Sterilization trays with magnetic drop latch devices and / or other features

Abstract

The system can include a valve cap positioned over an opening of the sterile container, the opening of the sterile container being sized to receive the valve cap. The system includes a valve frame attached to the lid of the sterile container and an electro-permanent magnet (EPM) assembly releasably magnetically coupled to the valve cap, the EPM assembly configured to orient the valve cap in an open position with a magnetic field and to orient the valve cap in a closed position by neutralizing the magnetic field in response to receiving an electric current.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 477,106, filed December 23, 2022, and U.S. Provisional Application No. 63 / 477,147, filed December 23, 2022, the disclosures of which are incorporated by reference herein in their entireties for all purposes. [Background technology]

[0002] Sterilization of items is used in a variety of industries, including healthcare, pharmaceutical, and food processing. A common and validated method used for sterilization is the application of pressurized, high-temperature steam in a pressure chamber or vessel for a predetermined period of time. Pressurized, high-temperature steam in a pressure chamber can be used in sterilization of laboratory equipment and industrial manufacturing departments. In hospital and healthcare environments, laboratory environments, and the pharmaceutical and food processing industries, sterilization can be achieved by contacting the items to be sterilized with high-temperature steam in a pressure vessel. Alternatively, the items to be sterilized may be contacted with a low-temperature sterilization medium (e.g., ethylene oxide or an equivalent low-temperature sterilization medium) in the pressure vessel. Various types of sterilization pressure vessels and autoclave chambers can be used to sterilize items. In many cases, the sterilization medium comes into contact with the items to be sterilized. Summary of the Invention

[0003]

[0003] The following presents a simplified summary of some embodiments of the invention in order to provide a basic understanding of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key / critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some embodiments of the invention in a simplified form as a prelude to the more detailed description that is presented later.

[0004] Apparatus and related methods are provided for sterilizing items (e.g., surgical instruments, instrument trays, implants, and / or implant trays) in a sterilization chamber and subsequently storing and / or transporting them until use. An exemplary apparatus includes a container having an interior space in which the items to be sterilized are placed. The apparatus is positionable in an open configuration in which the interior space is in fluid communication with the ambient environment. The apparatus (and the items to be sterilized therein) is placed in a sterilization chamber (e.g., an autoclave). The apparatus is configured to reposition to a closed configuration in which the interior space is isolated from the ambient environment. Repositioning to the closed configuration occurs automatically in response to the presence of a vacuum and / or certain other desired environmental conditions in the sterilization chamber, such as may occur after completion of a sterilization phase. The sterilization phase may be any suitable portion of a cycle, for example, in which the temperature within the apparatus is above a selected sterilization temperature for at least a predetermined time, or in which sterilizing steam or gas fills the interior space for a predetermined time. The apparatus can remain in the closed configuration with its contents sealed within the apparatus until the sterilized items are to be used, thereby preventing recontamination of the sterilized items prior to use. The device can be reused to sterilize additional batches of articles, thereby providing an effective and economical means for sterilizing articles and storing and / or transporting the sterilized articles within or between healthcare facilities prior to use.

[0005] The devices disclosed herein can be used for sterilization of instruments, implants, or other items for hospitals or other healthcare facilities. The devices may be used for sterilization at the healthcare facility or at a remote location and transported to the healthcare facility while maintaining the sterility of the items within the device.

[0006] In operation of certain embodiments of the device disclosed herein, an instrument tray and / or other items to be sterilized are placed in the base portion of the device, and a sterilization lid is attached to the base portion. A user places the lid, or a feature or mechanism associated with the lid, in an open position so that the space within the tray is in fluid communication with the surrounding environment. For example, a user can orient a trapdoor on the lid so that the trapdoor allows fluid communication through the lid. By way of example, a user can lift the valve cap to lock the valve in the open position, and the user can power an electro-permanent magnet (EPM), which opens the trapdoor by generating an electromagnetic force or the like. The valve can be held in the open state by any suitable latching mechanism or force, including, but not limited to, mechanical, electromagnetic, or magnetic features.

[0007] When the contents of the device are ready to be sterilized, the device is placed in a sterilization chamber (e.g., an autoclave) with the device's lid in an open position, and a sterilization cycle is initiated. At or a specific time after the start of the sterilization cycle, the device becomes susceptible to and / or begins monitoring one or more environmental conditions within the chamber. For example, the device can use any suitable electronic sensors, transducers, etc. to measure any relevant environmental conditions, including, but not limited to, pressure, temperature, and / or humidity. The device can additionally or alternatively include an electronic timer to measure any relevant time interval, including, but not limited to, the time elapsed since a particular threshold was reached and / or the duration of a condition within an appropriate range. Furthermore, the device can respond to a particular condition or time based on the status of some other time threshold and / or environmental condition threshold. For example, the device may begin monitoring temperature a certain amount of time after the start of the sterilization cycle and / or track pressure levels or durations only while the temperature is above a particular threshold or within a particular range.

[0008]

[0008] When the environmental conditions within the sterilization chamber meet certain criteria (e.g., pressure reaching a certain subatmospheric level after a duration of exposure to high temperatures sufficient to ensure adequate sterilization of the articles), the apparatus is repositioned from the open configuration to the closed configuration, thereby sealing the apparatus, for example, by releasing a trapdoor and / or moving it from the open configuration to the closed configuration. Sealing the apparatus (e.g., closing a trapdoor) isolates the sterilized articles from the outside world and maintains the environmental conditions (e.g., pressure and humidity) that existed within the sterilization chamber and equivalently within the apparatus at the time of repositioning, regardless of further changes that may occur within the sterilization chamber and / or the external environment. The apparatus can remain sealed until the sterilized articles are utilized for their intended use in the operating room.

[0009]

[0009] Thus, in various aspects, an apparatus is provided for sterilizing surgical instruments in a sterilization chamber and storing the sterilized surgical instruments prior to use. The apparatus includes a container configured to receive one or more surgical instruments and one or more valves attached to the container. The valve is coupled to the container so as to be repositionable between an open and a closed configuration. In the closed configuration, the valve and the container at least partially define a sealed interior space. In the open configuration, the valve cap is displaced from the container to form a fluid passage between the interior space and a space within the sterilization chamber external to the container. A mechanism is configured to selectively reposition the trapdoor from the closed configuration to the open configuration. The mechanism is configured to automatically reposition the trapdoor from the open configuration to the closed configuration upon completion of a designated portion of a sterilization cycle for one or more surgical instruments disposed within the interior space.

[0010] In many embodiments, the container includes a base portion and a top cover that is detachable from the base portion. One or more surgical instruments can be placed on the base portion, and then the top cover can be attached. The top cover can have an opening that is blocked by a valve cap when the valve is in a closed configuration. When in an open configuration, the valve cap does not block the opening, thereby fluidly connecting the interior space of the container to the ambient environment.

[0011] In many embodiments, the device includes one or more spring elements that generate an interface force between the valve cap and the top cover when the valve is in the closed configuration. Such an interface force can ensure compression of an interface seal provided between the valve cap and the top cover, thereby helping to increase the effectiveness of the interface seal. In many embodiments, the one or more spring elements generate a force against the valve cap that is counteracted by a mechanism when the valve is in the open configuration. In various embodiments, when the valve is closed, a vacuum pressure or other condition can exist within the interior space of the device, providing an additional force that biases the trapdoor toward the closed configuration.

[0012] In many embodiments, the valve includes a latching mechanism that holds the valve in an open position. The latching device may be mechanical, magnetic, or electromagnetic. The valve is configured to be manually displaced by a user to reposition the trapdoor from a closed configuration to an open configuration. The latching device is configured to maintain the valve cap in the open configuration until after completion of a designated portion of the sterilization cycle and / or until environmental conditions within the interior space meet certain criteria.

[0013] In many embodiments, the mechanism includes a temperature sensor, a pressure sensor, an electro-permanent magnet (EPM), and a control unit. The temperature sensor can be configured to generate a temperature sensor output indicative of the temperature of the interior space. The pressure sensor can be configured to generate a pressure sensor output indicative of the pressure within the interior space. The EPM can be coupled to the latching device and operable to unlatch the valve cap to reposition the trapdoor from the open configuration to the closed configuration. The control unit can be configured to receive the temperature sensor and / or pressure sensor output and control the solenoid. The control unit can be configured to determine whether conditions within the interior space meet certain criteria (e.g., corresponding to the completion of a specified portion of a sterilization cycle) and, in response to the criteria being met, activate the EPM to unlatch the valve cap, thereby repositioning the device to the closed configuration.

[0014] Any suitable criteria may be used, for example, the control unit may activate the EPM based on the temperature of the interior space being at or above a selected sterilization temperature for an appropriate period of time and / or based on the pressure in the interior space reaching a predetermined level or a combination of criteria. In other embodiments, the sterilization container is a sterilization cabinet, which is a larger device capable of holding one or more sterilization trays. The sterilization cabinet includes one or more valve mechanisms, one or more doors providing access to the interior space of the cabinet, one or more shelves on which one or more sterilization trays containing surgical instruments are placed, and a control unit having electronic sensors that monitor environmental conditions within the cabinet and trigger repositioning of the valves from an open state to a closed state. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a flowchart of a method for sterilizing a surgical instrument according to certain aspects of the present disclosure. [Figure 2] FIG. 1 is a schematic diagram of an electro-permanent magnet-based valve cap device in an open position, according to certain aspects of the present disclosure, for use in a sterile container. [Figure 3] FIG. 1 is a cross-sectional side view of an electro-permanent magnet-based valve cap device in an open position, according to certain aspects of the present disclosure, for use in a sterile container. [Figure 4] FIG. 1 is a schematic diagram of an electro-permanent magnet-based valve cap device in a closed position according to certain aspects of the present disclosure for use in a sterile container. [Figure 5] FIG. 1 is a cross-sectional side view of an electro-permanent magnet-based valve cap device in a closed position according to certain aspects of the present disclosure for use in a sterile container. [Figure 6] FIG. 1 is a cross-sectional side view of an electro-permanent magnet-based valve cap device having a spring for actuating the valve cap, according to certain aspects of the present disclosure. [Figure 7]FIG. 1 is a cross-sectional side view of an electro-permanent magnet-based valve cap device having a transverse magnet for centering the valve cap, according to certain aspects of the present disclosure. [Figure 8] FIG. 1 is a diagram of a sterilization cabinet having an electro-permanent magnet based valve cap device in accordance with certain aspects of the present disclosure. [Figure 9] 1 is a diagram of a hybrid electromechanical switch system that can be used to actuate an electro-permanent magnet-based valve cap device, in accordance with certain aspects of the present disclosure. FIG. [Figure 10] FIG. 1 is a block diagram of a control module that can be used to operate an electro-permanent magnet-based valve cap device, according to certain aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016]

[0025] Apparatuses and related methods are described for sterilizing articles (e.g., surgical instruments, instrument trays, implants, and / or implant trays) in a sterilization chamber and subsequently transporting and / or storing the sterilized articles prior to use. For example, a filterless, reusable sterilization apparatus is described that, in an initial (open) configuration, provides a pathway to allow the flow of gas (e.g., air, water vapor, etc.) into and out of the apparatus. The apparatus includes temperature sensing components, pressure sensing components, humidity sensing components, and / or a timer, which cooperate to initiate repositioning of the apparatus to a sealed, closed configuration. In many embodiments, the temperature sensing components monitor the temperature of gases surrounding and / or within the apparatus until a target temperature is reached (e.g., a selected sterilization temperature for sterilizing the articles within the apparatus). Once the target temperature is reached, the apparatus becomes susceptible to environmental pressure and / or humidity. When the environmental pressure and / or humidity reach a desired level (e.g., sub-atmospheric and / or low humidity), a pressure sensor initiates repositioning of the apparatus to the closed configuration, thereby blocking the gas pathway and preventing the flow of gas into and out of the apparatus. The device can be kept in a closed configuration, maintaining the environment established within the device (e.g., subatmospheric pressure and / or low humidity conditions) upon repositioning and hermetically sealing the device to prevent gas passage until the contents of the device are accessed for use. When access to the contents of the device is required, the device may be restored to its initial (open) configuration, which allows direct access to the contents via the above-mentioned pathway, or the device may be placed in a third configuration to provide access (e.g., the lid of the device is removed).

[0017]

[0026] High-temperature steam can be used to sterilize surgical instruments and other medical devices. Steam sterilizes instruments by transferring heat carried in the water vapor (gas) to the items in the sterilization chamber. This sterilization method generally exposes instruments being sterilized to temperatures exceeding 120°C. Temperatures in this range can present challenges for more delicate instruments that may not be able to withstand high temperatures. While water vapor or steam can be used, some sterilization methods can involve using gas, steam, or a combination of these as sterilants to sterilize medical instruments. These gases can sterilize instruments at significantly lower temperatures. Some of the gases used include ethylene oxide, which destroys microbial DNA; hydrogen peroxide plasma, which attacks microbial membrane lipids, DNA, and other cellular components; and ozone, which destroys microorganisms by oxidizing various cellular components. Like steam, these gases are introduced into a sterilization container holding the instruments to be sterilized and can remain in the container for a specified period of time before being removed from the container. A vacuum can be created within the sterilization chamber and container to facilitate removal of the sterilant. The sterilization container can be compatible with these gases and any other gas or steam based sterilization method in which the sterilant is injected into a chamber and a vacuum can be used to extract the sterilant from the container at the end of the sterilization stage.

[0018]

[0027] According to aspects of the embodiment, the sterilization container may be loaded with instruments and a cover placed on the container base and latched in place. A valve or trapdoor is opened to allow sterilant to flow unimpeded into and out of the container to sterilize the instruments during the sterilization process. After sterilization, a vacuum can be created within the sterilization chamber to draw sterilant from the chamber and sterilization container during the vent phase of the sterilization cycle. Upon completing the vent phase, as the chamber begins to rise back to atmospheric pressure, the control system governing the operation of the sterilization container triggers the valve / trapdoor to close, sealing the container from the external environment while maintaining subatmospheric pressure within the container before the sterilization chamber is opened.

[0019]

[0028] Referring now to the drawings, FIG. 1 is a flow chart of an exemplary method for sterilizing a surgical instrument according to certain aspects of the present disclosure.

[0020]

[0029] Block 102 of method 100 includes loading surgical instruments into a sterilization container. The sterilization container can include a door that can be opened to insert one or more surgical instruments and that can be latched closed before starting the sterilization process. In some examples, the sterilization container can include one or more perforated trays that can be used to hold the surgical instruments during the sterilization process.

[0021]

[0030] Block 104 of method 100 includes opening one or more valves of the sterilization container to allow sterilant to flow into the sterilization container and sterilize the surgical instruments. The sterilant may include high temperature steam, sterilizing steam, sterilizing gas, combinations thereof, or any other suitable sterilant. In some examples, the one or more valves of the sterilization container may be opened by a control module that may be coupled to the sterilization container.

[0022]

[0031] Block 106 of method 100 includes venting the sterilization container to remove the sterilant from the sterilization container. Venting the sterilization container can include using a pressure gradient within the sterilization container to force the sterilant out of the sterilization container. In some examples, venting the sterilization container can include creating a vacuum within the sterilization chamber and the container with a pump.

[0023]

[0032] Block 108 of method 100 includes automatically closing the valve to seal the interior space of the sterilization container in response to detecting that the sterilization container has been vented. In some examples, the valve may be automatically closed by a control module. In some examples, the valve may include an electro-permanent magnet-based valve cap device that can be closed by energizing a solenoid to neutralize a magnetic field associated with a permanent magnet in the electro-permanent magnet-based valve cap device.

[0024]

[0033] 2 and 3 show an example of an electro-permanent magnet (EPM)-based valve cap device 200 in the open position for use in a sterilization container 210. While only the top of the sterilization chamber is shown in FIGS. 2 and 3, the structure is known; an example is shown in U.S. Pat. No. 11,826,479, which is incorporated herein in its entirety. The electro-permanent magnet (EPM) 202 can be attached to a valve frame 204, which can be attached to the container 210 to cover a valve opening 208. For example, the illustrated valve frame 204 includes legs that space the valve frame 204 from the container 210 directly above the opening 208 in the container. The opening 208 can be located anywhere on the container, but in embodiments, is located on the lid of the container. A valve cap 206 is positioned between the lid of the container 210 and the valve frame 204 and can float freely within this space between the open position shown in FIGS. 2 and 3 and the closed position shown in FIGS. 4 and 5. The example shown in Figures 4 and 5 utilizes the legs of the valve frame 204 to control the lateral movement of the valve cap 206 to ensure that the valve cap is placed in a feasible manner in the center of the valve opening 208, thus forming an effective seal.

[0025]

[0034] An electropermanent magnet (EPM) is a device that includes a permanent magnet and an electric coil. Under normal conditions, the device behaves like a permanent magnet. When current is passed through the coil, an electromagnetic field can be generated that opposes the magnetic force of the permanent magnet, thereby neutralizing it. When the current is removed, the electromagnetic force disappears, allowing the magnetic force of the permanent magnet to be restored. Thus, the activated (i.e., powered) state of the EPM 202 eliminates existing magnetic fields and forces.

[0026]

[0035] The operation of the EPM202 differs from that of a solenoid actuator. A solenoid actuator is an electromechanical device used to cause movement of an integral shaft. When current is passed through or power is applied to a solenoid actuator, the device generates a magnetic field that moves the integral shaft and anything coupled to the shaft. When power is removed from the solenoid actuator, the integral shaft may stop in its current position or return to its default position under the force of a mechanical spring. Thus, a solenoid converts electrical energy into kinetic energy (i.e., mechanical motion), which differs from the EPM202, which converts electrical energy into magnetic energy to neutralize a permanent magnet. The EPM202 can operate without any integrated moving components. Therefore, any valve assembly incorporating the EPM202 can be simpler, more robust, and more reliable in construction compared to alternatives with solenoids.

[0027]

[0036] Rather than generating movement of the valve cap 206, the electromechanical valve assembly uses an EPM 202 that can be used to magnetically latch the valve cap 206 in an open position without consuming power. The valve cap 206 may be constructed from a magnetic material or may have a component constructed from a magnetic material affixed to the valve cap 206. Prior to initiating a sterilization cycle, the valve cap 206 is latched to the EPM 202 utilizing the passive / non-magnetic force of a permanent magnet. At the appropriate point in the sterilization cycle, an electric current is transmitted to a coil in the EPM 202 to neutralize the magnetic force of the permanent magnet, allowing the valve cap 206 to separate / release from the EPM 202 and move under gravity or with the assistance of a spring force to another position (e.g., a closed position capable of sealing the sterilization container 210 to which it is assembled).

[0028]

[0037] 6 shows a similar example of a valve structure that includes a spring 602 that can help actuate the valve cap 206 toward a closed position. The spring can exert a spring force that can increase the sealing pressure between the valve cap 206 and the wall of the container 210.

[0029]

[0038] As mentioned above, the EPM 202 functions as a magnet that can neutralize magnetic forces by generating a magnetic field that opposes and cancels the field generated by a permanent magnet. A linear solenoid induces shaft movement by using an electric coil to generate a magnetic field. The magnetic field is generated by passing a current through the electric coil, which moves the shaft along the coil's central axis. The EPM 202 in this example achieves its result by neutralizing the magnetic field and cannot induce movement. A solenoid, as previously shown, generates a magnetic field to induce movement.

[0030]

[0039] In some examples, the EPM 202 unlatches the valve cap 206, thereby allowing it to move by gravity or the application of some alternative force. Other examples may include a spring as an alternative method for controlling lateral movement of the valve cap 206 and / or ensuring that the valve cap 206 descends into a position that properly blocks the valve opening and seals the sterile container.

[0031]

[0040] 7 shows an exemplary valve cap 206 having outer lateral magnets 704 that may be attached to the inside surface of a leg or similar end of the valve frame 204, and inner lateral magnets 702 that may be attached to the edge of the valve cap 206 near each leg of the valve frame 204. The outer lateral magnets 704 attached to the valve frame 204 may have the same polarity as the inner lateral magnets 702 attached to the valve cap 206, such that the inner lateral magnets 702 repel the outer lateral magnets 704 and center the valve cap 206 without contacting within the valve frame 204. In some examples, three or more pairs of magnets may be arranged around the periphery of the valve cap 206 to adequately control lateral movement of the valve cap 206.

[0032]

[0041] FIG. 8 is a diagram of a sterilization cabinet 800 having an electro-permanent magnet-based valve cap device according to certain embodiments of the present disclosure. The aforementioned sterilization container example defines a structure including a base portion and a removable top cover attached to the base portion. One or more surgical instruments can be placed on the base portion, and then the top cover can be attached. The one or more surgical instruments are typically placed in a metal basket or arranged in one or more perforated metal trays 814. The basket or tray 814 is then placed in the described container base, and a removable top is placed on the base portion to completely enclose its contents. In some examples, the sterilization cabinet 800 can be sized so that only a small number (e.g., 1-3) of baskets or trays 814 can be placed in the sterilization container.

[0033]

[0042] Some examples of sterilization containers may be larger in size and may contain significantly more baskets or trays. The example of a sterilization cabinet 800 shown in FIG. 8 can best be described as a sterilization cabinet 800 in which the door 804 is not separate from the base. Similar to the top cover of the sterilization container 210, the door 804 provides access to the interior space of the cabinet 800 for the placement and retrieval of one or more baskets or trays that hold surgical instruments. In this example, the door 804 replaces the top cover and is located on the side of the container base. The door 804 is hinged on one edge, allowing it to swing open to provide access to the interior space of the cabinet. The door 804 may be equipped with a gasket 802 around its periphery to form a seal when the door 804 is closed. The cabinet may be equipped with one or more latches 816 that hold the door 804 closed during the sterilization process. The cabinet may also be equipped with one or more electromechanical or solenoid valves and control systems, as previously described. The valve provides a port that provides an open or filterless pathway for the inflow and outflow of sterilant between the interior and exterior spaces of the cabinet 800 during the sterilization process. As previously described for the valves mounted on smaller sterilization containers, the electromechanical valve 200 mounted on the wall of the sterilization cabinet 800 closes at the appropriate time during the sterilization process, thereby isolating the interior space of the cabinet from the exterior space and creating a vacuum seal. The valve may be included in any suitable wall of the cabinet, including, but not limited to, a side wall, a top wall, a bottom wall, or a wall forming at least a portion of a door.

[0034]

[0043] Sterilization cabinet 800 includes a control unit 810 that includes one or more electronic sensors (e.g., temperature sensors, pressure sensors, etc.) that output one or more signals indicative of environmental conditions within the interior space of cabinet 800. In many embodiments, control unit 810 monitors the temperature sensor output to determine when the measured temperature is at or above a temperature selected for sterilizing items within cabinet 800, and includes control electronics that activate EPM valve apparatus 200 after a target period of time and / or when specific environmental conditions exist within cabinet 800 and / or the autoclave (e.g., the period of time required to sterilize the cabinet contents, and optionally an additional period of time to achieve the desired environmental conditions within cabinet 800). Once the target period of time has elapsed or the specific environmental conditions exist, control unit 810 activates EPM valve apparatus 200 to reposition cabinet 800 to the closed configuration, thereby blocking the gas path and preventing the flow of gas into or out of cabinet 800. Cabinet 800 can then be maintained in the closed configuration until sterilized items within cabinet 800 are approached for use. Although the described sterilization cycle is based on the passage of a target period of time, the point at which the EPM valve arrangement 200 is actuated may be based on any suitable approach, such as, for example, by using a temperature sensor to track the actual temperature profile within the interior space of the cabinet 800 over time and determining the total sterilization time based on the measured actual temperature profile.

[0035]

[0044] In many embodiments, the control unit 810 includes a pressure sensor that outputs a pressure signal indicative of the internal pressure of the interior space of the cabinet 800. The control unit 810 can monitor the pressure signal to detect the pressure within the interior space of the cabinet 800 during a sterilization cycle. After the cabinet 800 is repositioned to a closed (sealed) configuration within a sterilization chamber (e.g., an autoclave), the environmental conditions within the cabinet 800 when repositioned to the closed configuration remain unchanged until the seal is broken. For example, a pressure difference between the interior space and the exterior space of the device may exist as a result of the interior space of the device remaining below the pressure of the exterior space at the end of the sterilization cycle. Unless significant air has entered the cabinet 800, the pressure within the cabinet 800 remains below the ambient atmospheric pressure. Thus, cabinet 800 can utilize the pressure sensor signal to indicate loss of seal and can trigger one or more indicators controlled by control electronics 810 used to indicate (1) whether the internal pressure of cabinet 800 is below ambient atmospheric pressure, thereby indicating retention of the seal, and (2) whether the internal pressure of the device is not below ambient atmospheric pressure, thereby indicating a possible loss of the seal. For example, a green indicator light (e.g., a green light-emitting diode (LED)) can be illuminated to indicate that the internal pressure of cabinet 800 is below ambient atmospheric pressure. Also, the green indicator light can be turned off and / or a red indicator light can be illuminated to indicate that the internal pressure of cabinet 800 is not below ambient atmospheric pressure. In some embodiments, the pressure indicators used to indicate seal integrity can additionally or alternatively be mechanical.

[0036]

[0045] The above functions can be achieved through the use of electronic devices such as microcontrollers or hard logic. A microcontroller can be a small computer on a single integrated circuit that includes a processor core, memory, and programmable input / output peripherals. Microcontrollers can be designed for embedded applications, as opposed to microprocessors used in personal computers or other general-purpose applications. Microcontrollers can be used in automatically controlled products and devices. By reducing size and cost compared to designs using separate microprocessors, memory, and input / output devices, microcontrollers can make it economical to digitally control many devices and processes. Hard logic can include a combination of electrical components operably connected and designed to perform one or more specific tasks. In contrast, a microcontroller can be programmed to perform different tasks by modifying and uploading programming code to the microcontroller. The sterilizers described herein can use such electronic devices to perform the associated functions described herein, including, but not limited to, reading continuous signals from temperature sensors, determining when the sensed temperature is at or above a predetermined target temperature, starting a timer, and activating a solenoid after an elapsed time to reposition the sterilizer to a closed (sealed) configuration.

[0037]

[0046] The sterilization cabinet 800 can be placed inside a sterilizer so that the entire cabinet and its contents can be sterilized simultaneously. Wheels 812 may be fixed to the outside of the sterilization cabinet 800 to allow the sterilization cabinet 800 to be moved.

[0038]

[0047] A further example of a sterilization cabinet 800 utilizes two doors, each hinged on the outer edge and swinging to latch in the center of the cabinet. The doors may also slide within the cabinet to provide easy access to the interior space of the cabinet without the swinging door area consuming additional space. The doors may also swing upward on hinges at the top edge of the door or downward on hinges at the bottom edge of the door. A further example of a sterilization cabinet 800 has doors that can be removed from the cabinet frame, or has removable or hinged doors on multiple sides of the cabinet to provide additional access to the contents inside the cabinet.

[0039]

[0048] 9 is a diagram of a hybrid electromechanical switch system 900 that can be used to actuate an electro-permanent magnet-based valve cap device, according to certain embodiments of the present disclosure. The hybrid electromechanical power switch system 900 can include an interactive switch element 902. In some examples, the interactive switch element 902 can include a button, a capacitive button, a screen, or any other interactive switch element 902. A user can interact with the interactive switch element 902 to form a momentary electrical connection or short circuit to provide a trigger / power / spark to turn on an electronic switch 906, which can power a larger control system or load. When the user releases the interactive switch element 902, the control system or load remains powered until some alternative event or control signal is given to remove power from the control system.

[0040]

[0049] Initially, system 900 can be in a steady / sleep state where no or little power is consumed by the entire system. A user-operated or manual switch is activated, which provides power to the electronic switch (indicated by the solid arrow between the two boxes) and activates / closes the electronic switch. Activation of the electronic switch provides power to a control system or load, which can then activate or close the switch even when the user-operated or manual switch is deactivated.

[0041]

[0050] Once the control system 908 or the load has completed its activity or operation, the control system can send a control signal to the electronic switch 906 to deactivate or open the switch 906, allowing the entire system 900 to return to a steady / sleep state. Implementing the system 900 within a sterilization container with electrical and / or electromechanical components for both operational and monitoring purposes can reduce power consumption by creating a process flow equivalent to disconnecting the control system from its power source (e.g., batteries 904 and 910) when the system is not performing one of its predetermined tasks (e.g., checking the container's status, managing operations during an autoclave cycle, etc.). When a user presses a button, it provides a trigger to power on and wake up the system, which then performs its assigned task and powers down. Thus, the system only consumes power while the system is performing a task and is essentially powered down when the system is not performing a task. This would dramatically extend battery life.

[0042]

[0051] While FIG. 9 shows multiple batteries 904 and 910, this is not a requirement for operation. A single power source can provide the necessary power through two different power loops. Any components requiring a constant power supply (e.g., a real-time clock or a subsystem that listens for a radio or other communication signal to power the entire system) can be managed through the use of a standalone battery or can utilize an independent power loop through one of the batteries, but may not be controlled by any of the switches shown. In this scenario, the system consumes power; however, the components requiring constant power generally require very little power to perform their necessary operations.

[0043]

[0052] 10 is a control module 1000 that can monitor environmental conditions within a sterilization container and close a valve associated with a sterilization chamber according to certain aspects of the present disclosure. The control module 1000 can include a processor 1002 and a memory 1004. The processor 1002 and the memory 1004 can be integrated into a single housing or can be distributed amongst each other.

[0044]

[0053] The processor 1002 may include a single processor or multiple processors. Non-limiting examples of the processor 1002 include a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a microprocessor, etc. The processor 1002 may execute instructions 1006 stored in the memory 1004 to perform one or more operations. In some examples, the instructions 1006 may include processor-specific instructions generated by a compiler or interpreter from code written in any suitable computer programming language, such as C, C++, C#, etc.

[0045]

[0054] The memory 1004 may include a single memory device or multiple memory devices. The memory 1004 may be volatile or non-volatile in that the memory 1004 can retain stored information when power is removed. Non-limiting examples of the memory 1004 include electrically erasable programmable read-only memory (EEPROM), flash memory, or any other type of non-volatile memory. At least a portion of the memory devices include non-transitory computer-readable media. The computer-readable media may include electronic, optical, magnetic, or other storage devices capable of providing instructions 1006 or other program code to the processor 1002. Non-limiting examples of non-transitory computer-readable media include magnetic disks, memory chips, ROM, random access memory (RAM), ASICs, configured processors, optical storage, or any other medium from which a computer processor can read the instructions 1006.

[0046]

[0055] In some examples, the control module 1000 can monitor various environmental conditions present within the sterilization chamber and container during a sterilization cycle to track the progress of the cycle so that valves can be closed at the appropriate time. For example, the control module can execute a monitoring program 1008 to monitor environmental conditions based on received sensor data. In some examples, output from the sensors can be recorded (i.e., stored in non-volatile memory) and queried at a later time to provide performance feedback to the user regarding the sterilization cycle. For example, data can be queried to determine or report the peak sterilization temperature achieved, the length of time the sterilization container was exposed to a particular temperature and / or pressure during the sterilization cycle, or other characteristics of the sterilization cycle that may indicate the quality or efficiency of the sterilization cycle.

[0047]

[0056] While modern sterilizers can report these and other parameters from each sterilization cycle performed, the sensors are part of the sterilizer and, as a result, represent measurements taken within the sterilization chamber, not within the sterilization container where the surgical instruments reside during sterilization. Therefore, the data represent averages across the sterilization chamber. In practice, environmental condition gradients exist within the sterilization chamber (e.g., local temperatures near the drain of a steam autoclave are generally cooler than areas near the top of the autoclave), and the exact conditions a container is exposed to may differ from those measured and reported by the sterilizer depending on where the container is located within the chamber during the sterilization process. The sterilization container control module 1000 collects and records data from the attached container, and this data is specific to that container and its contents.

[0048]

[0057] The control module 1000 may also store diagnostic data regarding the number of sterilization cycles the container has been exposed to, remaining battery life, shelf life (i.e., the time since the container was last sterilized and sealed), or other diagnostic-related parameters.

[0049]

[0058] In some examples, the control module 1000 may include a mechanism for uploading data related to a sterilization container and, if necessary, stored related to the particular container. For example, information about the contents of a sterilization container may be uploaded and stored in the control module 1000. This can provide data that can complement or be integrated with external databases and software reflecting large-scale inventory management and / or EHR (electronic health record) / EMR (electronic medical record) systems utilized by hospitals, healthcare facilities, and medical device manufacturers.

[0050]

[0059] Data may be retrieved from storage within control module 1000 and used to provide feedback to the user directly via a user interface (e.g., an LED on control module 1000 illuminates to indicate that proper sterilization parameters have been detected), or may be downloaded from control module 1000 via a wired or wireless connection from an external device or computer to control module 1000. Similarly, data uploaded to control module 1000 from an external device may be uploaded from the external device via a wired or wireless connection.

[0051]

[0060] The control module 1000 may include various data storage devices and other memory and storage media, as described above. These may reside in a variety of locations, such as on storage media local to (and / or inherent in) one or more computers, or on storage media remote from any or all of the computers via a network. In a particular set of embodiments, information may reside on a storage area network ("SAN") familiar to those skilled in the art. Similarly, files necessary to perform functions attributed to a computer, server, or other network device may be stored locally and / or remotely as needed. If the system includes computerized devices, each such device may include hardware elements that can be electrically coupled via a bus, including, for example, at least one central processing unit ("CPU"), at least one input device (e.g., a mouse, keyboard, controller, touchscreen, or keypad), and at least one output device (e.g., a display device, printer, or speaker). Such a system may also include one or more storage devices, such as disk drives, optical storage devices, and solid-state storage devices such as random access memory (“RAM”) or read-only memory (“ROM”), as well as removable media devices, memory cards, and / or flash cards.

[0052]

[0061] Such devices may also include computer-readable storage medium readers, communication devices (e.g., modems, network cards (wireless or wired), infrared communication devices, etc.), and the working memory described above. The computer-readable storage medium readers may be configured to connect to or receive computer-readable storage media representing remote, local, fixed, and / or removable storage devices, as well as storage media for temporarily and / or more permanently containing, storing, transmitting, and retrieving computer-readable information. The systems and various devices will also typically include several software applications, modules, services, or other elements located within at least one working memory device, including an operating system and application programs such as client applications or web browsers. It should be understood that alternative embodiments may have numerous variations from those described above. For example, customized hardware may also be used, and / or particular elements may be implemented in hardware, software (including portable software such as applets), or both. Additionally, connections to other computing devices, such as network input / output devices, may be utilized.

[0053]

[0062] Storage media computer-readable media for containing code or portions of code can include any suitable media known or used in the art, including storage media and communication media such as volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storing and / or transmitting information such as computer-readable instructions, data structures, program modules, or other data, including, but not limited to, RAM, ROM, Electrically Erasable Programmable Read-Only Memory ("EEPROM"), flash memory or other memory technology, compact disc read-only memory ("CD-ROM"), digital versatile disk (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage, or other magnetic storage devices, or any other medium that can be used to store the desired information and that can be accessed by a system device. Based on the disclosure and teachings provided herein, those skilled in the art will recognize other means and / or methods for implementing the various embodiments.

[0054]

[0063] While the present subject matter has been described in detail with reference to specific embodiments thereof, it will be understood that those skilled in the art, once they have gained the above understanding, will be able to readily produce modifications, variations, and equivalents to such embodiments. Accordingly, it should be understood that the present disclosure is presented for purposes of illustration and not limitation, and is not intended to exclude the inclusion of such modifications, variations, and / or additions to the present subject matter as would be readily apparent to those skilled in the art. Indeed, the methods and systems described herein may be embodied in a variety of other forms, and various omissions, substitutions, and changes can be made in the form of the methods and systems described herein without departing from the spirit of the present disclosure. The appended claims and their equivalents are intended to cover such forms or modifications as are within the scope and spirit of the present disclosure.

[0055]

[0064] Unless otherwise specified, throughout this specification, discussions utilizing terms such as "processing," "computing," "calculating," "determining," and "identifying" are understood to refer to the operations or processing of a computing device, such as one or more computers or similar electronic computing device(s), that manipulates or transforms data represented as physical electronic or magnetic quantities in the memory, registers, or other information storage, transmission, or display devices of the computing platform.

[0056]

[0065] The one or more systems discussed herein are not limited to any particular hardware architecture or configuration. A computing device can include any suitable arrangement of components that provide a result conditioned on one or more inputs. Suitable computing devices range from general-purpose computing devices to dedicated computing devices that implement one or more embodiments of the present subject matter, including general-purpose microprocessor-based computing systems that access stored software that programs or configures the computing system. Any suitable programming, scripting, or other type of language or combination of languages ​​can be used to implement the teachings contained herein in software used to program or configure a computing device.

[0057]

[0066] Embodiments of the methods disclosed herein may be performed in operation of such a computing device. The order of the blocks shown in the above examples may be changed, e.g., the blocks may be reordered, combined, and / or divided into sub-blocks. Certain blocks or operations may be performed in parallel.

[0058]

[0067] As used herein, conditional words such as, among others, "can," "could," "might," "may," "e.g.," and the like, unless expressly stated otherwise or understood otherwise within the context in which they are used, are generally intended to convey that certain examples include certain features, elements, and / or steps, while other examples do not. Thus, such conditional words are not generally intended to imply that the features, elements, and / or steps are somehow required in one or more examples, or that one or more examples, whether or not written or prompted by the author, necessarily include logic for determining whether those features, elements, and / or steps should be included in or performed in any particular example.

[0059]

[0068] Disjunctive language, such as the phrase "at least one of X, Y, or Z," is understood to mean, within the context of common usage, that the item, term, etc., can be either X, Y, or Z, or any combination thereof (e.g., X, Y, and / or Z), unless otherwise specified. Thus, such disjunctive language is not generally intended to, and should not, imply that a particular instance requires at least one of X, at least one of Y, or at least one of Z, respectively, to exist.

[0060]

[0069] Use of the word "or" herein is intended to cover an inclusive and exclusive OR condition. In other words, A or B or C includes any or all of the following alternative combinations as appropriate to the particular use: A alone, B alone, C alone, A and B only, A and C only, B and C only, and all three of A, B and C.

[0061]

[0070] The use of the terms “a,” “an,” and “the” and similar referents in the context of describing the disclosed examples (particularly in the context of the claims below) should be construed to encompass both the singular and the plural, unless specifically indicated otherwise herein or clearly contradicted by context. Terms such as “comprising,” “including,” and “having” are synonymous and are used in an inclusive, open-ended manner and do not exclude additional elements, features, acts, operations, etc. Also, the term “or” is used in its inclusive sense (rather than its exclusive sense), so that, for example, when used to connect a list of elements, the term “or” means one, some, or all of the elements in the list. The use of “adapted to” or “configured to” herein means open, inclusive language that does not exclude devices adapted or configured to perform additional tasks or steps. The term “connected” should be construed as partially or wholly contained within, attached to, or joined together, even if there is intervening material. The recitation of ranges of values ​​herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated herein as if it were individually recited herein. Furthermore, the use of "based on" means open and inclusive in that a procedure, step, calculation, or other operation "based on" one or more recited conditions or values ​​may, in fact, be based on additional conditions or values ​​beyond those recited. Similarly, the use of "based at least in part on" means open and inclusive in that a procedure, step, calculation, or other operation "based at least in part on" one or more recited conditions or values ​​may, in fact, be based on additional conditions or values ​​beyond those recited.Headings, lists, and numbering contained herein are for ease of description only and are not meant to be limiting.

[0062]

[0071] The various features and procedures described above may be used independently of one another or may be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of the present disclosure. Furthermore, in some implementations, certain method or procedure blocks may be omitted. The methods and procedures described herein are also not limited to any particular order, and the associated blocks or states may be performed in other orders as appropriate. For example, the described blocks or states may be performed in an order other than the order specifically disclosed, or multiple blocks or states may be combined into a single block or state. The example blocks or states may be performed sequentially, in parallel, or in some other manner. Blocks or states may be added to or deleted from the disclosed examples. Similarly, the example systems and components described herein may be configured differently from that described. For example, elements may be added, removed, or rearranged compared to the disclosed examples.

[0063]

[0072] All references cited in this specification, including publications, patent applications, and patents, are herein incorporated by reference to the same extent as if each reference was individually and specifically indicated to be incorporated by reference and was set forth in its entirety herein.

Claims

1. a valve cap positioned over an opening of a sterile container, the opening of the sterile container being sized to receive the valve cap; a valve frame secured to the lid of the sterilization container; an electro-permanent magnet (EPM) assembly removably magnetically coupled to the valve cap, the EPM assembly configured to orient the valve cap in an open configuration with a magnetic field and to orient the valve cap in a closed configuration by neutralizing the magnetic field in response to receiving an electric current; A system comprising:

2. The system comprises: A pressure sensor; a control module communicatively coupled to the pressure sensor and configured to transmit the current to the EPM assembly in response to the pressure sensor detecting that the pressure within the interior volume of the sterilization container reaches a threshold pressure; The system of claim 1 further comprising:

3. 10. The system of claim 1, wherein the valve cap, while in the open configuration, connects an interior space of the sterilization container with an exterior space such that sterilant can pass through the sterilization container.

4. 4. The system of claim 3, wherein the sterilant is at least one of high temperature steam, sterilizing steam, or sterilizing gas.

5. 1. A method for sterilizing an instrument, comprising: loading the surgical instruments into a sterile container; opening one or more valves of the sterilization container to allow sterilant to flow into the sterilization container and sterilize the surgical instrument; venting the sterilization container to remove the sterilant from the sterilization container; automatically closing the valve to seal the interior space of the sterile container in response to detecting that the sterile container has been vented; A method comprising:

6. 6. The method of claim 5, further comprising aligning a plurality of inner lateral magnets associated with the valve cap of the valve with a plurality of outer lateral magnets associated with a valve frame of the valve to magnetically center the valve cap.

7. detecting that the sterilization container has been vented; measuring a pressure associated with the sterilization container using a pressure sensor; determining that the pressure meets or exceeds a particular pressure threshold; The method of claim 5 , comprising:

8. 6. The method of claim 5, wherein the sterilant is at least one of high temperature steam, sterilizing steam, or sterilizing gas.

9. 1. A sterilization cabinet comprising: one or more sterilized containers; a door providing access to an interior space of the sterilization cabinet, the interior space of the sterilization cabinet being sized to receive the one or more sterilization containers; one or more electromechanical valves configured to allow sterilant to pass through the interior volume of the sterilization cabinet while in an open configuration and to seal the interior volume of the sterilization cabinet while in a closed configuration; A sterilization cabinet.

10. 10. The sterilization cabinet of claim 9, further comprising a sensor system communicatively coupled to a control module coupled to the sterilization cabinet, the sensor system configured to measure pressure and other environmental conditions within the sterilization cabinet.

11. 11. The sterilization cabinet of claim 10, further comprising a control module operable to operate the one or more electromechanical valves to allow the sterilant to pass through the interior volume of the sterilization cabinet.

12. 10. The sterilization cabinet of claim 9, wherein the sterilant is at least one of high temperature steam, sterilizing steam, or sterilizing gas.

13. 1. A hybrid electromechanical switch system for a sterilization container, the system comprising: an interactive switch element that can be activated by a user; a control system configured to control one or more electromechanical valves of the sterilization container and coupled to a switch; a switch electrically coupled to the interactive switch element and configured to send a control signal to the switch; a first battery electrically coupled to the switch and the interactive switch element; a second battery electrically coupled to the switch and the control system; A system comprising:

14. 14. The system of claim 13, wherein the control signal is configured to cause the control system to close the one or more electromechanical valves, thereby sealing the sterile container from an external environment.

15. 14. The system of claim 13, wherein the control system comprises a control module configured to actuate an electro-permanent magnet valve device based on one or more determined environmental parameters meeting or exceeding thresholds.

16. 15. The system of claim 14, wherein the sterilant is at least one of high temperature steam, sterilizing steam, or sterilizing gas.

17. 1. A control module for a sterilization container, said control module comprising: a processor; obtaining one or more measurements from a sensor related to one or more environmental conditions within the sterilization container; instructions executable by the processor to determine one or more environmental parameters associated with the sterilization container based on the one or more measurements; a non-transitory computer-readable memory; A control module comprising:

18. 20. The control module of claim 17, wherein the control module is coupled to an external display peripheral capable of displaying parameters related to a sterilization process.

19. The control module of claim 17 , wherein the control module is configured to actuate an electro-permanent magnet valve device based on the one or more determined environmental parameters meeting or exceeding a threshold value.

20. 20. The control module of claim 18, wherein the sterilant used in the sterilization process is at least one of high temperature steam, sterilizing steam, or sterilizing gas.

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