Sterilization container capable of providing an indication of whether the sterilized surgical instruments in the container have been properly sterilized

Abstract

A sterilization container is used to sterilize at least one surgical instrument. The container includes at least one sensor for measuring an environmental characteristic of the container during sterilization of the instrument. The measured value of the environmental characteristic is provided to a processor. The processor compares the measured value of the container environment to a validated measured value for the sterilization process. If the measured environmental characteristic is at least equal to the validated sterilization process measured value, the processor gives an indication that the surgical instrument is properly sterilized.

Description

[0001] This application is a divisional application of the invention patent application filed on March 12, 2014, with application number 202110493796.9 and invention title "A sterilization container capable of providing a prompt on whether the sterilized surgical instruments in the container have been properly sterilized". Technical Field

[0002] This invention generally relates to sterilization systems for surgical instruments. More specifically, the invention relates to a container and an electronic sensor module for monitoring and verifying that appropriate sterilization measurements have been met during the sterilization process, and a method using the electronic sensor module to determine whether the surgical instruments within the container are properly exposed to a required set of process measurements during a sterilization cycle. Background Technology

[0003] Sterilization of instruments and equipment used in medical and surgical procedures is crucial for preventing postoperative infections in patients. Hospitals and medical facilities utilize various cleaning and sterilization techniques and methods to reprocess contaminated or previously used surgical instruments. Hospitals or medical centers typically include aseptic processing areas for cleaning and sterilizing the facility's medical instruments.

[0004] Aseptic processing areas typically consist of multiple departments, including a cleaning department, a sterilization department, and a sterile storage department. Surgical instruments used during medical procedures are returned from the operating room to the cleaning department. In the cleaning department, surgical instruments are cleaned to remove all visible liquid or solid medical waste and processed through manual or automated cleaning processes. Automated cleaning machines use high-pressure steam containing water and detergent to remove debris and residue from the instrument surfaces. These machines expose surgical instruments to hot water and sometimes to damaging chemicals for a period of time. Some surgical instruments cannot withstand automated cleaning and require manual cleaning.

[0005] After cleaning, the surgical instruments undergo a functional equipment check to inspect for damaged parts or defects. Defective parts are repaired or replaced. The instruments are then prepared for sterilization by placing them in containers. Some surgical instruments require specific geometric orientation during the sterilization process to ensure effective entry, contact, and exit of the sterilizing agent during treatment. These instruments can be grouped together according to the surgical procedure to form a surgical tool kit.

[0006] To maintain the sterility of surgical instruments during post-sterilization handling and storage, instruments are typically placed in various container systems that form a sterile barrier around them. Assuming this barrier is intended to prevent surrounding microbial organisms from adhering to the sterilized instruments, these barriers are sometimes referred to as microbial barriers or SBS (sterile barrier systems). One commonly used container system is constructed from two types of materials: a rigid, impermeable material and a microbial filter. The microbial filter is configured to allow sterilizing agents, typically vapors or gases, to pass through during sterilization but prevent microorganisms, such as mycobacteria, vegetative bacteria, viruses, fungi, and bacterial spores, from entering the container. Another container system uses a perforated rigid material, such as aluminum or stainless steel, and the entire perforated container is encased in a material similar to a microbial filter. The perforated rigid material provides the structure for transporting, handling, and stacking surgical instruments but does not itself prevent microorganisms from entering the container. The sterile barrier material protects the surgical instruments from contamination during post-sterilization handling and storage. The external sterile encapsulation material can be a spin-formed polypropylene encapsulation layer, allowing the sterilization fluid or gas to pass through while forming a microbial barrier. When not using a container system, individual surgical instruments can be packaged with flexible encapsulation materials such as Tyvek, typically consisting of semi-permeable Tyvek on one side to allow sterilizing agents to pass through and impermeable Mylar on the other side to allow the contents to be seen.

[0007] To visually confirm that a surgical instrument container has been exposed to a sterilizing agent, chemical indicators can be added inside and / or outside the sterile barrier system prior to the sterilization process. Chemical indicators are specifically designed for that type of sterilizing agent, gas, or vapor used. Class I chemical indicators, using chemical indicator systems recognized by the FDA and JCAHO, are used in hospitals in the United States. European regulatory bodies currently recognize proof of exposure chemical indicators that provide parameter release, as well as Class I chemical indicators. Class I chemical indicators provide a visual indication that the instrument has been exposed to a sterilizing agent, but do not indicate the degree or duration of exposure. External chemical indicators are typically used so that hospital aseptic staff can determine the location of individual instrument containers within the workflow of that department, while internal chemical indicators are used to indicate to hospital staff that the surgical procedure setup within the sterile barrier has been exposed to a sterilizing agent. If the external chemical indicator does not indicate sterilizing agent exposure within the aseptic department, the surgical instrument assembly must be processed to ensure sterility. If the internal chemical indicator does not indicate sterilization exposure when the container is opened, the container and equipment must be returned to the aseptic processing unit for reprocessing, typically starting with the cleaning process. Determining that the container of surgical equipment has not been exposed to sterilization during surgical procedure preparation is detrimental to the efficiency of the operating room and requires another set of surgical equipment to be positioned and correctly set up, ultimately leading to scheduling delays and / or other adverse disruptions. Different types of chemical indicators have been developed, including tapes, paper strips, and catalytic activation systems. Tapes, labels, and paper strips are printed with ink that changes color when exposed to a specific sterilizing agent or chemical. One-piece paper or wick paper is manufactured with ink or chemical at one end that melts over time at a predetermined process value and is carried away along the paper by capillary action. If the process value is met, the colored strip reaches the permissible area. Chemical indicators for different types of sterilization are different, and therefore the visual changes of chemical indicators vary across various sterilization methods. Sometimes, the color change indicating exposure to one form, such as steam sterilization, is opposite to the color change used for a different form of sterilization, such as hydrogen peroxide sterilization. This can confuse healthcare workers when reading and interpreting different color changes of chemical indicators.

[0008] Once the surgical instruments are fully packaged and ready for sterilization, the surgical instrument set undergoes a sterilization process to destroy microorganisms. Various sterilization methods and reagents have been used to sterilize surgical instruments.

[0009] Saturated steam heat is a sterilizing agent used to destroy microorganisms. Pressure above atmospheric pressure is necessary to raise the temperature of the steam used to destroy microorganisms, which presents a significant challenge. Saturated steam with the required temperature and time must penetrate and reach every surface of the items to be sterilized. The sterilization chamber contains the items to be sterilized. When steam initially enters the sterilizer chamber under pressure, it condenses upon contact with the cold items. This condensation releases heat, simultaneously heating and wetting the items in the load. The entire load must be exposed to this moist heat for a minimum duration and at a minimum defined temperature to achieve sterilization. For example, a type of surgical instrument set might require 34 minutes at 270 degrees Fahrenheit to destroy microorganisms, and an additional 20 minutes under vacuum to dry the instruments within the sterile barrier so that condensate does not accumulate within the sterile barrier. Minimum temperature-time and steam concentration relationships must be maintained throughout all parts of the sterile barrier and across the load throughout the sterilization chamber to complete sterilization. The time, temperature, and steam concentration used to destroy microorganisms depend on many factors. For example, the dimensions, surface area, thermal mass, orientation, and depth of the cavity within the sterile barrier containing the contents, as well as the steam penetration characteristics of the sterile barrier used, can all affect the reliability of microbial destruction. After steam circulation is complete, the condensate of water must evaporate to dry the contents and maintain sterility. A vacuum can be applied within the cavity to aid in the evaporation of any remaining water. Conventional references for determining appropriate sterilization exposure times are listed in Table 5, which is directly obtained from ANSI / AAMIST79:2010 / A2:2011 “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, Amendment 2”.

[0010] Table 5-Minimum cycle times for dynamic-air-removal steamsterilization cycles

[0011]

[0012] NOTE-This table represents the variation in sterilizer manufacturers' recommendations for exposure at different temperatures. For a specific sterilizer, consult only that manufacturer's recommendations.

[0013] Some surgical instruments, such as gastroscopes and endoscopes, are sensitive to the steam and high temperatures required for steam sterilization. Hydrogen peroxide vapor is another reagent used to sterilize surgical instruments. Hydrogen peroxide is vaporized from outside the sterilization chamber in a defined reaction chamber. The vaporized hydrogen peroxide is introduced into the sterilization chamber, where it contacts the sterile barrier and passes through it to contact the contents of the container to be sterilized. Hydrogen peroxide vapor is introduced into the sterilization chamber containing the items to be sterilized. Current hydrogen peroxide sterilizers typically operate at temperatures much lower than steam sterilizers, with a maximum temperature of approximately 122 degrees Fahrenheit for hydrogen peroxide sterilizers. Minimum hydrogen peroxide concentration, a "pulse cycle" of pressure changes, and the temperature over time need to be maintained throughout the load to complete sterilization. After the hydrogen peroxide vapor circulation is complete, the remaining and condensed hydrogen peroxide is blown out of the chamber. RF energy can be used during this ventilation phase to power the remaining hydrogen peroxide vapor, creating plasma to facilitate this ventilation process. Some older plasma systems use RF energy during the sterilizing agent exposure phase, hoping that the plasma phase will be more effective at killing microorganisms than the steam phase. Residual hydrogen peroxide needs to be removed from surgical instruments and packaging before use to prevent burns and injuries to healthcare workers and patients.

[0014] Other liquid and gaseous agents can also be used to sterilize surgical instruments, such as ethylene oxide gas, formaldehyde gas, and ozone gas. These sterilizers, like the hydrogen peroxide sterilizer described above, use “low-temperature” sterilization conditions, allowing them to be used as an alternative to potentially destructive high-temperature steam sterilization on sensitive medical devices. Unfortunately, these gases are slightly more toxic and / or difficult to control during the sterilization process, so they are not particularly commonly used in hospital systems.

[0015] Industry regulations for medical devices require Original Equipment Manufacturers (OEMs) to provide hospitals and healthcare providers with guidance on the proper use and maintenance of reusable medical devices. OEMs can be designers, manufacturers, or distributors of reusable medical devices. Within the reusable medical device category, some devices and instruments may become contaminated during use with biological material from patients, such as bodily fluids, mucus, and tissue, necessitating cleaning and / or sterilization before reuse. Certain reusable medical devices, such as colonoscopes, cannot be sterilized using equipment in hospital central processing units. Based on risk and benefit analyses, sterilization can be replaced by high-level disinfection of these devices. A generally acceptable definition of a sterilization process is “reducing 10^6 organic matter to zero,” while a high-level disinfection process is “reducing 10^3 organic matter to zero.” Sterilization is defined as the Assurance Level of Sterility (SAL), which utilizes the “overkill method” to demonstrate the 12-log removal rate (12 log) of the most challenging organic matter for the sterilization method being employed. (reduction). 12 logarithmic removal rate refers to the probability that a single viable organic matter will survive the sterilization process in one part per million. Disinfection is defined in three categories: High-level disinfection (HLED): kills many or all pathogenic microorganisms, except bacterial spores; Medium-level disinfection (ILED): may use cidal for mycobacteria, vegetative bacteria, most viruses, and most fungi; but does not necessarily kill bacterial spores; and Low-level disinfection (LLED): kills most vegetative bacteria, some fungi, and some viruses. OEMs are responsible for providing healthcare providers with accurate cleaning and sterilization (or disinfection) guidance. OEMs are not allowed to arbitrarily choose cleaning and sterilization technologies before selling new reusable medical devices; they are required to validate the cleaning and sterilization processes. For steam sterilization validation, OEMs may use the US National Standard ANSI / AAMI ST79 in the US and ISO in other international standards. 17665-1. All of the above standards are incorporated herein by reference. These standards include sterilization (or disinfection) validation test protocols for cleaning and sterilization methods used by OEMs, so that healthcare organizations are not required to individually validate these methods using their sterilization equipment for each medical device they purchase. Even if these standards are accepted by healthcare regulators and providers throughout the medical device industry, there is still the possibility of human error, uncontrollable variations, and equipment problems with the sterilization system that could enter the healthcare delivery system and lead to inconsistent sterilization or disinfection results for reusable medical devices. For example: An OEM validates a new set of devices according to a generic standard. The generic standard requires the use of organic compound X for inoculating the new set of devices with a given sterilizing agent.OEMs adhere to general protocols and validate the new equipment to 10E-6 Aseptic Assurance Level (SAL) using nominal steam process values ​​in small-chamber autoclaves (e.g., 14” x 14” x 24” chambers capable of holding only one unit of equipment. OEM guidance from SAL validation might include: wrapping with Class 500 packing material, pre-vacation circulation, sterilization temperature 132°C, exposure time 4 minutes, and drying time 30 minutes. Hospitals establish aseptic barrier systems and follow all instructions, but not with single-container autoclaves; these systems have chambers capable of holding 40 aseptic barrier systems. The container features a large steam autoclave and a pulley system capable of rolling the loaded rack into the autoclave. Uncontrollable variables: The OEM validated their equipment at an ambient temperature of 25°C (pre-sterilized equipment started at 25°C), while the hospital stored their pre-sterilized equipment in a controlled environment at 20°C. Thermodynamically, the lower starting temperature and much larger total cavity load in the hospital reduced the actual exposure time to steam / temperature to below empirically proven levels for proper organic degradation. Human error: The hospital correctly followed all instructions, but no containerized heavy medical devices were included within the sterile barrier system. This resulted in internal issues within the sterile barrier system. Temperature rises and falls across all equipment. Example of a sterilization equipment problem: A power spike causes the sterilizer to advance by one minute, thus shortening the actual exposure duration by the same amount. Similar examples can occur with other sterilization processes, such as hydrogen peroxide sterilization. Another factor that can cause problems with the sterilization of medical devices is the sterilization of mixed loads of equipment in a single process. In this example, a mixed load consists of medical devices with containers sterilized together for the same sterilization duration but different drying times. If this occurs, some residual moisture may remain in the equipment, requiring a longer drying time. This residual moisture may be wicked up. Absorption causes watermarks to form on the SBS wrapping material used on perforated containers, but these watermarks are not detected until operating room staff are preparing equipment for the next surgical procedure. Once operating room staff discover watermarks during preparation, they must return all equipment to the aseptic processing department for reprocessing. SBS material is designed to lose its antimicrobial properties if it becomes wet. Because it is unknown when or how the equipment became wet, the presence of watermarks leads to suspicion of the entire equipment group, requiring reprocessing. These are just some examples of problems that necessitate better systems and solutions for delivering healthcare services effectively and safely.

[0016] Furthermore, current practice, as part of the sterilization process for surgical instruments, involves testing to verify that the sterilizer is functioning correctly. This testing utilizes biological indicators. Biological indicators include known numbers and types of microorganisms that exhibit significant resistance to the sterilization method being practiced.

[0017] Biological indicators are placed in trays or containers and subjected to a specific sterilization process. Biological indicators may be placed within a sterile barrier and encapsulation layer prior to processing, exposing them to sterilizing agents similar to surgical instrument sets. Many biological indicators currently in use are stand-alone. Stand-alone biological indicators have an outer shell sealed to a microbial barrier material, providing a pathway for the sterilizing agent to pass through and reach the biological reagent but preventing the entry of other microorganisms. These biological indicators do not require containers or encapsulation materials during use.

[0018] Therefore, different biological indicators are typically used for each type of sterilization process used in the aseptic processing department. This necessitates training the aseptic processing department to correctly perform biological indicator testing for each type of sterilizer and sterilization process within the department. For example, if a hospital has both autoclave steam and hydrogen peroxide equipment, the aseptic processing department must purchase and maintain both types of biological indicators and provide training to handle them correctly. Furthermore, hydrogen peroxide equipment from different manufacturers often requires the use of specific biological indicators in this testing process. So, if the aseptic processing department has two hydrogen peroxide systems, each manufactured by a different company, the department needs to be proficient in operating both biological indicator tests, one system at a time. Bacterial spores have been used as biological indicators. Biological indicators are sealed or encapsulated in secure packaging. After exposure to the sterilization process, the biological indicators are placed in a culture medium and incubated for a period of time before being read by staff. For example, biological indicators for autoclave steam sterilizers utilize 10... 6 The population of thermophilic *Bacillus stearothermophilus* was cultured in a medium for at least 24 hours. For hydrogen peroxide sterilization, 10... 6 The population of *Bacillus stearothermophilus* was cultured in a medium at a specific temperature for 24 hours. Subsequent culturing of the biological reagent indicated sterilization failure, and the subsequent non-growth of the biological reagent microorganisms under appropriate conditions indicated correct operation of the sterilization process for that specific cycle. Because the biological reagents used in the biological indicators are more resistant to their specific sterilizing agents than common microorganisms that may be found on surgical instruments, the evidence of the biological indicators' deactivation provides assurance that other microorganisms, including pathogens that may be present in the load, have also been destroyed.

[0019] For hydrogen peroxide sterilizers, a typical aseptic process unit performs a biological indicator test every 24 hours as a check for proper operation of the equipment. The biological indicator test is usually run automatically or using the first batch of medical devices processed by the sterilizer machine that day. A biological indicator test can take up to 24 hours to complete. Therefore, subsequent loads of surgical instruments and tools are quarantined based on the time required to complete the biological indicator test to confirm that the sterilizer is functioning correctly.

[0020] Many sterilization processes take less than an hour. However, because it is necessary to verify that the sterilizer is functioning correctly, instruments may be quarantined for up to an additional 24 hours to obtain results from biological indicator tests. This means that in a hospital, at any given time, a considerable number of surgical instruments may be under quarantine. This necessitates that hospitals maintain a large inventory of surgical instruments so that a substantial number of instruments can be sterilized and available at any given time. Requiring hospitals to maintain this large inventory of instruments can increase hospital maintenance costs.

[0021] If the biological indicator test fails, then all surgical instruments in that batch processed in the sterilizer machine may have been non-sterile because of the last biological indicator test. In this case, the equipment must be reprocessed and sterilized.

[0022] If the first biological indicator test indicates that the sterilizer is functioning correctly, it is assumed that the sterilizer has sterilized the instruments placed within it until the next biological indicator test is performed. This assumption remains even though there is a possibility that the sterilizer may begin to malfunction between these two successive tests. The possibility that the sterilizer has begun to malfunction may not be known until the results of the second biological indicator test are read. However, during this period, the equipment sterilized between the first and second tests may have been released from quarantine and used in surgery. This means that the equipment used on the patient may not have been properly sterilized.

[0023] In addition, performing biological indicator tests requires resources that include the time of hospital staff.

[0024] The current process for determining the correct operation of sterilization procedures for various sterilization equipment, as well as for using microbial barriers for subsequent storage and use, presents numerous problems, increasing the time and cost of the entire sterilization process. Using microbial barriers and encapsulation materials to package surgical instruments increases the cost of purchasing materials and the time required for departmental staff to encapsulate and manufacture sterile barriers containing surgical instruments. Using microbial barriers also increases the difficulty of sterilizing agents entering the encapsulated package and completing sterilization, especially for low vapor pressure sterilizing agents, such as hydrogen peroxide vapor. Variations in sterilization barrier materials and how they are applied can cause variations in the concentration of sterilizing agents within the encapsulated package. Changes in mass, constituent materials, and the surface area of ​​the instrument load can also cause variations in the concentration of sterilizing agents within the encapsulated package.

[0025] Using chemical indicators increases the cost of purchasing them and the time required for department staff to place and read them. Using biological indicators increases the cost of purchasing them and the time required for department staff to place, culture, and subsequently read the results.

[0026] If a chemical or biological indicator test fails, all unused surgical instruments processed in that sterilizer machine must be reprocessed, undergoing cleaning and sterilization again due to the last acceptable test, increasing time, cost, and the required surgical instrument inventory. As discussed above, there is a possibility that instruments that have not been sterilized may be used on patients. If this occurs, appropriate measures may be required. Additionally, if the sterilizer has a device or process problem during a biological culture phase, the problem may not be detected until the subsequent biological indicator (BI) culture phase is read (by reading the failed biological indicator in a subsequent test). This allows for the possibility of releasing medical devices from quarantine from the moment the problem occurs (during the first culture phase) until the BI test fails.

[0027] Another problem with current processes for validating sterilization procedures is that many steps in the process depend on human action and judgment, and are therefore susceptible to human error. Human error can occur when surgical instruments are incorrectly oriented and placed on supports and containers. Human error can occur when items are placed in a way that obstructs the flow of sterilizing agent into the container and adversely affects the sterilization efficiency of those items. Human error can occur when too many instruments are placed in the container, adversely affecting sterilization efficiency. Human error can occur when containers are stacked one on top of the other, preventing the sterilizing agent from flowing freely into all of them. Human error can occur when the sterilization machine is operated incorrectly. Human error can occur when chemical indicators are incorrectly placed and read. Human error can occur when biological indicators are incorrectly prevented, cultured, and read. Summary of the Invention

[0028] This invention relates to a novel and useful system and method for determining whether a surgical instrument has completed a sterilization cycle and whether a desired set of measurements has been met during that cycle. The system includes a container defined by multiple panels. These panels define a cavity within the container and an opening for entry into the container. The container receives surgical instruments, possibly located within a removable tray, into the cavity. A lid is engaged with the container and is movable between an open position and a closed position. A sensor module is mounted to the container. The sensor module includes one or more sensors. These sensors are configured and positioned to monitor at least one characteristic of the environment within the container. The sensor module includes a processor with instructions on how to interpret the environmental measurements obtained from the sensors.

[0029] The containers of these instruments are placed inside a sterilization chamber, the chamber door is closed, and a sterilization cycle is performed. Sensors monitor changes in the characteristics of the container environment as a result of the sterilization cycle. The processor compares the environmental measurements obtained by the sensors with measurements from previous validated sterilization processes. These validated sterilization process measurements are measurements of the container environment obtained during a previous sterilization process, which has subsequently been shown to be successful.

[0030] If the assessment of environmental measurements indicates that the environment within the container is sufficient to achieve successful sterilization of the instruments, the processor indicates that the surgical instruments have been successfully sterilized. Alternatively, the assessment may indicate that the container environment is not conducive to the successful sterilization of the instruments within the container. If this is the assessment result, then the processor indicates that the instruments have not been properly sterilized.

[0031] The advantage of this system is that, shortly after the sterilization process is performed, an indication is provided as to whether the instruments have been exposed to the process in which they were properly sterilized. Attached Figure Description

[0032] The specific features of the invention are pointed out in the claims. The above and other features and advantages of the invention will be understood from the following detailed description given in conjunction with the accompanying drawings, wherein:

[0033] Figure 1 This is a block diagram of a sterilization chamber used for sterilizing medical / surgical instruments;

[0034] Figure 2 This is a top perspective view of a container for sterilizing medical / surgical instruments according to one embodiment of the present invention, showing the container separated from the cap and instrument support;

[0035] Figure 3 yes Figure 2 A perspective view of the container, illustrating that, according to one embodiment, the electronic sensor module is separated from the container;

[0036] Figure 4A This is a rear view of an electronic sensor module according to one embodiment;

[0037] Figure 4B This is a front view of the electronic sensor module;

[0038] Figure 4C This is a cutaway view of the front of the electronic sensor module;

[0039] Figure 4D yes Figure 4A A bottom view of the module;

[0040] Figure 5 This is a top perspective view of an automatically closing container for sterilizing medical / surgical instruments according to one embodiment, wherein the lid is in the open position;

[0041] Figure 6 yes Figure 5 A top-view perspective view of an automatically closing container, with the lid in the closed position;

[0042] Figure 7A This is an exploded perspective view of a container for sterilizing medical / surgical instruments according to one embodiment, the container having a fall-proof bottom;

[0043] Figure 7B yes Figure 7A An enlarged partial cross-sectional view of the lid;

[0044] Figure 7C yes Figure 7A An enlarged cross-sectional view of one side wall embodiment of the container, illustrating details of the hermetic connector and internal light-emitting diodes;

[0045] Figure 7D yes Figure 7A An enlarged cross-sectional view of another side wall embodiment of the container, illustrating details of the hermetic connector and external light-emitting diode;

[0046] Figure 8 This is an exploded perspective view of a container for sterilizing medical / surgical instruments according to one embodiment, the container having a fault-proof side;

[0047] Figure 9A This is an exploded perspective view of another container for sterilizing medical / surgical instruments according to one embodiment, the container having a sensor mounted in the lid;

[0048] Figure 9B yes Figure 9A A bottom view of the lid;

[0049] Figure 10This is an exploded perspective view of another container for sterilizing medical / surgical instruments according to one embodiment, the container having sensors mounted on a tray or support;

[0050] Figure 11A This is an exploded perspective view of another container for sterilizing medical / surgical instruments according to one embodiment, the container having a removable optical sensor module mounted thereon.

[0051] Figure 11B yes Figure 11A Top-view assembly perspective of the removable optical sensor module;

[0052] Figure 11C yes Figure 11A A top-view assembly perspective of the container;

[0053] Figure 12A This is a top perspective view of a sensor printed circuit board for sensing steam concentration and other characteristics of the environment inside a container, according to one embodiment.

[0054] Figure 12B This is a top perspective view of another sensor printed circuit board used for sensing hydrogen peroxide concentration and other environmental characteristics according to one embodiment;

[0055] Figure 12C This is a top perspective view of a sensor printed circuit board for sensing hydrogen peroxide concentration and other environmental characteristics according to one embodiment.

[0056] Figure 13 This is an electrical block diagram of an electronic sensor module according to one embodiment;

[0057] Figure 14 It is a block diagram of a software program or instruction set stored in a memory or machine-readable medium according to one embodiment;

[0058] Figure 15 This is a perspective view of a docking station used with a container according to one embodiment;

[0059] Figure 16 This is a perspective view of another docking station, including sensor calibration, used with a container according to one embodiment;

[0060] Figure 17 yes Figure 15 and 16 A block diagram of the controller for the docking station;

[0061] Figure 18 This is a block diagram of a networked computer system for tracking container usage and billing, according to one embodiment.

[0062] Figure 19A-1 and19A-2 When placed side by side, they together constitute the equipment to be sterilized; empirically verified sterilization process measurements used in this equipment; sensor module usage data; sterilizer process nominal parameters; and a list of container identification data;

[0063] Figure 19B-19E It is a list of devices capable of sterilization based on specific content identifiers and at least some of the weight of the device;

[0064] Figure 20A This is a perspective view of an automatically closing cap installed on a container lid according to one embodiment;

[0065] Figure 20B yes Figure 20A Cross-sectional view of the automatic closing cap;

[0066] Figure 20C yes Figure 20A An exploded 3D view of the automatic closing cap;

[0067] Figure 21 This is a flowchart of a method according to one embodiment for determining whether empirical sterilization process measurements within a container are obtained during a sterilization process;

[0068] Figure 22 This is a flowchart of a method for verifying container environment measurements according to one embodiment;

[0069] Figure 23 This is a flowchart of another method for determining and validating sterilization process measurements according to one embodiment.

[0070] Figure 24 This is a flowchart of an additional method for determining and validating measurements during a sterilization process, according to one embodiment;

[0071] Figure 25 This is a flowchart of a method for monitoring the sterility of container components according to one embodiment;

[0072] Figure 26 This is a flowchart of a method for loading surgical instruments into a container assembly prior to sterilization, according to one embodiment;

[0073] Figure 27 This is a flowchart of a method for calibrating a sensor according to one embodiment;

[0074] Figure 28 This is a flowchart of a method for monitoring container usage and billing based on a single usage fee, according to one embodiment;

[0075] Figure 29This is a top perspective view of a container and lid including a removable sensor assembly for sterilizing medical / surgical instruments according to one embodiment.

[0076] Figure 30 This illustrates the installation of a removable sensor assembly into the container. Figure 29 A cross-sectional view of the container;

[0077] Figure 31 yes Figure 29 Exploded perspective view of the removable sensor assembly;

[0078] Figure 32 yes Figure 29 Exploded cross-sectional perspective view of the removable sensor assembly;

[0079] Figure 33 This is an enlarged cross-sectional view of the receiver casing;

[0080] Figure 34 This is an enlarged cross-sectional view of the receiver cover and retaining ring;

[0081] Figure 35 This is an enlarged cross-sectional view of the carrier assembly;

[0082] Figure 36 This is an enlarged cross-sectional view of the removable sensor module;

[0083] Figure 37A This is a rear view of the printed circuit board of the removable sensor module;

[0084] Figure 37B This is a front view of the printed circuit board of the removable sensor module;

[0085] Figure 38 This is a front view of the container's printed circuit board;

[0086] Figure 39 This is an assembly cross-sectional view of the removable sensor assembly, showing that the removable sensor module is separated from the receiver.

[0087] Figure 40 This is an assembly cross-sectional view of the removable sensor module, showing the initial position of the removable sensor assembly in the receiver;

[0088] Figure 41 This is an assembly cross-sectional view of the removable sensor module, showing that the internal locking mechanism is actuated and the plate is opened to expose the sensor to the internal environment of the container.

[0089] Figure 42 This is an assembly cross-sectional view of the removable sensor module, showing that the removable sensor module is in the locked position and ready to collect data during the sterilization process cycle;

[0090] Figure 43 This is an assembly cross-sectional view of the removable sensor module, showing the board closed and the removable sensor module removed from the receiver;

[0091] Figure 44 According to one embodiment, it includes and Figure 29 A three-dimensional view of a docking station where sensor calibration is performed using removable sensor assemblies.

[0092] Figure 45 According to one embodiment, it is used for utilization Figure 29 A flowchart of a method for determining whether empirical sterilization process measurements within a container have been completed using a container and a removable sensor assembly;

[0093] Figure 46 This is an exploded top perspective view of an automatically closing container assembly for sterilizing medical / surgical instruments according to one embodiment.

[0094] Figure 47 yes Figure 46 An enlarged top-down perspective view of the scissor-type lifting mechanism within the automatic closing container assembly;

[0095] Figure 48 These are enlarged cross-sectional views of the movable frame and container; and

[0096] Figure 49 According to one embodiment, it utilizes Figure 46 The flowchart describes a method for automatically closing container components to determine whether empirical sterilization process measurements obtained within the container have been met or exceeded.

[0097] Figure 50 This is a flowchart of a method for determining whether empirical sterilization process parameters within a container are met during a steam sterilization process, according to one embodiment.

[0098] Figure 51 It is used for Figure 50 A graph illustrating examples of steam process measurements versus time using this method;

[0099] Figure 52 This is a flowchart, according to one embodiment, of a method for determining whether empirical sterilization process parameters within a container are met during a hydrogen peroxide sterilization process; and

[0100] Figure 53 It is used for Figure 52 The method is illustrated in the graph, which shows an example of the measured values ​​of hydrogen peroxide process versus time. Detailed Implementation

[0101] I. Summary

[0102] Figure 1 A sterilization apparatus 50 for sterilizing medical and surgical instruments is illustrated. The sterilization apparatus 50 includes a sterilization chamber 52 for holding one or more sterilization containers 58. Each container 58 can hold one or more surgical instruments to be sterilized. The sterilization chamber 52 includes a container vessel 54 that can be sealed after a door 56 is closed. The container vessel 54 has one or more shelves 60. Containers 58 are arranged on the shelves 60.

[0103] The sterilization chamber 52 also includes a vacuum pump 64. The vacuum pump 62 reduces the pressure within the protector 54 to below atmospheric pressure. Sterilizing agents or disinfectants are injected into the protector 54. Different sterilizing agents can be used, including gaseous water vapor or steam (H2O) 70, hydrogen peroxide gas (H2O2) 74, or gaseous ethylene oxide (C2H4O) 74. During the sterilization cycle, at least one of the sterilizing agents is introduced into the protector 54.

[0104] During the sterilization cycle, using protector 54, the sterilizing agent is required to contact all surgical instruments at the desired concentration for the required time to achieve sterilization. After the sterilization cycle is complete, the sterilization chamber must be purged of all residual or condensed sterilizing agent. The removal rate of sterilizing agent from this chamber is increased by using vacuum pump 64. A vacuum is drawn within protector 54, causing all condensed sterilizing agent to evaporate into a gaseous state and be removed.

[0105] The sterilization chamber 52 is operated using a set of chamber process parameters (CPP) 66. CPP 66 are the environmental operating conditions generated by the sterilization equipment 50 within the protector 54. In one exemplary embodiment, CPP 66 includes temperature, pressure, humidity, hydrogen peroxide vapor, and time.

[0106] II. First Container Embodiment

[0107] Turning Figure 2 This illustration shows a container assembly 90 according to a first embodiment of the present invention. The container assembly 90 includes a container 100, which is generally rectangular in shape and defined by a planar front panel 102, a planar rear panel 103, and a pair of planar side panels 104 spaced apart. Panels 102 and 103 are oriented orthogonally to panel 104. A planar bottom panel 106 is perpendicular to panels 102, 103, and 104 and forms the bottom of the container 100. An inner cavity 120 is defined within the container 100 by panels 102, 103, 104, and 106. The container 100 has an outer surface 110, an inner surface 112, and an upper peripheral edge 113. The container 100 may be formed from materials such as stamped or deep-drawn aluminum, stainless steel, plastic, or other suitable materials.

[0108] The front panel 102 has a window or opening 114 defined therein. The opening 114 is covered by a panel 116 formed of a transparent material such as acrylic or glass. The transparent panel 116 allows the user to visually see the contents of the container 100. The panel 116 is sealed to the adjacent panel 102. The panel 116 is placed on the front panel 102, but may be placed on the back panel 103 or the side panel 104.

[0109] Each side panel 104 has a recess 122 defined on its outer surface 110, the recess 122 extending from just above the bottom panel 106 to just below the edge 113. A series of holes 124 are defined to pass through the recess 122 and extend into the cavity 120. A pivot handle 126 is attached to each side panel 104 and extends across the width of the recess 122. The handle 126 is located adjacent to a storage position of the recess 122 (e.g., Figure 2 (as shown in the diagram) and a transport position in which the handle 126 extends perpendicularly to the side panel 104. The handle 126 allows the user to grip and lift the container 100.

[0110] A pivot bolt 128 is attached to each side panel 104 via a hinge 130 below the edge 113. The bolt 128 has a U-shaped rail portion 132 that mates with a portion of the lid 150. The bolt 128 allows the user to releasably lock the lid 150 to the container 100. A pair of spaced-apart L-shaped side rails 136 are mounted to the inner surface 112 on opposite sides of the recess 122 and extend vertically toward the cavity 120 away from the inner surface 112. An L-shaped bottom rail 137 is mounted between the two ends of the rails 136 located at the bottom of the recess 122. A barcode or RFID tag 135 (…) Figure 3 It is mounted on the outer surface 110 of the side panel 104. The barcode or RFID tag 135 may contain information related to the container assembly 90, such as the container type or the contents of the container 100.

[0111] Filter assembly 140 is mounted within cavity 120, adjacent to the inner surface 112 of side panel 104. Each filter assembly 140 is supported and held by L-shaped guide rails 136 and 137. Filter assembly 140 covers orifice 124. Filter assembly 140 is generally square in shape and has a square frame 142 and filter material 144 mounted within the frame 142. Filter material 144 is a microbial barrier material permeable to sterilizing agents. Here, "sterilizing agent" should be understood as a gas, vapor, or aerosol having the ability to remove biological contaminants, including harmless microorganisms. Filter material 144 allows sterilizing agent to enter cavity 120 from container 100, through orifice 124, through filter material 144, and into the cavity, where sterilizing agent can contact surgical instruments 180. Filter material 144 also forms a microbial barrier preventing microorganisms from entering container 100 after sterilization.

[0112] The filter assembly 140 is positioned such that the user inserts the frame 142 and slides the frame 142 along the side rails 136 until the frame 142 abuts against the bottom rail 137. The rails 136 and 137 are sized to force the filter assembly 140 against the inner surface 112 of the side panel 104 when inserted into the rails 136 and 137. The rails 136, 137 and the frame 142 are sized to form a seal between the outer periphery of the frame 142 and the inner surface 112 when the filter assembly 142 is installed in the container 100. The filter assembly 140 is hermetically mounted to the inner surface 112 of the container 90 to form a continuous microbial barrier with the adjacent inner surface 112 of the panel.

[0113] A cover 150 is used to cover and close container 100. Cover 150 includes a generally rectangular frame 152 surrounding a transparent window panel 154. Cover 150 has a top surface 155 and a bottom surface 156. Frame 152 may be formed of a material such as stamped aluminum or other suitable materials. The transparent panel 154 is formed of a transparent material such as acrylic or glass. The transparent panel 154 allows a user to visually see the contents of container 100. A pair of blocks 157 are mounted to opposite sides of frame 152. Each block 157 defines a straight groove 158 extending through its length. A locking portion 132 of bolt 128 engages with the groove 158 to hold cover 150 to container 100. The locking portion 132 is positioned within the groove 158, and bolt 128 is pivoted downwards to a removable locked position where cover 150 is securely locked to container 100. An elastic seal (not shown) is mounted to the cap frame 152. When the cap 150 is mounted on the container 100, the elastic seal prevents microorganisms from entering the interior of the cap and the container 100 by sealing the gap between the cap and the upper peripheral edge 113 of the container 100, thereby completing the encapsulation for preventing microorganisms from entering the interior where the surgical instrument 180 is placed.

[0114] During aseptic processing, a support or tray 160 is used to hold a medical / surgical instrument 180 within the container 100. The support 160 includes a generally rectangular base 162 with four walls 164 extending vertically upward from the base 162. A pair of spaced-apart handles 165 are attached to opposing walls 164, allowing a user to lift the support 160. An aperture 166 is defined within the base 162. A plurality of support members 168 extend upward from the base 162.

[0115] Medical / surgical instruments 180 are placed on and supported by support members 168. Support members 168 are sized and shaped to hold the medical / surgical instruments 180 in a preferred orientation for sterilization. In one embodiment, the medical / surgical instrument 180 may be a manual instrument, such as a scalpel, forceps, or bone chisel. In another embodiment, the medical / surgical instrument 180 may be a power instrument, such as a rotary head, drill, or endoscope. Reusable medical / surgical instruments require cleaning and sterilization before reuse to eliminate any potential microorganisms. Medical / surgical instruments 180 with dead-end lumens need to be oriented during automated cleaning and sterilization to ensure the lumen is horizontal or downward-pointing, preventing fluid buildup and allowing sterilizing agents to enter and exit the lumen.

[0116] An electronic sensor assembly or module 200 is mounted below the front panel 102 and window 114. The electronic sensor module 200 contains electronic components and sensors that measure environmental conditions within the container 100. These components also determine whether the required conditions have been met to ensure the sterility of the contents of the container 100. The electronic sensor assembly 200 can be mounted to other container panels, such as the back panel 103, side panel 104, or lid 150.

[0117] refer to Figure 3 Further details of the container 100 and the electronic sensor module 200 are shown. The container 100 also includes a raised portion 190 extending upward from the base of the window 114. A ramp portion 192 extends between the base of the window 114 and the raised portion 190. A pair of spaced-apart holes 194 are defined in the panel 116. An opening 196 is defined in the transparent panel 116, above the raised portion 190, and between the holes 194.

[0118] The electronic sensor module 200 includes a generally trapezoidal housing 202 having a front side 204, a rear side 206, a top side 208, a bottom side 210, and an angled side 212. The housing 202 can be formed from any suitable material such as injection-molded plastic, aluminum, or stainless steel. A pair of threaded posts 220 extend vertically away from the rear side 206.

[0119] The electronic sensor module 200 is mounted to the container 100 by placing the housing 202 above the raised portion 190 and allowing the post 220 to pass through the hole 194. A gasket 224 is placed on the post 220, and fasteners 224, such as nuts, are threaded onto the post 220, thereby securing the electronic module 200 to the container 100. A gasket, seal, or curable sealing material 214 is used between the sensor module 200 and the container 100 to prevent microorganisms from entering the container interior through the mounting hole 194 or opening 196. In this position, the rear side 206 of the electronic module 200 abuts against the transparent panel 116 and extends above the opening 196. By modifying existing containers to include the hole 194 and opening 196, the electronic module 200 can be adapted to various existing types of containers.

[0120] Green light-emitting diodes (LEDs) 230, red LEDs 232, and yellow LEDs 233 are mounted within housing 202 and are visible through an opening on the front side 204. In another embodiment, the LEDs are replaced by an indicator or display of another visual type. These alternative embodiments provide operators using these systems with a visual status of the equipment load, sensor modules, or other items that serve as useful visual indicators during sterilization or sterilization processes. A display 234, such as an LCD, is mounted within housing 202, above LEDs 230-233, and is visible through an opening on the front side 204. LEDs 230-233 and LCD 234 provide visual information to personnel using container 100.

[0121] A barcode, UPC code, or RFID tag 135 is attached to the front side 124. The barcode or RFID tag 135 may contain information related to the electronic module 200, such as the type of the electronic module and / or the contents of the container 100. The barcode or RFID tag 135 may optionally be affixed to other outer panels of the container 100 or to the sensor module 200.

[0122] refer to Figure 4A Figures 4B and 4C illustrate other details of the electronic sensor module 200. A battery cavity 215 is positioned on the rear side 206. The battery cavity 215 houses a battery 216 mounted between terminals 217 and 218. A cover 219 is snap-fitted to the housing 202, covering the battery cavity 215. The battery 216 powers the electronic module 200. Connector terminals 243 and 244 are used for connection to external devices of the electronic module 200. For example, connector terminal 244 connects to the battery 216 and can be connected to a power source to charge the battery 216. Connector terminal 243 can be used to send and receive data between the electronic module 200 and external devices.

[0123] An opening 226 is positioned on the back side 206 of the housing 202. Multiple sensors 240 are coupled to a printed circuit board 242 mounted within the housing 202. The sensors 240 are visible or exposed through the opening 226. The sensors 240 measure environmental characteristics such as temperature, pressure, humidity, and chemical concentration levels. When the housing 202 is mounted to the container 100, the sensors 240 are positioned above the opening 196, exposing them to the environmental conditions within the cavity 120. In one embodiment, the sensors 240 may extend through the opening 196 into the cavity 120.

[0124] Other electronic components are such as Figure 4CThe circuit board 242 shown is mounted to allow the electronic module to monitor the characteristics of the environment within container 100. Processor 250 and memory 252 are mounted to the printed circuit board 242. Wireless module 254 and passive components 256 are mounted to the printed circuit board 242. Wireless module 254 allows electronic module 200 to communicate with other external devices. These devices include transceiver heads and computer systems. In one embodiment, wireless module 254 can send and receive data and instructions from other external computer systems and networks.

[0125] A green light-emitting diode (LED) 230, a red LED 232, and a yellow LED 233 are mounted on a printed circuit board 242. Alternatively, these three LEDs can be replaced with a colored LED assembly to produce one or more completely different colors. These completely different colors provide the user with information such as the container's status. For example, a red LED 232 may indicate that the container is not sterile. A yellow LED 233 may indicate that the container is ready for sterilization. A green LED 230 has been properly sterilized. A display 234, such as an LCD, may be mounted on the printed circuit board 242. LEDs 230, 232, 233, and LCD 234 provide visual information to personnel using container 100.

[0126] III. Second Container Embodiment

[0127] Figure 5 This illustration shows a container assembly 300 according to a second embodiment of the present invention. Figure 5 In, with Figure 2 Similar devices are given similar reference numerals. Container assembly 300 includes a container 302 of generally rectangular shape. Container 302 is similar to container 100; however, some features of container 100 are omitted and other features are added. For example, container 302 does not include any orifice 124 or filter assembly 140.

[0128] Electronic module 200 is mounted to front panel 102. Electronic sensor module 200 includes electronic components and sensors that measure environmental characteristics within container 302 and determine whether the required conditions have been met to ensure the sterility of the contents of container 302.

[0129] The container 302 also includes four rounded shoulders 304. Each shoulder 304 is positioned at an inner corner 306 of the container 302 and extends along the length of the corner 306 between the bottom panel 106 and the edge 113. An inner bore 308 is defined in each shoulder 304 and extends into the inner compartment 310. Linear actuators 312 are mounted in each of the compartments 310. Each linear actuator 312 communicates with the electronics module 200 via a cable 314.

[0130] A cover 350 is used to cover and close container 302. The cover 350 includes a generally rectangular frame 352 surrounding a transparent window panel 354. The cover 350 has a top surface 355 and a bottom surface 356. A resilient gasket 357 is mounted to the bottom surface 356 and establishes a seal when the cover 350 is in the closed position, engaging with edge 113. Control buttons 358 and 359 are mounted to the front top surface of the frame 352 and communicate with electronic module 200 via a wireless communication device (not shown). Control button 358 closes the cover 350, while control button 359 opens the cover 350.

[0131] Four levers 360 are engaged between the cover 350 and the linear actuator 312. Each lever 360 has a proximal end 362 and a distal end 364. The proximal end 362 is situated within the compartment 310 and is connected to the linear actuator 312. Each lever 360 extends through an inner bore 308 and terminates at the distal end 364. The distal end 364 is removably coupled to the frame 352. The electronic module 200 triggers the linear actuator 312 to move the levers 360 and the cover 350 in a linear direction toward and away from the container 302.

[0132] The cover 350 is attachable to and detachable from the rod 360 to facilitate loading and unloading of the container 302. Four quick-release pins 372 are passed through apertures 374 located at each inner corner of the frame 352. The quick-release pins 372 engage with inner holes (not shown) on the distal end 364 of the rod 360 to hold the frame 352 to the distal end 364. Each quick-release pin 372 has one or more ball supports (not shown) that are biased outward by an internal spring. When all four quick-release pins 372 are removed, the cover 350 can be removed from the rod 360 to allow access to the cavity 120. Medical personnel can manually place the tray 160 and surgical instruments to be sterilized into the cavity 120.

[0133] In the open location, such as Figure 5 As shown, the cover 350 is supported by a rod 360 and spaced apart from the edge 113. A slit or opening 370 is formed between the frame 352 and the edge 113. During aseptic processing, in this open position, sterilizing agent can enter and exit the cavity 120 through the opening 370.

[0134] Turning Figure 6The lid 350 is shown in the closed position of the sealed container 302 and its contents (i.e., the support 160 and surgical instrument 180). During aseptic processing, after the electronic module 200 determines that the operating conditions within the container 302 are sufficient to meet or exceed a required set of operating conditions, the electronic module 200 directs the linear actuator 312 to close the lid 350 and turn on the green LED 230. The closing and sealing of the lid 350 and the "lit" green LED 230 indicate that the contents of the container have been properly sterilized and the container has been properly sealed. Optionally, the continuously "lit" green LED 230 can be a flashing "lit" green LED 230 to slow down the battery discharge rate and thus extend battery life.

[0135] In the closed position, gasket 357 is held against edge 113, forming a seal between frame 352 and container 302. The sealed container allows sterile instruments within to be removed from sterilizer 50 while maintaining a sterile environment within container 302 after processing. When surgical instruments 180 within the sealed container 302 are needed for a surgical procedure, the user presses open button 359, causing electronic sensor module 200 to actuate actuator 312 to move lid 350 to the open position. The user then manually removes quick-release pin 372 and lid 350 to allow access to the inner cavity 120 to remove the sterilized surgical instruments 180.

[0136] After the lid 350 is opened, the environment inside the container assembly 300 is no longer sterile. When the electronic sensor module 200 opens the lid 350, it also turns off the green LED 230 and turns on the red LED 232. The illumination of the red LED 232 indicates to the user that the container seal has been broken. Therefore, this indicates that the contents of the container are no longer sterile. If the lid 350 is opened and then closed, and the red LED 232 remains lit, it tells the user that the contents of the container are no longer sterile.

[0137] Except for the tamper-proof sensor 380 ( Figure 5 In addition to the container assembly 300, the container assembly 300 may further optionally include one or more tamper-proof seals 376. Figure 6 The tamper-evident seal 376 and tamper-evident sensor 380 are used to indicate whether the container assembly 300 has been opened during storage, thereby compromising the sterility of the contents of the container assembly 300. The tamper-evident seal 376 is a tape or seal installed between the container 302 and the cap 350. Removal or opening of the cap 350 causes the tamper-evident seal 376 to break, indicating to the user that the sterility of the contents of the container assembly 300 has been compromised.

[0138] return Figure 5The tamper-proof sensor 380 may include a Hall effect sensor 382 and a magnet 384. The Hall effect sensor 382 is mounted on the top of the shoulder 304, adjacent to the inner bore 308. The magnet 384 is mounted on the bottom side of the frame 352. The Hall effect sensor communicates with the electronics module 200 via a cable 386 installed within the container 302. When the lid 350 is in the closed position, the magnet 384 is juxtaposed with the Hall effect sensor 382. The Hall effect sensor 382 senses the magnetic field generated by the magnet 384 and sends an electrical signal to the electronics module 200 indicating the presence of the magnet 384. The electronics module 200 can keep a green LED 230 lit, indicating to the user that the contents of the container assembly 300 are sterile. When the lid 350 is removed from the container 302, disrupting the sterile barrier established by the container assembly 300, the Hall effect sensor 382 sends an electrical signal indicating a weakening of the magnetic field generated by the magnet 384 to the electronics module 200. The electronic module therefore turns off the green LED 230 and turns on the red LED 232. The illumination of the red LED 232 indicates to the user that the contents of the container assembly 300 are no longer sterile. To prolong the battery charge of the battery 216, the LED can flash as described above to provide a reminder to the user.

[0139] IV. Third Container Embodiment

[0140] refer to Figures 7A-7D This illustrates a container assembly 400 according to a third embodiment of the present invention. (See also: Special Reference) Figure 7A The container assembly 400 includes a container 402, which is generally rectangular in shape and defined by a planar front panel 403, an opposing planar rear panel 404, and a pair of opposing, spaced-apart planar side panels 405 and 406. Panels 403 and 404 are oriented orthogonally to panels 405 and 406. A planar bottom panel 407 is mounted perpendicular to panels 403-406 and forms the bottom of the container 402. A cavity 420 is defined within the container 402. The container 402 has an outer surface 410 and an inner surface 412. An upper peripheral edge 413 is defined by the upper edges of panels 403-406. The container 402 may be formed of a material such as stamped aluminum or other suitable materials.

[0141] Side panel 406 has an opening 414 covered by a panel 416 that is transparent to visible light but opaque to infrared (IR) and / or ultraviolet (UV) light frequencies. Panel 416 prevents external or internal UV and / or IR light from passing through panel 416. The transparent panel 416 allows the user to visually see the contents inside container 402. An elastic gasket 415 seals panel 416 to side panel 406. Gasket 415 and panel 416 are attached to side panel 406 using adhesive.

[0142] Another opening 418 is defined on the side panel 406, extending from directly above the bottom panel 406 below the opening 414. The opening 418 is smaller than the opening 414. The opening 418 is sized to receive a window 421. The window 421 can be transparent or opaque and can be made of plastic. A gasket or hermetic seal 422 seals the window 421 to the side panel 406. The gasket 422 and the panel 421 are attached to the side panel 406 using adhesive.

[0143] A pivot handle 424 is attached to each of the side panels 405 and 406. The handle 424 has an end 425 held to the side panels 405 and 406 by a circularly shaped slat 426. Both slats 426 are rigidly attached and sealed to the side panel 405. The end 425 is received by and rotatable within the slats 426. The handle 424 pivots between a storage position adjacent to the side panels 405 and 406 and a transport position in which the handle 424 extends perpendicularly to the side panels 405 and 406. The side panels 405 and 406 also include a pair of opposing L-shaped steps 496 mounted to opposite ends of the container 402. More specifically, the steps 496 extend generally vertically away from the opposing portion of the flange 453 and are angled slightly downwards. The step 496 is used in conjunction with the locking cap bolt 446, which is installed onto the cap 450, to secure the cap 450 to the container 402. The locking cap bolt 446 is rotated downwards by the user onto the step 496 to the locked position, in which the cap 450 is held and locked to the container 402 while compressing the cap gasket 456 between the cap 450 and the container 402. This compression prevents microorganisms from entering the container.

[0144] For further reference Figure 7BA cover 450 is used to cover and seal container 402. The cover 450 comprises a generally rectangular panel 452. The cover 450 may be formed of a material such as stamped aluminum or other suitable material. Two arrays of holes 459 are defined on and extend through the panel 452. The holes 459 are positioned toward each end of the panel 452. During sterilization, the holes 459 allow sterilizing agents to enter and exit container 402. An outer peripheral flange 453 extends downward from the outer edge of the panel 452. A rectangular inner wall 454 extends downward from the panel 452 and is spaced inwardly along the entire length of the flange 453. The flange 453 and the wall 454 define a U-shaped groove 455 between them. A resilient washer 456 is fitted within the groove 455. The cover 450 is mounted on panels 403, 404, 405, and 406 such that edge 413 sits between flange 453 and wall 454 and contacts gasket 456. Gasket 456 forms a seal between cover 450 and container 402. Wall 454 also defines an internal recess 457 below panel 452. A pair of spaced-apart, opposing L-shaped guide rails 458 extend vertically into the recess 457 away from the bottom surface of panel 452. The terminal lips 451 of the L-shaped guide rails 458 face each other.

[0145] Two filters 440 are mounted in recesses 457. Each filter 440 is supported by a filter support member 442. The filter support member 442 has outwardly extending shoulders 443 extending from each end of the filter support member 442. The shoulders 443 are secured by the terminal lip 451 of a guide rail 458. The filter support member 442 also includes an array of apertures 445. The filters 440 cover apertures 459. The filters 440 and the filter holder 442 are generally rectangular in shape.

[0146] The filter 440 and filter support member 442 may be formed of a flexible material, allowing them to bend to allow the shoulder 443 to slide beneath the terminal lip 451. Optionally, the filter 440 may be placed by a user on the filter support 442 and the assembly inserted along the guide rail 458. The guide rail 458 is sized such that when the filter 440 and clamp 442 are inserted into the guide rail 458, the filter 440 is compressed or pressed against the inner surface of the cover 450.

[0147] Filter 440 is formed of a microbial barrier material permeable to sterilizing agents. Filter 440 allows sterilizing agents to enter the inner cavity 420 from outside the cap 450, through the hole 459, through the filter 440, and through the pores 445, where the sterilizing agents come into contact with the surgical instruments. Filter 440 also forms a microbial barrier to prevent microorganisms from entering the container assembly 400 after the container assembly 400 has undergone a sterilization process.

[0148] A locking cap bolt 446 is attached to each end of the cap 450. One end of the locking cap bolt 446 is rotatably attached to each end of the cap. The locking cap bolt 446 can be rotated up and down. When the locking cap bolt 446 is rotated down and engages with the L-shaped step 496, the cap 450 is removably locked to the container 402. A magnet 448 is mounted to the inward-facing surface of the locking cap bolt 446 and works in conjunction with a Hall effect sensor 480 as described below.

[0149] An electronic sensor assembly or module 460 is installed inside the container 402. The electronic sensor module 460 includes electronic components and sensors that measure the characteristics of the environment inside the container 402 during the sterilization process and determine whether the required conditions have been met to ensure the sterility of the contents of the container 402.

[0150] refer to Figure 7A The electronic sensor module 460 has a rectangular printed circuit board (PCB) 462. The PCB 462 contains printed circuit lines (not shown) that electrically connect the various components of the electronic module 460. The PCB 462 is mounted above and spaced apart from the bottom panel 407 by two or more insulating spacers or supports 463. Fasteners 464, such as screws, secure the PCB 462 and supports 463 to the bottom panel 407.

[0151] Sensors are mounted to PCB 462 to monitor one or more characteristics of the environment within container 402. These sensors include sensor 472, which monitors water vapor concentration. This is sometimes referred to as a humidity or vapor sensor. Sensor 473 monitors the fluid (gas) pressure within the container. Sensor 474 monitors the temperature within the container. A processor 479 and a memory 471 are also included. Furthermore, mounted to the top of PCB 462 is an optical sensor 465, which senses the amount of infrared (IR) or ultraviolet (UV) light transmitted through an optical path length 466 within container 402. In one embodiment, optical sensor 465 detects the concentration of hydrogen peroxide gas (H2O2). In another embodiment, optical sensor 465 detects the concentration of ethylene oxide gas (C2H4O). In another embodiment, optical sensor 465 detects the concentration of water or water vapor (H2O). In yet another embodiment, optical sensor 465 detects both hydrogen peroxide vapor (H2O2) and water vapor (H2O).

[0152] Optical sensor 465 includes an IR or UV source or emitter 467 and an IR or UV receiver or detector 468 mounted to the top side of PCB 462. A filter (not shown) may be mounted around the IR detector 468 and / or the light source 467 to remove any unwanted wavelengths. Because hydrogen peroxide gas absorbs infrared light at wavelengths of 2.93 micrometers, the amount of light of that frequency transmitted through a known path length 466 containing hydrogen peroxide gas is proportional to the concentration of hydrogen peroxide gas. Hydrogen peroxide gas also absorbs ultraviolet light at wavelengths around 240 nanometers. The absorption of light through the gas is explained by Beer-Lambert's law.

[0153] A semi-circular concentrator 469 is mounted to PCB 462. One concentrator 469 is positioned around emitter 467 while the other concentrator is positioned around detector 468. Concentrator 469 reflects light rays that are not coaxial with detector 468. An elongated light shield 470 is mounted over optical path length 466 and above emitter 467, detector 468, and both concentrators 469. Light shield 470 is attached to PCB 462. Light shield 470 prevents stray light rays from leaving optical sensor 465 and entering cavity 420. Concentrator 469 and shield 470 are formed of light-reflecting material such as polished stainless steel. Concentrator 469 and light shield 470 can work together to reflect rays from emitter 467 and concentrate those rays to increase the energy detected by detector 468.

[0154] Battery 497 is mounted to PCB 462 and supplies power to the various components of electronic module 460. Depending on the voltage or power requirements of electronic sensor module 460, battery 497 may be formed from one or more battery cells to form a battery pack. In one embodiment, battery 497 is a rechargeable battery. In another embodiment, battery 497 is replaced with a new battery after discharge. Light-emitting diodes (LEDs) 487, such as green, red, and yellow LEDs, are mounted to PCB 462. LEDs 487 provide visual information to users of container assembly 400.

[0155] Figure 7C Other components included in window component 421 are shown. Figure 7C The window 421 is made of a transparent material such as plastic. An airtight connector 485 is mounted in the window 421 and includes multiple terminals 486 extending through the connector 485 and electrically connected to the PCB 462. The airtight connector 485 connects to an external connector 475 and cable 476 (FIG. 7) to transmit and receive data from the container assembly 400. The user can see the LED 487 on the PCB 462 through the window 421. A light shield 477 blocks the light emitted by the LED 487, preventing it from reaching the optical sensor 465.

[0156] Figure 7D Another embodiment of the component included within window 421 is illustrated. Figure 7D The window 421 is made of an opaque material such as plastic. An airtight connector 485 is mounted within the window 421 and includes multiple terminals 486 extending through connector 865 and electrically connected to PCB 462. The airtight connector 485 connects to an external connector 475 and cable 476 (FIG. 7) to transmit and receive data from the container assembly 400. Figure 7D In this embodiment, LED 487 is not mounted on PCB 462. LED 487 is mounted on the outside of window 421 and connected to PCB 462 via a wire or terminal 478 extending through window 421. Window 412 is sealed to container wall 406 with a sealant, gasket, or curable sealant 422.

[0157] return Figure 7A A Hall effect sensor 480 is mounted below the inner surface 412 and edge 413 of sidewall 406, and another Hall effect sensor 480 is mounted below the inner surface 412 and edge 413 of sidewall 405. The Hall effect sensors 480 are connected to PCB 462 via wire 481. When lid 450 is placed over container 402, magnet 448 is placed alongside Hall effect sensors 480. Hall effect sensor 480 senses the magnetic field generated by magnet 448 and outputs an electrical signal indicating the presence of a detected magnetic field. When latch 446 is opened to remove lid 450 from container 402, Hall effect sensor 480 senses no magnetic field and outputs an electrical signal indicating no magnetic field was detected. Electronic sensor module 460 can use the signal from Hall effect sensors 480 to monitor whether latch 446 has been properly maintained or tampered with after sterilization. Alternatively, a mechanical component similar to a one-way locking zipper (not shown) used to prevent the locking cap bolt 446 from disengaging from the L-shaped step 496 can be used as a visual indication that the locking cap bolt 446 has been held in the correct position. These mechanical one-way locking zipper straps are generally disconnected and removed to allow the locking cap bolt 446 to disengage from the L-shaped step 496.

[0158] A dummy base plate 490 is mounted above the electronic module 460 and the bottom panel 407. The dummy base plate 490 is rectangular in shape and has a series of holes 491 extending through it. The dummy base plate 490 is supported above the electronic module 460 by supports 492. The supports 492 rest on the bottom panel 407. Fasteners 494 secure the plate 490 to the bottom panel 407. Fasteners 494, such as screws, extend through the dummy base plate 490, and supports 493 are threaded into the bottom panel 407. The holes 491 allow sterilizing agent to flow under the dummy base plate 490 and into the electronic sensor module 460. This allows sensors in the module to measure characteristics of the internal environment of the container 400.

[0159] During use, 180 medical / surgical instruments (including those intended for sterilization) are included. Figure 2 ) brackets or trays 160 ( Figure 2 The tray 160 can be placed inside container 402. A support 160 is placed and rests on plate 490. Electronic modules and sensors 460 are concealed beneath plate 490. After placing tray 160 inside container 402, lid 450 is placed over container 402 and locking bolt 496 is moved to the locked position, locking and sealing lid 450 to container 402. Connector 475 and cable 476 are attached to connector 485, and memory 471 is programmed with validated sterilization process measurements (VSPM). After programming, container assembly 400 can be cycled through the sterilization process.

[0160] V. Fourth Container Embodiment

[0161] Figure 8 A container assembly 500 according to a fourth embodiment of the present invention is illustrated. The container assembly 500 includes a container 502, which is generally rectangular in shape and defined by a planar front panel 503, an opposing planar rear panel 504, and a pair of opposing spaced-apart planar side panels 505 and 506. Panels 503 and 504 are oriented orthogonally to panels 505 and 506. A planar bottom panel 507 is mounted perpendicular to panels 503, 504, 505, and 506 and forms the bottom of the container 502. An inner cavity 520 is defined within the container 502. The container 502 has an outer surface 510 and an inner surface 512. An upper peripheral edge 513 is defined by the upper edges of panels 503-506. The container 502 may be formed of a material such as stamped aluminum or other suitable materials.

[0162] Side panel 506 has a rectangular opening 514 that is covered by a panel 516 that is transparent to visible light but opaque to IR and / or UV light frequencies. Panel 516 prevents IR and / or UV light from the inside or outside of container 502 from passing through panel 516. The transparent panel 516 allows the user to visually see the contents inside container 502. An elastic gasket 515 seals panel 516 to side panel 506. Gasket 515 and panel 516 are attached to side panel 506 using adhesive or suitable mechanical fasteners (not shown). Another rectangular opening 518 is defined on side panel 506, above opening 514 and below edge 513. Opening 518 is sized to receive a hermetically sealed switch 521. A plurality of mounting blocks 519 are attached to inner surface 512 of panel 506 and extend into cavity 520. Two mounting blocks 519 are positioned below the edge 513 and at the bottom of the panel 506.

[0163] A pivot handle 524 is attached to each of the side panels 505 and 506. The handle 524 has an end 525 held to the side panels 505 and 506 by circularly shaped side strips 526. Two side strips 526 are welded to the side panels 505 and 506 respectively. The end 525 is received by the side strips 526 and can rotate within them. The handle 524 pivots between a storage position adjacent to the side panels 505 and 506 and a transport position in which the handle 524 extends perpendicularly to the side panels 505 and 506.

[0164] A lid 550 is used to cover and seal container 502. The lid 550 comprises a generally rectangular panel 552. The lid 550 may be formed of a material such as embossed aluminum or other suitable materials. An array of holes 559 is defined on and extends through the panel 552. During sterilization, the holes 559 allow sterilizing agents to enter and exit container 502. An outer peripheral flange 553 extends downward from the outer edge of the panel 552. An inner wall 554 extends downward from the panel 552 and is spaced inward from the flange 553. The flanges 553 and 554 define a U-shaped groove 555 between them. A resilient gasket 556 is installed in the groove 555. The lid 550 is mounted on panels 503-506 such that an edge 513 is positioned between the flange 553 and the wall 554 and contacts the gasket 556. The gasket 556 forms a seal between the lid 550 and container 502. Four generally C-shaped retaining clamps 558 extend downward from the bottom surface of panel 552. The clamps 558 are positioned around the outermost hole 559 toward the center of panel 552.

[0165] A single-use or reusable filter 540 is mounted on the orifice 559. The filter 540 is supported by a filter support member 542. The filter support member 542 is held to the panel 552 by a retaining clamp 558. The filter support member 542 is formed of a flexible material, allowing its ends to bend under the retaining clamp 558 to hold the filter 540 and the support member 542 to the retaining clamp 558. The filter 540 covers the orifice 559. The support member 542 and the retaining clamp 558 press the filter 540 against the underside of the panel 552 and onto the orifice 559. The filter 540 is formed of a microbial barrier material permeable to sterilizing agents. The filter 540 allows sterilizing agents to enter the inner cavity 520 from outside the container 502, through the orifice 559, through the filter 540, and into the inner cavity 520, where the sterilizing agents come into contact with the surgical instruments. The filter 540 also forms a microbial barrier to prevent microorganisms from entering the container assembly 500 after the container assembly 500 has undergone a sterilization process.

[0166] The container assembly 500 also includes a sleeve hinge 545. The sleeve hinge 545 has a C-shaped flange 546 extending from the edge 513 away from the side panel 505 and another C-shaped flange 547 extending from one end away from the lid 550. The flanges 546 and 547 engage with each other to form the hinge 545. The flanges 546 and 547 are designed to be sized such that when the lid 550 is rotated toward the closed position with the flanges 546 and 547 engaged with each other, one end of the lid 550 is held to the container 502.

[0167] A pivoting bolt 548 is attached to the other end of the cover 550. The user rotates the bolt 548 downwards onto the switch 521, until the cover 550 is held and locked in the locked position against the container 502. Movement of the bolt 548 against the switch 521 switches the switch 521 from an open circuit to a closed circuit. The container assembly 500 is unlocked and opened by the user moving the bolt 548 away from the switch 521 and rotating the cover 550 around the hinge 545. Movement of the bolt 548 away from the switch 521 switches the switch 521 from a closed circuit to an open circuit.

[0168] An electronic sensor assembly or module 560 is installed inside container 502. The electronic module 560 includes electronic components and sensors that measure the characteristics of the internal environment of container 502 during the sterilization process and determine whether the required conditions are met to ensure the sterility of the contents of container 502.

[0169] The electronic sensor module 560 has a rectangular printed circuit board (PCB) 562. The PCB 562 contains printed circuit lines (not shown) that electrically connect the various components of the electronic sensor module 560. Various electronic components and sensors are mounted to the PCB 562 to allow the electronic module 560 to monitor the environment inside the container 502. A processor 570, a memory 571, a water vapor or steam sensor 572, and an isolated temperature sensor 574 are mounted to the top side of the PCB 562. A diaphragm pressure sensor 573 and / or a capacitive pressure gauge are mounted within the cavity 520 and connected to the PCB 562 via a cable 575.

[0170] Furthermore, mounted to the PCB 562 is an optical sensor 565 that senses the amount of IR or UV light transmitted through an optical path length 566 within the container 502. In one embodiment, the optical sensor 565 detects the concentration of hydrogen peroxide gas (H2O2). In another embodiment, the optical sensor 565 detects the concentration of water (H2O).

[0171] The optical sensor 565 includes a light source or emitter 567 and a light receiver or detector 568 mounted to a PCB 562. A filter (not shown) may be mounted around the detector 568 to remove any unwanted wavelengths. A semi-circular condenser 569 is mounted to the PCB 562. These condensers may be parabolic, elliptical, or other shapes that focus light onto a photodetector facing the emitter 567. One condenser 569 is positioned around the emitter 567, and another IR condenser is positioned around the detector 568.

[0172] A replaceable and / or rechargeable battery 580 is received in an opening 581 of a battery cavity 582. The battery cavity 582 is mounted to the back side of a PCB 562. The battery 580 supplies power to the components of the electronic module 560 via printed circuit lines (not shown) within the PCB 562. The battery 580 can be a single battery cell or packaged together in a battery pack structure.

[0173] Light-emitting diodes (LEDs) 584, such as green, red, and yellow LEDs, are mounted on the top side of PCB 562. A transparent cover 585 is mounted above PCB 562 and LED 584. LED 584 is visible to the user through cover 585 and window 516. LED 584 provides visual information to personnel using the container assembly 500. Connector 594 is mounted to PCB 562 and passes through the bottom of battery cavity 582. Connector 594 is used to connect external connectors and cables to enable electronic sensor module 560 to send data or command sets and receive data or command sets from external systems and devices.

[0174] A portion of the battery cavity 582 and the PCB 562 are contained within an insulating housing 586. The housing 586 is formed of an insulating material such as plastic. The housing 586 is generally rectangular in shape, including an inner cavity 587 and a cover 588. A mounting flange 589 extends perpendicularly to the side panel 506, away from the housing 586. The battery cavity 582 and a portion of the PCB 562 are mounted within the cavity 587. The cover 588 is rotated to a closed position above the battery cavity 582. A switch 521 also communicates with the PCB 562 via a wire 588.

[0175] The housing 586 is mounted to the inner surface 512 of the panel 506. The housing 586 is spaced apart from the bottom panel 507 by an insulating spacer or support 590. Fasteners 591, such as screws, extend through the mounting flange 589 and are threaded into the mounting block 519.

[0176] During use, 180 medical / surgical instruments (including those intended for sterilization) are included. Figure 2 ) brackets or trays 160 ( Figure 2 It is placed inside container 502. Support 160 is placed on and rests against bottom panel 507.

[0177] An external cable (not shown) is attached to connector 594 to store Validated Sterilization Process Measurements (VSPM) in memory 571. After the instrument is placed inside container 502, lid 550 is positioned above container 502, engaging hinge 545, and then latch 548 is moved to engage switch 521, reaching the locked position to lock lid 550 to container 502. Container assembly 500 is now ready for a sterilization process cycle.

[0178] VI. Fifth Container Embodiment

[0179] refer to Figure 9A The diagram illustrates a container assembly 600 according to a fifth embodiment of the present invention. The container assembly 600 includes the form of a container 402. Figure 9A The form of container 402 is the same as that of container 402 in FIG7 described above, except that there is no opening 418. In addition, magnet 624 is mounted on the inwardly facing vertical side surfaces of side panels 405 and 406, slightly below the edge 413.

[0180] For further reference Figure 9BA lid 650 is used to cover and seal container 402. The lid 650 comprises a generally rectangular panel 652. The lid 650 may be formed from a material such as embossed aluminum or other suitable materials. The lid 650 has an inner surface 651, an outer surface 654, and opposing ends 653. An array of holes 655 is defined on and extends through the panel 652. During sterilization, the holes 655 allow sterilizing agents to enter and exit container 402. A surrounding outer wall 656 extends downward from the outer edge of the panel 652. Another rectangular wall 657 extends downward from the panel 652 and is spaced inwardly along the entire length of the wall 656. Walls 656 and 657 define a U-shaped groove 658 between them. A resilient washer 659 is fitted into the groove 658.

[0181] The cover 650 is mounted above panels 403, 404, 405, and 406 such that edge 413 sits between walls 656 and 657 and contacts resilient gasket 659. Gasket 659 forms a seal between cover 650 and container 402.

[0182] The cover 650 also includes an opening 648 defined at one end 653. The opening 648 is sized to receive a window 621. The window 661 is transparent and made of a plastic material. An airtight seal 622 seals the window 621 to the end 653. The window 621 and the airtight seal 622 are attached to the end 653 using an adhesive.

[0183] Side panels 405, 406 also include a pair of opposing L-shaped steps 496 mounted to opposite ends of container 402. More specifically, steps 496 extend generally vertically away from side panels 405, 406 and are angled slightly downward in an upward arc shape. Steps 496 are used in conjunction with locking cap bolts 646 mounted to cap 650 to secure cap 650 to container 402. Locking cap bolts 646 are rotated downward by the user onto steps 496 to a locked position, wherein cap 650 is held and locked to container 402 while a cap washer 659 is pressed between cap 650 and container 402, forming a seal. Locking cap bolts 646 are attached to each end of cap 650. One end of locking cap bolt 646 is rotatably attached to each cap end. Locking cap bolts 646 are operable upward and downward. When the locking cap bolt 646 is turned downwards and engages with the L-shaped step 496, the cap 650 is locked to the container 402. A magnet 686 is mounted to the inward-facing surface of the locking cap bolt 646 and works in conjunction with the Hall effect sensor 680 as described below.

[0184] A single-use or reusable filter 640 is mounted on the bottom surface 651 and orifice 655 of the cover 650. The filter 640 is supported by a filter support member 642 extending the length of the filter 640. The filter support member 642 includes an array of orifices 643 and a pair of opposing shoulders 644 extending away from both ends of the filter support member 642. A pair of spaced-apart C-shaped clamps 645 (… Figure 9B The filter 640 extends away from the bottom surface 651. When the filter 640 and filter support member 642 are mounted to the bottom side 651 of the cover 650, a portion of the clamp 645 extends onto the shoulder 644 of the filter support member 642 to hold the filter 640 to the cover 650. The filter 640 covers the orifice 655. The filter support member holds the filter 640 to the cover so that all material passing through the orifice 655 must pass through the filter.

[0185] The filter 640 and filter support member 642 are formed of a flexible material, allowing them to bend and slide the shoulder 644 under the clamp 644. The filter 640 is formed of a microbial barrier material permeable to sterilizing agents. The filter 640 allows sterilizing agents to enter the inner cavity 420 from outside the cap 650, through the hole 655, through the filter 640, and through the pores 643, where the sterilizing agents come into contact with the surgical instruments. The filter 640 also forms a microbial barrier to prevent microorganisms from entering the container assembly 600 after the container assembly 600 has undergone a sterilization process.

[0186] The cover 650 also includes a housing 630. The housing 630 has a generally rectangular shape with a U-shaped cross-section. The housing 630 may be formed of a material such as stamped aluminum or other suitable materials. The housing 630 includes a bottom wall 631 and side walls 632. The side walls 632 are spaced apart from the bottom wall 631 and oriented perpendicular to the bottom wall 631. Flanges 633 extend vertically away from the distal ends of each side wall 632. Mounting holes 635 extend through the flanges 633 at opposite ends of the housing 630. The bottom wall 631 and side walls 632 define an exit cavity or closed cavity 638 within the housing 630. An array of holes 634 is defined on the bottom wall 631 and side walls 632. The holes 634 allow sterilizing agents to enter and exit the cavity 638. The housing 630 is mounted to the inner surface 651 of the panel 652, adjacent to the end 653 and slightly spaced from the wall 657, using fasteners 636 such as screws. Fastener 636 extends through mounting hole 635 and is threaded into inner surface 651.

[0187] The electronic sensor assembly or module 660 is mounted within the housing 630, which is held in place by the cover 650. The electronic sensor module 660, as well as modules 760 and 850 described below, all contain components that perform the same general functions as module 560.

[0188] refer to Figure 9A The electronic sensor module 660 has a rectangular printed circuit board (PCB) 662. PCB 662 contains printed circuit lines (not shown) that electrically connect the various components of the electronic module 660. PCB 662 is mounted and contained within a housing cavity 638. An insulating spacer 618 is mounted above PCB 662 and positioned between the inner surface of the cover 651 and PCB 662.

[0189] Various electronic components and sensors are mounted on PCB 662 to allow electronic sensor module 660 to monitor operating conditions within container 402. Processor 670, memory 671, humidity or vapor sensor 672, pressure sensor 673, and isolated temperature sensor 674 are mounted on the top side of PCB 662. Mounted on the bottom side of PCB 662 is optical sensor 665, which senses the amount of IR and / or UV light transmitted through optical path length 666 within cavity 638. In one embodiment, optical sensor 665 detects the concentration of hydrogen peroxide gas (H2O2).

[0190] The optical sensor 665 includes a light source or emitter 667 and a light receiver or detector 668 mounted to the bottom side of a PCB 662. The light emitter 667 generates IR or UV light. A filter (not shown) may be mounted around the emitter 667 or detector 668 to remove any unwanted wavelengths.

[0191] A rechargeable battery 697 is mounted on the bottom side of PCB 662 and supplies power to the components of electronic module 660 via printed circuit lines (not shown) within PCB 662. Light-emitting diodes (LEDs) 687, such as green, red, and yellow LEDs, are mounted at one end of PCB 662. LEDs 687 provide visual information to personnel using container assembly 600. LEDs 687 within cover 650 are visible to the user through window 621.

[0192] An airtight connector 685 is mounted within the window 621 and extends between the outside and inside of the cover 650. The airtight connector 685 includes multiple terminals electrically connected to a PCB 662. The airtight connector 685 can connect to an external connector 610 and cable 612 to transmit and receive data from the container assembly 600. When the container assembly 600 is sealed, the airtight connector 685 allows communication with the electronic sensor module 660.

[0193] For further reference Figure 9BA Hall effect sensor 680 is mounted to the interior portion of wall 657 at each end 653. The Hall effect sensor 680 is connected to PCB 662 via wire 681. When lid 650 is placed over container 402, magnet 624 is placed alongside Hall effect sensor 680. Hall effect sensor 680 senses the magnetic field generated by magnet 624 and outputs an electrical signal indicating the presence of a magnetic field to processor 670. When lid 650 is removed from container 402, Hall effect sensor 680 senses no magnetic field and outputs an electrical signal indicating no magnetic field was detected to processor 670.

[0194] During use, 180 medical / surgical instruments (including those intended for sterilization) are included. Figure 2 ) brackets or trays 160 ( Figure 2 The tray 160 is placed inside container 402. The support 160 is placed and rests on the bottom panel 407. After the tray 160 is placed inside container 402, the lid 650 is placed on top of container 402, and the locking bolt 646 is moved onto step 496 to the locking position, locking the lid 650 to container 402. External connector 610 and cable 612 are attached to airtight connector 685, and memory 671 is loaded with validated sterilization process measurements (VSPM). After programming, container assembly 600 is ready for sterilization process cycles.

[0195] VII. Sixth Container Embodiment

[0196] refer to Figure 10 The diagram illustrates a container assembly 700 according to a sixth embodiment of the present invention. The container assembly 700 includes a container 402. Figure 10 The container 402, filter 440, and cap 450 are as described above. Figure 7A The container 402, filter 440 and cap 450 are the same, except that the opening 418 is omitted from the container 402.

[0197] Container assembly 700 includes a support or tray 720 containing an electronic sensor assembly or module 760. Tray 720 may be formed of a suitable material such as stainless steel or aluminum. Tray 720 includes a generally planar, rectangular base 722 through which an array of holes 726 passes. Base 722 has an upper surface 723 and a bottom surface 724. A peripheral flange 728 extends vertically downward from the edge of base 722 and surrounds base 722. Flange 728 and base 722 define an outlet cavity 730 below base 722. Holes 726 allow sterilizing agents to enter and exit cavity 730.

[0198] The tray 720 is used to hold the medical / surgical instrument 180 within the container 402 during aseptic processing. The tray 720 includes a pair of spaced-apart handles 732 attached to opposite ends of a base 722. The handles 732 allow a user to grasp and lift the tray 720. Each handle 732 includes a pair of vertical bars 734 attached to the base 722 and horizontal gripping bars 736 extending between the bars 734.

[0199] Multiple support members 738 are mounted to a base 722 and extend upward from the base 722. Medical / surgical instruments 180 are spaced against and supported by the support members 738. The support members 738 are sized and shaped to hold and retain the medical / surgical instruments 180 in a predetermined orientation for aseptic processing. For some medical / surgical instruments 180, it is important to be oriented to a specific geometric orientation during aseptic processing so that sterilizing agents can easily enter and exit the surgical instrument.

[0200] A base plate 714 is mounted to the bottom surface 724 of the base 722 to enclose the cavity 730. The plate 714 has a top surface 716 and a bottom surface 718. Four spacers or supports 706 are positioned at each corner of the plate 714. The spacers 706 position the plate 714 at a fixed distance from the base 722. Fasteners 708, such as screws, extend through the corners of the plate 714, the spacers 706, and are threaded into the base 722, thereby securing the plate 714 to the base 722.

[0201] The electronic sensor module 760 is installed within the cavity 730. More specifically, the module 760 is mounted to the top side 716 of the board 714.

[0202] The electronic sensor module 760 has a rectangular printed circuit board (PCB) 762. The PCB 762 contains printed circuit lines (not shown) that electrically connect the various components of the electronic module 760. The PCB 762 is mounted to one side 716 of the board 714.

[0203] Various electronic components and sensors are mounted on PCB 762 to allow electronic module 760 to monitor operating conditions within container 402. Processor 770, memory 771, humidity or vapor sensor 772, pressure sensor 773, and isolated temperature sensor 774 are mounted on the top side of PCB 762.

[0204] Furthermore, mounted on the top side of the PCB 762 is an optical sensor 765 that senses the amount of IR and / or UV light transmitted through an optical path length 766 within the cavity 730. In one embodiment, the optical sensor 765 detects the concentration of hydrogen peroxide gas (H2O2).

[0205] The optical sensor 765 includes a light source or emitter 767 and a light receiver or detector 768 mounted on the top side of a PCB 762. The light source 767 generates IR or UV light. A filter (not shown) may be mounted around the detector 768 to remove any unwanted wavelengths.

[0206] A replaceable or rechargeable battery 797 is mounted on the top side of PCB 762 and supplies power to the components of electronic module 760 via printed circuit lines (not shown) within PCB 762. Light-emitting diodes (LEDs) 787, such as green, red, and yellow LEDs, are mounted at one end of PCB 762. LEDs 787 provide visual information to personnel using container assembly 700. When tray 720 is placed inside container 402, LEDs 787 are visible to the user through transparent panel 416.

[0207] Connector 785 is mounted to the other end of PCB 762. Connector 785 can be attached to external connector 710 and cable 712 to transmit and receive data from electronics module 760. Connector 785 is used to load validated sterilization process measurements (VSPM) into memory 771.

[0208] Tray 720 is programmed with a VSPM. External connector 710 is attached to connector 785. The VSPM is downloaded from an external source to memory 771. Because each tray 720 is designed to fit a specific medical / surgical instrument 180, tray 720 only needs to be programmed with a VSPM once. The VSPM is stored in memory 771 for reuse in subsequent sterilization cycles.

[0209] A tray 720 containing medical / surgical instruments 180 to be sterilized in their intended orientation is placed inside a container 402. The tray 720 is placed and rests on a bottom panel 407. After the tray 720 is placed inside the container 402, a lid 450 is placed over the container 402, and a locking cap bolt 446 is moved onto a step 496 to the locking position, locking and sealing the lid 450 to the container 402.

[0210] A locking tag or destructible seal 792 is attached between the locking cap bolt 496 and the step 446. The two ends of the tag 792 extend through the opening 444 in the locking cap bolt 446 and through the locking bolt 49, engaging to form a continuous loop. The tag 792 indicates to the user whether any tampering has occurred within the container assembly 700 or whether the sterile barrier within the container assembly 700 has been breached after aseptic processing. The tag 792 is for single use only and is cut to access the contents of the container assembly 700. After the locking tag 792 is attached, the container assembly 700 is ready for a sterilization cycle.

[0211] VIII. Seventh Container Embodiment

[0212] refer to Figure 11A This illustration shows a container assembly 800 according to a seventh embodiment of the present invention. The container assembly 800 includes a container 802, which is generally rectangular in shape and defined by a planar front panel 803, an opposing planar rear panel 804, and a pair of opposing spaced-apart planar side panels 805 and 806. Panels 803 and 804 are oriented orthogonally to panels 805 and 806. A planar bottom panel 807 is mounted perpendicular to panels 803, 804, 805, and 806 and forms the bottom of the container 802. An inner cavity 820 is defined within the container 802. The container 802 has an outer surface 810 and an inner surface 812. An upper peripheral edge 813 is defined by the upper edges of panels 803-806. The container 802 may be formed of a material such as stamped aluminum or other suitable materials.

[0213] Side panel 806 has an opening 814 covered by a panel 816 that is transparent to visible light but opaque to IR and UV light frequencies. Panel 816 prevents IR and UV light from entering the inner cavity 820. The transparent panel 816 allows the user to visually see the contents inside container 802. An elastic gasket 815 seals panel 816 to the outer surface of side panel 806. Gasket 815 and panel 816 are attached to side panel 806 using adhesive.

[0214] The container 802 also includes a generally U-shaped cutout 830, which is located at the bottom of the side panel 806, below the opening 814. The cutout 830 is defined by a horizontal shelf 832 extending vertically from the side panel 806 into the cavity 820 and a U-shaped wall 834 extending vertically downward from the shelf 832 and terminating at the bottom panel 807. The U-shaped wall 834 has a central portion 835 and two outer portions 836 disposed opposite each other in the diametrical direction.

[0215] Windows 837, arranged opposite each other in the diametrical direction, are defined on each of the outer portions 836. The windows 837 are spaced apart from each other by a portion of the inner cavity 820. The windows 837 are formed of a transparent material such as plastic and are attached to the outer portions 836 by an adhesive.

[0216] An airtight connector 838 is mounted towards the center of the central portion 835. The airtight connector 838 includes multiple terminals extending through the side panel 838 into the inner cavity 820. The airtight connector 838 allows communication with electronic components within the container 802. A latching receiver 839 is mounted towards the center of the side panel 806 below the edge 813.

[0217] Cover 550 and the previously described Figure 8The design is largely the same as the previous one, except that a magnet 840 is added to the inner surface of the pivot bolt 548. During sterilization, the orifice 559 allows the sterilizing agent to enter and exit the container 802. A gasket 556 forms a seal between the cap 550 and the container 802. A disposable filter 540 is mounted above the orifice 559. The filter 540 is supported by a filter support member 542. The filter support member is secured to the panel 552 by a retaining clamp 558. The filter 540 covers the orifice 559.

[0218] Support member 542 and fixing clamp 558 press filter 540 onto the underside of panel 552 and onto orifice 559. Filter 540 is formed of a microbial barrier material permeable to sterilizing agent. Filter 540 allows sterilizing agent to enter the inner cavity 820 from outside the cover 550, through orifice 559, and through filter 540, where the sterilizing agent can contact surgical instruments. Filter 540 also forms a microbial barrier to prevent microorganisms from entering container assembly 800 after the container assembly 800 has undergone a sterilization process.

[0219] The container assembly 800 also includes a sleeve hinge 545. The sleeve hinge 545 has a C-shaped flange 846 extending from the edge 813 of the side panel 805 and another C-shaped flange 547 extending from one end of the lid 550. The flanges 846 and 547 engage with each other to form the hinge 545. The flanges 846 and 547 are designed to be sized such that when the lid 550 is rotated toward the closed position with the flanges 846 and 547 engaged with each other, one end of the lid 550 is held to the container 802.

[0220] A pivoting bolt 548 is mounted to the other end of the cover 550. The bolt 548 can be rotated downwards by the user to a locked position where it engages with the bolt receiver 839. Figure 11C As shown in the diagram. When the latch 548 is fully engaged with the latch receiver 839, the cover 550 is sealed and locked to the container 802. By unlocking the latch 548 from the latch receiver 839, the cover 550 is removed from the container 802.

[0221] The fixed sensor module 850 is mounted inside container 502. The electronic components of the fixed sensor module 850 use relatively low power.

[0222] The fixed sensor module 850 has a rectangular printed circuit board (PCB) 852. PCB 852 contains printed circuit lines (not shown) that electrically connect the various components of the electronic sensor module 850. Hall effect sensor 854, processor 870, memory 871, humidity or vapor sensor 872, pressure sensor 873, and isolated temperature sensor 874 are mounted on the front side of PCB 852.

[0223] A replaceable and / or rechargeable battery 855 is mounted to the rear of PCB 852. In one embodiment, battery 855 is a watch battery because the components mounted to PCB 852 consume a relatively low amount of power. Battery 855 powers the various components of electronic sensor module 850.

[0224] Light-emitting diodes (LEDs) 856, such as green, red, and yellow LEDs, are mounted on the front of PCB 852. A transparent cover 857 is mounted on PCB 852 and LED 856. The LED 856 inside container 802 is visible to the user through cover 857 and transparent panel 816. LED 856 provides visual information to personnel using container assembly 800.

[0225] PCB 852 is mounted and contained within housing 860. Housing 860 is formed of an electrically insulating material such as plastic. Housing 860 has two generally rectangular portions, an upper portion 862 and a lower portion 863. The upper portion 862 defines a socket 864, and the lower portion 863 defines a socket 865. PCB 852 is mounted to housing 860 such that both ends of PCB 852 are contained within sockets 864 and 865.

[0226] A housing 860 with PCB 852 is mounted within cavity 820. Housing 860 rests on shelf 832 and is attached to inner surface 812 of panel 806. Fasteners 866, such as screws, attach housing 860 to inner surface 812. PCB 852 is further attached to and communicates with vacuum connector 838 via terminals 879 extending from PCB 852 and connecting to vacuum connector 838.

[0227] A removable optical sensor assembly or module 900 can be attached to and removed from container 502. The electronics contained in the removable optical sensor module 900 consume a relatively larger amount of power compared to the electronics in the fixed sensor module 850. The electronics used in the removable optical sensor module 900 are also more expensive than those used in the fixed sensor module 850. During sterilization, the removable optical sensor module 900 measures one or more characteristics of the environment within container 802.

[0228] refer to Figure 11A11B and 11C, the removable optical sensor module 900 includes a generally U-shaped housing 902 and at least one optical sensor 950. The housing 902 is formed of an electrically insulating material such as plastic. The housing 902 includes a generally U-shaped outer wall 904 and a U-shaped inner wall 910. A hollow cavity 920 is defined between the outer wall 904 and the inner wall 910. The outer wall 904 has a central portion 905 and end portions 906 extending vertically at opposite ends away from the central portion 905. A rectangular opening 908 is defined toward the top of the central portion 905.

[0229] The inner wall 910 has a central portion 912 and end portions 913 extending vertically at opposite ends away from the central portion 912. A step 914 extends vertically away from the distal end of each end portion 913. The step 914 is parallel to the central portion 912. A rectangular transparent window 916 is provided on each outer portion 913. The windows 916 are arranged opposite each other in the diametrical direction. A connector channel 918 is defined on the central portion 912. The connector channel 918 allows a connector to be attached to the sensor 950 to pass through the channel 918. Fasteners 919, such as screws, are used to secure the inner wall 910 to the outer wall 904.

[0230] The optical sensor module 900 is installed within the cutout 830 of the container 802 and is received therefrom, such as... Figure 11C As shown in the diagram, a retaining clamp 924 is installed in the opening 908. When the optical sensor module 900 is placed horizontally and slid into the cutout 830, the retaining clamp 924 engages and cooperates with a retaining tab 925 on the container 802. The retaining tab 925 extends downward from the bottom of the shelf 832 toward the cutout 830. The retaining clamp 924 and the tab 925 hold the optical sensor module 900 to the container 802. The optical sensor module 900 is removed from the container 802 by the user pulling the retaining clamp 924 away from the side panel 806, thereby releasing the retaining clamp 924 from its engagement with the retaining tab 925. The optical sensor module 900 can then be slid horizontally away from the side panel 806.

[0231] Within cavity 920, optical sensor 950 is mounted to housing 902. Optical sensor 950 is positioned between outer wall 904 and inner wall 910. Optical sensor 950 senses signals transmitted within container 802 along an optical path length 966 ( Figure 11B The optical sensor 950 detects the amount of IR or UV light emitted. It measures the concentration of gases, such as hydrogen peroxide (H2O2) or ethylene oxide (C2H4O).

[0232] The optical sensor 950 has a printed circuit board (PCB) 952. An IR and / or UV light source or emitter 967 and a light receiver or detector 968 are mounted to one side of the PCB 952. A filter (not shown) may be mounted around the light source 968 to remove any unwanted wavelengths.

[0233] Connector 958 is mounted to one side of PCB 952. Connector 958 extends through connector channel 918. Figure 11B When the housing 902 is inserted into the notch 830 and attached to the container 802, connector 958 mates with connector 838 of container 802. Connectors 958 and 838, when attached, allow communication between the optical sensor 950 and the fixed sensor module 850. In an alternative embodiment, the optical sensor 950 includes a wireless transceiver that communicates with another wireless transceiver within the fixed sensor module 850.

[0234] A battery 954 is mounted on the second side of the PCB 952 to power the optical sensor 950. The battery 954 is rechargeable via connector 958. A signal conditioning and communication device 956 is also mounted on the second side of the PCB 952. The signal conditioning and communication device 956 includes logic circuitry, amplifiers, filters, and input / output interfaces to condition and output electrical signals between the transmitter 967, receiver 968, and the fixed sensor module 850.

[0235] When the optical sensor module 900 is attached to the container 902, the light generated by the transmitter 967 is transmitted through the first window 916, the second window 837, along an optical path length 966 within the cavity 920, through the third window 837, and the fourth window 916, and is received by the detector 967. The windows are transmissive to the wavelength / wavelength of the photon energy transmitted through them.

[0236] Detector 967 generates an electrical signal proportional to the amount of IR or UV light received, which is proportional to the concentration of the sterilizing agent within container 802. This electrical signal is regulated by signal conditioning and communication device 956 and transmitted to processor 870 via connectors 958 and 838 for use in determining the sterility of the contents of container assembly 800.

[0237] During use, 180 medical / surgical instruments (including those intended for sterilization) are included. Figure 2 ) brackets or trays 160 ( Figure 2 It is placed in container 802. Support 160 is placed and rests on bottom panel 807.

[0238] An external cable and connector (not shown) are attached to connector 838 to load the validated sterilization process measurement (VSPM) into memory 871. After placing tray 160 inside container 802, lid 550 is placed over container 802, hinge 545 is engaged, and latch 548 is moved to engage with latch receiver 839 to the locked position, locking lid 550 to container 802. Container assembly 800 is now ready for sterilization cycle.

[0239] The removable optical sensor module 900 can be attached to and removed from container 802, and offers several advantages. Because the removable optical sensor module 900 contains higher-cost electronic sensor components that may consume more power, it is desirable to repeatedly load and reuse a relatively small number of removable optical sensor modules 900 with a relatively large number of containers 802, including the fixed sensor module 850, to reduce the overall cost of the sterilization system. Separating the sterilization sensor electronics into two separate components 850 and 950 allows for the use of a smaller number of removable optical sensor modules.

[0240] IX. Electronic sensor printed circuit board

[0241] Figure 12A Figures 12B and 12C illustrate further details of the design of sensor modules 200, 460, 560, 660, and 760. See also: Special Reference Figure 12A The diagram illustrates a steam sensing module 1000. The steam sensing module is specifically designed to monitor and record measurements during the steam sterilization process. The steam sensing module 1000 includes a multilayer printed circuit board (PCB) 1010 with a generally rectangular shape having a top side 1012 and a bottom side 1014. Printed circuit lines 1016 are patterned on each side and layer of the PCB 1010 to electrically connect the components of the steam sensing module 1000.

[0242] Processor 1020 and memory 1022 are mounted on top side 1012. Humidity or water vapor sensor 1024 is mounted on top side 1012. Humidity or water vapor sensor 1024 can be a hygrometer-type humidity sensor or a capacitive humidity sensor. Humidity sensor 1024 outputs an electrical signal (voltage) proportional to the concentration of water vapor around steam sensing module 1000. In another embodiment, the water vapor sensor is an optical sensor with a transmitter and detector that operate at a specific wavelength to monitor and read the concentration of water vapor around the optical sensor. The operation of the water vapor optical sensor is not described in detail here, but operates at a different wavelength than the optical sensor 1052 for hydrogen peroxide vapor described below.

[0243] Pressure sensor 1026 is mounted to the top side 1012. Pressure sensor 1026 may be a semiconductor piezoresistive strain gauge, which utilizes the piezoresistive effect of combined or arranged strain gauges to detect strain caused by applied pressure. Pressure sensor 1026 uses the connected strain gauges to form a Witstone bridge circuit that maximizes the electrical output and reduces sensitivity to error. Pressure sensor 1026 measures absolute pressure, expressed in atmospheric pressure (atm) or bar. Pressure sensor 1026 outputs an electrical signal (voltage) proportional to the absolute pressure surrounding steam sensing module 1000.

[0244] Temperature sensor 1028 is mounted on the top side 1012. The structure of temperature sensor 1028 is not part of this invention. Temperature sensor 1028 outputs an electrical signal (typically a voltage) proportional to the temperature surrounding steam sensor module 1000. Temperature sensor 1028 is mounted and positioned in an isolated manner such that the thermal characteristics of this mounting method maximize the sensor's ability to measure ambient temperature while minimizing interference from the mounting structure and location.

[0245] Light-emitting diodes (LEDs) 1030, such as green, red, and yellow LEDs, are mounted on the top side 1012. A connector 1032 is also mounted on the top side 1012. Connector 1032 is used to connect to external connectors and cables to enable processor 1020 to send and receive data from external systems and devices. A replaceable and / or rechargeable battery or battery pack 1034 is mounted on the bottom side 1014. Battery 1034 powers the various components of the vapor sensing module 1000. Processor 1020 and memory 1022 communicate with each other. Processor 1020 also communicates with each of sensors 1024, 1026, 1028, LED 1030, connector 1032, and battery 1034.

[0246] Turning Figure 12B The diagram illustrates a hydrogen peroxide sensing module 1050. The hydrogen peroxide sensing module 1050 is used when sterilizing instruments with hydrogen peroxide. The hydrogen peroxide sensing module 1050 includes the same sensors and components as those described previously for the vapor sensing module 1000. Additionally, the hydrogen peroxide sensing module 1050 includes one or more optical sensors 1052 that sense the amount of IR and / or UV light transmitted through an optical path length 1054.

[0247] The one or more optical sensors 1052 include an IR or UV light source or emitter 1056. The emitter 1056 may be a light bulb or LED. Sensor 1052 also includes a detector 1058 capable of outputting a signal proportional to the wavelength intensity of the light emitted by the emitter 1055. Sensor 1052 is mounted on a top side 1012. A filter 1060 is mounted towards the detector 1058 to remove any unwanted wavelengths. A semi-circular condenser 1062 is mounted on the top side 1012. One condenser 1062 is positioned around the emitter 1054, while the other condenser 1062 is positioned around the detector 1058. Condenser 1062 reflects light rays that are not coaxial with the detector 1058. Condenser 1062 is formed of a material such as polished stainless steel that effectively reflects the energy of the emitter 1054 towards the detector 1058. Processor 1020 also communicates with the emitter 1056 and detector 1058.

[0248] An optical sensor 1052 is configured to detect hydrogen peroxide (H2O2) vapor. Because hydrogen peroxide vapor absorbs infrared light at a wavelength of 2.93 micrometers and UV light at a wavelength of 240 nanometers, the amount of light transmitted through the known path length 1054 of the hydrogen peroxide vapor is proportional to the concentration of the hydrogen peroxide vapor. Higher concentrations of hydrogen peroxide gas result in less light reaching the detector 1058. Lower concentrations of hydrogen peroxide gas result in more light reaching the detector 1058. In one embodiment, the optical sensor is capable of measuring hydrogen peroxide concentrations from 0.05 mg / L to 25 mg / L specifically designed for sterilization.

[0249] The transmittance of light through a gas is described by Beer-Lambert's law. Beer-Lambert's law states the logarithmic dependence of the transmittance T of a material on the product of the material's absorption coefficient α and the distance the light travels through the material (i.e., the path length) l. This absorption coefficient can be written as the product of the molar absorption (extinction coefficient) ε of the absorber and the molar concentration or absorption cross-section σ of the absorbing species in the material with the (number) density N of the absorbers. For hydrogen peroxide gas,

[0250]

[0251] Where I0 and I are the intensity of the transmitted light when there is no light-absorbing gas, respectively; σ is the molar absorptivity of hydrogen peroxide, and N is the concentration of hydrogen peroxide. The photodetector 1058 outputs an electrical signal (voltage) that is proportional to the concentration of hydrogen peroxide gas around the hydrogen peroxide sensing module 1050.

[0252] Figure 12CAnother embodiment of the hydrogen peroxide sensing module 1080 is illustrated. The hydrogen peroxide sensing module 1080 includes the same sensors and components as those described above for the hydrogen peroxide sensing module 1050, except that the condenser 1062 has been replaced with a different type of condenser. The elliptical condenser assembly 1082 is mounted to the top side 1012 of the PCB 1010.

[0253] The concentrator assembly 1082 includes a pair of arc-shaped or U-shaped concentrators 1084 and a pair of elongated, parallel light shields 1086. One concentrator 1084 surrounds the emitter 1056, and the other concentrator 1084 surrounds the detector 1058. The light shields 1086 extend between the concentrators 1084 and are spaced parallel to and from the light path 1054. An array of apertures 1088 is defined on the light shields 1086. The apertures 1088 allow hydrogen peroxide gas to flow along the light path 1054. The concentrators 1084 and the light shields 1086 are formed of a material that reflects the energy of the emitter, such as polished stainless steel. In one embodiment, a sensor module combines sensors and electronics from both the steam sensor module 1000 and the hydrogen peroxide sensor module 1050, so that a single sensor module can monitor and record both the steam and hydrogen peroxide sterilization processes. When the vapor sensor module and the hydrogen peroxide sensor module are combined into a single sensor module, all components and sensors from both sensor modules 1000 and 1050 can be incorporated into a single sensor module system as described above, or redundant components can be removed to save costs and reduce the size of the combined sensor module.

[0254] X. Electrical schematic diagram

[0255] Turning Figure 13 A block diagram 1100 of an exemplary electronic sensor module is shown. Figure 13 The schematic diagram is intended to illustrate the features of electronic sensor modules 200, 460, 560, 660, 760, 1000, 1050 and 1080. Figure 13 The description will generally refer to the electronic sensor module 1050.

[0256] The electronic sensor module 1050 includes a controller 1120. The controller 1120 includes a processor 1020, a memory 1022, a power monitor 1122, and an input / output interface 1124. The processor 1020 communicates with the memory 1022, the power monitor 1122, and the input / output interface 1124 via one or more communication buses 1126.

[0257] Processor 1020 is a suitable microprocessor, field-programmable gate array, or application-specific integrated circuit. One or more instruction sets or software are stored on a computer-readable medium or memory 1022 embodied in any one or more of the methods or functions described herein. Memory 1022 is random access memory (RM) or non-volatile memory, such as NND flash memory or any other suitable memory. Processor 1020 may also include memory that stores programs at least partially within processor 1020 during processor operation. Memory 1022 stores software or programs that at least partially control the operation of container components 90, 300, 400, 500, 600, 700, and 800.

[0258] The term "memory or computer-readable medium" should also be understood to include any medium capable of storing, encoding, and implementing instruction sets for execution by a processor and causing the processor to perform any one or more of the methods illustrated in the various embodiments of the invention. Therefore, computer-readable medium or memory should be understood to include, but not limited to, solid-state memory, optical and magnetic media, and carrier signals.

[0259] The power monitor 1122 regulates and controls the power from the power supply 1034. The input / output interface 1124 provides the necessary timing, signal levels, and protocols to allow the processor 1020 to communicate with components outside the controller 1120.

[0260] The electronic sensor module 1050 also includes a timer 1132, an LED / display 1030, a power supply 1034, a wireless transceiver 1138, and one or more sensors. The timer 1132 provides a clock signal and a real-time clock to the processor 1020. The timer 1132 may also include additional time information for the processor 1020, such as the date and time information within the date. The LED / display 1030 provides visual information to the user. The power supply 1034 supplies power to the electronic sensor module 1050. The power supply 1034 is a battery or other suitable power source.

[0261] I / O interface 1124 communicates with connector 1032 and wireless transceiver 1138. Wireless transceiver 1138 includes a wireless transmitter and receiver capable of transmitting and receiving wireless signals 1140 containing data and instructions between electronic sensor module 1050 and other components and devices. In one embodiment, electronic sensor module 1050 wirelessly communicates with sterilization chamber 52. Figure 1 In another embodiment, the electronic sensor module 1050 is connected to the on 359 and off 358 buttons. Figure 5 Wireless communication. In another embodiment, the electronic sensor module 1050 communicates wirelessly with the docking station, as described below.

[0262] The processor 1020 also communicates with the sensors of the electronic sensor module 1050 via I / O interface 1124. In one embodiment, the sensors and the electronic sensor module 1050 are mounted within a common enclosure. In another embodiment, the sensors are located far from the electronic sensor module 1050 and communicate with the electronic sensor module 1050 via a signal cable or a wireless communication device.

[0263] Humidity or water vapor sensor 1024, pressure sensor 1026, temperature sensor 1028, and hydrogen peroxide gas sensor 1052 all communicate with I / O interface 1124 via one or more communication buses 1142. Actuator 312 ( Figure 5 Hall effect sensor 382 ( Figure 5 ) and switch 521 ( Figure 8 It is also via one or more external cables 314. Figure 5 ), 588 Figure 8 The processor 1020 communicates with the I / O interface 1124. The processor 1020 receives data from the sensor via the I / O interface 1124 representing environmental characteristics within the container undergoing the sterilization process.

[0264] Figure 13 and 14 The related discussion is intended to provide a summary description of exemplary controllers or processors suitable for implementing the described embodiments. While the embodiments are described in general context of instructions residing in memory stored within the controller, those skilled in the art will recognize that the embodiments can be implemented in a combination of program modules running in an operating system. Generally, program modules include routines, programs, components, and data structures that perform specific tasks or implement specific abstract data types.

[0265] refer to Figure 14 Details of the contents of memory 1022 are shown. Memory 1022 is capable of storing various data, instruction sets, software, firmware, programs, or applications to be executed by processor 1020 and to cause processor 1020 to perform any one or more of the methods described herein. Memory 1022 includes Validated Sterilization Process Measurement (VSPM) 1150, sterilization validation software 1152, sensor calibration software 1154, data logging software 1155, data 1156, and aseptic monitoring software 1158.

[0266] The Validated Sterilization Process Measurement (VSPM) 1150 is a measured value, minimum value, or limit value that ensures sterilization of the equipment load when met within the container during the sterilization process. The Sterilization Validation Software 1152 utilizes VSPM 1150 to determine whether the environment within the container meets the VSPM measured value, minimum value, or VSPM limit value.

[0267] Sensor calibration software 1154 is used to calibrate the sensors during the sensor calibration process. Sensor calibration software 1154 is used to calibrate or verify the accuracy of these sensors before using them to monitor measurements of the sterilization process within the container. Sensor calibration can be combined with... Figure 16 The calibration can be performed in conjunction with stop 1300, or the sensor calibration software can be used independently of stop 1300 to calibrate the sensor.

[0268] As an example, sensor calibration software 1154 calibrates a sensor measuring environmental characteristics by measuring the degree to which light of a specific wavelength is absorbed. One such sensor is a vaporized hydrogen peroxide sensor. Specifically, this calibration is performed when the cavity is near perfect vacuum, for example, about 0.2 Torr. At this point, there is virtually no gas (vapor) inside the cavity. When the cavity and container environment are in this state, it is not extended to say that there is substantially no absorption of emitted light. Data logging software 1155 records the measured value, with the signal from the sensor detector representing the absence of gas in the container when it is in this state. The signal representing the gas being measured is then compared with this baseline signal. Based on this comparison and the constant derived from the Beer-Lambert law, the concentration of the gas being measured is calculated.

[0269] XI. Stops

[0270] Figure 15 An embodiment of a docking station 1200 is illustrated for use in conjunction with container assemblies 90, 300, 400, 500, 600, 700, and 800. The docking station 1200 is used during the loading of surgical instruments into the container and for recharging the battery of the container embodiment described herein. Reference Figure 15 The docking station 1200 includes a frame 1202 and a display 1230. The frame 1202 includes a base 1204 having four legs 1206 spaced 90 degrees apart from each other and a support member 1208. The legs 1206 extend outward from the bottom of the support member 1208. Wheels 1210 are mounted to the distal ends of the legs 1206 to allow the docking station 1200 to move within the medical facility.

[0271] A shelf or container holder 1212 is mounted to the upper end of the support member 1208. Containers, for example... Figure 2 The container 100 rests on and is supported by the shelf 1212. The display 1230 is mounted to the base 1202 via a hinged arm 1232 having one or more pivot joints 1234. By moving and rotating the pivot joints 1234, the arm 1232 can be moved to several different angles and positions. The arm 1232 allows the display 1230 to be positioned within the optimal viewing angle for medical personnel.

[0272] The docking station 1200 also includes a handheld reader 1240 and a connector plug 1250. The handheld reader 1240 communicates with the connector plug 1250 via a cable 1242. The handheld reader 1240 may be a barcode scanner or an RFID reader. In one embodiment, the handheld reader 1240 is capable of scanning barcodes 135, 235 (…) set on container assemblies 90-800. Figure 3 The barcode scanner is used to read barcodes on instrument trays or supports 160 and 720 that can be placed in containers. In another embodiment, handheld reader 1240 is capable of reading RFID tags 135, 235 (…) set on container assemblies 90-800. Figure 3 The RFID reader 1240 transmits scanned data to the docking station 1200. The handheld reader 1240 is used to obtain data and information related to the containers and / or their contents. This read data can be processed by the docking station to provide information back to the user. For example, the docking station can generate images of the equipment groups and equipment racks to be loaded into the container. The docking station can provide instructions on what to load, in what orientation, and how to achieve a sterile barrier for the container.

[0273] As discussed above, each instrument tray or holder is designed to hold a specific set of instruments. A set of validated sterilization process measurements for that particular holder / tray and associated instruments are known. A handheld reader acquires data identifying the tray or holder from that tray or holder. Based on the data identifying the tray or holder, the docking station acquires VSPM data from the docking station's memory. This data is loaded into the sensor module memory for the set of instruments to be sterilized. The read data can also be used in conjunction with other asset tracking and workflow tracking systems within the hospital to track the location and contents of container components.

[0274] Connector plug 1250 is mounted to the proximal portion of shelf 1212. Connector plug 1250 is used to connect the device to dock 1200 via cable and connector. Container 100 with electronic sensor module 200 is connected to dock 1200 via cable 1246. One end of cable 1246 is connected to connector 244, and the other end of cable 1246 is connected to a plug in connector plug 1250. Cable 1246 is used to recharge the battery of electronic sensor module 200 and to send and receive data between electronic module 200 and dock 1200. For example, measurements of the validated sterilization process can be transmitted from dock 1200 via cable 1246 and stored in electronic sensor module 200. In another embodiment, dock 1200 can communicate with electronic sensor module 200 via a wireless device.

[0275] Display 1230 and controller 1402 located inside dock 1230 Figure 17 Communication. Display 1230 is a touchscreen display, such as an LCD, LED, or plasma display, that allows users to provide input to the docking station. Other input devices, such as a keyboard, can be connected to docking station 1200. Controller 1402 can display various images or screen 1260 on display 1230. For example, in Figure 15 In this display, screen 1260 shows the user the surgical instruments 180 that will be placed in tray 160 of container 100. Screen 1260 indicates to the user the type, name, or quantity of the instruments 180 to be placed on tray 160, as well as the correct position and orientation of each instrument 180 on tray 160. Figure 15 In the image, the surgical instrument 180 shown is an electric surgical drill or head.

[0276] In one embodiment, a handheld reader 1240 reads the barcode on the surgical instrument 180 to be sterilized. The handheld reader transmits the barcode information to a controller 1402 via cable 1242. The controller 1402 searches a database of tray configurations and displays a screen 1260 to the user, identifying the correct tray 160 to be used with the identified surgical instrument 180, as well as the number, position, and orientation of the identified surgical instruments 180 to be placed in the tray 160. The combination of surgical instruments, instrument holders 160, and other validated items constitutes an equipment load within the sterile barrier. This equipment load is depicted as Content ID 1610 in Figure 19. The user can assemble the correct surgical instruments 180 in the correct position on the tray 16 for sterilization while viewing the screen 1260. The screen 1260 helps prevent the incorrect surgical instruments 180 from being placed with the incorrect tray 160. The screen 1260 also helps prevent the user from incorrectly orienting the surgical instruments 180 in the tray 160.

[0277] refer to Figure 16 Another embodiment of docking station 1300 is shown. Docking station 1300 is used in conjunction with container assemblies 90, 300, 400, 500, 600, 700, and 800. Docking station 1300 is used during the loading of surgical instruments into containers to calibrate sensors and rechargeable batteries. Docking station 1300 includes a frame 1302 and a display 1230. Frame 1302 includes a generally rectangular base 1304, with four wheels 1306 mounted to the corners of base 1304.

[0278] Panel 1308 covers the sides and rear of frame 1302. A pair of doors 1310 are mounted to the front of frame 1302 to allow access to the interior cavity 1312 of frame 1302. A rectangular calibration cavity 1320 is mounted to the upper half of frame 1302, above the doors 1310. Calibration cavity 1320 has a proximal end extending above the doors 1310 and a distal end abutting the rear panel 1308. Calibration cavity 1320 has an inner panel or wall, a top panel or wall, a bottom panel or wall, and a rear panel or wall 1322. Panel 1322 defines an interior cavity 1324. During calibration, calibration cavity 1320 accommodates a container assembly, such as container assembly 400, to calibrate a sensor contained within container assembly 400.

[0279] Door 1326 is mounted to the front of calibration chamber 1320 via hinge 1328. Door 1326 is moved to open and close calibration chamber 1320. Door lock 1330 engages with lock slot 1332 to hold door 1326 in the closed position. Resilient washer 1334 is mounted around the outer peripheral edge of door 1326 and forms a seal when door 1326 is closed.

[0280] Connector 1336 is mounted to the inner wall 1322. When container assembly 400 is placed in the inner cavity 1324, connector 1336 mates with connector mating portion 1338 and cable 1340. The other end of cable 1340 can be connected to connector 485 mounted to container 402. During the calibration process, connectors 485, 1336, 1338, and cable 485 allow docking station 1300 to communicate with electronic sensor module 460 within container 402. Figure 7A Communication. Although connector 1336 is in Figure 16 The container assembly 90, 400, 500, 600, 700 and 800 are shown connected to the connector 1336 and calibrated using the calibration chamber 1320.

[0281] A flat shelf 1342 is mounted above the calibration chamber 1320 and has an angled portion 1344. The user can place the container on the shelf 1342. The handheld reader 1240 is stored in a holder 1345 within the angled portion 1344 when not in use.

[0282] Multiple charging ports 1346 are mounted to the angled portion 1344. The charging ports 1346 are shaped to receive electronic sensor modules 200 that have been removed from their respective containers. Figure 1 This is to recharge the battery within the electronic sensor module 200. The charging port 1346 can also accept a removable battery pack, such as battery 1034 ( Figure 12BThe charging port 1346 includes terminals (not shown) for connecting to a battery charger inside the dock 1300.

[0283] The display 1230 is mounted to the frame 1302 via a hinged arm 1232 having one or more pivot joints 1234. By moving and rotating the pivot joints 1234, the arm 1232 can be moved to multiple different angles and positions. The arm 1232 allows the display 1230 to be positioned for optimal viewing by medical personnel. The display 1230 can display information as previously described. Figure 15 The screen described is 1260.

[0284] Now refer to Figure 17 An electrical block diagram 1400 of docking stations 1200 and / or 1300 is shown. A docking station controller 1402 controls the operation of docking stations 1200 and 1300. The docking station controller 1402 includes a processor 1410, a memory 1412, and an input / output interface 1414. The processor 1410 communicates with the memory 1412 and the input / output (I / O) interface 1414 via one or more communication buses 1416. Components of the controller 1402 are mounted on a printed circuit board (not shown).

[0285] Processor 1410 is a suitable microprocessor, field-programmable gate array, or application-specific integrated circuit. One or more instruction sets or software are stored on a computer-readable medium or memory 1412 embodied in any one or more of the methods or functions described herein. Memory 1412 is random access memory (RM) or non-volatile memory, such as NND flash memory or any other suitable memory. Processor 1410 may also include memory that stores programs at least in part within processor 1410 during processor operation. Memory 1412 stores software or programs that control the operation of docks 1200 and 1300.

[0286] Power supply 1418 supplies power to the components of controller 1402 and other components of docks 1200 and 1300. Power supply 1418 is connected to a common power source. I / O interface 1414 provides the necessary timing, signal levels, and protocols for communication with internal and external components of controller 1402.

[0287] I / O interface 1414 communicates with battery charger 1420 and wireless transceiver 1422. Battery charger 1420 is used to recharge a battery contained in an electronic sensor module connected to the docking station. Wireless transceiver 1422 includes a wireless transmitter and receiver capable of sending and receiving data and instructions via wireless signal 1424. In one embodiment, docking station 1200 and / or 1300 uses wireless signal 1424 to communicate with container assemblies 90-800.

[0288] I / O interface 1414 also communicates with other external components such as keyboard 1426, display 1230, and handheld reader 1240. Keyboard 1426 is used to input information to docks 1200 and 1300. Processor 1410 sends video display data to be displayed on display 1230, such as screen 1260. Handheld reader 1240 sends data to processor 1410.

[0289] I / O interface 1414 also communicates with multiple components used during calibration using dock 1300. The I / O interface communicates via communication bus 1416 with steam generator 1430, hydrogen peroxide generator 1432, pressure pump 1434, vacuum pump 1436, and heater 1438. All these calibration components are mounted in calibration chamber 1320. Figure 16 The inner cavity 1312 below Figure 16 )Inside.

[0290] A steam generator 1430 is connected to the calibration chamber 1320 via a pipe connection. During calibration, the steam generator 1430 generates steam of a known concentration within the calibration chamber 1320. A hydrogen peroxide generator 1432 is connected to the calibration chamber 1320 via a pipe connection. During calibration, the hydrogen peroxide generator 1432 generates hydrogen peroxide of a known concentration within the calibration chamber 1320. A pressure pump 1434 is connected to the calibration chamber 1320 via a pipe connection. During calibration, the pressure pump 1434 generates a known pressure level within the calibration chamber 1320.

[0291] Vacuum pump 1436 is connected to calibration chamber 1320 via a pipe connection. During calibration, vacuum pump 1436 is used to generate a known vacuum level within calibration chamber 1320. Heater 1438 is mounted to the outer surface of the inner wall 1322 of calibration chamber 1320. Figure 16 During calibration, heater 1438 is used to generate a known temperature within calibration chamber 1320. During calibration, processor 1410 controls the operation of steam generator 1430, hydrogen peroxide generator 1432, pressure pump 1434, vacuum pump 1436, and heater 1438.

[0292] Processor 1410 communicates with network 1450 via network communication structure 1452. In one embodiment, network 1450 communicates with a medical institution or hospital data processing system or computer system 1454 via network communication structure 1458. Docks 1200 and 1300 can send and receive information from computer system 1454. For example, hospital computer system 1454 can maintain a database 1456 of surgical instruments and tools used within the medical institution. Docks 1200 and 1300 can send information relating to the quantity and type of sterile or non-sterile surgical instruments contained in containers to hospital computer system 1454 to update database 1456. For security purposes, data sent and received between different computer systems and data sources can be encrypted to prevent unauthorized access or tampering.

[0293] Memory 1412 is capable of storing various data, instruction sets, software, programs, or application programs for execution by processor 1410 and causing processor 1410 to perform any one or more of the methods described herein. For security purposes, items stored in memory 1412 may be encrypted before storage.

[0294] The memory 1412 includes nominal cavity process parameters (CPP) 66, sensor calibration software 1460, container programming software 1461, container loading software 1464, container configuration data 1465, equipment load data, validated sterilization process measurement (VSPM) 1150, process measurement limit determination software 1466, application data 1470, and application software 1472.

[0295] CPP 66 is a nominal process setting used by healthcare workers to program CPP 66 into the nominal sterilization process of sterilization chamber 52 to control the sterilization process cycle. During the calibration of sensors associated with the corresponding containers, sensor calibration software 1460 is used by docking station 1300. During calibration, sensor calibration software 1460 at least partially controls the operation of steam generator 1430, hydrogen peroxide generator 1432, pressure pump 1434, vacuum pump 1436, and heater 1438.

[0296] Container programming software 1461 is used to load VSPM 1150 into container storage 1022. Container loading software 1464 is used in conjunction with container / tray configuration data 1465 to verify that the correct surgical instruments are loaded into the appropriate trays and containers.

[0297] VSPM 1150 is a value measured in relation to the sterilization process for the equipment load, ensuring the sterilization of the container contents when the requirements for that equipment load are met within the container. Container and tray configuration 1464 is a database of container types, possible tray and support types, and surgical instruments, detailing the trays to be used with specific surgical instruments and the placement and orientation of the instruments within the trays. Using the methods described herein, VSPM 1150 is correlated with the surgical equipment load. Container loading software extracts the surgical equipment load configuration to assist healthcare workers when loading and preparing containers for sterilization. The container loading software also facilitates data entry to record who prepares the container, when they prepare it, what is loaded onto it, and other relevant information required by regulations or good business practice for recording, tracking, or improving the quality of the container loading process. Container and tray configuration data can be written as text, images, or a combination of both, representing instrument supports, instrument configurations, and / or instrument orientations.

[0298] Process Measurement Limits Determination Software 1466 is used to determine and generate VSPM 1150 data values. Typically, Process Measurement Limits Determination Software 1466 will be used by the OEM of the device group to establish VSPM data for that device group and to correlate that VSPM data with sterilization validation. Hospitals or users of VSPM data generally do not use Process Measurement Limits Determination Software 1466. Hospitals may use Process Measurement Limits Determination Software 1466 if they need to validate and correlate surgical equipment loads different from those provided by the OEM. Application Data 1470 contains data tracking the number of sterilization process cycles experienced by each container in the corresponding container, or tracking the number of hours each container in the corresponding container has been in use. Application Software 1472 is a software program that monitors the number of sterilization process cycles experienced by each container in the corresponding container, or tracks the number of hours each container in the corresponding container has been in use, and generates Application Data 1470. Application data can be used for billing, aseptic processing or workflow status, calibration status, or for the routine maintenance of electronic sensor modules or containers.

[0299] In some forms of the invention, a handheld reader is used to identify which specific instruments are placed in the container. After a sterilization cycle, sterilization process measurements recorded by a sensor module for the container are matched against the data identifying the instruments in that container. A log is maintained for each instrument regarding the number of sterilization processes in which the instrument was exposed and the environmental measurements taken during those processes. This data can also be used for inventory and billing control.

[0300] XII. Computerized methods for tracking container usage and billing based on single-use fees

[0301] refer to Figure 18 The diagram illustrates a block diagram of a networked computer system 1500 used for tracking container usage and billing. The networked computer system 1500 includes one of docking stations 1200 and 1300, a manufacturer's computer system 1510, and a hospital computer system 1454, all interconnected and communicating with each other via a communication network 1450. The communication network 1450 may include various networks, such as the Internet, a local area network (LAN), a wide area network (WAN), or a wireless communication network.

[0302] Manufacturer computer system 1510 and hospital computer system 1454 include any type of computing device or machine capable of receiving, storing, and running software products, including not only computer systems and servers, but also devices such as routers and switches, mainframe computers, and terminals. The operation of manufacturer computer system 1510 and hospital computer system 1454 will be described below with respect to the general environment of instructions residing on the hardware within the server computer. Those skilled in the art will recognize that embodiments can be implemented in combinations of program modules running in an operating system. Program modules include software, routines, programs, components, and data structures that perform specific tasks or implement specific abstract data types. The invention can also be implemented in a distributed computing environment, where tasks are performed by remote processing devices linked via a communication network. In a distributed computing environment, software program modules can be located in both local and remote memory storage devices.

[0303] The manufacturer's computer system 1510 communicates with network 1450 via communication fabric 1552. The manufacturer's computer system 1510 includes a processor 1520 and memory 1522. Memory 1522 is capable of storing various data, instruction sets, software, programs, or application programs for execution by the processor 1520. Memory 1522 includes billing software 1530, billing 1532, and application data 1472. Application data 1472 may include hospital account information, such as hospital name, account number, billing interval, contract price, and other relevant information, to accurately track equipment usage and billing.

[0304] Docks 1200 and 1300 send application data 1472 to the manufacturer's computer system 1510. Billing software 1530, executed by processor 1520, generates a bill 1532 based on the application data 1472 received from docks 1200 and 1300. Processor 1520 stores the bill in memory 1532 and sends the bill 1532 to the hospital computer system 1454.

[0305] Hospital computer system 1510 communicates with network 1450 via communication structure 1458. Hospital computer system 1454 includes processor 1570 and memory 1572. Memory 1572 is capable of storing various data, instruction sets, software, programs, or application programs to be executed by processor 1570. Memory 1572 includes bills 1532 and database 1456 received from the manufacturer's computer system 1510.

[0306] A networked computer system 1500, in conjunction with docking stations 1200 and 1300 and containers 90-800, is used in an enterprise model where these are leased or rented to medical institutions or hospitals. The medical institution or hospital pays for the use of the docking stations and containers on a per-use basis. In one embodiment, docking stations 1200 and 1300 track the frequency of use of containers 90-800 during sterilization processes and generate application data 1472, which is sent to the manufacturer's computer system 1510. The manufacturer's computer system 1510 generates an invoice 1532 based on the usage of containers 90-800 and sends the invoice to the hospital's computer system 1454, where it is then processed and reimbursed.

[0307] XIII. Validated Sterilization Process Measurements (VSPM)

[0308] Figure 19A-1 and 19A-2 When placed side-by-side, this forms a table of Validated Sterilization Process Measurements (VSPM) 1150. VSPM 1150 is stored in memory 1412, memory 1522, or memory 1572. Figure 17In some embodiments, VSPM 1150 is stored in sensor module memory 1022. In other embodiments, VSPM 1150 data is reliably stored in memory 1412, or memory 1522 or memory 1572, such that the intercorrelated or correlated VSPM data is not modified after undergoing the validation and correlation processes described herein. VSPM 1150 data is determined during the validation and correlation processes, which will be described in detail below. Typically, this validation and correlation process is used to correlate or correlate sterilization process measurements measured by sensors within the container during sterilization validation to expected microbial kill results for a given set of surgical devices or device loads. Data measured and recorded by the electronic sensor system during validation is then used to establish a dataset of VSPM measurements, thresholds, or VSPM limits. After the VSPM datasets are validated and correlated, these VSPM datasets are used to compare sterilization process measurements at healthcare facilities, such as those monitored by sensors within the container assembly, to determine whether the process measurements for this device load meet, exceed, or fall within the VSPM dataset. This comparative method is considered a verification method, which can be used with appropriate sensor systems and container components each time a healthcare professional sterilizes a surgical equipment load or group using the methods and systems described herein. In one embodiment, VSPM data are time-based sterilization process measurements or limits that, according to this verification and cross-correlation method, confirm that those sterilization process measurements have been verified to ensure the same result is achieved during the verification process, i.e., the same sterilization or disinfection level of the equipment load, when achieved for an associated group of surgical devices during the sterilization process. VSPM 1150 includes one or more datasets (VSPM 1150-Steam1, VSPM-1150-HPV) associated with Content Identifier (ID) 1610. Content Identifier 1610 identifies the surgical equipment load within a sterile barrier or container. Content ID 1610 describes the surgical instruments, surgical tools 180 ( Figure 2), and instrument holders 160, 720 within containers or sterile barriers that are associated with or related to Validated Sterilization Process Measurements (VSPM) datasets, are commonly referred to as surgical device loads. For example, content CID 1160-3 can identify Stryker battery-powered surgical device loads, including rechargeable batteries for rotary surgical instruments 180. CID 1160-3 can be handwritten, electronic, or both types of text, images, or photographs illustrating the composition of the device load associated with VSPM data. For example, content identifiers may include surgical device type, part number, serial number, quantity, and other unique device load identifiers validated together during sterilization validation and inter-association processes. In one embodiment, content identifier 1610 may be a... Figure 22-24 The method described herein is used to obtain electronic photographs of the device load during sterilization validation. In another embodiment, the contents identifier 1610 may include a list of tray or support identifier models for instrument supports (160, 720) used during sterilization validation, as well as a list of all devices contained therein. For example, the device contents identifier CID-1610-1 includes the instruments and utensils 180-1 listed in Figure 19(a) and the instrument support (160, 720) identified as Stryker 7102-450-010. Identification is important for the tray or support 720 because it orients the cannula in a generally downward orientation within the rotary surgical head, facilitating air removal and water drainage, thereby facilitating sterilization.

[0309] When one or more sterilization processes are validated and said validations are associated with Content Identifier 1610 or Equipment Load, the VSPM 1150 also includes one or more datasets of validated sterilization process measurements. For example, a dataset (VSPM-1150-S-1) for an effective steam sterilization process may include steam measurements, temperature measurements, time limits, absolute pressure measurements, and time limits for Content Identifier CID 1610-1. In another embodiment, another dataset (VSPM-1150-H-1) for a hydrogen peroxide sterilization process may include temperature limits, pressure limits, steam concentration, and the area under the time-based hydrogen peroxide steam concentration curve associated with the same Content Identifier CID_1160-1. For steam sterilization, this temperature is a critical or minimum temperature that must be maintained for the minimum time period during the sterilization process, within the internal environment and equipment load of the container assembly (90-4600), to ensure that the VSPM data measurements are met. For example, empirical sterilization process measurements used for container No. 7102-450-040, when stent No. 7102-450-010 is contained within... Figure 19A-1 and 19A-2The first row of the table shows the data. More specifically, these are VSPM data used when the stent and the instruments mounted on the stent (collectively, the load) undergo a steam sterilization process. As indicated in the table cells, the instruments on the stent are considered sterilized if the interior of the container is subjected to saturated steam at a minimum temperature of 270°F and this temperature is maintained for at least 3 minutes and 55 seconds.

[0310] The temperature of saturated steam can be calculated from pressure measurements and compared with temperature measurements to verify that the steam is saturated. The comparison between the measured steam temperature and the calculated saturation temperature can also be used to confirm the absence of air of sufficient quantity to adversely affect sterilization efficiency.

[0311] Validated sterilization process measurements 1150 may have critical or limit values ​​that must be simultaneously within their range as a function of time for a single measurement or across the same time interval. For example, as just provided, the temperature, absolute pressure, and saturation level of steam may have limit values ​​established for a time interval of 3 minutes and 55 seconds. Optionally, the process measurements obtained from these measurements may have specific limit values ​​that vary as a function of time. For example, for the first 2-minute steam sterilization cycle, the temperature may have a minimum critical value of 131°C or higher, while for the next 2 minutes, the temperature may have a different critical value of 133°C or higher. When an instrument group is designed and validated for more than one type of sterilization cycle, the VSPM may include more than one type of VSPM dataset. If an OEM designs and validates its equipment to be sterilized using both steam and hydrogen peroxide sterilization processes, the VSPM table contains VSPM data for both sterilization processes. Figure 19A-1 and 19A-2In the table, VSPM data for different sterilization processes are shown in different columns. In this table, VSPM measurements for steam sterilization are shown in the first row. The second row contains VSPM data for the same load when the device is subjected to vaporized hydrogen peroxide sterilization. The table has two VSPM datasets: one for steam sterilization (VSPM-1150-1) and one for hydrogen peroxide sterilization (VSPM-1150-H-2), with the same content CID 1610-1. More specifically, content CID 1610-1 can be correlated with the VSPM 1150-S-1 dataset for temperature, absolute pressure, and steam saturation for steam sterilization, and the VSPM 1150-H-1 dataset for temperature, absolute pressure, hydrogen peroxide concentration, and water concentration for hydrogen peroxide sterilization. This provides the ability to add these VSPM datasets to include additional VSPM data for a specific sterilization form, after the VSPM datasets for a given device load or content ID have been validated and cross-correlated as described herein. The sensor module can be designed for use in a single sterilization method, denoted as SM0000XS for steam or SM0000XH for hydrogen peroxide, where 0000X indicates the type of sensor module. In another embodiment, the sensor module can also be designed for use in more than one sterilization method. For example, a sensor module denoted as SM0000XSH can be used in both steam sterilization and hydrogen peroxide sterilization, where 0000X is the serial number assigned to the sensor module. Figure 19 shows a unique sensor module arranged in each row. The sensor module can be used with any compatible content ID 1610. For example, the Stryker sensor module SM00001S can be used with content identification CID 1610-1, CID 1610-2, or CID 1610-5.

[0312] For some sterilization processes, the validated sterilization process measurements are those generated over time. In their simplest form, these measurements represent the minimum concentration of a specific sterilizing agent in the container environment over a defined minimum time period. A simple example is a set of measurements representing a container environment containing saturated vapor over a period of at least 5 minutes.

[0313] A more complex set of measurements is used to generate the area under the curve (AUC). The X-axis of this curve represents time; the Y-axis is the concentration of the sterilizing agent. Typically, time is expressed in seconds and concentration in mg / L. Thus, for a set of instruments in a container, this validated sterilization process can be a process where the AUC is 5000 (mg / L) (seconds) of vaporized hydrogen peroxide concentration. This means that for the first sterilization cycle, a validated sterilization process measurement is satisfactory if a vaporized hydrogen peroxide concentration of 25 mg / L is measured over a time period of at least 200 seconds. For the second sterilization cycle, a validated sterilization process measurement is satisfactory if a vaporized hydrogen peroxide concentration of 20 mg / L is measured over a time period of at least 100 seconds. It should be further understood that this AUC is typically used for the minimum concentration of the sterilizing agent. Therefore, in the above embodiment, the time periods where the container environment has a vaporized hydrogen peroxide concentration below 18 mg / L are not integrated into the target measurement.

[0314] The area under the time-based hydrogen peroxide concentration curve is the critical or minimum value (mg / L) (seconds) of hydrogen peroxide that exposes the interior of one of the containers to ensure sterilization of the container contents. For example, when a device with contents ID CID 1610-1 is provided, as illustrated in line 2 of Figure 19, the interior of container Stryker 7102-450-040 needs to be exposed to a minimum of 2500 mg-s / L of hydrogen peroxide during the sterilization cycle. If, at any time, the water vapor content is lower under these exposure conditions compared to its 100% saturation state, then the effective concentration at that moment can be reduced when it is added to the area under the time-based concentration curve. For example, the effective concentration can be halved when the water vapor concentration is below 80% of the saturation concentration. The saturation concentration of water vapor depends on both the vapor temperature and the concentration of hydrogen peroxide vapor present.

[0315] Additional information in other embodiments described in Figure 19A may optionally be associated with a CID 1610 or VSPM 1150 dataset, or both. For example, Container ID 1605 identifies and describes a specific type of container 90-4600 that has undergone a previous sterilization validation process. When the sterilization process result is known or suspected to be affected by the container type or the type of sterile barrier used for the device load, the Container ID may be associated with a Contents ID or a VSPM dataset, or both. If the container type or the sterile barrier used in the sterilization process is known not to affect the sterilization result, then the Container ID may not be associated with a Contents ID or a VSPM dataset. The latter embodiment described above allows the sterile barrier or container type used for sterilization at a healthcare facility to be replaced with a device load without changing the sterilization result, provided that these process measurements are correctly verified to conform to VSPM 1150 using the sensor modules and methods described herein. For example, the identified container is identified by a specific container serial number provided by an OEM or within a healthcare facility. The container ID can be identified and translated into container type, sterile barrier used, and electronic sensor module type 200, 460, 560, 660, 760, 1000, 1050, 1080 or sensor module configuration. When using different embodiments of the invention, other data associated with the content ID 1610 or VSPM 1150 data listed in Figure 19, or both, may be useful but not required. For example, nominal process parameters may be output from the docking station so that the sterilizer operator can set nominal process parameters for programming the sterilizer. In this example, these nominal process parameters will be greater than or equal to the nominal process parameters used in VSPM 1150 data verification and correlation to content ID 1610. In other embodiments, the data table may also include sensor module usage. The total number of sterilization cycles can be obtained from sensor module application data and can be used for commercial purposes such as automated billing, periodic maintenance, and periodic replacement of container and sensor components. The date, contents identifier, and container identifier for the sterilized load are used by the central processing unit for inventory tracking, invoicing, and control purposes.

[0316] During the loading and programming of the container using the docking station, at least a portion of the VSPM 1150 is sent from the docking station to the electronic sensor module and stored in the module memory 1022. Figure 14 For example, if a container is loaded and programmed with Content ID 1610-1 and Tray ID Stryker7102-450-010, then only VSPM 1150--1 associated with Content ID 1610-1 and the associated sterilization process is sent from memory 1412 to memory 1022.

[0317] XIV. Automatically closes the container vent plug.

[0318] Figures 20A-20C The diagram illustrates container assembly 1700 having an automatic closing lip cap assembly 1720 mounted to container lid 1710. Container assembly 1700 can modify an existing sterilization container into one that automatically closes after receiving a closing signal from an electronic sensor module. The automatic closing container vent plug, when positioned in the open state during the sterilization process, allows unobstructed passage of sterilizing agent into the container, providing easier access to the container contents for sterilization.

[0319] Container assembly 1700 is used when the sterilization process is reduced in efficiency or rendered ineffective due to the presence of a filter in the through-opening of the container. One reason a filter may have this effect on the sterilization process is that its presence, due to its construction and the composition of the sterilizing agent, obstructs the flow of the sterilizing agent. The presence of a filter may also adversely affect sterilization because a chemical reaction occurs when the sterilizing agent is exposed to the material forming the filter, reducing its efficiency.

[0320] Therefore, to avoid these adverse effects caused by the presence of a filter, the container assembly 1700 typically does not include a filter. At least during the period of sterilization cycles of the container and its contents, the vent plug is open and flow through it is unobstructed.

[0321] Container lid 1710 is roughly similar to Figure 7A The lid 450; however, the lid 1710 does not have any holes 459 or filter assembly 440. The lid 1710 has a flat top panel 1712. The top panel 1712 has an upper surface 1714 and a bottom surface 1716. A circular central opening 1718 is defined on the top panel 1712. The lid 1710 is positioned over the container 402 to close the container 402.

[0322] The container cap 1710 and container vent plug assembly 1720 can be adapted to any of the containers 100, 402, 502, and 802 described above to provide the container with a cap that automatically closes after the sterilization cycle is completed. While the container vent plug assembly 1720 is shown mounted to the cap 1710, it can optionally be mounted to either side panel of the container 402. By repositioning the container vent plug to different panels, it allows for more efficient entry and exit of the sterilizing agent to achieve sterilization of the container contents. Furthermore, more than one container vent plug 1720 positioned on one or more panels can be used on a single container.

[0323] An automatic closing container vent plug assembly 1720 is mounted to the top panel 1712. More specifically, the container vent plug assembly 1720 is received by an opening 1718. The container vent plug assembly 1720 includes a circular carrier 1722, a cap 1760, a circuit board 1770, and a linear helical tube 1780. The carrier 1722 includes an outer ring 1728 connected to a central drum-shaped portion 1734 via a transverse member 1724. The outer ring 1728 is perpendicular to the transverse member 1724. A peripheral edge 1726 extends perpendicularly away from and surrounds the ring 1728. A recess 1730 is defined between the ring 1728 and the transverse member 1724. The carrier 1722 and the container vent plug 1760 are formed of injection-molded plastic.

[0324] The carrier 1722 is mounted within the opening 1718. An edge 1726 rests against the top surface 1714, supporting the carrier 1722. The outer surface of the ring 1728 abuts against the annular portion of the panel 1712 defined by the opening 1718. In one embodiment, the carrier 1722 is press-fitted into the opening 1718. In another embodiment, the carrier 1722 is sealed to the panel 1712 using adhesive or sealed mechanical fasteners.

[0325] The central drum-shaped portion 1734 is cylindrical in shape and has a base 1736. An outer wall 1738 and an inner hub 1740 extend vertically away from the base 1736. The base 1736, outer wall 1738, and inner hub 1740 define a groove 1742 therein. A central inner bore 1744 passes entirely through the base 1736 and the inner hub 1740. Another inner bore 1746 passes vertically through the inner hub 1740 approximately halfway along its length. The inner bore 1746 extends between the groove 1742 and the inner bore 1744. A plurality of mounting protrusions 1748 are attached to the base 1736 adjacent to the wall 1738. The mounting protrusions 1748 extend vertically into the groove 1742 away from the base 1736. The mounting protrusions 1748 are used to attach the circuit board 1770 to the carrier 1722.

[0326] The cap 1760 includes a circular disc-shaped portion 1761 attached to a cylindrical shaft 1765. The disc-shaped portion 1761 has an annular outer side surface 1762. An annular groove 1763 is defined on the side surface 1762. The groove 1763 is sized to receive a circular, resilient O-ring 1764. The cylindrical shaft 1765 extends vertically away from the bottom side of the disc-shaped portion 1761. The shaft 1765 has a central inner bore 1766 that extends partially into the shaft 1765 parallel to its axis. The shaft 1765 also has two inner bores 1767 and 1768 that extend partially into the shaft 1765 perpendicular to its axis. The lengths of the inner bores 1767 and 1768 are approximately half the diameter of the shaft 1765. The inner hole 1767 is spaced apart from the bottom side of the disc-shaped portion 1761, and the inner hole 1768 is spaced apart from the end of the central inner hole 1766.

[0327] Printed circuit board 1770 is attached to a groove 1742 via fastener 1771. Groove 1742 is sized to receive printed circuit board 1770. Fastener 1771 extends through circuit board 1770 and is threaded into mounting protrusion 1748. Multiple electrical components are mounted to circuit board 1770. Battery 1772, wireless transceiver 1773, helical tube housing 1774, and helical tube driver 1775 are mounted to circuit board 1770. Linear helical tube 1780 is mounted within and held by helical tube housing 1774. Battery 1772 is a rechargeable or replaceable battery or supplies power to components of circuit board 1770. Printed circuit board 1770 communicates with one of electronic sensor modules 200, 460, 560, 660, 760, and 850. In one embodiment, wireless transceiver 1773 receives wireless communication from one of electronic sensor modules 200-850. In another embodiment, cable 1779 connects circuit board 1770 and one of electronic sensor modules 200-850. Solenoid driver 1775 communicates with linear solenoid 1780 and causes linear solenoid 1780 to move an attached rod 1782. Rod 1782 can move linearly between an extended position and a retracted position.

[0328] A coil spring 1790 surrounds a shaft 1765. A spring retainer 1792 is mounted above the coil spring 1790 and includes a protrusion 1793 extending into an inner bore 1766. The spring retainer 1792 retains the coil spring 1790 to the shaft 1765. The spring retainer 1792 has an annular lip 1794 extending over and abutting the distal end of the spring 1790. The proximal end of the spring 1790 abuts the end portion of an inner hub 1740. The spring retainer 1792 is press-fitted into the inner bore 1766 or attached to the inner bore 1766 using an adhesive. The coil spring 1790 biases the vent plug 1760 to move it toward the carrier 1722. In the open position, as... Figure 20B As shown, a channel 1996 is formed between the bottom of the carrier 1722 and the disc-shaped portion 1761.

[0329] The container vent plug 1760 is held in the open position by passing the helical rod 1782 through the inner bore 1746 of the inner hub and extending into the inner bore 1768 of the container vent plug. In this position, the coil spring 1790 is compressed. The container vent plug 1760 is opened from the closed position in a two-step process. First, the user triggers the helical rod 1782 to retract from the inner bore 1767 via the helical tube 1780 using an input device. In one embodiment, the input device is the touchscreen 1230 of the docking station 1200. Figure 15 Then, the user manually grasps the container vent plug 1760 and pulls it upwards, moving the container vent plug 1760 away from the carrier 1722. The spiral rod 1782 is biased outwards by a spring (not shown) such that when the container vent plug inner hole 1768 moves to axial alignment with the inner hub inner hole 1746, the rod 1782 automatically extends into the container vent plug inner hole 1768, thereby holding the container vent plug 1760 in the open position.

[0330] During use, the lip cap assembly 1720 and the container cap 1710 are part of a container assembly that undergoes a sterilization cycle within the sterilization chamber. When the electronic sensor module 200-850 determines that the environment inside the container 402 during the aseptic process is sufficient to meet or exceed a required set of environmental characteristics (VSPM 1150) to ensure the sterility of the surgical instrument being sterilized, the sensor module 200-850 transmits an electrical signal via the wireless transceiver 1773 or cable 1779 to the spiral tube driver 1775, commanding the spiral tube driver 1775 to close the container vent plug 1760.

[0331] The helical actuator 1775 causes the helical tube 1780 to retract the helical rod 1782. As the rod 1782 moves out of engagement with the inner bore 1768, the spring 1790 biases the container vent plug 1760, causing it to move into the recess 1730, thereby closing the passage 1796. The movement of the container vent plug 1760 is restricted by the bottom of the disc-shaped portion 1761 abutting against the transverse member 1724. Simultaneously, the O-ring 1764 is compressed between the outer surface of the disc-shaped portion 1762 and the inner surface of the ring 1728 to form a seal.

[0332] In one embodiment, when the container vent plug inner bore 1767 moves to axial alignment with the inner hub bore 1746, the rod 1782 automatically extends into the container vent plug inner bore 1767, thereby holding the container vent plug 1760 in the closed position. In another embodiment, after the container vent plug 1760 is closed, the sensor module 200-850 transmits an electrical signal via the wireless transceiver 1773 or cable 1779 to the helical tube actuator 1775, commanding the helical tube actuator 1775 to extend the helical tube rod 1782 from the helical tube 1780. In this extended position, the distal end of the rod 1782 is received by and engages with the inner bore 1767, thereby locking the container vent plug 1760 to the carrier 1722.

[0333] The use of the automatic closing container assembly 1700 and the automatic closing lip cap assembly 1720 allows existing containers to be modified with automatic closing devices, eliminating the need for filters or filter assemblies. When channel 1796 is open, sterilizing agent can easily enter and permeate container 402 without interference.

[0334] After the container and its contents have undergone the stage where the sterilizing agent is introduced into the container during the sterilization cycle, channel 1796 remains open for another period of time. This allows any residual sterilizing agent that may be present in the container to evaporate and be discharged from the container. The advantage of allowing the sterilizing agent to be discharged is that the possibility of residual sterilizing agent coming into contact with patients or hospital staff if the sterilizing agent could potentially harm tissue is substantially eliminated.

[0335] In some embodiments of the invention, when a sensor measurement indicates that the container environment has reached a selected temperature or pressure over a selected time period, the processor integrated with the sensor module closes the cap 1760 above channel 1796. In other embodiments of the invention, the processor closes the cap when a sensor measurement indicates that the container has cycled through a predetermined number of pressure setpoints.

[0336] XV. Operating procedures for determining whether validated sterilization process measurements in a container have been verified during the sterilization process.

[0337] refer to Figure 21A flowchart of method 2100 for verifying whether a verified sterilization process measurement (VSPM) within a container has been achieved during a sterilization or disinfection process is shown. Method 2100 illustrates exemplary methods using container assemblies 90, 300, 400, 500, 600, 700, 800, 2900, and 4600 (90-4600) and electronic sensor modules 200, 460, 560, 660, 760, 850, 950, 1000, 1050, 1080, and 3500 (200-3500) presented in the preceding figures to perform different aspects of a process capable of implementing one or more embodiments of this disclosure. Method 2100 is specifically described as utilizing container assembly 400 (FIG. 7) and sensor module 1050 (FIG. 800, 950, 1000, 1050, 1080, and 3500 (200-3500) to perform different aspects of a process capable of implementing one or more embodiments of this disclosure. Figure 12B Method 2100 can be performed using either the container assemblies 90-800 or the electronic sensor modules 200-3500. A description of this method is generally given by reference to the specific components shown in the preceding figures. Figure 21 The discussion also referenced Figure 1-2 Components in 0.

[0338] Method 2100 begins at step 2102, in which the operator prepares the surgical instruments 180 of the equipment load for sterilization. Step 2102 includes positioning container 402 onto docking station 1200 or 1300, and, if the container has a connector, connecting the corresponding connector 485, 1032 to the docking station. In an alternative embodiment, connecting the sensor module to the docking station can be done via a wireless communication system. In step 2102, a handheld reader 1240 is used to scan the equipment load to be sterilized. In an alternative embodiment, the equipment load or contents ID can be entered into the docking station or selected from a list or menu containing all equipment load or contents IDs with associated VSPM data. Step 2102 also includes placing the equipment load into container 402 and closing the container with lid 450. During loading of the surgical instruments 180, the operator refers to the display screen 1260 shown by docking station 1200 or 1300 to observe the correct equipment load items and instrument loading orientation. This display helps the operator set the same equipment load and orientation as when validating and associating VSPM data with the equipment load. In optional step 2104, the sensors of electronic sensor modules 460, 1050 are calibrated prior to use. Electronic sensor modules 460, 1050 are calibrated using dock 1300. In another optional step 2106, surgical instruments 180 and / or trays 160 and / or containers 402 are wrapped with sterile barrier material prior to sterilization.

[0339] In step 2108, sensor module memories 471, 1022 are programmed to write Verified Sterilization Process Measurement (VSPM) data 1150 associated with the device load or contents ID 1610. At the docking station processor 1410 ( Figure 17 Container programming software 1461 running on ) Figure 17 Using the data obtained in step 2102, a specific VSPM 1150 associated with the container device load is identified, and the VSPM 1150 is transmitted via connector 485 for storage on sensor module memories 471, 1022. As previously discussed, the transmitted VSPM 1150 is dedicated to the device load (content ID) to be sterilized. In another embodiment, the VSPM 1150 is transmitted wirelessly from the docking station to the container memory for storage. In another embodiment, step 2108 confirms that the VSPM data currently present in the sensor memory is suitable for the container device load and does not perform a transfer of a new VSPM 1150 from the docking station to the sensor memory. This alternative embodiment can be used for reusable sensor modules for the same device load, such as sensor modules 760 mounted to a custom instrument holder 720 or a dedicated container assembly.

[0340] In an optional step at box 2110, sterilization verification software 1152 running on processor 1020 turns on the yellow light-emitting diode (LED) in LED 1030. Figure 3 The indicator light (also shown as a yellow LED 233) indicates to the user that the container components have not yet undergone a sterilization cycle.

[0341] In step 2112, container 402 is placed in sterilization chamber 52 ( Figure 1 Inside the chamber. The container and its contents are sterilized; this is step 2114. During sterilization, the chamber is heated and pressurized, and a sterilizing agent, such as steam or hydrogen peroxide vapor, is introduced into the sterilization chamber. Furthermore, the environment inside the container is heated, pressurized, and / or filled with a sterilizing agent. The sterilization process may include a cooling phase, a drying phase, or a vacuum phase on the chamber to remove any residual condensed sterilizing agent. The sterilization chamber is configured to utilize a set of nominal chamber process parameters (CPP) 66 ( Figure 1 )operate.

[0342] During the sterilization process in step 2114, sterilization verification software 1152 running on processor 1020 monitors and collects measurements from corresponding electronic sensors that communicate with it during this sterilization process cycle. These sensors measure characteristics of the environment within the container. The software 1152 running on processor 1020 receives signals representing these environmental characteristics. These measurements are stored as data 1156 in memory 1022.

[0343] After the sterilization process is completed, in step 2116, software 1152 compares the measurement data 1156 collected during this sterilization process with VSPM data 1150. In decision step 2118, the sterilization validation software 1152 running on processor 1020 determines whether the measurement data 1156 during the sterilization process meets or exceeds the VSPM data 1150 value set within the VSPM data to ensure the sterility of the container contents. For example, if VSPM 1150 has a minimum temperature and time value of 250 degrees Fahrenheit for 20 minutes, the sterilization validation software 1152 compares these values ​​with the time and temperature measurements recorded in data 1156.

[0344] The measured container characteristics may meet or exceed VSPM data 1150. If this condition test is true, then for containers including a closable channel or vent plug, the process of the present invention proceeds to step 2120. Step 2120 is to close the vent plug or channel. It should be understood that after the evaluation in step 2118 determines that the container environment meets the requirements for the validated sterilization process, step 2120 is not performed immediately. Instead, step 2120 is performed after a programmed time period or after a set trigger event is detected. This ensures sufficient time for residual sterilizing agent to drain from the container between the completion of the actual sterilization phase of the sterilization cycle and the vent plug closure. For containers that do not contain a closable channel, step 2120 is of course not performed. Method 2100 proceeds to step 2122.

[0345] After the test evaluation in step 2118 is true, the process continues to step 2122. In step 2122, this is achieved by turning on a green LED, such as LED 230 (…). Figure 3 ) or the green LED in LED 1030 ( Figure 12B The processor 1020 indicates that the contents of the container have been successfully sterilized.

[0346] A false result in step 2118 is interpreted as indicating that the contents of the container have not been sterilized to the desired level. In response to this decision, the processor proceeds to step 2126. In step 2126, this is achieved by turning on or flashing a red LED, such as LED 232. Figure 3 ) or the red LED in LED 1030 ( Figure 12B The processor 1020 indicates that the contents of the container have not been successfully sterilized. In the form of the invention with a cap that can be selectively closed and opened, the opening of the vent plug or port is not shown in the figures.

[0347] The completion of step 2122 or step 2126 marks the end of a single sterilization cycle.

[0348] XVI. Determine empirical sterilization process measurements for single container loads.

[0349] Figure 22 This is a flowchart of a method 2200 for determining a validated sterilization process measurement (VSPM) 1150 for a single, defined container load. This method can also be applied to determine a validated disinfection process measurement where the primary difference between sterilization and disinfection is the magnitude of biologically challenging organic matter removal, which is 10 for sterilization. 6 For disinfection, the organic matter removal rate is 10%. 3 Method 2200 is specifically discussed as using container assembly 400 (Figure 7) and sensor module 1050 (…). Figure 12B However, any of the aforementioned container assemblies 90-800 and electronic sensor modules 200-3500 can be used to perform this method 2200. The description of the method generally refers to the specific components shown in the preceding figures. Figure 22 The discussion also referenced Figure 1-2 0 components.

[0350] Method 2200 begins at step 2202, where the operator prepares a surgical instrument load 180 for sterilization validation. In step 2202, the surgical instrument load is selected and prepared for validation of the selected sterilization method. The surgical instrument load includes all items within the sterile barrier intended for sterilization validation. The instrument load may include surgical instruments 180 and an instrument tray or support 160 as intended. Step 2202 may also include placing the surgical instrument load within container 402. In step 2202, documentation is prepared for all contents of the container constituting the instrument load. Documentation may include a handwritten bill of materials, an electronic bill of materials, descriptions and part numbers of the contents, photographs of the contents, or a combination of these types of documentation. The instrument load for which documentation is prepared may be designated as Content ID 1610, as described in Figure 19. In another embodiment, step 2202 further includes placing a biological challenge or inoculation device containing a biological challenge microorganism according to standard practices for sterility assurance level validation or disinfection validation. A standard practice for inoculating the device with microorganisms used for steam sterilization can be found in ANSI / AAMI / ISO TIR17665-2:2009, Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ANSI / AAMI / ISO17665-1. Step 2202 includes completing the sterile barrier for the container, which may involve encasing the container in sterile barrier material, installing a new filter, appropriately setting a container vent plug, or other appropriate methods for completing the sterile barrier for the container, the type of sterile barrier, and the form of sterilization. For container assembly 400, the sterile barrier is completed by installing a new filter 440 and a locking cap assembly 450 to seal it to container 402.

[0351] Furthermore, in step 2202, data logging software 1155 stored in memories 471, 1022 is triggered to run on processor 1020. Data logging software 1155 monitors and records evaluation process measurements, such as those measured by the sensor module, during the test sterilization process cycle, and stores them in sensor module memories 471, 1022.

[0352] Container 402 is placed in sterilization chamber 52. Figure 1 The sterilization process cycle is then tested within sterilization chamber 52 (step 2204). The sterilization chamber is typically configured to operate using a set of nominal chamber test process parameters. During the test sterilization process cycle, the sterilization chamber is heated, pressurized, and a sterilizing agent, such as steam or hydrogen peroxide vapor, is introduced into the sterilization chamber. The sterilization process cycle typically includes a cooling or evacuation phase to remove any residual and / or condensed sterilizing agent.

[0353] Furthermore, in step 2204, data logging software 1155 running on processor 1020 monitors and collects measurement data from corresponding electronic sensors communicating with it during the sterilization test. The sensors record evaluation process measurements and conditions within the sterile barrier. The collected measurement data is stored in memory 1022 as data 1156. For example, data logging software 1155 running on processor 1020 collects water vapor data from water vapor sensor 1024, pressure data from pressure sensor 1026, temperature data from temperature sensor 1028, and hydrogen peroxide concentration data from hydrogen peroxide gas sensor 1052. In some embodiments, these data are simultaneously tracked and recorded as a function of time to obtain time-based evaluation process measurements experienced within the sterile barrier.

[0354] In step 2206, container 402 is removed from sterilization chamber 52 and the achieved sterilization level is assessed on the equipment load. In one embodiment, the operator culture and reads the biological challenge (inoculated microorganisms) and determines whether the microbial survival rate is below a predetermined expected level. In another embodiment, a 0% microbial survival rate indicates that the assessment process measurement is sufficient to ensure that all pathogens are destroyed during sterilization.

[0355] If the sterilization level is not acceptable, the operator may modify the equipment load, nominal sterilization process parameters, or sterility barrier. The operator may modify one or more of these items, or any other controllable items that may affect the test sterilization process results. For example, modifying the chamber (52) process parameters may include increasing one or more sterilization chamber 52 process parameters. In one embodiment, at step 2208, the temperature level and the lethal portion of the test sterilization process time are increased. In another embodiment, step 2208 includes modifying the contents of container 402. For example, fewer surgical instruments 180 are placed inside the sterility barrier. Method 2200 then returns to step 2202, where container 402 and equipment load are reprocessed in sterilization chamber 52, repeating the steps described above until the desired sterilization level is achieved at step 2206.

[0356] Responding to an acceptable sterilization level for the equipment load, recorded sensor measurements are collected from sensor module memory 1022 and these measurements serve as Validated Sterilization Process Measurements (VSPMs) associated with the equipment load. VSPM 1150 is based on received evaluation measurement data 1156, which are functionally confirmed to have acted on contaminants within the equipment load, whereby these evaluation measurements become validated measurements. In one embodiment, at step 2210, process measurement validation software 1466 running on docking station processor 1410 reads the recorded evaluation measurement data 1156 from sensor module memory 1022 and stores this data on docking station memory 1412. Furthermore, in this embodiment, at step 2210, the operator uses the evaluation measurement data 1156 recorded by the sensor module to determine and generate a value for the Validated Sterilization Process Measurement (VSPM) 1150. After identifying VSPM 1150, the operator inputs VSPM 1150 into docks 1200 and 1300 and guides VSPM 1150 to be stored in memory 1412.

[0357] In another embodiment, process measurement verification software 1466 running on docking station processor 1410 automatically generates VSPM 1150 from evaluation measurement data 1156 and stores this data on docking station memory 1412, in step 2210. In all embodiments, the interrelation of equipment load to VSPM is used at the end of process step 2210 for the expected sterilization level.

[0358] In optional step 2212, the operator establishes measurement limits for the VSPM 1150. Measurement limits may include upper and lower limits for one or more sensor readings included in the VSPM 1150 dataset. These reading limits may include only the upper limit or only the lower limit. For example, in one embodiment, the operator can determine that the minimum time or lower time limit experienced during the sterilization test is 20 minutes and the maximum time or upper time limit is 40 minutes. In another embodiment, the operator can determine that the temperature limit experienced during the sterilization test is 270°F. After the measurement limits are determined in this optional step, the operator sets the measurement limits for the VSPM and guides the measurement limits to be stored in memory 1412. Optional step 2212 ends when the measurement limits for the VSPM 1150 are associated with the equipment load for the expected sterilization level. Method 2200 terminates.

[0359] It should be understood that the definition of whether the load of the instrument has been successfully sterilized in step 2206 is related to the acceptable level of sterilization of these instruments. Some instruments are considered adequately sterilized if they have only been disinfected. It should be understood that disinfection has a lower level of sterility assurance than sterilization. Therefore, the method 2200 of the present invention, as well as the sterilization process and equipment, can be used to provide instruments that are sterile, but not as sterile as typically required for instruments applied to tissues under the skin.

[0360] Once a set of validated sterilization process measurements for container loads is generated, these measurements are used to determine whether the load has been sterilized, even if the load is placed in a different container than the one from which the VSPM for that load was generated. This is because changing the form of the sterile barrier (container) surrounding the load only changes the rate at which the environment surrounding the load changes during the sterilization process.

[0361] For example, when the only difference between two containers is their porosity, the key difference in the environmental characteristics within these containers is the rate at which these characteristics change. Therefore, when a sterilizing agent is introduced into both containers, the concentration of the sterilizing agent in the container with more pores rises faster than the concentration in the container with fewer pores. Thus, when the same load is sterilized in these two different containers, the main difference is the time required for the sterilizing agent concentration adjacent to the device forming the load to reach the expected, validated level. As long as the sterilizing agent concentration remains at the validated concentration level for the validated time period, the device forming the load will achieve the expected level of sterility.

[0362] This feature of the invention eliminates the need for hospitals to place instruments in specific containers each time they sterilize a particular load of instruments. If a container designed for a set of instruments becomes unavailable, the instruments can be placed in an alternative container. Only a sensing unit integrated with the container needs to be able to (1) measure the characteristics inside the container and (2) compare the measured environmental characteristics with the VSPM used for that load. When these conditions are met, the alternative container can be used to contain the instruments during sterilization, and its sensing unit will provide an indication of whether the instruments have been successfully sterilized.

[0363] XVII. Procedures for validating and correlating measurements from validated sterilization processes

[0364] refer to Figure 23 A flowchart of another method 2300 for determining, correlating, and validating sterilization process measurements (VSPM) 1150 is shown. Method 2300 is discussed as using container assembly 400 (Figure 7) and sensor module 1050 (Figure 8). Figure 12B) Execution. However, any of the aforementioned container assemblies 90-800 and electronic sensor modules 200-1080 can be used to execute method 2300. The description of the method generally refers to the specific components illustrated in the preceding figures. Figure 23 The discussion also referenced Figure 1-2 0 components.

[0365] Method 2300 describes the steps for an operator to validate an equipment load by achieving a sterilization assurance level. In step 2302, the surgical equipment load is selected and prepared for validation using a chosen form of sterilization, such as steam, chemicals, or hydrogen peroxide. The surgical equipment load comprises all items within a sterile barrier intended for sterilization validation. Step 2302 includes positioning container 402 on docking station 1200 or 1300, and, if the container has connectors, connecting the corresponding connectors 485, 1032 to the docking station. In step 2302, all contents of the container constituting the equipment load are documented. Documentation may include handwritten bills of materials, electronic bills of materials, descriptions and part numbers of contents, photographs of the contents, or a combination of these types of documentation. In step 2302, a handheld reader 1240 may be used to scan container 402, tray 160, and surgical instruments 180 to aid in the documentation preparation for the equipment load.

[0366] In step 2304, a biological challenge device, biological indicator, or microbial inoculation process is used to perform a biological challenge for sterilization assurance level validation. These biological devices or processes include a known number of microorganisms that exhibit resistance to the sterilization mode during use. These biological loads are used to determine whether the correct sterilization level has been achieved for a given equipment load using a test sterilization process.

[0367] In step 2306, the device payload is placed in container 402, which contains the electronic sensor module 460 and is sealed with a cap 450 assembly including a suitable sterile barrier filter 440. In step 2308, data logging software 1155 stored in memories 471, 1022 is triggered and runs on processor 1020. At the docking station processor 1410 ( Figure 17 The process measurement verification software 1466 runs on the machine. Figure 17 Instructions are issued to the data logging software 1155 to monitor and record process measurements during the test sterilization cycle for storage on sensor module memories 471, 1022. The data logging software 1155, running on processor 1020, monitors and records these process measurements during the test sterilization cycle. In optional step 2310, a sterile barrier suitable for this type of container and sterilization process is established before the container is placed within the sterilizer chamber 52.

[0368] Container 402 is placed in sterilization chamber 52. Figure 1 The sterilization process cycle is then initiated within sterilization chamber 52 (step 2312). During the sterilization process cycle, the sterilization chamber is heated and pressurized, and a sterilizing agent, such as steam or hydrogen peroxide vapor, is introduced into the sterilization chamber. The sterilization process cycle typically includes a cooling phase and a vacuum phase within the chamber to remove any residual and / or condensed sterilizing agent. The sterilization chamber is configured to operate using a set of nominal test process parameters.

[0369] Furthermore, in step 2312, software 1155 monitors and collects time-based data from corresponding electronic sensors in communication with it during the sterilization process cycle. The sensors measure environmental characteristics within the sterile barrier. The collected measurements are stored as data 1156. For example, data logging software 1155 running on processor 1020 collects water vapor or humidity data from humidity sensor 1024, pressure data from pressure sensor 1026, temperature data from temperature sensor 1028, and hydrogen peroxide concentration data from hydrogen peroxide vapor sensor 1052. These measurements may be stored in memory 1022 until they are sent to docking station memory in step 2320.

[0370] After the sterilization process is completed, in step 2314, appropriate tests are performed to determine whether the instrument forming the load is sterile to an acceptable level. The means of performing these tests are not part of this invention.

[0371] In decision step 2316, the operator determines whether the test results of step 2314 indicate that the instruments forming the load have been acceptablely sterilized. If the evaluation test in step 2316 is false, the instruments are subjected to a subsequent test sterilization process, reselecting steps 2306-2312. Before performing this subsequent sterilization process, in step 2318, the subsequent sterilization process is modified to have at least one difference between the just-performed test sterilization process and the subsequent test sterilization process. This modification to the sterilization process may include adding one or more process parameters for sterilization chamber 52. In one embodiment, the temperature level or process cycle time is increased in step 2318. In another embodiment, step 2318 includes modifying the contents of container 402. For example, fewer surgical instruments 180 are used for the device load, or a different type of sterile barrier design may be used.

[0372] After performing the subsequent sterilization process, the instrument load is subjected to the sterilization test step 2314 described above. Step 2316 is then repeated to determine whether the result of the test indicates that the instruments constituting the container load have been successfully sterilized.

[0373] After the sterilization process, the evaluation result of step 2316 may be tested as true. When this occurs, the operator specifies the data 1156 recorded by the sensor to determine the value of the Verified Sterilization Process Measurement (VSPM) 1150 for that load. In step 2302, the VSPM 1150 data is associated with the load. After determining the VSPM 1150, the operator uses the keyboard 1426 or an electronic data transmission method to input the VSPM 1150 and the associated equipment load to docking stations 1200 and 1300, and directs the VSPM 1150 to be stored in the memory 1412 associated with the equipment load.

[0374] In another embodiment, in step 2322, process measurement verification software 1466 running on docking station processor 1410 automatically generates a VSPM 1150 from real-time measurement data and stores the data on docking station memory 1412. In all embodiments, the device load to the VSPM interrelationship is used at the end of process step 2322 for the expected sterilization level.

[0375] In optional step 2324, the operator establishes measurement limit values ​​for the VSPM 1150. These measurement limit values ​​include upper and / or lower limit values ​​for one or more process measurements included in the VSPM 1150. For example, in one embodiment, the operator can determine that the minimum temperature or temperature limit for the first 2 minutes is 270°F for the expected sterilization level, and another minimum temperature limit for the next 3 minutes is 272°F. The determination of these process limit values ​​is performed using data collected from one or more sterilization process validation cycles with different sterilization process measurements and conditions. After the process measurement limit values ​​are determined, the operator sets the process measurement limit values ​​for the VSPM 1150 and associates them with the device load using keyboard 1426 or electronic data transfer, and directs these process measurement limit values ​​to memory 1412. Additionally, the association of the VSPM dataset to the device load is stored in memory 1412. Method 2300 then ends.

[0376] XVIII. Procedures for determining and correlating validated sterilization process measurements using overkill methods.

[0377] refer to Figure 24 A flowchart is shown for an additional method for determining and correlating Validated Sterilization Process Measurements (VSPM) 1150. Method 2400 is discussed as utilizing container assembly 400 ( Figure 7A ) and sensor module 1050 ( Figure 12B) Execution. However, any of the aforementioned container assemblies 90-800 and electronic sensor modules 200-1080 can be used to execute method 2400. The description of this method is provided with general reference to the specific components illustrated in the preceding figures. Figure 24 The discussion also specifically referenced Figure 1-2 Components in 0.

[0378] Method 2400 begins at step 2402, where surgical instruments 180 of the device load are selected for sterilization. The device load is defined as all items within the sterile barrier, which may include not only surgical instruments 180 but also any instrument holders 160 that may be present. Positioning the instrument holders helps achieve sterilization by painstakingly locating the instruments into optimal orientation for sterilizing agent penetration and sterilization. In step 2404, a biological testing device or biological challenge microorganism is placed within the device load in a location that would normally be difficult to sterilize. For example, if the device load has instruments with small diameters and long, closed-end lumens, then the biological challenge microorganism can be placed in the location where the closed end is most difficult to reach. The biological challenge microorganism is then cycled through the test sterilization process along with the surgical instruments.

[0379] Biological challenges involve biological agents. These agents are typically killed during a successful sterilization cycle. Biological challenges include a known number of microorganisms resistant to the form of sterilization during use. For validation of a sterilization process, a minimum 3-log removal rate of surviving microorganisms is required. For a biological challenge starting with 10^6 organics, a 3-log removal rate will result in the killing of at least 10^3 organics. For validation of a sterilization process with an equipment load, a minimum 6-log removal rate of surviving microorganisms is required.

[0380] In optional step 2405, the operator documents the type of biological challenge used and its location within the equipment load. The operator can input this information into the docking station using keyboard 1426 or electronic data transfer (i.e., inputting scanned copies or documents). In another embodiment, step 2405 includes taking a photograph of the location of the biological challenge on the equipment load within container 402 using a camera and storing the captured image in docking station memory 1412.

[0381] In step 2406, the device load is documented and then placed in a container 402 containing the electronic sensor module 460 and sealed with a lid 450, completing the sterile barrier. To document the device load, the operator enters the type and quantity of surgical instruments, tray type, and other items within the sterile barrier. Container 402 is placed on docking station 1200 or 1300 and connected to the docking station using connector 485.

[0382] In an alternative step 2407, the operator creates photographic documentation of the device load of the surgical instruments to be sterilized and the positions of the sensors within container 402. The photographs capture the device load, the orientation of the instruments and devices within the load, and the type and location of the sensors within the container. Step 2407 includes taking photographs of the contents and sensors within container 402 using a camera and storing the photographs in docking station memory 1412.

[0383] In step 2408, the data logging software 1155 stored in the memories 471 and 1022 is triggered and runs on the processor 1020. The process measurement verification software 1466 runs on the docking station processor 1410. Figure 17 ()( Figure 17 The processor 1020 sends instructions to the data logging software 1155 to monitor and record process measurements during the test sterilization cycle, for storage on sensor module memories 471, 1022. The data logging software 1155, running on the processor 1020, monitors and records these process measurements during the test sterilization cycle.

[0384] Container 402 is placed by the operator inside sterilization chamber 52. Figure 1 And a test sterilization process cycle is initiated within sterilization chamber 52 (step 2412). In step 2412, this test sterilization process cycle utilizes half of the test sterilization process performed within sterilization chamber 52. For example, for a standard 4-minute autoclave steam cycle at 270°F, half the test sterilization process is a 2-minute autoclave steam cycle at 270°F. In another example, for a 4-pulse hydrogen peroxide cycle, half the test sterilization cycle is a 2-pulse cycle. During the sterilization process cycle, sterilization chamber 52 is heated and pressurized according to the semi-lethal chamber process parameter values, and a sterilizing agent, such as steam or hydrogen peroxide vapor, is introduced into the sterilization chamber.

[0385] Furthermore, in step 2412, data logging software 1155 running on processor 1020 monitors and collects time-based data from the corresponding electronic sensors communicating with it during the sterilization process. The sensors monitor operational process measurements and conditions within their respective containers. The collected time-based measurement data is stored as data 1156 in memory 1022. For example, data logging software 1155 running on processor 1020 collects humidity data from humidity sensor 1024, pressure data from pressure sensor 1026, temperature data from temperature sensor 1028, and hydrogen peroxide concentration data from hydrogen peroxide gas sensor 1052. These measurements are typically obtained simultaneously as a function of time.

[0386] After half of the sterilization process is completed, the biological challenge is extracted, placed in a culture medium, and cultured for a period of time before microbial growth analysis. The level of microbial survival is determined in step 2414. In one embodiment, step 2414 includes determining whether the number of surviving microorganisms is greater than a 6-log removal rate.

[0387] In step 2416, the operator determines whether 100% or the expected number of biological challenge microorganisms have been killed. In response to the fact that not all microorganisms were killed in step 2414 (i.e., a certain number are viable and the sterilization level is unacceptable), the operator may modify the set of test chamber process parameters in step 2418. Modifying the test chamber process measurements may include increasing one or more sterilization chamber 52 process parameters. In one embodiment, the temperature level or process cycle time is increased in step 2418. In another embodiment, step 2418 includes modifying the contents of container 402. For example, fewer surgical instruments 180 are placed in tray 160 or different types of sterile barrier materials may be used.

[0388] New biological challenges are placed on the load, and such as Figure 24 The method 2400 shown returns to step 2404, in which container 402 is reprocessed in sterilization chamber 52 using the new half of the test sterilization chamber process.

[0389] In response to the fact that all microorganisms have been killed in step 2414 (i.e., zero percent survival), container 402 is placed on docks 1200 and 1300 and the docks are connected to container connector 485. In step 2420, process measurement verification software 1466 running on dock processor 1410 reads the recorded measurement data from container memory 1022 and stores the data 1156 on dock memory 1412.

[0390] In step 2422, the operator utilizes the data 1156 recorded by the sensors and correlates it to the device load and sterilization level. This correlation is based on the received measurement data, which has been functionally validated to address the biological challenges and achieve the desired sterilization level.

[0391] In another embodiment, process measurement verification software 1466 running on processor 1410 automatically generates half-test sterilization values ​​from time-based measurement data.

[0392] In step 2424, the lethal portion of the test sterilization cycle is doubled to generate VSPM 1150. As shown in the previous example, for an autoclave steam cycle at 270°F, the test cycle time is doubled for the portion of the test sterilization cycle above 270°F. In another example, the lethal portion of this half-test sterilization cycle for hydrogen peroxide, i.e., the number of hydrogen peroxide pulses, is doubled from 2 pulses to 4 pulses. VSPM 1150 can be generated by process measurement verification software 1466. The process measurement verification software 1466, running on processor 1410, multiplies the lethal portion of the test process operation time by a factor of two. In an exemplary embodiment, if all biological organic matter is killed after a 20-minute lethal process cycle time, the process cycle time is increased to 40 minutes by the process measurement verification software 1466. The new VSPM 1150 and the increased cycle time are stored in memory 1412. Once the VSPM 1150 is identified, the operator uses the keyboard 1426 or an electronic data transfer method to input the VSPM 1150 and associated equipment load to the docking station 1200, 1300 and guide the VSPM 1150 to be stored in the memory 1412 associated with the equipment load.

[0393] In optional step 2426, the operator establishes process limit values ​​for the VSPM 1150. Process limit values ​​may include upper and / or lower limits for one or more process measurements included in the VSPM 1150. For example, in one embodiment, the operator can determine that the minimum hydrogen peroxide concentration or lower limit for the sterilization process is 8 mg / L and the maximum hydrogen peroxide concentration or upper limit is 10 mg / L. The determination of process limit values ​​can be performed using data collected from multiple sterilization process cycles with different sterilization process measurements and conditions. After the process limit values ​​are determined, the operator sets the process limit values ​​for the VSPM 1150 using keyboard 1426, or the process measurement verification software 1466 transmits and guides the process limit values ​​to be stored in memory 1412. Additionally, the association between the VSPM and the device load is stored in memory 1412. Method 2400 terminates.

[0394] XIX. Procedures for monitoring the sterility of container contents

[0395] refer to Figure 25 A flowchart of a method 2500 for monitoring the sterility of container contents is shown. Method 2500 is specifically described as being performed using container assembly 400 (FIG. 7). However, this method can be performed using any of the container assemblies described above. The description of this method generally refers to the specific components shown in the preceding figures. Figure 25The discussion also referenced Figures 7A-7D The components and sensor module 200 in 14.

[0396] Method 2500 begins at step 2502, where aseptic monitoring software 1158 running on processor 1020 monitors the electrical signal transmitted from Hall effect sensor 480. In step 2504, the aseptic monitoring software 1158 determines whether the Hall effect sensor signal has changed to indicate that the magnetic field is no longer detected.

[0397] In response to no change in the Hall effect sensor signal, the aseptic monitoring software 1158 running on processor 1020 continues to monitor the electrical signal sent from Hall effect sensor 480 (step 2502). In response to a change or loss of the Hall effect sensor signal, the aseptic monitoring software 1158 running on processor 1020 causes the green LED in LED 487 to be de-energized and the red LED in LED 487 to be illuminated, indicating in step 2506 that the container latch has been changed, potentially allowing the sterilization within the container to be compromised. The Hall effect sensor signal changes with movement of latch 446 or lid 450, such as lifting off or removing from container 402. When magnet 448 is removed from Hall effect sensor 480, the magnetic field to sensor 480 disappears. The illumination of the red LED indicates that the contents of container 402, such as surgical instrument 180, are at increased risk of sterility or are no longer sterile. Method 2500 terminates.

[0398] XX. Procedure for loading surgical instruments into the container

[0399] refer to Figure 26 A flowchart is shown for method 2600, which involves loading surgical instruments into a container prior to sterilization. Method 2600 is explained as utilizing container assembly 100 ( Figure 2-4C ) and stop 1200 ( Figure 15 ) Execution. However, method 2500 can be executed using any of the aforementioned container assemblies with sensor modules or docking stations. The description of this method generally refers to the specific components shown in the preceding figures. Figure 26 The discussion also referenced Figure 2-4C , components in 15 and 17.

[0400] Method 2600 begins at step 2602, in which the operator positions container 100 against dock shelf 1212. In an optional step, electronic sensor module 200 is connected to dock 1200 via cable 146 for communication.

[0401] In step 2604, the operator uses a handheld reader 1240 to scan the barcode or RFID tag 135 on container 100 and the barcode or RFID tag 167 on tray 160. In step 2606, the container loading software 1464 running on processor 1410 searches for container / tray configuration data 1465, selects display screen 1260 from the data 1465 corresponding to the scanned barcodes and RFID tags, and displays display screen 1260 on monitor 1230. Display screen 1260 indicates the surgical instruments 180 to be loaded into tray 160 and the correct position and orientation of the surgical instruments 180 to be loaded.

[0402] In step 2608, the operator uses a handheld reader 1240 to scan the first surgical instrument barcode or RFID tag 181. In decision step 2610, the container loading software 1464 running on the processor 1410 uses the container / tray data 1465 to determine whether the scanned surgical instrument 180 is the correct surgical instrument to be loaded into the tray 160.

[0403] In response to the scanned surgical instrument 180 being incorrectly loaded into the tray 160, in step 2612, the container loading software 1464 running on the processor 1410 selects the incorrect surgical instrument for loading by changing the indication on the video screen 1260. In one embodiment, a red warning symbol flashes on the display 1230, and an audible warning indicates to the operator that they have selected the wrong instrument. Method 2600 returns to step 2608, where the operator scans the next surgical instrument 180 to be loaded.

[0404] In response to the fact that the surgical instrument 180 scanned in step 2608 is correct, it will be loaded into the tray 160. The operator places the surgical instrument 180 into the tray 160 with reference to the position and orientation information displayed on the display screen 1260 (step 2614). During the placement of the surgical instrument into the tray 160, the display screen 1260 guides the operator.

[0405] Although not shown as a separate step, the container loading software 1464 running on processor 1410 determines whether tray 160 is completely full of surgical instruments 180. If this evaluation test is negative, the operator scans for the next instrument 180 to be loaded when step 2608 is re-executed. When the evaluation determines that the tray is full, in step 2618, processor 1410 causes display screen 1260 to indicate that all surgical instruments have been loaded into tray 160 and container 100 is ready for further processing.

[0406] In step 2616, container loading software 1464 running on processor 1410 sends container / tray data 1465 to hospital computer system 1454 to update database 1456 with the current location and status of the loaded containers, trays, and surgical instruments. In an exemplary embodiment, container / tray data 1465 updates database 1456 with the location of container 100, a specific surgical instrument 180 contained in tray 160, and the fact that the container and its contents are not currently sterile.

[0407] XXI. Sensor Calibration Procedure

[0408] refer to Figure 27 The diagram illustrates a flowchart of method 2700 for calibrating or verifying sensor accuracy and electronic sensor module. Calibration and sensor accuracy verification are used to check (verify) and / or adjust (calibrate) the sensor in response to a known set of simulated or generated environmental conditions. The calibration and sensor accuracy verification method is used to ensure that sensor measurements are accurate when used to generate VSPM data or to verify VSPM data with the sensor module. Method 2700 is explained as utilizing container assembly 400 ( Figures 7A-7C ), Sensor module 1050 ( Figure 12B ,14) and stop 1300 ( Figure 16 , 17) Execution. However, method 2700 can be executed using any of the sensor modules described herein. The description of this method is generally based on the specific components illustrated in the preceding figures.

[0409] Method 2700 begins at step 2702, in which the operator positions the container assembly 400 against the docking station shelf 1342 or within the calibration chamber 1320 and connects the docking station cable 1340 to the container connector 485. The operator also connects docking station connectors 1336 and 1338 together, enabling the docking station 1300 to communicate with the container assembly 400 for sensor calibration. More specifically, the docking station controller 1402 communicates with the electronic sensor module controller 1120.

[0410] In step 2704, the sensor calibration software 1460 running on processor 1410 causes display screen 1260 to be displayed on display 1230. If the sensor module has a sensor that requires calibration or sensor performance verification, display screen 1260 shows container 402, the sensor to be calibrated, and operator instructions for proper calibration or sensor verification. If not already positioned, the operator places container assembly 400 into calibration chamber 1320 and closes door 1326.

[0411] For example, in step 2708, sensor calibration software 1460 running on processor 1410 causes calibration chamber 1320 and electronic sensor module 1050 to perform a sensor calibration process or sensor verification cycle. Depending on the type of sensor to be calibrated or verified, different systems within the dock are used individually or in combination to calibrate or verify sensor accuracy. In step 2708, the sensor calibration process may include energizing and operating steam generator 1430, hydrogen peroxide generator 1432, pressure pump 1434, vacuum pump 1436, and heater 1438. Steam generator 1430, hydrogen peroxide generator 1432, pressure pump 1434, vacuum pump 1436, and heater 1438 all operate according to a set of defined calibration operation parameters generated by sensor calibration software 1460 running on processor 1410 and transmitted via input / output interface circuitry 1414.

[0412] During the sensor calibration cycle, in step 2708, steam generator 1430 supplies standard concentration steam to calibration chamber 1320 and hydrogen peroxide generator 1432 supplies standard concentration hydrogen peroxide gas to calibration chamber 1320. During the first part of the calibration cycle, pressure pump 1434 increases the pressure in calibration chamber 1320 to a standard pressure. During the latter part of the calibration cycle, vacuum pump 1436 evacuates calibration chamber 1320 to a standard vacuum level. Heater 1438 heats calibration chamber 1320 to a predetermined standard temperature. One or more states of each generator system can be generated to achieve known single-point, two-point, or multi-point parameter states to calibrate or verify the sensor response.

[0413] In another embodiment, in step 2708, sensor calibration software 1460 running on processor 1410 triggers sensor calibration software 1154 running on processor 1020 to operate one or more generator systems for calibrating water vapor sensor 1024, pressure sensor 1026, temperature sensor 1028, and hydrogen peroxide sensor 1052.

[0414] In step 2710, the sensor calibration software 1460 running on processor 1410 queries and receives feedback from the calibration software 1154 running on processor 1020 regarding whether the calibration process on each sensor was successful or failed. The calibration software 1460 running on processor 1410 determines whether all sensors have been correctly calibrated or verified to a specific accuracy.

[0415] In response to one or more of sensors 1024-1052 not being properly calibrated to the specified calibration measurement, in step 2714, these specific sensors are identified and marked for verification and repair. Calibration software 1460 running on processor 1410 causes display screen 1260 indicating the defective sensor to be displayed on dock 1300. In another embodiment, the calibration software may instruct the sensor modules to provide a visual indication of calibration failure to the operator, for example, using a flashing LED. Method 2700 terminates.

[0416] In response to sensors 1024-1052 being correctly calibrated and / or verified to specific measurements, in step 2712, the sensors are indicated to have undergone successful calibration. Calibration software 1460 running on processor 1410 causes display screen 1260 to appear on dock 1300, indicating that all sensors 1024-1052 in container assembly 400 have been correctly calibrated or verified and are ready for use in their appropriate sterilization process. Method 2700 terminates.

[0417] In an alternative embodiment of the invention, the sensor calibration software 1460 is configured to perform sensor calibration based on the number of times the sensor is used.

[0418] XXII. Methods for monitoring container usage and billing based on single-use fees

[0419] Turning Figure 28 The flowchart illustrates a method 2800 for monitoring container usage and billing based on single-use fees. Method 2800 is explained as utilizing docking station 1200 ( Figure 18 Manufacturer Computer System 1510 Figure 18 ) and hospital computer system 1454 ( Figure 18 ) Execution. Method 2800 is used in conjunction with any of the containers 90-800 described above. Method 2800 is referenced Figure 18 and Figure 28 Describe it.

[0420] Method 2800 begins at step 2802, where application software 1470, operating on processor 1410, monitors and tracks the use of a container or sensor module within a medical facility. When docking station 1200 is used during container loading and / or sensor programming prior to sterilization, application software 1470 tracks the frequency of container or sensor use, generates application data 1472, and stores the application data in memory 1412. In another embodiment, application software 1472 reads the sensor module memory and extracts the application data for processing. In yet another embodiment, application software 1472 clears or resets the application data in the sensor module memory. In step 2804, application software 1470, running on processor 1410, periodically sends application data 1472 to manufacturer computer system 1510. In one embodiment, application data 1410 is sent from docking station 1200 to manufacturer computer system 1510 once a week.

[0421] In step 2806, billing software 1530 running on the manufacturer's computer system processor 1520 periodically generates invoices 1532 based on application data 1472. The invoices are stored in memory 1522. In step 2808, the billing software 1530 running on processor 1520 periodically sends invoices 1532 to the hospital computer system 1454. In one embodiment, invoices 1532 are generated and sent weekly from the manufacturer's computer system 1510 to the hospital computer system 1454. In step 2810, the hospital computer system 1454 receives invoices 1532 and stores them in memory 1572 for payment processing. Method 2800 terminates.

[0422] Method 2800 is used in conjunction with a business model in which docking stations 1200 and sensor modules or containers 90-800 are leased or rented to medical institutions or hospitals. The medical institution or hospital pays a fee for the use of the docking stations, sensor modules, and containers based on a single-use fee, as determined by application software 1470 and billing software 1530.

[0423] XXIII. Container with removable sensor

[0424] Figures 29-39 This illustration shows a container with a removable sensor. (Special Reference) Figure 29 and 30The container assembly 2900 includes a container 2902 and a removable sensor device 3000. The removable sensor device 3000 is described below as an optional embodiment including a tamper-evident sterile barrier monitoring system. In the following description, the tamper-evident sterile barrier monitoring system of this optional embodiment uses one or more magnets and Hall effect sensors. Other tamper-evident systems, such as destructible plastic mechanical locks, can be used to notify the operator that the sterile barrier has been tampered with, and these other tamper-evident systems can be combined with the removable sensor device 3000.

[0425] Figure 29 and 30 The container 2902 is the same as the container 402 in FIG7 described above, except that the rectangular openings 414 and 418 on the side panel 406 are omitted and a circular opening 415 is added to the side panel 406. Figure 29 and 30 The cover 450 is the same as the cover 450 in Figure 7 described above, except that the magnet 488 has been removed from the cover 450 and installed on the inward-facing surface of the container lid bolt 496 (see reference). Figure 41 In addition to the above, cover 450 includes a disposable filter 440 held to cover 450 by filter support member 442.

[0426] Filter 440 is formed of a microbial barrier material permeable to sterilizing agents. Filter 440 allows sterilizing agents to enter the inner cavity 420 of container 2902 from outside the cap 450, through orifice 459, through filter 440, and through pores 445, where the sterilizing agents come into contact with the surgical instruments contained therein. Filter 440 also forms a microbial barrier to prevent the entry of microorganisms after the container assembly 2900 has undergone the sterilization process. The filter may be disposed on one or more other container panels, replacing or as an attachment to the cap filter shown in container assembly 2900. This allows one or more filtered paths for sterilizing agents to enter and exit the container assembly while maintaining the microbial barrier.

[0427] 180 surgical instruments to be sterilized Figure 2 ) pallet 160 ( Figure 2 The lid 450 is placed inside container 2902 such that tray 160 rests against bottom panel 407. The lid 450 is secured to container 2902 using locking bolt 496. The locking bolt 496 is rotated upwards by the user above lid step 446 and then downwards to the locked position, wherein lid 450 is secured and locked to container 2902.

[0428] refer to Figure 31Figures 32 and 33 show details of the removable sensor device 3000. The removable sensor device 3000 includes a sensor module receiver 3100 and a removable sensor unit, device, or module 3500. The removable sensor unit or module 3500 can be inserted into and removed from the sensor module receiver 3100.

[0429] The sensor module receiver 3100 includes a receiver housing 3102, a retaining ring 3200, a housing cover 3250, a carrier assembly 3300, and a locking mechanism 3400, all of which may be formed from injection-molded plastic or metal. The receiver housing 3102 has a generally square-shaped central body 3104, which has an integrally attached triangular extension 3105. The body 3104 has a front surface 3106, a rear surface 3108, and five sides 3110. Two slots 3112 are defined on two of the sides 3110. The slotted sides 3110 are parallel to each other on opposite sides of the body 3104 and are diametrically opposed to each other. The length of the slots 3112 is defined by the thickness of the body 3104. A threaded hole 3114 is defined at the base of each slot 3112. An inner hole 3114 extends vertically from the base of each slot 3112 and partially into the body 3104.

[0430] Special Reference Figure 33 A cylindrical sleeve 3118 extends vertically away from the front surface 3106 and terminates at a distal end 3120. A step 3128 is provided on the outer surface of the sleeve and positioned approximately halfway between the distal end 3120 and the groove 3126. The step 3128 separates a proximal annular outer surface 3123 and a distal annular outer surface 3124. The proximal annular outer surface 3123 has a larger diameter than the distal annular outer surface 3124. A thread 3129 is defined on the outer surface 3123. The sleeve 3118 also includes an annular inner surface 3122 defining a through hole 3125. At the base or proximal end of the sleeve 3118, an annular groove 3126 is provided around the sleeve 3118 on the front surface 3106 of the body. The groove 3126 is sized to receive the container O-ring 3127 ( Figure 32 The O-ring 3127 is placed within the groove 3126. After assembly, the seal 3127 is compressed between the inner surfaces 412 of the panel 406 by the threaded compression of the retaining ring 3200, and the container O-ring 3127 forms a seal between the receiver housing 3102 and the container panel 406.

[0431] Two diametrically opposed portions of the distal end 3120 are removed to define diametrically opposed arcuate grooves 3132. The remaining portion of the distal end 3120 forms two diametrically opposed arcuate shoulders 3134. The shoulders 3134 are beveled adjacent to the innermost edge of the annular inner surface 3122. Two threaded holes 3136 are defined in the base of each groove 3132. The inner holes 3136 extend vertically from the base of each groove 3132, partially extending into the sleeve 3118.

[0432] Finger portions 3138 and 3140 extend vertically away from the annular inner surface 3122, partially extending into the through hole 3125. Finger portions 3138 and 3140 are arranged opposite each other in the diametrical direction on opposite sides of the inner hole 3125 and are positioned towards the proximal end of the inner hole 3125. Finger portion 3140 has a wider width than finger portion 3138.

[0433] An annular groove 3142 is positioned on the rear surface 3108 of the body, spaced apart from and surrounding the opening of the through hole 3125. The groove 3142 is sized to receive the O-ring 3144. Figure 32 An O-ring 3144 is disposed within a groove 3142. The O-ring 3144 forms a seal between the receiver housing 3102 and the plate 3350. In some forms of the invention, an adhesive is used to hold the O-ring 3144 in the groove 3412. A rectangular cavity 3146 is defined within a triangular extension 3105 and has an opening toward the front surface 3106. The cavity 3146 is sized to receive a printed circuit board, as will be described below.

[0434] Terminal assembly 3150 is mounted in receiver housing 3102. Terminal assembly 3150 includes a plurality of elongated conductive terminals 3152 electrically isolated by insulator 3154. Terminals 3152 are formed of a conductive material such as a copper alloy. Insulator 3154 is a material, such as polyimide, molded around the terminals 3152 to form terminal assembly 3150.

[0435] In one embodiment, the terminal assembly 3150 is placed in the same mold as the mold used for injection molding the receiver housing 3102 from plastic. In another embodiment, the terminal assembly 3150 is hermetically sealed to the receiver housing 3102. After molding or sealing, the terminal assembly 3150 is an integral part of the receiver housing 3102. The terminal assembly 3150 defines an internal channel 3155 through which the terminal 3152 extends within the sleeve 3118.

[0436] In another embodiment, the terminal assembly 3150 is a flexible circuit inserted into an internal channel 3155 within the sleeve 3118. The flexible circuit is held in place using a silicone adhesive or other suitable curable adhesive or sealant.

[0437] Terminal 3152 also has a flush proximal contact end 3156 facing the inner bore 3125. Terminal 3152 also has a distal contact end 3158 extending vertically away from the outer surface 3124 of the sleeve. Contact ends 3156 and 3158 are electrically connected to other electrical components, as described below. In another embodiment, another set of terminals 3160 may extend through channel 3155 and through another channel 3162 defined in extension 3105. Terminal 3160 has an end 3164 terminating in cavity 3146 and an end 3166 extending vertically away from the outer surface 3124 of the sleeve and adjacent to contact end 3158.

[0438] For further reference Figure 31 Optionally, an electronic sterile barrier monitoring system may be included, featuring a Hall effect printed circuit board 3170 with an attached Hall effect sensor 3172. The Hall effect printed circuit board 3170 is mounted within a cavity 3146 and electrically connected to terminal ends 3164 by appropriate methods, such as soldering or wire bonding. The Hall effect sensor 3172 detects a magnet 448 (…). Figure 29 The presence or absence of a magnetic field is determined by the presence or absence of a magnetic field. When the lid 450 is installed and fastened to the container 2902, the Hall effect sensor 3172 detects the magnetic field generated by the magnet 448 and emits an electrical signal indicating that a magnetic field has been detected. When the lid 450 is removed from the container 2902, the lid bolt 496 is pivoted away from the Hall effect sensor 3172, causing the sensor 3172 to detect that the magnetic field is not present and emit an electrical signal indicating that there is no magnetic field.

[0439] Turning Figure 34 Details of the retaining ring 3200 and the cap 3250 are shown. The retaining ring 3200 is generally circular in shape and has a proximal side 3202, a distal side 3204, an annular outer surface 3206, and an annular inner surface 3208. The outer peripheral edge of the distal side 3204 is beveled. A thread 3210 is defined on the annular inner surface 3208. The retaining ring thread 3210 mates with the receiver housing thread 3129 to secure and seal the sensor module receiver 3100 to the container 2902. A threaded hole 3212 extends vertically from the distal side 3204 and partially extends into the retaining ring 3200.

[0440] The cover 3250 is generally circular in shape, with an extended portion 3252. The cover 3250 has a distal side 3254, a proximal edge 3255, an annular outer surface 3256, and an inner step 3258. The inner step 3258 defines an annular inner surface 3262. The annular inner surface 3262 terminates at the proximal side 3254 and defines an opening 3263. A circular skirt 3260 extends proximally away from the step 3258 and terminates at the edge 3255. The skirt 3260 and the annular surface 3262 define a through-hole 3264. The outer peripheral edge of the distal side 3254 is beveled.

[0441] Two diametrically opposed arcuate ribs 3270 extend vertically from the annular inner surface 3262 into the inner hole 3264. The inner edges of the ribs 3270 are beveled. The distal surface of the ribs 3270 is flush with the proximal surface 3254. Two holes 3272 are defined on each rib 3270. The holes 3272 extend entirely through the ribs 3270. The ribs 3270 define two diametrically opposed arcuate slots 3274 located between each rib 3270.

[0442] The extended portion 3252 is formed with a rectangular circuit board holder 3280. The holder 3280 includes an opening 3282 facing distally and a bottom wall 3284. The holder 3280 is open at the distal side 3254. An aperture 3286 is defined in the bottom wall 3284.

[0443] For further reference Figure 31 The container printed circuit board (PCB) 3800 is mounted and held in a retainer 3280. An opening 3282 is sized to receive the PCB 3800. Specifically, the PCB 3800 is secured to a bottom wall 3284 by self-tapping screws 3290 screwed into an aperture 3286. A bracket 3292 is positioned between the bottom wall 3284 and the PCB 3800 to space the PCB 3800 from the bottom wall 3284. The screws 3290 also pass through the bracket 3292. Components of the container PCB 3800 will be described below. A transparent lens 3294 is mounted to the distal side 3254, covering the opening 3282. The lens 3294 allows the user to visually see the light-emitting diodes mounted on the PCB 3800. The lens 3294 is attached to the distal side 3254 using ultrasonic welding or by thermal erection.

[0444] PCB 3800 is electrically connected to terminal assembly 3150 ( Figure 33 Specifically, PCB 3800 is connected to terminal ends 3158 and 3166 by appropriate methods such as soldering or wire bonding. PCB 3800 is connected via terminal 3160 ( Figure 33 It communicates with an optional embodiment that includes a Hall effect PCB 3170.

[0445] The retaining ring 3200 is attached to the receiver housing 3102 by engaging the retaining ring thread 3210 with the receiver housing thread 3129. Then, the cover 3250 is installed onto the retaining ring 3200. The cover 3250 is aligned with the receiver housing 3102 and moved proximally, causing the cover rib 3270 to slide into or be installed within the receiver housing slot 3138, and the receiver housing shoulder 3134 to slide into or be installed within the cover slot 3274.

[0446] The cover 3250 contacts the retaining ring 3200 such that the cover step 3258 abuts against the distal side 3204 of the ring and the cover skirt 3260 surrounds the annular outer surface 3206 of the ring. Fasteners such as screws 3296 pass through the rib hole 3272 and are held in the threaded hole 3212, thereby attaching the cover 3250 to the retaining ring 3200.

[0447] Now for reference Figure 31 and 35 The sensor module receiver 3100 also includes a carrier assembly 3300. The carrier assembly 3300 is attached to the receiver housing 3102. The carrier assembly 3300 guide plate 3350 moves between open and closed positions. The carrier assembly 3300 includes a support bracket 3302, a plate 3350, and a locking mechanism 3400.

[0448] The support bracket 3302 includes a base 3304 and four orthogonal arms 3306 extending away from the base 3304. The arms 3306 form an X-shape. Each arm 3306 has an attached distal leg 3310, oriented at approximately 45 degrees to the arm 3306. From the center of each leg 3310, a cylindrical support column 3312 extends perpendicularly away from the leg 3310 and has a terminal end 3313. From the outside of each leg 3310, a rectangular leg 3314 extends perpendicularly away from the leg 3310 and has a terminal end 3315. The support column 3312 is parallel to the leg 3314. A hole 3316 is defined in each leg 3314 toward the terminal end 3315. An aperture 3320 is defined on each of the lowermost arms 3306. The support bracket 3302 surrounds an inner region 3322.

[0449] Plate 3350 is generally circular in shape and is mounted to support bracket 3302 to slide along post 3312. Plate 3350 has a proximal side 3354, a distal side 3352, and an annular outer surface 3356. Four ear-shaped portions 3358 extend radially away from the annular outer surface 3356. The ear-shaped portions 3358 are spaced 90 degrees apart from each other on the annular outer surface 3356. An inner hole 3359 is formed in each ear-shaped portion 3358. The inner hole 3359 extends through the entire thickness of the ear-shaped portion 3358. The inner hole 3359 is precisely formed to allow plate 3350 to slide along post 3312.

[0450] Plate 3350 also has a first annular step 3360 defined on the proximal side 3354 and a second annular step 3362 defined on the proximal side 3354. Step 3360 has a larger diameter than step 3362 and surrounds step 3362. Threaded hole 3364 is defined at the center of step 3362. Inner hole 3364 is perpendicular to step 3362.

[0451] A third annular step 3368 is formed on the distal side 3352 and defines an annular channel 3370. The remaining portion of the distal side 3352 forms an annular surface 3355 pointing distally. After assembly, the annular surface 3355 is juxtaposed with a face sealing O-ring 3144 located in the groove 3142. A circular drum-shaped portion 3372 extends vertically away from the center of the step 3368 in the distal direction. A cylindrical protrusion 3374 extends parallel to the drum-shaped portion 3372 in the distal direction. The protrusion 3374 has a smaller diameter than the drum-shaped portion 3372. A pair of shoe-shaped portions 3376 opposed in the diametrical direction are attached to the protrusion 3374 by a rod 3378. The shoe-shaped portions 3376 are separated from the protrusion 3374 by the rod 3378. A slot 3377 is defined between the opposing surfaces of the shoe-shaped portions 3376. The socket 3380 is defined between the proximal portion of the shoe-shaped portion 3376 and the distal portion of the protrusion 3374. The slot 3377 and the socket 3380 are designed to be part of the receiving housing 3502, as described below.

[0452] Plate 3350 is engaged with post 3312 such that plate 3350 slides along post 3312. Plate reset disc spring 3382 is mounted on each post 3312 and surrounds post 3312. One end of disc spring 3382 abuts against foot 3310, and the other end abuts against the proximal side of ear 3358. Inner bore 3359 is aligned with post 3312, and plate 3350 is slid onto post 3312 such that post 3312 extends through inner bore 3359. In this position, plate reset disc spring 3382 is compressed between foot 3310 and the proximal side of ear 3358. Plate reset disc spring 3382 biases plate 3350 toward receiver housing 3102 in a distal direction.

[0453] The carrier assembly 3300 also includes a locking mechanism 3400. When the plate 3350 is in the closed position, the locking mechanism 3400 prevents the plate 3350 from being opened or moved to the open position. The locking mechanism 3400 includes a hub 3402, with four orthogonal arms 3406 extending away from the hub 3402. The ends of the arms 3406 are rounded. The hub 402 has an elliptical raised wall 3408 facing distally, which surrounds and defines an elliptical central opening 3410.

[0454] A lever 3412 is mounted to the proximal surface of each arm 3406. The lever 3412 extends perpendicularly to and away from the arm 3406 in the proximal direction. Both terminating ends of the lever 3412 are rounded. A control lever 3414 is attached to a hub 402. Specifically, the end 3416 of the control lever is attached to the hub 3402. Another end 3418 of the control lever is bent or hooked. The control lever 3414 is configured to be manually grasped by the operator.

[0455] The locking mechanism 3400 is held to the plate 3350 in a manner that allows the locked mechanism 3400 to slide relative to the plate 3250. A fastener, such as a threaded screw 3422, passes through the opening 3410 and is received and held in a threaded hole 3364 in the plate. The screw 3422 has a head designed to have a diameter larger than the diameter of the opening 3410. During installation, the head of the screw 3422 is pulled against the proximal surface of the hub 402, thereby securing the locking mechanism 3400 to the plate 3250.

[0456] The inner cavity 3424 is formed to pass through the bottom of the elliptical raised wall 3408 and below the opening 3410. A lock reset disc spring 3426 is disposed within the inner cavity 3424, with one end of the spring abutting against the screw 3422 and the other end abutting against the outer peripheral wall of the step 3362. The reset disc spring 3426 faces upward toward the cover 450. Figure 30 Bias locking mechanism 3400.

[0457] The carrier assembly 3300 is assembled by sliding the plate 3350 with a coil spring 3382 above the support column 3312, such that the support column 3312 extends through the inner hole 3359. The carrier assembly 3300 is then installed onto the receiver housing 3102. Each of the four support bracket legs 3314 is positioned in the receiver slot 3112 of the housing, with the leg hole 3316 aligned with the receiver inner hole 3114. Threaded fasteners 3430 extend through the leg holes 3316 and into the inner hole 3114. Thus, the carrier assembly 3300 is connected to the receiver housing 3102.

[0458] Special Reference Figure 31and 36 The diagram illustrates details of the removable sensor module 3500. The removable sensor module 3500 is inserted into and received by the sensor receiver 3100. The removable sensor module 3500 includes features for sensing container 2902. Figure 29 One or more sensors within the operating environment. A removable sensor module 3500 includes a circuit board assembly 3700 mounted to a sensor housing 3502. The sensor housing 3502 is generally cylindrical in shape and has a proximal end 3504 and a distal end 3506. The housing 3502 has an annular outer surface 3508. The housing 3502 also includes a central dividing wall 3510 that divides the housing 3502 in two and is perpendicular to the outer surface 3508. A first annular skirt 3512 extends distally from the wall 3510 and terminates at the distal end 3506. A second annular skirt 3520 extends proximally from the wall 3510 and terminates at the proximal end 3504. The second skirt 3520 and the dividing wall 3510 define an annular cavity 3530.

[0459] The first skirt 3512 is divided in two by a gripping portion 3514 extending across the diameter of the first skirt 3512. The base of the gripping portion 3514 is connected to the distal side of the dividing wall 3510. The gripping portion 3514 and the first skirt 3512 define two finger-shaped cutouts 3516. The operator manually operates or rotates the removable sensor module 3500 by inserting their fingers into the cutouts 3516 and squeezing the gripping portion 3514 between their fingers.

[0460] A cylindrical drum-shaped portion 3522 extends vertically proximally from the center of the dividing wall 3510. An elliptical head 3523 is attached to the drum-shaped portion 3522 via a shaft 3526. The head 3523 is spaced proximally from the drum-shaped portion 3522 by the shaft 3526. The head 3523 includes a pair of wing-shaped portions 3524 opposed in the diametrical direction, extending away from the head 3523 in opposite directions. The wing-shaped portions 3524 are perpendicular to the shaft 3526. The head 3524 and the wing-shaped portions 3525 are sized to match the shoe-shaped portion 3376. Figure 35 The gap 3525 is defined between the wing-shaped portion 3524 and the drum-shaped portion 3522 on the proximal side.

[0461] The wing-shaped portion 3524 mates with the shoe-shaped portion 3376. Figure 35 The housing 3502 is joined to the plate 3350. The head 3523 is designed to be sized such that the wing-shaped portion 3524 is parallel to the shoe-shaped portion 3376 when the housing 3502 is oriented. Figure 35 When installed in the plate slot 3377 ( Figure 35As the housing 3502 is manually inserted into the receiver housing 3102 in a proximal direction, the head 3523 will eventually contact and abut the protrusion 3374 on the distal side. In this position, the housing 3502 is rotated 90 degrees, causing the fin 3524 to move into the socket 3380. The socket 3380 is sized to receive the fin 3524. The housing 3502 is now secured to the plate 3350.

[0462] An annular groove 3532 is defined on an annular outer surface 3508. The groove 3532 is designed to receive a circular O-ring 3534. The O-ring 3534 is disposed within the groove 3532. The O-ring 3534 and the sleeve 3118 ( Figure 33 The annular inner surface 3122 forms a seal.

[0463] Two channels 3540 and 3541 are defined on the outer annular surface 3508 of the housing. Channels 3540 and 3541 are arranged opposite each other in the diametrical direction on opposite portions of the circumference of the housing 3502. Channel 3540 has an inlet 3542 adjacent to the proximal end 3504. Figure 31 Channel 3541 has an inlet 3543 (not shown) adjacent to the proximal end 3504. Channel 3541 and inlet 3542 are formed to have a width greater than or wider than channel 3540 and inlet 3542. Channel 3540 starts from opening 3542, angled along the circumference of surface 3508 in a distal direction, and terminates in L-shaped trap 3544. Channel 3541 starts from opening 3543, angled along the circumference of surface 3508 in a distal direction, and terminates in another L-shaped trap 3544. Channel 3540 is designed to engage with and receive finger 3138 during the loading of sensor housing 3502 into receiver housing 3102. During the loading of sensor housing 3502 into receiver housing 3102, channel 3541 receives and engages with finger 3140. The fingers 3138, 3140 and the channels 3540, 3541 function as keys and keyways respectively to properly align and guide the housing 3502 relative to the receiver 3100.

[0464] Because the opening 3542 is smaller than the width of the finger portion 3140, if the housing 3502 is not aligned with the receiver 3100, the housing 3502 will be blocked and cannot be inserted into the receiver 3100. The housing 3502 can only be inserted into the receiver 3100 when the finger portion 3138 is aligned with the channel opening 3543 and the finger portion 3140 is aligned with the channel opening 3542.

[0465] The housing 3502 also includes a connector channel 3550 disposed between one of the catchers 3544 and the proximal end 3504. The connector channel 3550 extends vertically into the cavity 3530 via a second skirt 3520. The connector channel 3550 is sized to receive a connector 3750 attached to the circuit board assembly.

[0466] A threaded hole 3554 is defined on the proximal surface of a partition wall 3510 located at the bottom of cavity 3530. The threaded hole 3554 extends vertically into wall 3510 and is sized to receive the externally threaded distal end 3558 of PCB support 3556. PCB support 3556 also has an internally threaded proximal end or head 3560. PCB support 3556 is screwed into the inner hole 3554 to form a support for circuit board assembly 3700.

[0467] Turning Figure 36 Figures 37A and 37B show details of the circuit board assembly 3700. The assembly 3700 has a printed circuit board (PCB) 3701, which is generally planar and annular. PCB 3701 includes a proximal side 3702 and a distal side 3704, with a circular opening 3706 defined through the center of PCB 3701. PCB 3701 is mounted within a housing cavity 3530. Specifically, the distal side 3702 of the PCB abuts against and is supported by a support 3556 such that its side 3702 abuts against a head portion 3560. A skirt 3520 surrounds the circumferential outer edge of PCB 3701. In this position, a head 3523 ( Figure 36 ) and drum-shaped part 3522 ( Figure 36 The screw 3710 extends through the central opening 3706. The screw 3710 extends through the PCB hole 3712 and is received by the internally threaded head 3560, securing the PCB 3701 to the housing 3502.

[0468] PCB 3701 is a multilayer printed circuit board including numerous printed circuit lines 3716 that interconnect electrical components and sensors mounted on PCB 3701. Battery 3720, processor 1020, memory 1022, I / O interface 1124, and wireless transceiver 1138 are mounted to the distal side 3704 of PCB 3701. Battery 3720 powers the various components mounted to the circuit board assembly 3700. Processor 1020, memory 1022, I / O interface 1124, and wireless transceiver 1138 are as described above. Figure 12B and 13 The same as in [the previous sentence].

[0469] One or more sensors are mounted to a removable sensor module 3500 and connected to a PCB 3701. In the illustrated embodiment, the sensors are mounted to the proximal side 3702 of the PCB 3701. A water vapor sensor 1024, a pressure sensor 1026, and a temperature sensor 1028 are mounted to the side 3702. The water vapor sensor 1024, pressure sensor 1026, and temperature sensor 1028 are as described previously. Figure 12B and 13 The same applies in the example. In an alternative embodiment, an optical sensor 1052 is also mounted to the side 3702 to sense the amount of infrared (IR) or ultraviolet (UV) light transmitted through an optical path length 3770 within the container 2902. In one embodiment, the optical sensor 1052 detects and measures the concentration of hydrogen peroxide vapor (H2O2). In another embodiment, the optical sensor 1052 detects water vapor or another gas or vapor, wherein the absorbance characteristics of the gas or vapor are known.

[0470] The optical sensor 1052 includes an IR or UV source or emitter 1056 mounted to side 3702, an optical emitter or mirror 3764, and an IR or UV receiver or detector 1058. A filter (not shown) may be mounted around the source 1056 or detector 1058 to remove any unwanted wavelengths. The mirror 3764 is positioned to reflect incident light toward the detector 1058. The mirror 3764 is formed of vacuum-deposited aluminum on a material that reflects emitted energy 1056 back to the detector 1058, such as glass.

[0471] Compared to the optical path length that could be obtained without using mirror 3764, mirror 3764 allows for a longer optical path length 3770. The longer optical path length 3770 improves the accuracy and precision of the measured value of the detected hydrogen peroxide vapor concentration.

[0472] Because hydrogen peroxide vapor absorbs infrared or ultraviolet light with specific known wavelengths, the amount of light of that frequency transmitted through a known path length 3770 containing hydrogen peroxide vapor is proportional to the concentration of hydrogen peroxide vapor. Other vapors or gases with known wavelength absorbance characteristics can be detected and measured by appropriately selected emitter 1056 and detector 1058.

[0473] Connector 3740 is mounted to PCB 3701. Specifically, connector 3740 has an insulating body 3742 containing a plurality of terminals 3744. Terminals 3744 are attached to PCB 3701 by a suitable method, such as soldering. The other end of terminal 3744 is connected to a push-button contact 3746. Push-button contact 3746 faces radially outward from body 3742. Push-button contact 3746 contacts the proximal end 3156 of receiver housing. Figure 33This is to cooperate to form an electrical connection between the removable sensor circuit board assembly 3700 and the container printed circuit board 3800. When the PCB 3701 is mounted in the housing 3502, the connector 3740 is received by the connector opening 3550 and disposed in the connector opening 3550. Figure 36 In the middle. Button contact 3746 extends slightly beyond the insulating body 3742 and extends slightly beyond the adjacent annular outer surface 3708. Figure 36 The button contacts 3746 are extended in this way to allow them to mate with the proximal contact 3156 when the removable sensor module 2500 is properly inserted into the sensor receiver 3100.

[0474] Figure 38 This illustration shows details of the container printed circuit board (PCB) 3800. PCB 3800 is mounted on the cover circuit board holder 3280. Figure 34 PCB 3800 is generally planar and rectangular in shape. PCB 3800 includes a proximal side 3802 and a distal side 3804. PCB 3800 is a multilayer printed circuit board including numerous printed circuit lines (not shown) for interconnecting various electrical components and, in some embodiments, sensors mounted on PCB 3800. Hole 3810 is defined on PCB 3800. Screw 3290 ( Figure 31 ) Through hole 3810 to hold PCB 3800 to cover 3250 ( Figure 31 ).

[0475] Battery 3820, controller 3830, and one or more LEDs 3842, 3844, 3846 are all mounted on the distal side 3804. Battery 3820 powers the components of PCB 3800. Controller 3830 is a microcontroller that includes memory for storing instruction sets or software. PCB 3800 may also include memory capable of storing data such as measurement data from the sterilization process, VSPM data, application data, or other workflow process data, such as the time and date of the sterilization process, for example, the time and date of the operator programming the sensor module into the VSPM data or the time and date of the equipment load being assembled into the container. PCB 3800, combined with the removable sensor PCB 3700, functions similarly to the steam sensor module 1000, the hydrogen peroxide sensor module 1050, the combined steam and hydrogen peroxide sensor module, or other sensor modules 200, 460, 560, 660, 760, 850 described herein. PCB 3800 will have some additional electronic components, with some redundant components from the removable sensor module PCB 3700, so that after the removable sensor module 3500 is removed, the memory of PCB 3800 can contain information related to a specific sterilization process, equipment load, operator information, programming information, and other information required for tracking, recording, or monitoring commercial, regulatory, or quality control processes for sterilization events. Controller 3830 is connected via terminal 3162 ( Figure 33 ) and optional Hall effect circuit board 3170 ( Figure 31 Communication. When the removable sensor module 3500 is coupled to the sensor module receiver 3100 ( Figure 31 When the controller 3830 communicates with the processor 1020 via the I / O interface 1024, the controller 3830 allows data and instructions to be sent to and received from the processor 1020.

[0476] Red LED 3842, yellow LED 3844, and green LED 3846 provide visual information to the user using container assembly 2900. The user sees this information through transparent lens 3294. Figure 31 Observe LEDs 3842, 3844, and 3846. In one embodiment, red LED 3842 indicates that container 2902 and its contents have undergone a sterilization cycle, but this sterilization cycle was unsuccessful in meeting a pre-defined set of minimum validated sterilization process measurements, such as the VSPM 1150 described above (Figure 19). Therefore, the contents of container 2902 are considered non-sterile.

[0477] In another embodiment, yellow LED 3842 indicates that container 2902 and its contents have not undergone a sterilization cycle. In an additional embodiment, green LED 3846 indicates that container 2902 and its contents have undergone a sterilization cycle that has been successful in meeting a pre-defined set of minimum validated sterilization process measurements, such as the previously described VSPM 1150 (Figure 19). Therefore, the contents of container 2902 are considered sterile.

[0478] XXIV. Insertion and Removal of Removable Sensor Modules

[0479] Figures 39-43 The illustration shows a series of steps for inserting and removing the removable sensor module 3500 from the sensor receiver 3100. (See also: Special Reference) Figure 31 and 39 The removable sensor module device 3000 is shown in an initial or first position, wherein the sensor module 3500 is separated from the receiver 3100. In this position, the plate 3350 is pressed against the face sealing ring 3144 by the spring 3382, on the distal annular surface 3355 ( Figure 35 A seal is formed between the plate and the O-ring 3144. In some embodiments, this seal and the plate form part of a sterile barrier enclosure with the container assembly 2900. Furthermore, in a first position, the locking mechanism 3400 is in a locked state. In the locked state, the locking mechanism 3400 prevents the plate 3350 from being opened or removed from the receiver housing 3102, maintaining the sealed position. In this locked position, the locking mechanism 3400 is in its uppermost position, where the wall 3408 is raised. Figure 35 ) Connecting steps 3362 ( Figure 35 The upper sidewall of the plate 3350 and the rod 3412 are positioned adjacent to and in contact with the bracket arm 3306 to prevent the plate 3350 from moving away from the receiver housing 3102 in the proximal direction.

[0480] Turning Figure 31 and 40 The sensor module 3500 is shown in a second position, being loaded into the receiver 3100. In this position, the cover 450 has been removed from the container 2902, and the removable sensor module 3500 has been manually inserted into the opening 3263. Figure 34 ) and sleeve 3118 ( Figure 34 The inner diameter of 3125 ( Figure 34 Inside. In the second position, O-ring 3534 and sleeve 3118 ( Figure 33 ) inner annular surface 3122 ( Figure 33A seal is formed. Because the housing 3502 is manually inserted into the receiver housing 3102 in the proximal direction, the head 3523 eventually contacts and abuts the distal side of the protrusion 3374, restricting movement in the proximal direction. Furthermore, in this position, the fingers 3138 and 3140 are connected to the channel opening 3542 ( Figure 31 Alignment. Plate 3350 remains in the sealed and locked position.

[0481] As part of the sensor module insertion process, lever 3414 is manually pressed downwards. This places locking mechanism 3400 in the unlocked position. This repositioning of the locking mechanism frees plate 3350, allowing it to move inwards. Freeing plate 3500 and allowing it to move allows sensor module 3500 to continue insertion into container receiver 3100. As the sensor module is inserted into the receiver, it pushes against plate 3350 and displaces it. This displacement of plate 3350 temporarily breaks the seal between receiver housing 3102 and plate.

[0482] In this unlocked position, the locking mechanism 3400 is in its lowest position, with the raised wall 3408 ( Figure 35 ) abutting the lower side wall of step 3362 ( Figure 35 The end of the control lever 3418 abuts against the outer surface of the plate 3350. This prevents the control lever 3414 from moving further downward. Furthermore, in this unlocked position, the upper two levers 3412 are positioned below the upper bracket arm 3306, and the lower two levers are aligned with the hole 3320. Figure 35 Axial alignment allows plate 3350 to move away from receiver housing 3102 in a proximal direction.

[0483] Next, the operator rotates the housing 3502 by 45°. This rotation causes the fin-shaped portion 3524 to move into the plate slot 3380 and the adjacent shoe-shaped portion 3376. Figure 35 Inside. The socket 3380 is designed to receive the fin-shaped portion 3524. Now, the housing 3502 is secured to the plate 3350.

[0484] The housing 3502 is then rotated another 45°. As a result of this rotation, the fingers 3138 and 3140 follow along the channel 3540. This causes the housing 3502 to be pulled towards the bracket 3302 in the proximal direction. Because the housing 3502 is engaged with the plate 3350, the rotation of the housing 3502 also causes the plate 3350 to move similarly away from the receiver housing 3102 in the proximal direction, opening the plate 3350. As the plate 3350 moves in the proximal direction, the spring 3382 is compressed, and the rod 3412 also moves in the proximal direction past the bracket arm 3306 and through the hole 3320 ( Figure 35Plate 3350 is moved away from O-ring 3144, forming a channel 4110 between plate 3350 and sensor circuit board assembly 3700. This channel 4110 allows the sensor on circuit board assembly 3700 to be exposed to the operating environment and conditions within container 2902.

[0485] like Figure 41 As shown, housing 3502 is located in which the distal end 3506 of housing 3502 has been moved slightly past the distal side 3254 of cover 3250 and into the inner hole 3264. Figure 34 The position of ).

[0486] refer to Figure 31 and 42 The removable sensor module 3500 is shown in the fourth operating position. When the operator manually releases the housing 3502, the compressed coil spring 3382 causes the plate 3350 and the housing 3502 to move in a distal direction, causing the fingers 3138 and 3140 to be positioned in the catcher 3544 (in Figure 36 (Best seen in the middle). Now, the housing 3502 is rotatably locked to the receiver housing 3102. Simultaneously, the distal movement of the housing 3502 also causes the contact button 3746 ( Figure 37B ) is engaged and rests on terminal end 3156 ( Figure 33 ), via terminal 3152 ( Figure 34 An electrical connection is established between sensor PCB 3702 and container PCB 3800. Components on sensor PCB 3702 are now in communication with components on container PCB 3800.

[0487] The surgical instruments 180 to be sterilized are manually loaded into container 2902 and cap 450 is placed above container 2902. Locking cap bolt 496 is moved to the locked position, securing cap 450 to container 2902. In an alternative embodiment, pivoting of cap bolt 496 causes magnet 448 to be positioned close to Hall effect sensor 3172, such that Hall effect sensor 3172 senses the magnetic field generated by magnet 448. Container assembly 2900 is now ready in sterilization chamber 52. Figure 1 The sterilization process is cycled within the container. During the sterilization cycle, the removable sensor module 3500 monitors and collects data on the operating environment, conditions, and process measurements within the container 2902.

[0488] After the sterilization cycle is completed, the sensor module 3500 is removed from the sensor receiver 3100 while maintaining the sterility of the interior of the container assembly 2900. The sensor module is removed by pressing the module housing 3502 proximally while simultaneously rotating the housing counterclockwise. The proximal movement of the housing 3502 causes the fingers 3138 and 3140 to retract from the catcher 3544. As the housing 3502 is rotated counterclockwise, the fingers 3138 and 3140 track along the channel 3540, causing the housing 3502 to be pulled distally away from the receiver housing 3102. It should be understood that the plate 3350 is engaged with the housing 3502 for axial movement. Therefore, the longitudinal displacement of the housing 3502 results in a similar displacement of the plate 3350. The distal movement of the housing 3502 and the plate 3350 is assisted by the coil spring 3382. The counterclockwise rotation of housing 3502 also causes contact button 3746 to disconnect from terminal end 3156. Figure 41 The sensor module 3500 is shown in this location.

[0489] Finally, the annular surface 3355 of plate 3350 pointing to the far side ( Figure 35 Contact O-ring 3144. This establishes a seal between plate 3350 and receiver housing 3102. This seal closes channel 4110. Figure 42 After the seal is established, the locking mechanism 3400 is biased by the disc spring 3426. Figure 35 The spring 3426 causes the locking mechanism 3400 to move to its uppermost position, whereby the raised wall 3408 ( Figure 35 ) Connecting steps 3362 ( Figure 35 The upper sidewall of the locking mechanism 3400 restricts the upward movement of the locking mechanism 3400, and the rod 3412 is positioned adjacent to the bracket arm 3306 to prevent the plate 3350 from moving away from the receiver housing 3102 in the proximal direction.

[0490] During this removal of the sensor module, plate 3350 is pulled outward. This causes plate 3350 to be pressed against O-ring 3144. This increases the force applied to the plate by spring 3382 to hold the plate in a sealed and locked position.

[0491] As the housing 3502 is rotated further counterclockwise, the fin-shaped portion 3524 disengages from the shoe-shaped portion 3376 and moves out of the plate socket 3380, allowing the housing 3502 to separate from the plate 3350. The operator continues to manually move the housing 3502 in a distal direction, causing the removable sensor module 3500 to exit from the receiver housing inner hole 3125. Figure 34 ) and opening 3263 ( Figure 34Removal and separation. During the removal of the removable sensor module from the sensor receiver, seals 3534 and 3144 work together to ensure that at least one seal remains sealed to the adjacent surface, preventing air and microorganisms from entering the container interior during removal. In embodiments where this at least one seal is retained during removal, it temporarily forms part of a sterile barrier enclosure. The removable sensor module 3500 can now be used with other containers 2902 during sterilization processes.

[0492] Sensor module 3000 is configured such that a sterile seal is maintained between container 2902 and receiver 3100, regardless of the position of removable sensor module 3500. When sensor module 3500 is removed from receiver 3100, the annular surface 3355 of plate 3350 ( Figure 35 The O-ring 3144 and the inner annular surface 3122 form a sterile seal to prevent contaminants from entering the container 2902 through the receiver 3100. When inserting or removing the sensor module 3500, regardless of when the plate 3350 is in the open position, the O-ring 3534 and the inner annular surface 3122 ( Figure 33 Maintain another sterile seal to form another sterile barrier.

[0493] When the container undergoes sterilization, the surfaces of plate 3500 and the adjacent receiver, as well as the exposed surface of O-ring 3534, are exposed to the sterilizing agent. Therefore, when these surfaces come together to form a seal during the removal of the sensor module, there is virtually no possibility of contaminants being trapped between these surfaces.

[0494] The locking mechanism 3400 is designed so that the plate 3350 can only be opened when the lid 450 is opened or removed. The locking mechanism 3400 must be manually actuated from inside the container 2902. After the container 2902 has been sterilized and the sensor module 3500 has been removed from the receiver 3100, any subsequent attempt to insert another removable sensor module 3500 into the receiver 3100 is blocked by the locked locking mechanism 3400, thus maintaining the sterile conditions within the container 2902. Fourth, because the removable sensor module 3500 is removable from the container 2902, it can be used in conjunction with other additional containers 2902 during the sterilization process. If the removable sensor module 3500 is a relatively expensive item, then using a small number of removable sensor modules 3500 with a larger number of containers 2902 will result in a more economical and efficient solution for monitoring process measurements during sterilization. Furthermore, sensors or electronic components mounted on the removable sensor module 3500 will not be exposed to potential damage from cleaning, automatic washing, and coarse handling, whereas sensors or electronic components permanently mounted to the container may experience these damage conditions.

[0495] In some embodiments of the invention, some of the components forming part of the sensing assembly are mounted to the container. Typically, these components are mounted to a receiver. Components that may be attached to the receiver include a processor, memory, indicator lights, or a battery. Additionally, some sensors may be permanently mounted to the container.

[0496] XXIV. Docks used with removable sensor modules

[0497] refer to Figure 44 Another embodiment of docking station 1300 is shown. Docking station 4400 is used in conjunction with removable sensor instrument 3000. Docking station 4400 is used during the loading of surgical instruments into container 2902 for calibrating the sensors of removable sensor module 3500 and recharging the battery. Docking station 4400 is consistent with the previously referenced... Figure 16 The described docking station 1300 shares many common features. The difference between docking station 4400 and docking station 1300 is that the calibration cavity 1320 has been modified to remove door 1326. Figure 16 A fixed front panel 4410 was added. Multiple sensor receivers 3100 were mounted to the front panel 4410. Although six sensor receivers 3100 are shown mounted in the calibration cavity 1320, more or fewer sensor receivers 3100 can be used.

[0498] The removable sensor module 3500 is attachable to and detachable from each of the sensor receivers 3100. The sensor receivers 3100 of the dock 4400 are connected to the dock controller 1402. Figure 17 And communicate with the stop controller 1402. When the sensor module 3500 is inserted into the receiver 3100, the sensor processor 1020 (FIG. 37) communicates with the stop controller 1402 and the stop processor 1410 (FIG. 37). Figure 17 ) communication.

[0499] Dock 4400 includes a steam generator 1430, a hydrogen peroxide generator 1432, a pressure pump 1434, a vacuum pump 1436, and a heater 1438. Figure 17 All of these can be used as needed to provide known concentrations and values ​​within calibration chamber 1320 during the calibration process.

[0500] In the same manner as docking station 1300 and container 402, docking station 4400 is used in conjunction with removable sensor device 3000. Docking station 4400 is used in conjunction with, as described above... Figure 21Prior to the sterilization process in step 2108, the removable sensor module 3500 is programmed with the Validated Sterilization Process Measurement (VSPM) 1150. Dock 4400 is used to recharge the battery 3720 in the removable sensor module 3500 (Figure 37). Dock 4400 is used in conjunction with the previously described... Figure 27 In the same manner as steps 2704-2714, the sensors in the removable sensor module 3500 are calibrated. During the calibration of the sensors associated with the corresponding removable sensor module 3500, the sensor calibration software 1460 ( Figure 17 It is used by docking station 4400. During the calibration process, sensor calibration software 1460 controls at least partially the operation of steam generator 1430, hydrogen peroxide generator 1432, pressure pump 1434, vacuum pump 1436 and heater 1438.

[0501] Please note that docking station 4400 can be used to simultaneously program and calibrate a large number of removable sensor modules 3500.

[0502] XXV. An operating method that utilizes a removable sensor module during the sterilization process to determine the validated sterilization process measurements that have been obtained.

[0503] refer to Figure 45 A flowchart is shown for a method 4500 for determining whether empirical sterilization process measurements within a container have been obtained during the sterilization process using a removable sensor module 3500. Method 4500 illustrates exemplary methods performed by the container assembly 3000 and the removable sensor module 3500, as presented in the preceding figures, capable of implementing one or more aspects of the present disclosure. Figure 45 The discussion also referenced Figure 29-44 Components in.

[0504] Method 4500 begins with step 4502, in which the removable sensor module 3500 is programmed into the VSPM 1150. The removable sensor module 3500 is then loaded into dock 4400. Figure 44 The memory 1022 (Figure 37) is used for programming. In step 4502, the memory 1022 is programmed with a specific validated sterilization process measurement (VSPM) 1150, which is then processed by the docking station processor 1410. Figure 17 Container programming software 1461 running on ) Figure 17 ) using handheld reader 1240 ( Figure 44 The acquired data identifies a specific VSPM 1150 associated with the container equipment load, and the VSPM 1150 is transmitted for storage in memory 1022. The transmitted VSPM 1150 is specifically for this equipment load to be sterilized.

[0505] Optionally, in step 4502, the sensor of the removable sensor module 3500 is calibrated before use. The removable sensor module 3500 is used by the dock 4400.

[0506] In step 4504, the removable sensor module 3500 is removed from the dock 4400 and loaded onto the attachment container 2902. Figure 40 ) sensor receiver 3100 ( Figure 40 Step 4504 includes manually pressing the inner locking mechanism 3400 into the container 2902 when the lid is opened to allow insertion into the housing 3502. The sensor module 3500 processor 1020 (Figure 37) establishes communication with the container controller 3830 at this time.

[0507] In step 4506, the operator prepares the surgical instruments 180 loaded on the device. Figure 2 ) is used for sterilization. In step 4506, the surgical instruments are placed on tray 160 ( Figure 2 The tray 160 is placed inside the container 2902. The lid 450 ( Figure 40 It is attached to and sealed into container 2902.

[0508] In optional step 4508, surgical instruments 180 and / or trays 160 and / or containers 2902 are wrapped in sterile barrier material before sterilization.

[0509] In another optional step at box 4510, sterilization verification software 1152 runs on processor 1020. Figure 14 Open the container and the yellow LED 3844 ( Figure 38 This indicates to the user that the container components have not yet undergone a sterilization process.

[0510] In step 4512, container 402 is placed in sterilization chamber 52. Figure 1 The sterilization process cycle begins within sterilization chamber 52 (box 4514). During the sterilization process cycle, the sterilization chamber is heated and pressurized, and a sterilizing agent, such as steam or hydrogen peroxide gas, is pumped into the sterilization chamber. The sterilization process cycle also includes a cooling phase and vacuuming within the chamber. These sub-steps remove any remaining condensed sterilizing agent from the container. The sterilization chamber is configured to utilize a set of chamber process parameters (CPP) 66 ( Figure 1 CPP 66 is a set of nominal process parameters within the sterilization chamber. The sterilization chamber is configured to operate using CPP 66.

[0511] Furthermore, in step 4514, during the sterilization process, sterilization verification software 1152 running on processor 1020 monitors and collects real-time data from corresponding electronic sensors in sensor module 3500. The sensors monitor environmental characteristics within their respective containers. The collected real-time operational data is used as data 1156 (…). Figure 14 The data is stored in memory 1022. For example, sterilization verification software 1152 running on processor 1020 collects water vapor data from water vapor sensor 1024, pressure data from pressure sensor 1026, temperature data from temperature sensor 1028, and hydrogen peroxide concentration data from hydrogen peroxide gas sensor 1052. All data recorded during the sterilization process is stored in memory 1022 as data 1156.

[0512] In step 4516, processor 1020 compares the observed environmental measurements with VSPM 1150. In decision step 4520, sterilization validation software 1152 running on processor 1020 determines whether real-time measurement data 1156 during the sterilization process meets or exceeds the minimum VSPM 1150 value for each operating parameter to ensure sterilization of the container contents. For example, if the minimum temperature and time value for VSPM 1150 is 250 degrees Fahrenheit for 20 minutes, sterilization validation software 1152 compares these values ​​with the recorded time and temperature values ​​in data 1156.

[0513] In response to the recorded data 1156 value meeting or exceeding the minimum VSPM 1150 value used for each sterilization operation measurement, method 4500 proceeds to step 4526, in which the sterilization verification software 1152 running on processor 1020 indicates that the contents of the container have been successfully sterilized by energizing the green container LED 3846. Figure 38 In one embodiment, additional data related to the sterilization process may be transferred to the container memory of PCB 3800 for storage, workflow processes, or quality control practices. For example, in one embodiment, measurement data, VSPM programming datasets, sterilization verification results, sterilization data, and VSPM program operators may be stored on the container memory of PCB 3800. In step 4528, the container assembly is removed from the sterilization chamber and the removable sensor module 3500 is removed from container 2902. During and after the disconnection of sensor module 3500 from container 2902, the contents of container 2902 remain in a sealed, sterile state. Method 4500 then ends.

[0514] In response to the recorded data 1156 value not meeting or exceeding the minimum VSPM 1150, the processor 1020 continues to step 4524, which is the same as step 2126 described above.

[0515] In step 4528, the container is removed from the sterilization chamber and the removable sensor module 3500 is removed from container 2902. The contents of container 2902 should be reprocessed before use. Then method 4500 ends.

[0516] During storage, controller 3830 ( Figure 38 ) Performs similar aseptic monitoring software 1158 ( Figure 14 The instruction set enables the controller 3830 to monitor data stored from the Hall effect sensor 3172 during storage. Figure 31 The optional embodiment receives the electrical signal. If the cover 450 is opened, the electrical signal from the Hall effect sensor 3172 changes, triggering the controller 3830 to de-energize the green LED 3846. Figure 38 And turn on the red LED 3842. Figure 38 The illumination of the red LED 3842 indicates to the operator that the contents of container 2902 are no longer considered sterile.

[0517] XXVI. Automatic closing container with scissor-type lifting mechanism

[0518] Turning Figure 46 and 47 Another automatically closing container assembly 4600 is shown. Container assembly 4600 utilizes a scissor mechanism 4700 to close the movable frame 4750. The frame is closed after the sterilization process is performed and any residual sterilizing agent is removed from the container.

[0519] Container component 4600 includes container 4602. Figure 46 The container 4602 is the same as the container 402 in Figure 7 described above, except that the opening 414 and the cap bolt 496 are omitted from the container 402. For the purpose of illustrating the container assembly 4600, the container 4602 will be referred to with the same reference numerals as in Figure 7.

[0520] The container assembly 4600 also includes a support or tray 4620. The tray 4620 may be formed of a suitable material such as stainless steel or aluminum. The tray 4620 includes a generally planar rectangular base 4622, which is perforated by an array of holes 4626. The holes 4626 allow sterilizing agents to circulate beneath the base 4622. The base 4622 has an upper surface 4623 and a bottom surface 4624. Four support feet 4628 are attached to the base 4622 and extend vertically downward from the bottom surface 4624. When the tray 4620 is placed inside the container 4602, the feet 4628 rest on the upper surface of the support frame 4710.

[0521] During aseptic processing, tray 4620 is used to hold medical / surgical instruments 180 within container 4602. Tray 4620 includes a pair of spaced-apart handles 4632 mounted to opposite ends of base 4622. Handles 4632 allow a user to grasp and lift tray 4620.

[0522] The tray 4620 is formed with a plurality of support members 4638 extending upward from the base 4622. The medical / surgical instrument 180 rests against and is supported by the support members 4638. The support members 4638 are sized and shaped to hold and retain the medical / surgical instrument 180 in a preferred orientation for aseptic processing. For some medical / surgical instruments 180, it is important to be oriented to a specific geometric orientation during aseptic processing so that sterilizing agents can easily enter and exit the surgical instrument.

[0523] A cover 4650 is used to cover and close container 4602. The cover 4650 includes a generally rectangular panel 4652 surrounded by a raised peripheral flange 4654. The cover 4650 is formed of a material such as stamped aluminum or other suitable material. Two latches 4658 are mounted on opposite sides of the cover 4650. Each latch 4658 is arranged diametrically opposite to the other and attached to the flange 4654. The latches 4658 engage with clamps 4758 extending outward from both ends of a movable frame 4750. When the cover 4650 is moved downward to contact the movable frame 4750, the latches 4658 pivot slightly and engage the clamps 4758, thereby securing the cover 4650 to the frame 4750. The cover 4650 has a groove 455 (reference) that is secured to it. Figure 7B The elastic washer 456 in ) (reference) Figure 7B Gasket 456 mates with the peripheral lip 4760 of frame 4750 to form a seal between cap 4650 and movable frame 4750. Other latches for securing and sealing the cap to the movable frame may be used, provided that such latches allow an operator to release, remove the cap and access the contents inside the container.

[0524] The container assembly 4600 also includes a scissor mechanism 4700. The scissor mechanism 4700 is received through the cavity 420 of the container 4602 and rests on the bottom panel 407. The scissor mechanism 4700 is used to raise and lower the frame 4750 during the sterilization process of the container assembly 4600. The scissor mechanism 4700 includes a dog-bone shaped frame 4710 linked by a pair of central transverse members 4712. The frame 4710 has opposite ends 4738 and 4739. The frame 4710 and the transverse members 4712 define three cavities 4713, 4714, and 4715 within the frame 4710. Four openings 4716 are defined at opposite ends of the frame 4710. Opening 4716 receives locking fingers 4717, which have attached, slotted heads 4718 extending upwards from the top surface of the frame 4710. When the frame 4710 rests against the container bottom panel 407, the slotted heads 47...

Claims

1. A sterilization system, the sterilization system comprising: A sterilization container for holding an equipment load including surgical instruments, the sterilization container being configured to allow sterilizing agent entry and allow residual sterilizing agent exit, enabling the equipment load within the sterilization container to undergo a sterilization process, the sterilization container including an electronic sensor module mounted on the sterilization container for measuring characteristics of the environment within the sterilization container, the electronic sensor module including a memory; and A docking station capable of electronically communicating with the electronic sensor module and including a reader configured to identify the load of the device, the docking station including a docking station memory; The sterilization system is configured to load empirical sterilization process measurements for equipment load from the docking station into the memory of the electronic sensor module. The docking station is configured to track the location of the sterilization container within the medical facility based on data transmitted to the docking station by the electronic sensor module, stored in the docking station memory.

2. The sterilization system according to claim 1, wherein, The docking station also includes a calibration chamber configured to receive sterilization containers.

3. The sterilization system according to claim 2, further comprising at least one of the following: A steam generator, which is connected to the calibration chamber and configured to generate a known steam concentration within the calibration chamber; A hydrogen peroxide generator, which is connected to the calibration chamber and configured to generate a known hydrogen peroxide concentration within the calibration chamber; and A pressure pump is connected to the calibration chamber and is configured to generate a known pressure level within the calibration chamber.

4. The sterilization system according to claim 2 or 3 further includes a vacuum pump connected to the calibration chamber and configured to generate a known vacuum level within the calibration chamber.

5. The sterilization system of claim 2 further includes a heater mounted on the outer surface of the calibration chamber and configured to generate a known temperature within the calibration chamber.

6. The sterilization system according to claim 1, wherein, The docking station also includes a reader configured to identify the load of equipment to undergo the sterilization process.

7. The sterilization system according to claim 6, wherein, The docking station is configured to load validated sterilization process measurements onto the electronic sensor module based on the equipment load identified by the reader.

8. The sterilization system according to any one of claims 1 to 3 or 5 to 7, further comprising a display configured to indicate the correct loading orientation of surgical instruments under equipment load.

9. The sterilization system according to claim 1, wherein, The docking station communicates wirelessly with the electronic sensor module.

10. A sterilization system, the sterilization system comprising: A sterilization container for holding surgical instruments, the sterilization container being configured to allow sterilizing agent to enter and allow residual sterilizing agent to leave, such that the surgical instruments within the sterilization container can undergo a sterilization process, the sterilization container comprising: An electronic sensor module installed on a sterilization container, the electronic sensor module being used to measure characteristics of the environment inside the sterilization container during the sterilization process; and A docking station capable of electronically communicating with the electronic sensor module of the sterilization container, the docking station including a docking station memory. The docking station is configured to track the location of the sterilization container within the medical facility based on data transmitted to the docking station by the electronic sensor module.

11. The sterilization system according to claim 10, wherein, The docking station communicates wirelessly with the electronic sensor module.

12. A method for sterilization, the method comprising: A sterilization container for holding surgical instruments is provided, the sterilization container including an electronic sensor module mounted thereon and formed to define an antimicrobial barrier surrounding the surgical instruments, the electronic sensor module being used to measure characteristics of the environment within the sterilization container during sterilization; Provides a docking station capable of electronically communicating with the electronic sensor module of the sterilization container; and The location of the sterilization container within the medical facility is tracked using the stop station memory and based on data measured by the electronic sensor module.

13. A sterilization system, the sterilization system comprising: The docking station includes a calibration chamber and a docking station memory; An electronic sensor module, which is removably coupled to the calibration chamber, disposed within the calibration chamber, and in electronic communication with the docking station, is configured to measure the characteristics of the environment within the sterilization container during the sterilization process; and A steam generator is connected to the interior of the calibration chamber and is configured to provide a known steam concentration to the interior of the calibration chamber during calibration. The docking station is configured to track the location of the sterilization container within the medical facility based on data measured by the electronic sensor module and stored in a docking station memory.

14. The sterilization system of claim 13 further includes a hydrogen peroxide generator configured to apply a known concentration of hydrogen peroxide to the interior of the calibration chamber of the docking station.

15. The sterilization system of claim 13 further includes a pressure pump configured to apply a known pressure level to the interior of the calibration chamber at the docking station.

16. The sterilization system according to any one of claims 13 to 15, further comprising a vacuum pump configured to apply a known vacuum level to the interior of the calibration chamber at the docking station.

17. The sterilization system according to any one of claims 13 to 15, further comprising a heater coupled to the calibration chamber and configured to heat the interior of the calibration chamber of the docking station to a known temperature.

18. The sterilization system according to any one of claims 13 to 15, wherein, The docking station is configured to recharge the battery of the electronic sensor module.

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