Low-temperature sterilization apparatus and method thereof

Abstract

A low-temperature sterilization apparatus and a method thereof. The low-temperature sterilization apparatus is used for disinfecting and sterilizing a contaminated medical device placed therein. Ultrasonic waves, ultraviolet rays, and ozone are combined with a disinfectant in an aqueous solution to achieve rapid desorption, destruction, and decomposition reactions, thereby removing adhering contaminants and bacteria from all pores and corners of the contaminated medical device.

Description

Low temperature sterilization device and method thereof

[0001] The present disclosure claims priority to U.S. Patent Application No. US 18 / 758,292, filed on June 28, 2024, the entire contents of which are incorporated by reference in the present disclosure. TECHNICAL FIELD

[0002] The present disclosure is a low temperature sterilization device and method thereof, particularly refers to the use of ultrasonic waves, chemical agents, ozone, ultraviolet light, and photocatalysts to improve the disinfection effect of medical devices. BACKGROUND

[0003] In today's medical environment, invasive catheterization and therapeutic procedures have become a common medical practice, but have also caused a considerable number of healthcare-associated infections.

[0004] One of the most common and effective methods for disinfecting medical devices in medical institutions is high-temperature steam sterilization, also known as pressure steam sterilization or automatic sterilization. This method uses high temperature and pressure to effectively eliminate bacteria, viruses, and other microorganisms on the surface of medical devices through water vapor. It is a widely used sterilization method suitable for various types of medical devices, including surgical instruments, instrument containers, rubber products, etc.

[0005] In addition, chemical sterilization methods are also one of the common choices, such as using hydrogen peroxide gas, ethylene oxide, or other chemical agents for disinfection.

[0006] However, the above methods are not suitable for endoscopes because of their special structure and material, making it difficult to ensure effective disinfection effect for traditional high-temperature steam sterilization and chemical sterilization methods. Therefore, for special devices such as endoscopes, special disinfection methods need to be developed to ensure their safe and sanitary use.

[0007] The current disinfection method for special devices such as endoscopes is the ethylene oxide sterilization method. Although this method has achieved low-temperature sterilization standards for special devices such as endoscopes, it has brought a series of inconveniences. First, ethylene oxide used in this method is a carcinogenic substance, posing potential risks to the human body and the environment. Second, due to the lack of automatic cleaning function, users need to perform an additional cleaning step after endoscope disinfection, increasing the complexity and time cost of operation. In addition, this method requires the endoscope to be exposed to ethylene oxide at room temperature for up to 7 days, which makes the equipment unable to be recycled in real time. For expensive endoscopic medical devices, the cost of spare parts is extremely high. Therefore, this disinfection method not only affects the rapid reuse of special devices such as endoscopes, but also causes additional trouble and cost burden to users and medical institutions.

[0008] The present applicant has previously applied for a low-temperature sterilization method and device for sterilizing, disinfecting and decontaminating contaminated reusable medical equipment. The method includes rapid desorption, destruction and decomposition reactions of the contaminated medical equipment using ultrasonic waves, ultraviolet light and ozone in combination with a disinfectant in an aqueous solution. The method can completely decontaminate, sterilize and disinfect the contaminated medical equipment and ensure that all contaminants and bacteria are completely removed. The present application further improves the low-temperature sterilization device, which can adjust the concentration of the aqueous solution through a metering unit to ensure that the disinfectant is within a certain range. The device can automatically clean and sterilize the contaminated reusable medical equipment at room temperature in about 30 minutes, greatly reducing the time required for cleaning the contaminated reusable medical equipment. SUMMARY

[0009] The present application provides a low-temperature sterilization device for sterilizing contaminated medical equipment. The device includes a reaction tank, an operating device, an ultrasonic device, a metering unit, a feeding pump and a circulating pump.

[0010] The reaction tank is used to accommodate the contaminated medical equipment for sterilization and disinfection. The operating device is arranged above the reaction tank and is used to provide a user with a selection of multiple automatic operation programs to control and monitor the entire sterilization and disinfection process. The ultrasonic device is used to desorb the contaminants and bacteria adhered to the contaminated medical equipment through ultrasonic waves with a frequency ranging from 20 Hz to 1 GHz. The metering unit calculates the required dose of the chemical agent based on the volume of the aqueous solution in the reaction tank to maintain the concentration of the aqueous solution within the range of 100 ppm to 10,000 ppm. The feeding pump is arranged in the operating device and is used to introduce the chemical agent into the reaction tank according to the required dose. The circulating pump is connected to the medical equipment channel and the reaction tank, respectively, and is used to transport the aqueous solution in the reaction tank to the contaminated medical equipment channel.

[0011] According to another embodiment, the low-temperature sterilization device further includes an ultraviolet device for sterilizing and disinfecting the contaminated medical equipment through ultraviolet irradiation.

[0012] According to another embodiment, the low-temperature sterilization device further includes a photocatalyst device for sterilizing and disinfecting the contaminated medical equipment through a photocatalytic reaction between the photocatalyst in the photocatalyst device and ultraviolet light.

[0013] According to another embodiment, the low-temperature sterilization device further comprises an ozone generator, and ozone generated by the ozone generator is delivered to the reaction tank through the aeration pipe to mix the ozone with the aqueous solution.

[0014] According to another embodiment, the low-temperature sterilization device further comprises a drying pump for drying the medical instrument after sterilization.

[0015] According to another embodiment, the chemical agent can be one or more mixed sterilization agents, and the chemical agent can be selected according to the required concentration and agent.

[0016] According to an embodiment, the disclosure provides a low-temperature sterilization method for sterilizing contaminated medical instruments using slightly acidic electrolyzed water in a low-temperature sterilization device, comprising: operating a device to select one of a plurality of automatic operation programs for sterilization; a metering unit calculating a required dose of a chemical agent according to the capacity of an aqueous solution in a reaction tank to maintain the concentration of the aqueous solution in the range of 100 ppm-10000 ppm or the oxidation-reduction potential in the range of 800 mv-1500 mv; an ultrasonic device performing ultrasonic oscillation according to the selected automatic operation program to detach the contaminants and bacteria adhered to the contaminated medical instruments; a feeding pump controlling a chemical agent tank to release the required dose of the chemical agent; an ozone generator releasing generated ozone; an ultraviolet device sterilizing and disinfecting the contaminated medical instruments by ultraviolet irradiation; and a circulating pump delivering the aqueous solution containing the chemical agent in the reaction tank to the internal space of the medical instruments to contact with the contaminated medical instruments to perform a sterilization and disinfection reaction; and the ozone gas in supersaturation will rise to the upper part of the reaction tank and form a sterile space with the ultraviolet rays.

[0017] According to another embodiment, the chemical agent can be one or more mixed sterilization agents, and the chemical agent can be selected according to the required concentration and agent.

[0018] According to another embodiment, the low-temperature sterilization device further comprises a drying pump for drying the medical instrument after sterilization.

[0019] According to an embodiment, the disclosure provides a concentration control method of a low-temperature sterilization device, comprising: an operating device for setting the concentration of an aqueous solution in a reaction tank; a metering unit calculating a required dose of a chemical agent according to the volume of the aqueous solution in the reaction tank to maintain the concentration of the aqueous solution in the range of 100 ppm-10000 ppm; a feeding pump introducing the chemical agent according to the required dose of the chemical agent; and a circulating pump delivering ozone generated by an ozone generator through the aqueous solution to the reaction tank.

[0020] According to an embodiment, the circulating pump is connected to the medical equipment channel and the reaction tank respectively, for transporting the aqueous solution in the reaction tank to the contaminated medical equipment channel.

[0021] According to an embodiment, the chemical agent can be one or more mixed disinfectants, and the chemical agent can be selected with appropriate concentration and agent as needed.

[0022] The effects that the present disclosure can claim include: (1) high-efficiency disinfection and sterilization of medical equipment through the combination of multiple means such as ultrasonic waves, chemical agents, ozone, ultraviolet rays, and photocatalysts; (2) low-temperature sterilization method to avoid equipment damage or structural changes; (3) real-time monitoring and adjustment of the concentration of the aqueous solution by the detection unit and the metering unit to ensure that the disinfectant is within a certain range, thereby improving the stability and reliability of sterilization; (4) the disinfectant is a diluted low-concentration harmless agent, which is harmless to the environment and operating personnel, and can be directly discharged after use, without secondary pollution problems; (5) reducing the time required for cleaning medical equipment, reducing the operation burden of medical staff, and reducing the required spare parts of medical equipment; (6) saving the cost and labor of manual operation through the automatic control device; (7) providing a sterile reaction space to ensure that the gas phase and liquid phase in the reaction tank reach a sterile state, thereby avoiding secondary pollution of the equipment during the disinfection process. BRIEF DESCRIPTION OF DRAWINGS

[0023] In order to make the above-mentioned technologies and other purposes, features, advantages and embodiments of the present disclosure more obvious and easy to understand, the following describes the accompanying drawings:

[0024] Figure 1 shows a low-temperature disinfection and sterilization device of the prior art.

[0025] Figure 2 shows a front view of a low-temperature sterilization device according to an embodiment of the present disclosure.

[0026] Figure 3 shows a perspective view of a low-temperature sterilization device according to an embodiment of the present disclosure.

[0027] Figure 4 shows a side view of a low-temperature sterilization device according to an embodiment of the present disclosure.

[0028] Figure 5 is a photograph of a low-temperature sterilization device according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0029] To more specifically describe the various embodiments of the present disclosure, the following is described with reference to the accompanying drawings. It should be understood that when a component is referred to as being "connected" or "coupled" to another component, it can be directly connected or coupled to the other component, or intervening components can also be present. Conversely, when a component is referred to as being "directly connected" or "directly coupled" to another component, it should be understood that there are no intervening components present.

[0030] Referring to FIGS. 1 to 5, the present disclosure provides a low-temperature sterilization device and a method thereof, particularly, a combination of various technical means such as ultrasonic waves, chemical agents, ozone, ultraviolet rays, and photocatalysts is used to achieve efficient disinfection and sterilization of the surface and interior of medical equipment in accordance with the requirements of the Chinese national standard.

[0031] According to the Ministry of Health's notice on the issuance of "Endoscope Cleaning and Disinfection Technical Operation Specification 2004 Edition", Article 12 of the endoscope and accessories cleaning, disinfection or sterilization must comply with the following principles:

[0032] I. Any endoscope and accessories that enter the sterile tissue or organ of the human body or enter the sterile cavity of the human body through surgical incision, such as laparoscopes, arthroscopes, brain scopes, cystoscopes, and other official cavity scopes, must be sterilized.

[0033] II. Any endoscope accessories that penetrate the mucosa, such as biopsy forceps and high-frequency electric knives, must be sterilized.

[0034] The requirements for the effect of micro-acidic electrolytic water on killing microorganisms are shown in Table 1.

[0035] Table 1 Requirements for the effect of micro-acidic electrolytic water on killing microorganisms

[0036]

[0037] In summary, the low-temperature sterilization device 100 uses micro-acidic electrolytic water to disinfect and sterilize contaminated medical equipment to ensure its safe and sanitary reuse. Its main components include a reaction tank 120, an operating device 130, a detection unit 140, a metering unit 154, an ultrasonic device 160, a feeding pump, and a circulating pump 150. The micro-acidic electrolytic water used must meet the standards in Table 1.

[0038] The reaction tank 120 is used to contain contaminated medical equipment for disinfection and sterilization treatment. In this embodiment, as shown in FIG. 4, the containing tank 120 has a certain depth of containing space to contain sufficient disinfectant and treat medical equipment. The design of the reaction tank 120 ensures that the equipment is fully soaked in the disinfectant to achieve comprehensive disinfection. The reaction tank 120 is arranged inside the central part of the low-temperature sterilization device 100.

[0039] The operation device 130 is disposed above the reaction tank 120 to provide a user interface for selecting one of a plurality of automatic operation programs to control and / or monitor the entire disinfection and sterilization process. The operation device 130 can include control buttons, a touch screen, or other interactive interfaces. Referring to Table 2, the present embodiment provides a plurality of automatic operation programs F1-F6.

[0040] Table 2 Automatic operation programs

[0041]

[0042] The interface of the operation device 130 also displays the stages of the automatic operation program and their status.

[0043] The metering unit 154 is disposed at the lowermost layer inside the low-temperature sterilization device 100. The metering unit 154 calculates the required dosage of the chemical agent based on the volume of the aqueous solution in the reaction tank 120 (in the present embodiment, this parameter is obtained by an ultrasonic water level meter) to ensure that the disinfectant and sterilization agent concentration is maintained within the range of 100 ppm-10000 ppm or the oxidation-reduction potential (ORP) is within the range of 800 mv to 1500 mv.

[0044] The ultrasonic device 160 is disposed outside the periphery of the reaction tank 120. When the medical equipment is placed in the reaction tank 120 and the aqueous solution is injected, the ultrasonic device 160 generates ultrasonic oscillations with a frequency in the range of 20 hertz (Hz) to 1 gigahertz (GHz) when the liquid surface of the aqueous solution exceeds the medical equipment. The ultrasonic oscillations are high-frequency vibration waves with sufficient energy to destroy the cell membrane structure of bacteria, viruses, and other microorganisms, causing them to die. At the same time, tiny bubbles are generated on the surface of the object, and these bubbles release high-temperature and high-pressure energy when they collapse, thereby destroying the cell structure of the bacteria. In addition, the ultrasonic oscillations generate eddy currents and tiny liquid flows, thereby flushing or expelling dirt and microorganisms attached to the surface or inside of the contaminated medical equipment, thereby achieving the effect of cleaning and decontamination. In general, the ultrasonic device 160 is an efficient, fast, and hands-free automatic cleaning method that can effectively ensure the disinfection and cleaning of medical equipment and improve the safety and reliability of medical equipment.

[0045] A feeding pump (not shown in the figure) is disposed in the operation device 130 to introduce the chemical agent into the reaction tank 120 according to the required dosage from the chemical tank 8 (located at the lowermost layer inside the low-temperature sterilization device 100, as shown in FIG. 5) through the filter element 152.

[0046] The circulating pump 150 is connected to the medical equipment channel and the reaction tank 120. The circulating pump 150 is responsible for transporting the aqueous solution containing the chemical agent (i.e., the disinfectant solution containing the disinfectant) in the reaction tank 120 to the medical equipment channel to ensure that the disinfectant in the disinfectant solution can fully cover and contact the surface of the medical equipment, thereby achieving a thorough disinfection effect. The chemical agent, which can be one or more mixed disinfectants, can be released in the aqueous solution to destroy and eliminate harmful microorganisms such as bacteria, viruses, and fungi on the surface and inside of the equipment through a chemical reaction, thereby improving the disinfection effect. The above-mentioned chemical agent is, for example, a super oxidant such as hypochlorous acid or other chlorine-containing compounds used for microbial killing. Chlorine-containing compounds and other chemical agents can rapidly oxidize the cell membranes and cell walls of bacteria, viruses, fungi, and other microorganisms, thereby causing their death. Chlorine-containing compounds and other chemical agents can effectively disinfect medical equipment at an appropriate concentration, and are relatively safe for the environment and the human body because they will quickly decompose into harmless salts and water. During low-temperature disinfection, hypochlorous acid or chlorine-containing compounds and other chemical agents can be used as an effective chemical disinfectant in combination with other disinfection methods to improve the disinfection and sterilization effect and ensure the thorough cleaning and safe use of medical equipment.

[0047] In this embodiment, the low-temperature sterilization device 100 further comprises a drying device 190. The drying device 190 is located in the middle layer of the low-temperature disinfection device and is used to dry the medical equipment after disinfection and sterilization.

[0048] According to an embodiment, the aqueous solution concentration control method of the low-temperature sterilization device 100 is achieved by the following steps:

[0049] 1. The operating device 130 is used to set the concentration of the aqueous solution in the reaction tank 120, and the required disinfectant concentration is set according to specific needs.

[0050] 2. The metering unit 154 calculates the required dose of the chemical agent according to the volume of the aqueous solution in the reaction tank 120 to maintain the aqueous solution concentration in the range of 100 ppm-10000 ppm. The volume of the reaction tank ranges from 10L to 100L. Assuming that the volume of the aqueous solution in the reaction tank 120 is 10L and the disinfectant concentration is set to 100ppm, the required dose of the chemical agent is 1ml.

[0051] 3. The feeding pump introduces the chemical agent from the chemical tank 8 to the reaction tank 120 according to the required dose of the chemical agent, thereby forming the required disinfectant in the reaction tank 120.

[0052] 4. The circulating pump 150 is responsible for transporting the aqueous solution containing the chemical agent from the reaction tank 120 into the medical equipment channel. At the same time, in this embodiment, the circulating pump 150 also transports the ozone generated by the ozone generator 180 through the aqueous solution into the reaction tank 120.

[0053] Through the above steps, the low-temperature sterilization device 100 can ensure that the concentration of the disinfectant is within the required range, thereby improving the stability and reliability of the disinfection and sterilization.

[0054] According to another embodiment, the above-mentioned low-temperature sterilization device 100 also includes an ultraviolet device 170, such as an ultraviolet lamp, for disinfecting and sterilizing the contaminated medical equipment through ultraviolet irradiation. Ultraviolet light has strong sterilization ability and can effectively destroy the nucleic acid of bacteria and viruses, thereby rendering them inactive. In the low-temperature sterilization device 100, the ultraviolet device 170 is located on the back plate of the operating device 130, i.e., above the reaction tank 120, to ensure that the medical equipment is fully exposed to the range of ultraviolet irradiation. In this embodiment, when the medical equipment is placed in the reaction tank 120, the ultraviolet device 170 automatically starts and irradiates the equipment with ultraviolet light for a certain period of time to ensure complete disinfection and sterilization.

[0055] According to another embodiment, the above-mentioned low-temperature sterilization device 100 can also include a photocatalyst device, which functions to disinfect and sterilize the contaminated medical equipment by generating a photocatalytic reaction using photocatalysts and ultraviolet light. In this embodiment, the photocatalyst device is disposed within the reaction tank 120. Photocatalysts are special materials that have a surface containing catalysts that can absorb light energy and initiate chemical reactions. Photocatalysts are typically made of semiconductor materials, the most common of which is titanium dioxide (TiO2). When light is irradiated onto the surface of the photocatalyst, the catalyst on the photocatalyst reacts with water or oxygen in the air to produce active oxygen species (such as hydroxyl radicals), thereby causing organic pollutants and microorganisms to be oxidized and decomposed.

[0056] According to another embodiment, the above-mentioned low-temperature sterilization device 100 also includes an ozone generator 180 for generating ozone and applying it to the disinfection and sterilization process. In this embodiment, the ozone generator 180 is located in the middle layer of the low-temperature disinfection device. Ozone is a strong oxidizing agent with strong disinfecting and sterilizing effects. In the low-temperature sterilization device 100, the ozone generator 180 typically generates ozone through a specific method and introduces it into the reaction tank 120 or the equipment, where it reacts with pollutants and bacteria to achieve the purpose of disinfection and sterilization.

[0057] The ozone generating device 180 typically employs technologies such as electrolytic ozone generators or ultraviolet ozone generators to generate ozone. Electrolytic ozone generators utilize an electrolysis process to decompose oxygen into ozone and oxygen, while ultraviolet ozone generators utilize ultraviolet radiation to convert oxygen into ozone. The generated ozone is then delivered to the reaction tank 120 or the equipment, and undergoes an oxidation reaction with pollutants and bacteria, achieving the effect of disinfection and sterilization. When ozone comes into contact with bacteria, viruses, and other microorganisms, it damages their cell membranes and cell nucleic acids, causing them to die. During the disinfection process, ozone quickly decomposes into oxygen, leaving no harmful residues. In addition, the over-saturated ozone gas rises to the upper part of the reaction tank 120 and forms a sterile space with ultraviolet light, preventing secondary contamination of the equipment during the disinfection process.

[0058] Various disinfection and sterilization methods were tested and evaluated in the laboratory. These methods include but are not limited to ultrasonic waves, chemical agents, ultraviolet light, and photocatalysts. Their disinfection effect on medical equipment and their ability to kill residual microorganisms were evaluated through experiments. These tests include the following steps:

[0059] 1. Pre-treatment of the specimen: First, clean and disinfect the specimen to ensure its sterile state.

[0060] 2. Preparation of test bacterial solution: Prepare the test bacterial solution, including activation of the bacterial strain and preparation of the test bacterial strain suspension.

[0061] 3. Inoculation of test bacterial solution: Inoculate the bacterial solution according to the requirements of the test literature, using a method that meets the culture conditions. Typically, a 108 concentration of bacterial solution is used, with 1 milliliter being placed into a 100-milliliter sterile water cup for testing.

[0062] 4. Disinfect and sterilize the above test groups using the present disclosure

[0063] 4.1 Leakage test phase

[0064] The low-temperature sterilization device 100 performs a leakage test during the F6 process of the device operation, with a pressure of z15 kPa during the leakage test phase.

[0065] 4.2 Cleaning step

[0066] The low-temperature sterilization device 100 performs pre-washing on both the inner and outer surfaces of the endoscope. The time unit is set to 180 seconds. In this phase, the contaminants adhering to the equipment are detached from the inside and outside of the equipment using ultrasonic waves at a frequency of 40,000 times per second, and the detached contaminants are decomposed, destroyed, and eliminated using ultraviolet ozone and disinfecting agents. After the treatment process, the liquid is discharged through the interface 200 located at the bottom of the low-temperature sterilization device 100 and cannot be reused.

[0067] 4.3 Sterilization step

[0068] 4.3.1 Selection and requirements of disinfectants

[0069] In this stage, the ultrasonic wave is used to shake the adhered pollutants on the equipment at 40,000 times per second, and the ultraviolet ozone and disinfectants are used to decompose, destroy and eliminate the pollutants. The selection of disinfectants should meet the requirements of the equipment manual and relevant health standards. The selected disinfectants should meet the following requirements at the sterilization time of 900 seconds introduced in the sterilizer manual:

[0070] (1) Kill 1g6 Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa,

[0071] (2) Kill 1g6 Candida albicans, Mycobacterium and Aspergillus niger;

[0072] (3) Kill 1g6 Bacillus subtilis var. niger spores.

[0073] 4.3.2 Sterilization treatment

[0074] (1) The low-temperature sterilization device 100 has a recording function, and the disinfectants are used only once and cannot be reused to ensure that the disinfectants have consistent quality and performance in killing microorganisms.

[0075] (2) The sterilization simulation experiment (as shown in Table 3 below) should meet the following requirements under the standard sterilization time and concentration introduced in the manual: remove 1g6 Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa, remove 1g6 Candida albicans, Mycobacterium and Aspergillus niger, and remove 1g6 Bacillus subtilis var. niger spores.

[0076] (3) The detection method of sterilization effect meets the requirements of “Sterilization Technical Specification” (2002 edition).

[0077] 4.4 Final rinsing step

[0078] (1) The disclosed device does not have a water treatment device, and the manual should specify the requirements for the final rinsing water. The physicochemical indicators of the water quality should meet the purification requirements, and the purified water should meet the requirements of the Chinese Pharmacopoeia (2015 edition). The total number of bacteria should be less than 10 CFU / 100 ml.

[0079] (2) The low-temperature sterilization device 100 is used to finally rinse the inner surface and outer surface of the endoscope. The rinsing time is set in seconds, and the rinsing time is set in the range of 0-9999s. The rinsing water is discharged during or after the treatment and cannot be reused.

[0080] 4.5 Drying step

[0081] (1) The low-temperature sterilization device 100 has a drying program. The residual rinse water in the sterilized equipment pipeline should be blown out using filtered gas. The air filtration pipeline should be able to remove 99.99% of particles above 0.2 um. After the automatic program is completed, the outer surface of the equipment should not contain too much moisture, and it is not necessary to wipe it dry again before use.

[0082] (2) The low-temperature sterilization device 100 dries the inner surface and the outer surface of the endoscope. The drying time is set in seconds, and the drying time is set in the range of 0-9999s.

[0083] (3) The drying stage can use alcohol to perfuse the inside of the lumen. The alcohol infusion time is set in the range of 0-9999s.

[0084] 5. Detection step: detect the amount of residual bacteria.

[0085] 6. Antimicrobial efficacy evaluation: deduce the antimicrobial efficacy from the residual bacteria amount, as shown in Tables 3 and 4 below.

[0086] Table 3 is the running steps, time and removal effect of the low-temperature sterilization device

[0087]

[0088] Table 4 is the index bacteria, time and removal effect of the low-temperature sterilization device running standard sterilization

[0089]

[0090] According to Tables 3 and 4, it can be known that the present disclosure can achieve nearly 100% sterilization. The main effective component of Shuqian as a disinfectant is hypochlorous acid (HClO), and the effective chlorine content is between 10 mg / L and 100 mg / L. After the toxicological risk assessment test verification, the waste liquid after reaction is safe and non-toxic, and can be directly discharged into the sewage collection tank of the hospital place without additional treatment, thereby significantly saving the treatment cost.

[0091] In summary, the present disclosure has many advantages: first, the combination of ultrasonic waves, chemical agents, ozone, ultraviolet rays and disinfectants can efficiently disinfect and sterilize medical equipment without damaging or changing the structure of the medical equipment. By monitoring and adjusting the concentration of the aqueous solution in real time, the disinfectant is ensured to be within a certain range, improving the stability and reliability of sterilization. The disinfectant is a harmless dilute low-concentration agent, which is harmless to the environment and operating personnel, and can be directly discharged after use, without the problem of secondary pollution. In addition, the present disclosure can also reduce the time required for cleaning medical equipment, reduce the operation burden of medical staff, reduce the number of medical equipment spare parts, and save the cost and labor of manual operation.

[0092] The present disclosure is described herein with reference to the figures, which illustrate only preferred embodiments of the present disclosure, and thus, should not be taken to limit the scope of the present disclosure. Those skilled in the art will readily perceive improvements, changes and modifications to the preferred embodiments, and the present disclosure is intended and adapted to include all such improvements, changes and modifications in the spirit and scope of the present disclosure. The scope of the present disclosure is defined by the claims set forth below.

Claims

1. A low-temperature sterilization device, comprising placing contaminated medical devices into slightly acidic electrolyzed water for disinfection and sterilization, thereby removing adhering contaminants and bacteria from all pores and corners of the contaminated medical devices, wherein the low-temperature sterilization device is characterized in that: A reaction tank is used to contain the contaminated medical equipment for disinfection and sterilization. An operating device, located above the reaction tank, is provided for the user to select one of a plurality of automatic operating programs to control and monitor the entire disinfection and sterilization process; An ultrasonic device for desorbing contaminants and bacteria adhering to the contaminated medical device by means of ultrasonic vibrations in the frequency range of 20 Hz to 1 GHz. A metering unit is used to calculate the required dosage of chemical reagents based on the volume of the aqueous solution in the reaction tank, so as to maintain the concentration of the aqueous solution in the range of 100ppm-10000ppm. A feed pump, located within the operating device, is used to introduce the chemical reagent from the chemical tank into the reaction vessel at the required dosage; as well as A circulation pump, connected to both the medical device channel and the reaction tank, is used to deliver the aqueous solution to the contaminated medical device channel.

2. The low-temperature sterilization device as described in claim 1, characterized in that: It also includes an ultraviolet (UV) device for disinfecting and sterilizing the contaminated medical equipment by UV irradiation.

3. The low-temperature sterilization device as described in claim 1, characterized in that: It also includes a photocatalytic device, which reacts the photocatalyst in the photocatalytic device with ultraviolet light to produce a photocatalytic reaction to disinfect and sterilize the contaminated medical device.

4. The low-temperature sterilization apparatus as described in claim 1, characterized in that: It also includes an ozone generating device, through which ozone generated by the ozone generating device is transported to the reaction tank via an aeration pipe to mix the ozone with the aqueous solution.

5. The low-temperature sterilization apparatus as described in claim 1, characterized in that: It also includes a drying pump, used to dry medical devices after sterilization.

6. The low-temperature sterilization apparatus as described in claim 1, characterized in that: The chemical agent may be one or more mixed disinfectants and sterilizers, and the appropriate concentration and agent may be selected as needed.

7. A low-temperature sterilization method, comprising placing contaminated medical devices into a low-temperature sterilization device and sterilizing them using slightly acidic electrolyzed water, characterized in that: The operating device selects one of several automatic operation programs for disinfection and sterilization. The metering unit calculates the required dosage of chemical reagents based on the aqueous solution capacity of the reaction tank to maintain the aqueous solution concentration in the range of 100ppm-10000ppm or the redox potential in the range of 800mv-1500mv. The ultrasonic device performs ultrasonic vibrations according to the selected automatic operation program to desorb contaminants and bacteria adhering to the contaminated medical equipment; the feed pump controls the chemical reagent tank to release the required dosage of chemical reagents; the ozone generator releases ozone; the ultraviolet device disinfects and sterilizes the contaminated medical equipment through ultraviolet irradiation; and the circulation pump delivers an aqueous solution containing chemical reagents from the reaction tank to the internal space of the medical equipment to contact the contaminated medical equipment for disinfection and sterilization. Supersaturated ozone gas will rise to the top of the reaction tank and form a sterile space with ultraviolet light.

8. The low-temperature sterilization method as described in claim 7, characterized in that: The chemical agent may be one or more mixed disinfectants and sterilizers, and the appropriate concentration and agent may be selected as needed.

9. The low-temperature sterilization method as described in claim 7, characterized in that: It also includes a drying pump, used to dry medical devices after sterilization.

10. A concentration control method for a low-temperature sterilization device, characterized in that: The operating device is used to set the concentration of the aqueous solution in the reaction tank; The metering unit calculates the required dosage of chemical reagents based on the volume of the aqueous solution in the reaction tank in order to maintain the concentration of the aqueous solution in the range of 100ppm-10000ppm. The feed pump introduces the chemical agent according to the required dosage; and A circulating pump delivers the ozone generated by the ozone generating device through an aqueous solution to the reaction tank.

11. The low-temperature sterilization method as described in claim 10, characterized in that: The circulating pump is connected to both the medical device channel and the reaction tank, and is used to transport the aqueous solution in the reaction tank to the contaminated medical device channel.

12. The low-temperature sterilization method as described in claim 10, characterized in that: The chemical agent may be one or more mixed disinfectants and sterilizers, and the appropriate concentration and agent may be selected as needed.

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