Endoscope disinfection method and disinfection machine and application thereof

Abstract

The invention discloses a disinfection and sterilization method and a disinfection machine, the disinfection and sterilization method is applied to a soft or non-soft endoscope sterilization system.The method comprises the steps that sodium percarbonate particles are converted into hydrogen peroxide gas within a short time under the action of high-temperature heating and ultrasonic concussion; a gas nozzle at the top end of the flow control module is introduced into an endoscope tube cavity for disinfection. The gaseous hydrogen peroxide has stronger diffusion performance and shorter disinfection time compared with the same type of liquid disinfectant, and the disinfection efficiency is as good as that of the latter, so that the disinfection process can be completed more quickly and effectively. Compared with a liquid disinfectant, the solid raw material is more stable, occupies smaller space and is convenient to store and transport.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and more specifically, to a flexible endoscope disinfection machine that does not rely on water media, and a preparation method and application thereof. Background Art

[0002] As an extension of the doctor's eyes and hands, modern endoscopes can not only make accurate diagnoses, but also perform minimally invasive treatment and surgery under the microscope. Digestive flexible endoscopes are the most widely used. With the increasing use of flexible endoscopes, the need for disinfection of flexible endoscopes is becoming more and more urgent, and the requirements for disinfection efficiency are also getting higher and higher. In addition, the uneven surface of the endoscope tube directly leads to the formation of bacterial biofilm, which makes it very difficult to disinfect flexible endoscopes.

[0003] Currently, the automatic endoscope disinfection machine uses peracetic acid disinfectant and the disinfection supply room uses ethylene oxide gas. However, peracetic acid disinfectant is relatively expensive. The price of 10L disinfectant is 660 yuan, which can only disinfect 22-24 endoscopes. The storage of disinfectant takes up a large space and has high requirements for the storage environment. It has a certain irritating odor and is harmful to disinfection workers. Ethylene oxide gas is carcinogenic and has certain hazards to disinfection workers. The aeration process is too long, making the entire disinfection process too long and difficult to meet the high-intensity use of digestive endoscopes. In addition, ethylene oxide gas has certain explosiveness, and its storage has high requirements for equipment and high cost of use. Summary of the invention

[0004] In view of the above problems, the present invention provides an environmentally friendly, portable, safe, stable and time-saving method for sterilizing flexible endoscopes by using solid chemicals as raw materials to generate gas and a flexible endoscope sterilizer. The details are as follows:

[0005] The present invention provides a disinfection and sterilization method, characterized in that the method comprises: using solid chemicals as raw materials to generate a disinfectable gas, and introducing it into the lumen of an endoscope for disinfection and / or sterilization. The disinfectable gas comprises: hydrogen peroxide, chlorine dioxide or ethylene oxide, and preferably the gas is hydrogen peroxide.

[0006] Furthermore, the solid chemical is sodium percarbonate.

[0007] Preferably, sodium percarbonate particles are converted into hydrogen peroxide gas in a short time under the action of high temperature heating and ultrasonic vibration, and introduced into the lumen of the endoscope for disinfection.

[0008] More preferably, sodium percarbonate particles are converted into hydrogen peroxide gas in a short time under the action of high temperature heating and ultrasonic vibration, and introduced into the lumen of the endoscope through the gas nozzle at the top of the flow control module for disinfection.

[0009] The present invention also provides a disinfection machine that can be used in the above disinfection and sterilization method, characterized in that the disinfection machine converts solid chemicals into disinfection gas under the action of high temperature heating and / or ultrasonic vibration, and introduces it into the lumen of the endoscope for disinfection. The disinfectable gas includes: hydrogen peroxide, chlorine dioxide or ethylene oxide, and preferably the gas is hydrogen peroxide.

[0010] Furthermore, the solid chemical is sodium percarbonate.

[0011] Preferably, the disinfection machine converts the sodium percarbonate particles into hydrogen peroxide gas in a short period of time under the action of high-temperature heating and ultrasonic vibration, and introduces the hydrogen peroxide gas into the lumen of the endoscope for disinfection.

[0012] More preferably, the disinfector converts the sodium percarbonate particles into hydrogen peroxide gas in a short time under the action of high-temperature heating and ultrasonic vibration, and introduces the hydrogen peroxide gas into the lumen of the endoscope through the gas nozzle at the top of the flow control module for disinfection.

[0013] The disinfection machine provided by the present invention does not rely on water medium, and mainly includes a reaction container, a heating control module, an ultrasonic oscillation module and a flow control module.

[0014] Furthermore, the heating control module in the disinfection machine includes: a temperature control panel and a heating plate. The ultrasonic oscillation module includes an ultrasonic generator, an ultrasonic control panel and a vibration plate. The flow control module includes: a gas nozzle and a flow meter. In the heating control module, the heating coil is controlled by the temperature control panel to heat the heating plate, and the heating plate is covered with a heating sleeve, which wraps the reaction container to heat the sodium percarbonate particles therein; in the ultrasonic oscillation module, the ultrasonic generator is connected to the vibration plate through a vibrator, and the vibration plate contacts the reaction container so that the reaction container and the sodium percarbonate particles therein vibrate at the same frequency. When the gas is rapidly generated in the reaction container, it is discharged through the gas nozzle, and the real-time flow rate of the discharged gas is controlled by the flow meter.

[0015] The sterilizer is centered on an airtight sterilization cabin, which is equipped with a gaseous hydrogen peroxide generator. The gas generator uses heating combined with ultrasonic vibration to quickly decompose sodium percarbonate particles into gaseous hydrogen peroxide for sterilization.

[0016] The disinfection machine also includes a guide tube, which is used to connect the various channels of the endoscope, introduce gaseous hydrogen peroxide into the lumen, and use the "internal flushing and external immersion" method to disinfect the lumen and outer surface of the endoscope.

[0017] The sterilizer also includes an automatic drying system, a humidification and drying module, a gas hydrogen peroxide concentration sensor, a relative humidity sensor, a pressure sensor, and a gas flow regulator.

[0018] The invention also provides a method for preparing the sterilizing machine.

[0019] Another aspect of the present invention also provides an application of the above method and disinfection machine, which is not limited to the disinfection and / or sterilization of flexible or non-flexible endoscope sterilization systems.

[0020] Beneficial effects

[0021] 1. The disinfection raw materials and disinfection media are solid and gaseous respectively, which is free from dependence on water resources and greatly reduces the consumption of water resources.

[0022] 2. Gaseous hydrogen peroxide has stronger diffusion performance and disinfection efficiency than similar liquid disinfectants, and can complete the disinfection process more quickly and effectively.

[0023] 3. The disinfection time of the gas hydrogen peroxide disinfector (30 minutes) is shorter than that of the fully automatic endoscope disinfector and peracetic acid solution (37 minutes for gastroscopes and colonoscopes, 68 minutes for duodenoscopes). The cost of the disinfectant (sodium percarbonate particles) is only 1.5 yuan per piece, which is much lower than the 28.7 yuan per piece of peracetic acid disinfectant.

[0024] 4. The raw materials of disinfectant are solid particles with stable chemical properties. They can be used at any time and are easy to transport and store.

[0025] 5. Compared with traditional automatic endoscope disinfection machines, it is smaller in size, disinfects more quickly, and the reaction products are more environmentally friendly. During the disinfection process, the prototype almost emits no irritating odor, the disinfectant is harmless to the disinfection workers, and the disinfection concentration can be monitored in real time, ensuring convenience and facilitating promotion to primary medical institutions. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 Sodium percarbonate particles used in the present invention

[0027] Figure 2 Perspective view of gas hydrogen peroxide generator (① gas nozzle ② flow meter ③ reaction vessel ④ ultrasonic generator ⑤ temperature control panel ⑥ heating plate ⑦ vibration plate ⑧ ultrasonic control panel)

[0028] Figure 3 Detailed diagram of each component of the reaction device (A reaction vessel, B temperature control panel, C ultrasonic control panel, D flow meter)

[0029] Figure 4 Schematic diagram of digestive endoscopy model

[0030] Figure 5 Laboratory test equipment assembly diagram

[0031] Figure 6 Simulation field test site map

[0032] Figure 7 The logarithmic killing value of hydrogen peroxide gas against Bacillus fusiformis under four relative humidity conditions (vH2O2 concentration: 90 mg / L, time: 30 minutes, flow rate: 2.2 L / min, relative humidity: 60%-90%, * represents P < 0.05; ** represents P < 0.01; *** represents P < 0.001; ns represents P > 0.05)

[0033] Figure 8 The logarithmic killing value of hydrogen peroxide gas against Bacillus fusae under four exposure dose conditions (relative humidity: 80%, flow rate: 2.2L / min, exposure dose: 24-45mg / Lh, * represents P < 0.05; ** represents P < 0.01; *** represents P < 0.001; ns represents P > 0.05)

[0034] Fig. 9 The logarithmic killing value of hydrogen peroxide gas on Bacillus fusae under four intraluminal flow conditions (vH2O2 concentration: 90 mg / L, time: 30 minutes, relative humidity, 80%, intraluminal flow: 0.8-2.2 L / min, * represents P < 0.05; ** represents P < 0.01; *** represents P < 0.001; ns represents P > 0.05)

[0035] Fig.10 The logarithmic killing value of hydrogen peroxide gas against Bacillus fusae under four organic matter loading conditions (vH2O2 concentration: 90 mg / L, time: 30 minutes, relative humidity, 80%, intraluminal flow rate: 2.2 L / min, * represents P < 0.05; ** represents P < 0.01; *** represents P < 0.001; ns represents P > 0.05)

[0036] Fig.11 On-site picture of the disinfection prototype disinfection reusable endoscope DETAILED DESCRIPTION

[0037] The present invention is further described in detail below in conjunction with specific embodiments, and the examples provided are only for illustrating the present invention, rather than for limiting the scope of the present invention. The examples provided below can be used as a guide for further improvements by those of ordinary skill in the art, and do not constitute a limitation of the present invention in any way.

[0038] The experimental methods in the following examples, unless otherwise specified, are all conventional methods, and are performed according to the techniques or conditions described in the literature in the field or according to the product instructions. The materials, reagents, etc. used in the following examples, unless otherwise specified, can all be obtained from commercial channels.

[0039] Example 1: Design of a gas hydrogen peroxide flexible endoscope disinfection machine using solid as raw material

[0040] The airtight disinfection chamber is the core, and a gas hydrogen peroxide generator is installed inside. The gas generator uses heating combined with ultrasonic vibration to quickly decompose sodium percarbonate particles into gas hydrogen peroxide for disinfection.

[0041] The various channels of the endoscope are connected using a guide tube, and gaseous hydrogen peroxide is introduced into the lumen. The lumen and outer surface of the endoscope are disinfected using the "internal flushing and external immersion" method.

[0042] The disinfection machine is equipped with an automatic drying system, and a drying step can be performed after the endoscope is inserted and after disinfection.

[0043] The humidification and drying modules are installed in the disinfection machine to adjust the relative humidity in the disinfection chamber to 10%-90%.

[0044] The disinfection chamber is equipped with a gas hydrogen peroxide concentration sensor, a relative humidity sensor, a pressure sensor, and a gas flow regulator to monitor the gas disinfection parameters in the chamber.

[0045] When the concentration of hydrogen peroxide in the disinfection chamber is lower than a certain set value, sodium percarbonate particles are automatically added to maintain the concentration of hydrogen peroxide in the disinfection chamber within the set range.

[0046] The disinfection process of the disinfection machine is fully automatically controlled and the disinfection parameters are monitored in real time.

[0047] 1. Disinfection raw materials

[0048] The disinfection raw material used in this flexible endoscope disinfection machine is sodium percarbonate particles (Puyang Shengkai Environmental Protection New Materials Technology Co., Ltd.), the chemical formula is 2Na2CO3·3H2O2, the hydrogen peroxide content is 11%-14%, the company's actual measured value is 13.91%, the actual picture of the raw material is shown in Figure 1 .

[0049] 2. Gas hydrogen peroxide generator

[0050] like Figure 2 It is a perspective view, a physical view and detailed views of some components of a gas hydrogen peroxide generating device. Figure 3Detailed diagram of each component of the reaction device. The device is mainly composed of four parts: a reaction container, a heating control module, an ultrasonic oscillation module and a flow control module. The heating control module in the disinfector includes: a temperature control panel ⑤ and a heating plate ⑥. The ultrasonic oscillation module includes an ultrasonic generator ④, an ultrasonic control panel ⑧, and a vibration plate ⑦. The flow control module includes: a gas nozzle ① and a flow meter ②. In the heating control module, the heating coil is controlled by the temperature control panel to heat the heating plate, and the heating plate is covered with a heating sleeve, which wraps the reaction container ③ to heat the sodium percarbonate particles therein; in the ultrasonic oscillation module, the ultrasonic generator is connected to the vibration plate through a vibrator, and the vibration plate contacts the reaction container to make the reaction container and the sodium percarbonate particles therein vibrate at the same frequency. When the gas is rapidly generated in the reaction container, it is exported through the gas nozzle, and the real-time flow of the exported gas is controlled by the flow meter.

[0051] The sterilizer is centered on an airtight sterilization cabin, which is equipped with a gaseous hydrogen peroxide generator. The gas generator uses heating combined with ultrasonic vibration to quickly decompose sodium percarbonate particles into gaseous hydrogen peroxide for sterilization.

[0052] The disinfection machine also includes a guide tube, which is used to connect the various channels of the endoscope, introduce gaseous hydrogen peroxide into the lumen, and use the "internal flushing and external immersion" method to disinfect the lumen and outer surface of the endoscope.

[0053] The sterilizer also includes an automatic drying system, a humidification and drying module, a gas hydrogen peroxide concentration sensor, a relative humidity sensor, a pressure sensor, and a gas flow regulator.

[0054] The temperature control panel controls the heating coil to heat the heating plate, which is covered with a heating jacket, wrapping the reaction container to heat the sodium percarbonate particles therein; the ultrasonic generator is connected to the vibrating plate through a vibrator, and the vibrating plate contacts the bottom of the reaction container to make the reaction container and the sodium percarbonate particles therein vibrate at the same frequency. The gas generated in a short period of time is discharged through the nozzle, and the real-time flow is controlled by a flow meter.

[0055] The working principle is that sodium percarbonate particles are converted into hydrogen peroxide gas in a short period of time under the action of high-temperature heating and ultrasonic vibration, and are introduced into the endoscope lumen for disinfection through the gas nozzle at the top of the flow control module.

[0056] Example 2: Disinfection effect verification test

[0057] The gas generator is placed in a disinfection chamber with a size of 500mm×500mm×500mm. A gas hydrogen peroxide concentration sensor (HPP271, Vaisala, Finland), a temperature and humidity sensor (HMD60Y, Vaisala, Finland) and a negative pressure ventilation duct are placed in the chamber to detect the working status of the disinfection device at any time. During disinfection, sodium percarbonate particles are first placed in the reaction container, the instrument parameters are set, the endoscope model or the endoscope channels are connected, and the heating and ultrasonic oscillation modules are turned on. After about 5 minutes, the hydrogen peroxide gas concentration in the chamber reaches the peak value, and the timing starts. After the disinfection is completed, the residual solids in the reaction container are cleaned, and then the next disinfection is carried out. All verification tests of the device set the device heating temperature to 80°C and the ultrasonic oscillation frequency to 50KHz.

[0058] According to the "Endoscope Disinfection Effect Evaluation Method GB / T38497-2020", Bacillus subtilis var. niger spores (ATCC9372) were selected as indicator bacteria, the diluent was tryptone saline (TPS), the organic interference was tryptone soy broth (TSB) and 0.3% (3g / L) and 3% (0.03g / ml) bovine serum albumin (BSA), and the culture medium was nutrient agar medium (9cm, Beekman Bio). Use a pipette to take 0.02ml of the spore suspension and drip it on the inner wall of the defatted and autoclaved polytetrafluoroethylene tube carrier (outer diameter 6mm, inner diameter 4mm, length 30mm), and spread it evenly. The amount of recovered bacteria on each bacterial sheet was 1×10 6 -5×10 6 CFU / slice, place the stained slide in a clean bench and dry for 30 minutes for later use. The prepared stained carrier must be used within 24 hours of inoculation with spore suspension. A polytetrafluoroethylene tube with an outer diameter of 8 mm, an inner diameter of 6 mm, and a total length of 2000 mm was selected as an endoscope model. It was cut into 4 sections at 50 mm, 1000 mm, and 1950 mm, and the stained carriers were inserted into the three cuts to simulate different contaminated parts of the endoscope, such as Figure 4 The lumen of the simulated endoscope model must be firmly connected to the bacterial carrier. The lumen of the endoscope model and the bacterial carrier are degreased and sterilized with pressure steam before use, and are disposable.

[0059] Laboratory tests

[0060] Connect the polytetrafluoroethylene bacterial carrier to the nozzle of the gas generator ( Figure 5), turn on the disinfection device, start the timing after 5 minutes of continuous operation; act for 10 minutes, 20 minutes, and 30 minutes respectively. After each time period, take out the bacterial slice immediately and move it into a test tube containing 5 ml of normal saline. After vortexing and mixing, take 1 ml and inoculate it directly into the plate. Place it in a 36±1℃ incubator and culture it for 72 hours. Observe the results and count the live bacteria as the test group. Select 3 test bacterial slices for each action time as parallel tests. After each bacterial slice is disinfected, inoculate 2 plates for culture. Take another similar polytetrafluoroethylene bacterial carrier and connect it to the nozzle of the gas generator. The disinfection device is kept in the closed state. After 30 minutes, take out the bacterial slice for culture. The steps are the same as before. Count the live bacteria as the positive control group. Take another 2 unstained bacterial carriers and perform similar steps as the negative control group. The experiment was repeated three times, and the viable bacteria count (CFU / piece) of each group was calculated and converted into a logarithmic value. Then, the killing logarithmic value was calculated according to the formula KL=N0-NX (KL: killing logarithmic value, N0: logarithmic value of the average viable bacteria concentration in the positive control group, NX: logarithmic value of the average viable bacteria concentration in the test group). According to the "Evaluation Method for Endoscope Disinfection Effect", the results were qualified if the positive control group had bacterial growth, the negative control group had no bacterial growth, and the killing logarithmic value of the test group was ≥5.00.

[0061] The experimental results are shown in Table 1. The gaseous hydrogen peroxide produced by 75g of sodium percarbonate particles can achieve a high level of disinfection effect on all the contaminated slides.

[0062] Table 1 Laboratory disinfection effect of hydrogen peroxide gas

[0063]

[0064] Sodium percarbonate particle mass: 75g

[0065] Simulated field test

[0066] Connect the polytetrafluoroethylene tube endoscope model with the contaminated slide to the nozzle of the disinfection device ( Figure 6), and then turn on the device to start disinfection. After disinfection, use sterile tweezers to remove the bacterial carriers from each part, place them in test tubes containing 5mL of normal saline, shake and mix them with a vortex oscillator, and then draw 1ml to inoculate directly into the plate, place it in a 36±1℃ incubator for 72h, observe the results, count the live bacteria, and use it as the test group. Inoculate 2 plates for each sample. Take the same polytetrafluoroethylene tube endoscope model to connect the nozzle of the gas generator, and keep the disinfection device in a closed state. After 30min, take out the bacterial slices from each part and culture them in the same way as above, as the positive control group. Take another batch of normal saline and inoculate it into the plate for 72h, observe the results, count the live bacteria, and use it as the negative control group. Repeat the experiment 3 times, and calculate the killing logarithm of each group. According to the "Evaluation Method for Endoscope Disinfection Effect", the results are qualified if the positive control group has bacterial growth, the negative control group has no bacterial growth, and the killing logarithm of the test group is ≥3.00. Previous studies on gas disinfectants have shown that relative humidity, intraluminal flow, exposure dose, and organic matter load may be the main factors affecting the disinfection effect. Therefore, exposure dose, relative humidity, intraluminal flow, and organic matter load were used as variables to further explore the disinfection parameters of hydrogen peroxide gas ( Figure 7-10 ).

[0067] The experimental results show that the device can complete high-level disinfection of the endoscope model by using a certain concentration of hydrogen peroxide gas generated by sodium percarbonate particles in 30 minutes. Relative humidity, exposure dose and organic matter load have a significant effect on the disinfection effect of hydrogen peroxide gas, and the intraluminal flow rate has no significant effect on the disinfection efficiency of hydrogen peroxide gas.

[0068] Effectiveness verification of the test prototype disinfection reusable endoscope

[0069] A total of 120 reusable digestive endoscopes (including 40 gastroscopes, 40 colonoscopes, and 40 duodenoscopes) were randomly selected from the digestive endoscopy center and each endoscope was randomly divided into two groups, one of which was designated as the experimental group. The hydrogen peroxide gas disinfection device was used for disinfection ( Fig.11 ), and samples were collected and sent for inspection after disinfection. One group was set as the control group, and high-level disinfection was performed using a fully automatic endoscope cleaning and disinfection machine. Samples were collected and sent for inspection after disinfection. According to the "Technical Specifications for Cleaning and Disinfection of Flexible Endoscopes WS507-2016", the total number of colonies ≤ 20 CFU / piece and no pathogenic bacteria are considered qualified for disinfection, and no colonies were detected in the entire endoscope to achieve the sterilization level.

[0070] The disinfection and sterilization effects of the waterless disinfection device and the current fully automatic endoscope disinfection machine were compared. The results are shown in Table 2-3. There is no statistical difference in the disinfection and sterilization ability of the two methods for different digestive endoscopes. It can be seen that the waterless disinfection method of the present invention can achieve the disinfection efficiency of the existing mature machines, proving that it is indeed feasible, while taking less time, using less water, and the disinfectant is more environmentally friendly.

[0071] Table 2 Comparison of the effects of two disinfection methods on high-level disinfection of digestive endoscopes

[0072]

[0073] Table 3 Comparison of the sterilization effects of two disinfection methods on digestive endoscopes

[0074]

[0075] The present invention has been described in detail above. It will be apparent to those skilled in the art that the present invention may be implemented in a wide range under equivalent parameters, concentrations and conditions without departing from the spirit and scope of the present invention and without unnecessary experimentation. Although the present invention provides specific embodiments, it should be understood that further improvements may be made to the present invention. In short, according to the principles of the present invention, this application intends to include any changes, uses or improvements to the present invention, including changes made by conventional techniques known in the art that depart from the scope disclosed in this application. Applications of some of the basic features may be made within the scope of the following appended claims.

Claims

1. A disinfection and sterilization method, characterized in that: The method comprises: using solid chemicals as raw materials to generate a sterilizable gas, and introducing the gas into the lumen of an endoscope for disinfection and / or sterilization, wherein the sterilizable gas comprises: hydrogen peroxide, chlorine dioxide or ethylene oxide.

2. The method according to claim 1, characterized in that The solid chemical is sodium percarbonate.

3. The method according to claim 1 or 2, characterized in that: The sodium percarbonate particles are converted into hydrogen peroxide gas under the action of high temperature heating and ultrasonic vibration, and introduced into the endoscope lumen for disinfection; preferably, the gas is introduced into the endoscope lumen for disinfection through the gas nozzle at the top of the flow control module.

4. A sterilising machine for use in the method as claimed in any one of claims 1 to 3.

5. A disinfection machine, characterized in that: The sterilizer does not rely on water medium, and mainly includes a reaction container, a heating control module, an ultrasonic oscillation module and a flow control module.

6. The sterilizing machine according to claim 5, characterized in that: The heating control module includes: a temperature control panel and a heating plate; the ultrasonic vibration module includes: an ultrasonic generator, an ultrasonic control panel and a vibration plate; the flow control module includes: a gas nozzle and a flow meter.

7. The sterilizing machine according to claim 6, characterized in that: The temperature control panel controls the heating coil to heat the heating plate, and the heating cover is covered on the heating plate to wrap the reaction container to heat the sodium percarbonate particles therein; the ultrasonic generator is connected to the vibrating plate through the vibrator, and the vibrating plate contacts the bottom of the reaction container to make the reaction container and the sodium percarbonate particles therein vibrate at the same frequency; the gas generated in a short time is discharged through the nozzle, and the real-time flow is controlled by the flow meter.

8. A method for disinfection and / or sterilization using a disinfection machine as claimed in any one of claims 4 to 7.

9. A method for preparing a sterilizing machine according to any one of claims 4 to 7.

10. Use of the method according to any one of claims 1 to 3 and the sterilizing machine according to any one of claims 4 to 7, characterized in that: Applicable to disinfection and / or sterilization of flexible or non-flexible endoscope sterilization systems.

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