Transvaginal ultrasound probe barrier membrane, method of making and use thereof

Abstract

The present application relates to the technical field of vaginal ultrasound probe isolation film, in particular to a transvaginal ultrasound probe isolation film, a preparation method and application thereof. The transvaginal ultrasound probe isolation film comprises a medical elastomer, a bundle port belt and a hydrophilic coating lubricant, and is characterized in that the hydrophilic coating lubricant is made of the following raw materials in the total amount of 100 parts: polyurethane acrylate-glycidyl acrylate copolymer 20-30 parts, polyisocyanate 8-16 parts, polymethyl vinyl ether-maleic anhydride 10-20 parts, cross-linking functional monomer 5-10 parts, functional additive 3-8 parts, and PEG aqueous solution in the remaining amount. The isolation film coated with the hydrophilic coating lubricant obtained by optimizing the raw materials has the technical effects of high light transmittance, low thickness and low friction, the bundle port belt naturally shrinks and clamps the probe tail groove, realizes the anti-dropping and non-contact wearing, reduces the operation difficulty and reduces the cross-infection risk.

Description

Technical Field

[0001] This invention belongs to the field of vaginal ultrasound probe isolation membrane technology, specifically relating to a transvaginal ultrasound probe isolation membrane, its preparation method, and its application. Background Technology

[0002] The isolating membrane (ultrasound isolating membrane) of a vaginal ultrasound probe is mainly used to improve image display quality and reduce the risk of infection. However, the comfort and experience of the isolating membrane during the examination are crucial, thus there is an urgent need to improve its lubrication performance. Existing isolating membranes require the application of a coupling agent to improve lubrication, which not only increases operational complexity but also poses a risk of cross-infection. Hydrophilic modification of the membrane material can improve its lubrication performance, and this has been studied in the prior art. For example, Chinese invention patent application CN106075602A discloses a method for preparing an aqueous hydrophilic lubricating coating solution for medical devices. This method firmly anchors a hydrophilic lubricating polymer to the surface of the medical device, providing abrasion resistance and super-lubrication. However, in practical applications, this application still requires further optimization of the coating solution formulation and preparation process based on the surface characteristics of different medical devices and clinical needs. Chinese invention patent application CN114748700A discloses a superhydrophilic coating for TPU-coated guidewires and its preparation method. This method involves pretreating the TPU-coated guidewire with a surface-modifying solution, followed by coating with a base layer and a top layer solution to form a superhydrophilic coating comprising a base layer and a top layer, exhibiting excellent superhydrophilicity and lubricity. However, in practical applications, this application still faces the problem that the formulations of the base layer and top layer of the coating need further optimization to improve the coating's superhydrophilicity and lubricity. Simultaneously, existing hydrophilic coating modification methods still have some problems, such as some hydrophilic coatings easily dissolving in water, leading to a decrease in lubricity, requiring pre-activation by breaking the water-filled pocket; some coatings experience a decrease or even loss of lubricity after irradiation sterilization; furthermore, some hydrophilic coatings have insufficient adhesion to the substrate, making them susceptible to shear forces and prone to detachment or wear.

[0003] Therefore, there is an urgent need to develop a hydrophilic coating lubricant that can form a stable, durable, and well-lubricating transvaginal ultrasound probe isolation membrane on a medical elastomer body, as well as its preparation method and application. Summary of the Invention

[0004] In view of the prior art, the present invention provides a transvaginal ultrasound probe isolation membrane, its preparation method and application. The hydrophilic coating lubricant obtained by optimizing the raw materials has good lubrication performance, good toughness, leak resistance and lubrication performance. It forms a stable and durable hydrophilic coating with the elastomer body of the isolation membrane, so that the isolation membrane achieves the technical effects of high light transmittance, low thickness and low friction. In addition, the ferrule naturally shrinks and tightens the groove at the tail of the probe to achieve anti-slip and contactless wearing, reducing the difficulty of operation and reducing the risk of cross-infection.

[0005] This invention is achieved through the following technical solutions:

[0006] The first aspect of the present invention relates to a transvaginal ultrasound probe isolation membrane, comprising a medical elastomer, a bandage, and a hydrophilic coating lubricant, wherein the hydrophilic coating lubricant, in a total of 100 parts, is made from the following raw materials in parts by weight: 20-30 parts of polyurethane acrylate-glycidyl acrylate copolymer; 8-16 parts of polyisocyanate; 10-20 parts of polymethyl vinyl ether-maleic anhydride; 5-10 parts of crosslinking functional monomer; 3-8 parts of functional additives; and the balance being an aqueous PEG solution.

[0007] Preferably, the hydrophilic coating lubricant, in a total of 100 parts, is made from the following raw materials in parts by weight: 22-28 parts of polyurethane acrylate-glycidyl acrylate copolymer; 10-14 parts of polyisocyanate; 12-18 parts of polymethyl vinyl ether-maleic anhydride; 6-9 parts of crosslinking functional monomer; 3-6 parts of functional additives; and the balance being PEG aqueous solution.

[0008] More preferably, the polyisocyanate is selected from one or more of 2,4-toluene diisocyanate, hexamethylene 1,6-diisocyanate, and 4,4'-diphenylmethane diisocyanate.

[0009] More preferably, the molecular weight of the polymethyl vinyl ether-maleic anhydride is 5000-8000.

[0010] More preferably, the crosslinking functional monomer is a hydrophilic crosslinking functional monomer.

[0011] More preferably, the hydrophilic crosslinking functional monomer is selected from at least one of polyethylene glycol diacrylate and hydroxyethyl acrylate.

[0012] More preferably, the functional additive is composed of polysiloxane diol and hydroxypropyl methylcellulose in a mass ratio of 1-3:1.

[0013] More preferably, the polysiloxane diol is selected from Momentive Advanced Materials' Silmer® hydroxyl-terminated silicone oil series, preferably at least one of Silmer® OH D-40, Silmer® OH D-100, Silmer® OH D-200 and Silmer® OH C-100.

[0014] More preferably, the molecular weight of PEG in the PEG aqueous solution is 400-600, and the mass concentration of PEG in the PEG aqueous solution is 20-30%.

[0015] The second aspect of the present invention relates to a method for preparing the above-mentioned transvaginal ultrasound probe isolation membrane, wherein the preparation steps of the preparation method are as follows: S1: Apply the hydrophilic coating lubricant evenly to the surface of the medical elastomer with straps, and control the coating thickness to 5-15μm; S2: Dry the medical elastomer coated with hydrophilic coating lubricant at 60-80℃ for 2-4 hours.

[0016] Preferably, the medical elastomer with straps mentioned in step S1 is a condom made of polyurethane.

[0017] Preferably, the hydrophilic coating lubricant in step S1 is prepared by the following steps: S1-1: Raw material pretreatment: Crush the raw materials to a finer mesh than 100 mesh and set aside; S1-2: Mixing and dissolving: Add solvent to the reactor, and while stirring, add polyurethane acrylate-glycidyl acrylate copolymer and polymethyl vinyl ether-maleic anhydride in sequence, control the temperature at 30-35℃, and stir for 60-90 minutes until completely dissolved; S1-3: Preparation of crosslinking system: Cool to 25-28℃, slowly add polyisocyanate and crosslinking functional monomer, stir at a constant speed for 30-40 min, add functional additives, continue stirring for 20-30 min, filter, and the product is obtained.

[0018] A third aspect of the present invention relates to the application of the above-mentioned transvaginal ultrasound probe isolation membrane in a transvaginal ultrasound probe.

[0019] The beneficial effects of the present invention are as follows: (1) The transvaginal ultrasound (TVUS) probe isolation membrane provided by the present invention can carry its own lubricant, without the need for additional application, which greatly simplifies the usage process, effectively prevents pollution during operation, and improves the convenience and efficiency of operation; (2) The present invention optimizes the design of the hydrophilic coating lubricant components, and the resulting hydrophilic coating lubricant has excellent lubrication performance, which can effectively reduce the friction coefficient between the transvaginal ultrasound (TVUS) probe isolation membrane and biological tissue, significantly improving comfort and experience. The hydrophilic coating lubricant components form a stable and durable hydrophilic coating with the elastomer body of the isolation membrane; (3) The isolation membrane band naturally shrinks and tightens the groove at the tail of the ultrasound probe, achieving anti-slip and contactless wearing. Detailed Implementation

[0020] To clarify the purpose, technical solution, and advantages of this invention, the following detailed description is provided in conjunction with specific embodiments. To facilitate understanding of the technical means, creative features, and achieved objectives and effects of this invention, the following detailed description further clarifies the invention in conjunction with specific embodiments. However, these embodiments are merely preferred embodiments and not exhaustive. Other embodiments obtained by those skilled in the art based on the embodiments described herein without creative effort are all within the scope of protection of this invention. In the following embodiments, unless otherwise specified, the operating methods used are conventional operating methods, the equipment used is conventional equipment, and the equipment materials used in each embodiment are the same. This invention does not limit the source of the raw materials used. Unless otherwise specified, the raw materials used in this invention are all commercially available products in this technical field, with a purity of 98% or higher.

[0021] Polymethyl vinyl ether-maleic anhydride (molecular weight 5000-8000): purchased from Hubei Xinjing New Materials Co., Ltd.; polyurethane condoms purchased from Lanzhou Ketian Health Technology Co., Ltd., China, model number Zhongchuan 001.

[0022] Polyurethane condoms were coated with the hydrophilic coating lubricants of Examples 1-3 and Comparative Examples 1-4, respectively, with a coating thickness of 10 μm. The coatings were then dried at 60°C for 4 hours to obtain transvaginal ultrasound probe isolation films coated with the hydrophilic coating lubricant. The raw material composition and preparation method of the hydrophilic coating lubricants of Examples 1-3 and Comparative Examples 1-4 are as follows.

[0023] Example 1: A hydrophilic coating lubricant, made from the following raw materials in parts by weight: 25 parts polyurethane acrylate-glycidyl acrylate copolymer, 12 parts hexamethylene 1,6-diisocyanate, 15 parts polymethyl vinyl ether-maleic anhydride (molecular weight 5000-8000), 7 parts PEG-400DA, 4 parts Silmer® OH D-100, and medical-grade hydroxypropyl methylcellulose (viscosity 4000 mPa). s) 2 parts, and 35 parts of PEG-400 aqueous solution with a mass concentration of 25%.

[0024] Preparation method: (1) Raw material pretreatment: Crush the raw materials to 120 mesh and set aside; (2) Mixing and dissolving: Add PEG-400 aqueous solution to the reactor, and add polyurethane acrylate-glycidyl acrylate copolymer and polymethyl vinyl ether-maleic anhydride in sequence while stirring. Control the temperature at 30°C and stir for 70 min until completely dissolved. (3) Preparation of crosslinking system: Cool down to 25°C, slowly add hexamethylene 1,6-diisocyanate and PEG-400DA, stir at a constant speed for 30 min, add Silmer® OH D-100 and medical grade hydroxypropyl methylcellulose, continue stirring for 20 min, filter, and the crosslinking system is obtained.

[0025] Example 2: 22 parts polyurethane acrylate-glycidyl acrylate copolymer, 14 parts hexamethylene 1,6-diisocyanate, 12 parts polymethyl vinyl ether-maleic anhydride (molecular weight 5000-8000), 9 parts PEG-400DA, 3 parts Silmer® OH D-100, and medical-grade hydroxypropyl methylcellulose (viscosity 4000 mPa). s) 3 parts, and 37 parts of PEG-400 aqueous solution with a mass concentration of 20%.

[0026] The preparation method is the same as in Example 1.

[0027] Example 3 28 parts polyurethane acrylate-glycidyl acrylate copolymer, 10 parts hexamethylene 1,6-diisocyanate, 18 parts polymethyl vinyl ether-maleic anhydride (molecular weight 5000-8000), 6 parts PEG-400DA, 4.5 parts Silmer® OH D-100, and medical-grade hydroxypropyl methylcellulose (viscosity 4000 mPa). s) 1.5 parts, 32 parts of PEG-400 aqueous solution with a mass concentration of 30%.

[0028] The preparation method is the same as in Example 1.

[0029] Comparative Example 1: A hydrophilic coating lubricant is made from the following raw materials in parts by weight: 25 parts polyurethane acrylate-glycidyl acrylate copolymer, 12 parts hexamethylene 1,6-diisocyanate, 15 parts polymethyl vinyl ether-maleic anhydride (molecular weight 5000-8000), 7 parts PEG-400DA, 6 parts Silmer® OH D-100, and 35 parts of a 25% aqueous solution of PEG-400.

[0030] The difference from Example 1 is that the raw materials do not contain medical-grade hydroxypropyl methylcellulose, which is replaced by an equal amount of Silmer® OH D-100. Everything else is the same as in Example 1.

[0031] The preparation method is the same as in Example 1.

[0032] Comparative Example 2: A hydrophilic coating lubricant is made from the following raw materials in parts by weight: 25 parts polyurethane acrylate-glycidyl acrylate copolymer, 12 parts hexamethylene 1,6-diisocyanate, 15 parts polymethyl vinyl ether-maleic anhydride (molecular weight 5000-8000), 7 parts PEG-400DA, and medical-grade hydroxypropyl methylcellulose (viscosity 4000 mPa). 6 parts of s) and 35 parts of PEG-400 aqueous solution with a mass concentration of 25%.

[0033] The difference from Example 1 is that the raw materials do not contain Silmer® OH D-100, and are replaced with an equal amount of medical-grade hydroxypropyl methylcellulose. Everything else is the same as in Example 1.

[0034] The preparation method is the same as in Example 1.

[0035] Comparative Example 3: A hydrophilic coating lubricant is made from the following raw materials in parts by weight: 25 parts polyurethane acrylate-glycidyl acrylate copolymer, 12 parts hexamethylene 1,6-diisocyanate, 15 parts polymethyl vinyl ether-maleic anhydride (molecular weight 5000-8000), 8.7 parts Silmer® OH D-100, and medical-grade hydroxypropyl methylcellulose (viscosity 4000 mPa). 4.3 parts of s) and 35 parts of PEG-400 aqueous solution with a mass concentration of 25%.

[0036] The difference from Example 1 is that it does not contain PEG-400DA, which is added to Silmer® OH D-100 and medical grade hydroxypropyl methylcellulose in proportion.

[0037] The preparation method differs from that in Example 1 in that the raw material in step (3) does not contain PEG-400DA, while the rest is the same as in Example 1.

[0038] Comparative Example 4: A hydrophilic coating lubricant is made from the following raw materials in parts by weight: 25 parts polyurethane acrylate-glycidyl acrylate copolymer, 12 parts hexamethylene 1,6-diisocyanate, 15 parts polymethyl vinyl ether-maleic anhydride (molecular weight 5000-8000), 13 parts PEG-400DA, and 35 parts PEG-400 aqueous solution with a mass concentration of 25%.

[0039] The difference from Example 1 is that the raw materials do not contain Silmer® OH D-100 and medical grade hydroxypropyl methylcellulose, but are replaced with an equal amount of PEG-400DA.

[0040] Preparation method: (1) Raw material pretreatment: Crush the raw materials to 120 mesh and set aside; (2) Mixing and dissolving: Add PEG-400 aqueous solution to the reactor, and add polyurethane acrylate-glycidyl acrylate copolymer and polymethyl vinyl ether-maleic anhydride in sequence while stirring. Control the temperature at 30°C and stir for 70 min until completely dissolved. (3) Preparation of crosslinking system: Cool down to 25°C, slowly add hexamethylene 1,6-diisocyanate and PEG-400DA, stir at a constant speed for 30 min, filter, and the crosslinking system is obtained.

[0041] Test Example 1 The transvaginal ultrasound probe isolation films were obtained by coating polyurethane condoms with the hydrophilic coating lubricant of Examples 1-3 and Comparative Examples 1-4. For ease of representation, the groups of transvaginal ultrasound probe isolation films in the table are represented by Examples 1-3 and Comparative Examples 1-4, which represent transvaginal ultrasound probe isolation films obtained by coating polyurethane condoms with the hydrophilic coating lubricant of Examples 1-3 and Comparative Examples 1-4. The following performance tests were performed on each group of transvaginal ultrasound probe isolation films: Lubrication and stability: The transvaginal ultrasound probe isolation membrane was placed at room temperature for six months. The coefficient of friction of the membrane was tested before placement (0 months) and after placement for six months (6 months), according to the method in GB / T 10006-2021. The standard is a coefficient of friction ≤0.05. The coefficient of friction of the isolation membrane was determined as follows: A stainless steel mold fitted with the isolation membrane was placed in a container filled with physiological saline and vertically fixed on a coefficient of friction tester. A force of 2 Newtons was applied to the surface of the isolation membrane through a rubber-coated annular clamp. The coefficient of friction tester has a measurement range of 0-5 Newtons. When the mold moved at a speed of 150 mm / min, the dynamic coefficient of friction was measured. A lower coefficient of friction indicates better lubrication performance.

[0042] Adhesion: The peel strength between the coating and the medical elastomer was determined according to GB / T2792-2014 standard. The standard is a peel strength between the coating and the release liner substrate of ≥1.5 N / 25 mm.

[0043] Biocompatibility: Cytotoxicity and mucosal irritation were determined according to the GB / T16886 series of medical standards. Cytotoxicity ≤ Grade 1, mucosal irritation ≤ Grade 1.

[0044] The measurement results are shown in Table 1.

[0045] Table 1: Performance test results of the transvaginal ultrasound probe isolation membrane

[0046] The test results show that the friction coefficients of all embodiments and comparative examples of the separator were low at 0 months, indicating good lubricity. However, after 6 months, the friction coefficients of the separators in the comparative examples increased to varying degrees, and their lubricity deteriorated. Furthermore, the peel strength test results between the coating and the medical elastomer show that the hydrophilic coating lubricant in each embodiment forms a stable and durable hydrophilic coating with the medical elastomer. In contrast, the coating formed by the hydrophilic coating lubricant in the comparative examples is less stable and easily peels off from the medical elastomer, thus increasing the friction coefficient of the separator and reducing user comfort. In addition, the hydrophilic coating lubricant in both the embodiments and comparative examples is non-cytotoxic and non-irritating to the mucous membrane, demonstrating high safety.

[0047] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A transvaginal ultrasound probe isolation membrane, comprising a medical elastomer, a bandage, and a hydrophilic coated lubricant, characterized in that, The hydrophilic coating lubricant, based on a total of 100 parts, is made from the following raw materials in parts by weight: 20-30 parts polyurethane acrylate-glycidyl acrylate copolymer; 8-16 parts polyisocyanate; 10-20 parts polymethyl vinyl ether-maleic anhydride; 5-10 parts crosslinking functional monomer; 3-8 parts functional additives; and the balance being PEG aqueous solution.

2. The transvaginal ultrasound probe isolation membrane according to claim 1, characterized in that, The hydrophilic coating lubricant, based on a total of 100 parts, is made from the following raw materials in parts by weight: 22-28 parts polyurethane acrylate-glycidyl acrylate copolymer; 10-14 parts polyisocyanate; 12-18 parts polymethyl vinyl ether-maleic anhydride; 6-9 parts crosslinking functional monomer; 3-6 parts functional additives; and the balance being PEG aqueous solution.

3. The transvaginal ultrasound probe isolation membrane according to claim 1 or 2, characterized in that, The polyisocyanate is selected from one or more of 2,4-toluene diisocyanate, hexamethylene 1,6-diisocyanate, and 4,4'-diphenylmethane diisocyanate.

4. The transvaginal ultrasound probe isolation membrane according to claim 1 or 2, characterized in that, The molecular weight of the polymethyl vinyl ether-maleic anhydride is 5000-8000.

5. The transvaginal ultrasound probe isolation membrane according to claim 1 or 2, characterized in that, The crosslinking functional monomer is hydrophilic and is selected from at least one of polyethylene glycol diacrylate and hydroxyethyl acrylate.

6. The transvaginal ultrasound probe isolation membrane according to claim 1 or 2, characterized in that, The functional additive is composed of polysiloxane diol and hydroxypropyl methylcellulose in a mass ratio of 1-3:

1.

7. The transvaginal ultrasound probe isolation membrane according to claim 1 or 2, characterized in that, The molecular weight of PEG in the PEG aqueous solution is 400-600, and the mass concentration of PEG in the PEG aqueous solution is 20-30%.

8. A method for preparing a transvaginal ultrasound probe isolation membrane according to any one of claims 1-7, characterized in that, The preparation method comprises the following steps: S1: Apply the hydrophilic coating lubricant evenly to the surface of the medical elastomer with straps, and control the coating thickness to 5-15μm; S2: Dry the medical elastomer coated with hydrophilic coating lubricant at 60-80℃ for 2-4 hours.

9. The preparation method according to claim 8, characterized in that, The hydrophilic coating lubricant described in step S1 is prepared by the following steps: S1-1: Raw material pretreatment: Crush the raw materials to a finer mesh than 100 mesh and set aside; S1-2: Mixing and dissolving: Add solvent to the reactor, and while stirring, add polyurethane acrylate-glycidyl acrylate copolymer and polymethyl vinyl ether-maleic anhydride in sequence, control the temperature at 30-35℃, and stir for 60-90 minutes until completely dissolved; S1-3: Preparation of crosslinking system: Cool to 25-28℃, slowly add polyisocyanate and crosslinking functional monomer, stir at a constant speed for 30-40 min, add functional additives, continue stirring for 20-30 min, filter, and the product is obtained.

10. The application of a transvaginal ultrasound probe isolation membrane according to any one of claims 1-7 or a transvaginal ultrasound probe isolation membrane prepared by the preparation method according to any one of claims 8-9 in a transvaginal ultrasound probe.

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