Method and apparatus for efficient sterilization of metallic instruments

Abstract

The application discloses a kind of high-efficiency sterilization method and device of metal instrument, belong to medical instrument, biomedical engineering, pharmaceutical and food processing etc.Field.Therein, heating unit is by detachable (such as buckle type, zipper type, irregular shape etc.), can be inductive displacement type electromagnetic induction coil to make metal instrument high-efficiency spontaneous heating due to eddy current effect, not only improve heating efficiency, but also can flexibly adapt to a variety of complex application scenarios.The application utilizes metal self in alternating magnetic field to generate eddy current effect to heat efficiently, warm up fast and uniformly, by adjusting the shape of coil, adapt to complex shape instrument;Through preset sterilization program and automatic adjustment function, solve the limitations existing in traditional sterilization method, such as only can realize surface sterilization, slow heat conduction speed, uneven heating and poor adaptability etc.Problems, with high efficiency, safety, low energy consumption, strong adaptability, depth sterilization Significant advantages.

Description

TECHNICAL FIELD

[0001] The present application relates to the fields of medical devices, biomedical engineering, pharmaceuticals and food processing, and specifically relates to a high-efficiency sterilization method and device for metal devices that can generate eddy current effect in an alternating magnetic field, efficiently generate heat, and kill pathogenic microorganisms. BACKGROUND

[0002] Medical devices (especially surgical devices, implants, etc.) directly contact the human body, and sterilization is a key link in preventing cross-infection. Incomplete sterilization can lead to infection, and even endanger life. Similarly, food and pharmaceuticals are also prone to microbial contamination during production, processing and packaging, which can cause serious safety problems. Therefore, for large or immobile devices, achieving comprehensive, dead-angle-free deep sterilization is a key measure to ensure the safety and stability of food and pharmaceuticals. In summary, in the fields of medical devices, biomedical engineering, pharmaceuticals and food processing, sterilization and disinfection are key links to ensure public health and product safety, and have irreplaceable importance.

[0003] Currently, the main sterilization methods for metal devices include the following four types:

[0004] 1. High-temperature sterilization is a physical method that destroys the structure of microorganisms by high temperature to achieve sterilization. High-pressure steam sterilization uses saturated steam at high pressure to generate high temperature, causing denaturation of microbial proteins and nucleic acids. The commonly used parameters are 121℃ for 15-30 minutes or 134℃ for 3-5 minutes, which can effectively kill various microorganisms including spores, and has the advantages of high efficiency and reliability. However, the process is accompanied by a large amount of water vapor, which may cause the metal device to be damp or corroded, and the sterilization cycle is relatively long, including heating, sterilization and cooling stages. Dry heat sterilization achieves sterilization by dry hot air, with a commonly used temperature of 160-180℃, which needs to be maintained for 1-2 hours, and is suitable for devices that are not resistant to moisture. Since no water is involved, the risk of metal rusting can be reduced, but long-term high temperature may affect the performance of some materials, and the overall processing efficiency is relatively low.

[0005] 2、Chemical sterilization is a method of killing microorganisms using chemicals (such as ethylene oxide, hydrogen peroxide, etc.). It is suitable for medical devices that cannot withstand high temperature, high pressure or moist heat. Ethylene oxide sterilization is non-corrosive to metals and can penetrate complex structures, but the sterilization cycle is long (several hours to several days), and it is toxic and carcinogenic, so it needs to be fully ventilated to remove residual. Hydrogen peroxide plasma sterilization has a short cycle (30 to 60 minutes) and no toxic residue, but its penetration ability is limited and is suitable for devices with simple structure or open packaging. Glutaraldehyde and o-Phthaldehyde are commonly used for high-level disinfection and are suitable for heat-sensitive metal devices such as endoscopes. The former requires long immersion and has irritant properties, while the latter acts faster and has less irritant properties, but it needs to be thoroughly rinsed after use; peracetic acid has a fast sterilization effect, but it is corrosive to some metals, so material compatibility needs to be evaluated when using it.

[0006] 3、Radiation sterilization destroys the DNA or RNA structure of microorganisms through high-energy radiation (such as gamma rays, electron beams, X-rays), achieving efficient sterilization. Gamma rays are released by radioactive isotopes (such as cobalt-60), which have strong penetration and are suitable for large quantities and high-density items, but there are radiation safety risks, uncloseable radioactive source management problems, and potential effects on material properties. Electron beam sterilization uses an accelerator to generate high-energy electron beams, which have fast sterilization speed and no radioactive residue, and are suitable for heat-sensitive materials, but have limited penetration and are only suitable for surface or thin layer products. X-ray sterilization is generated by high-energy electron beams hitting a target, combining good penetration ability with a controllable radiation source, and is suitable for packaged medium-density items, but the system is complex and the cost is high. Currently, all three methods require professional equipment support, and the scope of application is limited, so the promotion still faces technical and economic challenges.

[0007] 4、Low-temperature sterilization: Hydrogen peroxide low-temperature plasma sterilization is suitable for heat-sensitive metal devices, with the advantages of fast sterilization speed, no toxic residue, low temperature and low humidity, but has the disadvantages of poor penetration, strong oxidizing property, high cost and high loading requirements.

[0008] Currently, sterilization mainly relies on the treatment of the surface of the device, but traditional methods have many limitations. On the one hand, liquid or gas heat conduction sterilization is slow, especially when dealing with large or thick-walled metal devices, heat transfer is uneven, time-consuming and inefficient. On the other hand, for devices with complex shapes, long pipes or internal cavities, liquids or gases are difficult to fully contact all surfaces, and sterilization dead angles are easily produced. In addition, large fixed equipment is difficult to sterilize with existing methods due to its large size and fixed location. With the rapid development of medical devices, food and pharmaceutical processing industries, traditional technology has been unable to meet the needs of complex scenarios, and there is an urgent need to develop more efficient, flexible and adaptable sterilization methods.

[0009] Biomedical implants are at risk of infection during implantation and postoperatively. Traditional anti-infection strategies include systemic use of antibiotics, surface coating of antibacterial coatings, surgical debridement, and removal or replacement of implants. However, these methods have significant limitations: the abuse of antibiotics can easily lead to the rise of bacterial drug resistance, significantly reducing the therapeutic effect; antibacterial coatings can cause local side effects, affect tissue healing, and easily fail due to wear; and surgical debridement and implant replacement are not only traumatic, but can also cause secondary infection. Therefore, it is urgent to develop an efficient and controllable sterilization method and supporting device suitable for metal instruments in vitro and in vivo to improve the level of infection prevention and control and reduce the treatment burden of patients.

[0010] From the principle, the sterilization method based on the magnetic heating mechanism shows great potential in many fields. The magnetic heating can be attributed to the conversion of energy loss into heat energy in the alternating magnetic field, and the main mechanisms include magnetization relaxation, magnetic hysteresis loss and eddy current loss. For magnetic particles with a size of nanometers to microns, heat is mainly generated through magnetization relaxation and magnetic hysteresis mechanism; while for high-conductivity metal materials with a size of millimeters or more, the eddy current effect is the dominant mechanism, with strong induced current, high heating efficiency and rapid temperature rise. The metal materials commonly used in medical devices, biomedical engineering, and pharmaceutical and food processing (such as pure titanium, titanium alloy, magnesium alloy, aluminum alloy, cobalt-chromium alloy, etc.) have good electrical conductivity and structural size, and are suitable for efficient heating in alternating magnetic field through eddy current effect. Therefore, this strategy not only overcomes the limitations of traditional sterilization methods in terms of thermal sensitivity, material adaptability and residual toxicity, but also provides a new efficient, safe and flexible sterilization solution for many fields.

[0011] Through literature search of prior art, it is found that Chinese patent application No. 201711133143.X, entitled "A high-temperature sterilization system for medical devices and a sterilization method thereof", claims to be "a high-temperature sterilization system for medical devices and a sterilization method thereof, comprising a medical device and a sterilization box, the sterilization box forms a sterilization chamber inside, the sterilization chamber has a positioning assembly and a heating assembly". This patent uses a heat conduction piece to conduct heat to the medical device to achieve sterilization effect and improve sterilization efficiency, but the applicability of the medical device is limited, it needs to meet the pre-set positioning hole, and the contact between the heat conduction piece and the device may still cause incomplete local sterilization, especially for complex shaped devices. Another Chinese patent application No. 201711133152.9, entitled "An ionizing radiation sterilization system for medical devices and a sterilization method thereof", claims to comprise a medical device, an infrared scanning box, an ionizing sterilization box and a controller thereof, which scans the model information of the medical device through an infrared sensor, generates corresponding sterilization instructions, and then sterilizes accurately by an ionizing emitter. However, the use of bone or cesium as a radioactive source in this invention raises the problem of radioactive material management, which may increase the complexity and cost of operation; and the separation of the scanning step and the sterilization step may affect the sterilization efficiency.

[0012] Chinese patent application number 202210880088.5, entitled "Infrared-visible light photothermal photodynamic synergistic low-temperature antibacterial dental implant material", the invention "relates to an infrared-visible light photothermal photodynamic synergistic low-temperature antibacterial dental implant and its preparation method. The material is composed of a pure titanium substrate and a PDA-Cu2O / TNT coating. The TNT is generated in situ on the surface of the substrate by anodic oxidation, Cu2O is combined with TNT to form a heterojunction by electrodeposition, and PDA deposited on it controls the release of copper elements, giving the implant excellent light-responsive antibacterial properties and good bone regeneration function." After coating modification of the implant, the material exhibits antibacterial properties under visible light and near-infrared light conditions, but the preparation process of the material coating is relatively complex, and there may be side effects and safety hazards, which cannot be widely used in clinical practice.

[0013] Chinese patent application number 200510030112.2, entitled "Tumor alternating magnetic field hyperthermia system", the patent describes itself as: "A tumor alternating magnetic field hyperthermia system in the field of medical devices, the invention includes an alternating power supply system, a magnetic field generation system, a magnetic circuit system, a hyperthermia temperature measurement and feedback system, an alternating magnetic field intensity measurement and feedback system, a treatment bed system, a shielding system and a central operation control system." The core principle of this invention is the magnetic hysteresis effect of alternating magnetic field, which concentrates the alternating magnetic field in the air gap area through the magnetic conductor, making the ferromagnetic material implanted in the tumor heat up and kill tumor cells, thereby improving the efficiency and safety of hyperthermia. Chinese patent application number 200910157849.9, entitled "Magnetic induction therapy machine", the patent "relates to the field of magnetic induction therapy for tumor, especially to a magnetic induction therapy machine for treating tumor disease", although it uses artificial methods to implant magnetic materials into the tumor tissue, under the action of external alternating magnetic field, the magnetic materials cut the alternating magnetic force lines and generate alternating current, that is, eddy current, which makes the magnetic materials generate heat energy, thereby heating the tumor tissue and killing tumor cells. The shortcomings of both are that they need to pre-implant ferromagnetic materials into the tumor site, increasing the complexity of the operation. SUMMARY

[0014] To solve the problems existing in the prior art, the present application discloses a high-efficiency sterilization method and device for metal instruments, which uses the eddy current effect of metal medium in alternating magnetic field to generate self-heating and kill pathogenic microorganisms without introducing any reagents or materials, achieving the purpose of simple and efficient bacterial killing. The technical solution is as follows:

[0015] A high-efficiency sterilization device for metal instruments, comprising the following units:

[0016] Alternating power unit: the input end is connected with external standard alternating current, which is converted into alternating current with a frequency of 10 kHz to 1000 kHz, used for driving the coil to generate alternating magnetic field, and the output end is connected with the magnetic field generating unit; the alternating power unit adjusts the frequency and intensity of the output current through PWM modulation technology, so as to control the heat production efficiency of eddy current effect;

[0017] Magnetic field generating unit: the input end receives alternating current, and outputs alternating magnetic field with different intensity to the heating unit; the magnetic field generating unit comprises a multi-gear coil turn number switching module, which is used for adjusting the coil turn number according to the target magnetic field intensity;

[0018] Heating unit: comprising detachable and inductively displaceable electromagnetic induction coil, the coil adopts multi-layer copper winding, the outer layer is covered with high-temperature-resistant polyimide insulation layer, and a quick plug-in interface is arranged, which is suitable for metal instruments with various sizes and shapes; when the metal instrument is placed in the coil, the alternating magnetic field causes the internal eddy current to generate heat spontaneously;

[0019] Temperature monitoring unit: the local temperature distribution of the metal instrument is monitored in real time through optical fiber temperature sensor, infrared thermal imager and other technologies, a built-in PID algorithm controller is arranged, the local temperature is dynamically adjusted, and the output end is connected with the central control unit;

[0020] Circulating water cooling temperature control unit: the magnetic field generating unit and the heating unit are connected through a pipeline, and cold water circulates in the pipeline, so that the temperature of the device is stabilized at 25±1℃;

[0021] Central control unit: connected with each unit through data line, integrated with touch screen operation interface and built-in material database; the database stores the resistivity, magnetic permeability and safety temperature threshold parameters of titanium alloy, stainless steel and cobalt-chromium alloy, and is configured with matching algorithm, so that the alternating frequency, magnetic field intensity and sterilization time are automatically calculated and set according to the instrument material input by the user or the scanning bar code information; the central control unit is also provided with a magnetic field adjusting module, which eliminates the temperature unevenness of the metal instrument by independently controlling the position of the coil, adjusts the alternating current size to change the magnetic field intensity, and eliminates the deviation between the real-time temperature of the metal instrument and the preset target temperature.

[0022] Preferably, the alternating current frequency range output by the alternating power unit is 10 kHz to 1000 kHz.

[0023] Preferably, the electromagnetic induction coil of the heating unit is detachable and inductively movable, which is suitable for metal instruments with different shapes and sizes.

[0024] Preferably, the circulating water cooling temperature control unit cools the key parts of the electromagnetic coil and other devices through cold water circulation, so as to stabilize the temperature of the magnetic field generating unit and the heating unit.

[0025] Preferably, the central control unit has multiple preset sterilization programs, each designed to meet the sterilization requirements of different metal materials.

[0026] This invention also discloses a method for high-temperature sterilization of metal instruments, comprising the following steps:

[0027] Step S1: Instrument loading and material identification

[0028] The metal instrument is placed in the electromagnetic induction coil of the heating unit, and the instrument material is selected or the instrument barcode is scanned through the touch screen of the central control unit to call up the parameters in the built-in material database.

[0029] Among them, the material identification technology: the barcode adopts a label or QR code, which embeds the material, size and batch information of the instrument, and the scanning accuracy is ≥99.9%.

[0030] If you manually select a material, the touchscreen provides a visual material library (including icons and physical property parameters for titanium alloy, stainless steel, and cobalt-chromium alloy).

[0031] Fault tolerance mechanism: If the scan fails or the material does not match, the system automatically starts the infrared spectral analysis module and matches the database through the reflectance spectral characteristics.

[0032] Database scalability: Supports user-defined new materials (such as magnesium alloys), by inputting resistivity ( ρ ), heat capacity ( C The matching program is generated using parameters such as ().

[0033] Step S2: Parameter matching and program startup

[0034] Adaptive learning: The system records data from each sterilization process (such as actual heating rate and temperature difference), and optimizes preset parameters through artificial intelligence algorithms to improve the accuracy of subsequent matching.

[0035] Step S3: Dynamic sterilization and temperature control

[0036] The alternating power supply unit outputs a high-frequency, low-voltage, high-current alternating current to the magnetic field generating unit, which generates an alternating magnetic field that causes the metal instrument to heat up; the temperature monitoring unit provides real-time feedback of local temperature data, and the central control unit initiates magnetic field adjustment to dynamically regulate the temperature;

[0037] If the temperature monitoring unit shows that the temperature difference at different locations of the metal instrument exceeds the threshold, the central control unit adjusts the position of the coil to change the magnetic field strength in that area.

[0038] If the temperature monitoring unit shows that the deviation between the real-time temperature of the metal instrument and the target temperature exceeds the set threshold, the central control unit adjusts the magnitude of the alternating current to change the magnetic field strength.

[0039] Extreme scenario response: If the deviation between the real-time temperature of the metal instrument and the target temperature exceeds the safety threshold, the system automatically powers off, stops the alternating current output, and suspends heating.

[0040] Step S4: Safety protection and cooling

[0041] The circulating water cooling temperature control unit circulates through cold water in the pipeline to maintain the device temperature ≤25℃; if the device temperature exceeds the safety threshold, the central control unit triggers the frequency reduction or emergency stop;

[0042] Emergency stop reset: After stopping, manual confirmation of the fault reason (such as over-temperature, insufficient water level) is required, and after resetting, the system automatically executes the self-checking program (coil impedance detection, sensor calibration).

[0043] Stability verification: 24-hour continuous operation test shows that the temperature fluctuation is ≤±2℃.

[0044] Step S5: Sterilization completion and data recording

[0045] After reaching the preset sterilization duration, the heating is automatically stopped and a sterilization report is generated, recording the temperature curve, energy consumption, and microbial inactivation rate (ATP detection >99.99%).

[0046] Preferably: the sterilization temperature threshold is 121℃ for 20 minutes, or 134℃ for 5 minutes.

[0047] The central control unit automatically matches the sterilization program according to the material type of the metal instrument, including the preset parameters of titanium alloy, stainless steel, and cobalt-chromium alloy. The local temperature uniformity of the metal instrument is monitored by fiber-optic temperature sensors, infrared thermal imagers, etc. If the temperature difference exceeds the set threshold, the central control unit automatically adjusts the magnetic field distribution to eliminate thermal unevenness.

[0048] According to the above-mentioned metal instrument high-efficiency sterilization device, or according to the above-mentioned sterilization method, the metal instrument is an in-vivo implant, including a hip joint prosthesis, a heart stent, or an oral implant, which is instantaneously sterilized by a detachable electromagnetic induction coil during implantation surgery, and the sterilization duration is ≤60 minutes.

[0049] According to the above-mentioned metal instrument high-efficiency sterilization device, or according to the above-mentioned sterilization method, the metal instrument is a surgical instrument, an orthopedic implant, a dental drill bit, or an endoscope, which is used to kill surface and internal pathogenic microorganisms, and the microbial inactivation rate after sterilization is ≥99.99%, and the instrument has no thermal damage or chemical residue.

[0050] According to the above-mentioned high-efficiency metal instrument sterilization device or the above-mentioned sterilization method, the metal instrument is a metal container, pipeline or cutter in a food processing production line, and rapid sterilization is achieved through the alternating magnetic field eddy current effect, the sterilization temperature threshold is 100-200℃, and the sterilization time is ≤60 minutes; the metal instrument is an instrument with an elongated pipeline, an internal cavity or a special-shaped structure, and the local temperature difference is eliminated by adjusting the magnetic field distribution to ensure that the internal cavity temperature uniformity deviation is less than a set threshold.

[0051] Advantages

[0052] High efficiency: Based on the high heat generation efficiency of the magnetic heat effect, the local temperature can be quickly raised, the sterilization time is significantly shortened, and the pathogenic microorganisms can be effectively killed.

[0053] Flexibility: The heating unit can adopt different design structures according to different application scenarios, solving the limitations of traditional fixed sterilization devices, and can be applied to both in-vitro and in-vivo environments.

[0054] Intelligent control: Temperature monitoring is realized to ensure that the temperature is within a safe range and to avoid damage to the instrument. Combined with the central control unit, the whole process is intelligently operated to improve safety and reliability.

[0055] Safety: Compared with chemical disinfection, there is no chemical residue after sterilization, avoiding corrosion to the operator.

[0056] Wide applicability: It is suitable for various metal instruments such as titanium alloy, stainless steel, etc., avoiding corrosion or damage to metal instruments or equipment, and having wide application prospects.

[0057] Cost: Compared with large disinfection and sterilization devices, the magnetic heat effect in the device directly acts on the metal instrument, reducing energy loss, and the cost is lower in terms of equipment investment, energy consumption and maintenance cost. BRIEF DESCRIPTION OF DRAWINGS

[0058] Figure 1 It is a high-temperature sterilization device for metal instruments. DETAILED DESCRIPTION

[0059] The present application is based on the physical phenomenon that metal medium generates eddy current effect in alternating magnetic field. When the metal medium is placed in the alternating magnetic field, the change of the magnetic field will induce eddy current in the medium, thereby raising the local temperature of the metal medium.

[0060] The present application is realized by the following technical solutions, including the following units:

[0061] Alternating power unit: the power input end is connected to the external standard alternating current through wires, and converts it into high-frequency, low-voltage, and large-current alternating current. The power output end is connected to the magnetic field generating unit, and outputs the alternating current to the magnetic field generating unit. The function of the alternating power unit is to convert the external standard alternating current into high-frequency, low-voltage, and large-current alternating current, and to control the heat generation efficiency of the eddy current effect and the electric field strength by adjusting the frequency and intensity of the current.

[0062] Magnetic field generating unit: the power input end is connected to the alternating power unit through wires, receives the alternating current, and converts it into alternating magnetic output to the heating unit. The function of the magnetic field generating unit is to generate alternating magnetic field, and the magnetic field strength can be adjusted according to the needs to ensure that the metal instrument generates sufficient eddy current in the magnetic field. The current frequency is adjusted by the PWM modulation technology of the alternating power unit, and the magnetic field of different intensity is adjusted by combining the coil turn number switching (such as multi-gear selection) of the magnetic field generating unit.

[0063] Heating unit: connected to the magnetic field generating unit, composed of electromagnetic induction coil. The change rate of alternating magnetic field depends on the diameter of the coil, the smaller the diameter, the faster the change rate of magnetic field, the greater the induced electromotive force and eddy current. This unit can replace different electromagnetic induction coils according to needs: integrated coil can place the metal instrument in it; detachable coil can be flexibly assembled according to the special structure of the instrument equipment. The function of the heating unit is to connect the alternating magnetic field, when the alternating magnetic field acts on the metal medium, the eddy current is generated inside the medium, resulting in local temperature rise. The coil adopts multi-layer copper winding, the outer layer is covered with high-temperature resistant insulation material (such as polyimide), the detachable interface is buckle type structure, zipper type structure, irregular shape, etc., which is suitable for instruments of different sizes and shapes.

[0064] Temperature monitoring unit: the input end measures the temperature locally by optical fiber temperature sensor, infrared thermal imager and other temperature measurement methods, and the output end transmits the temperature data to the central control unit through feedback mechanism. The function of the temperature monitoring unit is to measure the temperature of the metal object in real time and feed back to the central control unit for real-time monitoring and adjustment, to ensure that the temperature control is within the safe, stable and effective range.

[0065] Circulating water cooling temperature control unit: the input end is connected to the external power supply, the output end is connected to the magnetic field generating unit and the heating unit through the pipeline, and the water inlet, outlet and liquid level sensor are set. The liquid level sensor signal is transmitted to the central control unit through the feedback mechanism. When the water level is lower than the standard, it will automatically replenish water, and stop when the water level is high, to ensure the stable operation of the device. The function of the circulating water cooling temperature control unit is to cool the magnetic field generating unit and the heating unit to prevent overheating of the device.

[0066] Central Control Unit: The central control unit serves as the control center of the sterilization device. It integrates an industrial-grade processor, supports multi-threaded computation, and enables rapid database access and real-time parameter adjustment. The hardware consists of an operation panel and a computer equipped with integrated control software. It connects to the alternating power supply unit, magnetic field generating unit, temperature monitoring unit, and circulating water cooling temperature control unit via sensors and control lines, acquiring feedback data from these units in real time and adjusting the device through the control lines. The operation panel is a touchscreen used to set sterilization parameters, including current intensity, working time, and circulating water cooling temperature, and displays feedback data from each unit for monitoring the operating status. It can also preset multiple sterilization programs suitable for different types of metal instruments, recording and saving data for subsequent analysis and optimization. The integrated control software is developed using a professional measurement and control software platform.

[0067] The central control unit integrates three levels of safety protection: ① When the deviation between the real-time temperature and the target temperature of the metal instrument exceeds the set threshold, current adjustment is triggered to change the magnetic field strength; ② When the deviation between the real-time temperature and the target temperature of the metal instrument exceeds the safety threshold, the power supply is automatically cut off; ③ When the liquid level is lower than the minimum water level, operation is suspended and an alarm is triggered.

[0068] The central control unit has a built-in material database that automatically matches the frequency, magnetic field strength, and sterilization time according to the material of the instrument.

[0069] The construction and logical matching mechanism of the materials database:

[0070] Database content: The central control unit has a built-in material database that stores the physical property parameters of various metallic materials, including: resistivity (which determines the efficiency of eddy current heat generation); heat capacity and thermal conductivity (which determine the heating rate and uniformity); and safe temperature threshold (to prevent material oxidation or deformation).

[0071] Example 1: Sterilization of titanium alloy implants, taking orthopedic bone screws as an example:

[0072] Material identification: The operator selects "titanium alloy" via the touch screen or scans the instrument barcode, and the central control unit retrieves the titanium alloy parameters from the database;

[0073] Parameter matching: The database automatically matches the preset program: frequency 100 kHz, alternating current 1-10 A, target temperature 121℃, sterilization time 15 minutes;

[0074] Dynamic adjustment: The temperature monitoring unit provides real-time data feedback. If the local temperature difference is ±5℃, the central control unit will adjust the position of the electromagnetic coil to make the temperature distribution more uniform.

[0075] Safety protection: If the temperature exceeds 134℃ (safety threshold), frequency reduction or shutdown will be triggered.

[0076] Example 2: Sterilization of stainless steel surgical instruments, using a stainless steel forceps as an example:

[0077] Parameter matching: stainless steel, frequency 100 kHz, alternating current 1-10 A, target temperature 121℃, duration 15 minutes;

[0078] Dynamic adjustment: the temperature monitoring unit feeds back data in real time, if the local temperature difference is ±5℃, the central control unit changes the displacement of the electromagnetic coil to make the temperature distribution uniform;

[0079] Effect: temperature rises to target value within 3 minutes, temperature difference ±2℃, ATP detection shows that the microbial inactivation rate is >99.99%, and the instrument has no discoloration.

[0080] Example 3: Chair-side sterilization treatment for implant surgery, using oral implant surgery as an example:

[0081] Application description: in oral implant surgery, after the implant is implanted into the alveolar bone, the heating unit is replaced with an electromagnetic coil suitable for the head to perform chair-side sterilization treatment to kill pathogenic microorganisms that may be introduced during the implant surgery.

[0082] Parameter matching: titanium alloy, frequency 100 kHz, alternating current 1-10 A, target temperature 50℃, duration 4 minutes;

[0083] Dynamic adjustment: the temperature monitoring unit detects that the temperature deviation of the implant tip is ±5℃, the central control unit reduces the current, and the temperature difference is adjusted to ±2℃;

[0084] Effect verification: there is no sign of infection in the tissue around the implant.

[0085] Example 4: Preoperative, intraoperative, and postoperative multiple sterilization treatments for in vivo metal implants, using hip replacement surgery as an example:

[0086] Application description: before, during, and after the implantation of metal implants, replace the heating unit with an electromagnetic coil suitable for the local area to perform preoperative, intraoperative, and postoperative multiple sterilization treatments.

[0087] Application scenario: in hip replacement surgery, immediately sterilize the cobalt-chromium alloy implant.

[0088] Parameter matching: frequency 20 kHz, alternating current 0.1-5 A, target temperature 50℃, duration 3 minutes;

[0089] Dynamic adjustment: the temperature monitoring unit detects an internal cavity temperature difference of ±5℃;

[0090] Effect verification: there is no sign of infection in the tissue around the implant.

[0091] The application produces heat efficiently through the eddy current effect of metal instruments in an alternating magnetic field, without the need to introduce any sterilization substance, so as to achieve the purpose of simply and efficiently killing bacteria. The magnetic heating coil connected with the alternating magnetic field in the device has the characteristics of flexible installation and removal and size adjustment, is suitable for instruments and equipment with complex structures and special shapes, and has rich application scenarios.

[0092] The basic principles, main features and advantages of the application are shown and described above. Those skilled in the art should understand that the application is not limited to the above examples, and the above examples and descriptions in the specification are only the principles of the application. Without departing from the spirit and scope of the application, various changes and improvements can be made to the application, and these changes and improvements all fall within the scope of the claimed application. The scope of protection required by the application is defined by the appended claims and their equivalents.

Claims

1. A high efficiency metal instrument sterilization apparatus, characterized by, It comprises the following units: Alternating power supply unit: the input end is connected to an external standard alternating current, which is converted into a high-frequency, low-voltage, and large-current alternating current for driving the coil to generate an alternating magnetic field, and the output end is connected to the magnetic field generating unit; the alternating power supply unit adjusts the frequency and intensity of the output alternating current through PWM modulation technology to control the heat generation efficiency of the eddy current effect; Magnetic field generating unit: the input end receives alternating current, and outputs alternating magnetic fields with different magnetic field strengths to the heating unit; the magnetic field generating unit contains a multi-gear coil diameter switching module for adjusting the coil diameter according to the target magnetic field strength; Heating unit: contains a detachable and inductively displaceable electromagnetic induction coil, the coil uses multi-layer copper winding, the outer layer is covered with a high-temperature-resistant insulation layer, and a quick plug-in interface is provided to adapt to different diameters, different shapes, and heavy and difficult-to-displace metal instruments; when the metal instrument is placed in the coil, the alternating magnetic field induces eddy current in the instrument to generate heat; Temperature monitoring unit: real-time monitoring of local temperature distribution of the metal instrument through optical fiber temperature sensor and infrared thermal imager, built-in PID algorithm controller, dynamic adjustment of alternating current according to the deviation between real-time temperature feedback value and preset target temperature; the output end transmits the processed control signal to the central control unit in real time; Circulating water cooling temperature control unit: connecting the magnetic field generating unit and the heating unit through a pipeline to guide the circulating cold water to the electromagnetic coil; Central control unit: connected with each unit through data line, integrated with touch screen operation interface and built-in material database; the central control unit adjusts the magnetic field according to the temperature feedback, and adjusts the magnetic field strength by adjusting the coil position and current size.

2. The apparatus for high level disinfection of metal instruments according to claim 1, wherein The database stores the resistivity and safety temperature threshold parameters of titanium alloy, stainless steel, and cobalt-chromium alloy, and configures a matching algorithm to automatically calculate and set the alternating frequency, magnetic field strength, and sterilization time according to the user input instrument material or scan bar code information; the database supports user-defined addition of new material parameters, including resistivity and safety temperature threshold, which automatically generates a matching program after input through the touch screen.

3. The apparatus for high level disinfection of metal instruments according to claim 1, wherein The electromagnetic induction coil of the heating unit is detachable and inductively displaceable, which is suitable for metal instruments of different shapes and sizes.

4. The apparatus for high level disinfection of metal instruments according to claim 1, wherein The circulating water cooling temperature control unit ensures the temperature stability of the magnetic field generating unit and the heating unit by circulating cooling water to the electromagnetic coil pipe.

5. The apparatus for high level disinfection of metal instruments according to claim 1, wherein The central control unit presets multiple sterilization programs for different metal materials.

6. A method for high temperature sterilization of metal instruments based on the high efficiency sterilization device for metal instruments according to claim 1, characterized in that, It comprises the following steps: Step S1: instrument loading and material identification; Place the metal instrument in the electromagnetic induction coil of the heating unit, select the instrument material or scan the instrument bar code through the touch screen of the central control unit, and call the parameters in the built-in material database; Step S2: parameter matching and program starting; Step S3: dynamic sterilization and temperature regulation: The alternating power unit outputs alternating current to the magnetic field generating unit to generate an alternating magnetic field to make the metal instrument self-heat; the temperature monitoring unit feeds back local temperature data in real time, and temperature regulation is performed through a PID algorithm; if the temperature difference between different parts of the metal instrument exceeds a set threshold, the central control unit starts magnetic field adjustment to make the electromagnetic induction coil move by induction to eliminate temperature unevenness; if the deviation between the real-time temperature of the metal instrument and the preset target temperature exceeds a set threshold, the central control unit starts magnetic field adjustment to change the strength of the alternating magnetic field by adjusting the size of the alternating current; Step S4: safety protection and cooling: the circulating water cooling temperature control unit maintains the device temperature to be less than a certain temperature through a cold water circulation device; if the device temperature exceeds a safety threshold, the central control unit triggers frequency reduction or emergency shutdown; Step S5: sterilization completion and data recording: after reaching the preset sterilization time, the heating is automatically stopped, and a sterilization report is generated, recording the temperature curve, energy consumption, and microbial inactivation rate.

7. The method of metal instrument high temperature sterilization according to claim 6, characterized in that, The local temperature uniformity of the metal instrument is monitored by an optical fiber temperature sensor and an infrared thermal imager, and if the temperature difference exceeds a set threshold, the central control unit automatically adjusts the magnetic field distribution to eliminate uneven heating; the central control unit immediately starts magnetic field adjustment upon detecting that the temperature difference exceeds the limit.

8. The method of high temperature sterilization of metallic instruments according to any of claims 6-7, characterized in that, The metal instrument is an in-vivo implant, including a hip joint prosthesis, a heart stent, or an oral implant, which is instantaneously sterilized by a detachable electromagnetic induction coil during and after implantation surgery, and the sterilization time is ≤60 minutes.

9. The method of high temperature sterilization of metallic instruments according to any of claims 6-7, characterized in that, The metal instrument is a surgical instrument, an orthopedic implant, a dental drill bit, or an endoscope, which is used to kill surface and internal pathogenic microorganisms, and the microbial inactivation rate after sterilization is ≥99.99%, and the instrument has no thermal damage or chemical residue.

10. The method of high temperature sterilization of a metal device of any one of claims 6-7, wherein, The metal instrument is a metal container, pipeline, or knife in a pharmaceutical or food processing production line, which is rapidly sterilized through the alternating magnetic field eddy current effect, the sterilization temperature threshold is 100-200℃, and the sterilization time is ≤60 minutes; the metal instrument is an instrument with an elongated pipeline, internal cavity, or special-shaped structure, which dynamically eliminates local temperature difference through magnetic field adjustment to ensure that the internal cavity temperature uniformity deviation is less than a set threshold.

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