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WO2025212857A1 - Sterilizer - Google Patents

Sterilizer

Info

Publication number
WO2025212857A1
WO2025212857A1 PCT/US2025/022916 US2025022916W WO2025212857A1 WO 2025212857 A1 WO2025212857 A1 WO 2025212857A1 US 2025022916 W US2025022916 W US 2025022916W WO 2025212857 A1 WO2025212857 A1 WO 2025212857A1
Authority
WO
WIPO (PCT)
Prior art keywords
door
sterilizer
main body
pins
pair
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/022916
Other languages
French (fr)
Inventor
Steffen Baumann
Jacob E. Broering
David P. HOSEY
Dean WELLMAN
Dale R. HAMBERG
Patrick J. REICHERT
Richard L. TURNER
Connor J. OSOWSKI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Midmark Corp
Original Assignee
Midmark Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Midmark Corp filed Critical Midmark Corp
Publication of WO2025212857A1 publication Critical patent/WO2025212857A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2/06Hot gas
    • A61L2/07Steam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/24Apparatus using programmed or automatic operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/12Apparatus for isolating biocidal substances from the environment
    • A61L2202/121Sealings, e.g. doors, covers, valves, sluices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/12Apparatus for isolating biocidal substances from the environment
    • A61L2202/122Chambers for sterilisation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/14Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

  • Sterilizers are beneficial for sterilizing medical or dental products prior to use.
  • Various methods of sterilization have been developed which allow for the sterilization of these products.
  • One of the notable methods is via steam sterilization using an autoclave.
  • Sterilizers can be situated on-site and in proximity to where the product will be used. These products may include instruments and implants such as for dental applications.
  • These sterilizers can be large enough to require their own floorspace which can prevent placement on a desktop or countertop such that they may be inconvenient for facilities with limited floor space.
  • autoclaves may need user intervention to help with ventilation and drying of the products after the sterilization process has completed. This need for user intervention may prolong the overall sterilization process if the user intervention is not prompt and the products remain in a wet state.
  • some users of sterilizers have manually attempted to determine, maintain, and report compliance with various sterilization standards during and after the sterilization process such that user error may occur.
  • FIG. 1 depicts a perspective view of an exemplary sterilizer of the present disclosure
  • FIG. 2 depicts a diagrammatic view of an exemplary operating environment of the sterilizer of FIG. 1;
  • FIG 3 depicts a diagrammatic view of an exemplary system overview of the sterilizer of FIG. 1;
  • FIG. 4 depicts a diagrammatic view of an exemplary computer system of the sterilizer of FIG. 1;
  • FIG. 5 depicts a perspective view of the sterilizer of FIG. 1, showing an exemplary housing covering an exemplary main body and an exemplary door in an open position;
  • FIG. 6 depicts a perspective view of the sterilizer of FIG. 1, showing the housing of FIG. 5 removed from the main body;
  • FIG. 7B depicts an enlarged view of the pair of brackets of FIG. 6 showing an exemplary through-hole and an exemplary channel;
  • FIG. 8A depicts a partial cross-sectional view of an exemplary gasket attached to the door of FIG. 5, the gasket including an exemplary gasket ring;
  • FIG. 11 A depicts a perspective view of an exemplary door locking assembly of the door of FIG. 5;
  • FIG. 11 B depicts a perspective view of the door locking assembly of FIG. 1 1 A with an exemplary retaining element omitted;
  • FIG. 13 depicts a bottom rear perspective view of the main body of FIG. 5;
  • FIG. 14B depicts a diagrammatic view of the user interface of FIG. 14A.
  • the present disclosure relates to a sterilizer (1) for use typically in a medical, dental, or veterinary environment for sterilizing equipment.
  • Main body (10) further includes a pressure relief valve test lever (15) and an access cover (17). Sterilizer (1) sits on a set of feet (12), as shown in FIG. 7A to stabilize and prevent slippage of sterilizer (1) when a user opens and closes door (9).
  • sterilizer (1) commonly exists in an operating environment (19), whereby sterilizer (1) may communicate over a network (24) with an update system (21).
  • the functionality and subprocesses of sterilizer (1) may be broken into an operation system (23), a sensor system (25), a user interface system (27), and a compliance system (29). While these systems and their sub-routines and operations are discussed separately, one will readily recognize that each of these systems overlap and interact with one another, and the separate terms and descriptions are merely for organizing the discussion of sterilizer (1).
  • Update system (21) enables sterilizer (1) to receive and implement software updates and improvements remotely. It facilitates over-the-air (OTA) updates for the underlying software functionality, including operating system (23), sensor system (25), user interface system (27), and compliance system (29). Update system (21) can receive updates through network (24) which may include wireless or wired connectivity options. Update system (21) allows for automatic or user-initiated updates, ensuring that sterilizer (1) maintains the latest features, security patches, and performance enhancements without requiring manual intervention or on-site servicing. Update system (21) may also be configured to schedule updates during periods of inactivity to minimize disruption to sterilizer (1) operations.
  • OTA over-the-air
  • Sensor system (25) comprises various sensors and monitoring devices distributed throughout sterilizer (1) to collect real-time data on the sterilization process. Some versions of sensor system (25) include sensors for temperature, pressure, water level, and door position. Sensor system (25) may be configured to continuously feed this information to operation system (23), enabling precise control and adjustment of the sterilization cycle. The data collected by sensor system (25) is beneficial for maintaining optimal conditions within sterilizer (1) and ensuring the effectiveness of the sterilization process.
  • User interface system (27) provides a means for users to interact with and control sterilizer (1). As will be discussed in greater detail below, user interface system (27) may include a touch screen which displays a user interface and allows for user input.
  • User interface system (27) presents information about the sterilization cycle status, enables users to initiate and customize sterilization cycles, and provides access to various features such as troubleshooting tools, educational content, and maintenance walkthroughs.
  • User interface system (27) may include a status bar, which offers visual feedback on the progress of the sterilization cycle.
  • update system (21), operation system (23), sensor system (25), user interface system (27), and compliance system (29) may send and receive communications between one another directly.
  • update system (21), operation system (23), sensor system (25), user interface system (27), and compliance system (29) may communicate with each other through a network (24).
  • Network (24) may include one or more private or public networks (e g. the Internet) that enable the exchange of data.
  • update system (21), operation system (23), sensor system (25), user interface system (27), and compliance system (29), and network (24) of operating environment (19) may be implemented on one or more computing devices or systems, such as an exemplary computer system (26).
  • Computer system (26) may include a processor (28), a memory (30), a mass storage memory device (32), an input/output (I/O) interface (34), and a Human Machine Interface (HMI) (36).
  • Computer system (26) may also be operatively coupled to one or more external resources (38) via network (24) or I/O interface (34).
  • External resources may include, but are not limited to, servers, databases, mass storage devices, peripheral devices, cloud-based network services, or any other suitable computer resource that may used by computer system (26).
  • Processor (28) may include one or more devices selected from microprocessors, micro-controllers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines, logic circuits, analog circuits, digital circuits, or any other devices that manipulate signals (analog or digital) based on operational instructions that are stored in memory (30).
  • Memory (30) may include a single memory device or a plurality of memory devices including, but not limited, to read-only memory (ROM), random access memory (RAM), volatile memory, non-volatile memory, static random access memory (SRAM), dynamic random access memory (DRAM), flash memory, cache memory, or any other device capable of storing information.
  • Mass storage memory device (32) may include data storage devices such as a hard drive, optical drive, tape drive, non-volatile solid state device, or any other device capable of storing information.
  • Processor (28) may operate under the control of an operating system (40) that resides in memory (30).
  • Operating system (40) may manage computer resources so that computer program code embodied as one or more computer software applications, such as an application (42) residing in memory (30), may have instructions executed by processor (28).
  • processor (28) may execute the application (42) directly, in which case operating system (40) may be omitted.
  • One or more data structures (44) may also reside in memory (30), and may be used by processor (28), operating system (40), or application (42) to store or manipulate data.
  • embodiments of the invention may include applications that are located externally to computer system (26), distributed among multiple computers or other external resources (38), or provided by computing resources (hardware and software) that are provided as a service over network (24), such as a cloud computing service.
  • Sterilizer (1) leverages cloud connectivity to enhance its functionality and user experience. Through network (24), sterilizer (1) can receive remote configuration updates, allowing administrators to modify settings and protocols across multiple devices simultaneously. This cloud integration enables sterilizer (1) to connect and function without additional components, requiring only the device itself and a compatible mobile application for remote monitoring and control.
  • Sterilizer (1) may incorporate a removable media slot, such as an SD card port, to facilitate data transfer of sterilization records to other devices. This feature enables easy backup, archiving, and sharing of critical sterilization data, enhancing record-keeping capabilities and compliance tracking.
  • a removable media slot such as an SD card port
  • HMI (36) may be operatively coupled to processor (28) of computer system (26) in a known manner to allow a user to interact directly with computer system (26).
  • HMI (36) may include a touch screen, a speaker, and any other suitable audio and visual indicators capable of providing data to the user.
  • HMI (36) may also include input devices and controls such as an alphanumeric keyboard, keypads, pushbuttons, control knobs, microphones, etc., capable of accepting commands or input from the user and transmitting the entered input to processor (28).
  • HMI (36) is designed to enhance workflow efficiency in stressful clinical environments. It provides intuitive navigation, clear visual cues, and customizable shortcuts to streamline user interactions. The interface adapts to user preferences and commonly performed tasks, reducing cognitive load and minimizing the potential for errors during critical sterilization procedures.
  • a database (46) may reside on mass storage memory device (32), and may be used to collect and organize data used by the various systems and modules described herein.
  • Database (46) may include data and supporting data structures that store and organize the data.
  • database (46) may be arranged with any database organization or structure including, but not limited to, a relational database, a hierarchical database, a network database, or combinations thereof.
  • a database management system in the form of a computer software application executing as instructions on processor (28) may be used to access the information or data stored in records of database (46) in response to a query, where a query may be dynamically determined and executed by operating system (40), other applications (42), or one or more modules.
  • [00048J Sterilizer (1) incorporates a steam flush pressure pulse (“SFPP”) algorithm for controlling how the heat up routine functions, the purge timing and cycles, and for tracking temperatures between sterilization cycles via sensor system (25).
  • the SFPP algorithm acts to increase the speed with which medical devices can be sterilized by increasing the efficiency of the steps within the sterilizing cycle process.
  • the SFPP algorithm controls when the internal air is purged after a user closes door (9), when steam is used to flush sterilizer (1), how many purges are incorporated into the sterilizing process and at what pressure and temperature, and related functionality to maintain speed and efficiency of the sterilizing process.
  • sterilizer (1) defines a sterilizing chamber (33), sized and oriented to receive one or more trays (37) therein and be selectively disposed on a tray rack (35) disposed within sterilizing chamber (33).
  • Sterilizing chamber (33) is surrounded and defined by a chamber housing (31), as shown in FIG. 6.
  • Chamber housing (31) is formed from a material suitable for heating and pressurizing, and in some versions of sterilizer (1), the chamber housing (31) material comprises stainless steel.
  • Tray rack (35) is sized and oriented to selectively receive one or more trays (37) thereon.
  • a user places a set of tools (not shown) onto tray (37) and thereafter inserts tray (37) into sterilizing chamber (33) and onto tray rack (35) to sterilize the set of tools.
  • Sterilizer (1) may include instrument viewing or tracking functionality that provides visibility of which instruments are currently inside sterilizing chamber (33) during processing. This system may use RFID tags, barcodes, or other identification methods to track individual instruments. Touch screen (13) may display real-time information about the contents of sterilizing chamber (33), allowing clinicians to quickly locate specific instruments and manage their sterilization workflow more efficiently. This feature is particularly useful when an instrument is missing or when a clinician is waiting for a specific instrument to complete sterilization.
  • Door (9) includes an outer side (39) and an inner side (41), and extends from a free end (43) to a hinged end (45).
  • Door (9) swings between the closed position (FIG. 1), the drying position (FIG. 15), and the open position (FIG. 5) by way of a hinge assembly (47) disposed at hinged end (45).
  • Door (9) is configured to: provide full user access to sterilizing chamber (33) in the open position; vent fluid and steam in the drying position, while detecting if a user opens the door fully to access sterilizing chamber (33); and close off and seal sterilizing chamber (33) in the closed position.
  • Sterilizer (1) includes a manual fill chamber (49) disposed proximate hinge assembly (47) and accessible when door (9) is in the open position.
  • Manual fill chamber (49) is fluidly connected to a water reservoir (51), as shown in FIG. 9, and facilitates manual addition of water by a user into water reservoir (51).
  • a user may connect a water line up to an electronic valve to automatically fill water reservoir (51) as needed.
  • Access to water reservoir (51) for a direct water line is provided under access cover (17).
  • a user wishing to utilize a direct water line simply opens access cover (17), drops in an electronic valve module and connects the direct line to a valve intake (not shown).
  • sterilizing chamber (33) As shown in FIG. 9, during the sterilization cycle, water enters sterilizing chamber (33) by passing through filter (48) to provide a final mechanism for removing contaminants and debris from water. Water passes through filter (48) and into sterilizing chamber (33) where it pools at the bottom of sterilizing chamber (33).
  • a filter (198) may be provided to filter air from an air valve (not shown).
  • a heating element (50) is provided at the bottom of sterilizing chamber (33) and is configured to heat up to a high temperature to convert the water into steam.
  • dam portion (67) of seal (65) disposed on the peripheral edge of sterilizing chamber (33) prevents water from flowing out of the circular sterilizing chamber (33).
  • dam gasket (63) presses against dam portion (67) to provide increased support and further seal water into the lower portion of sterilizing chamber (33) and surrounding heating element (50).
  • An upper portion of dam gasket (63) may be used to seal the lower area between dam gasket (63) and door (9) such that, upon cooling, precipitate is prevented from subsequently collecting in the lower area. Accordingly, door (9) may be opened without water dripping out of chamber 33.
  • outer surface (55) may include a drip rail (not shown) below door (9) arranged to collect any drip water.
  • a temperature sensor (54) provided inside sterilization chamber (33) provides feedback on the internal chamber temperature to sensor system (25). Sensor system (25) may use this temperature data as feedback for the sterilization cycle or to collect for later use in troubleshooting or compliance reporting.
  • a water level sensor (56) may be provided inside sterilization chamber (33) to provide feedback on the amount of water currently inside sterilization chamber (33) to ensure proper filling and boiling off of the water therein.
  • a water level fill sensor (52) may be provided as part of sensor system (25).
  • Water level fill sensor (52) is configured to determine the amount of water in water reservoir (51) and provide this information to sensor system (25) for use thereby. Sensor system (25) may thereby pass this information to user interface system (27) for providing to the user as an alert such as sound or visual.
  • Water level fill sensor (52) may be a pressure-based sensor to determine the amount of pressure the water within water reservoir (51) provides and if the pressure reading is below a set amount, water level fill sensor (52) provides this information to sensor system (25).
  • Water level fill sensor (52) may be positioned along chamber housing (31) or elsewhere and operable to determine water in water reservoir (51) via capacitive or magnetic detectors.
  • Door (9) includes an inner surface (53) on inner side (41) which is sized and configured to be adjacent to an outer surface (55) of main body (10) when door (9) is in the closed position.
  • Inner surface (53) defines a gasket recess (57) which is sized and oriented to receive a gasket (59).
  • Inner surface (53) may also define a dam gasket recess (61) which is sized and oriented to receive a dam gasket (63).
  • a seal surface (65) Surrounding the periphery of the opening to sterilizing chamber (33) is a seal surface (65), which may have a dam portion (67) as an integrated element or dam portion (67) may be provided as a separate feature.
  • a gasket housing (69) is constrained and supports gasket (59) and is preferably made out of similar material as the material used to form chamber housing (31), namely, stainless steel.
  • gasket (59) includes a particular profile, with a first wing (71) and a second wing (73) extending from a base (75), which are non-identical in shape.
  • First wing (71) includes a finger portion (83) and a grooved area (85).
  • Second wing (73) is shaped to sit within gasket recess (57) and press against gasket housing (69) to bias first wing (71) outwardly.
  • a gasket ring (77) is provided which extends around most of the interior periphery of gasket (59) to spread out gasket (59) and prevent shrinking, given the heating and cooling functionality of sterilizer (1).
  • Gasket ring (77) defines at least a portion of a circular shape sized for gasket (59) to be pressed against seal surface (65).
  • Gasket ring (77) may be of a rigid material sufficient to maintain at least a portion of the circular shape.
  • Gasket ring (77) may incorporate a poka-yoke design such that second wing (73) contacts gasket housing (69) but where first wing (71) is prevented from contacting gasket housing (69) because of gasket ring (77) disposed in the V-shaped notch of gasket (59). Gasket ring (77) may be selectively removed from gasket (59) for cleaning, inspection, and replacement.
  • Gasket ring (77) includes two ends, whereby each end extends inwardly to wrap around a corresponding pair of studs (81) to hold up gasket ring (77).
  • the poka-yoke design may be incorporated using the pair of studs (81).
  • a directional indicator (66) may be provided on gasket (59) to create an indicator to show how gasket (59) is inserted into door (9), provide an alignment and directional indicator, and also to project branding to the user.
  • Gasket ring (77) is configured to spread gasket (59) out radially and prevent shrinking or slipping down over time as gasket (59) heats and cools and may be thought of as a spring element.
  • the profile of gasket (59) provides a greater tolerance for misalignments, given outermost finger portion (83) and grooved area (85).
  • Finger portion (83) contacts seal (65) around the entire periphery and any missed contacts or reinforcement needed is provided by grooved area (85), which provides several successive featured, biased outwardly, to press against seal surface (65) of main body (10) to provide a tight, sealing engagement between door (9) and seal surface (65).
  • sterilizer (1) includes a door latch system (87) comprising a door latch assembly (89) associated with door (9) and a main body latch assembly (91) associated with main body (10).
  • Handle (11) actuates portions of the functionality of door latch system (87).
  • Housing (7) of main body (10) defines a recessed area (93) complementarily sized to receive handle (11) therein, with a pair of screws (95) passing through a pair of slots (97) to mate with a corresponding pair of bosses (99) at one end of each screw (95).
  • a latch bracket (101) is disposed within housing (7) and includes a similar pair of bosses (103) sized to receive the other end of screws (95) therein.
  • Latch bracket (101) also includes an actuator ledge (191) and interlock ledge (196), described below. Latch bracket (101) is configured to move up and down within door (9) in the directions of Arrow A.
  • slots (97) allow handle (11) to move and be pulled upwardly away from recessed area (93) to move latch bracket (101) between a lower position (FIG. 11A, 11B) and a raised position (not shown).
  • latch bracket (101) is coupled with a pair of pins (105)
  • pins (105) also selectively raises and lowers within door (9).
  • this raising and lowering of pins (105) locks and unlocks door (9) from main body (10), with the raising of the pins being referred to as the unlocked position, and the lowering of pins (105) being referred to as the locked position.
  • Lock assembly (106) further includes a pivot cam (115) having a surface (116) and a catch flange (117). Pivot plate (115) is configured to rotate about a shaft (119) between a first position (FIG. 11 A) and a second position (not shown). Inasmuch as pivot arm spring plunger (111) is secured at one end to pivot plate (115), the movement of pivot arm spring plunger (111) in turn rotates a pivot plate (115) about shaft (119).
  • Catch flange (117) is sized and positioned on pivot plate (115) to rotate down towards retaining ledge (109) of retaining element (107) to abut and frictionally engage retaining ledge (109) when a user moves handle (11) fully upwardly within recessed area (93) to unlock and open door (9). Because of this frictional engagement between catch flange (117) and retaining ledge (109), pins (105) stay in the upward and opened position while door (9) is open.
  • Locking slots (121) are defined by a pair of brackets (123) extending from main body (10). This movement of pins (105) into locking slots (121) is directed by the bias provided by way of pivot spring (113). As is shown in FIG.
  • locking slot includes a through-hole (193) (also referred to as an opening) and a channel (195) which is shallower than through-hole (193). Both through- hole (193) and channel (195) are sized to accommodate pins (105) for locking door (9) via through-hole (193) and venting door (9) via channel (195).
  • pins (105) are disposed into locking slots (121)
  • door (9) is locked to main body (10).
  • the rotation of catch flange (117) out of frictional engagement with retaining ledge (109) may be accomplished by various mechanical features associated with main body (10). For example, a finger or another mechanical feature may be used to press against surface (116) of pivot plate (115) to press catch flange (117) out of frictional engagement with retaining ledge (109).
  • catch flange (117) itself may be pressed out of engagement with retaining ledge (109) through use of upper bracket of the pair of brackets (123).
  • catch flange (117) moves into contact with proximal end of upper bracket (123).
  • the upper bracket (123) pushes catch flange (117) off engagement with retaining ledge (109).
  • pins (105) are no longer upwardly bound and thus fall into locking slots (121) of brackets (123).
  • catch flange (117) and retaining ledge (109) is one of friction, and not a mechanical lock, and because pivot spring (113) biases pins (105) downwardly, simply pressing door (9) against main body (10) overcomes the frictional engagement and drops pins (105) into locking slots (121) to lock door (9) to main body (10).
  • the physical pressing of door (9) can be done anywhere on the surface of door (9) and not necessarily on handle (11). This frees the user to press on another portion of door (9) and do it with one hand only, which may be a “clean” hand or a hand that hasn’t handled any of the unsterile and used equipment.
  • pins (105) are held in the upward position, a user may visually understand this from further away as handle (11) may be held in an upward position, away from recessed area (93). Dropping pins (105) may include an audible feedback to the user. The user may also understand that pins (105) have dropped when handle (11) has returned to recessed area (93).
  • a door actuator (110A) is operably connected with a door motor (125).
  • Door motor (125) is configured to move a proximal portion of door actuator (110A) upwards and downwards relative to outer surface (55) of main body (10).
  • Proximal portion of door actuator (1 10A) contacts actuator ledge (191) of latch bracket (101) on door (9) and thus drives actuator ledge (191) upwards.
  • Driving actuator ledge (191) upwards thus drives latch bracket (101) and pins (105) upwards.
  • Pins (105) being driving upwards thus allows door (9) to become unlatched.
  • pins (105) are sized to translate within through-hole (193).
  • Through-holes (193) are positioned along brackets (123) and distal to channels (195) such the door (9) is locked when pins (105) are inside of through-holes (193).
  • Door actuator (110A) may then push up on actuator ledge (191) to thus drive pins (105) upward to where a bottom surface of pins (105) is above a bottom surface of channels (195).
  • a biasing force either from proximal hinge assembly (47), or gasket (59), or from spring plunger (111) and catch flange (117) against brackets (123), or any combination thereof, translates pins (105) laterally away from through-holes (193) and into channels (195).
  • Forcing pins (105) into channels (195) creates a space between door (9) and main body (10) (a drying configuration).
  • a user may visually determine that this space has been created by the visible space between door (9) and main body (10) and also by handle (11) appearing in a slightly raised position away from recessed area (93).
  • There is a detection switch described below that is used to indicate the cycle has been interrupted if the user fully opens door (9) to retrieve the instruments right after the sterilization cycle while the instruments may be wet from the sterilizing process.
  • Door actuator (110A) may drive latch bracket (101) further upwards such that pins (105) leave channels (195) and thus door (9) is allowed to full open.
  • the biasing force from proximal hinge assembly (47) is enough to full open door (9) without user input.
  • the user opens door (9).
  • Door actuator (110A) may lower after raising pins (105) into channels (195) and out of channels (195) to thereby be out of the of retaining element upon a subsequent closing.
  • updates may be provided automatically and set up to automatically run and install during a time when sterilizer (1) is not in use or by way of a user actuating user interface (131) to prompt the OTA update to begin installation.
  • updates may be provided through ethernet jacks or direct line network access via I/O interface (34).
  • User interface (131) may have functionality to enable a user to toggle on or off compliance tracking functionality via compliance tracking (139).
  • “Compliance” in this sense refers to medical device sterilization standards such as the ANSI/AAMI ST79 (“ST79”) standard. ST79 provides requirements and standards for steam sterilization to ensure sterility of reusable medical devices, such as those used during a medical or dental procedure.
  • ST79 medical device sterilization standards
  • ST79 provides requirements and standards for steam sterilization to ensure sterility of reusable medical devices, such as those used during a medical or dental procedure.
  • ST79 medical device sterilization standards
  • ST79 provides requirements and standards for steam sterilization to ensure sterility of reusable medical devices, such as those used during a medical or dental procedure.
  • the user can choose whether sterilizer (1) monitors and records sterilization cycles according to ST79 parameters. This data can then be used to generate reports or alerts, helping to ensure proper sterilization practices and adherence to relevant regulations.
  • this functionality provides users with greater transparency and reporting over the sterilization process.
  • compliance tracking functionality can be further enhanced with user management functionality provided by compliance system (29).
  • Compliance system (29) can be configured with different user roles, each with specific access levels to compliance tracking user interface (131), data, and functionalities. This ensures only authorized personnel can modify compliance tracking (139) settings or access sensitive information. Compliance system (29) can maintain an audit trail that logs all user activity related to compliance tracking functionality. These records provide tracking of user actions and help maintain accountability within the sterilization process.
  • Compliance system (29) may also collect information on whether the user allows door (9) to stay in the drying position long enough for the instruments to effectively dry and vent steam from between door (9) and main body (10).
  • Door position switch (HOB) collect information on how long door (9) is in the drying position and when a user lifts handle (11) to fully open door (9). This information may be helpful in troubleshooting a user’s experience or provide feedback to the user regarding the length of time needed to properly dry instruments after a sterilizing cycle.
  • the user thereafter manipulates touch screen (13) to step through the process of initiating the sterilizing cycle via user interface (131), and may select to turn on or off compliance tracking (139).
  • the water fill valve (Fig 6 add number) is opened to fill the chamber with water until it contacts the chamber water level sensor (Fig 9 add number), then the heating element (Fig 9 ID 50) is energized to start the sterilization cycle.
  • pressure builds within sterilizing chamber (33). Once this pressure exceeds a set threshold, interlock feature (127) of main body (10) engages with door (9) to prevent door (9) from opening, even if a user pulls on handle (11). This may be done by way of disposing a bolt stud into carriage (101) to prevent pins (105) from being able to be moved upwardly.
  • some versions of sterilizer (1) utilize a SFPP algorithm that optimizes the sterilization process by employing a series of pressure pulses and steam flushes. After initial water filling and heating, the algorithm initiates multiple cycles of pressurization and depressurization. During pressurization, saturated steam is forced into all areas of the sterilizing chamber (33), including potential air pockets within the load. The subsequent depressurization phase rapidly evacuates the chamber, effectively removing air and creating a near-vacuum condition. This process is repeated several times, with each cycle improving steam penetration and air removal. The number of pulses, their duration, and the pressure levels are precisely controlled by operation system (23) based on feedback from sensor system (25).
  • This pulsing action ensures thorough steam penetration into all surfaces and crevices of the items being sterilized, enhancing the efficiency and effectiveness of the sterilization process.
  • the SFPP algorithm continuously adjusts parameters to maintain optimal conditions, adapting to the specific load and environmental factors.
  • a vent valve (197) (FIG. 6) is operated to reduce pressure in chamber (33) to less than 1 PSI, interlock feature (127) retracts, and door motor (125) engages latch bracket (101) to move door (9) into the drying position.
  • the internal steam and moisture inside sterilizing chamber (33) is vented to the environment around sterilizer (1) to further dry the devices on tray rack (35).
  • the user is free to pull handle (11) to open door (9) into the open position and retrieve the sterilized devices.
  • a user is free to open door (9) at any point once door (9) is in the drying position.
  • a sterilizer comprising: (a) a main body defining a sterilizing chamber; (b) a door configured to move between a closed position, a drying position, and an open position, wherein the closed position prevents access to the sterilizing chamber, wherein the drying position allows for fluid communication between the sterilizing chamber and an environment external to the sterilizer, wherein the open position allows for user access to the sterilizing chamber; (c) an operation system, wherein the system is configured to determine whether the door is in the closed position, the drying position, or the open position; and (d) a door latch system comprising: (i) a door latch assembly associated with the door and including a pair of pins, wherein the door latch assembly is configured to retain the pair of pins in an unlocked position in response to a user actuating a handle, and (ii) a main body latch assembly associated with the main body and including a pair of brackets, wherein the main body latch assembly is configured to transition the pair of pins into a respective bracket of the pair of brackets to thus
  • the main body latch assembly comprising a door motor couple to a door actuator, wherein the door motor is configured to drive the door actuator between a lowered position and a raised position, wherein the lowered position allows the pair of pins to transition into the locked position, wherein the raised position transitions the pair of pins from the locked position to the unlocked position.
  • the sterilizer of any of the previous or subsequent Examples the main body latch assembly being configured to retain the pair of pins between the locked position, a vent position, and an unlocked position, wherein the locked position retains the door in the closed position, wherein the vent position retains the door in the drying position, and wherein the unlocked position retains the door in the open position.
  • each bracket of the pair of brackets includes an opening and a channel, wherein a respective pin of the pair of pins is configured to be positioned into the opening and the channel.
  • the sterilizer of any of the previous or subsequent Examples the channel being proximal to the opening such that the channel is away from the body and towards the door relative to the opening.
  • Example 11 The sterilizer of any of the previous or subsequent Examples, the door latch assembly further including a pivot plate configured to movably engage the retaining ledge to thereby maintain the pin carriage in the unlocked position.
  • the sterilizer of any of the previous or subsequent Examples including an interlock configured to engage the door latch assembly to thereby prevent the pair of pins from transitioning out of the locked position.
  • the sterilizer of any of the previous or subsequent Examples, wherein the sensor system is further configured to detect a pressure in the sterilizing chamber, wherein the interlock is configured to prevent the pair of pins from transitioning out of the locked position upon a detection of pressure in the sterilizing chamber that is above a predetermined pressure.
  • the sterilizer of any of the previous or subsequent Examples further comprising a touch screen interface configured to display guidance for operating the sterilizer in compliance with ANSEAAMI ST79 standards.
  • a sterilizer comprising: (a) a main body defining a sterilizing chamber; (b) a door configured to move between a closed position, a drying position, and an open position, wherein the closed position presses the door against the main body to thereby seal the sterilizing chamber, wherein the drying position is between the closed position and the open position; and (c) a door latch system configured to retain the door in the closed position and the drying position to thereby prevent the door from transitioning into the open position.
  • the door latch system comprising: (i) a door latch assembly associated with the door and including a pin, wherein the door latch assembly is configured to retain the pin in an unlocked position in response to a user actuating a handle, and (ii) a main body latch assembly associated with the main body, wherein the main body latch assembly is configured transition the pin into a locked position in response to a user moving the door into the closed position
  • the main body latch includes a bracket configured to engage the pin, wherein the bracket includes an opening and a channel, wherein the pin is configured to be positioned into the opening and the channel.
  • the sterilizer including a main body defining a sterilizing chamber, a door hingedly coupled to the main body, and a door latch system, the method comprising: (i) maintaining the door in a locked position such that the door is against the main body via the door latch system to thereby seal the sterilizing chamber; (ii) maintaining the door in a drying position such that at least a portion of the door is away from the main body via the door latch system to thereby dry the sterilizing chamber; (iii) selectively preventing the door from transitioning from the drying position towards an open position via the door latch system, the open position including the door fully away from the main.
  • any of the examples described herein may include various other features in addition to or in lieu of those described above.
  • any of the examples described herein may also include one or more of the various features disclosed in any of the various references that are incorporated by reference herein.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

A sterilizer includes a main body defining a sterilizing chamber, a door movable between closed, drying, and open positions, and a door latch system. The door latch system comprises a door latch assembly with pins and a main body latch assembly with brackets. The system retains the pins in an unlocked position when a handle is actuated and transitions the pins into the brackets for a locked position when the door is closed. A door motor and actuator can transition the pins between positions. The sterilizer features a touch screen interface providing guidance for compliance with ST79 standards, displaying instructions, real-time feedback, and alerts. An operation system manages sterilization cycles, interfacing with sensor, user interface, and compliance systems. The sterilizer employs a steam flush pressure pulse (SFPP) algorithm to optimize the sterilization process, using multiple pressurization and depressurization cycles. The device includes various sensors for monitoring temperature, pressure, and water levels throughout the sterilization process.

Description

STERILIZER
PRIORITY STATEMENT
[0001] This application claims priority to U.S. Provisional Pat. App. No. 63/574,312, entitled “Sterilizer,” filed April 4, 2024.
BACKGROUND
[0002] Sterilizers are beneficial for sterilizing medical or dental products prior to use. Various methods of sterilization have been developed which allow for the sterilization of these products. One of the notable methods is via steam sterilization using an autoclave. Sterilizers can be situated on-site and in proximity to where the product will be used. These products may include instruments and implants such as for dental applications. These sterilizers can be large enough to require their own floorspace which can prevent placement on a desktop or countertop such that they may be inconvenient for facilities with limited floor space. Further, autoclaves may need user intervention to help with ventilation and drying of the products after the sterilization process has completed. This need for user intervention may prolong the overall sterilization process if the user intervention is not prompt and the products remain in a wet state. Further, some users of sterilizers have manually attempted to determine, maintain, and report compliance with various sterilization standards during and after the sterilization process such that user error may occur.
[0003] While several sterilizer devices and methods have been made and used, it is believed that no one prior to the inventors has made or used the invention described, illustrated and claimed herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [0005] FIG. 1 depicts a perspective view of an exemplary sterilizer of the present disclosure;
[0006] FIG. 2 depicts a diagrammatic view of an exemplary operating environment of the sterilizer of FIG. 1;
[0007] FIG 3 depicts a diagrammatic view of an exemplary system overview of the sterilizer of FIG. 1;
[0008] FIG. 4 depicts a diagrammatic view of an exemplary computer system of the sterilizer of FIG. 1;
[0009] FIG. 5 depicts a perspective view of the sterilizer of FIG. 1, showing an exemplary housing covering an exemplary main body and an exemplary door in an open position;
[00010] FIG. 6 depicts a perspective view of the sterilizer of FIG. 1, showing the housing of FIG. 5 removed from the main body;
[00011] FIG. 7A depicts a side elevational view of the sterilizer of FIG. 1, showing an exemplary pair of brackets extending from the main body of FIG. 5;
[00012] FIG. 7B depicts an enlarged view of the pair of brackets of FIG. 6 showing an exemplary through-hole and an exemplary channel;
[00013] FIG. 8A depicts a partial cross-sectional view of an exemplary gasket attached to the door of FIG. 5, the gasket including an exemplary gasket ring;
[00014] FIG. 8B depicts a cross-sectional view of the gasket of FIG. 8A;
[00015] FIG. 8C depicts a partial cross-sectional view of the gasket of FIG. 8A;
[00016] FIG. 8D depicts a perspective view of the gasket ring of FIG. 8A;
[00017] FIG. 9 depicts a front perspective view of the sterilizer of FIG. 1, showing the housing of FIG. 5 removed from the main body;
[00018] FIG. 10 depicts a partial exploded view of an exemplary handle of the door of FIG. 5;
[00019] FIG. 11 A depicts a perspective view of an exemplary door locking assembly of the door of FIG. 5; [00020] FIG. 11 B depicts a perspective view of the door locking assembly of FIG. 1 1 A with an exemplary retaining element omitted;
[00021] FIG. 12 depicts a bottom rear perspective view of the main body of FIG. 5;
[00022] FIG. 13 depicts a bottom rear perspective view of the main body of FIG. 5;
[00023] FIG. 14A depicts a perspective view of an exemplary user interface of the sterilizer of FIG. 1;
[00024] FIG. 14B depicts a diagrammatic view of the user interface of FIG. 14A; and
[00025] FIG. 15 depicts a perspective view of the sterilizer of FIG. 1 in an exemplary drying position.
[00026] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.
DETAILED DESCRIPTION
[00027] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
[00028] It will be appreciated that any one or more of the teachings, expressions, versions, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, versions, examples, etc. that are described herein. The following- described teachings, expressions, versions, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
[00029] I. Sterilizer Components and Systems
[00030] As shown in FIG. 1, the present disclosure relates to a sterilizer (1) for use typically in a medical, dental, or veterinary environment for sterilizing equipment.
[00031] A. External Components
[00032] Sterilizer (1) includes a front side (3) and a spaced apart rear side (5) and is generally encased by way of a housing (7). A door (9) is provided at front side (3) and pivotably connected to a main body (10). Door (9) is movable with respect to main body (10) between a closed position (FIG. 1), a drying position (FIG. 15), and an open position (FIG. 5). Door (9) includes a handle (11), which a user manipulates to open or close door (9). Main body (10) of sterilizer (1) further includes a touch screen (13) whereby a user may interact with system controls and observe visual feedback, as will be discussed in greater detail below. Housing (7) and the surface of touch screen (13) are designed to be resistant to impact and harsh chemicals commonly used in medical environments. This durability ensures longevity and reliability of sterilizer (1) in demanding clinical settings. Main body (10) further includes a pressure relief valve test lever (15) and an access cover (17). Sterilizer (1) sits on a set of feet (12), as shown in FIG. 7A to stabilize and prevent slippage of sterilizer (1) when a user opens and closes door (9).
[00033] B. Operating Components and Systems
[00034] As shown in FIGS. 2 and 3, sterilizer (1) commonly exists in an operating environment (19), whereby sterilizer (1) may communicate over a network (24) with an update system (21). Similarly, for the purposes of discussion, the functionality and subprocesses of sterilizer (1) may be broken into an operation system (23), a sensor system (25), a user interface system (27), and a compliance system (29). While these systems and their sub-routines and operations are discussed separately, one will readily recognize that each of these systems overlap and interact with one another, and the separate terms and descriptions are merely for organizing the discussion of sterilizer (1).
[00035] Update system (21) enables sterilizer (1) to receive and implement software updates and improvements remotely. It facilitates over-the-air (OTA) updates for the underlying software functionality, including operating system (23), sensor system (25), user interface system (27), and compliance system (29). Update system (21) can receive updates through network (24) which may include wireless or wired connectivity options. Update system (21) allows for automatic or user-initiated updates, ensuring that sterilizer (1) maintains the latest features, security patches, and performance enhancements without requiring manual intervention or on-site servicing. Update system (21) may also be configured to schedule updates during periods of inactivity to minimize disruption to sterilizer (1) operations.
[00036] Operation system (23) controls and manages the overall functionality of sterilizer (1). It coordinates the various components and processes involved in the sterilization cycle, including water filling, heating, pressure management, and venting. Operation system (23) interfaces with sensor system (25) to monitor conditions within sterilizer (1), such as temperature, pressure, and water levels. It executes the steam flush pressure pulse (SFPP) algorithm to optimize the sterilization process for efficiency and effectiveness. Operation system (23) also communicates with user interface system (27) to provide status updates and receive user inputs. Additionally, operation system (23) interacts with compliance system (29) to ensure adherence to sterilization standards when enabled. The system manages the transition between different door positions (closed, drying, open) and controls the door latch system, including the interlock feature for safety. Operation system (23) may also facilitate over-the-air updates and integrate with external networks for data sharing and remote management capabilities.
[00037] Sensor system (25) comprises various sensors and monitoring devices distributed throughout sterilizer (1) to collect real-time data on the sterilization process. Some versions of sensor system (25) include sensors for temperature, pressure, water level, and door position. Sensor system (25) may be configured to continuously feed this information to operation system (23), enabling precise control and adjustment of the sterilization cycle. The data collected by sensor system (25) is beneficial for maintaining optimal conditions within sterilizer (1) and ensuring the effectiveness of the sterilization process. [00038] User interface system (27) provides a means for users to interact with and control sterilizer (1). As will be discussed in greater detail below, user interface system (27) may include a touch screen which displays a user interface and allows for user input. User interface system (27) presents information about the sterilization cycle status, enables users to initiate and customize sterilization cycles, and provides access to various features such as troubleshooting tools, educational content, and maintenance walkthroughs. User interface system (27) may include a status bar, which offers visual feedback on the progress of the sterilization cycle.
[00039] Compliance system (29) is responsible for monitoring and recording sterilization cycles according to relevant medical device sterilization standards, such as ANSI/AAMI ST79. When enabled, compliance system (29) tracks various parameters throughout the sterilization process to ensure adherence to these standards. Compliance system (29) can generate reports and alerts related to compliance, providing users with documentation of proper sterilization practices. Compliance system (29) may also include user management functionality to control access to compliance-related settings and data, maintaining an audit trail of user actions for accountability purposes.
[00040] In some versions of operating environment (19), update system (21), operation system (23), sensor system (25), user interface system (27), and compliance system (29) may send and receive communications between one another directly. Alternatively, in other versions of operating environment (19), update system (21), operation system (23), sensor system (25), user interface system (27), and compliance system (29) may communicate with each other through a network (24). Network (24) may include one or more private or public networks (e g. the Internet) that enable the exchange of data.
[00041] Referring now to FIG. 4, update system (21), operation system (23), sensor system (25), user interface system (27), and compliance system (29), and network (24) of operating environment (19) may be implemented on one or more computing devices or systems, such as an exemplary computer system (26). Computer system (26) may include a processor (28), a memory (30), a mass storage memory device (32), an input/output (I/O) interface (34), and a Human Machine Interface (HMI) (36). Computer system (26) may also be operatively coupled to one or more external resources (38) via network (24) or I/O interface (34). External resources may include, but are not limited to, servers, databases, mass storage devices, peripheral devices, cloud-based network services, or any other suitable computer resource that may used by computer system (26).
[00042] Processor (28) may include one or more devices selected from microprocessors, micro-controllers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines, logic circuits, analog circuits, digital circuits, or any other devices that manipulate signals (analog or digital) based on operational instructions that are stored in memory (30). Memory (30) may include a single memory device or a plurality of memory devices including, but not limited, to read-only memory (ROM), random access memory (RAM), volatile memory, non-volatile memory, static random access memory (SRAM), dynamic random access memory (DRAM), flash memory, cache memory, or any other device capable of storing information. Mass storage memory device (32) may include data storage devices such as a hard drive, optical drive, tape drive, non-volatile solid state device, or any other device capable of storing information.
[00043] Processor (28) may operate under the control of an operating system (40) that resides in memory (30). Operating system (40) may manage computer resources so that computer program code embodied as one or more computer software applications, such as an application (42) residing in memory (30), may have instructions executed by processor (28). In an alternative embodiment, processor (28) may execute the application (42) directly, in which case operating system (40) may be omitted. One or more data structures (44) may also reside in memory (30), and may be used by processor (28), operating system (40), or application (42) to store or manipulate data.
[00044] I/O interface (34) may provide a machine interface that operatively couples processor (28) to other devices and systems, such as network (24) or external resource (38). Application (42) may thereby work cooperatively with network (24) or external resource (38) by communicating via I/O interface (34) to provide the various features, functions, applications, processes, or modules comprising embodiments of the invention. Application (42) may also have program code that is executed by one or more external resources (38), or otherwise rely on functions or signals provided by other system or network components external to computer system (26). Indeed, given the nearly endless hardware and software configurations possible, persons having ordinary skill in the art will understand that embodiments of the invention may include applications that are located externally to computer system (26), distributed among multiple computers or other external resources (38), or provided by computing resources (hardware and software) that are provided as a service over network (24), such as a cloud computing service. Sterilizer (1) leverages cloud connectivity to enhance its functionality and user experience. Through network (24), sterilizer (1) can receive remote configuration updates, allowing administrators to modify settings and protocols across multiple devices simultaneously. This cloud integration enables sterilizer (1) to connect and function without additional components, requiring only the device itself and a compatible mobile application for remote monitoring and control.
[00045] Sterilizer (1) may incorporate a removable media slot, such as an SD card port, to facilitate data transfer of sterilization records to other devices. This feature enables easy backup, archiving, and sharing of critical sterilization data, enhancing record-keeping capabilities and compliance tracking.
[00046] HMI (36) may be operatively coupled to processor (28) of computer system (26) in a known manner to allow a user to interact directly with computer system (26). HMI (36) may include a touch screen, a speaker, and any other suitable audio and visual indicators capable of providing data to the user. HMI (36) may also include input devices and controls such as an alphanumeric keyboard, keypads, pushbuttons, control knobs, microphones, etc., capable of accepting commands or input from the user and transmitting the entered input to processor (28). HMI (36) is designed to enhance workflow efficiency in stressful clinical environments. It provides intuitive navigation, clear visual cues, and customizable shortcuts to streamline user interactions. The interface adapts to user preferences and commonly performed tasks, reducing cognitive load and minimizing the potential for errors during critical sterilization procedures.
[00047] A database (46) may reside on mass storage memory device (32), and may be used to collect and organize data used by the various systems and modules described herein. Database (46) may include data and supporting data structures that store and organize the data. In particular, database (46) may be arranged with any database organization or structure including, but not limited to, a relational database, a hierarchical database, a network database, or combinations thereof. A database management system in the form of a computer software application executing as instructions on processor (28) may be used to access the information or data stored in records of database (46) in response to a query, where a query may be dynamically determined and executed by operating system (40), other applications (42), or one or more modules.
[00048J Sterilizer (1) incorporates a steam flush pressure pulse (“SFPP”) algorithm for controlling how the heat up routine functions, the purge timing and cycles, and for tracking temperatures between sterilization cycles via sensor system (25). The SFPP algorithm acts to increase the speed with which medical devices can be sterilized by increasing the efficiency of the steps within the sterilizing cycle process. The SFPP algorithm controls when the internal air is purged after a user closes door (9), when steam is used to flush sterilizer (1), how many purges are incorporated into the sterilizing process and at what pressure and temperature, and related functionality to maintain speed and efficiency of the sterilizing process.
[00049] C. Internal Components
[00050] As shown in FIG. 5, sterilizer (1) defines a sterilizing chamber (33), sized and oriented to receive one or more trays (37) therein and be selectively disposed on a tray rack (35) disposed within sterilizing chamber (33). Sterilizing chamber (33) is surrounded and defined by a chamber housing (31), as shown in FIG. 6. Chamber housing (31) is formed from a material suitable for heating and pressurizing, and in some versions of sterilizer (1), the chamber housing (31) material comprises stainless steel. Tray rack (35) is sized and oriented to selectively receive one or more trays (37) thereon. As will be described in more detail below, during operation of sterilizer (1), a user places a set of tools (not shown) onto tray (37) and thereafter inserts tray (37) into sterilizing chamber (33) and onto tray rack (35) to sterilize the set of tools.
[00051] Sterilizer (1) may include instrument viewing or tracking functionality that provides visibility of which instruments are currently inside sterilizing chamber (33) during processing. This system may use RFID tags, barcodes, or other identification methods to track individual instruments. Touch screen (13) may display real-time information about the contents of sterilizing chamber (33), allowing clinicians to quickly locate specific instruments and manage their sterilization workflow more efficiently. This feature is particularly useful when an instrument is missing or when a clinician is waiting for a specific instrument to complete sterilization.
[00052] Door (9) includes an outer side (39) and an inner side (41), and extends from a free end (43) to a hinged end (45). Door (9) swings between the closed position (FIG. 1), the drying position (FIG. 15), and the open position (FIG. 5) by way of a hinge assembly (47) disposed at hinged end (45). Door (9) is configured to: provide full user access to sterilizing chamber (33) in the open position; vent fluid and steam in the drying position, while detecting if a user opens the door fully to access sterilizing chamber (33); and close off and seal sterilizing chamber (33) in the closed position.
[00053] Sterilizer (1) includes a manual fill chamber (49) disposed proximate hinge assembly (47) and accessible when door (9) is in the open position. Manual fill chamber (49) is fluidly connected to a water reservoir (51), as shown in FIG. 9, and facilitates manual addition of water by a user into water reservoir (51). Conversely, a user may connect a water line up to an electronic valve to automatically fill water reservoir (51) as needed. Access to water reservoir (51) for a direct water line is provided under access cover (17). A user wishing to utilize a direct water line simply opens access cover (17), drops in an electronic valve module and connects the direct line to a valve intake (not shown).
[00054] As shown in FIG. 9, during the sterilization cycle, water enters sterilizing chamber (33) by passing through filter (48) to provide a final mechanism for removing contaminants and debris from water. Water passes through filter (48) and into sterilizing chamber (33) where it pools at the bottom of sterilizing chamber (33). A filter (198) may be provided to filter air from an air valve (not shown). A heating element (50) is provided at the bottom of sterilizing chamber (33) and is configured to heat up to a high temperature to convert the water into steam. Inasmuch as sterilizing chamber (33) has a generally circular crosssection, dam portion (67) of seal (65) disposed on the peripheral edge of sterilizing chamber (33) prevents water from flowing out of the circular sterilizing chamber (33). When door (9) is in the closed position, dam gasket (63) presses against dam portion (67) to provide increased support and further seal water into the lower portion of sterilizing chamber (33) and surrounding heating element (50). An upper portion of dam gasket (63) may be used to seal the lower area between dam gasket (63) and door (9) such that, upon cooling, precipitate is prevented from subsequently collecting in the lower area. Accordingly, door (9) may be opened without water dripping out of chamber 33. Further, outer surface (55) may include a drip rail (not shown) below door (9) arranged to collect any drip water. Once door (9) is in the closed position the heating element (50) is energized to increase the temperature where the water will boil, thereby increasing pressure inside the chamber. This creates saturated steam when the water eventually turns to steam in this pressurized environment, whereby the saturated steam aids in the sterilization process.
[00055] A temperature sensor (54) provided inside sterilization chamber (33) provides feedback on the internal chamber temperature to sensor system (25). Sensor system (25) may use this temperature data as feedback for the sterilization cycle or to collect for later use in troubleshooting or compliance reporting. Similarly, a water level sensor (56) may be provided inside sterilization chamber (33) to provide feedback on the amount of water currently inside sterilization chamber (33) to ensure proper filling and boiling off of the water therein.
[00056] As shown in FIG. 6, a water level fill sensor (52) may be provided as part of sensor system (25). Water level fill sensor (52) is configured to determine the amount of water in water reservoir (51) and provide this information to sensor system (25) for use thereby. Sensor system (25) may thereby pass this information to user interface system (27) for providing to the user as an alert such as sound or visual. Water level fill sensor (52) may be a pressure-based sensor to determine the amount of pressure the water within water reservoir (51) provides and if the pressure reading is below a set amount, water level fill sensor (52) provides this information to sensor system (25). Water level fill sensor (52) may be positioned along chamber housing (31) or elsewhere and operable to determine water in water reservoir (51) via capacitive or magnetic detectors.
[00057] Door (9) includes an inner surface (53) on inner side (41) which is sized and configured to be adjacent to an outer surface (55) of main body (10) when door (9) is in the closed position. Inner surface (53) defines a gasket recess (57) which is sized and oriented to receive a gasket (59). Inner surface (53) may also define a dam gasket recess (61) which is sized and oriented to receive a dam gasket (63). Surrounding the periphery of the opening to sterilizing chamber (33) is a seal surface (65), which may have a dam portion (67) as an integrated element or dam portion (67) may be provided as a separate feature. A gasket housing (69) is constrained and supports gasket (59) and is preferably made out of similar material as the material used to form chamber housing (31), namely, stainless steel.
[00058] As shown in FIGS. 6-8D, gasket (59) includes a particular profile, with a first wing (71) and a second wing (73) extending from a base (75), which are non-identical in shape. First wing (71) includes a finger portion (83) and a grooved area (85). Second wing (73) is shaped to sit within gasket recess (57) and press against gasket housing (69) to bias first wing (71) outwardly. A gasket ring (77) is provided which extends around most of the interior periphery of gasket (59) to spread out gasket (59) and prevent shrinking, given the heating and cooling functionality of sterilizer (1). Gasket ring (77) defines at least a portion of a circular shape sized for gasket (59) to be pressed against seal surface (65). Gasket ring (77) may be of a rigid material sufficient to maintain at least a portion of the circular shape. Gasket ring (77) may incorporate a poka-yoke design such that second wing (73) contacts gasket housing (69) but where first wing (71) is prevented from contacting gasket housing (69) because of gasket ring (77) disposed in the V-shaped notch of gasket (59). Gasket ring (77) may be selectively removed from gasket (59) for cleaning, inspection, and replacement. Gasket ring (77) includes two ends, whereby each end extends inwardly to wrap around a corresponding pair of studs (81) to hold up gasket ring (77). The poka-yoke design may be incorporated using the pair of studs (81). As shown in FIG. 8A, a directional indicator (66) may be provided on gasket (59) to create an indicator to show how gasket (59) is inserted into door (9), provide an alignment and directional indicator, and also to project branding to the user.
[00059] Gasket ring (77) is configured to spread gasket (59) out radially and prevent shrinking or slipping down over time as gasket (59) heats and cools and may be thought of as a spring element. The profile of gasket (59) provides a greater tolerance for misalignments, given outermost finger portion (83) and grooved area (85). When door (9) is in the closed position, gasket (59) presses against seal surface (65) to provide a tight sealing engagement between door (9) and seal surface (65). Finger portion (83) contacts seal (65) around the entire periphery and any missed contacts or reinforcement needed is provided by grooved area (85), which provides several successive featured, biased outwardly, to press against seal surface (65) of main body (10) to provide a tight, sealing engagement between door (9) and seal surface (65).
[00060] As shown in FIGS. 7 and 10, sterilizer (1) includes a door latch system (87) comprising a door latch assembly (89) associated with door (9) and a main body latch assembly (91) associated with main body (10). Handle (11) actuates portions of the functionality of door latch system (87).
[00061] Housing (7) of main body (10) defines a recessed area (93) complementarily sized to receive handle (11) therein, with a pair of screws (95) passing through a pair of slots (97) to mate with a corresponding pair of bosses (99) at one end of each screw (95). At the opposite end of screws (95), a latch bracket (101) is disposed within housing (7) and includes a similar pair of bosses (103) sized to receive the other end of screws (95) therein. Latch bracket (101) also includes an actuator ledge (191) and interlock ledge (196), described below. Latch bracket (101) is configured to move up and down within door (9) in the directions of Arrow A. Bosses (99) and/or bosses (103) may be threaded internally to engage those versions of studs (95) having threads thereon. Similarly, studs (95) may include threading or may be sized to press fit into bosses (99, 103) or may be any other suitable method for connecting handle (11) through slots (97) to latch bracket (101). Recessed area (93) may be sufficiently sized such that handle (11) is flush with, protrudes from, or is recessed relative to front side (3).
[00062] As shown in FIGS. 10, 11A ,and 1 IB, slots (97) allow handle (11) to move and be pulled upwardly away from recessed area (93) to move latch bracket (101) between a lower position (FIG. 11A, 11B) and a raised position (not shown). Inasmuch as latch bracket (101) is coupled with a pair of pins (105), as latch bracket (101) selectively moves between the lower position and raised position, pins (105) also selectively raises and lowers within door (9). As will be discussed in greater detail below, this raising and lowering of pins (105) locks and unlocks door (9) from main body (10), with the raising of the pins being referred to as the unlocked position, and the lowering of pins (105) being referred to as the locked position.
[00063] A lock assembly (106) is provided within door (9) and depicted in FIGS. 11 A and 11B. As shown in FIG. 11 A, lock assembly (106) includes a retaining element (107) having a retaining ledge (109). Retaining element (107) is shown removed from FIG. 1 IB to reveal other elements. Retaining element (107) is secured to latch bracket (101) to enclose each pin (105). Lock assembly (106) further includes a pivot arm spring plunger (111) and a spring (113) engaged with latch bracket (101) whereby moving latch bracket (101) from the lower position to the raised position builds bias and tension in spring (113) towards the downward direction.
[00064] Lock assembly (106) further includes a pivot cam (115) having a surface (116) and a catch flange (117). Pivot plate (115) is configured to rotate about a shaft (119) between a first position (FIG. 11 A) and a second position (not shown). Inasmuch as pivot arm spring plunger (111) is secured at one end to pivot plate (115), the movement of pivot arm spring plunger (111) in turn rotates a pivot plate (115) about shaft (119). Catch flange (117) is sized and positioned on pivot plate (115) to rotate down towards retaining ledge (109) of retaining element (107) to abut and frictionally engage retaining ledge (109) when a user moves handle (11) fully upwardly within recessed area (93) to unlock and open door (9). Because of this frictional engagement between catch flange (117) and retaining ledge (109), pins (105) stay in the upward and opened position while door (9) is open.
[00065] When a user is done loading instruments and the like into sterilizing chamber (33), the user simply presses on door (9) to push it towards main body (10). Once door (9) presses against main body (10), catch flange (117) is rotated out of frictional engagement with retaining ledge (109), which in turn allows pins (105) to drop downwardly into a corresponding pair of locking slots (121), as shown in FIG. 7. Locking slots (121) are defined by a pair of brackets (123) extending from main body (10). This movement of pins (105) into locking slots (121) is directed by the bias provided by way of pivot spring (113). As is shown in FIG. 7B, locking slot includes a through-hole (193) (also referred to as an opening) and a channel (195) which is shallower than through-hole (193). Both through- hole (193) and channel (195) are sized to accommodate pins (105) for locking door (9) via through-hole (193) and venting door (9) via channel (195).When pins (105) are disposed into locking slots (121), door (9) is locked to main body (10). The rotation of catch flange (117) out of frictional engagement with retaining ledge (109) may be accomplished by various mechanical features associated with main body (10). For example, a finger or another mechanical feature may be used to press against surface (116) of pivot plate (115) to press catch flange (117) out of frictional engagement with retaining ledge (109). Alternatively, catch flange (117) itself may be pressed out of engagement with retaining ledge (109) through use of upper bracket of the pair of brackets (123). In other words, as door (9) is pushed closed, catch flange (117) moves into contact with proximal end of upper bracket (123). As door is continually pushed, the upper bracket (123) pushes catch flange (117) off engagement with retaining ledge (109). Once disengaged, pins (105) are no longer upwardly bound and thus fall into locking slots (121) of brackets (123). Because the engagement between catch flange (117) and retaining ledge (109) is one of friction, and not a mechanical lock, and because pivot spring (113) biases pins (105) downwardly, simply pressing door (9) against main body (10) overcomes the frictional engagement and drops pins (105) into locking slots (121) to lock door (9) to main body (10). The physical pressing of door (9) can be done anywhere on the surface of door (9) and not necessarily on handle (11). This frees the user to press on another portion of door (9) and do it with one hand only, which may be a “clean” hand or a hand that hasn’t handled any of the unsterile and used equipment. The ability to press onto door (9) with one hand and on anywhere on the surface of door (9) works to keep the surface of sterilizer (1) cleaner and improve efficiency with the user’s sterilizing workflow. While pins (105) are held in the upward position, a user may visually understand this from further away as handle (11) may be held in an upward position, away from recessed area (93). Dropping pins (105) may include an audible feedback to the user. The user may also understand that pins (105) have dropped when handle (11) has returned to recessed area (93).
[00066J As shown in FIGS. 6, 7B, 11A, and 11B, a door actuator (110A) is operably connected with a door motor (125). Door motor (125) is configured to move a proximal portion of door actuator (110A) upwards and downwards relative to outer surface (55) of main body (10). Proximal portion of door actuator (1 10A) contacts actuator ledge (191) of latch bracket (101) on door (9) and thus drives actuator ledge (191) upwards. Driving actuator ledge (191) upwards thus drives latch bracket (101) and pins (105) upwards. Pins (105) being driving upwards thus allows door (9) to become unlatched. As described briefly above, pins (105) are sized to translate within through-hole (193). Through-holes (193) are positioned along brackets (123) and distal to channels (195) such the door (9) is locked when pins (105) are inside of through-holes (193). Door actuator (110A) may then push up on actuator ledge (191) to thus drive pins (105) upward to where a bottom surface of pins (105) is above a bottom surface of channels (195). From there, a biasing force either from proximal hinge assembly (47), or gasket (59), or from spring plunger (111) and catch flange (117) against brackets (123), or any combination thereof, translates pins (105) laterally away from through-holes (193) and into channels (195). Forcing pins (105) into channels (195) creates a space between door (9) and main body (10) (a drying configuration). A user may visually determine that this space has been created by the visible space between door (9) and main body (10) and also by handle (11) appearing in a slightly raised position away from recessed area (93). This creates a dry cycle at the end of the sterilization cycle and allows steam to vent out of the space between door (9) and main body (10), which facilitates drying of the instruments therein. This prevents the door from automatically opening fully during the dying phase. There is a detection switch described below that is used to indicate the cycle has been interrupted if the user fully opens door (9) to retrieve the instruments right after the sterilization cycle while the instruments may be wet from the sterilizing process. Upon entering the dry cycle with the space, a user may then pull upwards on handle to thereby remove pins (105) from channels (195) and thus fully open door (9) to remove contents. Door actuator (110A) may drive latch bracket (101) further upwards such that pins (105) leave channels (195) and thus door (9) is allowed to full open. In certain embodiments, the biasing force from proximal hinge assembly (47) is enough to full open door (9) without user input. In other versions, the user opens door (9). Door actuator (110A) may lower after raising pins (105) into channels (195) and out of channels (195) to thereby be out of the of retaining element upon a subsequent closing. To that end, a user may completely close door (9) during the dry cycle by pushing door (9) closed and thus driving pins (105) back into through-holes (193) should user wish to resterilize. A user may place door (9) into the drying configuration from the open position should user wish to secure door (9) away from the area immediately adjacent/in front of sterilizer (1). Directly stated, a user move pins (105) from a position away from locking slots (121) and then directly into channels (195). This may be useful to allow sterilizer (1) to continue venting/ drying even after contents of chamber (33) have been removed to thus prevent biological growth within chamber (33).
[00067] An interlock feature (127) is provided on main body (10) to engage with door (9) when pressure inside sterilizer chamber (33) increases beyond a set threshold. For example, pressure-driven interlock feature (127) may be configured to engage door (9) and prevent the opening thereof when pressure inside sterilizer chamber (33) reaches approximately 1 PSI. This prevents a user from opening door (9) when the pressure inside sterilizer chamber (33) would make it dangerous to do so. Interlock feature (127) is configured to engage with a corresponding feature (such interlock ledge (196) of latch bracket (101)) on door (9) to prevent opening of door (9). Specifically, interlock feature (127) engages interlock ledge(196) to thereby prevent latch bracket (101) from moving upwards and thus release door (9). This functionality may be accomplished by preventing handle (11) from being raised to move pins (105) upward and out of locking slots (121). Alternatively, door (9) may include a latch mechanism or similar features to allow interlock feature (127) to mechanically engage with this feature to lock door (9) in the closed position while the internal pressure is above the set threshold. An interlock sensor (not shown) may be incorporated into sensor system (25) to thereby detect when door (9) cannot be opened by a user. A user may be capable of visually inspecting sterilizer and determining that interlock feature (127) is engaged and thus preventing opening the door. Interlock feature (127) may also be based on a temperature inside of sterilization chamber (33). Interlock feature (127) may also be capable of preventing door (9) from being fully opened for a time while venting is occurring. Interlock feature (127) may additionally be operable to prevent a user from opening door (9) until such a time as contents inside of sterilization chamber (33) have been determined to have cooled.
[00068] As shown in FIG. 6, a door position switch (HOB) is disposed on main body (10), extending through outer surface (55) of main body (10) to project into door (9) when it is in both the closed position and the drying position. Door position switch (HOB) may be operably connected to operation system (23) and/or sensor system (25) and configured to sense when door (9) is in the closed position and in the drying position by way of the pressure against the door position switch (HOB). In some versions of sterilizer (1), door position switch (1 10B) takes the form of a limit switch configured to actuate an internal electrical contact. For example, door position switch (HOB) may be configured to sense when door (9) is in the closed position, by being pressed fully into main body (10) and close an electrical contact to inform sensor system (25) when door (9) is in the closed position. Similarly, door position switch (HOB) may also be configured to sense when door (9) is in the drying position, by being pressed partially into main body (10) and close an electrical contact to inform sensor system (25) when door (9) is in the drying position. In this way, the door position switch (HOB) may be configured to provide information to sensor system (25) regarding the position of door (9). Further, door position switch (HOB) may provide the length of time that door (9) is in a particular position to operation system (23) and/or sensor system (25), which may be used for compliance or reporting functionality.
[00069] II User Interface
[00070] As shown in FIGS. 1, 3, and 14, sterilizer (1) includes user interface system (27) for use in allowing the user to interact, provide input, and receive feedback with respect to sterilizer (1). As noted above, user interface system (27) includes touch screen (13), with some version including a top layer of glossy glass to serve as the touch area for users. Touch screen (13) provides functionality for a user interface (131) for sterilizer (1).
[00071] User interface (131) provides user feedback and accepts user input to actuate functionality of sterilizer (1). To that end, some versions of user interface (131) a set of functionality relating to troubleshooting tools (133), hereinafter “troubleshooting tools (133),” a set of functionality relating to educational content (135), hereinafter “educational content (135),” a set of functionality relating to maintenance walkthrough (137), hereinafter “maintenance walkthrough (137),” a set of functionality relating to compliance tracking (139), hereinafter “compliance tracking (139),” and a set of functionality relating to other features (141) hereinafter “other features (141).” User interface (131) further includes a status bar (143), having various functionality and coloring provided through user interface (131) to indicate the status of the sterilization cycle. User interface (131) further includes various indicia (145) for providing information, feedback, or input functionality to the user. User interface (131) offers configurable themes, including light and dark modes, to accommodate different lighting conditions and user preferences. These themes can be easily switched via touch screen (13), enhancing visibility and reducing eye strain during extended use.
[00072] With respect to troubleshooting tools (133), user interface (131) may provide a broad menu item to look up issues or provide contextual help on each screen, by providing a question mark or other noticeable feature to allow a user to seek help on that screen.
[00073] With respect to educational content (135), user interface (131) may provide educational content on touch screen (13), or may provide a walk-through for setting up sterilizer (1) or reconfiguring sterilizer (1), or may provide a user guide or training features.
[00074] With respect to maintenance walkthrough (137), functionality may be provided to prompt the user on how to walk through the cleaning process. Maintenance walkthrough (137) may also accept user input to set reminders for future prompting of the user for cleaning.
[00075] With respect to status bar (143), various user feedback is built into this visual feedback device to allow the user to quickly view and determine where sterilizer (1) is currently at in the sterilization cycle. For example, in some versions of status bar (143), multiple status blocks (147) are provided to depict gradual satisfaction of each step in the sterilization cycle. As shown in FIGS. 14A-14B, a user can visually observe that block (147A) is solidly filled, indicating that it has been completed; block (147B) is partially filled, indicating that this step in the cycle is currently underway; and block (147C) is unfilled, indicating that this step in the cycle hasn’t begun. In other versions, status bar (143) could turn from a first color, to a second color, to a third color to indicate various stages of competition of the sterilization process. The entire status bar (143) may turn a different color when the entire sterilization process is complete. For example, in some versions of sterilizer (1), status bar (143) may project blue colored blocks (147) until the entire cycle is completely, then status bar (143) and all blocks (147) project a green color to indicate completion to the user. Status bar (143) may be viewable from a wide range of angles up to 90 degrees in each direction from perpendicular. Accordingly, a user can be along the side of sterilizer (1) and still determine the state of status bar (143). The multiple status blocks (147) may be indicative of discrete operational steps of the sterilization process and thus advance nonlinearly to completion of the sterilization process. Alternatively, multiple status blocks (147) may be indicative of the total time of the sterilization process and thus advance linearly to completion of the sterilization process. Status bar (143) may flash continually upon completion of the sterilization process or may turn off entirely to thus indicate completion.
[00076] Status bar may also take the form of status bar (151), as shown in FIG. 14. Status bar (151) is separate from user interface (131) and is a series of physical light elements such as LED lights, which may be manipulated as required to depict the status of the sterilizing process in real time, as described above with status bar (143). Status bar (151), however, is a separate physical element on sterilizer (1), which provides user feedback through a series of lights (153), which may be colored accordingly. Status bar (151) may require a separate printed circuit board assembly (PCBA) (155), as shown in FIG. 12. PCBA (155) is used for controlling and actuating each light (153) according to the underlying software and functionality provided by sterilizer (1) with respect to visual feedback indicating sterilizing progress.
[00077] As shown in FIG. 4, sterilizer (1) further includes functionality to receive over the air (OTA) updates for its underlying software functionality, including the functionality, indicia, fonts, and iconography of user interface (131). Sterilizer (1) is connected to an underlying network (24) wirelessly by way of I/O interface (34), which may include a wireless module or wireless functionality therein. Pursuant to this, sterilizer (1) may receive system updates wirelessly from update system (21), which may update all or portions of operation system (23), sensor system (25), user interface system (27), and/or compliance system (29). These updates may be provided automatically and set up to automatically run and install during a time when sterilizer (1) is not in use or by way of a user actuating user interface (131) to prompt the OTA update to begin installation. Alternatively, updates may be provided through ethernet jacks or direct line network access via I/O interface (34).
[00078] III. Compliance Tracking
[00079] User interface (131) may have functionality to enable a user to toggle on or off compliance tracking functionality via compliance tracking (139). “Compliance” in this sense refers to medical device sterilization standards such as the ANSI/AAMI ST79 (“ST79”) standard. ST79 provides requirements and standards for steam sterilization to ensure sterility of reusable medical devices, such as those used during a medical or dental procedure. By enabling or disabling compliance tracking via user interface (131) and compliance tracking (139), the user can choose whether sterilizer (1) monitors and records sterilization cycles according to ST79 parameters. This data can then be used to generate reports or alerts, helping to ensure proper sterilization practices and adherence to relevant regulations. Ultimately, this functionality provides users with greater transparency and reporting over the sterilization process. As noted above, sterilizer (1) includes sensor system (25), encompassing all of the sensor elements within sterilizer (1). Sensor system (25) may be used to track various sub steps within ST79 compliance, catalog, and report this compliance data (with either each step satisfied or not satisfied) to an interested party or over network (24) to resource (38) such as a data storage device or a printer.
[00080] Compliance tracking may be turned on or off at sterilizer (1) itself via compliance tracking (139) of user interface (131). In addition, or alternatively, compliance tracking can be turned on or off at a higher level, such as allowing for an administrator to remotely manage this functionality over network (24) and I/O interface (34). This allows for system- wide configuration changes and ensures consistent compliance practices across multiple sterilizers (1).
[00081] Compliance tracking may also be utilized to force conformance with ST79 or any other compliance protocol by eliminating the potential for selecting non-conforming functionality. For example, if a user wishes to cycle sterilizer (1) for less than the standard amount of time of drying, this option may be greyed out or non-selectable on user interface (131) when compliance tracking is enabled.
[00082] Beyond basic on/off functionality, compliance tracking functionality can be further enhanced with user management functionality provided by compliance system (29). Compliance system (29) can be configured with different user roles, each with specific access levels to compliance tracking user interface (131), data, and functionalities. This ensures only authorized personnel can modify compliance tracking (139) settings or access sensitive information. Compliance system (29) can maintain an audit trail that logs all user activity related to compliance tracking functionality. These records provide tracking of user actions and help maintain accountability within the sterilization process.
[00083] In addition, compliance system (29) may be configured to sense and retain information about wear and tear of components within sterilizer (1). Sterilization cycles and replacement cycles for components may be tracked and recorded by compliance system (29). Further, maintenance or replacement prompts may be sent to the user, the administrator, or the manufacturer/servicing entity when a component has reached the end of a lifecycle or even pursuant to a failure of the component.
[00084] Compliance system (29) may also collect information on whether the user allows door (9) to stay in the drying position long enough for the instruments to effectively dry and vent steam from between door (9) and main body (10). Door position switch (HOB) collect information on how long door (9) is in the drying position and when a user lifts handle (11) to fully open door (9). This information may be helpful in troubleshooting a user’s experience or provide feedback to the user regarding the length of time needed to properly dry instruments after a sterilizing cycle.
[00085] IV. Operation Workflow
[00086] In operation, a user actuates handle (11) to open door (9). The actuation of handle (1 1) raises pins (105) inside door latch assembly (89), whereby catch flange (117) moves into frictional engagement with retaining ledge (109) and holds handle (11) and door latch assembly (89) in the unlocked position. A user fills sterilizer (1) with water to provide sufficient water for running a sterilizing cycle. Filling may be performed via manual fill chamber (49). This is accomplished by pouring water into water reservoir (51) until the water level is within the full zone indicated on the water level label. A user may inspect water level via a water level label next to water reservoir (51). The user thereafter places the devices to be sterilized onto tray (37) and tray rack (35) inside sterilizing chamber (33) and presses onto door (9) to move it from the open position to the closed position. This pressing may be with one hand and may be on any portion of door (9) because pins (105) are being held in the unlocked position until door (9) presses against main body (10). As door (9) presses against main body (10), a portion of main body (10) presses against surface (116) or catch flange (117) of pivot plate (115) disengaging catch flange (117) with retaining ledge (109), which in turn drops pins (105) downwardly into locking slots (121) and into the locked position. With pins (105) in locking slots (121) and through-holes (193), door (9) is locked against main body (10).
[00087] As door (9) moves into the closed position, gasket (59) of door (9) presses into seal (65) of main body (10) to ensure a tight fit between the two elements. Similarly, dam gasket (63) presses against dam portion (67) to further seal and reinforce these water retaining features. First gasket ring (77) press radially outwardly on gasket (59) to aid in retaining the overall shape of gasket (59).
[00088] The user thereafter manipulates touch screen (13) to step through the process of initiating the sterilizing cycle via user interface (131), and may select to turn on or off compliance tracking (139). Once the cycle is initiated the water fill valve (Fig 6 add number) is opened to fill the chamber with water until it contacts the chamber water level sensor (Fig 9 add number), then the heating element (Fig 9 ID 50) is energized to start the sterilization cycle. Once the sterilizing cycle begins, pressure builds within sterilizing chamber (33). Once this pressure exceeds a set threshold, interlock feature (127) of main body (10) engages with door (9) to prevent door (9) from opening, even if a user pulls on handle (11). This may be done by way of disposing a bolt stud into carriage (101) to prevent pins (105) from being able to be moved upwardly.
[00089] Prior to the building of pressure, water is disposed into sterilizing chamber (33) through fdter (48), tracked by water level sensor (56). After pressure builds, the water is heated by way of heating element (50). The steam generated by heating element (50) contacting the water results in saturated steam, given the increased pressure within sterilizing chamber (33). This temperature and pressure inside sterilizer chamber (33) is tracked by temperature sensor (54) which may also incorporate a pressure sensor. Various cycles and purges in accordance with the SFPP algorithm are undergone by sterilizer (1), with the status of the entire process being provided to the user by way of status bar (143) and status blocks (147).
[00090] To that end, some versions of sterilizer (1) utilize a SFPP algorithm that optimizes the sterilization process by employing a series of pressure pulses and steam flushes. After initial water filling and heating, the algorithm initiates multiple cycles of pressurization and depressurization. During pressurization, saturated steam is forced into all areas of the sterilizing chamber (33), including potential air pockets within the load. The subsequent depressurization phase rapidly evacuates the chamber, effectively removing air and creating a near-vacuum condition. This process is repeated several times, with each cycle improving steam penetration and air removal. The number of pulses, their duration, and the pressure levels are precisely controlled by operation system (23) based on feedback from sensor system (25). This pulsing action ensures thorough steam penetration into all surfaces and crevices of the items being sterilized, enhancing the efficiency and effectiveness of the sterilization process. Throughout these cycles, the SFPP algorithm continuously adjusts parameters to maintain optimal conditions, adapting to the specific load and environmental factors.
[00091] As shown in FIG. 15, once the sterilizing process is complete, a vent valve (197) (FIG. 6) is operated to reduce pressure in chamber (33) to less than 1 PSI, interlock feature (127) retracts, and door motor (125) engages latch bracket (101) to move door (9) into the drying position. In this position, the internal steam and moisture inside sterilizing chamber (33) is vented to the environment around sterilizer (1) to further dry the devices on tray rack (35). Once a certain amount of time has lapsed, the user is free to pull handle (11) to open door (9) into the open position and retrieve the sterilized devices. Alternatively, a user is free to open door (9) at any point once door (9) is in the drying position. Some versions of sensor system (25) or other elements within sterilizer (1) are configured to note the cycle was interrupted in the cycle history if a user opens door (9) in the drying position.
[00092] V. Exemplary Combinations
[00093] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.
[00094] Example 1
[00095] A sterilizer comprising: (a) a main body defining a sterilizing chamber; (b) a door configured to move between a closed position, a drying position, and an open position, wherein the closed position prevents access to the sterilizing chamber, wherein the drying position allows for fluid communication between the sterilizing chamber and an environment external to the sterilizer, wherein the open position allows for user access to the sterilizing chamber; (c) an operation system, wherein the system is configured to determine whether the door is in the closed position, the drying position, or the open position; and (d) a door latch system comprising: (i) a door latch assembly associated with the door and including a pair of pins, wherein the door latch assembly is configured to retain the pair of pins in an unlocked position in response to a user actuating a handle, and (ii) a main body latch assembly associated with the main body and including a pair of brackets, wherein the main body latch assembly is configured to transition the pair of pins into a respective bracket of the pair of brackets to thus transition into a locked position in response to a user moving the door into the closed position.
[00096] Example 2
[00097] The sterilizer of the previous or any of the subsequent Examples, the main body latch assembly comprising a door motor couple to a door actuator, wherein the door motor is configured to drive the door actuator between a lowered position and a raised position, wherein the lowered position allows the pair of pins to transition into the locked position, wherein the raised position transitions the pair of pins from the locked position to the unlocked position.
[00098] Example 3
[00099] The sterilizer of any of the previous or subsequent Examples, the door actuator extending from and away from the main body and towards the door.
[000100] Example 4 [000101] The sterilizer of any of the previous or subsequent Examples, the door actuator extending into the door.
[000102] Example 5
[000103] The sterilizer of any of the previous or subsequent Examples, the main body latch assembly being configured to retain the pair of pins between the locked position, a vent position, and an unlocked position, wherein the locked position retains the door in the closed position, wherein the vent position retains the door in the drying position, and wherein the unlocked position retains the door in the open position.
[000104] Example 6
[000105] The sterilizer of any of the previous or subsequent Examples, wherein each bracket of the pair of brackets includes an opening and a channel, wherein a respective pin of the pair of pins is configured to be positioned into the opening and the channel.
[000106] Example 7
[000107] The sterilizer of any of the previous or subsequent Examples, the channel being proximal to the opening such that the channel is away from the body and towards the door relative to the opening.
[000108] Example 8
[000109] The sterilizer of any of the previous or subsequent Examples, wherein the opening is positioned such that the door is in the closed position when a pin is inside of the opening, wherein the channel is positioned such that door is in the drying position when in the pin is inside of the channel.
[000110] Example 9
[000111] The sterilizer of any of the previous or subsequent Examples, wherein the pair of brackets extends away from the main body and towards the door.
[000112] Example 10
[000113] The sterilizer of any of the previous or subsequent Examples, the door latch assembly including a pin carriage coupled to the pair of pins such that the pin carriage is configured to transition with the pair of pins between the unlocked position and the locked position, wherein the pin carriage includes a retaining ledge configured to maintain the pin carriage and the pair in pins in the unlocked position.
[000114] Example 11 [000115] The sterilizer of any of the previous or subsequent Examples, the door latch assembly further including a pivot plate configured to movably engage the retaining ledge to thereby maintain the pin carriage in the unlocked position.
[000116] Example 12
[000117] The sterilizer of any of the previous or subsequent Examples, wherein the pivot plate includes a catch flange configured to engage the main body latch assembly to thereby transition the pair of pins from the unlocked position to the locked position.
[000118] Example 13
[000119] The sterilizer of any of the previous or subsequent Examples the door latch assembly further including a spring operably positioned between pivot plate and the pin carriage, wherein the spring is configured to pivot the pivot plate upon a translation of the pin carriage.
[000120] Example 14
[000121] The sterilizer of any of the previous or subsequent Examples, the main body latch assembly including an interlock configured to engage the door latch assembly to thereby prevent the pair of pins from transitioning out of the locked position.
[000122] Example 15
[000123] The sterilizer of any of the previous or subsequent Examples, wherein the sensor system is further configured to detect a pressure in the sterilizing chamber, wherein the interlock is configured to prevent the pair of pins from transitioning out of the locked position upon a detection of pressure in the sterilizing chamber that is above a predetermined pressure.
[000124] Example 16
[000125] The sterilizer of any of the previous or subsequent Examples, further comprising a touch screen interface configured to display guidance for operating the sterilizer in compliance with ANSEAAMI ST79 standards.
[000126] Example 17
[000127] The sterilizer of any of the previous or subsequent Examples, wherein the touch screen interface is configured to: (i) display step-by-step instructions for proper sterilization procedures in accordance with ST79 standards; (ii) provide real-time feedback on compliance with ST79 standards during sterilization cycles; and (iii) generate alerts when deviations from ST79 standards are detected.
[0001281 Example 18
[000129] A sterilizer comprising: (a) a main body defining a sterilizing chamber; (b) a door configured to move between a closed position, a drying position, and an open position, wherein the closed position presses the door against the main body to thereby seal the sterilizing chamber, wherein the drying position is between the closed position and the open position; and (c) a door latch system configured to retain the door in the closed position and the drying position to thereby prevent the door from transitioning into the open position.
[000130] Example 19
[000131] The sterilizer of any of the previous or subsequent Examples, the door latch system comprising: (i) a door latch assembly associated with the door and including a pin, wherein the door latch assembly is configured to retain the pin in an unlocked position in response to a user actuating a handle, and (ii) a main body latch assembly associated with the main body, wherein the main body latch assembly is configured transition the pin into a locked position in response to a user moving the door into the closed position
[000132] Example 20
[000133] The sterilizer of any of the previous or subsequent Examples, wherein the main body latch includes a bracket configured to engage the pin, wherein the bracket includes an opening and a channel, wherein the pin is configured to be positioned into the opening and the channel.
[000134] Example 21
[000135] The sterilizer of any of the previous or subsequent Examples, the channel being proximal to the opening such that the channel is away from the body and towards the door relative to the opening.
[000136] Example 22
[000137] The sterilizer of any of the previous Examples, the sterilizer including a main body defining a sterilizing chamber, a door hingedly coupled to the main body, and a door latch system, the method comprising: (i) maintaining the door in a locked position such that the door is against the main body via the door latch system to thereby seal the sterilizing chamber; (ii) maintaining the door in a drying position such that at least a portion of the door is away from the main body via the door latch system to thereby dry the sterilizing chamber; (iii) selectively preventing the door from transitioning from the drying position towards an open position via the door latch system, the open position including the door fully away from the main.
[000138] VI. Miscellaneous
[000139] It should be understood that any of the examples described herein may include various other features in addition to or in lieu of those described above. By way of example only, any of the examples described herein may also include one or more of the various features disclosed in any of the various references that are incorporated by reference herein.
[000140] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The above-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
[000141] It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
[000142] Having shown and described various versions of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, versions, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

I/we claim:
1. A sterilizer comprising:
(a) a main body defining a sterilizing chamber;
(b) a door configured to move between a closed position, a drying position, and an open position, wherein the closed position prevents access to the sterilizing chamber, wherein the drying position allows for fluid communication between the sterilizing chamber and an environment external to the sterilizer, wherein the open position allows for user access to the sterilizing chamber;
(c) an operation system, wherein the system is configured to determine whether the door is in the closed position, the drying position, or the open position; and
(d) a door latch system comprising:
(i) a door latch assembly associated with the door and including a pair of pins, wherein the door latch assembly is configured to retain the pair of pins in an unlocked position in response to a user actuating a handle, and
(ii) a main body latch assembly associated with the main body and including a pair of brackets, wherein the main body latch assembly is configured to transition the pair of pins into a respective bracket of the pair of brackets to thus transition into a locked position in response to a user moving the door into the closed position.
2. The sterilizer of claim 1, wherein the main body latch assembly comprises a door motor couple to a door actuator, wherein the door motor is configured to drive the door actuator between a lowered position and a raised position, wherein the lowered position allows the pair of pins to transition into the locked position, wherein the raised position transitions the pair of pins from the locked position to the unlocked position.
3. The sterilizer of claim 2, wherein the door actuator extends from and away from the main body and towards the door.
4. The sterilizer of claim 2, wherein the door actuator extends into the door.
5. The sterilizer of claim 1, wherein the main body latch assembly is configured to retain the pair of pins between the locked position, a vent position, and an unlocked position, wherein the locked position retains the door in the closed position, wherein the vent position retains the door in the drying position, and wherein the unlocked position retains the door in the open position.
6. The sterilizer of claim 1, wherein each bracket of the pair of brackets includes an opening and a channel, wherein a respective pin of the pair of pins is configured to be positioned into the opening and the channel.
7. The sterilizer of claim 6, wherein the channel is proximal to the opening such that the channel is away from the body and towards the door relative to the opening.
8. The sterilizer of claim 6, wherein the opening is positioned such that the door is in the closed position when a pin is inside of the opening, wherein the channel is positioned such that door is in the drying position when in the pin is inside of the channel.
9. The sterilizer of claim 1, wherein the pair of brackets extends away from the main body and towards the door.
10. The sterilizer of claim 1, wherein the door latch assembly includes a pin carriage coupled to the pair of pins such that the pin carriage is configured to transition with the pair of pins between the unlocked position and the locked position, wherein the pin carriage includes a retaining ledge configured to maintain the pin carriage and the pair in pins in the unlocked position.
11. The sterilizer of claim 10, wherein the door latch assembly further includes a pivot plate configured to movably engage the retaining ledge to thereby maintain the pin carriage in the unlocked position.
12. The sterilizer of claim 11, wherein the pivot plate includes a catch flange configured to engage the main body latch assembly to thereby transition the pair of pins from the unlocked position to the locked position.
13. The sterilizer of claim 11, wherein the door latch assembly further includes a spring operably positioned between pivot plate and the pin carriage, wherein the spring is configured to pivot the pivot plate upon a translation of the pin carriage.
14. The sterilizer of claim 1, wherein the main body latch assembly includes an interlock configured to engage the door latch assembly to thereby prevent the pair of pins from transitioning out of the locked position.
15. The sterilizer of claim 14, wherein the sensor system is further configured to detect a pressure in the sterilizing chamber, wherein the interlock is configured to prevent the pair of pins from transitioning out of the locked position upon a detection of pressure in the sterilizing chamber that is above a predetermined pressure.
16. The sterilizer of claim 1, further comprising a touch screen interface configured to display guidance for operating the sterilizer in compliance with ANSI/AAMI ST79 standards.
17. The sterilizer of claim 16, wherein the touch screen interface is configured to:
(i) display step-by-step instructions for proper sterilization procedures in accordance with ST79 standards;
(ii) provide real-time feedback on compliance with ST79 standards during sterilization cycles; and
(iii) generate alerts when deviations from ST79 standards are detected.
18. A sterilizer comprising:
(a) a main body defining a sterilizing chamber;
(b) a door configured to move between a closed position, a drying position, and an open position, wherein the closed position presses the door against the main body to thereby seal the sterilizing chamber, wherein the drying position is between the closed position and the open position; and
(c) a door latch system configured to retain the door in the closed position and the drying position to thereby prevent the door from transitioning into the open position.
19. The sterilizer of claim 18, the door latch system comprising:
(i) a door latch assembly associated with the door and including a pin, wherein the door latch assembly is configured to retain the pin in an unlocked position in response to a user actuating a handle, and
(ii) a main body latch assembly associated with the main body, wherein the main body latch assembly is configured transition the pin into a locked position in response to a user moving the door into the closed position
20. The sterilizer of claim 19, wherein the main body latch includes a bracket configured to engage the pin, wherein the bracket includes an opening and a channel, wherein the pin is configured to be positioned into the opening and the channel.
21. The sterilizer of claim 20, the channel being proximal to the opening such that the channel is away from the body and towards the door relative to the opening.
22. A method of using a sterilizer, the sterilizer including a main body defining a sterilizing chamber, a door hingedly coupled to the main body, and a door latch system, the method comprising:
(i) maintaining the door in a locked position such that the door is against the main body via the door latch system to thereby seal the sterilizing chamber;
(ii) maintaining the door in a drying position such that at least a portion of the door is away from the main body via the door latch system to thereby dry the sterilizing chamber;
(iii) selectively preventing the door from transitioning from the drying position towards an open position via the door latch system, the open position including the door fully away from the main.
PCT/US2025/022916 2024-04-04 2025-04-03 Sterilizer Pending WO2025212857A1 (en)

Applications Claiming Priority (2)

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US63/574,312 2024-04-04

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Citations (6)

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GB2351666B (en) * 1999-03-24 2003-03-19 Smiths Industries Plc Autoclaves
US7951342B2 (en) * 2003-06-11 2011-05-31 Midmark Corporation Sterilizing apparatus
EP1405967B1 (en) * 2002-10-01 2011-12-07 M.O.COM. S.r.L. A closing device in particular for a steam-sterilizing machine
CN219208198U (en) * 2023-02-01 2023-06-20 常州赛乐医疗技术有限公司 A pressure sterilizer door control system
US20230200396A1 (en) * 2020-06-08 2023-06-29 Chorus, Llc Systems, methods, and apparatuses for disinfection and decontamination

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5223229A (en) * 1990-07-19 1993-06-29 Midmark Corporation Sterilizing apparatus having automatically actuated door
GB2351666B (en) * 1999-03-24 2003-03-19 Smiths Industries Plc Autoclaves
EP1405967B1 (en) * 2002-10-01 2011-12-07 M.O.COM. S.r.L. A closing device in particular for a steam-sterilizing machine
US7951342B2 (en) * 2003-06-11 2011-05-31 Midmark Corporation Sterilizing apparatus
US20230200396A1 (en) * 2020-06-08 2023-06-29 Chorus, Llc Systems, methods, and apparatuses for disinfection and decontamination
CN219208198U (en) * 2023-02-01 2023-06-20 常州赛乐医疗技术有限公司 A pressure sterilizer door control system

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