Novel biological amnion

Abstract

The utility model discloses a novel biological amniotic membrane which comprises an amniotic membrane main body, the amniotic membrane main body is circular, one surface of the amniotic membrane main body is an epithelial layer, the other surface of the amniotic membrane main body is a sponge layer, a U-shaped hole for distinguishing the epithelial layer and the sponge layer is formed in the edge of the amniotic membrane main body, the U-shaped hole is of an asymmetric structure, and the lengths of the two side edges of the U-shaped hole are different. The U-shaped hole is formed in the edge of the amniotic membrane body and used for distinguishing the epithelial layer and the spongy layer of the amniotic membrane, the U-shaped hole of the original asymmetric structure is easy to operate and easy to produce on a large scale, a nitrocellulose membrane supporting device can be saved, and the production efficiency is improved. And the damage to the mechanical property of the amnion caused by mechanical embossing is avoided, the yield of products is improved, and the method has wide application prospects and is beneficial to popularization and application.

Description

Technical Field

[0001] The utility model belongs to the category of medical products. The product can be used in the fields of ophthalmology, dermatology, trauma orthopedics, etc., and mainly relates to a new type of biological amniotic membrane. Background Art

[0002] Bio-amniotic membrane has been widely used in the treatment of ophthalmic diseases such as pterygium, corneal ulcer, chemical burns, blepharobulbar adhesion, etc., and has the effect of soft tissue regeneration and repair. It is mainly taken from the innermost layer of the human placenta, the transparent thin film "amniotic membrane", which has five layers: epithelial layer, basement membrane layer, matrix layer, fibroblast layer and sponge layer. In clinical applications in ophthalmology, bio-amniotic membrane is often set to a circular specification for easy fitting on the ocular surface. In some scenarios, the epithelial layer needs to be facing down to cover the wound, and sometimes the sponge layer needs to be facing down. However, the epithelial layer and the sponge layer are difficult to distinguish from the appearance, especially for circular specifications, so it is necessary to use special markings to distinguish the difference between the two layers.

[0003] At present, wet biological amniotic membrane products are generally attached to nitrocellulose film (NC membrane) or other supporting devices, and the product manual specifies which layer of the amniotic membrane is attached to the NC membrane. This process requires the product to be equipped with high-quality NC membranes, which is bound to increase production costs and ultimately lead to increased medical expenses. When preparing dry biological amniotic membrane products, mechanical embossing technology can be used to make specific marks on the epithelial layer or sponge layer, such as the dry biological amniotic membrane produced by Jiangxi Ruiji Bioengineering Technology Co., Ltd., but this process can easily cause damage to the mechanical properties of the amniotic membrane; in addition, because the amniotic membrane is extremely thin and easily broken during embossing, the yield rate is reduced. Therefore, there is an urgent need to develop a new type of biological amniotic membrane to solve the above technical problems.

[0004] In view of this, the present utility model is proposed. Utility Model Content

[0005] The purpose of the utility model is to provide a new type of biological amniotic membrane, in which a U-shaped hole is set at the edge of the amniotic membrane body to distinguish the epithelial layer and the spongy layer of the amniotic membrane. The original asymmetric structure U-shaped hole is simple to operate and easy to mass produce. It can save the configuration of nitrocellulose membrane support device, avoid the damage of the mechanical properties of the amniotic membrane caused by mechanical embossing, improve the product yield, have broad application prospects, and are conducive to popularization and application.

[0006] In order to achieve the above-mentioned purpose, the utility model provides a new type of biological amniotic membrane, wherein the amniotic membrane main body is circular, one side is an epithelial layer, and the other side is a sponge layer. A U-shaped hole is provided at the edge of the amniotic membrane main body for distinguishing the epithelial layer and the sponge layer. The U-shaped hole has an asymmetric structure, and the two sides have different lengths, and its longitudinal central axis does not pass through the center of the amniotic membrane main body.

[0007] Preferably, the difference in length between the two sides of the U-shaped hole is at least 1 mm.

[0008] Preferably, the length of the shorter side of the two sides of the U-shaped hole is 1mm-5mm, and the length of the longer side is 2mm-10mm.

[0009] Preferably, the arc portion at the bottom end of the U-shaped hole has a radius of 1 mm to 5 mm.

[0010] Preferably, the angle at which the U-shaped hole deviates from the longitudinal center axis of the amniotic membrane body is called a deviation angle, and the deviation angle is 10°-80°.

[0011] Preferably, the bio-amniotic membrane is a wet bio-amniotic membrane or a dry bio-amniotic membrane.

[0012] Preferably, the dry biological amniotic membrane is prepared by natural air drying, oven drying, vacuum drying or vacuum freeze drying.

[0013] The utility model provides a novel biological amniotic membrane, which has the following beneficial effects.

[0014] The utility model sets a U-shaped hole at the edge of the amniotic membrane body to distinguish the epithelial layer and the spongy layer of the amniotic membrane. The original asymmetric structure U-shaped hole is simple to operate and easy to mass produce. It can save the configuration of nitrocellulose membrane support device, avoid the damage of the mechanical properties of the amniotic membrane caused by mechanical embossing, and improve the product yield. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 A schematic diagram of the structure of a novel biological amniotic membrane provided by the utility model;

[0016] Figure 2 A schematic diagram of the deviation angle of the U-shaped hole of a novel biological amniotic membrane provided by the utility model.

[0017] In the figure:

[0018] 1. Amniotic membrane body 2. U-shaped hole. DETAILED DESCRIPTION

[0019] The present invention will be further described below in conjunction with specific embodiments and drawings to help understand the content of the present invention.

[0020] like Figure 1The figure is a schematic diagram of the structure of a new type of biological amniotic membrane provided by the utility model. The new type of biological amniotic membrane includes an amniotic membrane main body 1, which is circular, with one side being an epithelial layer and the other side being a sponge layer. A U-shaped hole 2 is provided at the edge of the amniotic membrane main body 1 for distinguishing the epithelial layer and the sponge layer of the amniotic membrane. The U-shaped hole 2 is an asymmetric structure, and the two sides are of different lengths, and its longitudinal center axis does not pass through the center of the circle of the amniotic membrane main body 1. The difference in length between the two sides of the U-shaped hole 2 is at least 1mm. The length of the two sides of the U-shaped hole 2, of which the shorter side is 1mm-5mm, and the length of the longer side is 2mm-10mm. The arc portion at the bottom end of the U-shaped hole 2 has a radius of 1mm-5mm. The angle at which the U-shaped hole 2 deviates from the longitudinal center axis of the amniotic membrane main body 1 is called the deviation angle, and the angle of the deviation angle is 10°-80°. As shown in FIG. Figure 2 The figure shows a schematic diagram of the deviation angle of the U-shaped hole of a novel biological amniotic membrane provided by the utility model. The angle α in the figure is the deviation angle. The biological amniotic membrane is a wet biological amniotic membrane or a dry biological amniotic membrane. The dry biological amniotic membrane is prepared by natural air drying, drying, vacuum drying or vacuum freeze drying.

[0021] During the processing, if the epithelial layer of the amniotic membrane is facing downwards when punching, and the U-shaped hole 2 is positioned at the upper right arc portion of the amniotic membrane body 1, then Figure 1 The upward side (front side) is the sponge layer, and the downward side (back side) is the epithelial layer. The method of distinguishing the epithelial layer and sponge layer of the biological amniotic membrane is: lay the biological amniotic membrane flat, invert or rotate the biological amniotic membrane until the U-shaped hole 2 is in the upper right arc position of the amniotic membrane body 1, and the opening of the U-shaped hole 2 faces directly upward. At this time, the front side is the sponge layer and the back side is the epithelial layer. Or vice versa, the front side is the epithelial layer and the back side is the sponge layer. The specific discrimination method is related to the punching method of the U-shaped hole 2. Example

[0022] (1) Preparation of biological amniotic membrane: Obtain human placenta according to conventional methods, peel off the amniotic membrane, clean the blood stains, and cut it into a circular wet biological amniotic membrane.

[0023] (2) Punching: Because the wet biological amniotic membrane is thin and soft, before punching, the sample is first attached to the filter paper with the epithelium facing down to facilitate punching, and then Figure 2 As shown, a U-shaped hole 2 is prepared at a deviation angle of 30° using a puncher. The length of the shorter side of the U-shaped hole 2 is 3 mm, the length of the longer side is 5 mm, and the radius of the arc portion at the bottom of the U-shaped hole is 2 mm. The amniotic membrane is peeled off from the filter paper to obtain a wet biological amniotic membrane product. The schematic diagram of the product is shown in Figure 1 .

[0024] The method for distinguishing the epithelial layer and sponge layer of the biological amniotic membrane is: lay the biological amniotic membrane sample flat, invert or rotate the sample until the U-shaped hole is at the upper right arc position of the amniotic membrane body 1, and the opening of the U-shaped hole faces directly upward. At this time, the front side is the sponge layer and the back side is the epithelial layer. In order to facilitate the distinction, the identification method should be clearly stated in the product manual. Example

[0025] (1) Preparation of biological amniotic membrane: Obtain human placenta according to conventional methods, remove the amniotic membrane to clean blood stains, cut it into a round shape, place it in a vacuum freeze dryer, and freeze-dry it to obtain dry biological amniotic membrane.

[0026] (2) Punching: Spread the dry biological amniotic membrane prepared in the previous step on the filter paper with the epithelium facing upward, and use a puncher to directly make a U-shaped hole at a deviation angle of 10°. The length of the shorter side of the U-shaped hole is 1 mm, the length of the longer side is 2 mm, and the radius of the arc part at the bottom of the U-shaped hole is 1 mm. The freeze-dried biological amniotic membrane is obtained.

[0027] The method to distinguish the epithelial layer and sponge layer of biological amniotic membrane is: lay the biological amniotic membrane sample flat, turn it upside down or rotate it until the U-shaped hole is in the upper right arc of the amniotic membrane, and the opening of the U-shaped hole is facing upward. At this time, the front side is the epithelial layer and the back side is the sponge layer. In order to facilitate the distinction, this identification method should be clearly stated in the product manual. Example

[0028] (1) Preparation of biological amniotic membrane: Obtain human placenta according to conventional methods, remove the amniotic membrane to clean blood stains, cut it into a round shape, place it in a vacuum dryer, and fully dehydrate it to obtain dry biological amniotic membrane.

[0029] (2) Punching: Lay the dry amniotic membrane epithelial layer prepared in the previous step downward, and use a puncher to directly make a U-shaped hole at a deviation angle of 80°. The length of the shorter side of the U-shaped hole is 5 mm, the length of the longer side is 10 mm, and the radius of the arc part at the bottom of the U-shaped hole is 5 mm. The dehydrated biological amniotic membrane is obtained.

[0030] The method to distinguish the epithelial layer and sponge layer of the biological amniotic membrane is: lay the biological amniotic membrane sample flat, invert or rotate the sample until the U-shaped hole is in the upper right arc of the amniotic membrane, and the opening of the U-shaped hole is facing upward. At this time, the front side is the sponge layer and the back side is the epithelial layer. In order to facilitate the distinction, this identification method should be clearly stated in the product manual.

[0031] Comparative Example 1 Preparation and performance comparison test of mechanically embossed biological amniotic membrane

[0032] (1) Preparation of biological amniotic membrane: Obtain human placenta according to conventional methods, remove the amniotic membrane to clean blood stains, cut it into a round shape, place it in a vacuum dryer, and fully dehydrate it to obtain dry biological amniotic membrane.

[0033] (2) Mechanical embossing: Use a stainless steel mold with English letters to emboss the "UP" logo on the dehydrated biological amniotic membrane to distinguish the front and back sides. Press 50 samples continuously, calculate the yield rate, and take 6 samples of each sample to test the tensile strength using a universal testing machine and compare them with the samples prepared in Example 3.

[0034] The results showed that 8 out of 50 pieces showed signs of being crushed, and the yield rate was 84%. However, Example 3 was prepared by the punching method, and only 1 out of 50 pieces was defective, with a yield rate of 98%. In addition, the tensile strengths of the samples of Comparative Example 1 and Example 3 were 4.17±2.43Mpa and 6.02±1.23Mpa, respectively. The results showed that the mechanical strength of the samples using the mechanical embossing process was low, and the sample deviation was large. The above tests show that the U-shaped hole design of the utility model can save the configuration of the nitrocellulose membrane support device, avoid damage to the mechanical properties of the amniotic membrane caused by mechanical embossing, and improve the product yield.

[0035] This article uses specific examples to elaborate on the concept of the utility model, and the description of the above embodiments is only used to help understand the core idea of ​​the utility model. It should be pointed out that for ordinary technicians in this technical field, without departing from the concept of the utility model, any obvious modifications, equivalent substitutions or other improvements made should be included in the scope of protection of the utility model, such as changing the shape of the U-shaped hole to other shapes such as circle, triangle, or setting the hole in the upper left, lower left, or lower right arc part of the sample. The method of marking the front and back sides through the U-shaped hole proposed in this utility model is also applicable to square biological amniotic membranes and other biomaterial products with a centrally symmetrical structure. The design principle is that the longitudinal center axis of the U-shaped hole should not pass through the symmetry center of the sample.

Claims

1. A novel biological amniotic membrane, characterized in that: It includes an amniotic membrane body, which is circular, with one side being an epithelial layer and the other side being a spongy layer. A U-shaped hole is provided at the edge of the amniotic membrane body for distinguishing the epithelial layer from the spongy layer. The U-shaped hole is an asymmetric structure, with two sides of different lengths, and its longitudinal central axis does not pass through the center of the amniotic membrane body.

2. A novel biological amniotic membrane according to claim 1, characterized in that: The difference in length between the two sides of the U-shaped hole is at least 1 mm.

3. A novel biological amniotic membrane according to claim 2, characterized in that: The length of the shorter side of the two sides of the U-shaped hole is 1mm-5mm, and the length of the longer side is 2mm-10mm.

4. A novel biological amniotic membrane according to claim 3, characterized in that: The arc part at the bottom of the U-shaped hole has a radius of 1mm-5mm.

5. A novel biological amniotic membrane according to claim 4, characterized in that: The angle at which the U-shaped hole deviates from the longitudinal center axis of the amniotic membrane body is called a deviation angle, and the deviation angle is 10°-80°.

6. A novel biological amniotic membrane according to claim 5, characterized in that: The biological amniotic membrane is a wet biological amniotic membrane or a dry biological amniotic membrane.

7. A novel biological amniotic membrane according to claim 6, characterized in that: The dry biological amniotic membrane is prepared by natural air drying, drying, vacuum drying or vacuum freeze drying.

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