Disposable sterile coating for preventing blood-borne disease from contact of an instrument surface with a wound, method of manufacture and cup-shaped medical device

Abstract

This invention relates to the field of medical device protection, and particularly to a disposable sterile coating, preparation method, and cup-shaped medical device for preventing bloodborne infectious diseases caused by contact between the surface of medical devices and wounds. Before film formation, the coating is a uniformly mixed solution containing the following components: 10-70 parts by weight of prepolymer resin; the prepolymer resin is selected from lactide prepolymer, acrylate prepolymer, polycyclopropane carbonate, polypropylene fumarate, or combinations thereof with a molecular weight of 500-10000 g / mol. The disposable sterile coating of this invention can be photocured within 20-60 seconds to form a uniform protective film, greatly improving the efficiency of medical operations, especially suitable for emergency medical situations. Through liquid dip coating, the coating can perfectly adapt to medical devices of various shapes and sizes, solving the problem that pre-made films cannot adapt to various shapes.

Description

Disposable sterile coating for preventing bloodborne infectious diseases from contact with wounds, preparation method, and cup-shaped medical device. Technical Field

[0001] This invention relates to the field of medical device protection technology, and particularly to a disposable sterile coating for preventing bloodborne infectious diseases caused by contact between medical device surfaces and wounds, its preparation method, and a matching cup-shaped medical device. This invention is especially suitable for the surfaces of medical devices that are difficult to sterilize, providing reliable sterile protection for the surfaces of medical therapeutic devices that are inconvenient or cannot be quickly and thoroughly sterilized. Background Technology

[0002] In medical procedures, medical devices often come into direct contact with patients' wounds and bodily fluids. Especially during surgery, emergency situations, or special medical environments, the surfaces of medical devices are difficult to thoroughly disinfect in a short time, posing a potential risk of cross-infection, particularly the spread of blood-borne infectious diseases. Although existing technologies have proposed methods and devices to reduce infection risks, the possibility of cross-infection still exists under certain conditions.

[0003] Currently, some film or patch materials are being developed for the surface protection of medical devices. For example, Chinese patent CN1100543C discloses a povidone-iodine film, a pre-prepared medical protective film used to cover the surface of medical devices. However, this pre-made film has significant drawbacks: firstly, the size and shape of the film are fixed and cannot be adapted to various irregularly shaped medical devices; secondly, the film has low adhesion and cannot adhere tightly to metal or plastic mechanical surfaces; furthermore, when exposed to friction with human skin, the film is prone to detachment, making it difficult to provide continuous and stable protection.

[0004] On the other hand, US Patent 5888494A discloses a film-forming composition for anti-hyperalodynia opioids and a method for treating hyperalgesia and pruritus with the same. This composition, used for topical application, forms a continuous film and continuously releases the drug to prolong its duration of action. This film-forming composition contains an anti-hyperallergenic opioid for treating pain and pruritus. However, this film also faces several problems in practical applications: good application tools are often lacking, leading to operational difficulties; the formulation easily causes uneven coating, resulting in films of varying thicknesses, affecting the protective effect; and the film requires a long time to dry naturally, making it difficult to meet the rapid needs of emergency medical situations.

[0005] In summary, existing medical device surface protection methods suffer from numerous problems, including poor conformability, insufficient adhesion, complex operation, and long film formation time, making it difficult to meet the demands of modern medical environments for efficient, convenient, and reliable medical device surface protection. Therefore, there is an urgent need to develop a medical device surface protection technology that can rapidly form a uniform protective film, is suitable for medical devices of various shapes, has good adhesion, and is easy to peel off after use. Summary of the Invention

[0006] The main objective of this invention is to overcome the aforementioned shortcomings in the prior art and provide a disposable sterile coating for preventing bloodborne infectious diseases caused by contact between medical device surfaces and wounds, its preparation method, and a matching cup-shaped medical device. This coating can form a film rapidly, is suitable for medical devices of various shapes and sizes, and features high strength and complete peelability, effectively preventing cross-infection caused by blood contact.

[0007] To achieve the above objectives, the present invention adopts the following technical solution:

[0008] The main objective of this invention is to overcome the aforementioned shortcomings in the prior art and provide a disposable sterile coating for preventing bloodborne infectious diseases caused by contact between medical device surfaces and wounds, its preparation method, and a matching cup-shaped medical device. This coating can form a film rapidly, is suitable for medical devices of various shapes and sizes, and features high strength and complete peelability, effectively preventing cross-infection caused by blood contact.

[0009] To achieve the above objectives, the present invention adopts the following technical solution:

[0010] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact with wounds on the surface of medical devices, wherein the coating, when not forming a film, is a homogeneous solution, the mixed solution of the film-forming substance comprising the following components: 10-70 parts by weight of a prepolymer resin; wherein the prepolymer resin is selected from lactide prepolymer, acrylate prepolymer, polycyclopropane carbonate, polypropylene fumarate, or a combination thereof with a molecular weight of 500-10000 g / mol.

[0011] Preferably, the mixed solution further contains 1-10 parts by weight of a small molecule crosslinking agent; the small molecule crosslinking agent molecules can form hydrogen bonds with the prepolymer resin, and the viscosity of the mixed solution is controlled at 5000-20000 cps through supramolecular interaction; the small molecule crosslinking agent molecular chain contains C=C unsaturated bonds with a molar number ≥1, serving as a key component for rapid UV curing to form a crosslinked structure.

[0012] Furthermore, the mixed solution also contains 0.05-0.5 parts by weight of a photoinitiator; the photoinitiator can generate free radicals under ultraviolet light irradiation, initiating the polymerization reaction of C=C unsaturated bonds to form a three-dimensional cross-linked network structure.

[0013] More preferably, the mixed solution contains 30-50 parts by weight of solvent; the solvent is selected from deionized water, physiological saline, ethanol-water mixed solvent or a combination thereof; preferably an ethanol-water mixed solvent with soaking sterilization effect.

[0014] In one embodiment of the present invention, the mixed solution further comprises 1-10 parts by weight of a functional additive; the functional additive is selected from antibacterial agents, anti-inflammatory agents, analgesics, or combinations thereof; the antibacterial agent is selected from nano-silver, povidone-iodine, miconazole, econazole, amphotericin B, selenium disulfide, or combinations thereof; the anti-inflammatory agent is selected from dexamethasone, fluocinolone acetonide, clobetasol propionate, triamcinolone acetonide, hydrocortisone, or combinations thereof; the analgesic is selected from naproxen, indomethacin, acetaminophen, ibuprofen, diclofenac, or combinations thereof.

[0015] The present invention also provides a method for preparing the above-mentioned disposable sterile coating, comprising the following steps: directly immersing the part of the medical device that needs to be isolated and protected into the sterile coating solution; after complete immersion, removing it and allowing it to stand under ultraviolet light irradiation for 20-60 seconds; forming a high-strength sterile protective film on the surface of the device; the thickness of the protective coating is 50μm-300μm; the tensile strength of the protective coating is greater than 1 MPa and the elongation at break is greater than 300%, so that it can be completely peeled off from the surface of the device after single use.

[0016] To better realize the application of the above-mentioned disposable sterile coating, the present invention also provides a matching cup-shaped medical device, wherein the cup-shaped medical device has at least an upper space and a lower space, each of which is independent; the lower space of the cup-shaped medical device is used to load a sterile coating solution; the cup-shaped medical device is used to immerse medical devices in the sterile coating solution and cure them with ultraviolet light to form a peelable sterile protective film.

[0017] Preferably, the upper space of the cup-shaped medical device is equipped with multiple ultraviolet light generators on its sides and bottom; when a small medical device is lifted from the solution in the lower space of the device, it slowly passes through and briefly stays in the ultraviolet curing layer of the upper space; after rapid curing by ultraviolet light irradiation, a protected device coated with a disposable sterile coating can be obtained.

[0018] Furthermore, a partition is provided between the lower and upper spaces of the cup-shaped medical device; the partition has a controllable switch-close structure; an ultraviolet light generator is installed on the partition; the ultraviolet light generator on the partition is used to ensure that ultraviolet light can irradiate the inner wall coating of the tubular instrument.

[0019] The beneficial effects of this invention are as follows:

[0020] 1. Rapid film formation: The disposable sterile coating of this invention can be photocured within 20-60 seconds to form a uniform protective film, which greatly improves the efficiency of medical operations and is especially suitable for emergency medical situations.

[0021] 2. Good conformability: Through liquid dip coating, the coating of the present invention can perfectly adapt to medical devices of various shapes and sizes, solving the problem that prefabricated membranes cannot adapt to various shapes.

[0022] 3. Excellent mechanical properties: The formed protective coating has excellent mechanical properties with tensile strength greater than 1 MPa and elongation at break greater than 300%, ensuring that the coating does not break during use and can be completely peeled off after use.

[0023] 4. High-efficiency protection: The disposable sterile coating of the present invention can form a reliable physical isolation layer, and contains functional additives, including antibacterial agents, anti-inflammatory agents and analgesics, which can effectively block the transmission route of blood-borne infectious diseases and reduce the risk of cross-infection.

[0024] 5. Easy to operate: The matching cup-shaped medical device realizes the integrated operation of soaking-solidification-extraction, which simplifies the medical device protection process and improves medical efficiency.

[0025] 6. Multifunctional protection: By adding different functional additives, the disposable sterile coating of the present invention not only has a physical isolation function, but also provides a variety of pharmacological functions such as antibacterial, anti-inflammatory, and analgesic effects, meeting the needs of different medical scenarios. Attached Figure Description

[0026] Figure 1 is a schematic diagram of the structure of the cup-shaped medical device that is compatible with the present invention, wherein: 001 is the lower space, which is used to load the sterile coating solution; 002 is the upper space, which is used for ultraviolet curing; and 003 is the ultraviolet light generator. Detailed Implementation

[0027] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. Those skilled in the art should understand that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. In the description of the present invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in the present invention based on the specific circumstances.

[0028] The disposable sterile coating of the present invention is a homogeneous solution before film formation, which mainly consists of the following components:

[0029] 1. Prepolymer Resin: As the main material for film formation, it provides basic film-forming properties and mechanical strength. The molecular weight range of prepolymer resins is 500-10000 g / mol. This range is carefully designed to ensure both good solution flowability and the mechanical properties of the film after formation. Too low a molecular weight will result in an incomplete cross-linking network and insufficient strength; too high a molecular weight will result in excessive solution viscosity, which is not conducive to uniform coating. Prepolymer resins can be selected from lactide prepolymers, acrylate prepolymers, polycyclopropane carbonates, polypropylene fumarate, or combinations thereof. Different prepolymer resins offer different performance characteristics: the ester bonds in lactide prepolymers provide good biocompatibility; the carbonate groups in polycyclopropane carbonates provide excellent flexibility; and the α,β-unsaturated ester structure in polypropylene fumarate provides additional cross-linking sites, enhancing network stability.

[0030] 2. Small molecule crosslinking agent: This is a key component in the rapid UV curing process that forms a crosslinked structure. The crosslinking agent molecular chain contains ≥1 molar number of C=C unsaturated bonds. These unsaturated bonds rapidly polymerize under the action of a photoinitiator, forming a three-dimensional crosslinked network. Simultaneously, hydrogen bonds can form between the crosslinking agent molecules and the prepolymer resin, controlling the viscosity of the mixed solution within the ideal range of 5000-20000 cps through supramolecular interactions. This viscosity range ensures uniform coverage of the instrument surface without being too viscous, leading to excessive coating thickness or sagging. The design of the crosslinking agent molecule reflects precise reaction control: the number of C=C double bonds is optimized to ensure sufficient crosslinking point density; the molecular conformation affects its ability to form hydrogen bonds with the prepolymer and the exposure degree of C=C double bonds; appropriate steric hindrance controls the crosslinking reaction rate, avoiding stress concentration and film cracking caused by excessively rapid crosslinking.

[0031] 3. Photoinitiators: Under ultraviolet light irradiation, photoinitiator molecules absorb photon energy and undergo cleavage, generating free radicals that initiate the polymerization reaction of C=C double bonds, promoting the formation of cross-linked networks. The working mechanism of photoinitiators involves complex photochemical reactions: First, after absorbing ultraviolet photons of a specific wavelength, the photoinitiator molecules transition from the ground state to an excited state; then, they may generate primary free radicals through α-cleavage or secondary free radicals by extracting hydrogen atoms from a hydrogen donor; finally, these free radicals attack the π-electron cloud of the C=C double bond, forming new carbon free radicals and initiating a chain reaction. By controlling the concentration of the photoinitiator and the light intensity, the film formation rate and cross-linking density can be precisely controlled.

[0032] 4. Solvents: Solvents not only dissolve the components to form a homogeneous mixed solution, but also provide a preliminary bactericidal effect. Ethanol-water mixed solvents, in particular, effectively dissolve organic components while also exhibiting good bactericidal properties. In solution systems, solvents also participate in the formation of hydrogen bond networks, affecting the stability of the supramolecular structure. In ethanol-water mixed solvents, water molecules can participate in hydrogen bond formation, while the organic portion of ethanol weakens the interference of water, forming a balanced solvation environment and stabilizing the supramolecular structure.

[0033] 5. Functional Additives: These provide additional protective functions and enhance the multifunctionality of the coating. The functional additives in this invention include three categories: antibacterial agents, anti-inflammatory agents, and analgesics. Different types of additives play different roles: antibacterial agents, such as nano-silver, slowly release silver ions, disrupting bacterial cell membrane integrity and inhibiting DNA replication, achieving broad-spectrum antibacterial effects; povidone-iodine forms a semi-interpenetrating network structure in the polymer network, slowly releasing active iodine upon contact with body fluids, providing a continuous disinfection effect; anti-inflammatory agents, such as dexamethasone and fluocinolone acetonide, are glucocorticoids that inhibit inflammatory responses, reducing inflammation in the tissues surrounding the wound; analgesics, such as naproxen and indomethacin, are nonsteroidal anti-inflammatory drugs (NSAIDs) that inhibit prostaglandin synthesis, reducing pain and inflammation. The functional additives may employ a gradient distribution design in the coating, resulting in a higher concentration at the surface of the film layer for immediate protection, and a lower concentration internally for sustained release.

[0034] The disposable sterile coating of this invention achieves synergy between supramolecular pre-assembly and photocuring covalent cross-linking at the molecular level. First, a solution with specific rheological properties is pre-assembled through supramolecular forces such as hydrogen bonding to ensure uniform coverage of the instrument surface. Then, photocuring technology transforms the supramolecular network into a stable covalently cross-linked network, forming a protective film with excellent mechanical properties. This two-stage process ensures the uniformity and integrity of the coating.

[0035] The mechanical property design of the coating (tensile strength > 1 MPa, elongation at break > 300%) is based on precise molecular engineering. Crosslinking density directly affects coating rigidity; precise control of crosslinking density is achieved by adjusting light intensity and time. Flexible segments in the prepolymer backbone provide ductility, while rigid segments provide strength; the balance between these two is key to achieving high strength and high ductility. Longer prepolymer molecular chains retain a certain degree of physical entanglement after crosslinking; this physical entanglement, combined with chemical crosslinking, enhances the material's toughness. Reversible dynamic covalent bonds or supramolecular interactions may be designed into the network, enabling the material to rearrange molecular chains during stretching, dispersing stress and improving elongation at break.

[0036] The adhesion between the coating and the instrument surface is precisely controlled—strong enough to prevent detachment during use, yet not strong enough to facilitate peeling after use. Specifically, the surface energy of the coating is adjusted by regulating the ratio of hydrophilic to hydrophobic groups in the prepolymer resin. Selecting a prepolymer resin containing appropriate amounts of polar groups such as hydroxyl and carboxyl groups increases the polarity and surface energy of the coating, thereby enhancing its adhesion to metal or plastic instrument surfaces. Furthermore, the cohesive force and peel strength of the coating can be adjusted by controlling the crosslinking density and the degree of photocuring. When the molecular weight of the prepolymer resin is 500-10000 g / mol and the content of the small molecule crosslinking agent is 1-10 parts by weight, the resulting coating has a moderate crosslinking density, keeping the adhesion between the coating and the instrument surface within the range of 5-15 N / cm. This prevents detachment during use while facilitating peeling after use. During peeling, the untangling of polymer chains and the breaking of hydrogen bonds proceed gradually, with energy gradually dissipated, avoiding brittle fracture and ensuring complete peeling.

[0037] The cup-shaped medical device provided by this invention mainly consists of the following parts:

[0038] 1. Lower Space 001: Used to hold the sterile coating solution. The geometry of this space is optimized to ensure uniform solution flow during the immersion and removal of medical devices, avoiding bubble formation and solution waste.

[0039] 2. Upper Space 002: Used for UV curing. Multiple UV generators 003 are installed on the sides and bottom of this layer to provide omnidirectional irradiation, ensuring uniform curing of the coating. The arrangement of the light sources is carefully designed to avoid "hot spots" or "dark areas," achieving uniform light intensity distribution.

[0040] 3. Partition: Located between the lower and upper spaces, this partition is a controllable, openable / closed structure. An ultraviolet (UV) generator is also installed on the partition to ensure that UV light can reach the inner coating of the tubular instrument. The partition's opening and closing mechanism is synchronized with the instrument's position to prevent cross-contamination of solutions.

[0041] 4. Ultraviolet Light Generator 003: Provides an ultraviolet light source with a wavelength range of 365-405nm and an energy density of 10-100mW / cm³. ² The wavelength of the ultraviolet light source is sufficient to initiate the photocuring reaction without causing thermal degradation of the material. The wavelength of the ultraviolet light source is precisely matched to the maximum absorption wavelength of the photoinitiator, ensuring high photoinitiation efficiency.

[0042] The equipment's workflow is as follows:

[0043] First, pour the sterile coating solution into the lower space 001 of the cup-shaped device and let it stand. Then, immerse the medical device to be protected in the sterile coating solution in the lower space 001, ensuring complete submersion for 1-2 minutes to allow the solution to evenly cover the device surface. Next, slowly lift the device into the upper space 002, while simultaneously activating all UV generators 003 in the upper space to begin the photocuring process. When the device is completely removed from the lower space, the partition automatically closes to prevent direct UV light irradiation of the solution in the lower space. The device remains in the upper space for 20-60 seconds to complete the photocuring process, forming a sterile protective film with a thickness of 50μm-300μm. Finally, the device automatically removes the protected device, ready for direct use. After use, completely peel off the polymer film from the device surface; the device can undergo the same protective process again.

[0044] The design of this equipment solves the problems of uneven coating and complex operation in traditional methods, achieving a highly efficient and convenient protection process. In particular, the ultraviolet light generator on the partition solves the problem of curing the coating on the inner wall of tubular instruments, which is an easily overlooked but very critical technical detail.

[0045] The present invention will be further illustrated by specific embodiments below, but these should not be regarded as limitations on the present invention.

[0046] Example 1

[0047] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact with wounds on the surface of medical devices comprises the following components: 100 parts by weight of acrylate prepolymer (molecular weight 5000 g / mol); 10 parts by weight of small molecule crosslinking agent (polyethylene glycol diacrylate); 0.5 parts by weight of photoinitiator (phenyl-2,4,6-trimethylbenzoyl lithium hypophosphite, abbreviated as LAP, UV absorption peak 365nm); 30 parts by weight of ethanol-water mixed solvent (volume ratio 7:3); and 1 part by weight of antibacterial agent (nano silver, particle size 20nm).

[0048] Preparation method: First, the acrylate prepolymer was dissolved in an ethanol-water mixture at room temperature and stirred until homogeneous. Then, the small molecule crosslinking agent polyethylene glycol diacrylate was added, and stirring continued until completely dissolved to form a transparent solution. Next, the photoinitiator phenyl-2,4,6-trimethylbenzoyl lithium hypophosphite was added, and the mixture was stirred for 30 minutes under light-protected conditions to ensure complete dissolution. Finally, the nano-silver antibacterial agent was added, and the mixture was ultrasonically dispersed for 15 minutes to obtain a uniform film-forming solution.

[0049] Pour 500 ml of the film-forming solution into the lower space 001 of the matching cup-shaped medical device and let it stand. Using the device's built-in clamps, clamp the medical device to be treated and place it into the bottom of the cup-shaped device, immersing the portion that may directly contact human tissue or blood in the film-forming solution for 1 minute to allow the solution to evenly cover the device surface. Then, slowly lift the device into the upper space 002 of the device, simultaneously activating all UV generators 003 to begin the photocuring process. When the device is completely removed from the lower space, the partition automatically closes. The device remains in the upper space for 30 seconds, allowing the surface solution to complete the curing process, forming a sterile protective film approximately 150 μm thick. Finally, the device automatically removes the protected device, ready for direct use. After use, gently peel off the polymer film from the device surface; the device can undergo the same protective process again.

[0050] The sterile protective film prepared in this embodiment has a tensile strength of 2.5 MPa and an elongation at break of 350%, maintaining its integrity during use and being completely peeled off after use without leaving any residue. The coating surface is smooth and flat, with uniform thickness, and exhibits good antibacterial properties, with 24-hour inhibition rates of 96% and 95% against Staphylococcus aureus and Escherichia coli, respectively.

[0051] Example 2

[0052] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact with wounds on the surface of medical devices comprises the following components: 70 parts by weight of polycyclopropane carbonate prepolymer (molecular weight 8000 g / mol); 15 parts by weight of small molecule crosslinking agent (glyceryl triacrylate); 0.3 parts by weight of photoinitiator (phenyl-2,4,6-trimethylbenzoyl lithium hypophosphite); 20 parts by weight of ethanol-water mixed solvent (volume ratio 8:2); and 3 parts by weight of antibacterial agent (povidone-iodine, active iodine content 10%).

[0053] Preparation method: First, the polycyclopropane carbonate prepolymer was dissolved in an ethanol-water mixture in a 40°C water bath and stirred until homogeneous. Then, the mixture was cooled to room temperature, and the small molecule crosslinking agent glyceryl triacrylate was added. Stirring continued for 60 minutes until completely dissolved, forming a transparent solution. Next, a photoinitiator was added, and the mixture was stirred for 45 minutes under light-protected conditions to ensure complete dissolution. Finally, povidone-iodine antibacterial agent was added and stirred until homogeneous, yielding a film-forming solution.

[0054] Pour 1000 ml of the film-forming solution into the lower space 001 of the matching cup-shaped medical device and let it stand. Using the device's built-in clamps, clamp the medical device to be treated and place it into the bottom of the cup-shaped device, immersing the portion that may directly contact human tissue or blood in the film-forming solution for 2 minutes to ensure the solution evenly covers the device surface. Then, slowly lift the device into the upper space 002 of the device, simultaneously activating all UV generators 003 to begin the photocuring process. When the device is completely removed from the lower space 001, the partition automatically closes. The device remains in the upper space 002 for 60 seconds, allowing the surface solution to complete the curing process, forming a sterile protective film approximately 200 μm thick. Finally, the device automatically removes the protected device, ready for direct use. After use, gently peel off the polymer film from the device surface; the device can undergo the same protective process again.

[0055] The sterile protective film prepared in this embodiment has a tensile strength of 3.2 MPa and an elongation at break of 320%, exhibiting excellent mechanical properties. It remains intact during use and can be completely peeled off after use without leaving any residue. The coating surface is smooth and uniform in thickness, demonstrating excellent antibacterial properties, with 24-hour inhibition rates of 98% and 97% against Staphylococcus aureus and Escherichia coli, respectively.

[0056] Example 3

[0057] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact between medical device surfaces and wounds, comprising the following components: 50 parts by weight of polypropylene fumarate prepolymer (molecular weight 3000 g / mol); 5 parts by weight of small molecule crosslinking agent (bis(methacrylamide)cysteine); 45 parts by weight of photoinitiator (phenyl-2,4,6-trimethylbenzoyl lithium hypophosphite); 2 parts by weight of physiological saline; and 2 parts by weight of antibacterial agent (miconazole, purity >99%).

[0058] Preparation method: First, dissolve the polypropylene fumarate prepolymer in physiological saline at room temperature and stir until homogeneous. Then, add the small molecule crosslinking agent dimethacrylamide cysteine ​​and continue stirring until completely dissolved to form a transparent solution. Next, add the photoinitiator and stir for 30 minutes under light-protected conditions to ensure complete dissolution. Finally, add the miconazole antibacterial agent and stir until homogeneous to obtain the film-forming solution.

[0059] The same equipment and operating method as in Example 2 were used, but the immersion time of the instrument in the solution in the lower space 001 was adjusted to 1.5 minutes, and the residence time in the upper space 002 was adjusted to 45 seconds, forming a sterile protective film with a thickness of about 120 μm.

[0060] Testing showed that the sterile protective film prepared in this embodiment had a tensile strength of 1.8 MPa and an elongation at break of 380%, exhibiting better flexibility and making it particularly suitable for medical devices requiring significant bending deformation. The coating surface was smooth and flat, with uniform thickness, and good antibacterial properties, achieving 24-hour inhibition rates of 92% and 90% against Staphylococcus aureus and Escherichia coli, respectively.

[0061] Example 4

[0062] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact with wounds on the surface of medical devices comprises the following components: 30 parts by weight of lactide prepolymer (molecular weight 1000 g / mol); 8 parts by weight of small molecule crosslinking agent (pentaerythritol tetraacrylate); 0.1 parts by weight of photoinitiator (phenyl-2,4,6-trimethylbenzoyl lithium hypophosphite); 40 parts by weight of deionized water; and 5 parts by weight of anti-inflammatory agent (dexamethasone, purity >98%).

[0063] Preparation method: First, the lactide prepolymer was dissolved in an ethanol-water solution in a 50°C water bath and stirred until homogeneous. Then, the solution was cooled to room temperature, and the small molecule crosslinking agent pentaerythritol tetraacrylate was added. Stirring continued until completely dissolved, forming a transparent solution. Next, a photoinitiator was added, and the solution was stirred for 30 minutes under light-protected conditions to ensure complete dissolution. Finally, dexamethasone antibacterial agent was added, and the solution was stirred until homogeneous, yielding a film-forming solution.

[0064] The film-forming solution was poured into a matching cup-shaped medical device, and the operation method was similar to that in Example 1, but the immersion time of the device in the solution in the lower space 001 was extended to 3 minutes, and the residence time in the upper space 002 was adjusted to 40 seconds, forming a sterile protective film with a thickness of about 100 μm.

[0065] Testing showed that the sterile protective film prepared in this embodiment has a tensile strength of 1.5 MPa, an elongation at break of 400%, and excellent flexibility, making it particularly suitable for delicate medical devices requiring a high degree of fit. The dexamethasone in the coating is slowly released during use, providing good anti-inflammatory effects.

[0066] Example 5

[0067] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact with wounds on the surface of medical devices comprises the following components: 60 parts by weight of acrylic prepolymer (molecular weight 6000 g / mol); 20 parts by weight of polycyclopropane carbonate prepolymer (molecular weight 4000 g / mol); 7 parts by weight of small molecule crosslinking agent (bisacrylamide cysteine); 0.4 parts by weight of photoinitiator (phenyl-2,4,6-trimethylbenzoyl lithium hypophosphite); 35 parts by weight of ethanol-water mixed solvent (volume ratio 7:3); and 4 parts by weight of analgesic (ibuprofen, purity >99%).

[0068] Preparation method: First, the acrylic acid prepolymer and polycyclopropane carbonate prepolymer are mixed and dissolved in an ethanol-water mixture in a 45°C water bath, and stirred until homogeneous. Then, the mixture is cooled to room temperature, and the small molecule crosslinking agent bisacrylamide cysteine ​​is added. Stirring continues until completely dissolved, forming a transparent solution. Next, a photoinitiator is added, and the mixture is stirred for 30 minutes under light-protected conditions to ensure complete dissolution. Finally, ibuprofen antibacterial agent is added, and the mixture is stirred until homogeneous, yielding a film-forming solution.

[0069] Using similar equipment and operating methods as those in the aforementioned embodiments, a sterile protective film with a thickness of approximately 180 μm is formed.

[0070] Testing showed that this embodiment, by mixing different types of prepolymer resins, produced a sterile protective film with superior overall performance, exhibiting a tensile strength of 2.8 MPa and an elongation at break of 360%, demonstrating both sufficient strength and good flexibility. The ibuprofen in the coating provides excellent anti-inflammatory and analgesic effects, making it particularly suitable for medical devices used in wound treatment.

[0071] Example 6

[0072] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact with wounds on the surface of medical devices comprises the following components: 10 parts by weight of acrylate prepolymer (molecular weight 10000 g / mol); 1 part by weight of small molecule crosslinking agent (glycidyl methacrylate); 0.05 parts by weight of photoinitiator (phenyl-2,4,6-trimethylbenzoyl lithium hypophosphite); 50 parts by weight of ethanol-water mixed solvent (volume ratio 6:4); and 10 parts by weight of antibacterial agent (nano silver, particle size 10 nm).

[0073] The preparation method is similar to that in Example 1, but the proportions of each component have been adjusted, especially the content of antibacterial agent has been increased and the content of prepolymer resin has been reduced to form a thinner protective film.

[0074] Testing revealed that the sterile protective membrane prepared in this embodiment has a thickness of approximately 50 μm, a tensile strength of 1.2 MPa, and an elongation at break of 420%. It is the thinnest and most flexible of all the embodiments, making it particularly suitable for medical devices requiring delicate handling. Due to its high nano-silver content, this coating exhibits optimal antibacterial properties, achieving a 24-hour inhibition rate of over 99% against both Staphylococcus aureus and Escherichia coli.

[0075] Example 7

[0076] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact between medical device surfaces and wounds is disclosed. Its composition is the same as in Example 2, but the method of using the accompanying equipment is changed. In this embodiment, an automated operating system is employed: the medical devices to be processed are stacked in a square tray, and the automated grippers provided with the equipment pick up each device one by one, placing them into the bottom of a cup-shaped device. After soaking for 2 minutes, the device is slowly lifted to the upper space 002, where it remains for 1 minute to complete photocuring. Then, it is automatically removed and placed in a sterilization tray for direct use by the physician.

[0077] This automated operation significantly improves work efficiency, and is particularly suitable for scenarios requiring the batch processing of multiple medical devices, such as during operating room preparation or peak emergency room hours. Testing has shown that the automated system can complete the protective processing of 20 medical devices within 30 minutes, greatly improving medical efficiency.

[0078] Comparative Example 1 (without small molecule crosslinking agent)

[0079] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact with wounds on the surface of medical devices, comprising the following components: 100 parts by weight of acrylate prepolymer (molecular weight 5000 g / mol); 0.5 parts by weight of photoinitiator (phenyl-2,4,6-trimethylbenzoyl lithium hypophosphite); 30 parts by weight of ethanol-water mixed solvent (volume ratio 7:3); and 1 part by weight of antibacterial agent (nano silver, particle size 20 nm).

[0080] The preparation method is similar to that in Example 1, but without the addition of small molecule crosslinking agents.

[0081] Testing revealed that, due to the lack of a small molecule crosslinking agent, the coating prepared in this comparative example failed to form a stable three-dimensional network structure. Even after 60 seconds of UV irradiation, it remained incompletely cured and its surface remained tacky. The resulting coating exhibited low mechanical strength, with a tensile strength of only 0.3 MPa and an elongation at break of 150%. It was prone to breakage during use and could not be completely peeled off, leaving residue on the instrument surface. This result demonstrates the crucial role of the small molecule crosslinking agent in this invention.

[0082] Comparative Example 2 (without photoinitiator)

[0083] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact with wounds on the surface of medical devices, comprising the following components: 100 parts by weight of acrylate prepolymer (molecular weight 5000 g / mol); 10 parts by weight of small molecule crosslinking agent (polyethylene glycol diacrylate); 30 parts by weight of ethanol-water mixed solvent (volume ratio 7:3); and 1 part by weight of antibacterial agent (nano silver, particle size 20 nm).

[0084] The preparation method is similar to that in Example 1, but without the addition of a photoinitiator.

[0085] Testing revealed that, due to the lack of a photoinitiator, the coating in this comparative example failed to cure even after 5 minutes of exposure to ultraviolet light, remaining in a liquid state. This result demonstrates the indispensable role of the photoinitiator in the photocuring process of this invention.

[0086] Comparative Example 3 (Unsuitable prepolymer molecular weight)

[0087] A disposable sterile coating for preventing bloodborne infectious diseases caused by contact with wounds on the surface of medical devices comprises the following components: 100 parts by weight of acrylate prepolymer (molecular weight 15000 g / mol); 10 parts by weight of small molecule crosslinking agent (polyethylene glycol diacrylate); 0.5 parts by weight of photoinitiator (phenyl-2,4,6-trimethylbenzoyl lithium hypophosphite); 30 parts by weight of ethanol-water mixed solvent (volume ratio 7:3); and 1 part by weight of antibacterial agent (nano silver, particle size 20 nm).

[0088] The preparation method is similar to that in Example 1, but a prepolymer resin with a molecular weight exceeding the range of the present invention was used.

[0089] Testing revealed that the viscosity of the mixed solution reached 50,000 cps due to the excessively high molecular weight of the prepolymer, far exceeding the ideal range of this invention. This resulted in an excessively thick and uneven coating, with sagging in some areas. The cured coating exhibited uneven thickness, a coefficient of variation of 40%, unstable mechanical properties, and difficulty in complete peeling. These results demonstrate the rationality of the molecular weight range set for the prepolymer resin in this invention.

[0090] Comparative Example 4 (Conventional gel-like coating agent)

[0091] A protective layer is formed on the surface of a medical device by brushing with a commercially available gel-like medical coating agent.

[0092] Testing revealed that brush coating is complex, requiring specialized tools and techniques, and results in uneven coating thickness with a coefficient of variation reaching 50%. Furthermore, it requires 15-20 minutes of natural drying to form a stable coating, which is unsuitable for emergency medical situations. The resulting coating has a tensile strength of 0.8 MPa and an elongation at break of 180%, exhibiting mechanical properties inferior to the coating of this invention. It is also difficult to completely peel off after use, often leaving residue on the instrument surface, requiring additional cleaning steps.

[0093] Comparative Example 5 (Pre-fabricated diaphragm)

[0094] Commercially available pre-fabricated medical protective films are used and directly attached to the surface of medical devices.

[0095] Testing revealed that pre-fabricated membranes are unsuitable for various irregularly shaped medical devices, especially curved or complex-shaped devices, resulting in insufficient coverage and unprotected areas. Air bubbles are easily generated during application, affecting the protective effect. The membrane's adhesion to the device surface is insufficient, making it prone to detachment during use, especially when in contact with wet surfaces. These results demonstrate the significant advantages of the liquid dip-coating method of this invention compared to pre-fabricated membranes.

[0096] To comprehensively evaluate the performance of the disposable sterile coating of the present invention, systematic tests were conducted on the above-mentioned embodiments and comparative examples. The main test indicators included physical properties, antibacterial properties, and ease of use.

[0097] 1. Physical Performance Testing: Physical performance testing mainly includes indicators such as coating thickness, thickness uniformity, tensile strength, elongation at break, and peel integrity. The test results are shown in Table 1.

[0098] Table 1. Test results of physical properties of the sterile coating

[0099]

[0100] As shown in Table 1, all embodiments of the present invention formed sterile protective films with uniform thickness and excellent mechanical properties. The coefficients of variation for coating thickness in Examples 1-6 were all below 15%, indicating good coating uniformity; the tensile strength was greater than 1 MPa, and the elongation at break was greater than 300%, meeting the requirements of the present invention; the peel integrity was good or excellent, indicating that it could be completely peeled off after use without leaving any residue. In contrast, the physical properties of the coatings in Comparative Examples 1, 3, and 4 were significantly worse, either lacking strength, having poor uniformity, or being unable to be completely peeled off; Comparative Example 2 even failed to form a stable coating; and Comparative Example 5, although possessing a certain strength, could not adapt to medical devices of various shapes.

[0101] The antibacterial performance test mainly included the antibacterial effect against common pathogens in the medical environment. Staphylococcus aureus (Gram-positive bacteria) and Escherichia coli (Gram-negative bacteria) were selected as test species to evaluate the 24-hour antibacterial rate of the coating. The test results are shown in Table 2.

[0102] Table 2. Test results of antibacterial properties of the aseptic coating.

[0103]

[0104] As can be seen from Table 2, all embodiments of the present invention exhibit excellent antibacterial properties, with a 24-hour inhibition rate generally exceeding 90%. Example 6, in particular, demonstrates the most outstanding performance, achieving an inhibition rate of 99% due to its high proportion of nano-silver antibacterial agent. In contrast, Comparative Examples 1, 4, and 5 show significantly insufficient antibacterial properties; Comparative Example 2 fails to form a stable coating; and Comparative Example 3 exhibits unstable antibacterial properties due to uneven coating.

[0105] The ease of use test mainly evaluates indicators such as coating formation time, operational complexity, and conformability. The test results are shown in Table 3:

[0106] Table 3. Results of the test on the ease of use of the aseptic coating.

[0107]

[0108] As can be seen from Table 3, the embodiments of the present invention all demonstrate excellent ease of use. The film-forming time for all embodiments is within 60 seconds, with low operational complexity, excellent conformability, and perfect adaptation to medical devices of various shapes. In contrast, Comparative Example 1 has a long film-forming time, Comparative Example 2 cannot form a film at all, Comparative Example 3 is complex to operate and has poor conformability, Comparative Example 4 has a film-forming time as long as 15-20 minutes, and Comparative Example 5, although having a shorter adhesion time, is complex to operate and has poor conformability.

[0109] Based on the above test results, the disposable sterile coating of the present invention exhibits significant advantages in physical properties, antibacterial properties, and ease of use, particularly in film formation speed, coating uniformity, mechanical properties, and conformability. These superior properties make the present invention particularly suitable for the surface protection of medical devices in emergency medical situations, effectively preventing cross-infection caused by blood contact.

[0110] Based on the above test results, Example 2 exhibits the most comprehensive and superior performance and can be considered the best embodiment of the present invention. The sterile protective film prepared in this example has the following characteristics:

[0111] Excellent physical properties. The coating thickness is 200 μm, with a thickness variation coefficient of only 7%, indicating that the coating is extremely uniform; the tensile strength reaches 3.2 MPa, and the elongation at break is 320%, demonstrating excellent mechanical properties. It can remain intact during use and can be completely peeled off after use.

[0112] Excellent antibacterial properties. It exhibits 98% and 97% inhibition rates against Staphylococcus aureus and Escherichia coli within 24 hours, respectively, providing reliable antibacterial protection.

[0113] Excellent ease of use. Film formation time is 60 seconds, operation is simple, and it has excellent conformability, perfectly adapting to medical devices of various shapes.

[0114] Example 2 uses polycyclopropane carbonate prepolymer as the main resin, combined with a small molecule crosslinking agent containing three C=C unsaturated bonds, to form a stable three-dimensional crosslinking network, which is the basis for its excellent mechanical properties. Meanwhile, povidone-iodine, as an antibacterial agent, provides a sustained bactericidal effect, making it particularly suitable for medical devices used for extended periods.

[0115] This preferred embodiment fully demonstrates the technical features and innovative value of the present invention, providing an efficient, convenient, and reliable new solution for the surface protection of medical devices.

[0116] Through in-depth analysis and system testing of this invention, the following innovations and technical effects can be summarized:

[0117] The core innovation of this invention lies in combining supramolecular chemistry with photocuring technology. A solution with specific rheological properties is pre-assembled using supramolecular forces such as hydrogen bonding, and then transformed into a covalently cross-linked network through photocuring. This two-stage process ensures the uniformity and integrity of the coating, which is key to achieving rapid and uniform film formation in this invention.

[0118] Compared with traditional technologies, this synergistic technology significantly shortens the film formation time from the traditional 15-20 minutes to 20-60 seconds, improving medical efficiency; at the same time, supramolecular pre-assembly ensures uniform distribution of the solution on the surface of the medical device, solving the problem of uneven coating of traditional film-forming agents.

[0119] This invention achieves precise control over the physical properties of the coating by accurately controlling parameters such as the molecular weight of the prepolymer resin, the structure and content of the crosslinking agent, and the type and concentration of the photoinitiator. In particular, the balanced design of tensile strength greater than 1 MPa and elongation at break greater than 300% ensures that the coating has sufficient strength to prevent damage during use, as well as good flexibility to adapt to instruments of various shapes, and can be completely peeled off after use.

[0120] This precise material system design overcomes the problems of insufficient strength or excessive brittleness in traditional technologies, providing a more reliable physical protection effect.

[0121] The cup-shaped medical device provided by this invention integrates soaking, curing, and extraction into one device, achieving automation and standardization of operation. In particular, the ultraviolet light generator on the partition solves the problem of curing the coating on the inner wall of the tubular instrument, which is an easily overlooked but very critical technical detail.

[0122] Compared to traditional methods that require multiple devices and complex operations, this integrated design greatly simplifies the operation process, reduces the skill requirements for operators, and improves medical efficiency, making it particularly suitable for emergency medical situations.

[0123] This invention achieves a synergistic effect of physical isolation and chemical protection by adding different types of functional additives to the coating. The physical isolation layer blocks direct contact with pathogens, while the antibacterial components provide additional bactericidal protection; in some embodiments, the addition of anti-inflammatory agents (such as glucocorticoids like dexamethasone) and analgesics (such as nonsteroidal anti-inflammatory drugs like ibuprofen) can provide additional pharmacological functions in specific treatments.

[0124] The synergistic effect of this multi-functional protection significantly improves the protective effect, not only effectively preventing cross-infection, but also providing customized functional protection according to the needs of different medical scenarios.

[0125] During the research process of this invention, some unexpected technical effects were discovered:

[0126] First, the microstructure formed during the curing process of the coating possesses unique surface properties, enabling it to adhere well to various medical devices made of materials such as metal, plastic, and ceramics, while allowing for complete peeling after use without leaving any residue. This seemingly contradictory characteristic is achieved through precise control of the interfacial bonding strength, providing an ideal solution for the protection and cleaning of medical devices.

[0127] Secondly, the antibacterial components in the coating exhibit gradient release characteristics, with a rapid initial release rate providing immediate bactericidal effects; subsequently, the release rate gradually decreases, maintaining sustained antibacterial activity. This adaptive release characteristic is determined by the micro-network structure of the coating and the interaction between the antibacterial agent and the polymer chains, providing long-lasting antibacterial protection for medical devices used for extended periods.

[0128] Furthermore, the coating of this invention exhibits excellent self-healing properties. After minor deformation or surface scratches, the coating can quickly recover its original shape and maintain its protective effect. This self-healing property stems from the partial dynamic supramolecular interactions retained within the network, providing additional safety assurance for the use of medical devices in complex environments.

[0129] This invention provides a disposable sterile coating for preventing bloodborne infectious diseases caused by contact between medical device surfaces and wounds, its preparation method, and a matching cup-shaped medical device. It successfully solves the problems of poor conformability, insufficient adhesion, complex operation, and long film-forming time in existing technologies. Through multiple innovations, including supramolecular pre-assembly and photocuring synergistic technology, precise material system design, and integrated system innovation, this invention achieves multiple technical effects such as rapid film formation, uniform protection, good conformability, and excellent antibacterial properties, providing a highly efficient, convenient, and reliable new solution for the surface protection of medical devices.

[0130] This invention is particularly suitable for surface protection of medical devices in emergency medical situations, effectively preventing cross-infection caused by blood contact and protecting the health of patients and medical personnel. Furthermore, the technical concept and method of this invention can also be extended to other fields requiring surface protection, showing broad application prospects.

[0131] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A disposable sterile coating for preventing bloodborne infectious diseases caused by contact between medical device surfaces and wounds, wherein the coating, before film formation, is a homogeneous solution, characterized in that: The homogeneous solution contains the following components: 10-70 parts by weight of prepolymer resin; the prepolymer resin is selected from lactide prepolymer, acrylate prepolymer, polycyclopropane carbonate, or a combination thereof with a molecular weight of 500-10000 g / mol; the homogeneous solution also contains 1-10 parts by weight of a small molecule crosslinking agent; the small molecule crosslinking agent is polyethylene glycol diacrylate, bisacrylamide cysteine, bismethacrylamide cysteine, bisacrylamide ethylene oxide ether, glycidyl methacrylate, triacrylate, pentaerythritol tetraacrylate, or a combination thereof; the small molecule crosslinking agent molecules can form hydrogen bonds with the prepolymer resin, and the viscosity of the homogeneous solution is controlled at 5000-20000 g / mol through supramolecular interaction. The small molecule crosslinking agent contains ≥1 molar number of C=C unsaturated bonds on its molecular chain, serving as a key component for rapid UV curing to form a crosslinked structure. The uniformly mixed solution also contains 0.05-0.5 parts by weight of a photoinitiator. The photoinitiator is lithium phosphate phenyl-2,4,6-trimethylbenzoylphosphonate, Irgacure 2959, TPO-L water-soluble type, or a combination thereof. Under UV irradiation, the photoinitiator can generate free radicals, initiating a polymerization reaction of the C=C unsaturated bonds to form a three-dimensional crosslinked network structure. The uniformly mixed solution contains 30-50 parts by weight of a solvent. The solvent is selected from deionized water, phosphate buffer solution, physiological saline, ethanol-water mixed solvent, or a combination thereof.

2. The disposable aseptic coating according to claim 1, characterized in that: The uniformly mixed solution also contains 1-10 parts by weight of functional additives; the functional additives are selected from antibacterial agents, anti-inflammatory agents, analgesics, or combinations thereof; the antibacterial agents are selected from nano-silver, povidone-iodine, miconazole, econazole, amphotericin B, selenium disulfide, or combinations thereof; the anti-inflammatory agents are selected from dexamethasone, fluocinolone acetonide, clobetasol propionate, triamcinolone acetonide, hydrocortisone, or combinations thereof; the analgesics are selected from naproxen, indomethacin, acetaminophen, ibuprofen, diclofenac, or combinations thereof.

3. A method for preparing the disposable sterile coating according to any one of claims 1-2, characterized in that, Includes the following steps: The parts of the medical device that require isolation and protection are directly immersed in the well-mixed solution; after complete immersion, they are removed and left to stand under ultraviolet light for 20-60 seconds; a high-strength sterile protective film is formed on the surface of the device; the thickness of the sterile protective film is 50μm-300μm; the tensile strength of the sterile protective film is greater than 1 MPa and the elongation at break is greater than 300%, so that it can be completely peeled off from the surface of the device after single use.

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