fig. 4.

Example 4

On the basis of embodiment 1, change the insulating layer for the sponge that contains hydrogel, insulating layer bubble celloidin surface does not have isolation layer 2, and isolation layer 1 covers simultaneously and applies layer viscose and insulating layer, and isolation layer 1 material is the PE membrane, and it is big ellipse to paste backing, the 1 appearance of isolation layer, and the appearance of light shield layer, insulating layer and isolation layer 2 is little ellipse, and big ellipse size is 10mm bigger than little ellipse, as shown in figure 5.

Example 5

On the basis of example 1, the profile of the present invention was designed to be raindrop-shaped, and the size of the patch layer and the insulation layer 1 was about 12mm larger than that of the light-shielding layer, the insulation layer and the insulation layer 2, as shown in fig. 6.

Claims

1. A gel shading eye protection patch is characterized by comprising a patch coating layer, a shading layer, a thermal insulation layer, an isolation layer 1 and an isolation layer 2 from outside to inside.

2. The gel light-shielding eye protector according to claim 1, wherein the coating layer is composed of three layers of PE film/TPU film/adhesive, and the adhesive is one of silicone gel or pressure sensitive adhesive.

3. The gel light-shielding eye protection mask as claimed in claim 1, wherein the light-shielding layer is composed of a white or blue PE film/aluminum foil/PE binder/non-woven fabric four-layer structure.

4. The gel eye protector according to claim 1, wherein the light shielding layer is composed of blue cotton/sponge/black cotton.

5. The gel eye protector according to claim 1 wherein the thermal barrier is hydrogel or foam cotton or sponge with voids filled with hydrogel.

6. The gel shading eye protector as claimed in claim 1, wherein the heat insulating layer, the isolating layer 2, is omitted when the gel shading eye protector is used for shading blue light.

7. The gel shading eye protection patch as claimed in claim 1, wherein the isolation layer 1 and the isolation layer 2 are made of one of a pearlized film, release paper or a PE film, preferably the isolation layer 1 is a pearlized film, and preferably the isolation layer 2 is a PE film.

8. The gel light-shielding eye protector as claimed in claim 1, wherein the insulating layer 1 is in direct contact with the adhesive of the applied layer, and the intermediate portion of the insulating layer 1 and the portion of the light-shielding layer having the same size and shape are removed so that the light-shielding layer is directly fixed to the applied layer, and the insulating layer 2 is in direct contact with the heat-insulating layer.

9. The gel light-shielding eye protector according to claim 1, wherein the isolating layer 1 covers both the coating layer and the heat-insulating layer.

10. The gel shading eye protector as claimed in claim 1, wherein the surface of the thermal insulation layer is provided with a isolation layer 2, and the isolation layer 1 covers the surface of the adhesion layer and the isolation layer 2 at the same time.

11. The gel shading eye protection patch according to claim 1, wherein the shape and shading layer are adapted to the structure and physiological characteristics of the eye, and may be a raindrop shape, a spectacle frame shape, a bean sprout shape, an oval shape, a dolphin shape, and the patch layer and the isolation layer 1 are larger in size by 4 to 15mm than the shading layer, the thermal insulation layer and the isolation layer 2.