A medical protective headgear, its preparation method and usage method

Abstract

This invention relates to a shell and a cushioning liner, wherein the shell is hemispherical; the cushioning liner has the same shape as the shell and is positioned below the medical protective headgear on the side that contacts the head; the shell and the cushioning liner are bonded together; the shell thickness is 0.5-5 mm, preferably 1-3 mm. The medical protective headgear has a shell hardness that can change with time and temperature, exhibiting excellent plasticity, tear resistance, water resistance, and dimensional stability, while also having a pleasant aroma to improve the user experience.

Description

Technical Field

[0001] This invention relates to the field of medical rehabilitation and nursing devices, and more specifically to a medical protective headgear, its preparation method, and its usage method. Background Technology

[0002] After a head injury or craniotomy, the wound is typically covered with a sterile dressing, secured with medical tape, and then tightly wrapped with an elastic bandage. No protection is provided for the wound or surgical site. During the recovery process, the head may be subjected to external impacts or collisions, posing a risk of secondary injury. While helmets can protect the wound from impacts, their weight can compress the wound.

[0003] Most existing medical protective headgear is made of soft, fabric materials, and its main function is to isolate or protect against viruses. It has little effect on wound protection. Therefore, there is a need for a rigid medical protective headgear that can protect wounds or surgical sites. Summary of the Invention

[0004] In view of the problems existing in the prior art of medical protective headgear, one of the objectives of this invention is to provide a medical protective headgear whose shell hardness can change with time and temperature, exhibiting excellent plasticity and allowing it to be shaped according to the patient's head shape and wound distribution; it is lightweight and possesses good mechanical strength and dimensional stability, providing effective protection for injured or surgical sites; and it also has an aromatic scent to improve the user experience. The medical protective headgear provided by this invention is particularly suitable for rehabilitation care after head injuries or craniotomy.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0006] A medical protective headgear includes a shell and a cushioning liner. The shell is hemispherical. The cushioning liner has the same shape as the shell and is placed below the medical protective headgear on the side that contacts the head when in use. The shell and the cushioning liner are bonded together. The shell has a thickness of 0.5-5 mm, preferably 1-3 mm.

[0007] In the above technical solution, the medical protective headgear shell has and / or does not have a perforated structure, preferably having a perforated structure; the cushioning liner has and / or does not have a perforated structure, preferably having a perforated structure. The perforated structure is distributed throughout the shell and / or cushioning liner, with a spacing of 1-10 mm, preferably 2-4 mm; the diameter of the perforated structure is 0.5-5 mm, preferably 1-3 mm. When both the shell and the cushioning liner have perforated structures, it is preferable that the perforated structures of both are interconnected to ensure good breathability of the medical protective headgear.

[0008] The cushioning liner material is selected from at least one of rubber, silicone, sponge, thermoplastic elastomer, cloth, paper, gel, leather and modeling clay, and the thickness of the cushioning liner is 1 to 15 mm, preferably 3 to 10 mm.

[0009] Furthermore, the fact that the shape of the cushioning liner is the same as the shape of the shell means that the unfolded shape of the cushioning liner is the same as or similar to the unfolded shape of the inner side of the shell, as long as it is attached to the inner side of the shell to separate the head from the inner side of the shell and provide a cushioning effect. The shape of the cushioning liner material is not limited, but it is preferably a rectangular, square, or circular sheet larger than the head, and is cut according to the shape of the medical protective headgear shell during use. The cushioning liner material can be a perforated material or a non-perforated material, which is perforated together with the medical protective headgear shell during use.

[0010] In the above technical solution, the medical protective headgear shell is made of copolyester material, which includes copolyester X and copolyester Y; wherein the copolyester X includes aliphatic diacid and / or its derivative segments, aromatic diacid and / or its derivative segments, and diol segments; the diol segments include at least one diol segment with a cyclic structure and at least one aliphatic diol segment; wherein the aromatic diacid and / or its derivative segments account for 15-60% of the total diacid and / or its derivative segments in molar percentage.

[0011] The copolyester Y comprises aliphatic diacid and / or its derivative segments, aromatic diacid and / or its derivative segments, and at least one aliphatic diol segment; wherein the aromatic diacid and / or its derivative segments account for 50-95% of the total diacid and / or its derivative segments in molar percentage. The aromatic diacid content of copolyesters X and Y in this invention is within the above range, which can improve the rigidity of the copolyester to varying degrees.

[0012] In the above technical solution, based on a total copolyester weight of 100 parts, the copolyester X is 50 to 99 parts, preferably 55 to 80 parts; the content of copolyester X in the present invention is within the above range, which can reduce the temperature required for material to trigger softening to varying degrees, and increase the hardness and wear resistance of the material.

[0013] The copolyester Y is 1 to 50 parts, preferably 20 to 45 parts. The content of copolyester Y in this invention is within the above range, which can reduce the curing time required for the copolyester composition material to varying degrees.

[0014] In the above technical solution, the aromatic diacid and / or its derivative segments in the copolyester X account for 25-60% of the total diacid and / or its derivative segments, more preferably 30-60%.

[0015] Preferably, the cyclic diol segments in the copolyester X account for 1-60% of the total diol segments, more preferably 5-25%. The introduction of cyclic diols can increase the rigidity of the copolyester, reduce the temperature required for material softening, and increase the hardness and wear resistance of the material.

[0016] Preferably, the molar ratio of total diacid segments to total diol segments in the copolyester X is (0.8-1):1, more preferably (0.9-1):1.

[0017] Preferably, the aromatic diacid and / or its derivative segments in the copolyester Y account for 60-85% of the total diacid and / or its derivative segments.

[0018] Preferably, the molar ratio of total diacid segments to total diol segments in the copolyester Y is (0.8-1):1, more preferably (0.9-1):1.

[0019] In the above technical solution, the copolyester X and copolyester Y are each independently at least one of random copolymer, alternating copolymer, block copolymer and graft copolymer, preferably random copolymer and / or block copolymer.

[0020] In the above technical solution, the molecular weight range of copolyester X and copolyester Y is 20,000-200,000, preferably 80,000-150,000.

[0021] In the above technical solution, the aliphatic diacid and / or its derivatives are selected from at least one of 1,4-succinic acid and / or its derivatives, and 1,6-adipic acid and / or its derivatives.

[0022] The aromatic diacid and / or its derivatives are selected from terephthalic acid and / or its derivatives.

[0023] The diol with the cyclic structure is selected from at least one of 1,4-cyclohexanediol, isosorbide, and 2,2,4,4-tetramethyl-1,3-cyclobutanediol.

[0024] The aliphatic diol is selected from at least one of 1,3-propanediol / 1,4-butanediol or 1,6-hexanediol.

[0025] The introduction of the diol with a cyclic structure into the copolyester X reduces the thickness of the copolyester lamellars, thereby lowering the melting point of the copolyester and increasing its ease of use. On the other hand, the introduction of the diol with a cyclic structure reduces the crystallization rate of the copolyester, leading to an increase in the curing time of the copolyester material.

[0026] Compared to copolyester X alone, copolyester Y has a shorter curing time but a higher softening temperature and poorer hardness and abrasion resistance. Therefore, a composition of copolyester X and copolyester Y is used to compensate for the shortcomings of copolyester X or Y alone. By adjusting the ratio of the two, a suitable softening temperature, hardness, abrasion resistance, and curing time can be obtained for the copolyester composition.

[0027] In the above technical solution, the aliphatic diol segments in copolyester X are different from those in copolyester Y; preferably,

[0028] The aliphatic diol segments in copolyester X are derived from 1,4-butanediol; the aliphatic diol segments in copolyester Y are derived from 1,3-propanediol and / or 1,6-hexanediol.

[0029] In the above technical solution, based on a total weight of 100 parts of copolyester X and copolyester Y, it also contains 0.5 to 10 parts, preferably 1.5 to 8 parts, of fragrance.

[0030] The fragrance is selected from at least one of fruit fragrances and floral fragrances; the fruit fragrances include, but are not limited to, strawberry, banana, sweet orange, pineapple, grape and other fragrances; the floral fragrances include, but are not limited to, rose, jasmine, tuberose, lily of the valley, magnolia and other fragrances.

[0031] In the above technical solution, based on a total weight of 100 parts of copolyester X and copolyester Y, it also contains 1-15 parts of lubricant, wherein the lubricant is selected from at least one of stearic acid, butyl stearate, oleamide, ethylene bis-stearamide and low-density polyethylene.

[0032] The method for preparing the copolyester material of the present invention includes a step of melting and blending components including copolyester X and copolyester Y.

[0033] In the above technical solution, the mixing is carried out under stirring conditions, and the stirring rate is 20-150 r / min.

[0034] In the above technical solution, the stirring time is 5-15 minutes.

[0035] In the above technical solution, the melt blending is carried out by extrusion granulation using a twin-screw extruder; preferably, the temperature of the extrusion granulation is 110-260℃, more preferably 160-220℃.

[0036] The second objective of this invention is to provide a method for preparing the aforementioned medical protective headgear, which has low production costs, is convenient to use, and provides a good user experience.

[0037] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0038] A method for preparing a medical protective headgear includes sequentially extruding, molding and / or cutting a copolyester material to obtain a shell profile of the medical protective headgear, wherein the extrusion is preferably melt extrusion.

[0039] The extrusion temperature is 90-230℃, preferably 110-170℃;

[0040] The molding method is injection molding and / or compression molding. The equipment used also employs commonly used extrusion, injection molding, and compression molding equipment in the prior art.

[0041] The third objective of this invention is to provide a method for using a medical protective headgear, which includes heating the headgear shell to soften it sufficiently, then rapidly cooling it to a temperature acceptable to the human body, shaping it according to the shape of the patient's head and the distribution of wounds; after shaping, allowing it to harden, and then fixing the cushioning liner to the side of the shell that contacts the head with double-sided tape.

[0042] Preferably, the medical protective headgear shell material is heated to fully soften it. Heating methods include, but are not limited to, immersion in hot water, especially boiling water, microwave oven, oven, hot plate heating, etc. Then, it is rapidly cooled to a temperature acceptable to the human body. Cooling methods include, but are not limited to, immersion in cold water, ice water, or liquid nitrogen, contact with ice cubes or ice packs, or placement in a refrigerator, freezer, or freezer. After cleaning, it is shaped according to the patient's head shape and wound distribution, leaving a gap between the shell and the head for subsequent placement of the cushioning liner. The gap at and near the head wound is at least twice the thickness of the cushioning liner to prevent the shell from touching the wound. The gaps at other locations are roughly the same thickness as the cushioning liner, providing support for the head. After shaping, it is allowed to harden to obtain the shell. The cushioning liner is then fixed to the side of the shell that contacts the head using double-sided tape. Preferably, the portion of the cushioning liner not covered by the shell is trimmed off. Finally, a bandage is fixed along the face and chin to both sides of the shell near the ears using medical tape to secure the headgear.

[0043] The beneficial effects of this invention are: the medical protective headgear of this invention provides protection for injured or surgical sites of the head, avoiding secondary damage; it also has a pleasant aroma, providing a better user experience. Attached Figure Description

[0044] Figure 1 This is a schematic diagram of the structure of the medical protective headgear of the present invention.

[0045] Reference numerals: 1. Shell; 2. Cushioning liner; 3. Bandage. The illustration shows a medical protective hood, comprising a shell and a cushioning liner. The shell is hemispherical; the cushioning liner has the same shape as the shell and is positioned below the medical protective hood on the side that contacts the head. Detailed Implementation

[0046] The present invention will now be described in detail with reference to specific embodiments. It should be noted that the following embodiments are only used to further illustrate the present invention and should not be construed as limiting the scope of protection of the present invention. Some non-essential improvements and adjustments made by those skilled in the art based on the content of the present invention are still within the scope of protection of the present invention.

[0047] It should also be noted that the various specific technical features described in the following embodiments can be combined in any suitable manner without contradiction. To avoid unnecessary repetition, the various possible combinations will not be described separately in this invention.

[0048] Furthermore, various embodiments of the present invention can be combined in any way, as long as they do not violate the spirit of the present invention. The resulting technical solutions are part of the original disclosure of this specification and also fall within the protection scope of the present invention.

[0049] Reagent source: All reagents used in this invention are commercially available.

[0050] In the following examples and comparative examples, the weight-average molecular weight of the polymers was measured by gel permeation chromatography (GPC) with tetrahydrofuran (THF) as solvent on a Waters-208 instrument (with Waters 2410RI detector, 1.5 mL / min flow rate, 30 °C) and calibrated with styrene standards.

[0051] The composition of the polyester composition is determined by the amount of raw materials fed. Unless otherwise specified, the types of reactants can be adjusted according to the composition and molecular weight of the target product, and the molecular weight of the product and the content of each repeating unit in the product can be controlled by adjusting the amount and ratio of raw materials fed.

[0052] Example 1

[0053] A medical protective headgear includes a shell and a cushioning liner. The shell is hemispherical. The cushioning liner has the same shape as the shell and is positioned below the head, on the side that contacts the head. The shell and the cushioning liner are connected by double-sided adhesive tape. The shell is 2mm thick. The shell has a perforated structure. The perforations are distributed throughout the front and rear clamps, with a 2mm interval between the perforations and a 2mm diameter. The cushioning liner is made of sponge and has a thickness of 5-10mm.

[0054] Under stirring conditions (stirring speed of 30 rpm for 10 min), 7 kg of terephthalic acid-butanediol-succinic acid-1,4-cyclohexanediethanol copolyester X (weight average molecular weight of 120,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units; and the content of 1,4-cyclohexanediethanol repeating units is 25 mol% based on the total moles of butanediol and 1,4-cyclohexanediethanol repeating units) granules, 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight average molecular weight of 100,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units) granules, 0.2 kg of jasmine fragrance, and 0.3 kg of low-density polyethylene were mixed. The copolyester X has a molar ratio of total diacid segments to total glycol segments of 0.95:1, and the copolyester Y has a molar ratio of total diacid segments to total glycol segments of 0.95:1. The resulting mixture is extruded and granulated using a twin-screw extruder. The screw speed is controlled at 10 rpm, and the torque is 20 N*m. The temperatures of each section from the feed inlet to the extrusion outlet in the twin-screw extruder are 150℃, 160℃, 170℃, 170℃, 170℃, and 170℃ respectively, yielding copolyester material A1. Copolyester material A1 is melted and pressed into a 2mm thick sheet at 170℃ and 1000MPa, then cut to a suitable shape to obtain sheet P1. In use, sheet P1 is softened by heating with boiling water, then quickly placed in ice water to cool to 37℃, removed, dried, and shaped according to the patient's head shape and wound distribution. After hardening, a medical protective headgear shell B1 is obtained. The cushioning liner is fixed to the inside of the shell B1, and a bandage of appropriate length is fixed to both sides of the shell near the ears with medical tape to obtain the medical protective headgear Q1.

[0055] Example 2

[0056] A medical protective headgear includes a shell and a cushioning liner. The shell is hemispherical. The cushioning liner has the same shape as the shell and is positioned below the head, on the side that contacts the head. The shell and the cushioning liner are connected by double-sided adhesive tape. The shell is 2mm thick. The shell has a perforated structure. The perforations are distributed throughout the front and rear clamps, with a 2mm interval between the perforations and a 2mm diameter. The cushioning liner is made of sponge and has a thickness of 5-10mm.

[0057] Under stirring conditions (stirring speed of 30 rpm for 10 min), 6.5 kg of terephthalic acid-butanediol-adipic acid-isosorbate copolyester X (weight average molecular weight of 130,000, wherein the content of terephthalic acid repeating units is 55 mol% based on the total moles of terephthalic acid and adipic acid repeating units; and the content of isosorbate repeating units is 20 mol% based on the total moles of butanediol and isosorbate repeating units) granules, 3 kg of terephthalic acid-hexanediol-succinic acid copolyester Y (weight average molecular weight of 100,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units) granules, 0.2 kg of jasmine fragrance, and 0.3 kg of low-density polyethylene were mixed. In the copolyester X, the molar ratio of total diacid segments to total glycol segments is 1:1, and in the copolyester Y, the molar ratio of total diacid segments to total glycol segments is 1:1. The resulting mixture is extruded and granulated using a twin-screw extruder. The screw speed is controlled at 10 rpm, and the torque is 20 N*m. The temperatures of each section from the feed inlet to the extrusion outlet in the twin-screw extruder are 150℃, 160℃, 170℃, 170℃, 170℃, and 170℃ respectively, to obtain copolyester material A2. Copolyester material A2 is melted and pressed into a 2mm thick sheet at 170℃ and 1000MPa, and then cut into a suitable shape to obtain sheet P2. In use, sheet P2 is softened by heating with boiling water and then quickly placed in ice water to cool to 37℃. After being removed and dried, it is shaped according to the patient's head shape and wound distribution. After hardening, a medical protective headgear shell B2 is obtained. The cushioning liner is fixed to the inside of the shell B2, and a bandage of appropriate length is fixed to both sides of the shell near the ears with medical tape to obtain the medical protective headgear Q2.

[0058] Example 3

[0059] A medical protective headgear includes a shell and a cushioning liner. The shell is hemispherical. The cushioning liner has the same shape as the shell and is positioned below the head, on the side that contacts the head. The shell and the cushioning liner are connected by double-sided adhesive tape. The shell is 2mm thick. The shell has a perforated structure. The perforations are distributed throughout the front and rear clamps, with a 2mm interval between the perforations and a 2mm diameter. The cushioning liner is made of sponge and has a thickness of 5-10mm.

[0060] Under stirring conditions (stirring rate 30 rpm, time 10 min), 6.5 kg of terephthalic acid-butanediol-succinic acid-2,2,4,4-tetramethyl-1,3-cyclobutanediol copolyester X (weight average molecular weight 150,000, wherein, based on the total molar number of repeating units of terephthalic acid and succinic acid, the content of repeating units of terephthalic acid is 30 mol%; based on the total molar number of repeating units of butanediol and 2,2,4,4-tetramethyl-1,3-cyclobutanediol) was added. Based on the total molar number of alcohol repeating units, 3 kg of terephthalic acid-hexanediol-succinic acid copolyester Y (weight average molecular weight of 100,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%) granules, 0.2 kg of jasmine fragrance, and 0.3 kg of low-density polyethylene are mixed. The molar ratio of total diacid segments to total glycol segments in copolyester X is 0.9:1, and the molar ratio of total diacid segments to total glycol segments in copolyester Y is 0.9:1. The obtained mixture was extruded and granulated using a twin-screw extruder. The screw speed was controlled at 10 rpm and the torque at 20 N*m. The temperatures of each section from the feed inlet to the extrusion outlet in the twin-screw extruder were 150℃, 160℃, 170℃, 170℃, and 170℃ respectively, to obtain copolyester material A3. Copolyester material A3 was melted and pressed into 2mm thick sheets at 170℃ and 1000MPa, and then cut into suitable shapes to obtain sheet P3. In use, sheet P3 was softened by heating with boiling water and then quickly placed in ice water to cool to 37℃. After being removed and dried, it was shaped according to the patient's head shape and wound distribution. After hardening, a medical protective headgear shell B3 was obtained. A cushioning liner was fixed to the inside of shell B3, and a bandage of appropriate length was fixed to both sides of the shell near the ears with medical tape to obtain a medical protective headgear Q3.

[0061] Example 4

[0062] A medical protective headgear includes a shell and a cushioning liner. The shell is hemispherical. The cushioning liner has the same shape as the shell and is positioned below the head, on the side that contacts the head. The shell and the cushioning liner are connected by double-sided adhesive tape. The shell is 2mm thick. The shell has a perforated structure. The perforations are distributed throughout the front and rear clamps, with a 2mm interval between the perforations and a 2mm diameter. The cushioning liner is made of sponge and has a thickness of 5-10mm.

[0063] Under stirring conditions (stirring speed of 30 rpm for 10 min), 7 kg of terephthalic acid-butanediol-succinic acid-1,4-cyclohexanediethanol copolyester X (weight average molecular weight of 120,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units; and the content of 1,4-cyclohexanediethanol repeating units is 25 mol% based on the total moles of butanediol and 1,4-cyclohexanediethanol repeating units) granules, 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight average molecular weight of 110,000, wherein the content of terephthalic acid repeating units is 80 mol% based on the total moles of terephthalic acid and succinic acid repeating units) granules, 0.2 kg of jasmine fragrance, and 0.3 kg of low-density polyethylene were mixed. In the copolyester X, the molar ratio of total diacid segments to total glycol segments is 0.95:1, and in the copolyester Y, the molar ratio of total diacid segments to total glycol segments is 1:1. The resulting mixture is extruded and granulated using a twin-screw extruder. The screw speed is controlled at 10 rpm, and the torque is 20 N*m. The temperatures in each section of the twin-screw extruder from the feed inlet to the extrusion outlet are 150℃, 160℃, 170℃, 170℃, 170℃, and 170℃ respectively, yielding copolyester material A4. Copolyester material A4 is melted and pressed into a 2mm thick sheet at 170℃ and 1000MPa, then cut to a suitable shape to obtain sheet P4. For use, sheet P4 is softened by heating with boiling water, then quickly cooled to 37℃ in ice water, removed, dried, and shaped according to the patient's head shape and wound distribution. After hardening, a medical protective headgear shell B4 is obtained. The cushioning liner is fixed to the inside of the shell B4, and a bandage of appropriate length is fixed to both sides of the shell near the ears with medical tape to obtain the medical protective headgear Q4.

[0064] Example 5

[0065] A medical protective headgear includes a shell and a cushioning liner. The shell is hemispherical. The cushioning liner has the same shape as the shell and is positioned below the head, on the side that contacts the head. The shell and the cushioning liner are connected by double-sided adhesive tape. The shell is 2mm thick. The shell has a perforated structure. The perforations are distributed throughout the front and rear clamps, with a 2mm interval between the perforations and a 2mm diameter. The cushioning liner is made of sponge and has a thickness of 5-10mm.

[0066] Under stirring conditions (stirring speed 30 rpm, time 10 min), 7 kg of terephthalic acid-butanediol-succinic acid-2,2,4,4-tetramethyl-1,3-cyclobutanediol copolyester X (weight average molecular weight 150,000, wherein, based on the total molar number of repeating units of terephthalic acid and succinic acid, the content of repeating units of terephthalic acid is 60 mol%; based on the total molar number of repeating units of butanediol and 2,2,4,4-tetramethyl-1,3-cyclobutanediol) was added. Based on the total molar number of the complex units, the following are mixed: 2,2,4,4-tetramethyl-1,3-cyclobutanediol repeating units (content of 10 mol%) granules, 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight average molecular weight of 100,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%) granules, 0.2 kg of jasmine fragrance, and 0.3 kg of low-density polyethylene. The molar ratio of total diacid segments to total glycol segments in copolyester X is 1:1, and the molar ratio of total diacid segments to total glycol segments in copolyester Y is 0.9:1. The obtained mixture was extruded and granulated using a twin-screw extruder. The screw speed was controlled at 10 rpm and the torque at 20 N*m. The temperatures of each section from the feed inlet to the extrusion outlet in the twin-screw extruder were 150℃, 160℃, 170℃, 170℃, and 170℃ respectively, to obtain copolyester material A5. Copolyester material A5 was melted and pressed into 2mm thick sheets at 170℃ and 1000MPa, and then cut into suitable shapes to obtain sheet P5. For use, sheet P5 was softened by heating with boiling water and then quickly cooled to 37℃ in ice water. After being removed and dried, it was shaped according to the patient's head shape and wound distribution. After hardening, a medical protective headgear shell B5 was obtained. A cushioning liner was fixed to the inside of shell B5, and a bandage of appropriate length was fixed to both sides of the shell near the ears using medical tape, resulting in a medical protective headgear Q5.

[0067] Example 6

[0068] A medical protective headgear includes a shell and a cushioning liner. The shell is hemispherical. The cushioning liner has the same shape as the shell and is positioned below the head, on the side that contacts the head. The shell and the cushioning liner are connected by double-sided adhesive tape. The shell is 2mm thick. The shell has a perforated structure. The perforations are distributed throughout the front and rear clamps, with a 2mm interval between the perforations and a 2mm diameter. The cushioning liner is made of sponge and has a thickness of 5-10mm.

[0069] Under stirring conditions (stirring rate of 30 rpm for 10 min), 7 kg of terephthalic acid-butanediol-succinic acid-isosorbate copolyester X (weight average molecular weight of 130,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units; and the content of isosorbate repeating units is 5 mol% based on the total moles of butanediol and isosorbate repeating units) granules, 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight average molecular weight of 100,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units) granules, 0.2 kg of jasmine fragrance, and 0.3 kg of low-density polyethylene were mixed. In the copolyester X, the molar ratio of total diacid segments to total glycol segments is 0.95:1, and in the copolyester Y, the molar ratio of total diacid segments to total glycol segments is 0.9:1. The resulting mixture is extruded and granulated using a twin-screw extruder. The screw speed is controlled at 10 rpm, and the torque is 20 N*m. The temperatures in each section of the twin-screw extruder from the feed inlet to the extrusion outlet are 150℃, 160℃, 170℃, 170℃, 170℃, and 170℃ respectively, yielding copolyester material A6. Copolyester material A6 is melted and pressed into 2mm thick sheets at 170℃ and 1000MPa, then cut to a suitable shape to obtain sheet P6. For use, sheet P6 is softened by heating with boiling water, then quickly cooled to 37℃ in ice water, removed, dried, and shaped according to the patient's head shape and wound distribution. After hardening, a medical protective headgear shell B6 is obtained. The cushioning liner is fixed to the inside of the shell B6, and a bandage of appropriate length is fixed to both sides of the shell near the ears with medical tape to obtain the medical protective headgear Q6.

[0070] Comparative Example 1

[0071] Under stirring conditions (stirring rate 30 rpm, time 10 min), 9.5 kg of terephthalic acid-butanediol-succinic acid-1,4-cyclohexanediethanol copolyester X (weight average molecular weight 120,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total molar number of repeating units of terephthalic acid and succinic acid; and the content of 1,4-cyclohexanediethanol repeating units is 25 mol% based on the total molar number of repeating units of butanediol and 1,4-cyclohexanediethanol) granules, 0.2 kg of jasmine fragrance, and 0.3 kg of low-density polyethylene were mixed. The molar ratio of total diacid segments to total glycol segments in the copolyester X was 1:1. The obtained mixture was extruded and granulated using a twin-screw extruder. The screw speed was controlled at 10 rpm and the torque at 20 N*m. The temperatures of each section from the feed inlet to the extrusion outlet in the twin-screw extruder were 150℃, 160℃, 170℃, 170℃, 170℃, and 170℃ respectively, to obtain copolyester material A7. Copolyester material A7 was melted and pressed into 2mm thick sheets at 170℃ and 1000MPa, and then cut into suitable shapes to obtain sheet P7. In use, sheet P7 was softened by heating with boiling water and then quickly placed in ice water to cool to 37℃. After being removed and dried, it was shaped according to the patient's head shape and wound distribution. After hardening, the medical protective headgear shell B7 was obtained.

[0072] Comparative Example 2

[0073] Under stirring conditions (stirring rate of 30 rpm for 10 min), 9.5 kg of terephthalic acid-butanediol-adipic acid-isosorbate copolyester X (weight average molecular weight of 130,000, wherein the content of terephthalic acid repeating units is 55 mol% based on the total molar number of repeating units of terephthalic acid and adipic acid; and the content of isosorbate repeating units is 20 mol% based on the total molar number of repeating units of butanediol and isosorbate) granules, 0.2 kg of jasmine fragrance, and 0.3 kg of low-density polyethylene were mixed. The molar ratio of total diacid segments to total glycol segments in the copolyester X was 0.9:1. The obtained mixture was extruded and granulated using a twin-screw extruder. The screw speed was controlled at 10 rpm and the torque at 20 N*m. The temperatures of each section from the feed inlet to the extrusion outlet in the twin-screw extruder were 150℃, 160℃, 170℃, 170℃, 170℃, and 170℃ respectively, to obtain copolyester material A8. Copolyester material A8 was melted and pressed into 2mm thick sheets at 170℃ and 1000MPa, and then cut into suitable shapes to obtain sheet P8. In use, sheet P8 was softened by heating with boiling water and then quickly placed in ice water to cool to 37℃. After being removed and dried, it was shaped according to the patient's head shape and wound distribution. After hardening, the medical protective headgear shell B8 was obtained.

[0074] Comparative Example 3

[0075] Under stirring conditions (stirring rate of 30 rpm for 10 min), 6.5 kg of terephthalic acid-butanediol-succinic acid copolyester Y (weight average molecular weight of 100,000, wherein the content of terephthalic acid repeating units is 25 mol% based on the total molar number of terephthalic acid and succinic acid repeating units), 3 kg of terephthalic acid-butanediol-adipic acid copolyester (weight average molecular weight of 100,000, wherein the content of terephthalic acid repeating units is 65 mol% based on the total molar number of terephthalic acid and adipic acid repeating units) granules, 0.2 kg of jasmine fragrance, and 0.3 kg of low-density polyethylene were mixed. The molar ratio of total diacid segments to total glycol segments in the copolyester Y was 0.95:1. The obtained mixture was extruded and granulated using a twin-screw extruder. The screw speed was controlled at 10 rpm and the torque at 20 N*m. The temperatures of each section from the feed inlet to the extrusion outlet in the twin-screw extruder were 150℃, 160℃, 170℃, 170℃, 170℃, and 170℃ respectively, to obtain copolyester material A9. Copolyester material A9 was melted and pressed into 2mm thick sheets at 170℃ and 1000MPa, and then cut into suitable shapes to obtain sheet P9. In use, sheet P9 was softened by heating with boiling water and then quickly placed in ice water to cool to 37℃. After being removed and dried, it was shaped according to the patient's head shape and wound distribution. After hardening, the medical protective headgear shell B9 was obtained.

[0076] Test Example 1

[0077] The medical protective headgear shells obtained in Examples 1-6 and Comparative Example 3 were placed in hot water at different temperatures to soften them. The temperatures required to trigger the softening of the medical protective headgear shells were recorded, and the results are shown in Table 1.

[0078] It can be seen that the softening temperatures required for the medical protective headgear shells B1-B6 obtained in Examples 1-6 are all lower than those required for the medical protective headgear shell B9 obtained in Comparative Example 3, with a maximum reduction of 20°C. Lowering the softening trigger temperature of the medical protective headgear shell can greatly increase the convenience of using the medical protective headgear.

[0079] Table 1. Temperatures required for softening of medical protective headgear shells B1-B9.

[0080]

[0081] Test Example 2

[0082] Shore A hardness test

[0083] The copolyesters A1-A8 obtained in Examples 1-6 and Comparative Examples 1-2 were melted and treated at 170 and 1000 MPa for 5 min respectively, and then pressed into 4 mm thick sheets C1-C8 with a side length of 7 cm. The hot sheets were removed and quenched for 1 min using a cold iron block that had been left at room temperature for a long time, and the time was recorded as zero. The Shore A hardness of the quenched sheets was tested as a function of time (measured with a Drickshore A handheld hardness tester, and the measurement result was taken after 3 seconds). The results are shown in Table 2 below.

[0084] Table 2 Shore A Hardness Test

[0085]

[0086] As can be seen from the results in Table 2 above, the sheets C1-C8 made from copolyesters A1-A8 obtained in Examples 1-6 and Comparative Examples 1-2, respectively, all had low hardness at the beginning of the test (at higher temperatures), but the hardness increased slowly over time after cooling. Compared with the sheets C7-C8 made from copolyesters A7-A8 obtained in Comparative Examples 1-2, the sheets C1-C6 made from copolyesters A1-A6 obtained in Examples 1-6 cured faster, reaching a Shore A hardness of 50 in only about 4 minutes, while the latter required about 7 minutes. The copolyesters A1-A6 obtained in Examples 1-6 have good plasticity and fixation, and a short curing time, making them suitable for preparing medical protective headgear.

[0087] Test Example 3

[0088] 1. Waterproofing test

[0089] The sheets C1-C6 made from the copolyesters A1-A6 obtained in Examples 1-6 were weighed, measured, photographed, and their appearance observed. The sheets were immersed in water at 25°C for 24 hours, then removed, dried, and their weight, dimensions, and appearance were observed again. If the appearance of the sheet after immersion was unchanged compared to before immersion, it was recorded as "no change"; otherwise, it was recorded as "change". If the dimensions of the sheet after immersion changed within ±5% compared to before immersion, it was recorded as "no change"; otherwise, it was recorded as "change". If the weight of the sheet after immersion changed within ±5% compared to before immersion, it was recorded as "no change"; otherwise, it was recorded as "change". The results are shown in Table 3.

[0090] 2. Storage time test

[0091] The sheets C1-C6 made from the copolyesters A1-A6 obtained in Examples 1-6 were weighed, measured, photographed, and their appearance observed. Then, the sheets were placed in a normal atmospheric pressure environment at room temperature (25°C) for 2 years, and the sheets were weighed, measured, photographed, and their appearance observed. If the appearance of the sheet remained unchanged after 2 years compared to before placement, it was recorded as "no change"; otherwise, it was recorded as "change". If the dimensions of the sheet remained unchanged after 2 years compared to before placement, it was recorded as "no change"; otherwise, it was recorded as "change". If the weight of the sheet changed within ± the weight before placement after 2 years, it was recorded as "no change"; otherwise, it was recorded as "change". The results are shown in Table 3.

[0092] Table 3 Waterproofing and Storage Time Tests

[0093]

[0094] As can be seen from the results in Table 3 above, the medical protective headgear provided by the present invention has good waterproofness and dimensional stability, so it does not require special packaging such as waterproofing during storage and transportation; and, its shelf life is at least two years at room temperature.

[0095] The present invention has been described in detail above with reference to specific embodiments and exemplary examples; however, these descriptions should not be construed as limiting the present invention. Those skilled in the art will understand that various equivalent substitutions, modifications, or improvements can be made to the technical solutions and embodiments of the present invention without departing from the spirit and scope of the invention, and all such modifications and improvements fall within the scope of the present invention. The scope of protection of the present invention is defined by the appended claims.

Claims

1. A medical protective headgear, comprising a shell and a cushioning liner, wherein the shell is hemispherical; the cushioning liner has the same shape as the shell and is positioned below the medical protective headgear on the side in contact with the head; the shell and the cushioning liner are bonded together; the shell has a thickness of 0.5-5 mm; The shell is made of copolyester material; the copolyester material includes copolyester X and copolyester Y; The copolyester X comprises aliphatic diacid segments, aromatic diacid segments, and diol segments; the diol segments include at least one diol segment with a cyclic structure and at least one aliphatic diol segment. The aromatic diacid segments in copolyester X account for 25-60% of the total diacid segments; The molar percentage of cyclic diol segments in copolyester X is 5-25% of the total diol segments; The molar ratio of total diacid segments to total diol segments in copolyester X is (0.9~1):1; The copolyester Y comprises aliphatic diacid segments, aromatic diacid segments, and at least one aliphatic diol segment; The aromatic diacid segments in copolyester Y account for 60-85% of the total diacid segments; The molar ratio of total diacid segments to total diol segments in copolyester Y is (0.9~1):1; The aliphatic diacid is selected from at least one of 1,4-succinic acid and 1,6-adipic acid; Aromatic diacids are selected from terephthalic acid; The diol with a cyclic structure is selected from at least one of 1,4-cyclohexanediol, isosorbide, and 2,2,4,4-tetramethyl-1,3-cyclobutanediol; The aliphatic diol is selected from at least one of 1,3-propanediol, 1,4-butanediol and 1,6-hexanediol; Copolyester X and copolyester Y are each independently at least one of random copolymers, alternating copolymers, block copolymers and graft copolymers; The molecular weight range of copolyester X and copolyester Y is 20,000-200,000; Based on a total copolyester weight of 100 parts, copolyester X consists of 55-80 parts and copolyester Y consists of 20-45 parts; the aliphatic diol segments in copolyester X are different from those in copolyester Y.

2. The medical protective headgear according to claim 1, characterized in that, The medical protective headgear shell and the buffer liner have a perforated structure; the perforated structure is distributed throughout the shell and the buffer liner, with a spacing of 1-10 mm between the perforations and a perforation diameter of 0.5-5 mm.

3. The medical protective headgear according to claim 2, characterized in that, The spacing between holes is 2-4mm, and the diameter of the hole structure is 1-3mm.

4. The medical protective headgear according to claim 1, characterized in that, The thickness of the buffer liner is 1~15mm; and / or, The shell and the cushioning liner are bonded together with double-sided adhesive; and / or, The cushioning lining material is selected from at least one of rubber, sponge, thermoplastic elastomer, cloth, paper, gel, leather and modeling clay.

5. The medical protective headgear according to claim 4, characterized in that, The thickness of the buffer liner is 3~10mm.

6. The medical protective headgear according to claim 1, characterized in that, The shell thickness is 1-3 mm.

7. The medical protective headgear according to claim 1, characterized in that, The molecular weight range of copolyester X and copolyester Y is 80,000-150,000.

8. The medical protective headgear according to claim 1, characterized in that, The aliphatic diol segments in copolyester X are derived from 1,4-butanediol; The aliphatic diol segments in copolyester Y are derived from 1,3-propanediol and / or 1,6-hexanediol.

9. The medical protective headgear according to claim 1, characterized in that, Based on a total weight of 100 parts of copolyester X and copolyester Y, it also contains 0.5 to 10 parts of fragrance.

10. The medical protective headgear according to claim 9, characterized in that, The amount of fragrance is 1.5 to 8 parts.

11. The medical protective headgear according to claim 1, characterized in that, Based on a total weight of 100 parts of copolyester X and copolyester Y, it also contains 1 to 15 parts of lubricant.

12. The medical protective headgear according to claim 11, characterized in that, The amount of lubricant is 5 to 15 parts.

13. The medical protective headgear according to claim 11, characterized in that, The lubricant is selected from at least one of stearic acid, butyl stearate, oleamide, ethylene bis-stearamide, and low-density polyethylene.

14. A method for preparing a medical protective headgear according to any one of claims 1 to 13, comprising extruding, molding and cutting a copolyester material in sequence to obtain the front and rear clamp profiles of the medical protective headgear.

15. The preparation method according to claim 14, characterized in that, The extrusion is melt extrusion.

16. The preparation method according to claim 14, characterized in that, The extrusion temperature is 90-230℃; and / or, The molding method is injection molding and / or compression molding.

17. The preparation method according to claim 16, characterized in that, The extrusion temperature is 110-170℃.

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